id
int64 3
7.01k
| topic_id
int64 1
50
| statement_medical
stringclasses 50
values | statement_pol
stringclasses 50
values | premise
stringlengths 111
17k
| NCT_title
stringlengths 18
299
| NCT_id
stringlengths 11
11
| label
stringclasses 2
values |
|---|---|---|---|---|---|---|---|
5,291 | 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 > 18 years
- Presence of:
- at least one and at most two acute VCF (< 6 weeks) at levels caudate to T4, confirmed
with physical examination and radiographic imaging
- if timing of the fracture is unclear, the following criteria are required for
inclusion in the trial
1. an MRI scan showing edema at the fracture level(s) or
2. a bone scan showing increased uptake
- Physical examination showing axial back pain likely secondary to the VCF with
restricted mobilization (score not maximum on any one of the following Barthel's Index
items: transfer, mobility, bathing, dressing, stairs and toilet use)
- French or English speaking patient willing to return for follow-up or capable of
following up with phone interviews if needed
Exclusion Criteria:
- Recent (<30 days) major surgery causing debilitating pain
- Coagulopathy or thrombocytopenia precluding interventional treatment
- Inability to provide informed 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.
| Vertebroplasty In The Treatment Of Acute Fracture Trial - The VITTA Trial | NCT02370628 | Entailment |
3,038 | 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:
- Diagnosis of mile to moderate IDD as determined by a Community Service Provider
operating in Kansas under the auspices of a Community Developmental Disability
Organization (CDDO)
- Able to understand and give informed consent
- If there is a guardian with power of attorney, both the guardian and participant must
give informed consent
- Participants must live in a supported living condition either at home or with no more
than 1-4 residents and have a care giver (ie. parent, staff) who assists with food
shopping, meal planning, and meal preparation
- Overweight or obese determined by a BMI > 25 kg/m2
- Able to walk
- Clearance provided from physician
- Able to communicate preferences
Exclusion Criteria:
- Uncontrolled hypertension
- Severe heart disease
- Cancer diagnosis
- Positive for HIV
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.
| Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD) | NCT01724905 | Entailment |
133 | 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:
- Total testosterone level <10.4 nanomoles per liter (nmol/L) [300 nanograms per
deciliter (ng/dL)] at screening
- Presents with 1 or more of the following symptom(s) of ejaculatory dysfunction:
delayed ejaculation, anejaculation, decreased force of ejaculation, or decreased
ejaculatory volume, as determined by investigator assessment
- Prostate-Specific Antigen (PSA) <4 nanograms per milliliter (ng/mL) at screening
Exclusion Criteria:
- Sexual partner who is or becomes pregnant at any time during the study
- Premature ejaculation as determined by investigator assessment
- Currently receiving testosterone replacement therapy or have a history of insufficient
response to testosterone replacement therapy for ejaculatory dysfunction symptoms
- Currently receiving treatment with cancer chemotherapy or antiandrogens
- History of use of estrogenizing agents
- Current use of warfarin
- History of selective serotonin reuptake inhibitor (SSRI) and/or
serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in the 6 months prior to
screening
- History of frequent opioid use within 30 days prior to screening, with exception of
treatment for chronic pain as determined by investigator.
- Body Mass Index (BMI) >35 kilograms per square meter (kg/m^2) at screening
- Significant peripheral neuropathy affecting erectile, ejaculatory, or orgasmic
function
- Hematocrit ≥50% at screening
- Exhibit systolic blood pressure >170 millimeters of mercury (mm Hg) or <90 mm Hg or
diastolic blood pressure >100 mm Hg or <50 mm Hg at screening (if stress is suspected,
retest under basal conditions at screening), or have history of malignant hypertension
- History of any of the following coronary conditions within 90 days of screening:
myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary
intervention (for example, angioplasty or stent placement)
- Known or suspected carcinoma (or history of carcinoma) of the prostate or suspicious
nodules on digital rectal exam at screening
- Known or suspected breast cancer (or history of breast cancer) or other active cancer
(with the exception of nonmelanotic skin cancer)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 26 Years old.
| A Study of Ejaculatory Dysfunction in Men With Low Testosterone Levels | NCT01419236 | Contradiction |
3,001 | 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:
- Male between the ages of 16-50 years old at the time of consent
- Diagnosis of full mutation FXS.
- Stable on any psychoactive medication for at least 4 weeks before receiving study
drug, including antidepressants, stimulants, antipsychotics, and mood stabilizers.
- Seizure free for at least the past 3 months.
- No major health issues or diseases expected to interfere with the study
- No history of diabetes
- Not currently taking metformin at the time of enrollment
- Average basal blood glucose HgbA1c < 7.0
- Study partner with frequent contact with patient willing to accompany patient to
visits and complete caretaker/partner study forms
- No contraindication to metformin
- Willing to complete all baseline assessments and study procedures
Exclusion Criteria:
- Has a medical condition that would make treatment unsafe such as diabetes, pancreatic
disease, liver or kidney disease, a history of epilepsy or seizure disorder that is
not controlled, as well as any other medical condition as determined by the study
doctor.
- Has an eating disorder that has been clinically diagnosed, predisposing them to low
BMI.
- Has received any investigational compound within 30 days prior to the first dose of
study medication.
- Has received metformin in a previous clinical study or as a therapeutic agent.
- Is an immediate family member, study site employee, or in a dependent relationship
with a study site employee who is involved in the conduct of this study (e.g., spouse,
parent, child, sibling), or may consent under duress.
- Has uncontrolled, clinically significant neurological, cardiovascular, pulmonary,
hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality
which may impact the ability of the participant to participate or potentially confound
the study results.
- Has a known hypersensitivity to any component of the formulation of metformin.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
abuse within 6 months prior to the screening visit or is unwilling to agree to abstain
from alcohol and drugs throughout the study.
- Currently taking any excluded medication, supplements, or food products, or has taken
any in the 3 weeks preceding Visit 1. This includes carbonic anhydrase inhibitors and
the medication topamax.
- Has evidence of current cardiovascular, hepatic, hematopoietic disease, renal
dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia,
hypertension or allergic skin rash. There is any finding in the participant's medical
history, physical examination, or safety laboratory tests giving reasonable suspicion
of a disease that would contraindicate taking metformin or a similar drug in the same
class, or that might interfere with the conduct of the study. This includes, but is
not limited to uncontrolled seizure disorders, and cardiac arrhythmias.
- History of any surgical intervention known to impact absorption (e.g., bariatric
surgery or bowel resection).
- Compromised renal function at screening as determined by creatinine levels >1.5mg/dL
and/or creatinine clearance <45mL/min based on Cockcroft-Gault calculation.
- Liver dysfunction at screening as evidenced by alanine transaminase (ALT/SGPT) values
> 2X upper limit of normal or aspartate transaminase (AST/SGOT) values > 3X upper
limit of normal or total bilirubin > 2X upper limit of normal.
