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1,373 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Children between 2 and 16 years and referral to our out patient clinic with either
constipation or fecal incontinence.
- Patients must fulfill the Rome III criteria of constipation, which mean they must have
at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more
than 1 episode of fecal incontinence weekly, large stools in the rectum by digital
rectal examination or palpable on abdominal examination, occasional passing of large
stools, display of retentive posturing and withholding behavior, and painful
defecation.
Exclusion Criteria:
- Children with known organic causes of constipation, including Hirschsprungs disease,
spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory
bowel disease, allergy and metabolic or endocrine diseases.
- Children receiving drugs known to affect bowel function during a 2 month period before
initiation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 16 Years | Outpatient Treatment of Constipation in Children | NCT01582659 | Contradiction |
3,982 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- ambulatory, unilateral knee OA of at leas 3 months confirmed by radiography, pain
requiring NSAIDS for at least 2 months
Exclusion Criteria:
- no trauma to target knee within last 5 years, prior viscosupplementation therapy,
allergy to avian products, inflammatory disease, joint sepsis,varus/valgus >12
degrees, clinically apparent tense effusion, oral corticosteroids, intra-articular
injection in any joint within the last 3 months, venous or lymphatic stasis in the
leg, claudication or PVD, major surgery, arthroplasty in the target joint,
arthroplasty in non-target knee within the last 6 months, current malignancy or
treatment within the last 5 years, except for non-melanoma skin cancer, planned
surgery during the study period, diabetes requiring insulin, use of an investigational
device or drug (including glucosamine and chondroitin sulfate) within 90 days before
entering the study, significant psychiatric or neurological disorder, active alcohol
abuse or drug abuse within the past year.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 41 Years old.
| The Effectiveness of Hylan GF-20 on Joint Reaction Forces and Kinematic Patterns During Gait in Patients With Knee Osteoarthritis | NCT00147186 | Entailment |
979 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Aged 18 - 90
- Definite diagnosis of IPJ osteoarthritis (American College of Rheumatology criteria
for OA)
- A previous radiograph of the hands with changes consistent with OA
- Either, Intervention group: At least 2 'affected' IPJs (symptomatic (>2/10 average
pain on 0-10 scale in past week) and radiological OA associated with 10 degrees of
either radial or ulnar deviation of the joint evident clinically and on Xray)
- OR Control group: At least 1 'affected' IPJ (symptomatic (>2/10 average pain on 0-10
scale in past week) and radiological OA associated with 10 degrees of either radial or
ulnar deviation of the joint evident clinically and on X-ray)
- Stable oral therapy for month prior to study entry e.g. non steroidal
anti-inflammatory drugs (NSAIDs)
- Capable of providing written informed consent
Exclusion Criteria:
- Contraindication to splinting e.g. allergy to materials
- Planned surgery during study period
- Oral, intramuscular or intraarticular steroids within 3 months of study entry
- Intraarticular hyaluronans to any nominated IP joints within 6 months of study entry
- Not resident in UK
- Pregnancy
- Other inflammatory arthritis
- History of psoriasis
- Participation in other intervention trials
- Patients with any uncontrolled or severe medical problems which in the opinion of the
investigator makes them unsuitable for study participation
- Unable to give informed written consent in English
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Splinting to Treat Hand Osteoarthritis | NCT01249391 | Entailment |
4,207 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Age 18-45 years, inclusive, of both genders
- Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy
- No history of episodic wheezing, chest tightness, or shortness of breath consistent
with asthma, or physician-diagnosed asthma.
- Forced expiratory volume at one second (FEV1) of at least 80% of predicted and FEV1/
forced vital capacity (FVC) ≥0.70.
- Oxygen saturation of ≥93%
- Ability to provide an induced sputum sample.
- Subject must demonstrate a ≥10% increase in sputum %PMNs 6 hours following inhaled WSP
exposure, when compared to baseline sputum (to be completed in a separate protocol
IRB# 15-1775).
Exclusion Criteria:
Clinical contraindications:
- Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes, chronic renal
disease, chronic thyroid disease, history of chronic infections/immunodeficiency.
- Viral upper respiratory tract infection within 4 weeks of challenge.
- Any acute infection requiring antibiotics within 4 weeks of exposure or fever of
unknown origin within 4 weeks of challenge.
- Abnormal physical findings at the baseline visit, including but not limited to
abnormalities on auscultation, temperature of 37.8° C, Systolic BP > 150mm Hg or < 85
mm Hg; or Diastolic BP > 90 mm Hg or < 50 mm Hg, or pulse oximetry saturation reading
less than 93%.
- Physician diagnosis of asthma
- If there is a history of allergic rhinitis, subjects must be asymptomatic of allergic
rhinitis at the time of study enrollment.
- Mental illness or history of drug or alcohol abuse that, in the opinion of the
investigator, would interfere with the participant's ability to comply with study
requirements.
- Medications which may impact the results of the WSP exposure, interfere with any other
medications potentially used in the study (to include steroids, beta antagonists,
non-steroidal anti-inflammatory agents)
- Cigarette smoking > 1 pack per month
- Unwillingness to use reliable contraception if sexually active (IUD, birth control
pills/patch, condoms).
- Use of immunosuppressive or anticoagulant medications including routine use of NSAIDS.
Oral contraceptives are acceptable, as are antidepressants and other medications may
be permitted if, in the opinion of the investigator, the medication will not interfere
with the study procedures or compromise safety and if the dosage has been stable for 1
month.
- Orthopedic injuries or impediments that would preclude bicycle or treadmill exercise.
- Inability to avoid NSAIDS, Multivitamins, Vitamin C or E or herbal supplements.
- Allergy/sensitivity to study drugs or their formulations
- Pregnant/lactating women and children (< 18 years as this is age of majority in North
Carolina) will also be excluded since the risks associated with WSP exposure to the
fetus or child, respectively, are unknown and cannot be justified for this
non-therapeutic protocol. Individuals over 45 years of age will not be included due to
the increased possibility of co-morbidities and need for prohibited medications.
- Inability or unwillingness of a participant to give written informed consent
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Woodsmoke Particulate + Prednisone | NCT03861390 | Contradiction |
2,879 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
- diagnosis of amyotrophic lateral sclerosis according to revised El Escorial criteria
- minimum of 18 years
- minimum of 6 months of residency in Rhinelnad-Palatinate
Exclusion Criteria:
- patients below 18 years
- ALS patients outside Rhineland-Palatinate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Amyotrophic Lateral Sclerosis Registry Rhineland-Palatinate | NCT01955369 | Entailment |
2,651 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- >= 18 years of age
- undergoing one of 9 elective outpatient operations: partial mastectomy, partial
mastectomy and sentinel node biopsy, melanoma wide excision and sentinel node
excision, thyroidectomy, parathyroidectomy, open inguinal hernia repair, laparoscopic
inguinal hernia repair, laparoscopic cholecystectomy OR
- an inpatient on the general surgery service who took at least one oral narcotic
Exclusion Criteria:
- allergic to all narcotics
- chronic opioid use
- history of opioid or benzodiazepine abuse
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Prospective Study of Post-operative Opioid Use in General Surgery Patients | NCT02782884 | Entailment |
3,657 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria
Candidates for this study must meet ALL of the following criteria:
1. Age ≥18 years
2. Leg/buttock pain with or without back pain
3. Failed nonoperative medical management
4. A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS)
5. Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region
6. Able and willing to give voluntary, written informed consent to participate in this
clinical study
Exclusion Criteria
Candidates will be excluded from the evaluation if ANY of the following apply:
1. Back pain only
2. A diagnosis of central stenosis only
3. More than two levels requiring decompression
4. Fixed motor deficit
5. Significant instability of the lumbar spine as defined by ≥ 4mm translation between
standing flexion and extension lumbar spine plain film radiographs
6. Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae
and/or hips
7. Primary disc pathology and/or patients who will undergo a discectomy
8. Prior surgery of the lumbar spine at the level(s) of planned treatment
9. Spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale
of 1 to 4)
10. Spondylolysis (pars fracture) at any level in the lumbar spine
11. Degenerative lumbar scoliosis with a Cobb angle greater than or equal to 25°
12. Symptomatic vascular claudication in the lower extremities
13. Cauda equina syndrome (neural compression causing neurogenic bowel or bladder
dysfunction)
14. Evidence of active (systemic or local) infection at time of surgery
15. Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or
other metabolic bone disease
16. Tumor in the spine or a malignant tumor except for basal cell carcinoma
17. Prisoner or transient
18. Recent history of known narcotic abuse
19. Any significant psychological disturbance past or present, psychotic or neurotic, that
could impair the consent process or ability to complete subject self-report
questionnaires
20. Involved in pending litigation of the spine or worker's compensation related to the
back
21. Inability to communicate clearly in the English language
22. Morbid obesity (BMI > 40)
23. Plans to relocate within the next 2 years
24. Pregnant or planning to become pregnant
25. Irreversible coagulopathy or bleeding disorder
a. Subjects on Coumadin or other anticoagulants may participate. Investigators should
follow routine practices for perioperative discontinuation and reinitiation of
anticoagulants.
26. Subject unwilling to undergo blood transfusion, if necessary
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery | NCT01067014 | Contradiction |
5,260 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Are at least 18 years of age
- Have sustained a painful osteoporotic vertebral compression fracture (VCF) for at
least 4 weeks but no longer than 1 year or have radiographic evidence of at least 5%
worsening vertebral collapse as compared to previous radiographic evidence
- Give written Informed Consent to participate in the study and be willing to comply
with protocol requirements
- Have pain requiring the regular use of analgesics or have a substantially altered
life-style due to pain or disability
- Have central pain over the spinous process upon palpation at the planned level(s)
- Are appropriately communicative to verbalize and differentiate with regard to location
and intensity of their pain
- Are physically and mentally willing and able to comply with the clinical and
radiographic follow-up schedule
- Have radiographic evidence of one or two, Grade 1 or greater according to Genant's
criteria, osteoporotic VCF(s) between (and including) the level of the sixth (6th)
thoracic to the fifth (5th) lumbar
- Have an acute or persistent (not healed) fracture demonstrated by magnetic resonance
imaging (MRI) or bone scan
- Have a patient self-assessment VAS score >= 50 mm at the pre-treatment visit
- Have a 30% or greater disability score on the baseline ODI (version 2.0).
Exclusion Criteria:
- Have significant vertebral collapse defined as more than 70% of original vertebral
height, or a burst or pedicle fracture with posterior cortical wall disruption
- Have posterior vertebral wall displacement occupying more than 20% of the cross
sectional area of the spinal canal
- Have neurologic symptoms or deficits, or radiculopathy related to the VCF
- Have pain based on a clinical diagnosis of herniated nucleus pulposus, high energy
trauma, severe spinal stenosis as evidenced by progressive weakness or paralysis, or
bone tumor at the level(s) of pathology as evidenced by computed tomography (CT) scan
- Have indications of instability related to the VCF at the level to be treated (e.g.,
neurologic deficit, kyphosis > 30º, translation > 4 mm, and/or interspinous process
widening)
- Have canal compromise causing clinical manifestations of cord, neural foramen, or
nerve root compression at the level(s) to be treated
- Have a bleeding disorder, including coagulopathy
- Have severe cardiopulmonary deficiencies
- Have an active systemic or local infection
- Are currently being treated for cancer or HIV
- Have a known allergy to acrylics (e.g., methyl methacrylate)
- Subject is currently an alcohol, solvent or drug abuser
- Female patients who are pregnant or nursing, or of childbearing potential not using a
reliable contraceptive method
- Are involved in medical litigation
- Are prisoners
- Have participated in another investigational study within 30 days prior to inclusion
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis | NCT00290862 | Entailment |
5,939 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- all patients with primary hiatus hernia type II-IV who are deemed suitable for surgery
Exclusion Criteria:
- inability to understand the nature of the purpose of the study and/or to give informed
consent.
- American Society of Anesthesiologists physical status-system (ASA) I-III
- Achalasia or another severe esophageal motor disorder
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Value of Lateral Release in Reconstruction of the Diaphragmatic Hiatus Hernia | NCT04179578 | Contradiction |
1,827 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | - INCLUSION CRITERIA:
- Patients with Cadherin-1 (CDH1) germline mutation known to be pathogenic or likely
pathogenic, which may also be classified as "significant" or "likely significant"
(patients with variants of "uncertain significance " are excluded)
or
-Patients with Catenin Alpha 1 (CTNNA1) and partner and localizer of breast cancer 2
(BRCA2) (PALB2) germline mutations suspected to be, or reported to be, associated with
hereditary diffuse gastric cancer (HDGC) syndrome.
or
- In the absence of a germline CDH1 mutation, patients must meet clinical criteria for
genetic testing due to a history suggestive of Hereditary Diffuse Gastric Cancer
(HDGC) syndrome
- Age greater than or equal to 18 years.
- Physiologically able to undergo upper endoscopy.
- Ability to understand and the willingness to sign a written informed consent document.
- Pregnant women are eligible during second trimester of pregnancy if clinically
indicated for evaluation of cancer.
EXCLUSION CRITERIA:
- Current use of therapeutic anticoagulation medication
- Known bleeding disorder or thrombocytopenia.
- Unstable angina or recent (within 3 months) myocardial infarction
- Any clinical contraindication to general anesthesia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Confocal Endoscopic Microscopy for Detection of Early Stage Gastric Cancer in Subjects With Hereditary Diffuse Gastric Cancer Syndrome | NCT03648879 | Entailment |
5,218 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Postmenopausal Female patients up to 89 years, inclusive;
- BMI ≤ 35 kg/m2, inclusive;
- In good health, determined by medical history and physical examination, as well as
normal 12-lead ECG and vital signs;
- Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1
year, surgically sterile (including tubal ligation, hysterectomy) for at least 3
months, until 30 days following Study Completion be willing to use an approved method
of contraception;
- Have a minimum of two evaluable non-fractured lumbar vertebrae.
- Have low bone mineral density defined as having a T-score ≤ -2.0 as determined by DXA
scan at either the lumbar spine (L1-L4) or total hip
Exclusion Criteria:
- Serious Medical Condition
- History of diseases which affect bone metabolism other than postmenopausal
osteoporosis such as Paget's disease, any secondary causes of osteoporosis,
hypoparathyroidism, or hyperparathyroidism
- Have a history of cancer within the past 5 years, except for basal cell carcinoma
- Have hypocalcemia or hypercalcemia from any cause or have a recent history of kidney
stones or pre-existing hypercalciuria;
- Have used any of the mostly commonly prescribed osteoporosis medications within 3
months of starting the investigational product, or for more than 1 month at any time
within 6 months prior to starting investigational product.
Female
No healthy subjects accepted to join the trial.
Subject must be at most 89 Years | Study to Evaluate Effect of Intranasal Teriparatide on Bone Mineral Density in Postmenopausal Women With Low BMD | NCT00624481 | Entailment |
4,590 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Has, in the opinion of the investigator, suitable general and uterine conditions for
inserting the LCS.
- Normal cervical smear (normal cervical smear within the last six months prior to visit
1 presented in writing can be accepted. The cervical smear should be analyzed and
reported according to the Bethesda System.)
- Has clinically normal safety laboratory results (i.e., inside the specified range for
inclusion).
- Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity
without hormonal contraceptive use).
Exclusion Criteria:
- Known or suspected pregnancy or is lactating.
- Vaginal delivery, cesarean delivery, or abortion within 6 weeks prior to visit 2.
Note: Postpartum insertions should be postponed until uterus is fully involuted, however
not earlier than 6 weeks after delivery. If involution is substantially delayed, consider
waiting until 12 weeks postpartum. In case of a difficult insertion and/or exceptional pain
or bleeding during or after insertion, physical examination and ultrasound should be
performed immediately to exclude perforation.
- History of ectopic pregnancies. Note: For Korea only: History of ectopic pregnancies
or high probability of ectopic gestation.
- Infected abortion within 3 months prior to visit 1. Note: For Korea only: Endometritis
after delivery or infected abortion within 3 months prior to visit 1.
- Abnormal uterine bleeding of unknown origin.
- Any genital infection (until successfully treated).
- History of, or current, pelvic inflammatory disease
- Congenital or acquired uterine anomaly.
- Any distortion of the uterine cavity (by e.g., fibroids) likely to cause problems (in
the opinion of the investigator) during insertion, retention or removal of the LCS.
- History of, diagnosed or suspected genital malignancy, and untreated cervical
dysplasia.
- Current deep venous thrombosis or thrombophlebitis; history of deep venous thrombosis.
- Clinically significant endometrial polyp(s), which, in the opinion of the
investigator, will interfere with the assessment of the bleeding profile during the
study
- Clinically significant ovarian cyst(s)
- Use of any long-acting injectable sex-hormone preparations within 12 months prior to
start of study medication, and if entering subset: any sex-hormone administration
within one month prior to start of the study medication.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | GA Levonorgestrel Intrauterine Contraceptive System (LCS) Phase III Study China | NCT00884260 | Contradiction |
4,173 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Participants will have:
1. a diagnosis of COPD which is clinically stable (including medications) for at
least one month;
2. spirometry results showing at least mild obstructive disease defined as post
bronchodilator forced expiratory volume in one second (FEV1)/forced vital
capacity (FVC) ratio <0.70 with FEV1<80% predicted or post-bronchodilator
FEV1/FVC ratio <0.60 with FEV1>80% predicted;
3. ADL limited by dyspnea;
4. a designated primary care physician;
5. ability to speak English and sign consent form;
6. actively using a computer and the Internet;
7. no formal pulmonary rehabilitation training for at least 12 months;
8. patients receiving supplemental oxygen will be acceptable if their O2 saturation
can be maintained at >80% on <6L/min of nasal oxygen;
9. understands how to and is able to rate their shortness of breath during exercise;
10. age > 40 years.