- Has donated or lost 450 mL or more of his blood volume (including plasmapheresis), or
had a transfusion of any blood product within 3 months prior to Day 1.
- Has a history of abnormal (clinically significant) electrocardiogram (ECG). Entry of
any participant with an abnormal (not clinically significant) ECG must be approved,
and documented by signature by the principal investigator.
- Has abnormal Screening or Day 1 vital sign values that suggest a clinically
significant underlying disease.
- Is at risk of suicide, has made a suicide attempt within the last year or has current
active suicidal ideation. In accordance with previous FDA regulated studies on
patients with FXS this determination will include asking 3 questions. 1) Has the
subject made a suicide attempt? 2) Has the subject expressed any (active) suicidal
thoughts or intent to harm him/herself or others? 3) Has there been a significant
increase in the severity or frequency of self-injurious behaviors, or harm toward
others, such that continued safety is a concern?
- Laboratory abnormalities in B12, or other common lab parameters that might contribute
to cognition or participation in study
- In the opinion of the investigator or sponsor, the participant is unsuitable for
inclusion in the study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Metformin in Patients With Fragile X | NCT04141163 | Contradiction |
732 | 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:
- Candidates must meet ALL of the following:
1. Voluntary signature of the Institutional Review Board/Research Ethics Board
approved Informed Consent,
2. Male or female subjects between the ages of 30 to 75 years,
3. Body Mass Index ≤ 40 (BMI=kg/m2),
4. Has experienced pain in study knee for at least 3 months,
5. Kellgren-Lawrence grade 1-3 Osteoarthritis, as reviewed on preoperative XR
imaging, in the study knee,
6. BML is confirmed on T2 weighted or Proton Density MR Imaging by presence of white
signal,
7. Single BML of tibia, single BML of femur, or adjoining BML's of tibia & femur, in
the same compartment, extending to the articular surface of the joint,
8. Surgical candidate for knee arthroscopy due to mechanical symptoms, meniscus
tear, loose body and/or synovitis,
9. Must record a response, at the preoperative study visit, of moderate to extreme
pain for any one of the KOOS Pain Scale questions, P2 through P9,
10. Index knee alignment is defined radiographically as one of the following:
Neutral, ≤ 6° mechanical varus, or ≤ 6° mechanical valgus,
11. Ligaments in the study knee are stable,
12. The contralateral (non-study) knee is stable and functional,
13. Is refractory to conservative non-surgical management
1. having failed 2 or more of the following: hyaluronic acid injection,
corticosteroid injection, NSAIDs, physical therapy, bracing, activity
modification, or minimal surgical intervention (e.g., arthroscopy,
debridement/chondroplasty, and/or loose body removal)
2. and is ≥ 3 months from the start of treatment,
14. Must be physically and mentally willing and able, in the Investigator's opinion
at the time of enrollment, to be compliant with the protocol - including all
follow-up visits, survey completion, weight-bearing restrictions, and
post-operative rehabilitation.
Exclusion Criteria:
- Candidates will be excluded if they meet ANY of the following:
1. BML caused by acute trauma less than 3 months prior to enrollment,
2. Clinical and/or radiographic disease diagnosis of the index knee that includes
any of the following:
1. Kellgren-Lawrence Grade 4 Osteoarthritis with complete loss of joint space
(bone-on-bone) or subchondral bone collapse,
2. Rheumatoid arthritis, or history of septic or reactive arthritis,
3. Gout or a history of gout or pseudogout in the affected knee,
4. Has more than two clinically relevant BMLs in the index knee,
5. Osteochondritis dissecans of the knee with significant bone loss,
6. Collapse of subchondral bone,
7. Clinically relevant BML located at ACL/PCL insertion,
8. MRI evidence of frank ligament instability,
3. Passive knee flexion < 110° or flexion contracture >30°,
4. History of systemic diseases which could contribute to secondary arthropathies
(e.g., sickle cell disease, hemochromatosis, or autoimmune disease),
5. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the
ability to perform objective functional assessment of either knee,
6. If diabetic, blood glucose over 200 mg/dL at time of enrollment,
7. Current daily tobacco or high nicotine product user or < 3 months from nicotine
cessation,
8. Presents a high surgical risk due to unstable cardiac and/or pulmonary disease,
9. Has HIV or other immunodeficient state including subjects on immunosuppressant
therapies, or has significant illness (metastasis of any type) that decreases the
probability of survival to the 2 year endpoint,
10. Is at substantial risk for the need of organ transplantation, such as renal
insufficiency,
11. Is pregnant or breast-feeding at the time of surgery,
12. Has a history of any invasive malignancy (except non-melanoma skin cancer),
unless treated with curative intent and with no clinical signs or symptoms of the
malignancy for 5 years,
13. Has primary bone tumor in the knee area,
14. Anticipates having a lower extremity surgery other than the investigational
surgery during the course of the study,
15. Is participating concurrently in another clinical trial, or has participated in a
clinical trial within 30 days of surgery,
16. Is receiving prescription pain medication other than NSAIDs or acetaminophen for
conditions unrelated to the index knee condition, chronic use of anticoagulants,
or taking corticosteroids,
17. Active joint infection or history of chronic joint infection at the surgical
site,
18. Prior total meniscectomy of index knee,
19. Has primarily patellofemoral symptoms,
20. Is indicated for concomitant procedures (i.e., microfracture, subchondral
drilling, cartilage allograft, ligament or tendon repair, distal
realignment/osteotomy, root repair) in the index knee, with the exception of
incidental loose body removal, debridement, synovectomy, osteophyte removal in
locations other than adjacent to BMLs, and/or partial meniscectomy,
21. Has contraindications for Magnetic Resonance Imaging (MRI),
22. Is receiving worker's compensation or is currently involved in litigation
relating to the index knee,
23. Has a history of substance abuse.
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.
Subject must be at most 75 Years | Subchondroplasty® Knee RCT | NCT03112200 | Contradiction |
1,728 | 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:
- Speaking the Dutch language
Exclusion Criteria:
- No serious cognitive impairments
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.
| Basic Care Revisited_Communication for Patient Participation | NCT02401919 | Entailment |
6,241 | 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. Adults ≥18 years old requiring hospital admission for COVID-19
2. COVID-19 confirmed by either*:
- A positive swab (using RT-PCR)
- OR based on a high level of clinical probability confirmed by the presence of typical
symptoms and compatible radiological findings on imaging with no alternative cause for
these findings identified by the treating physician.
Exclusion Criteria:
- 1. Renal replacement therapy on ITU
2. Significant trauma (including an acute fracture or significant head injury)
3. Massive transfusion of blood products
4. Confirmed bacteraemia with pathogenic organism on blood cultures or other severe
bacterial infections (including abscess/empyema) which persist despite broad-spectrum
antibiotics and are thought to be significantly contributing to the patient's symptoms
and clinical state. Recruitment will not be delayed however pending a negative
culture.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| The CASCADE Study - Measures of Complement Activation and Inflammation in Patients With Covid-19 | NCT04453527 | Contradiction |
2,129 | 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:
- infertile males
Exclusion Criteria:
- suergery
Male
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 60 Years | Semen Analysis and Insight Into Male Infertility | NCT04178954 | Entailment |
6,937 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form and protocol. If the
subject is incapable of giving or signing informed consent, the subject must have a
legally authorized representative willing to consent on their behalf.