Exclusion Criteria:
- Subjects will be excluded if they have active symptomatic illness (e.g., cancer, left
heart failure, ischemic heart disease with known coronary artery or valvular heart
disease, psychiatric illness, and neuromuscular disease).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Dyspnea Self-Management: Internet or Face-to-Face | NCT00461162 | Contradiction |
836 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Patients (men and nonpregnant women) with systemic hypertension and patients with
hypercholesterolema will be included for this study.
Patient with aspirin allergies and those with a platelet count less than 50,000 will be
excluded.
Volunteers cannot be in any kind of medication while participating in this study.
No history of diabetes, peripheral vascular disease, coagulopathy, or vasculitis.
Must be capable of rendering informed consent for all procedures.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| The Role of Cyclooxygenase Activity in the Endothelial Function of Hypertensive and Hypercholesterolemic Patients | NCT00001742 | Entailment |
4,650 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- females complaining of pelvic congestion: dysmenorrhea, dyspareunia, chronic pelvic
pain, menorrhagia, metrorrhagia
Exclusion Criteria:
- refusal of the patient to get enrolled in the study
Female
Accepts Healthy Volunteers
Subject must be at least 38 Years old.
Subject must be at most 52 Years | Histopathological Diagnosis of Adenomyosis | NCT02340533 | Entailment |
4,123 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- All male volunteers aged 18 to 45 years belonging to a couple reporting an involuntary
infertility greater than 12 months
- Conventional spermatic parameters compatible with spontaneous pregnancy
- Sperm Count> 5M / ml and
- Progressive sperm mobility> 20%
- Negative spermoculture
- Fragmentation of sperm DNA> 20%
- Patient able to understand dietary recommendations given in French, in writing and
orally
- Social insured patient receiving benefits from the French Social Security health
branch
- Patient with a mobile phone (iOS or Android) with internet access
Exclusion Criteria:
- Patient diagnosed with severe oligospermia (<5 million spz / ejaculate)
- Patient with BMI> 35 or <18.5
- Patient with known and treated diabetes
- Patient with known and treated lipid disorders
- Patient with known and treated cardiovascular diseases
- Patients with known and treated hypertension
- Patients with known and treated dysthyroidism
- Patients with known symptomatic varicocele
- Patient with known inflammatory bowel diseases
- Patient with renal failure diagnosed
- Patient presenting a viral risk (HIV / Hepatitis B and C / ...) requiring support in a
dedicated circuit
- Patient unable to give informed consent
- Minors and protected adults, vulnerable people
- Patient participating in another clinical research study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Evaluation of Personalised Support Program Effectiveness in Sperm Quality Improvement | NCT03475199 | Contradiction |
6,685 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Subjects living at urban and rural parishes from Cuenca district.
- Subjects referred from professionals of public and private health services, who have
filled the initial hemorrhage survey.
- Must be referred women who sign the informed consent form.
- Patients who answer the standardized bleeding score questionnaire (BS).
- Patients who answer the quality of life questionnaire (SF-12).
- Patients who answer the socio-economic survey.
- Patients who accept to provide a venous blood sample for the initial laboratory tests.
Exclusion Criteria:
- Women with organic or hormonal bleeding etiologies.
- Patients taking medicines which may affect the coagulation cascade or the number or
function of platelets.
- Those women who otherwise do not comply with the inclusion criteria.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador | NCT01589848 | Contradiction |
59 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Males who meet the criteria of obese, hypogonadotropic hypogonadism defined as:
- Patients with a Body Mass Index (BMI) ≥ 30 kg/m2
- Patients with a morning serum total testosterone level < 300 ng/dL on at least
two separate occasions during the Screening and/or Baseline periods.
- Patients with inappropriately low gonadotropins at screening given the low
testosterone:
- Luteinizing hormone (LH) ≤ ULN
- Follicle stimulating hormone (FSH) ≤ ULN
- Estradiol within or above the normal range (defined as ≥ LLN of the approved assay)
- Normal hypothalamic/pituitary function, including:
- Prolactin: within the normal range
- Thyroid stimulating hormone (TSH): within the normal range
- Ferritin: within the normal range
- Patients agree to use a barrier method of contraception (e.g., condom), for the
duration of the study and for at least 3 months following their Study Completion visit
to prevent BGS649 exposure to their partners.
Exclusion Criteria:
- Patients with hypogonadism, not related to obesity or as a result of other underlying
issues
- Patients with significant major organ class illness (e.g. kidney or liver disease).
- Other protocol-defined inclusion/exclusion criteria may apply
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 65 Years | Safety and Efficacy of BGS649 in Obese, Hypogonadotropic Hypogonadal Men | NCT01200862 | Contradiction |
1,916 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- age >= 18 yrs
- undergoing upper endoscopy procedure under general anesthesia without emergency
- informed written consent
Exclusion Criteria:
- emergency
- might impair gastrointestinal motility (intestinal obstruction, stenosis)
- diseases of the central and peripheral nervous system or neuromuscular diseases
- drug-induced gastric emptying disorders
- pregnancy
- ionic disorders (hyponatremia<125mmol/l ; hypokalemia<3,5mmol/l
- hemodynamic disorders (systolic arterial pressure <100mmHg)
- unstable diabetes (glycemia>2,5g/l) ± insulin- dependent diabetes ± diabetic
gastroparesis
- the potential for difficult airway management
- understanding of the information
- patient with bad prognosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia | NCT01471600 | Entailment |
2,260 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- No signs and symptoms of pulmonary diseases, normal ventilatory muscle strength and
agreement to participate and sign the informed consent form.
Exclusion Criteria:
- Presenting neuromuscular diseases, claustrophobia, ruptured eardrum, history of
spontaneous pneumothorax and playing wind instruments or being a singer. Sample loss
will be considered as non-attendance at all training sessions.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 24 Years | Ventilatory Muscle Training by Breath-Stacking in Healthy Youngsters | NCT03258944 | Contradiction |
5,294 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory women greater or equal to 55 years, at least 2 years postmenopausal.
- Lumbar spine or total hip or femoral neck bone mineral density measurement must be at
least 2.5 standard deviations (SD) below the average bone mass for young women
(T-score -2.5 or less).
- Presence of at least one known and documented preexisting clinical fragility fracture,
in the past 3 years.
Patients may be included in substudy 2 if they meet any one of the following additional
criteria - Patients who have sustained at least one new fragility fracture (vertebral or
nonvertebral), despite prescription of antiresorptive therapy* during the 12 months prior
to the last new fracture or patients who, after a minimum of two years after initiating
antiresorptive therapy*, either have a lumbar spine, femoral neck, or total hip BMD of at
least - 3SD below the average bone mass for young women (T-score -3 or less), or who show a
decrease of at least 3.5% in BMD at any one of these sites.
*Antiresorptive therapy includes all bisphosphonates, raloxifene, ERT/HRT, calcitonin, and
vitamin D metabolites.
Exclusion Criteria:
For substudy 1 patients only:
- current or history of vaginal bleeding or spotting of unknown cause in the 1 year
prior to study start
- currently suspected or history of venous thrombotic events (VTE), including lower
extremity thrombosis, and other major venous thromboses, or high risk of developing
VTE as assessment by the investigator.
Treatment with
- Vitamin D >50,000 IU/week or with any dose of calcitriol or vitamin D analogs or
agonists in the 6 months prior to visit 2
- Fluorides in the 12 months prior to visit 2.
- Systemic corticosteroids (other than for replacement therapy) in the 1 month prior to
visit 2.(Ophthalmic, otic topical, orally inhaled, nasally inhaled, or intra-articular
corticosteroid therapy may be used without these restrictions.)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
| 2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis | NCT00191425 | Entailment |
4,101 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
- Signed informed consent
- Diagnosed with narcolepsy (diagnose code G47.4)
- 16 - 60 years of age
- MSLT has shown hypersomnia (sleeping latency < 8 min) & 1 episode REM
- HLA-type associated with increased occurrence of narcolepsy
Exclusion Criteria:
- Reduced cognitive function
- Other relevant organ disease (that could affect the study results or put the patient
at risk)
- Ongoing bacterial infection in the nose
- Comorbidity that can increase the risk of bleeding
- Has received treatment with an implantable stimulator or other implantable product in
the head and / or in the neck
- Known pronounced septal deviation
- Known allergy to polyvinylchloride or medicinal liquid paraffin
- Women not using adequate contraceptives
- Participated in a clinical investigational drug trial within the previous 30 days
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 60 Years | Narcolepsy - New Potential Treatment | NCT02077036 | Entailment |
2,856 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Clinically definite or probable Amyotrophic Lateral Sclerosis (ALS) or
laboratory-supported probable ALS as defined in the revised El Escorial/Airlie House
diagnostic criteria
2. The site of onset of ALS symptoms is a limb and experiencing symptoms of lower motor
dysfunction (e.g., weakness, atrophy, cramps, poor circulation, etc.) with upper motor
neuron symptoms (e.g., weakness, brisk reflexes, spasticity)
3. Onset of ALS symptoms ≤ 4 years
4. Slow Vital Capacity (SVC) ≥ 50% of predicted value at Screening
5. Not taking riluzole, or on a stable dose (defined as no noted toxicities) for at least
30 days prior to Screening and throughout the study
6. Not taking edaravone or on a maintenance cycle for at least 30 days prior to Screening
and throughout the study
7. For females of childbearing potential, a negative urine pregnancy test at Screening
and on Day 0
8. Male Participants and their female partners must agree to use double-barrier
contraception during the study or provide proof of postmenopausal state (minimum 1
year) or surgical sterility
9. Male Participants must not donate sperm during the study
10. Female Participants must be nonpregnant, nonlactating, and either postmenopausal for
at least 1 year, or surgically sterile for at least 3 months, or agree to use
double-barrier contraception from 28 days prior to randomization (Day 0) and/or their
last confirmed menstrual period prior to study randomization (whichever is longer)
until the end of the study
11. Capable of complying and willing to comply with the requirements and restrictions in
the informed consent form and this protocol
12. Willing to forgo new experimental ALS treatments for at least 6 months following
randomization
Exclusion Criteria:
1. Progressive or degenerative neurological disorder such as Alzheimer's disease,
Parkinson's disease, vascular dementia, multiple sclerosis, and other neurological or
vascular disorders felt by the Investigator to preclude participation
2. Requires tracheotomy ventilation or noninvasive ventilation related to bulbar function
3. Evidence by physical examination, history, or laboratory evaluation of significant
concomitant disease with a life expectancy of < 6 months at Screening
4. INR values >2.0
5. Platelet count <100,000/µL
6. Inflammatory disorder of the blood vessels (inflammatory angiopathy or vasculitis,
such as Buerger's disease)
7. Active infection (chronic infection or severe active infection that may compromise the
Participant's wellbeing or participation in the study in the Investigator's judgment)
8. Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis)
9. Positive human immunodeficiency virus (HIV) or human T-cell lymphotrophic virus (HTLV)
I/II test at Screening
10. Active acute or chronic hepatitis B
11. Active hepatitis C
12. Immunosuppression due to underlying disease (e.g., rheumatoid arthritis, systemic
lupus erythematosus) or to currently receiving immunosuppressive drugs, (e.g.,
chemotherapy, corticosteroids) or to radiation therapy
13. Stroke or myocardial infarction within 3 months prior to Screening
14. Active deep vein thrombosis
15. Recent history (< 3 years) or presence of cancer except basal cell carcinoma or
squamous cell carcinoma of the skin that was excised and has shown no evidence of
recurrence for at least 1 year
16. Major psychiatric disorder diagnosed in the past 6 months that has not been stabilized
or in the Investigator's opinion would not allow the patient to participate in the
scheduled procedures
17. Use of an investigational drug for the treatment of ALS in the past 30 days or 5
half-lives (if available), whichever is longer, or previous participation in a
clinical study with Engensis
18. Stem cell administration for investigational treatment of ALS or other conditions in
the 6 months prior to Screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis | NCT04632225 | Entailment |
6,409 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients with clinically diagnosed influenza, body temperature ≥ 38 ºС or other acute
respiratory viral infection, body temperature ≥ 37 ºС, with no less than 2 symptoms of
catarrhal and intoxication each:
- Intoxication symptoms: Dizziness, headache, chills, fever, sweating, fatigue,
myalgia, pain while moving eyes, flushing, pale skin, sleep disturbances,
decreased appetite, nausea, vomiting, epistaxis, cyanosis, meningeal signs.
- Catarrhal symptoms: Sore throat, rhinorrhea and nasal congestion, difficulty
swallowing, hoarseness, stridor, wheezing, rattling dry and wet cough,
expectoration.
- Laboratory confirmation of viral origin of the disease
- Uncomplicated influenza and other acute respiratory viral infections
- Interval between onset of symptoms and enrollment to the study not more than 48 hours
- Have read, understood and signed an informed consent form
Exclusion Criteria:
- Complicated course of influenza and other acute respiratory viral infections
(secondary bacterial infection)
- Pregnancy and Breastfeeding
- Severe decompensated or unstable medical or psychiatric conditions (any diseases or
conditions that threaten the life of the patient or worsen the patient's prognosis)
- Cancer, HIV infection, tuberculosis, including those in history
- History of alcohol and drug abuse
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Efficacy and Safety Study of Ingavirin® 90 mg Once Daily to Treat Influenza and Other Acute Viral Infections in Adults | NCT03154515 | Entailment |
5,313 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Men and postmenopausal women who have a previous vertebral osteoporotic fracture that
was sustained at least 6 weeks prior to joining the study.
- Patients who are free of severe or chronically disabling conditions other than
osteoporosis.
- Patients who are not currently receiving and have not previously received
teriparatide.
- Patients who agree to participate, return to follow-up visits, and who have signed
informed consent to participate in the study.
- Patients, who in the opinion of the prescribing physician, are eligible to receive the
intended treatment and comply with all the recommendations stated in the relevant
product information.
Exclusion Criteria:
- Are investigator site personnel directly affiliated with the study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
- Are Lilly employees (that is, employees, temporary contract workers, or designees
responsible for conducting the study). Immediate family of Lilly employees may
participate in Lilly-sponsored clinical trials, but are not permitted to participate
at a Lilly facility.
- Patients who have any contraindications according to the relevant product information
in the country in which they are being treated.
- Patients who are simultaneously participating in a different study that includes a
treatment intervention and/or an investigational drug.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
| Back Pain in Patients With Severe Osteoporosis | NCT00761332 | Entailment |
3,228 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Suspicion of Sjogren's syndrome based on 2016 American College of Rheumatology (ACR)
criteria;
- Age ≥ 18 years
- Being affiliated to health insurance
- Willing to participate
Exclusion Criteria:
- Pregnant or breastfeeding women,
- Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty
by a judicial or administrative decision, minors, persons of legal age who are the
object of a legal protection measure or unable to express their consent)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Involvement of Immune Cells Derived From the Intestine in Sjogren's Syndrome | NCT03841318 | Entailment |
863 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Self-reported hip or knee osteoarthritis
Exclusion Criteria:
- Persons who do not understand the Norwegian language
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Improve Osteoarthritis Care | NCT04670549 | Entailment |
500 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- The inclusion criteria for RIF group were: unexplained repeated implantation failure
(RIF) is defined as the absence of a gestational sac on ultrasound at 5 or more weeks
after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after
the transfer of ≥10 embryos in multiple transfers.
The inclusion criteria for control group were: (1) age <35 years; (2) regular menstrual
cycles of 24-35 days; (3) baseline follicle- stimulating hormone (FSH) < 9.0 IU/L; (4)
endometrial thickness ≥8.0 mm on the day of hCG administration.
Exclusion Criteria:
- (1) uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus); (2)
intrauterine adhesions（moderate - severe）, endometriosis, adenomyosis, untreated
hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm
and/or endometrial pressure) (3) history of adverse pregnancy (including spontaneous
abortion, stillbirth, and fetal malformation).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Transcriptomic Profile of Endometrium in Different Histological Dating of Natural Cycle | NCT03222830 | Contradiction |
2,322 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Known null mutation of the Dystrophin gene
- Male age of 5 years or older
- If taking corticosteroids, must have dose unchanged for the past 3 months
- Serum creatine kinase elevation greater than 10x normal value (established by
Children's Hospital)
- Progressive, symmetrical proximal muscle weakness of arms and legs
Exclusion Criteria:
- Unable to cooperate for muscle strength testing
- Joint contractures that prohibit muscle strength testing
- Concomitant illness
- Individuals predisposed to excessive vagal responses (bradyarrhythmia or hypotension)
- Controlled substance abuse
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
Subject must be at most 15 Years | Safety Study of Mini-dystrophin Gene to Treat Duchenne Muscular Dystrophy | NCT00428935 | Entailment |
2,282 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Patients 10 - 18 years of age at Baseline.
2. Signed and dated informed consent.
3. Documented diagnosis of DMD or severe dystrophinopathy and clinical features
consistent of typical DMD at diagnosis (i.e. documented delayed motor skills and
muscle weakness by age 5 years). DMD should be confirmed by mutation analysis in the
dystrophin gene or by substantially reduced levels of dystrophin protein (i.e. absent
or <5% of normal) on Western blot or immunostain.