- Subject must be ≥ 55 to 85 years old at the time of consent.
- Magnetic resonance imaging (MRI) scans of the brain within the past six months reveal
evidence and findings consistent with Alzheimer's disease, including hippocampal
volume loss and/or overall cerebral atrophy (cerebral volume loss).
- Fluorodeoxyglucose-positron emission tomography (FDG-PET) scans of the brain within
the past six months reveal evidence and findings consistent with mild cognitive
impairment or Alzheimer's disease.
- Subject presenting, during evaluation by the study Investigator, to have spontaneous
memory loss or presenting abnormal memory function in early screening.
- Subject must be in good health with adequate hearing and vision.
- Subject must have a reliable caregiver.
- Women of childbearing potential who are not abstinent and intend to be sexually active
with a nonsterilized male partner must be willing to use an adequate method of
contraception throughout the study and for one month following the last day of the
last administration of final study drug dose. Acceptable methods include hormonal
contraception (oral contraceptives [taken 90 days prior to administration of study
drug], intrauterine devices (IUD), or double barrier methods (e.g., vaginal
diaphragm/vaginal sponge plus condoms, or condom plus spermicidal jelly), sexual
abstinence, or a vasectomized partner.
Exclusion Criteria:
- Any medical or neurological conditions, other than Alzheimer's disease, that could
contribute to the cause of cognitive impairment in the subject. Examples include, but
are not limited to, frontotemporal dementia (FTD), Lewy body dementia, vascular
dementia, Parkinson's disease, corticobasal degeneration, Creutzfeldt-Jakob disease,
progressive supranuclear palsy, Huntington's disease, normal pressure hydrocephalus,
seizure disorders or cerebral hypoxia, post-traumatic stress disorder (PTSD), or
alcohol or medication use or abuse.
- Subject does not present with signs of mild cognitive impairment or Alzheimer's
disease at screening, or during evaluation by the study Investigator.
- Subject presents with significant brain disease including hemorrhage or infarction.
- Subject has a history of cerebrovascular accident or transient ischemic attack (TIA),
or unexplainable loss of consciousness during the past year.
- Subject has a history of schizophrenia, schizoaffective disorder, major depressive
disorder (MDD), bipolar disorder, or any other clinically relevant psychiatric
disease.
- Subject has a history of seizure episodes within the past three years.
- Subject has uncontrolled diabetes mellitus.
- Subject has a history of unstable angina, myocardial infarction, chronic heart
failure, or clinically relevant conduction abnormalities within the year prior to
screening.
- Subject suffers from renal or hepatic failure.
- Subject is infected with the human immunodeficiency virus (HIV), Hepatitis B (Hep B),
Hepatitis C (Hep C), or any other infection or active systemic disease.
- Subject is using anticoagulants (except aspirin at or below a prophylactic dose).
- Subject is currently exceeding the normal recommended dosage for any drug used to
treat Alzheimer's disease (e.g., memantine or acetylcholinesterase inhibitors
[AChEI]).
- Subject has contraindication to MRI scans, FDG-PET scans, or lumbar spinal taps.
- Subject whose safety is considered to be at risk from trial's intervention, as
determined by the study Investigator.
- Pregnant or lactating female subjects.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | Safety of SNK01 in Subjects With Mild Cognitive Impairment (MCI) and Alzheimer's Disease | NCT04678453 | Entailment |
2,699 | 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:
- Unilateral primary inguinal hernia presenting for repair
Exclusion Criteria:
- Recurrent repairs
- Females
- Bilateral repairs
- Repairs done with other operative procedures
Male
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| The Economic Impact of Four Varieties of Mesh Inguinal Hernia Repair- a Double-Blinded, Prospective, Randomized Trial | NCT00416364 | Entailment |
4,649 | 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:
laparoscopic assisted vaginal hysterectomy leiomyoma adenomyosis-
Exclusion Criteria:
other types of operations other types of gynecological disease-
Female
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 80 Years | Health-Related QoL Among Women Receiving Hysterectomy in NTUH | NCT00155870 | Entailment |
124 | 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:
- Age: 50 or older
- Total Testosterone <=280 ng/dl
- Subsyndromal depressive disorder: either dysthymia or minor depression (per DSM IV and
DSM IV appendix)
Exclusion Criteria:
- PSA >=3.0
- Klinefelter's syndrome
- Prostate or breast cancer
- Hospitalized in the past month
- Obstructive BPH
- Current testosterone treatment
- Schizophrenia, bipolar disorder, dementia
- Treatment with antipsychotics or benzodiazepines
- Alcohol dependence or other substance dependence
- Suicidal or psychotic symptoms
Male
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| The Effect of Testosterone on Mood and Quality of Life | NCT00202462 | Contradiction |
5,617 | 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:
- Chronological Age ≥ 3.0 years and ≤ 10.0 (girls) and ≤ 11.0 (boys).
- Pre-pubertal status: Absent breast development in girls, testicular volume < 4.0 mL in
boys.
- Diagnosis of GHD as documented by two or more GH stimulation test results ≤ 10.0
ng/mL.
- Height SD score ≤ -2.0 at screening.
- Weight for Stature ≥ 10th percentile.
- IGF-I SD score ≤ -1.0 at screening.
- Delayed bone age (≥ 6 months).
Exclusion Criteria:
- Prior treatment with any growth promoting agent
- History of or concurrent significant disease (e.g. diabetes, cystic fibrosis, renal
insufficiency).
- Chromosomal aneuploidy, significant gene mutations (other than those that cause GHD)
or confirmed diagnosis of a named syndrome.
- A diagnosis of Attention Deficit Hyperactivity Disorder.
- Daily use of anti-inflammatory doses of glucocorticoid.
- Prior history of leukemia, lymphoma, sarcoma or cancer.
- Treatment with an investigational drug in the 30 days prior to screening.
- Known allergy to constituents of the study drug formulation.
- Ocular findings suggestive of increased intracranial pressure and/or retinopathy at
screening.
- Significant spinal abnormalities including scoliosis, kyphosis and spina bifida
variants.
- Significant abnormality in screening laboratory studies
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 11 Years | Versartis Long-Acting Growth Hormone in Children Compared to Daily rhGH | NCT02339090 | Contradiction |
6,854 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | Patients age greater than or equal to 18 years.
Patients with a diagnosis of definite or probable dermatomyositis by criteria of Bohan et.
al., with either active rash typical of dermatomyositis, history of rash typical of
dermatomyositis, or Gottron's papules.
Patients with a manual muscle testing score less than or equal to 136/170.
Patients with a disease duration greater than or equal to 6 months.