4. Ability to provide reliable and reproducible repeat PEF within 15% of the first
assessment (i.e. Baseline vs. Screening).
5. Patients assessed by the investigator as willing and able to comply with the
requirements of the study, possess the required cognitive abilities and are able to
swallow study medication.
Exclusion Criteria:
1. Patients dependent on assisted ventilation at Screening and/or Baseline (defined as
non-invasive nocturnal ventilation, daytime non-invasive ventilation or continuous
invasive ventilation).
2. Patients with documented DMD-related hypoventilation for which assisted ventilation is
needed according to current standard of care guidelines (e.g. FVC< 30%) or is required
in the opinion of the Investigator.
3. Patients with a percent predicted PEF > 80% at Baseline.
4. Patients unable to form a mouth seal to allow precise respiratory flow measurements
and mouth pressures.
5. Symptomatic heart failure (high probability of death within one year of Baseline)
and/or symptomatic ventricular arrhythmias.
6. Participation in the previous Phase II or Phase II Extension study (SNT-II-001 or
SNT-II-001-E) for idebenone.
7. Participation in any other therapeutic trial and/or intake of any investigational drug
within 90 days prior to Baseline.
8. Use of carnitine, creatine, glutamine, oxatomide, or any herbal medicines within 30
days prior to Baseline.
9. Use of coenzyme Q10 or vitamin E (if taken at a dose of 5 times above the daily
physiological requirement) within 30 days prior to Baseline.
10. Any previous use of idebenone.
11. Any concomitant medication with a depressive or stimulating effect on respiration or
the respiratory tract.
12. Planned or expected spinal fixation surgery during the study period (as judged by the
investigator).
13. Asthma, bronchitis/COPD, bronchiectasis, emphysema, pneumonia or the presence of any
other non-DMD respiratory illness that affects PEF.
14. Chronic use of beta-2 agonists or any use of other bronchodilating medication (e.g.
inhaled steroids, sympathomimetics, anticholinergics).
Please note: Chronic use if defined as a daily intake for more than 14 days.
15. Moderate or severe hepatic impairment or severe renal impairment.
16. Prior or ongoing medical condition or laboratory abnormality that in the
Investigator's opinion could adversely affect the safety of the subject.
Please note: Patients who suffer from a severe, unstable condition including (but not
limited to) cancer, auto-immune diseases, haematological diseases, metabolic disorders
or immunodeficiencies, and who are at risk of an aggravation unrelated to the study
condition, can only be included in the study if accepted in writing by the Sponsor's
Medical Monitor.
17. Relevant history of or current drug or alcohol abuse or use of any tobacco/marijuana
products/smoking
18. Known individual hypersensitivity to idebenone or to any of the ingredients/excipients
of the study medication
19. Systemic glucocorticoid therapy
1. Chronic use of systemic glucocorticoid therapy for DMD related conditions within
12 months of Baseline (the "12 month non-use period")
2. More than 2 rounds of acute systemic glucocorticoid burst therapy (of ≤2 week
duration) for non-DMD related conditions within the 12 month non-use period
3. Use of any round of systemic glucocorticoid burst therapy of longer than 2 weeks
duration within the 12 month non-use period
4. Use of systemic glucocorticoid burst therapy less than 8 weeks prior to baseline
Male
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 18 Years | Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD) | NCT01027884 | Contradiction |
214 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male, 18 - 65 years of age;
- Documented testosterone deficiency;
- BMI 18 to 33.
Exclusion Criteria:
- Evidence of prostate cancer and benign prostate hyperplasia;
- Taking medications that interfere testosterone metabolism;
- History of alcohol or drug substance abuse;
- Abnormal ECG;
- Allergic to transdermal products;
- Skin condition that interfere transdermal system application and assessment
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems | NCT01323140 | Entailment |
6,352 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Positive COVID-19 RT-PCR to the subject or his/her household.
- Over 18 years old
- Ability to sign an informed consent
Exclusion Criteria:
- Inability to sign an informed consent
- Pregnancy
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Evaluating the Immune Response for COVID-19 | NCT04348422 | Entailment |
2,599 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- recurrent inguinal hernia
- willing to participate
Exclusion Criteria:
- unwilling to participate
- bilateral hernia
- preference towards either treatment arm
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Recurrent Inguinal Hernia Treatment - Lichtenstein Versus Laparoscopic Totally Extraperitoneal Preperitoneal Hernioplasty | NCT00642200 | Contradiction |
363 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Patient with thickened endometrium
- Abnormal uterine bleeding
Exclusion Criteria:
- Pregnant
- Active pelvic infection
- Pelvic inflammatory disease
- Blood clotting disorders
- Sexually transmitted disease
- Uterine perforation
- Recent cesarean section
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of the Goldstein SonoBiopsy™ Catheter for Diagnosing Endometrial Pathology | NCT01969396 | Contradiction |
5,532 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Age ≥ 50 years
- ACR criteria for Giant cell arteritis (HUNDER 1990)
- Positive Temporal artery biopsy
- Plus standard inclusion criteria for Humira protocols
Exclusion Criteria:
- Prednisone treatment for a different disease at a dose >15 mg/day
- Corticoid treatment for GCA more than 10 days
- GCA treatment with prednisone > 1 mg/kg whatever period of time
- GCA treatment with an anti-TNF, MTX, cyclosporine, cyclophosphamide, dapsone or
steroid bolus
- Recent, permanent or transient visual loss due to GCA and the presence of any specific
visual abnormality (diplopia, hallucination)
- Plus standard exclusion criteria for Humira protocols
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis | NCT00305539 | Entailment |
5,439 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- at least one prescription medicine for a chronic condition for at least six months
- deemed to be suitable for MUR by a pharmacist, certified to provide the MUR service;
- ability to communicate in Slovenian; The inclusion of patients was performed in
accordance with the SOP MUR, to reflect how patients are generally offered MUR service
in Slovenia.
Exclusion Criteria:
- urgent need of MUR (the service delay due to randomization would risk their health);
- referred for MUR by a healthcare professional (general practitioner, nurse, etc.);
- the patient's carer, rather than the patient themselves, was able to attend the
interviews and receive MUR;
- previously received MUR or an advanced medication review;
- difficulties understanding, communicating or other issues (vision, hearing) that might
affect study outcomes.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Evaluation of Medicines Use Review in Slovenia | NCT04417400 | Entailment |
5,104 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Age 65 - 85 years • BMI 30 - 40 kg/m2 • Stable body weight (±2 kg) during the past 6
months • Sedentary (regular exercise <1 h/wk. or <2 x/wk. for the last 6 months) •
Willing to provide informed consent
Exclusion Criteria:
- Failure to provide informed consent.
- Any major chronic diseases, or any condition that would interfere with exercise or
dietary restriction, in which exercise or dietary restrictions are contraindicated, or
that would interfere with interpretation of results
- Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke)
or unstable disease (e.g., New York Heart Class III or IV congestive heart failure,
severe pulmonary disease requiring steroid pills or the use of supplemental oxygen )
that would contraindicate exercise or dietary restriction
- Severe orthopedic (e.g. awaiting joint replacement) and/or neuromuscular (e.g.
multiple sclerosis, amyotrophic lateral sclerosis, active rheumatoid arthritis)
disease or impairments that would contraindicate participation in exercise
- Other significant co-morbid disease that would impair ability to participate in the
exercise-based intervention (e.g. renal failure on hemodialysis, severe psychiatric
disorder [e.g. bipolar, schizophrenia], excess alcohol use [more than14 drinks per
week])
- Severe visual or hearing impairments that would interfere with following directions
- Significant cognitive impairment, defined as a known diagnosis of dementia or positive
screening test for dementia using the Mini-Mental State Exam score less than 24)
- Uncontrolled hypertension (BP>160/90 mm Hg)
- History of malignancy during the past 5 years (except non-melanoma skin cancers)
- Current use of bone acting drugs (e.g. use of estrogen, or androgen containing
compound, raloxifene, calcitonin, parathyroid hormone during the past year or
bisphosphonates during the last two years)
- Osteoporosis (T-score -2.5 and below on hip or spine scan) or history of fragility
fractures - Diabetes mellitus requiring insulin for treatment or with a fasting blood
glucose of >140 mg/dl, and/or HbA1c >8.5% (Those excluded from the study because of
fasting blood glucose of >140 mg/dl or HbA1c>8.5% will be referred to their primary
care provider for follow-up and appropriate treatment).
- Terminal illness with life expectancy less than 12 months, as determined by a
physician
- Use of any drugs or natural products designed to induce weight loss within past three
months.
- Positive exercise stress test for ischemia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
Subject must be at most 85 Years | Lifestyle Intervention to Improve Bone Quality | NCT03329963 | Contradiction |
391 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | - Inclusion criteria
- Patients whose written IC approved by the EC has been obtained, after having been
duly informed of the nature of the study and voluntarily accepted to participate
after being fully aware of the potential risks, benefits and any discomfort
involved.
- Patients undergoing their first IVF/ICSI cycle (first oocyte pick up, freezing
all) with their own oocytes that will receive single embryo transfer of frozen
blastocyst stage embryos (day 5/6) on an HRT cycle.
- At least 2 morphologically good quality embryos already vitrified in blastocyst
stage (day 5/6).
- Maternal Age: ≤37 years to rule out embryo factor in aging patients.
- BMI: 18.5 - 30.0 kg / m2 (both inclusive).
- Normal ovarian reserve (defined as: AFC ≥ 8; AMH level ≥1.0 ng/ml and/or FSH < 8
mU/ml) before the controlled ovarian stimulation (COS) initiation.
- Serum P levels ≤ 1.5 ng/ml, measured within 24 hours before the hCG
administration in the COS cycle.
- Negative serological tests for HIV, HBV, HCV, RPR.
- Exclusion criteria
- Patients with repeated miscarriages (> 2 previous biochemical pregnancies or > 2
spontaneous miscarriages).
- Male partner with severe male factor (spermatozoa < 2 million/ml). Semen donor is
allowed.
- Patients who are intrauterine device (IUD) carriers in the last 3 months before
sample collection.
- Adenomyosis or any pathological finding affecting the endometrial cavity such as
polyps/sub-mucosal myomas, intramural myomas > 4 cm, or hydrosalpinx must be
previously operated at least 3 months before the endometrial samples are
obtained.(Note: Patients are allowed to participate if the pathology is corrected
before performing any study procedure).
- Embryos analysed using preimplantation genetic testing for aneuploidies (PGT-A)
- Women who have received antibiotics in the last month previous to sample
collection, except for the prophylaxis for the oocyte retrieval. In the control
group, antibiotics cannot be provided during the ET cycle
- Illness or unstable medical condition that may put at risk the patient's safety
and her compliance in the study
Female
Accepts Healthy Volunteers
Subject must be at most 37 Years | RCT to Assess the Impact of Microbiome Status in Infertile IVF Patients at Their First IVF/ICSI Cycle | NCT04686357 | Contradiction |
4,892 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- Clinical diagnosed Cushing's disease
Exclusion Criteria:
- Already received treatment in other hospital
- Ectopic Cushing's syndrome
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| The Factors Associated With the Recurrence in Patients With Cushing Disease | NCT02233335 | Entailment |
4,974 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | No eligibility criteria
Male
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | Antecedents of Bronchopulmonary Dysplasia | NCT00005293 | Entailment |
3,522 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written
informed consent
Exclusion Criteria:
- • hypothyroidism of other origin
- pregnancy and lactation
- oral contraception
- glucocorticoid therapy during the last 2 months
- History of malignancy or chronic infections (Hepatitis, HIV)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis | NCT00552487 | Contradiction |
6,541 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Healthy male and female subjects age 18 to 45 years of age included, and in good
health as determined by past medical history, physical examination, vital signs,
electrocardiogram, and laboratory tests at screening.
- Vital signs must be within the following ranges: oral body temperature between
35.0-37.5 °C; systolic blood pressure, 90-145 mm Hg; diastolic blood pressure, 50-95
mm Hg; pulse rate, 40-90 bpm
- Female subjects must either:have been surgically sterilized or hysterectomized at last
6 months prior to study participation with clinical documentation be postmenopausal
(no regular menstrual bleeding for at least 1 year prior to study start)
- Body mass index must be within the range of 18 to 28 kg/m². Subjects must weigh at
least 50 kg to participate in this study.
Exclusion Criteria:
- Smokers (any subject who uses tobacco or has cotinine greater than 500 ng/mL)).
- Subjects who received live vaccine 4 weeks prior to dosing, any prescription drug use
with 4 weeks prior to dosing, or over-the-counter medication use within 2 weeks prior
to dosing.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer
if required by local regulations, and for any other limitation of participation based
on local regulations.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or
longer if required by local regulation.
- Flu-like symptoms or significant within two weeks prior to dosing.
- A past medical history of clinically significant abnormality detected during
electrocardiogram (ECG) examination or an evident family history (grandparents,
parents and siblings) of a ECG abnormality (i.e. prolonged QT-interval syndrome).
- History of fainting, hypotension when standing up, arrhythmia.
- History of acute or chronic bronchospastic disease (including asthma and chronic
obstructive pulmonary disease (including asthma and chronic obstructive pulmonary
disease, treated or not treated).
- History of clinically significant drug allergy or history of atopic allergy,
urticaria, eczematous dermatitis). A known hypersensitivity to the study drugs or
drugs similar to the study drugs.
- Any history of surgical or medical condition(s) which could change the absorption,
distribution, metabolism or excretion of drugs or which may jeopardize the subject,
including history of gastrointestinal, pancreatic, liver, kidney, bladder, blood, or
immune systems.
- History of drug or alcohol abuse within the 12 months prior to dosing or evidence of
such abuse as indicated by the laboratory assays conducted the screening or baseline
evaluations.
Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHT956 in Healthy Subjects | NCT00410228 | Contradiction |
2,125 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | - INCLUSION CRITERIA:
1. Patients previously identified through outside research or diagnostic labs as
having sex-chromosome variants causing deletion/duplication of sex-linked genes
or entire sex chromosomes, male and female.
2. In the event that a patient with a sex-chromosome variant self-refers to the
protocol, medical records will be reviewed by a committee to include Dr. David
Page, Dr. Maximilian Muenke, and others to decide whether the patient is
appropriate for enrollment in the protocol.
3. Willing family members of subjects enrolled may be enrolled as control subjects.
EXCLUSION CRITERIA:
1. Anyone unwilling to provide informed consent or assent.
2. We reserve the right to exclude patients with medical conditions that would place a
potential participant at high risk of complications if managed at the NIH clinical
center (ex. dialysis dependency, unstable cardiac conditions, unstable severe
depression/suicidality).
3. We reserve the right to exclude cases that are clearly not related to Ychromosome
variants, infertility or our direct research interests (e.g. infertility with clearly
non-genetic etiology). This almost never happens, and we would attempt to make
referrals to a more appropriate investigator.
It is our intention to try to remove as many economic, cultural, geographic, racial, and
gender barriers as we reasonably can to promote a diverse participation of infertility
cases for research purposes.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Clinical Study of Sex Chromosome Variants | NCT01661010 | Entailment |
1,675 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- American Indian ethnicity
- Membership in the White Mountain Apache community. (Although the investigators
anticipate the vast majority of participants will be White Mountain Apache tribal
members, study participation is open to all American Indian individuals who live on
the Fort Apache Indian Reservation or on/near the border).
- Participants ages 11+ must have parent/legal guardian consent
- Adult participants must sign written informed consent
Exclusion Criteria:
- Inability to participate in full intervention or evaluation (e.g., planned move,
residential treatment, etc.)
- Unwilling to be randomized
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 11 Years old.
| Evaluation of Respecting the Circle of Life on Pregnancy Prevention Outcomes Among American Indian Adolescents | NCT02904629 | Entailment |
292 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Singleton Pregnancy.
- Age20-35years.
- Gestational age between6 to 8weeks.
- Threatened miscarriage is diagnosed by vaginal bleeding, closed cervix and positive
fetal life.
- Patients who are sure of their dates (three regular menstrual cycles before conception
without the use of hormonal contraception.
Exclusion Criteria:
Patients with recurrent miscarriage or pregnancy of unknown location (PUL).
- Patients had ovulation induction medications or on progesterone treatment.
- Patients with past medical history of diabetes mellitus or chronic hypertension.
- Patients who are unsure of the last menstrual period date or with irregular menstrual
cycle.
- Pregnancy associated with presence of ovarian cyst.
- Molar pregnancy.
- Those who had a history of maternal disease which would cause an increase in
CA-125level. These diseases include chronic pelvic infection, endometriosis, myoma
uteri, endometrioma and lung, kidney and hepatic diseases.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Biochemical Versus Ultrasound Findings as Predictors of Fetal Loss in Cases of First Trimester Threatened Miscarriage | NCT03797508 | Contradiction |
3,061 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Patients with Fragile X Syndrome, who are at least moderately ill based on a Clinical
Global Impression Severity score of at least 4 and have qualifying scores on the ABC-C
and IQ test at Visit 1
Exclusion Criteria:
- Advanced, severe or unstable disease that may interfere with the study outcome
evaluations
- Cancer within the past 5 years, other than localized skin cancer
- Current treatment with more than two psychoactive medications, excluding
anti-epileptics
- History of severe self-injurious behavior
- Weigh less than 32 kg
- Females who are sexually active
Other protocol-defined inclusion/exclusion criteria may apply
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 17 Years | Safety and Efficacy of AFQ056 in Adolescent Patients With Fragile X Syndrome | NCT01357239 | Entailment |
5,511 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
Cases:
- 1) age ≥50 years, 2) CRP>15mg/l or ESR>40mm/h, 3) either a) cranial symptoms, b)
new-onset extremity claudication or c) weight loss >5 kilograms or fever>38oC for >3
weeks and a clinical diagnosis of giant cell arteritis judged by expert
rheumatologist.
Controls:
- age-(+/-3 years) and sex-matched malignant melanoma (MM) patients
- follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection
Exclusion Criteria:
- Previous diagnosis of polymyalgia or giant cell arteritis
- immunosuppresive treatment within last month
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA | NCT03409913 | Entailment |
2,281 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- All patients with the diagnosis of muscular dystrophy.
Exclusion Criteria:
- Patients that do not carry the diagnosis of muscular dystrophy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 1 Month old.
Subject must be at most 65 Years | The Cardiovascular Genetic and Therapeutic Implications of Muscular Dystrophy | NCT00518817 | Contradiction |
3,680 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
- Patients who have attended Darlington Memorial Hospital between 01-08-2016 and
31-07-2017
- Aged 16 or over
Exclusion Criteria:
- Below the age of 16
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
| Characteristics of Back Pain Attendances at ED | NCT03762174 | Entailment |
2,008 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Stomach pain, swelling or dispeptic complaints.
- Men and women between the ages of 18-60.
- Patients with VAS> 5.
Exclusion Criteria:
- Pregnancy and lactation.
- Sucralfate, alginate, hydrotalcite allergy.
- Emergency service arrives with acute psychiatric symptoms.
- Gastrointestinal system bleedings.
- Chronic renal failure, liver cirrhosis, structural and functional heart disease.
- Gastric malignancy and terminal illness.
- Patients suspected of having a different problem such as ileus, biliary colic,
- pancreatitis, hepatitis.
- Patients who refuse to participate in the study.
- Those who can not use VAS.
- Presence of ischemic findings on the arrival ECG.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | A Comparison of Effectiveness of Oral Sucrolfate, Alginate and Hydrotalcide in Dispeptic Pain Treatment | NCT03635372 | Entailment |
6,645 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Females of reproductive age who experience monthly menstrual bleedings
- Female Hemophilia A or B carrier (heterozygote, lyonized or Turner's Syndrome)
- FVIII or FIX activity ≤60% at time of the study
- Baseline Pictorial Bleeding Assessment Chart >150 mean at time of recruitment
- Negative pregnancy test at time of enrollment
- Both female and her male partner have agreed to use an acceptable barrier method of
birth control (e.g., diaphragm, cervical cap, male condom, female condom, and
spermicidal foam, sponges, and film) throughout the duration of this study (for
sexually active participants)
Exclusion Criteria:
- Has not reached menarche
- Menopause: natural or induced by surgical/medical treatment
- Pregnant or breasfeeding
- Female or her male partner refuses to use barrier method of birth control (for
sexually active)
- Current use of any of the following contraceptives (copper IUD, oral combined,
Progestin-only including but not limited to: Provera, Aygestin, Nexplanon, Implanon,
Depo Provera, Mirena IUD)
- VWF:Ag or VWF:RCo <40%
- Diagnosis of a qualitative platelet disorder
- Personal history of thrombosis or superficial thrombosis
- First degree relative with a history of thrombosis
- Personal history of concomitant bleeding or clotting disorder
- Cigarette smoker
- Willing to avoid taking an anti-fibrinolytic agent (amicar, transexamic acid, lysteda)
during the trial
Female
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
Subject must be at most 55 Years | Extended Half Life Factor (EHF) Products For Heavy Menstrual Bleeding in Hemophilia Carriers | NCT03272568 | Contradiction |
3,390 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Healthy subjects at the time of enrollment.
- Each subject will give informed consent to participate in this study and agrees to the
treatment protocol.
- Each subject will be interviewed regarding hearing and health to reveal any history of
hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic
medications (i.e. diuretics, minocycline).
- Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools)
will be avoided during the 24-hour period preceding baseline testing and throughout
the duration of the study.
- Subjects will have vital signs (i.e., heart rate, blood pressure, respirations,
temperature) within normal limits upon medical examination.
- Subjects must have normal audiologic assessment at baseline consisting of:
- Baseline audiometric evaluation confirms that subjects have symmetric hearing with air
conduction thresholds no worse than 25 decibels of Hearing Loss (dBHL) at frequencies
between 0.25 to 8 kilo Hertz (kHz) bilaterally.
- No significant threshold asymmetry (i.e. greater than 15 dB) between the ears at any
tested frequency.
- No significant air-bone gaps (i.e. greater than 10 dB)
- Type A tympanograms bilaterally, defined as a range of -140 to +40 dekaPascals (daPa)
based on the 90% range for adults (Margolis and Hunter 2000)
Exclusion Criteria:
- • Subjects with abnormal hearing levels > 25 dBHL at any tested frequency (250, 500,
1000, 2000, 3000, 4000, 6000 and 8000 Hz) for either ear.
- Exposure to any duration of non-occupational high-level sound (e.g., concerts,
firearms, fireworks, power tools) during the 24 hour period preceding baseline
audiometric testing as revealed in the subject questionnaire or during the medical
examination.
- Pathology of the external ear discovered upon otoscopic examination.
- Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry,
or reported history of middle ear problems.
- Pathology of the inner ear or auditory nerve as revealed by reported history.
- Subject complaints of aural pain, pressure, fullness, or drainage.
- Subjects testing positive for pregnancy will be excluded from the study.
- Subjects with other medical/health issues that would preclude voluntary participation
in a drug study may be excluded at the discretion of the Principal Investigator.
- Subjects that have previously received any known potentially ototoxic medication. This
includes, but is not limited to, high dose salicylates (>2 g/day), platinum-based
chemotherapeutics and aminoglycoside antibiotics, such as streptomycin,
gentamicin,tobramycin, amikacin, neomycin, and netilmycin.
- Subjects that are currently using of any potentially ototoxic medications (i.e.
diuretics or minocycline).
- Subjects that have received any investigational treatment (drug or device) in the six
months prior to this study.
- Subjects exhibiting or self-reporting shortness of breath, wheezing, coughing, or
hemoptysis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 31 Years | Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift | NCT01444846 | Contradiction |
184 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Male research participant, aged 18 years or older, with BMI between 18.50 and 32.00
kg/m2;
2. To present symptomatic or asymptomatic hypogonadism and serum total morning
testosterone levels ≤ 300 ng / dL;
3. Laboratory evaluation of prostate specific antigen (PSA) levels within the normal
range established by the laboratory or with non clinically significant changes (NCS)
judged by the study Investigator;
4. Rhinoscopy and Glatzel mirror test normal or with changes that do not interfere with
nasal absorption of medication Test;
5. Present healthy skin in the region of Comparator product application (skin of the
shoulder).
Exclusion Criteria:
1. Diagnostic of prostatic and/or breast neoplasia;
2. PSA levels 4 ng/mL or higher, or 3 ng/mL or higher with elevated risk for prostatic
neoplasia development;
3. Treatment with estrogens, gonadotropin releasing hormone (GnRH), growth hormone (GH)
in the last 12 months;
4. Treatment with testosterone or any other androgen in the last two weeks (oral, buccal
and topic), four weeks (intramuscular) or twelve weeks (implant) that precede
randomization in the study;
5. Active rhinitis: allergic, seasonal, medicinal, vasomotor and atrophic;
6. Presence of grade II or III septum deviation (in any region of the nasal septum) and /
or presence of nasal polyps or other conditions that determine nasal obstruction;
7. Hypersensibility of testosterone as well as to components present in the formulation
of drugs.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy and Safety of Testosterone Nasal Gel for Treating Hypogonadism in Men. | NCT03281187 | Entailment |
5,774 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Ability to understand and consent to participate in this clinical research, expressed
by signing the Informed Consent Form (ICF);
- Participants with moderate or severe clinical diagnosis of superficial mycoses caused
by Candida ssp or following fungal /dermatophytosis infections: inflammatory tinea
corporis inflammatory (except face), inflammatory tinea cruris and inflammatory tinea
pedis, with confirmation through direct mycological examination. In moderate or severe
superficial mycosis that present at least moderate erythema and itching signs and
slight peeling according to the evaluation by the four-point category scale (0=absent,
1-mild, 2-moderate, 3-severe);
Exclusion Criteria:
- Any observational finding (clinical/ physical evaluation) that is interpreted by the
investigator as a risk to the research participant's participation in the clinical
trial;
- Known hypersensitivity to the drug components used during the study;
- Use of prohibited drugs and treatment prohibited in the last 90 days;
- Immune impairment, according to investigator assessment;
- Vulvovaginal candidiasis diagnostics, balanopreputial, nail, chronic mucocutaneous or
oral;
- Diagnosis of chickenpox, rosacea, herpes simplex or zoster, skin tuberculosis or skin
syphilis, systemic fungal infection;
- Participants who, though they have studied diagnosis of fungal infections requiring
systemic treatment according to the severity of injury and according to the opinion of
the investigator;
- Participants that have skin lesions with clinical signs of bacterial infection;
- Participants who, according to investigator assessment, require systemic antibiotic
treatment;
- Participants that are in any treatment , in the opinion of the investigator, may
affect the results of the study;
- Participants diagnosed with HIV;
- Participants diagnosed with Diabetes Mellitus;
- Participants with a history of smallpox vaccine reaction;
- Women in gestation period or who are breastfeeding;
- Female participants who are in the reproductive age and do not agree to use acceptable
methods of contraception (oral contraceptives, injectable contraceptives, intrauterine
device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation);
except surgically sterile (bilateral oophorectomy or hysterectomy), the menopausal for
at least one year and participants who declare to perform sexual practices on a not to
reproductive way;
- Participant who participated in clinical in the last twelve months, unless the
investigator considers that there may be direct benefit to thereof;
- Participant has some kinship of second degree or bond with employees or employees of
Sponsor and Research Center.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis | NCT02582177 | Contradiction |
1,962 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion criteria:
-) subjects with small gastric subepithelial tumors who underwent endoscopic unroofing
Exclusion criteria:
-) none
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Endoscopic Unroofing for Small Gastric SETs | NCT02587923 | Entailment |
2,507 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
1. Between 6 and 65 years old, female or male.
2. Atopic dermatitis fulfilling the diagnostic criteria of Williams et al.
3. Atopic dermatitis involving <40% of BSA. (Base on the BSA result of Screening)
4. An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to
mild, moderate or severe disease. (Base on the IGA result of Screening)
5. Female patients of child-bearing age with negative pregnancy test at screening.
6. Female patients of child-bearing age that agree to continue using birth control
measures approved by the investigator and agree not to lactate for the duration of the
study.
7. Agree to only receive stable doses of an additive-free, basic bland emollient for at
least 7 days before baseline (day0)
8. Willing to comply with study protocol and agree to sign an informed consent form.
Exclusion Criteria:
1. Having a history of topical or systematical hypersensitivity to indigo naturalis or
its excipient (e.g. beeswax) in ointment
2. Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive
agents) within 30 days.
3. Having used topical therapy (e.g. topical corticosteroids) for dermatitis within 7
days before the first application of the study medication.
4. Having a significant concurrent disease, such as: significant abnormalities in
hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes
mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
5. Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).
6. Women who are lactating, pregnant or preparing to be pregnant.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 65 Years | Indigo Naturalis in Treating Atopic Dermatitis Topically | NCT02669888 | Contradiction |
4,056 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | 1. Inclusion criteria:
1. Age between 18 to 50
2. Ant. Knee pain
3. Resistant cases to medical and physiotherapy after 6 months.
4. Intact tibiofemoral joints or early O.A , and intact meniscus, cruciate
ligaments, and Collateral ligaments.
2. Exclusion criteria:
1. Old Age >50 or < 18
2. Combined cases with severe tibiofemoral OA (either deformity or malignment).
3. Combined injury to (collateral ligaments, meniscus, cruciate ligament)
4. Cases with tibial torsion
5. Malalignment that necessitate correction.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Arthroscopic Treatment of Resistant Cases of Patellofemoral Pain | NCT03615976 | Entailment |
2,274 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
1. Male patients with a 35% ≤ FVC ≤ 80% of predicted value at Screening and at Baseline
and who, in the opinion of the investigator are in the respiratory function decline
phase.
2. Minimum 10 years old at Screening.
3. Signed and dated Informed Consent Form.
4. Documented diagnosis of DMD (severe dystrophinopathy) and clinical features consistent
of typical DMD at diagnosis (i.e. documented delayed motor skills and muscle weakness
by age 5 years). DMD should be confirmed by mutation analysis in the dystrophin gene
or by substantially reduced levels of dystrophin protein (i.e. absent or <5% of
normal) on Western blot or immunostaining.
5. Chronic use of systemic glucocorticoid steroids for DMD related conditions
continuously for at least 12 months prior to Baseline without any dose adjustments on
a mg/kg basis in the last 6 months (only dose adjustments determined by weight changes
are allowed).
6. Ability to provide reliable FVC values at Screening and Baseline, and reproducible
within 15% (relative change) at Baseline compared to Screening.
7. Patients assessed by the Investigator as willing and able to comply with the
requirements of the study, possess the required cognitive abilities and are able to
swallow study medication.
8. Patients who prior to Screening have been immunized with 23-valent pneumococcal
polysaccharide vaccine or any other pneumococcal polysaccharide vaccine as per
national recommendations, as well as annually immunized with inactivated influenza
vaccine.
Exclusion Criteria:
1. Symptomatic heart failure (defined as patients with structural heart disease, dyspnea,
fatigue and impaired tolerance to exercise; Stage C by the ACCF/AHA guideline or NYHA
Classes III-IV) and/or symptomatic ventricular arrhythmias.
2. Ongoing participation in any other therapeutic trial and/or intake of any
investigational drug within 90 days prior to Baseline (only exception allowed is use
of Deflazacort in the US as part of the Expanded Access Program, or any approved
corticosteroid product in trial for regimen optimization, for which the patient met
the inclusion criterion 5).
3. Ongoing exon-skipping therapy or read-through gene therapy for DMD; previous
exon-skipping or read-through gene therapy is allowed if the stop date was more than 6
months prior to Screening.
4. Planned or expected spinal fusion surgery during the study period (as judged by the
Investigator; i.e. due to rapidly progressing scoliosis), previous spinal fusion
surgery is allowed if it took place more than 6 months prior to Screening.
5. Asthma, bronchitis/COPD, bronchiectasis, emphysema, pneumonia or presence of any other
non-DMD respiratory illness that affects respiratory function.
6. Chronic use of beta2-agonists or any use of other bronchodilating/bronchoconstricting
medication (inhaled steroids, sympathomimetics, anticholinergics, antihistamines);
chronic use is defined as a daily intake for more than 14 days.
7. Any bronchopulmonary illness that required treatment with antibiotics within 3 months
prior to Screening.
8. Moderate or severe hepatic impairment (use as guidance Child-Pugh class B [7 to 9
points] or Child-Pugh class C [10 to 15 points] - see Appendix B) or severe renal
impairment (eGFR <30 mL/min/1.73 m2).
9. Prior or ongoing medical condition or laboratory abnormality that in the
Investigator's opinion may put the patient at significant risk may confound the study
results or may interfere significantly with the patient's participation in the study.
10. Relevant history of or current drug or alcohol abuse, or use of any tobacco or
marijuana products/smoking.
11. Known individual hypersensitivity to idebenone or to any of the ingredients or
excipients of the study medication.
12. Daytime ventilator assistance (defined as use of any assisted ventilation while
awake).
Note: Patients who suffer from a severe, unstable condition including (but not limited to)
cancer, auto-immune diseases, hematological diseases, metabolic disorders or
immunodeficiencies, and who are at risk of an aggravation unrelated to the study condition,
can only be included in the study if accepted in writing by the Sponsor's Senior Clinical
Research Physician.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
| A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids | NCT02814019 | Contradiction |
3,594 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
1. 18-45 years of age at the time of screening
Exclusion Criteria:
2. Participants unable to tolerate the scanning procedures or would be unfit for scanning
purposes (e.g. metal implants, claustrophobic, unable to lie still for the duration of
the scan)
3. Psychiatric Illness Criteria:
1. Controls: No current or past history of psychiatric illness, including substance
use disorder (except nicotine)
2. AUD: No history of, or current, psychotic disorder, antisocial personality
disorder, or bipolar disorder, or concurrent post-traumatic stress disorder. Must
meet DSM-5 criteria for current moderate-to-severe AUD, abstinent from alcohol
for 2-8 weeks prior to study enrollment, express a desire to achieve abstinence
or to greatly reduce alcohol consumption
4. Illicit Drug Use
1. Control: Any reported current (within the last 2 months) use of any category of
illicit drugs
2. Patients: Dependence (moderate to severe) to any other substance within the last
2 months other than alcohol or nicotine
5. Any current or past history of any serious medical or neurological illness
6. Acute or uncorrected medical illnesses, including history of hepatic or renal
dysfunction, hyponatremia, traumatic brain injury, atrophic rhinitis, recurrent nose
bleeds, and cranial-surgical procedures (hypophysectomy).