Patients with persistent disease (defined as active rash plus CK greater than or equal to 2
times ULN), or rapidly progressive disease, or response to steroids with inability to taper
dose, or unacceptable side effects of steroids.
Patients may be on stable (times 28 days prior to Visit 2) dose of MTX or AZA.
No other immunosuppressive agents times 84 days prior to first dose.
Patients on stable oral steroid use for 28 days prior to Visit 2.
Patients with adequate hematologic function, defined as hemoglobin greater than or equal to
8.5 g/dl, WBC greater than or equal to 3,000 mm(3), neutrophils greater than or equal to
1,200 mm(3), platelets greater than or equal to 100,000 mm(3).
Patients must be willing and able to give informed consent.
Women must be post-menopausal, surgically sterile or practicing a medically approved method
of contraception.
Patients with liver disease will be excluded.
Patients with history of alcohol or drug abuse within two years of screening, or a history
of positive Hepatitis B or Hepatitis C serology, unless vaccinated will be excluded.
Patients with renal insufficiency, defined as creatinine greater than or equal to 2.0 mg/dl
will be excluded.
Patients with history of malignancy, except basal cell carcinoma and remote (greater than
or equal to 5 years) malignancies in complete remission will be excluded.
Patients with history of poorly controlled diabetes will be excluded.
Patients with presence or suspicion of active infection, recent serious infection, or
chronic/recurrent viral or bacterial infection will be excluded.
Patients with throat culture positive for pathogenic Neisseria species (meningitidis or
gonorrhoeae) will be exluded. Subjects with a positive culture may be treated with
appropriate antibiotic therapy and retested.
Patients with joint disease or replacement that would interfere with patient's ability to
perform muscle testing will be excluded.
Patients with any clinically significant medical condition that is likely to interfere with
the participation in the study or the evaluation of the study medication's safety profile
will be excluded.
No patients with known or suspected hereditary complement deficiency will be excluded.
Patients with history of allergic reaction to murine proteins will be excluded.
Patients participating in any other investigational drug trial, or exposure to other
investigational agent or device within thirty days prior to screening will be excluded.
Pregnant or breastfeeding patients will be excluded.
Women intending to conceive during the course of the study, including follow-up period will
be excluded.
Patients with history of HIV, Lyme disease, or other environmentally induced myositis will
be excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis | NCT00005571 | Entailment |
2,704 | 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:
- Inguinal hernia
Exclusion Criteria:
- Recurrences, child
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
Subject must be at most 90 Years | A New Approach in Inguinal Hernia Repair: Double Repair. A Prospective, Randomized, Controlled Clinical Trial | NCT01003509 | Entailment |
3,645 | 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:
- Patients and healthy volunteers with non-opposition to participate in the evaluation
- Healthy volunteers : from 18 years to 70 years
- Patients : minimum age limit 18 years - no maximum age limit
Exclusion Criteria:
- Healthy volonteers with ongoing treatment
- Healthy volonteers with abnormal hemostasis results
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Determination of Fibrin Activity in Plasma on STA-R® Prototype | NCT02856789 | Entailment |
2,636 | 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:
- 18-80 years old male patients, with a symptomatic inguinal hernia that can be
diagnosed by clinical examination. Primary and unilateral hernia. The operation
performed at a day surgery unit.
Exclusion Criteria:
- female
- bilateral hernia
- Incarcerated hernia
- Scrotal hernia
- ASA-classification >3
- BMI >35 or <18
- No hernia found in clinical examination
- Liver cirrhosis
- Other contraindication for inguinal hernia operation
- Anticoagulant therapy, that needs bridge therapy when paused
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Inguinal Hernia Operation and Postoperative Pain | NCT03734224 | Entailment |
6,401 | 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:
- COVID-19 cases
- Oxygen saturation > 93%
- Age >18 years
Exclusion Criteria:
- Patients <18 years,
- patients with Oxygen saturation < 93%, patients with
- Diabetes mellitus or
- heart failure,
- patients on chemotherapy or immunosuppressive therapy
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.
| Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection | NCT04622891 | Entailment |
1,032 | 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:
- Age 45 to 80 years old, inclusive
- Clinical diagnosis of osteoarthritis in one target knee based on the following
American College of Rheumatology (ACR) criteria:
1. Knee Pain
2. At least 1 of 3:
- Age > 50 years
- Morning stiffness lasting < 30 minutes
- Crepitus on motion
3. Osteophytes on radiograph
- Symptoms associated with osteoarthritis of the knee (including pain) for ≥ 6 months
prior to Screening
- Knee pain associated with osteoarthritis, which required NSAID or other therapy for ≥
15 days during the preceding month
- Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a
rating of Grade 2 or 3 in the target knee (does not include borderline Grade 2), as
confirmed by the Sponsor's designated rheumatologist through radiographic review of
x-ray(s) taken no more than 1 year prior to the Screening visit. (Sharpening of the
tibial spine is not considered to be an osteophyte) (See Appendix 4 for additional
details)
- Meets pain assessment entry criteria as defined by Sponsor's pain eligibility
algorithm and calculated by the study Interactive Web Response System
- No clinically significant change in physical activity and/or therapy for the past 3
months
- Able to provide written informed consent prior to initiation of any clinical
trial-related procedures; and willing and able, in the opinion of the Investigator, to
comply with all requirements of the clinical trial for the duration of the trial (such
requirements include, but are not limited to: attending all study visits, refraining
from elective surgery or extensive travel during participation)
Exclusion Criteria:
General
- Women of childbearing potential, or men whose sexual partner(s) is a woman of
childbearing potential may not be entered into the study if:
1. They are or intend to become pregnant (including use of fertility drugs) during
the study
2. They are nursing
3. They are not using an acceptable, highly effective method of contraception until
all follow-up procedures are complete. (Acceptable, highly effective forms of
contraception are defined as: oral contraception, intrauterine device, systemic
[injectable or patch] contraception, double barrier methods, naturally or
surgically sterile, strict abstinence or partner has been sterilized. If
hormonal-based birth control is being used, subject or subject's sexual
partner(s) must be on a stable-dose for ≥ 3 months prior to the Baseline visit
and maintained at the same dosing level throughout the 9-week clinical trial.)