7. Abnormal MRI (except if due to technical factors)
8. Female subjects who are pregnant, trying to become pregnant, or nursing
9. Known allergies to oxytocin or to preservatives in the nasal spray
10. Participants reporting use of an intranasal medication in the past two weeks
11. Participants taking medications including any current treatment with antipsychotics,
antidepressants, mood stabilizers, psychostimulants and psychostimulant appetite
suppressants, or past treatment with isoniazid, glucocorticoids, centrally active
antihypertensive drugs (e.g., clonidine, reserpine), or sedative hypnotic medications
(e.g. benzodiazepines, barbiturates, within 1 week prior to study enrollment).
Treatment within six months with any of the following: hormone use (i.e. testosterone,
DHEA), opioid drugs.
12. Unable to comply with study procedures or protocols
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II | NCT02652195 | Contradiction |
2,942 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | To be eligible for enrollment in this study, subjects must meet the following eligibility
criteria within fourteen days prior to randomization:
Inclusion criteria:
- A clinical diagnosis of laboratory-supported probable, probable or definite ALS,
according to modified EL Escorial criteria.
- FVC greater or equal to 75% of predicted.
- Onset of weakness within 3 years prior to enrollment.
- If patients are receiving riluzole they must be on a stable dose for at least the past
thirty days.
- Women of childbearing age must be non-lactating and surgically sterile or using an
effective method of birth control and have a negative pregnancy test (adequate birth
control includes use of intra-uterine device or oral contraceptives plus a barrier
method, e.g. condom, diaphragm).
- Willing and able to give signed informed consent that has been approved by your
Institutional Review Board (IRB).
Exclusion criteria:
- Requirement for tracheotomy ventilation (or non-invasive ventilation > 23 hours/day).
- Diagnosis of other neurodegenerative diseases (Parkinson's disease, Alzheimer's
disease, etc).
- FVC < 75% of predicted.
- A clinically significant history of unstable medical illness (unstable angina,
advanced cancer, etc) over the last 30 days.
- History of renal disease (screening creatinine greater than 1.5).
- History of liver disease (screening alanine aminotransferase greater than 3 times the
upper limit of normal).
- History of hematologic disease (screening white blood cell count less than 3,800/mm3).
- History of system lupus erythematosis (or screening ANA of 1:160 or greater).
- Treatment with any medications that may cause lupus-like symptoms within 4 weeks of
baseline visit (e.g. procainamide, hydralazine).
- History of vestibular disease (excluding benign position vertigo).
- Pregnancy or lactation.
- Allergy to tetracycline antibiotics.
- Use of minocycline within thirty days of enrollment (baseline visit).
- Use of anti-epileptic medications other than gabapentin.
- Limited mental capacity rendering the subject unable to provide written informed
consent or comply with evaluation procedures.
- History of recent alcohol or drug abuse or noncompliance with treatment or other
experimental protocols.
- Use of any investigational drug within the past 30 days (Creatine, Vioxx, Celebrex,
Topiramate).
- Women with the potential to become pregnant who are not practicing effective birth
control.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 85 Years | Minocycline to Treat Amyotrophic Lateral Sclerosis | NCT00047723 | Entailment |
3,298 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | - INCLUSION CRITERIA:
To be eligible, the following inclusion criteria must be met, when applicable.
1. Participant must be 18 years of age or older.
2. Participant must understand and sign the protocol s informed consent document.
3. Participant must have normal renal function, liver function, and platelet counts or
have mild abnormalities no greater than grade 1 as defined by the Common Terminology
Criteria for Adverse Events v4.0 (CTCAE).
4. Any female participant of childbearing potential must have a negative pregnancy test
at screening and must be willing to undergo pregnancy testing immediately prior to the
start of the investigational product and while on the investigational product.
5. Any female participant of childbearing potential and any male participant able to
father children must have (or have a partner who has) had a hysterectomy or vasectomy,
be completely abstinent from intercourse, or must agree to practice two effective
methods of contraception while taking the investigational product and for at least two
months following the last dose of investigational product. Acceptable methods of
contraception include:
- Hormonal contraception (i.e., birth control pills, injected hormones, dermal
patch, or vaginal ring),
- Intrauterine device,
- Barrier methods (diaphragm, condom) with spermicide, or
- Surgical sterilization (tubal ligation).
6. Participant must have OCA1B, as defined by ALL (a-d) of the following criteria:
1. Participant has ophthalmic signs or symptoms of albinism, including:
- Bilateral visual acuity E-ETDRS EVA letter score of less than or equal to 83
(i.e., Snellen equivalent of 20/25 or worse) that is not attributable to any
other pathology.
- Bilateral iris transillumination that can be seen in clinical photographs.
2. Predominant contralateral decussation of ganglion cell axons, as determined by
pattern visual evoked potential (VEP).
3. Participant has at least one definitive mutation in the OCA1 gene (tyrosinase).
4. Participant has no definitive mutations in the OCA2 gene.
EXCLUSION CRITERIA:
- Participant is pregnant or breast-feeding.
- Participant is a male AND has a definitive mutation in the OA1 gene.
- Participant has any of the following abnormal laboratory test results:
1. Serum potassium < 3.0 mEq/L,
2. Serum CK > 500 U/L,
3. Hemoglobin < 10.0 g/dL,
4. White blood cell (WBC) count < 3.0 k/microL,
5. Plasma tyrosine > 150 microM,
6. ESR > 100 mm/h, and/or
7. Serum T4 > 15 microg/dL OR Serum T4 < 4 microg/dL.
- Participant has keratopathy.
- Participant has a current malignancy.
- Participant has open skin lesions.
- Participant is on a diet that deliberately increases protein intake to
disproportionate levels (e.g., Atkins diet). The diet must be reasonably balanced, as
determined by a dietician.
- Participant has uncontrolled hypertension, defined as systolic blood pressure above
180 mmHg or diastolic blood pressure above 95 mmHg.
- Participant has another chronic ocular disease that may confound the results of visual
tests, such as age-related macular degeneration, cataract of possible visual
significance, or uncontrolled glaucoma.
- Participant drinks more than the equivalent of two glasses of wine per day on average,
has a history of alcohol abuse, or has a severe liver illness.
- Participant s liver is > 3 cm below the right costal margin.
- Participant has a muscle disease.
- Participant is currently taking a medication known to cause elevated liver function
tests including statins/HMG-Co-A reductase inhibitors (e.g., lovastatin, simvastatin);
anti-epileptic medications (e.g., carbamazepine, phenytoin, phenobarbital);
tetracycline or its derivatives, if used chronically; acetaminophen, if used
daily/chronically; amiodarone; and any other medications with known significant liver
toxicity.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Nitisinone for Type 1B Oculocutaneous Albinism | NCT01838655 | Contradiction |
4,072 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
- Veteran Enrolled in the Minneapolis/St. Cloud VAHCS.
- Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the
fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- Equal to or older than 22 years of age.
- Proficient in both reading and writing in the English language.
- Pittsburgh Sleep Quality Index (PSQI) score 10 or higher.
- Epworth Sleepiness Scale (ESS): On question #8 any score above "0" will prompt an
additional question: Do you drive ("get behind the wheel") when you are drowsy? The
answer must be "No" to be enrolled in the study due to safety concerns.
- Have repetitive nightmares contributing to disrupted sleep as reported by the patient
- Wireless Internet and two power outlets where they sleep
- Prazosin use; if yes, the patient may be included if tapered by prescribing provider.
Taper must be completed and subject must be off prazosin for 2 days prior to
enrollment.
Exclusion Criteria:
- Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 20. A score of 1
or more on the suicide ideation item of the PHQ-9 will trigger a risk assessment.
- Uncontrolled atrial fibrillation
- Current use of varenicline
- Current use of beta-blockers (unless ophthalmic solutions)
- Current use of non-dihydropyridines
- Current use of Prazosin for the treatment of nightmares (can include patients 2 days
following taper and discontinuation) This would be coordinated with the prescribing
provider
- Circadian rhythm disruption on a regular basis (shift-work)
- Known diagnosis of Obstructive Sleep Apnea
- Diagnosis of an active disorder of arousal from non-rapid eye movement sleep
- Diagnosis of rapid eye movement sleep behavior disorder
- Diagnosis of narcolepsy
- Alcohol Use Disorders Inventory Test (AUDIT) (score of 8 or higher)
- Drug Abuse Screening Test-10 (DAST-10) (score greater than 2)
- Suspicion of nightmares being secondary to substance abuse or withdrawal
- Diagnosis or suspicion of dementia
- Previous or foreseeable legal proceedings involving nightmares or trauma
- Nocturia that causes awakening from sleep
- Known sleepwalking
- Acting out of dreams prior to PTSD trauma
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 22 Years old.
| Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) | NCT03795987 | Contradiction |
3,773 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
1. Males or Females 40 years and older
2. According to the clinical diagnosis standard of the American College of Rheumatology
(ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to
over 3 conditions of followings.
- Over 50 years of age
- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- 4 bony tenderness
- Bony enlargement
- Nopalpable warmth of synvium
3. Within 6 months from screening visit, someone who diagnosed with Kellgren & Lawrence
Grade I~III by the radioactive examination.
4. By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the
single or both sides of the osteoarthritis is over 40mm
5. Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or
other pain-killers in the past.
6. Patient who can walk by themselves without helper like cane or walker etc. (If the
patient who has used helper routinely from previous 6 months, evaluating the patient
including the helper is possible. In this case, patient needs to use same helper
continuously by end of the clinical trial test.)
7. Patient who agrees to participate in this clinical trial by themselves.
Exclusion Criteria:
1. Someone who has BMI≥32kg/m² at the screening visit.
2. Patient who has an experience dosing psychoactive drug, narcotic analgesic which can
have an effect on pain sense over 3 months habitually.
3. Patient who has been administrated gastrointestinal drug(for example H₂-blockers,
misoprostol or proton pump inhibitors) regularly, who can't stop injecting for
clinical study period.
4. Patient has attended abnormal values from screening test(2 times excess at upper limit
of the normal values at ALT, AST, BUN, Serum Creatinine).
5. Patient who has rheumarthritis or other inflammatory metabolic arthritis.
6. Patients having serious gastrointestinal, liver, renal, heart disease.
7. When the inflammatory disease is occurred on joint area to patient like septic
arthritis.
8. Patients having skin ailment at the injecting site of the joint region.
9. Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis
or systemic disease.
10. Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc
herniation.
11. Poly-articular patients who have suffered seriously by osteoarthritis at other parts
affect judge of the knee joint pain.
12. Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
13. Patients who were administrated below drugs before baseline visit.
- Patients who were injected HA at the target knee joint in recent 9 months.
- Patients who were injected HA at other parts of the knee joint in recent 6
months.
- Patients who were injected steroids into the intra-articular knee joint.
- Patients who were administrated steroids systemically by the oral medication
(But, except inhalation)
14. Patients who have joint effusion trouble were judged as a positive by tests like
Patella tap test.
15. Patients who have target knee joint gotten surgical operation history including
Arthroscopy within past one year (In case of having other side of knee joint or hip
joint gotten surgical operation history, excepting the patients if there is
possibility which can influence the target knee joint's appraisal.
16. Patients who have an operation history about target knee joint.
17. Patients who do the height weight aerobic exercise or anaerobic exercise.
18. Patients who need to be administrated anticoagulant agent together(But, except 300mg
daily dose aspirin)
19. Patients who have hypersensitivity history about Investigational Product.
20. In the midst of women in their childbearing years, patients who disagree to do *
contraception by medically permitted method for 12 weeks from administrating
investigational product.
* The contraception by medically permitted method: Condom, In case of using injection
or insertion, In case of installing a intrauterine contraception device etc.
21. Patients who were injected other investigational product over a time within 30 days
before participated in this clinical trail.
22. Besides that, the patients who have difficulty to be participated in this clinical
trial continuously by Principle Investigator (PI)'s decision.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Clinical Trial of YYD302 for Treatment of Osteoarthritis of the Knee | NCT02965495 | Entailment |
5,380 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Patients of either sex requiring removal of two impacted mandibular third molars (partial
bony or soft tissue impaction).
16 years of age of older.
Indicates willingness to undergo oral surgery with local anesthesia and intravenous
midazolam only.
Willing to return for the removal of the remaining maxillary third molars at a second
appointment.
Patients with a history of allergy to flurbiprofen, aspirin, or any NSAID will be excluded.
Those with a history of aspirin or NSAID-induced asthma will be excluded.
Females of childbearing potential who are not practicing adequate contraception will be
excluded.
Pregnant or nursing females will be excluded.
Patients with recent history or present signs of renal, hepatic, endocrine, pulmonary,
cardiac, gastrointestinal, neurologic, or cerebral function impairment will be excluded.
Those with psychiatric disorders will be excluded.
Patients who have taken an investigational drug within 30 days of this study will be
excluded.
Those who have taken another analgesic, steroid, opioid, or NSAID within 24 hours prior to
the study will be excluded.
Those with an absence of bilateral local anesthesia during surgery as evidenced by
anesthesia or paresthesia of the lower lip postoperatively will be excluded.
Patients who use drugs which will interact with NSAID such as aspirin, warfarin,
probenecid, methotrexate, lithium and diuretics will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction | NCT00001724 | Entailment |
6,162 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- healthy Caucasian origin
- age between 18 and 55 years
- accepting not to participate in another COVID-19 vaccine study until the end of the
study
- volunteers who do not plan to get a child in the next one year; the volunteer and the
partner should use a reliable form of contraception (abstinence, condom, birth control
implant, birth control pills used or IUD used by the partner) during the study for at
least 1 year
- participants must refrain from blood or plasma donation from the time of first
vaccination until 3 months after last vaccination
- the outcome of the following examinations should be clinically insignificant: medical
and surgical history (hypo-, hypertension, allergy, other diseases, major surgery,
micturition, defecation, sleep, illness within the last 4 weeks prior to the start of
the trial);
- life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special
diet, drug abuse) should be normal/acceptable
- body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ECG should
be normal/acceptable.
- physical examination (general state and abnormal findings per system:
endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose,
throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital,
musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be
normal/acceptable
- laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride,
total protein, albumin, glucose, creatinine, BUN, uric acid, total bilirubin, direct
and indirect bilirubin, lipid panel (total cholesterol, triglyceride, HDL, LDL), AST,
ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, leukocytes, platelet count,
prothrombin time (PT) and activated partial thromboplastin time (aPTT); HBsAg, HIV-Ab,
HCV-Ab; urine examination: urine color, appearance, specific gravity, pH, protein,
glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if
erythrocytes or leukocytes are out of the limits ) should be normal/acceptable.
- antiSARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.
- drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine,
opioids, barbiturates)
- normal body weight in relation to height and age according to BMI (accepted range 18.5
and 30 kg/m2)
Exclusion Criteria:
- women with a positive blood (β-HCG) pregnancy test
- lactating women
- history of COVID-19 infection or showing COVID-19 infection symptoms
- having had contact to people with known COVID-19 infection in the last 14 days
- having fever (> 37.4oC in the last 24 hours), dry cough or feeling tired and having
aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
- positive real time RT-PCR COVID-19 test.
- persons with autoimmune diseases
- allergic diathesis or any clinically significant allergic disease (i.e. asthma)
- any condition that might impair the immune response
- recent or current immunosuppressive medication
- any other vaccine application 30 days before the first dose
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC | NCT04691947 | Contradiction |
3,711 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | - INCLUSION CRITERIA:
Subjects must be 21-45 years of age.
Subject must be in good health and able to perform cycle ergometry for the length of the
study.
Subjects must provide informed, written consent for participation in this study.
Female subjects of childbearing age must have a negative pregnancy test.
EXCLUSION CRITERIA:
Subjects with a history of cardiac, pulmonary, peripheral vascular, or mitochondrial
disease.
Subjects with abnormal EKG other than sinus bradycardia.
Individuals with a future cardiovascular risk greater than 1 % in the next 10 years will be
excluded from the study. Risk will be calculated using the Framingham risk calculator
published on the web site: http://hin.nhlbi.nih.gov/atpiii/calculator.asp?usertype=prof.
Subjects with any physical condition (for example, knee problems) that may impair their
performance during exercise testing.
Subjects who have a history of smoking within one year.
Subjects with anemia (defined as hemoglobin less than 10 g/dL).
Subjects with a history of reaction to a medication or other substance characterized by
dyspnea and cyanosis will not participate in this study.
Subjects with G6PD deficiency.
Subjects with a baseline methemoglobin level greater than 1%.
Lactating females who are breastfeeding, will not participate since nitrite crosses into
breast milk and could cause methemoglobinemia in the infant.
No volunteer subject will be allowed to take any medication (oral contraceptive agents are
allowed), vitamin supplements, herbal preparations, nutriceuticals or other alternative
therapies for at least one month prior to study and will not be allowed to take aspirin or
NSAIDs for one week prior to study.
Subjects with a blood pressure of less than 100/70 mmHg on the study day will be excluded
from the protocol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 45 Years | Effect of Nitrite on Exercise Physiology and Metabolism | NCT00105222 | Contradiction |
6,380 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. The patient is attending for triage presenting with symptoms of an infection.
2. Subject has provided informed consent
3. Age ≥18 years
4. Fluent in Swedish (reading, writing, conversational)
5. Mental state is such that he or she is able to understand and give informed consent to
participation in the study by signing the Information and Consent Form
6. The investigator determines that the new method, and the reference methods, can be
used as intended with adequate reliability and safety
7. The time for investigations in this study is estimated to approximately 15-20 minutes.
Vital signs will be handed over to the care provider responsible for the further
management of the patient saving approximately 5-10 minutes of their time. Hence, the
delay in the management of each patient introduced by this study is approximately 10
minutes. Patients deemed being in such a severe medical condition on arrival, that 10
minutes of delay is deemed detrimental will not be included.
Exclusion Criteria:
1. Depressed level of consciousness from inclusion up until all investigations are
completed (during approximately 15-20 minutes).
2. Patient request to be withdrawn from the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Covid-19 Triage Using Camera-based AI | NCT04383457 | Entailment |
2,168 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Japanese HU patients (Outpatient)
- Patients who meet the following criteria concerning serum uric acid levels at the
screening [1) Gout: > 7.0 mg/dL, 2) HU with complications: ≥ 8.0 mg/dL, 3) HU without
complications: ≥ 9.0 mg/dL]
Exclusion Criteria:
- Patients who have any symptom of gouty arthritis within 2 weeks of investigational
product administration
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 64 Years | Phase II Exploratory Clinical Study of KUX-1151 | NCT02190786 | Contradiction |
6,717 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Subjects with severe hemophilia A (< 2% FVIII:C)
- Subjects with no history of FVIII inhibitor antibody formation
- Subjects with no measurable inhibitor activity
- Subjects with at least 200 EDs with FVIII concentrate in total, including 20 EDs in
the previous 6 months
- Subjects whose current treatment with any CHO rFVIII product
- Subjects with no elective surgery and/or continuous infusion FVIII administration is
foreseen during the study
- Subjects with normal prothrombin time (PT), partial thromboplastin time (PTT)
compatible with FVIII deficiency
Exclusion Criteria:
- Subjects with any other bleeding disease beside hemophilia A (i,e., von Willebrand's
disease)
- Subjects who have known intolerance or allergic reactions to constituents of rFVIII-FS
or known hypersensitivity to mouse or hamster proteins
- Any individual with a past history of severe reaction(s) to FVIII concentrates
- Subjects on treatment with immunomodulatory agents within the last 3 months prior to
study entry
- Subjects who were receiving or had received other experimental drugs within 3 months
prior to study entry
- Subjects who require any medication for FVIII infusions
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 60 Years | Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A | NCT00621673 | Contradiction |
879 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- • Subjects with hand OA having suffered from transient inflammatory attacks of the
interphalangeal finger joints characteristic for what has been termed 'inflammatory'
or 'erosive' hand OA.
- Subjects with hand OA showing inflammatory signs, either clinically or
ultrasonographically, of the interphalangeal finger joints.
- Subjects with hand OA in which at least 1 interphalangeal finger joint has the
typical appearance on the X-rays of a 'J' or 'E' phase joint as defined by the
criteria mentioned above.
- Subjects with hand OA where at least 1 interphalangeal finger joint in the 'J' or
'E' phase presents a palpable swelling.
Exclusion Criteria:
- • Patients with known hypersensitivities to mammalian-derived drug preparations.
- Patients with clinically significant hypersensitivity to any of the components of
Prolia.
- Current and/or Prior treatment with any investigational agent within 90 days, or
five half-lives of the product, whichever is longer.
- Previous administration of denosumab from clinical trials or others (e.g.
commercial use).
- Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (< 49.9 nmol/L)].
Possibility of replenishment and re-screening.
- Subjects with current hypo- or hypercalcemia (normal serum calcium levels:
8.5-10.5 mg/dl or 2.12-2.62 mmol/L).
- Patients currently under bisphosphonate (BP) treatment or any use of oral BPs
within 12 months of study enrollment or intravenous BPs or strontium ranelate
within 5 years of study enrollment
- Prior use of any chondroprotective drug within 90 days e.g. chondroitin sulfate,
glucosamine, avocado-soybean unsaponifiables, tetracyclins, corticosteroids.
- Prior use of any immunomodulating drug with possible effects on proinflammatory
cytokine metabolism within 90 days a.o. corticosteroids, methotrexate,
sulfasalazine, leflunomide, D-Penicillin, anti-malarials, cytotoxic drugs, TNF
(tumor necrosis factor) blocking agents.
- History of drug or alcohol abuse in the last year.
- Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid
arthritis, spondylarthropathy, psoriatic arthritis, gout, chondrocalcinosis or
other auto-immune diseases, e.g. systemic lupus erythematosus).
- History of cancer or lymphoproliferative disease other than a successfully and
completely treated squamous cell or basal cell carcinoma of the skin or cervical
dysplasia, with no recurrence within the last two years.
- History of any Solid Organ or Bone Marrow Transplant.
- Comorbidities: significant renal function impairment (glomerular filtration < 30
ml/min/1.73m2 or <50% of normal value), uncontrolled diabetes, unstable ischemic
heart disease, congestive heart failure (NYHA III, IV), uncontrolled hypo or
hyperparathyroidism, active inflammatory bowel disease, malabsorption, liver
failure or chronic hepatic disease (serum AST (aspartate aminotransferase )/ ALT
(alanine aminotransferase) levels 3 times above normal), recent stroke (within
three months), chronic leg ulcer and any other condition (e.g,. indwelling
urinary catheter) which, in the opinion of the investigator, would put the
subject at risk by participation in the protocol.
- Subject has any kind of disorder that compromises the ability of the subject to
give written informed consent and/or to comply with study procedures .
- Patient who is pregnant or planning pregnancy; if the female subject is of
child-bearing age, she must use a valid mean of contraception during the study
and for 9 months after last dose of study medication. For males with a partner of
childbearing potential: subject refuses to use 1 effective methods of
contraception for the duration of the study and for 10 months after the last dose
of study medication.
- Female subjects who are breast-feeding.
- History of osteonecrosis of the jaw, and/or recent (within 3 months) tooth
extraction or other unhealed dental surgery; or planned invasive dental work
during the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
| RANKL-blockade for the Treatment of Erosive Osteoarthritis (OA) of Interphalangeal Finger Joints | NCT02771860 | Entailment |
6,227 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Healthy on the basis of physical examination, medical history, vital signs, and
12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities,
they must be consistent with the underlying illness in the study population. This
determination must be recorded in the participant's source documents
- Healthy on the basis of clinical laboratory tests performed at screening. If the
results of the serum chemistry panel including liver enzymes, other specific tests,
hematology, urinalysis or breathing alcohol test are outside the normal reference
ranges, the participant may be included only if the investigator judges the
abnormalities or deviations from normal to be not clinically significant. This
determination must be recorded in the participant's source documents and initialed by
the investigator
- Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140
millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg
diastolic
- Have no history of psychiatric disorder within the 5 years prior to the screening
- Have no history of gastrointestinal resection that may affect drug absorption
Exclusion Criteria:
- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
abnormalities, significant pulmonary disease, including bronchospastic respiratory
disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below
60 milliliter per minute [mL/min]), thyroid disease, neurologic or psychiatric
disease, infection, or any other illness that the investigator considers should
exclude the participant or that could interfere with the interpretation of the study
results
- Clinically significant abnormal physical examination, vital signs, or 12 lead ECG at
screening as deemed appropriate by the investigator
- Known allergies, hypersensitivity, or intolerance to acetaminophen or its excipients
- History of malignancy within 5 years before screening (exceptions are squamous and
basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy,
which is considered cured with minimal risk of recurrence)
- Taken any disallowed therapies as noted in local prescribing information, concomitant
therapy before the planned first dose of study drug
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
| A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants | NCT04230252 | Contradiction |
2,121 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | Inclusion Criteria:
- Couple whose man is from 18 to 60 years old
- Couple whose man presents an infertility indicating a care in VITRO fertilization with
or without intracytoplasmic sperm injection (IVF +/- ICSI)
- Couple whose spouse is from 18 to 38 years old
- Couple whose spouse do not present particular factors of infertility
- Couple Taken care in IVF +/- ICSI
- Couple with social insurance
- 2 members of the couple having signed the consent
Exclusion Criteria:
- Etiology of not genetic known male infertility : infertility of neoplastic origine,
infertility of definitive obstructive origin
- Presence of a factor of feminine infertility : A definitive infertility tubal, Turned
out ovarian incapacity (FSH > 9 and/or CFA <= 8)
- Male infertility requiring the appeal to some sperm testicular or in some frozen
sperm- Men or women attend of HIV or hepatitis B or C
- Epileptic men
- Men under anti-folic treatment
- Men presenting a big sensibility to the folic acid or to one of the constituents of
the drug
- Couple of which one of the partners refuses to participate in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Impact of Folates in the Care of the Male Infertility | NCT01407432 | Entailment |
5,601 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- male or female children with ISS
- age greater than or equal to 8 years and less than or equal to 12 years and 3 months
for girls and greater than or equal to 9 years and less than or equal to 14 years and
3 months for boys
- bone age less than or equal to 12.0 years for girls and less than or equal to 14.0
years for boys based on a central reading of an X-ray of the left hand and wrist
- Pubertal stage B2 and B3 for girls based on the Tanner method
- Pubertal stage G2 and G3 for boys based on the Tanner method
Exclusion Criteria:
- Growth hormone deficiency (GHD)
- Insulin-like growth factor-I levels greater than 3 SDS
- Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to
eliminate a Turner syndrome, is mandatory
- Small for gestational age (SGA)
- Has reached menarche (had her first menstrual period)
- Have any significant concomitant disease that is likely to interfere with growth or
with the study, or is a known contraindication to Growth Hormone treatment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 171 Months | Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature | NCT00355030 | Contradiction |
5,583 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Adolescent girls 13-21 years old with bone age ≥ 14 years
- Overweight girls: Body Mass Index (BMI) greater than the 95th percentile for age
- Waist/Hip ratio ≥ 0.85
- Insulin Like Growth Factor -1 (IGF-1) below -0.5 standard deviations (SD) for pubertal
stage or age
Exclusion Criteria:
- Pregnancy (positive pregnancy test) prior to enrollment in the study
- Significant weight gain or loss within 3 months of study (more than 5 kg)
- Use of medications that affect GH or cortisol levels (such as estrogen including oral
contraceptive pills, oral glucocorticoids)
- Use of medications such as Meridian and Orlistat
- Presence of diabetes mellitus
- Uncontrolled Thyroid disorders
- Chronic renal insufficiency
- Participation in another simultaneous medical investigation or trial
- Active neoplasm or history of cancer
- Prader-Willi syndrome
- History of scoliosis if bone age is <15 years
- Hypersensitivity to rhGH or constituents of the injections
Female
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 21 Years | Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls | NCT01169103 | Contradiction |
3,153 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Male or female, aged 18 to 80 years (inclusive), and capable of providing their
written informed consent.
- Male subjects must be either not sexually active, surgically sterilized, or agree to
use an appropriate "double-barrier" method during study participation and for at least
30 days after the completion of dosing.
- Non-pregnant female subjects must be either not sexually active, post-menopausal,
surgically sterilized; or agree to use an appropriate "double-barrier" method; or are
currently using a prescribed transdermal, injection, implant, or oral contraceptive
for at least 30 days before study participation and at least 30 days after the
completion of dosing.
- Good health, as determined by a medical history, a physical examination, a detailed
oral examination, 12-lead ECG, and measurement of clinical chemistry, hematology,
urinalysis, and serology data.
- Demonstrated minimal level of unstimulated whole mouth salivary flow (greater than or
equal to 0.05 milliliters [ie, 0.05 grams] per 5 minutes).
- Demonstrated clinically significant, moderate to severe level of dry mouth at
screening as determined by his/her score on a 100-mm global VAS of dry mouth symptoms
with anchors ranging from 'not dry at all' (0) to 'dry as a desert' (100) as follows:
- Minimal VAS score of 50 mm at Visit 1.
- Diagnosis of primary Sjögren's syndrome.
Exclusion Criteria:
- Currently using a potassium-sparing diuretic antihypertensive drug that contains
amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton, Spiractin, Spirtone,
Verospiron or Berlactone); triamterene (e.g., Dyrenium); or plerenone (e.g., Inspra).
Chronic use antihistamines will be permitted if started at least 30 days before Visit
1, and a stable dose is maintained throughout the trial.
- Started using systemic cholinergic secretagogues or tricyclic antidepressant drugs
within 12 weeks before screening, is not on a stable dosing regimen for at least 14
days prior to the Screening visit, or who is unable to maintain stable dosing
throughout the study.
- Unable to withhold the use of oral comfort agents (eg, Oasis, MouthKote, etc)
following enrollment in the study (Visit 1).
- Shows evidence of a significant active or ongoing oral infection or other oral
conditions (eg, lichen planus) that, in the opinion of the Investigator, might affect
the safety of the subject or be exacerbated during study participation.
- Acutely infected salivary glands or suspected closure of the salivary glands.
- A condition that may confound the diagnosis of primary Sjögren's syndrome.
- Received an investigational drug within the past 30 days.
- Received 552-02 in a previous study.
- History of multiple drug allergies or allergy to any medicine chemically related to
the study drug (eg, amiloride, Moduretic, Midamor, triamterene).
- Any clinically significant allergic disease, including food allergies, with the
exception of nonactive hayfever.
- Present history of any clinically significant and uncontrolled neurologic,
gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic,
endocrine, or hematological disorder or disease, or any other major disorder or
disease, in the opinion of the Investigator.
- Sitting blood pressure at screening higher than 150/90 mmHg or lower than 100/50 mmHg
after resting for 5 minutes.
- Sitting pulse rate at screening outside the range of 50 - 90 beats per minute (bpm)
after resting for 5 minutes.
- Consumes more than 2 alcoholic drinks per day or has a significant history of
alcoholism or drug/chemical abuse within the past 12 months.
- History of using tobacco products within the last 3 months.
- Has viral hepatitis or tests positively for the hepatitis B surface antigen (HBsAg) or
hepatitis C (non-A, non-B) antibody, or a positive result for human immunodeficiency
virus (HIV) antibodies.
- Positive serum pregnancy test or is nursing (female subjects only).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome | NCT00852839 | Contradiction |
6,441 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Key Inclusion Criteria:
1. Male or female who is at least 18 years of age or older.
2. A clinical diagnosis of facial rosacea.
3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening
and at Baseline/Day 1 (prior to the study drug application).
4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and
at Baseline/Day 1 (prior to the study drug application).
Key Exclusion Criteria:
1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated
rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses
that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial
keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic
telangiectasia.
2. Presence of three (3) or more facial inflammatory lesions of rosacea.
3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates,
sedatives, systemic anesthetics, or alpha agonists.
4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac
glycosides, beta blockers or other antihypertensive agents.
5. Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic
hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal
or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea | NCT01355458 | Entailment |
4,048 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Key Inclusion Criteria (additional criteria may apply at screening):
1. A clinical diagnosis of osteoarthritis (OA) of the knee or hip based on the American
College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the
index joint) at the screening visit.
2. Willing to discontinue current pain medications and to adhere to study requirements
for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum
daily dose of 2500 mg [countries where 500 mg strength tablets/capsules are available]
or 2600 mg [countries where 325 mg strength tablets/capsules are available])
3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics
used for pain due to OA of the knee or hip
4. Currently using a stable dose of NSAID
5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during
the 24 weeks of treatment
Key Exclusion Criteria (additional criteria may apply at screening):
1. Non-compliance with the numeric rating scale (NRS) recording during the
pre-randomization period
2. History or presence at the screening visit of non-OA inflammatory joint disease,
Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple
sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal
osteodystrophy
3. History or presence on imaging of arthropathy, hip or knee dislocation, extensive
subchondral cysts, evidence of severe structural damage, bone collapse, or primary
metastatic tumor with the exception of chondromas or pathologic fractures
4. Trauma to the index joint within 3 months prior to the screening visit
5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
6. Patient is not a candidate for magnetic resonance imaging (MRI)
7. Is scheduled for a JR surgery to be performed during the study period or who would be
unwilling or unable to undergo JR surgery if needed
8. History or presence at the screening visit of autonomic or diabetic neuropathy, or
other peripheral neuropathy, including reflex sympathetic dystrophy
9. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)
10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic
failure, multiple system atrophy
11. Use of systemic corticosteroids within 30 days prior to the screening visit.
Intra-articular corticosteroids in the index joint within 12 weeks prior to the
screening visit, or to any other joint within 30 days prior to the screening visit
12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or
intolerance to anti-NGF antibodies
13. Women of childbearing potential who are unwilling to practice highly effective
contraception prior to the start of the first treatment, during the study, and for at
least 20 weeks after the last dose
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip | NCT03304379 | Entailment |
5,524 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
Participants must:
1. Meet the revised GCA diagnosis criteria (modified from ref 1)
2. Have either newly-diagnosed or relapsing disease
3. Have active disease (modified from ref 1, to remove ESR/CRP requirements)
4. Have been empirically started on glucocorticoid treatment (or had baseline
glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment
5. Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as
part of routine clinical care.
GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).