- Body Mass Index (BMI) over 40
- A history of osteoarthritis symptoms that are completely non-responsive to
non-steroidal anti-inflammatory drugs (NSAIDs) at the discretion of the Investigator
- Planned change (increase or decrease) in subject's level of physical activity (e.g.,
aerobic or anaerobic exercise) during the 6-week Treatment Period following
randomization
- Enrollment in any trial and/or use of any Investigational Drug or device within the
immediate 30-day period prior to the Baseline visit
- Enrollment in any study previously sponsored by Olatec Industries LLC, specifically
Study OLT1177-01 or OLT1177-02
Pain Related
- Does not meet pain assessment entry criteria as defined by Sponsor's pain eligibility
algorithm and calculated by the study Interactive Web Response System
- Clinically significant joint (other than the knee) or general pain at Baseline, at the
discretion of the Investigator
Musculoskeletal Related
- Clinically significant, excessive effusion heat and/or redness in the target knee as
determined by the Investigator
- Knock-kneed or bow-legged, as defined by a valgus or varus deformity of ≥ 15 degrees
- Radiographic evidence of osteoarthritis by Kellgren-Lawrence classification with a
rating of Grade 0, 1 or 4 in the target knee, as confirmed by the Sponsor's designated
rheumatologist through radiographic review of x-ray(s) taken no more than 1 year prior
to the Screening visit (sharpening of the tibial spine is not considered to be an
osteophyte)
- Documented history of clinically significant pain associated with osteoarthritis of
the spine or hips, at the discretion of the Investigator
- Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or
chondromalacia
- Clinically significant medio-lateral and/or anterior-posterior instability, at the
discretion of the Investigator
- Open surgery of the target knee within the prior year or surgery to the contralateral
knee or other weight-bearing joint within the prior year, if at the discretion of the
Investigator it would interfere with the study. If subject had open surgery more than
one-year prior, Sponsor's designated rheumatologist must confirm that such surgery did
not have any negative impact or consequence to the target knee (e.g., deformity of
angle to the bone, bone on bone, locking joints, etc.)
- Arthroscopic surgery of the target knee within the prior six months
- Any acute or chronic injury, other than osteoarthritis in the target knee, that will
be treated during the trial with any medication not allowed during the Treatment
Period
- Prior surgery of the target knee requiring insertion of a medical device or surgical
hardware (e.g., screws)
- Any major trauma or injury (including sports injuries) to the target knee in the past
12 months
- Documented history of inflammatory joint disease, including but not limited to:
rheumatoid arthritis, gout, pseudogout, Paget's disease, psoriatic arthritis,
ankylosing spondylitis, chronic inflammatory disease (e.g., colitis), fibromyalgia
(diagnosed in accordance with ACR criteria, as applicable), articular fracture,
ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary
osteochondromatosis, heritable disorders (e.g., hypermobility) or collagen gene
mutations
- Any planned interventional and/or surgical procedure during the 6-week Treatment
Period following randomization
Concomitant Conditions, Diseases, Medications/Therapies and Medical History Related
- Any use of Rescue Medication within 24 hours prior to the Baseline visit or use of any
other pain medication within 7 days prior to Baseline visit
- Uncontrolled hypertension, defined as blood pressure ≥ 150/95 mmHg
- A history of uncontrolled and untreated diabetes mellitus with an HbA1c level > 8; or
blood sugar levels that are outside of the normal range and HbA1c level > 8 is
subsequently confirmed
- Any inflammatory skin condition over the target knee application area
- Use of any prohibited concomitant medications/therapies during the 7-day Washout
Period or planned use of any prohibited concomitant medications/therapies during the 6
week Treatment Period
- Use of intraarticular or intramuscular steroids in the target knee within the previous
3 months or in any other joint within the previous 30 days
- Use of intraarticular hyaluronate in the target knee within the previous 6 months or
in any other joint within the previous 30 days
- Current substance abuse or history of chronic substance abuse within the past year, or
prior chronic substance abuse (including alcoholism and/or addiction to pain
medications) that is determined at the discretion of the Investigator as likely to
interfere with trial assessments or recur during the trial
- Use of any systemic (oral or parenteral) corticosteroids within the prior month
- Uncontrolled psychiatric conditions (e.g., mania, depression, anxiety, substance
dependence of any kind) that would impair the subject from safely participating in the
trial, including completing any protocol requirements
- Evidence of cognitive impairment including dementia that may interfere with subject's
ability to complete daily pain diaries requiring recall of average pain level in the
past 24 hours
- Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal,
hematological or neurological disease or prior surgery that may interfere with the
subject successfully completing the trial, including completing any protocol
requirements as determined by the Investigator
- History of or known positive for HIV, Hepatitis B surface antigen (HBsAg) or
antibodies to Hepatitis C Virus (HCV)
- Diagnosed with any form of cancer within the past 5 years, except for treated basal
cell or squamous cell carcinoma of the skin
- Any other medical conditions, diseases or prior surgeries that in the opinion of the
Investigator would impair the subject from safely participating in the trial and/or
completing any protocol requirements
- Active infection within 3 days of the Baseline visit
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 80 Years | Study of OLT1177 Gel to Treat Moderate to Severe OA Knee Pain | NCT02104050 | Entailment |
5,869 | 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! | Key Inclusion Criteria:
1. Patient seeks consultation for lack of satisfactory symptom response to once daily
PPIs.
2. Age≥ 21 years old.
3. Abnormal distal esophageal pH determined by total % time pH <4 or DeMeester Score.
Testing to be completed off GERD medications for at least 7 days, with the exception
of antacids, which may be taken up until the morning of assessment.
4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and
laparoscopic surgery).
5. Patient has provided written informed consent for participation in the randomized
study.
Key Exclusion Criteria:
1. Currently taking double-dose PPIs (twice daily dosing).
2. Hiatal hernia >3cm as determined by endoscopy.
3. Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg
peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.
4. Esophagitis Grade C or D (Los Angeles classification).
5. Body mass index >35.
6. Diagnosed with an esophageal motility disorder LES.
7. Esophageal stricture or gross esophageal anatomic abnormalities
8. History of/or known Barrett's esophagus.
9. Suspected or known allergies to titanium, stainless steel, nickel or ferrous
materials.
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.
| The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease | NCT02505945 | Contradiction |
2,058 | 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:
- IPF patients diagnosed by multidisciplinary discussion
Exclusion Criteria:
- Other interstitial lung diseases except for IPF
- connective tissue disease-related ILD
- exposure-related ILD
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.
Subject must be at most 100 Years | Korean Idiopathic Pulmonary Fibrosis Registry | NCT04160715 | Contradiction |
72 | 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. | DISEASE CHARACTERISTICS:
- Newly diagnosed high-grade glioma, including the following subtypes:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- Requires dexamethasone at a dose of > 4 mg/day to control symptoms of tumor-related
edema at time of study enrollment AND has been on a stable dose of steroids for ≥ 5
days prior to study enrollment
- Completed ≥ 80% of prescribed radiotherapy
- Hypogonadal, defined as serum testosterone level < 350 ng/dL
- No history of prostate or breast cancer
- No benign prostatic hypertrophy requiring therapy OR AUA score of ≥ 8
- PSA ≤ 4 ng/mL
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Able to keep daily records or has a care provider that agrees to keep daily records of
drug administration
- No clinical history of congestive heart failure requiring therapy
- No psychotic disorder requiring active treatment
- No structured exercise program involving exercise for > 3 hours/week
- No polycythemia (i.e., hematocrit > 52%)
PRIOR CONCURRENT THERAPY:
- More than 6 months since prior androgen therapy
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 120 Years | Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma | NCT00631137 | Contradiction |
3,838 | 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:
- Patients referred from a general practitioner in the North Denmark Region to the
orthopaedic clinic at Aalborg University Hospital
- Patients with painful OA in hip- or knee joint.
Exclusion Criteria:
- Patients unable to answer the questions in danish
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.
| RCT Measuring the Effect of the ERVIN Software | NCT04332055 | Entailment |
5,739 | 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:
- Is a male or a non-pregnant, non-lactating female.
- Has a history and clinical presentation consistent with a diagnosis of Behçet's
Disease and meets International Study Group criteria (Appendix B).
- Has a history of oral ulcers for at least 12 months.
- Has a history of monthly episodes of multiple oral ulcers.
- Has the presence of at least 2 oral ulcers at study entry, both of which are
accessible to measurement, with a total diameter of at least 4 mm.
- Has signed an IRB approved subject consent form.
- Has completed all screening procedures satisfactorily, is deemed to be an acceptable
subject and is otherwise eligible for entry into the study.
- Is willing and able to comply with the protocol.
Exclusion Criteria:
- Has a severe, acute, or chronic systemic disease other than Behçet's Disease such as
congestive heart failure, hepatic failure, renal failure, Systemic Lupus Erythematosus
(SLE), Stevens-Johnson syndrome, ulcerative colitis, cancer, leukemia, diabetes, AIDS
or ARC, or any other condition for which they are immunocompromised.
- Is under active treatment for dental conditions, such that multiple dental office
visits would be required during the study period, or presents with oral conditions
which are not thought to be related to Behçet's Disease and, in the judgment of a
qualified dentist, will require treatment during the study period.
- Is suffering from any medical condition other than Behçet's Disease known to cause
oral ulcerations, such as erosive lichen planus, benign mucous membrane pemphigoid,
SLE, Crohn's disease, Reiter's syndrome, or AIDS.
- Has an eating disorder and/or psychiatric illness requiring treatment.
- Has hypersensitivity to interferon-alpha.
- Is a pregnant or lactating female, or is of childbearing potential and is not using a
medically acceptable contraceptive method throughout the study.
- Has had previous exposure to any parenteral interferon therapy.
- Has had exposure to IFNα lozenges within 30 days of screening.
- Has had exposure to thalidomide within 30 days of screening.
- Has had exposure to methotrexate within 30 days of screening.
- Has had exposure to any immune-suppressive medication within 30 days of screening.
- Has a history of, or is currently exhibiting, any disease or condition which, in the
opinion of the Principal Investigator, would place the subject at increased risk
during study therapy.
- Has any abnormality in a hematological or biochemical variable which, in the opinion
of the Principal Investigator, would place the subject at increased risk during study
therapy.
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 | Low Dose Interferon Alpha Treatment for Oral Ulcers of Behcet's Disease | NCT00483184 | Contradiction |
3,120 | 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:
- Patients with vernal keratoconjunctivitis,
- mild or moderate : clinical score >3 and <= 14, calculated from 4 major symptoms
(itching, tearing, photophobia, foreign body sensation) and 6 major clinical signs
(conjunctival erythema, conjunctival chemosis, discharge, papillae, limbal infiltrates
and corneal epithelial disease)
- age >= 4 years old
Exclusion Criteria:
- no occurrence of ocular trauma or infection (within the 3 months preceding the study),
- no ocular medical treatment (topical or not) within the 5 days preceding the study,
- no ocular laser (within the 3 previous months),
- no ocular surgery (within the previous year),
- patient who signs the informed consent form (or his/her parents or legal guardian in
the case of underage patient).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
| Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis | NCT00357019 | Contradiction |
1,902 | 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:
1. Age: more than 18 years old;
2. Histologically confirmed advanced or metastatic adenocarcinoma of gastric cancer(AGC)
, including adenocarcinoma of the gastroesophageal junction;
3. At least one measurable and evaluable disease based on response evaluation criteria in
solid tumors (RECIST v1.1);
4. The patient with Prior Paclitaxel-Resistant;
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2;
6. An expected survival of ≥ 3 months;
7. Duration from the last therapy is more than 6 weeks for nitroso or mitomycin, More
than 4 weeks for other cytotoxic agents, operation or radiotherapy;
8. Major organ function has to meet the following criteria; (1) For results of blood
routine test:
1. Hemoglobin (HB) ≥ 80g / L,
2. ANC ≥ 1.5 × 109 / L,
3. PLT ≥ 75 × 109 / L, (2) For results of biochemical tests:
1. BLT ≤ 1.25 times the upper limit of normal (ULN),
2. ALT and AST ≤ 2.5 × ULN, liver metastases, if any, the ALT and AST≤ 5 × ULN,
3. Serum Cr≤1ULN, Endogenous creatinine clearance rate >50ml/min;
9. Pregnancy test (serum or urine) has to be performed for woman of childbearing age
within 7 days before enrolment and the test result must be negative. They shall take
appropriate methods for contraception during the study until the 8th week post the
last administration of study drug. For men, (previous surgical sterilization
accepted), shall agree to take appropriate methods of contraception during the study
until the 8th week post the last administration of study drug;
10. Patient has to voluntarily join the study and sign the Informed Consent Form for the
study.
Exclusion Criteria:
1. History of other malignancies except cured basal cell carcinoma of skin and carcinoma
insitu of uterine cervix;
2. Confirmed that apatinib and/or its accessories allergy;
3. Subjects with poor-controlled arterial hypertension (systolic blood pressure> 140 mmHg
and diastolic blood pressure > 90 mm Hg) despite standard medical management;
4. Serious cardiovascular disease: Ⅱ-level myocardial ischemia or myocardial infarction,
arrhythmia (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms);
III ~ IV level cardiac function insufficiency, or echocardiography showed that left
ventricular ejection fraction (LVEF < 50%);
5. Patients with positive urinary protein (urine protein detection of 2 or more, or 24
hour urine protein >1.0g);
6. Factors that could have an effect on oral medication (such as inability to swallow,
chronic diarrhea and intestinal obstruction);
7. Subjects with high gastrointestinal bleeding risk, including the following conditions:
local active ulcer lesions with positive fecal occult blood test (++); history of
black stool, or vomiting blood in the past 2 months;unresected primary lesion in
stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with
massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy
result;
8. Abnormal Coagulation (INR>1.5、APTT>1.5 UNL), with tendency of bleed;
9. With psychotropic drug abuse history and can't get rid or with mental disorder
patients;
10. Less than 4 weeks from the last clinical trial;
11. According to the researcher's judgment, with other serious diseases which harm to
patient safety or affect patients complete the study;
12. Evidence of central nervous system(CNS) metastasis;
13. Pregnant or lactating women;
14. Other conditions regimented at investigators' discretion.
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.
| Clinical Trial of Apatinib Reverses Chemotherapy-Resistance of Patients With Advanced Gastric Cancer | NCT02697838 | Entailment |
5,087 | 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:
- women with osteoporosis (T score lower than -2.5)
- women whom had suffered from non specific low back pain for the last 3 months or more.