1. Age ≥ 50 years
2. And at least 1 of a. or b. :
1. Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery
tenderness, ischemia-related vision loss, jaw/mouth claudication
2. Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or
hip girdle pain associated with inflammatory stiffness
3. And at least 1 of a. or b.:
1. Temporal artery biopsy revealing features of GCA
2. Evidence of large-vessel vasculitis by angiography or cross-sectional imaging
study such as magnetic resonance angiography (MRA), computed tomography
angiography (CTA), or positron emission tomography-computed tomography (PET-CT)
Exclusion Criteria:
- Patients not meeting the above criteria or who are unable to provide informed consent
will be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA) | NCT03812302 | Entailment |
1,248 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | DISEASE CHARACTERISTICS:
- Radiologic evidence of a unilateral malignant pleural effusion requiring sclerosis or
ongoing drainage because it is symptomatic (dyspnea and/or progressive fatigue)
- An asymptomatic patient is eligible if the patient underwent a prior
thoracentesis within the past 2 weeks and was symptomatic before the procedure
- No bilateral effusions by plain chest x-ray
- Histologically or cytologically confirmed solid tumor or hematologic malignancy
- Histologic confirmation of malignant cells in pleural fluid is not required
- Pleural spaces must be naive to pleurodesis attempts
- No prior intrapleural therapy (defined as a chest tube in place or placed to
drain an effusion, prior surgical pleurectomy, or any prior chemical or
mechanical pleurodesis on the ipsilateral side)
- Placement of a small interventional radiology catheter for temporary
drainage is not considered intrapleural therapy as long as no sclerosant
medication was given and it has not been in place longer than 10 days
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- CTC 0-2
Hematopoietic
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Pulmonary
- No active pleural infection
Other
- No allergy to talc
- No surgical contraindication to talc usage
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Chemotherapy
- Concurrent systemic chemotherapy allowed
Radiotherapy
- Concurrent palliative radiotherapy to a symptomatic lesion allowed except to the
treated hemithorax within 30 days of the drainage procedure
Surgery
- See Disease Characteristics
- Prior thoracotomies without specific pleural ablation (including lobectomy but not
pneumonectomy) allowed
- Prior needle-based diagnostic interventions (fine-needle aspiration, small bore
catheter drainage of less than 10 days, or thoracentesis) allowed
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Standard Chest Tube Compared With a Small Catheter in Treating Malignant Pleural Effusion in Patients With Cancer | NCT00042770 | Entailment |
5,798 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Patients with Oral ulcers due to Benin mucous membrane pemphioid, Pemphius vulgaris
and Steven Johnson's Syndrome with mucositis score 4 and pain score 10
Exclusion Criteria:
- patients with any systemic other systemic condition
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| PRF in Management of Chronic Multiple Oral Ulcers | NCT03878771 | Contradiction |
2,061 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- diagnosis of asbestosis
Exclusion Criteria:
- other diseases
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Oscillation Mechanics of the Respiratory System Asbestos Exposed: Early Diagnosis | NCT02280343 | Contradiction |
1,453 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- age > 18
- complaint of dysphagia
Exclusion Criteria:
- pregnancy
- age <18
- on inhaled steroids within the last 30 days
- on systemic steroids in the last 30 days
- known diagnosis of Eosinophilic Esophagitis
- obvious obstructive etiology found at endoscopy
- increased risk of bleeding (on blood thinners or anti-platelet agents other than
aspirin)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Routine Screening for Eosinophilic Esophagitis in Patients Presenting With Dysphagia | NCT01028235 | Entailment |
4,525 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
To enroll into the clinical trial, potential subjects must:
1. Be in good general overall health with no chronic medical conditions that result in
periodic exacerbations that require significant medical care.
2. Be women between 18 and 35 years inclusive at the enrollment visit.
3. Have regular menstrual cycles that occur every 21-35 days when not using hormonal
contraception.
a. If subject is postpartum or post-abortal, she must have one menstrual bleed prior
to enrollment.
4. Be seeking contraception, and willing to use the study drug as the only contraception
method during their months of study participation.
5. If using a ring, patch, pill, or implant prior to study treatment, the subject must
discontinue the active hormone at least 4 days, and no more than 7 days, prior to
study drug initiation. Note that for combined oral contraceptive users, placebo pills
are not counted as active hormone.
6. If using a hormonal intrauterine device (IUD) prior to study treatment, the IUD must
be removed prior to study drug initiation; removal and study drug initiation can occur
on the same day, but the subject must refrain from sexual intercourse for 7 days
following IUD removal.
7. If using a copper IUD prior to study treatment, the IUD must be removed prior to study
drug initiation; removal and study drug initiation can occur on the same day. The IUD
removal and study drug initiation must occur during the first 7 days of a spontaneous
menses.
8. If using a non-hormonal contraceptive method (e.g. condoms or withdrawal) prior to
study treatment, drug initiation should occur within the first 7 days of a spontaneous
menses.
9. If the woman has received a long-acting injectable contraceptive (e.g.
depomedroxyprogesterone acetate) during the 10 months prior to screening, she must
have resumed cyclic spontaneous menses (two menstrual bleeds) since last injection.
10. Have a negative urine pregnancy test at the enrollment visit.
11. Have an intact uterus and both ovaries.
12. In the opinion of the investigator, be willing and able to follow all study
requirements, including use of the study product and be willing to record requested
information on a daily diary.
13. Understand and sign an (Institutional Review Board) IRB approved informed consent form
prior to screening activities (including fasting blood draws).
14. Have a diastolic blood pressure (BP) ≤95 mm Hg and systolic BP ≤145 mm Hg after 5
minutes in a sitting position at the enrollment visit. Hypertensive subjects who are
treatment controlled and, in the judgment of the investigator, are good candidates
require a waiver for participation.
15. Have a body mass index (BMI) < 40 kg/m2.
16. Be planning to have at least one act of heterosexual vaginal intercourse each month
during study participation.
17. Be willing to accept an unknown risk of pregnancy during study participation.
Exclusion Criteria:
To enroll into the clinical trial, potential subjects must not:
1. Be women with irregular menstrual cycles defined as a variation in cycle length of
more than 5 days.
2. Be planning pregnancy within their months of study participation.
3. Be currently breast-feeding or within 30 days of discontinuing breast feeding, unless
the subject has already had a menses following discontinuation of breast feeding.
4. Have undiagnosed abnormal genital bleeding.
5. Have known hypersensitivity to the active substance UPA or any of the excipients of
the study treatment.
6. Have a history of endometrial hyperplasia or malignancy.
7. Have abnormal Transvaginal Ultrasound (TVUS) or safety labs done at the screening
visit recognized as clinically significant by the investigator (or medically qualified
designee).
8. Have a previous history of endometrial ablation.
9. Have a previous history of liver disease or screening liver enzyme results more than
three times the upper limit of normal values.
10. Have a known clinically significant Pap test abnormality, as managed by current local
or national guidelines, that would require treatment during study participation.
11. Have any of the following known contraindication to progestin-only oral contraceptive
(OC):
1. History or existing breast cancer, or other hormone sensitive neoplasia;
2. Current or history of ischemic heart disease or stroke while pregnant or taking
birth control pills;
3. Systemic Lupus Erythematosus with positive or unknown antiphospholipid
antibodies;
4. Benign or malignant liver tumors;
5. Severe (decompensated) cirrhosis.
12. Have known or suspected alcoholism or drug abuse.
13. Have known HIV infection.
14. Have an anticipated need for regular condom use as defined as use of at least one
condom per month after enrollment.
15. Have previously participated in the study.
16. Have a current need for exogenous hormones or therapeutic anticoagulants.
17. Have a current or history of deep vein thromboembolic disorder or aortic
thromboembolism, including stroke and myocardial infarction
18. Have a current or past medically diagnosed severe depression, which, in the opinion of
the investigator, could be exacerbated by use of a hormonal contraceptive, unless she
is stable on antidepressant medication.
19. Have concomitant use of medication thought to interact with UPA (per Summary of
Product Characteristics (SPCs)) such as CYP3A4 inducers (rifampin, barbiturates,
carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St John's
Wort, topiramate).
20. Have concomitant use of moderate or strong CYP3A4 inhibitors as identified by the FDA.
Subjects who begin use of a moderate CYP3A4 inhibitor after study enrollment require a
waiver to continue in the study.
21. Use any medications that can interfere with the metabolism of hormonal contraceptives,
antibiotics that can interfere with metabolism of hormonal contraceptives, or any
drugs designated by the FDA as falling in the Pregnancy and Lactation narrative
subsections (formerly Category D or X medications).
22. Currently participate in any other trial of an investigational medicine or device or
have participated in the three months before start of treatment or be planning to
participate in another clinical trial during this study.
23. Have a history of a bariatric surgery procedure associated with malabsorption.
24. Be planning to undergo major surgery during study participation.
25. Live outside of the catchment area of the study site.
26. Have used UPA, including Ella, within 30 days prior to enrollment and not had a menses
since using UPA.
27. Any site staff member with delegated study responsibilities or a family member of a
site staff member with delegated study responsibilities.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Study of the Safety and Efficacy of Ulipristal Acetate (UPA) Used Daily as a Contraceptive | NCT03296098 | Contradiction |
1,463 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
1. Dyslipidemia: Total cholesterol (TC) >200 mg/dL; LDL-C > 130 mg/dL ; TG > 200 mg/dL;
male HDL-C < 40 mg/dL, female HDL-C < 50 mg/dL, or under lipid lowering therapy
2. Atherosclerotic vascular disease:
1. Coronary atherosclerosis as evidenced by cardiac catheterization examination,
having history of myocardial infarction as evidenced by ECG or hospitalization,
angina patient showing ischemic ECG changes or positive response to stress test;
2. Cerebral vascular disease, cerebral infarction, intracerebral hemorrhage
(excluding intracerebral hemorrhage associated with other diseases); transient
ischemic attack (TIA) with carotid artery ultrasound confirming atheromatous
change with more than 70% blockage;
3. Peripheral atherosclerosis with symptoms of ischemia and confirmed by Doppler
ultrasound or angiography in history.
3. Control subjects: Age, gender-matched healthy adults without dyslipidemia and
atherosclerotic diseases will be recruited as control subjects.
Exclusion Criteria The main exclusion criteria will be hemodynamically significant valvular
or congenital heart disease, life-threatening malignancy, treatment with immunosuppressive
agents, or any condition or situation which, in the opinion of the investigator, might be
not suitable for this registration.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
| Circulating Non-coding RNAs and Cardiovascular Outcomes in Patients With Dyslipidemia and Atherosclerosis | NCT03279770 | Entailment |
4,335 | 33 | A 20-year-old man comes to the clinic for his routine checkup. The patient wears glasses for myopia and takes no medications. Vital signs are normal. On physical examination, the patient is tall with long upper extremities and fingers. The face appears narrow with down-slanted palpebral fissures, flattened malar bones, and a small jaw. The lungs are clear on auscultation. The abdomen is soft with no organomegaly. The patient is diagnosed with Marfan syndrome, and he is cooperative with his medical appointments. He is working as driver. | I'm a 20-year-old guy, working as a driver and I went to the clinic for my routine checkup. I have myopia, so I wear glasses and I don't take any other medications. My vitals were normal. I also did a physical exam, and I was told that I have long legs, arms, and fingers. They also told me that my face is quite narrow, with down-slanted eyes and a small jaw. My lungs were fine and my tummy too. I have been diagnosed with Marfan syndrome and I haven't been skipping any medical appointments since. | Inclusion Criteria:
1. Male and female subjects in the range of 18 - 45 years of age.
2. Body weight within ± 15% of ideal weight as related to height and body frame according
to Life Insurance Corporation (LIC) Chart. (Appendix A)
3. Subjects with normal findings as determined by baseline history, physical examination
and vital signs (blood pressure, pulse rate, respiration rate and body temperature)
4. Subjects with normal findings as determined by hematological tests, serum chemistry,
urine analysis, ECG and X-ray.
5. Willingness to follow the protocol requirement as evidenced by written, informed
consent.
6. Agreeing to, not using any medication (prescription and over the counter), including
vitamins and minerals for 15 days prior to study and during the course of the study.
7. No history or presence of significant alcoholism or drug abuse in the past one year.
8. Non-smokers, ex smokers and light smokers will be included. "Light smokers are defined
as someone smoking 10 cigarettes or less per day, ex smokers as someone who completely
stopped smoking for at least 3 months.
Exclusion Criteria:
1. Requiring medication for any ailment including enzyme-modifying drugs Use of any drugs
known to induce or inhibit hepatic drug metabolism (e.g.s, inducers: barbiturates,
carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRIs, cimetidine,
diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones,
antihistamines) within 30 days prior to administration of the study medication.
2. Any medical or surgical conditions, which might significantly interfere with the
functioning of gastrointestinal tract, blood-forming organs etc.
3. History of cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological,
metabolic diseases.
4. History of psychiatric disorder or history of suicide attempt.
5. Participation in a clinical drug study or bioequivalence study 90 days prior to
present study.
6. History of malignancy or other serious diseases.
7. Refusal to abstain from food for ten (10) hours prior to study drug administration the
day of each study period and for four (4) additional hours each, post dose.
8. Refusal to abstain from water for one (1) hour prior to study drug administration the
day of each study period and for two (2) additional hour, post dosing.
9. Any contraindication to blood sampling.
10. Refusal to abstain from smoking or consumption of tobacco products 24 hours before
dosing until last sample collection of each period. Habituation of tobacco
necessitating uninterrupted tobacco consumption.
11. Use of xanthine-containing beverages or food for 48 hours prior to each drug dose.
12. Blood donation 90 days prior to the commencement of the study.
13. Subjects with positive HIV tests, HbsAg or Hepatitis-C tests.
14. Known history of allergic reactions to zolpidem or other related drugs.
15. History of drug abuse in the past one year.
16. Use of prescription medication within 14 days prior to administration of study
medication or over the counter products (including natural food supplements, vitamins,
garlic as a supplement) within 2 weeks prior to administration of study medication,
except for topical products without systemic absorption.
17. Pregnant and lactating women.
- At the time of screening, prior to enrollment, presence of pregnancy will be
confirmed by urine pregnancy test.
- Female subjects not confirming to using birth control measures, from the date of
screening till the completion of the second period of the study. Abstinence,
barrier methods (condom, diaphragm, etc.) are acceptable. Use of hormonal
contraceptives either oral or implants will not be acceptable.
18. Female subjects whose menstruation cycle coincides with the study periods.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Zolpidem Tartrate Tablets Under Fasted Conditions | NCT00939536 | Contradiction |
1,578 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. Male subjects between the ages of 40 and 55 years with a body weight between 60 and 90
kg and a body mass index calculated using Quetelet's Index - weight (kg)/height2 (m2)
between 18.5 - 30.0
2. Signed and dated a written informed consent form (ICF) before undergoing any study
related activities, including discontinuation of any prohibited medications
3. Medically normal subjects with no significant abnormal findings at the screening
physical examination as evaluated by the investigator
4. Strictly normal values of ALT, AST and bilirubin and normal or abnormal and clinically
insignificant results (if agreed by the Investigator and the Sponsor on a case by case
evaluation) of the other blood and urine laboratory parameters at screening
5. All sexually active male subjects and their partners are willing to undergo
contraception as follows:
All male subjects, including those who are sterilised (i.e., vasectomy), should use a
condom. Their female partner must also use at least 1 of the medically acceptable
forms of contraceptives listed below. Male subjects must not donate sperm or have
unprotected sex during the study and until 87 days after taking the dose of
investigational product.
Medically acceptable contraceptives for this study are:
Condoms in addition to:
- Intrauterine devices
- Hormonal contraceptives (oral, depot, patch, injectable, or vaginal ring)
- Diaphragms with spermicidal cream or gel
- Cervical cap with spermicidal cream or gel
- Spermicidal foam
6. The ability to understand the requirements of the study and willingness to comply with
all study procedures
Exclusion Criteria:
1. Known history or evidence of clinically significant disorders such as cardiovascular
(including arrhythmia, acute QTc interval greater or equal to 450 mseconds),
respiratory (including active tuberculosis), hepatic, renal, gastrointestinal,
immunological (including active HIV-AIDS), neurological (including auditory),
endocrine, infectious, malignancy, psychiatric or other clinical abnormality
2. Known history of hypersensitivity, allergic or adverse reactions to Pyronaridine
3. Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or
Hepatitis C antibody (HCV Ab)
4. Seropositive HIV antibody
5. Previous participation in any clinical study with Pyramax
6. Presence or recent history (last two years) of tobacco abuse (≥10 cigarettes/day)
7. Known or suspected alcohol abuse or illicit drug use in the last 10 years before the
study start or positive findings on urine drug screen
8. Intake of grapefruit and grapefruit juice alcoholic beverages or caffeine-containing
food or beverages, such as coffee, tea, chocolate, or cola, 48 hours before study drug
administration
9. Use of over-the-counter (OTC) medications, including vitamins, analgesics, or
antacids, 1 week before the study start
10. Use of prescription medications 14 days before the study start or required chronic use
of any prescription medication
11. Use of enzyme-altering agents (e.g., barbiturates, phenothiazines, cimetidine, etc.)
within 30 days or 5 half lives, whichever the longer, before the study start
12. Plasma donation 1 month before the study start
13. Blood donation of 450 mL or more in the last 3 months before the study start
14. Participation in other clinical trials during the previous month in which an
investigational drug or a commercially available drug was tested
15. Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray
investigation, isotope studies)
Male
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 55 Years | Human Mass Balance Study of Pyronaridine | NCT01383109 | Contradiction |
4,409 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
1. Subject has signed the Institutional Review Board (IRB) approved Informed Consent Form
specific to this study prior to enrollment
2. Subject has a clinical diagnosis of lateral epicondylitis
3. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion
4. Subject's symptoms have persisted for at least 3 months despite conservative treatment
that includes one or combinations of:
1. Physical therapy
2. Splinting
3. Nonsteroidal antiinflammatory drug (NSAID)
4. Corticosteroid injection
5. Subject is independent, ambulatory, and can comply with all post-injection evaluations
and visits
6. Subject is 21-80 years of age and considered to be skeletally mature
Exclusion Criteria:
1. Subject has undergone previous corticosteroid injection therapy to the effected elbow
in less than three months prior to enrollment
2. Subject has received previous Platelet Rich Plasma (PRP) injection to the affected
elbow
3. Subject is deemed to require a corticosteroid injection into the affected elbow during
the course of the study
4. Subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid
usage >10mg/day)
5. Subject has undergone surgical intervention to the affected elbow for the treatment of
lateral epicondylitis
6. Subject has a positive medical history of any of the following:
1. medial epicondylitis
2. radial tunnel syndrome
3. carpal tunnel syndrome
4. septic or gouty arthritis
5. cervical radiculopathy
6. trauma to the affected elbow within the past 6 weeks
7. neuromuscular or musculoskeletal deficiency, which limits the ability to perform
functional measurement (e.g. grip strength test)
7. Subject currently has an acute infection at the injection site
8. Subject has tested positive or been treated for a malignancy in the past or is
suspected of having a malignancy or are currently undergoing radio- or chemotherapy
treatment for a malignancy anywhere in the body, whether adjacent to or distant from
the proposed rhPDGF-BB Injection treatment site
9. Subject is physically or mentally compromised (e.g. currently being treated for a
psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that
the Investigator judges the subject to be unable or unlikely to remain compliant
10. Subject has an allergy to yeast-derived products
11. Subject has received an investigational therapy or approved therapy for
investigational use within 30 days of injection procedure or during the follow-up
phase of this study
12. Subject is a prisoner, or is known or suspected to be transient
13. Subject's condition represents a worker's compensation case
14. Subject is currently involved in a health-related litigation procedure
15. Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol
abuse within the 12 months prior to screening for study entry
16. Subject is pregnant, or able to become pregnant but not practicing a
medically-accepted form of birth control, and/or intending to become pregnant during
this study period
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis | NCT01746420 | Contradiction |
4,460 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- written informed consent
- age 18-65
- employed
- chronic lateral epicondylitis (duration >3 months)
- pain in lateral epicondyle
- pain in resisted wrist extension in elbow extension (Cozen test)
- X-ray or Magnetic resonance imaging (MRI) of the elbow (<12 months from enrollment)
with no pathological findings other than lateral epicondylitis
Exclusion Criteria:
- pregnancy, verbal confirmation from patient required
- unemployment
- allergy to levobupivacaine, bupivacaine or liposomal bupivacaine
- constant use of strong analgesics (e.g. opioids)
- other source of elbow pain (e.g. medial epicondylitis, distal biceps/triceps
tendinitis)
- bilateral epicondylitis
- inability to give informed consent
- inability to understand the enrollment forms or to fill patient diary (forms are
written in Finnish)
- previous injection treatment (e.g. cortisone, botulin toxin A, autologous plasma) for
lateral epicondylitis during the past 3 months
- severe hepatic disease, or other underlying severe illness (cardiac failure, cancer,
other systemic diseases)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Levobupivacaine Versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis | NCT04382144 | Contradiction |
4,421 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
1. Clinically diagnosed tennis elbow defined as: Pain on the lateral side of the elbow,
made worse by pressure applied on the lateral epicondyle of the humerus and during
resisted extension of the wrist or when making a fist with the elbow joint straight.
2. Duration of symptoms over 10 months
3. Age between 35 and 60 years
4. Ability to fill in Finnish questionnaires
5. Written informed consent
Exclusion Criteria:
1. Earlier fracture or dislocation in the elbow joint area
2. Earlier surgical treatment of the same elbow joint
3. Congenital deformity in the elbow
4. Systemic muscle, tendon, nerve or joint disease
5. Other problems causing pain the elbow joint:
1. Pain in the medial epicondyle of the elbow
2. Pain in the biceps muscle tendon
3. Painful snapping or crepitus of elbow joint
4. Instability of elbow joint (table top, posterolateral drawer test)
6. A passive movement limitation of more than 10 degrees in the elbow joint
7. Abnormal finding in an elbow joint X-ray. An elbow joint X-ray is a routine
examination of elbow symptoms.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 60 Years | Finnish Tennis Elbow Trial Pilot Study | NCT02425982 | Contradiction |
5,364 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Generally healthy non-smoking (for at least 3 months) adolescent females 12-16 years
of age with a history of at least 1 year of cyclic heavy menstrual bleeding (HMB)
- Subjects must report regularly occurring menstrual periods ≤10 days in duration, with
21-45 days from the start of one period to the start of the next menstrual period
- Diagnosis of HMB based on the medical judgment of the Principal Investigator and will
include the following criteria:
1. Laboratory (including a bleeding disorders work-up) and Physical Findings;
2. Limitations in Activities of Daily Living (ADL);
3. Soiling, Staining and Clotting;
4. Sanitary product usage and extent of MBL using a patient reported pictorial blood
assessment chart (PBAC).
- Subjects should either be sexually inactive (abstinent) or be using one of the
following acceptable birth control methods and agree to continue its use throughout
the study:
- copper intrauterine device (IUD) in place for at least 3 months;
- barrier methods (condom, diaphragm) with spermicide for at least 1 month prior to
the first dose and throughout the study.
- Negative pregnancy test results
- Subject's legally authorized representative (e.g., parent, guardian) must voluntarily
sign a parental permission/informed consent form (ICF), and the subject must sign an
assent, before the conduct of any study procedure
Exclusion Criteria:
- Breast-feeding, or a history of abortion in the last 6 months
- Known bleeding or coagulation disorders based on medical history and/or laboratory
results
- Known systemic hematologic diseases (e.g., all types of sickle-cell disease,
thalassemia of all types, multiple myeloma, hemolytic anemia)
- Clinical evidence of any significant chronic illness, including cardiovascular, renal,
neurologic, hepatic, endocrine, gastric, central nervous system disease, any
psychiatric illness which could affect the efficacy or safety of study medication
- Subjects treated with systemic steroids in the last 1 month or hormonal treatment in
the last 3 months
- A history or presence of any drug abuse or alcohol abuse within the last 1 year
- History of subarachnoid hemorrhage.
- Active thromboembolic disease; history of thrombosis or thromboembolism, including
retinal vein or artery occlusion; an intrinsic risk of thrombosis or thromboembolism
- Use of vaginal hormone products (rings, creams, and gels) within 4 weeks prior to
screening. Use of oral estrogen-, progestin-, or selective estrogen receptor within 8
weeks prior to screening. Use of Lupron (3-month depot injection), estrogen pellet, or
long-acting progestin injectables within 6 months prior to screening
- Subjects whose sitting blood pressure is less than 90/60 mmHg at screening
- Subjects whose pulse is lower than 50 b.p.m. at screening
- Subjects whose PR interval is >200 msec at screening and prior to dosing
- Subjects whose QTc interval >450 msec
- Subjects with positive tests for hepatitis B, C, or human immunodeficiency virus (HIV)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 16 Years | Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding | NCT01190150 | Contradiction |
2,159 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
- Male or post-menopausal or surgically sterile female.
- 18 - 75 years of age.
- Hyperuricemic (i.e., screening sUA ≥8 mg/dL).
- Meets criteria for the diagnosis of gout as per the American Rheumatism Association
(ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
- Willing and able to give informed consent and adhere to visit/protocol schedules
(informed consent must be given before the first study procedure is performed).
- Subjects entering the optional Extension Period must have successfully completed the
Double-Blind Treatment Period and Follow-up Period within approximately 4 months and
must not have experienced any serious adverse events considered possibly related to
study drug.
Exclusion Criteria:
- Classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour
urine).
- Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of
wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).
- History or suspicion of drug abuse.
- Documented history of or suspicion of kidney stones.
- History of rheumatoid arthritis or other autoimmune disease.
- Confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
- Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
- History of malignancy, except treated non-melanomatous skin cancer or cervical
dysplasia.
- History of cardiac abnormalities, including abnormal and clinically relevant ECG
changes such as bradycardia (sinus rate <45 bpm), complete left bundle branch block
(LBBB), second or third degree heart block, intraventricular conduction delay with QRS
duration >120 msec, symptomatic or asymptomatic arrhythmias with the exception of
sinus arrhythmia, evidence of ventricular pre-excitation, frequent palpitations or
syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome,
and/or family history of sudden death in an otherwise healthy individual between the
ages of 1 and 30 years.
- Any condition predisposing them to QT prolongation including pathological Q-wave
(defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
- Any use of a concomitant medication that prolong the QT/QTc interval within the 14
days prior to Baseline (Day 0)
- QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at
Screening or pre-dose at Baseline (Day 0)
- Uncontrolled hypertension (above 150/95)
- Inadequate renal function
- Hemoglobin < 10 g/dL (males) or < 9 g/dL (females)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit
of normal (ULN)
- Gamma glutamyl transferase (GGT) > 3 x ULN
- Active peptic ulcer disease requiring treatment
- History of xanthinuria, active liver disease, or hepatic dysfunction.
- Requires therapy with any other urate-lowering medication, other than the study
medication.
- Requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine;
theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide;
sulfamethoxazole; or trimethoprim
- Taking medications known as enzyme inducers
- Receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month
prior to study drug dosing
- Gout flare at screening that is resolved for less than one week prior to the first
treatment with study medication (exclusive of chronic synovitis/ arthritis)
- Female of childbearing potential
- Received an investigational medication within 4 weeks prior to study medication
administration
- Previously participated in a clinical study involving RDEA806 or RDEA594.
- Known hypersensitivity or allergy to RDEA594 or colchicine or any components in their
formulations.
- Body mass index (BMI) >40 kg/m2.
- Taking greater than 1000 mg/day of Vitamin C.
- Any other medical or psychological condition, which in the opinion of the Investigator
and/or Medical Monitor, might create undue risk to the subject or interfere with the
subject's ability to comply with the protocol requirements, or to complete the study.
- Inadequate renal function after completing the Double-Blind Treatment period prior to
entering Extension Period.
- Requiring treatment with prohibited medications noted in exclusion criteria numbers
20-23 after completing the Double-Blind Treatment Period prior to entering the
Extension Period.
- Clinically relevant medical event as determined by the investigator in consultation
with medical monitor prior to entering the Extension Period.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Gout Dose Response Study | NCT00955981 | Contradiction |
1,114 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Patients with primary cardiac hypertrophy, non-dilated LV cavity and preserved LV
systolic function, hence, the diagnosis of HCM, who have at least an LV end diastolic
(LVSD) wall thickness of at least 15 mm on a 2D echocardiogram and
- Known to have mutations in genes encoding sarcomeric proteins
Exclusion Criteria:
- Hypersensitivity to NAC
- Individuals younger than 18 years old (in the pilot study)
- Phenocopy conditions, diagnosed clinically or genetically
- Patients who have undergone transcatheter (alcohol) septal ablation within 6 months.
- Individuals (typically family members) with causal mutations but an LVSD wall
thickness of <15 mm
- Patients with concomitant diseases such as:
- Significant coronary artery disease >70% luminal diameter stenosis in ny of the
major coronary arteries (if known);
- Valvular heart diseases (more than mild aortic stenosis and mitral regurgitation,
the latter judged to be due to primary mitral valve abnormalities);
- Uncontrolled hypertension, defined as systolic blood pressure of
- 140 mmHg and diastolic blood pressure of ≥90 mmHg on medication, mean of
three measurements at rest);
- Other significant medical problems, such as moderate to severe chronic renal
failure (GFR<45 ml/min/1.73m2), advanced liver disease, cancer, or other
disabling conditions
- Pregnant women, nursing mothers and those who plan pregnancy during the study period
- Those with active asthma (albeit the concern is relevant to nebulizer form but not
oral formulations)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Hypertrophic Regression With N-Acetylcysteine in HCM | NCT01537926 | Entailment |
592 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Request for elective abortion
- Ability to understand the consent form
- A pregnancy of 7 weeks gestation or less on Day 1
- Documented by endovaginal ultrasound
- Willingness to comply with visit schedules
Exclusion Criteria:
- Haemoglobin less than 90 g/L
- Uncontrolled seizure disorder
- Active liver disease (aspartate aminotransferase >2x normal)
- Renal insufficiency (serum creatinine >120umol/L)
- A history of intolerance to methotrexate or misoprostol
Female
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 60 Years | Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion | NCT00129506 | Entailment |
1,934 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Clinically diagnosed as early gastric cancer
- Willing to undergo endoscopic submucosal dissection or surgery for the treatment of
early gastric cancer
Exclusion Criteria:
- Advanced stage gastric cancer
- Not willing to undergo endoscopic submucosal dissection or surgery for the treatment
of early gastric cancer
- Not willing to participate in this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Endoscopic Submucosal Dissection Versus Surgery in the Treatment of Early Gastric Cancer | NCT03857737 | Entailment |
4,826 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | Inclusion Criteria:
- patients with both unilateral adrenal incidentaloma and hypercortisolism
- definition of hypercortisolism
- overnight dexamethasone suppression test, serum cortisol>1.8ug/dL
- 24hr urine cortisol > upper reference limit
Exclusion Criteria:
- patients who took medication influencing cortisol secretion
- patients with definite clinical feature of cushing syndrome
- moon face
- abdominal striae
- skin or proximal muscle atrophy
- metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure,
rheumatic disease, hematologic disease
- patients who took following medication
- insulin
- oral hypoglycemic agent
- thyroid hormone
- anti-hyperlipidemic drug
- sex hormone
- patients who taking steroid hormone or who took steroid hormone more than 2 weeks
within 1 year
- psychiatric disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 70 Years | Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma | NCT01382420 | Contradiction |
440 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Menstruating females with menorrhagia or menometrorrhagia referred to hematology or
gynecology clinics at Texas Childrens Hospital. Menorrhagia is defined as regular
periods with heavy menstrual bleeding with a PBAC score greater than 100;
menometrorrhagia is heavy vaginal bleeding occurring at irregular intervals.
2. PBAC Score greater than 100 for 2 consecutive cycles
3. Pelvic ultrasound that excludes pelvic pathology that can cause menorrhagia within 12
months prior to study participation.
4. Normal external genitalia examination within 6 months prior to study participation.
5. Normal thyroid stimulating hormone (TSH) in the last 6 months prior to study
participation.
6. Negative urine or serum pregnancy test within 4 weeks prior to study participation.
Exclusion Criteria:
1. Presence of intra uterine device.
2. Presence of a diagnosed bleeding disorder based on the standard work-up including
complete blood count (CBC), prothrombin time, partial thromboplastin time, fibrinogen,
von Willebrand panel and platelet function analysis (PFA-100) or platelet aggregation.
3. Intake of medications with increased risk of bleeding
4. Taking herbal products.
5. Sexually active status.
6. Body weight less than 40 kg.
Female
No healthy subjects accepted to join the trial.
Subject must be at most 21 Years | Tranexamic Acid (TA) vs Combined Oral Contraceptive (COCP) Pilot Study | NCT01428713 | Contradiction |
1,848 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Endoscopically proven gastric adenocarcinoma
- Standard gastrectomy and a D2 lymph node dissection;
- Desire to attend the study protocol
Exclusion Criteria:
- Metastatic or overt peritoneal disseminated cancer
- Undesired reaction to attend the study protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Serum and Peritoneal CEA and CA 19-9 for Gastric Adenocarcinoma | NCT02801955 | Entailment |
3,045 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- aged between 12 and 18 years
- overweight and obesity
- mild or moderate intellectual disability
Exclusion Criteria:
- physical disability
- medical predispositions towards obesity (genetic syndrome or drug treatment)
- contraindications (e.g. asthma, heart disease)
- having participated in other exercise programs in the past 6 months.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 12 Years old.
Subject must be at most 18 Years | School-based Physical Activity Intervention for Obesity Among Adolescents With Intellectual Disability in Hong Kong | NCT04463069 | Entailment |
3,999 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- At least one knee with osteoarthritis with Kellgren-Lawrence grade 3
- Significant osteoarthritis pain in the knee
- Presence of at least one of the risk factors: obesity (BMI > 28), osteoarthritis at
other sites, knee effusion, family history of total joint replacement
Exclusion Criteria:
- Women with childbearing potential
- Secondary osteoarthritis
- Treatment with intra-articular or systemic steroids
- Inability to undergo MRI acquisition
Other protocol defined inclusion/exclusion criteria may apply.
No condition on gender to be admitted to the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years | Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee | NCT00371670 | Entailment |
4,797 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
1. 18-30 years old, male or female;
2. PTA (0.5,1,2kHz) ≤25dB HL;
3. Tinnitus is a major problem faced by patients (except healthy volunteers);
4. tinnitus course > for 3 months;
5. Healthy, no history of other ear diseases, no history of hearing impairment;
6. There are no other medical, psychological or social problems that need urgent
treatment, and no other problems that interfere with tinnitus-related treatment;
7. Voluntary tinnitus treatment, and have enough time to cooperate with treatment.
Exclusion Criteria:
1. Pulsatile tinnitus;
2. Acute tinnitus;
3. Tinnitus is associated with severe hearing loss;
4. Tinnitus accompanied by vertigo;
5. Tinnitus accompanied by headache;
6. Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular
joint disorder;
7. Post-traumatic tinnitus;
8. Tinnitus is associated with serious psychiatric complications;
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention | NCT04449237 | Entailment |
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