Exclusion Criteria:
- history of operations in the spine
- history of cancer or neurologic disease
- history of fractures
- previous trauma to the spine
- persons whom for any reason cannot sit on a chair or lie on a mattress for 45 minutes
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Comparison of a Weight Bearing and a Non-weight Bearing Protocol on Osteoporotic Women With Chronic Low Back Pain | NCT03747289 | Contradiction |
3,712 | 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:
- 50 years old or older with knee osteoarthritis
- knee pain without joint effusion confirmed by ultrasonography
Exclusion Criteria:
- the presence of knee joint effusion determined using US
- a history of knee injury or surgery
- a history of knee injection within 3 months
- a history of inflammatory arthritis
- taking anticoagulants
- balance or gait disturbance
- diabetes mellitus
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Effects of Joint Effusion on Quadriceps Muscle | NCT01314820 | Contradiction |
4,289 | 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:
- Signed informed consent available before any study specific tests or procedures are
performed
- Patients must be at least 18 years of age at time of inclusion (i.e. upon signature of
informed consent)
- Patient diagnosed with Cystic Fibrosis according to standard criteria (i.e. either
elevated sweat chloride content above 60 mmol/ L and/ or genetic testing)
- Patient is homozygous for the deltaF508 mutation
- Patient has a mild-to-moderate stage of lung disease as determined by FEV1 (FEV1
between 40 and 100% predicted)
- Patient has a stable condition of lung disease (no ongoing or recent pulmonary
exacerbation and no change in current treatment) within the last 4 weeks prior to
screening
- Ability and willingness to understand and follow study procedures for the entire study
- Patients do not smoke. Patients with a history of smoking can be included, if they
have refrained from smoking for the last 3 months. If a patients starts smoking during
the study participation, he/ she needs to be excluded and considered to be a drop out
- Body mass index (BMI): ≥ 16 kg/ m² (calculated by dividing the patient's weight by the
square of his/ her height [kg/ m2])
Inclusion criterion valid for study part 1 only:
- Women of childbearing potential must agree to use adequate contraception when sexually
active. 'Adequate contraception' is defined as one highly effective form of contraception
(intrauterine devices [IUD], contraceptive implants or tubal sterilization) or a
combination of methods (hormone method with a barrier method ). If a partner's vasectomy is
the chosen method of contraception or if a partner has documented azoospermia, a hormone or
barrier method must be used in combination. Adequate contraception is required from the
signing of the informed consent form up until 4 weeks after the last study drug
administration
Inclusion criteria valid for study part 2 only:
- Women of childbearing potential must agree to use adequate contraception when sexually
active. 'Adequate contraception' is defined as one highly effective form of
contraception (intrauterine devices [IUD], contraceptive implants or tubal
sterilization) or a combination of methods (hormone method with a barrier method). For
patients on Orkambi hormonal methods (including hormonal oral contraceptives) cannot
be accepted in this study. They need to choose non-hormonal methods. If a partner's
vasectomy is the chosen method of contraception or if a partner has documented
azoospermia, a hormone or barrier method must be used in combination. Adequate
contraception is required from the signing of the informed consent form up until 4
weeks after the last study drug administration
- Patients receiving Orkambi (Lumcaftor + Ivacaftor) as part of their standard care need
to be on stable Orkambi treatment for at least 3 months prior to screening (patients
on Lumacaftor and/or Ivacaftor are excluded in part 1)
Exclusion Criteria:
- Patients with Cystic Fibrosis with any background other than homozygous deltaF508
mutation
- Exclusion criterion only valid for study part 1: Patients receiving treatment with
Lumacaftor and/ or Ivacaftor
- Active state of hemoptysis or pulmonary hemorrhage, including those events managed by
bronchial artery embolization. Also any history of moderate hemoptysis within the 3
months prior to inclusion
- Any history of pneumothorax, bronchial artery embolization or massive hemoptysis.
Massive hemoptysis being defined as acute bleeding >240 mL in a 24-hour period or
recurrent bleeding >100 mL/ d over several days
- A positive sputum culture for Burkholderia cenocepacia, Burkholderia dolosa, and/ or
Mycobacterium abscessus either currently or within the previous year
- Active allergic broncho-pulmonary aspergillosis
- Current pulmonary exacerbation
- Known history of solid organ transplantation
- Known history of any form of pulmonary hypertension
- Clinically relevant deviations of the screened laboratory parameters from reference
ranges outside of expected changes for Cystic Fibrosis patients, especially a
hemoglobin value below 110 g/L or a creatinine clearance based on the Cockcroft-Gault
formula < 15 ml/ min
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.
| Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients | NCT02170025 | Entailment |
6,741 | 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:
- Patients in different age groups with superficial soft tissue lesions
Exclusion Criteria:
- If the patient undergo previous operations at the same mass that could change the
criteria of that mass or if the mass is recurrent at the same site.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses | NCT03171857 | Contradiction |
2,318 | 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. | DMD Subject Inclusion Criteria
- Affected subjects must be male and between the ages of 2 and 30
- Affected subjects between the ages of 2 and 4 must have a diagnosis of DMD confirmed
by at least one the following OR have an older male sibling that meet at least one of
the following criteria:
- Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin
deficiency, and clinical picture consistent with typical Duchenne dystrophy OR
- Gene deletion test positive (missing one or more exons) in the central rod domain
exons 25-60) of dystrophin, where reading frame can be predicted as
'out-of-frame',and clinical picture consistent with typical Duchenne dystrophy.
- Complete dystrophin gene sequencing showing an alteration (point mutation,
duplication, other) that is expected to preclude production of the dystrophin
protein(i.e. nonsense mutation, deletion/duplication leading to a downstream stop
codon),with a typical clinical picture of DMD.
- Affected subjects between the ages of 5 and 30 must either fulfill the above criteria
OR show evidence of a dystrophinopathy and clinical picture consistent with Duchenne
Muscular Dystrophy
- Participants who have documented clinical symptoms referable to a
dystrophinopathy and direct support of the diagnosis by either (1) a positive DNA
analysis for dystrophin mutation, (2) a muscle biopsy demonstrating abnormal
dystrophin, or (3) an elevated CK (>5X normal), and X-linked pedigree and an
affected family member who meets either criterion (1) or (2) as described above.
NOTE: Determination of the appropriate clinical symptoms consistent with DMD will generally
be the responsibility of the clinician. At a minimum this will include progressive loss of
function, with additional consideration for other clinical features such as a
characteristic gait, a positive Gower sign and calf pseudohypertrophy. When immunostaining
of muscle biopsy is used to determining case definition, the clinical reviewer (site PI)
should confirm that appropriate testing has ruled out a secondary deficiency of dystrophin.
Affected subjects that do not exhibit the above symptoms consistent with DMD should be
excluded.
o Muscle weakness prevalent by 5 years of age
- Non-affected adult subjects must be Parent(s) or legal guardian(s) of an eligible
affected subject.
DMD Serum Biomarker Inclusion Criteria
- Participants must meet eligibility criteria for the DMD phenotyping portion of this
study
- For the GC-treatment response cohort, participants must initiate GC treatment within
the first year of study participation (i.e. between their first study visit and their
one year follow-up visit)
DMD Subject Exclusion Criteria
For those subjects that confirm DMD diagnosis through a clinical picture consistent with
DMD
- Steroid-naïve subjects ambulating past the 13th birthday
- Steroid users ambulating past the 16th birthday
- Subjects/families who are unwilling or unable to comply with the protocol study
procedures or visits
Controls Subject Inclusion Criteria
- Male sex
- Age 6-30 years
- Able to comply with functional testing instructions
Control Serum Biomarker Inclusion criteria
- Participants must be male
- Participants must be free of DMD, other neuromuscular disease, or other significant
concomitant illness
- Participant must be free of glucocorticoid therapy
Control Subject Exclusion Criteria
- Musculoskeletal disease
- Musculoskeletal injury within 6 months of enrollment
- Other concomitant illness that precludes functional testing in the judgment of the
investigator or clinical evaluator
- Completion of enrollment for age cohort
Male
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
Subject must be at most 30 Years | Longitudinal Study of the Natural History of Duchenne Muscular Dystrophy (DMD) | NCT00468832 | Entailment |
4,874 | 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:
- The patient is under consultation in the department of metabolic and endocrine
disorders at the CHU Nimes for diagnosis or follow-up of hypercortisol assessment
- The patient must be a member or beneficiary of a health insurance plan
Exclusion Criteria:
- The patient is pregnant, parturient or breastfeeding
- The patient has a cardiovascular or metabolic state against the indication of
dexamethasone
- Patient with DFG < 30 ml/min/1.73 m2
- The patient has suffered urinary incontinence rendering 24-hour urinary collection
impossible or non-interpretable
- The patient has a urinary catheter
- The patient is taking corticoids (oral, inhaled, intra-venous or cutaneous)
.Patient exposed to interfering treatments (Itraconazole, ritonavir, megestrol
acetate, medroxyprogesterone acetate, TSH, estrogen-progestogen pill, hormonal coil)
- The subject is in a period of exclusion determined by a previous study
- The subject opposes their participation in the study
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms | NCT03974789 | Entailment |
830 | 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. | Key Inclusion Criteria:
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. Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale
score of ≥4 at both the screening and randomization visits
3. Willing to discontinue current pain medications and to adhere to study requirements
for rescue treatments
4. A history of at least 12 weeks of analgesic use for pain due to OA of the knee or hip
5. History of regular use of analgesic medications for OA pain (defined as an average of
4 days per week over the 4 weeks prior to the screening visit), including NSAIDs,
selective cyclooxygenase 2 inhibitors, opioids, paracetamol/acetaminophen, or
combinations thereof
Key Exclusion Criteria:
1. History or presence at the screening visit of non-OA inflammatory joint disease
(eg,rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout,
spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5
years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple
sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal
osteodystrophy
2. History or presence on imaging of arthropathy (osteonecrosis, subchondral
insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture,
recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip
dislocation is eligible), knee dislocation (patella dislocation is eligible),
congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts,
evidence of bone fragmentation of collapse, or primary metastatic tumor with the
exception of chondromas or pathologic fractures during the screening period
3. Trauma to the index joint within 3 months prior to the screening visit
4. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
5. Patient is not a candidate for MRI
Note: Other protocol defined Inclusion/Exclusion criteria apply.
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.
| To Assess the Patients' Ability to Self-Administer Fasinumab | NCT03491904 | Entailment |
3,934 | 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 YY1201 for Treatment of Osteoarthritis of the Knee | NCT02554552 | Entailment |
6,724 | 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:
- Severe hemophilia A (< 1% FVIII)
- 30-45 years of age
- Previously treated subject (> 100 Exposure days to any FVIII)
- On-demand therapy with any FVIII
Exclusion Criteria:
- No history of inhibitor
- No planned elective orthopedic surgery during the study duration (13 months)
- No severe concomitant disease
- No history of anaphylactic or other severe reaction to previous FVIII treatment
Male
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 45 Years | BAY14-2222 Prophylaxis and Joint Function Improvement (Adults) | NCT00586521 | Contradiction |
2,477 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Have normal vision
- Are far-sighted or near-sighted
- Have no eye diseases Subjects aged 18 and over, who have refractive errors ranging
from +5.0 to -5.0 and/or who have eye disease will be included in the study.
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 35 Years | Comprehensive Evaluation of Visual Function | NCT00894192 | Contradiction |
3,531 | 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:
- Primary or secondary adrenal insufficiency, Healthy matched controls, acute or
unstable health conditions age 18 or older
Exclusion Criteria:
- Diabetes, Tertiary adrenal insufficiency
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency | NCT03000231 | Entailment |
5,916 | 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:
1. Male or Female aged ≥ 20 years
2. Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam.
3. Refractory reflux esophagitis to PPIs standard treatment as follows
1. Ongoing heartburn symptom with or without these GERD-related symptoms :
Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating,
Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia,
Odynophagia, Weight loss
2. Ongoing heartburn symptom with or without erosion ≥ grade A according to LA
Classification
4. Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose
of IP
5. Decided to participate and signed on an informed consent form willingly
Exclusion Criteria:
1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at
screening
2. History of operation in esophagus, stomach or duodenum
3. The following medical history
1. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric
stricture, Primary esophageal spasm
2. Barrett's esophagus ≥ 3 cm
3. Zollinger-Ellison syndrome
4. Infectious or inflammatory bowel disease, Severe malabsorption
4. Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma,
liver cirrhosis
5. History of cancer within 5 years, except completely recovered skin cancer
6. ALT or AST ≥ Upper limit of normal range X 3
7. Need antibiotics due to severe infection
8. Severe medical disease that needs these prohibited medication
- Anticoagulant(Heparin, Warfarin, etc.), High dose of aspirin(>325mg/d),
Digitalis(Digoxin, etc.), Diuretics, Atazanavir, NSAIDs or Steroids
9. Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need
other PPIs or H2RA medicine during trial period
10. Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol
derivatives, etc.)
11. Pregnant or breast-feeding women
12. Conversation impairment because of alcohol, drug addiction or mental illness, etc.
13. Administration of other IP within 28 days
14. Inability to record heartburn diary card
15. In investigator's judgement
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.
| The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD | NCT01860482 | Contradiction |
4,116 | 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:
- Females age < 42 with an indication for IVF
- Females with lowest AMH level 1.2 ng/mL or higher
- Females with FSH < 13 mIU/mL
- Sperm obtained via Surgical retrieval (any type) for IVF only
- Use of comprehensive chromosome screening (CCS) to screen embryos for aneuploidy
- BMI < 35
- Baseline antral follicle count of > 8
- Single embryo transfers only
Exclusion Criteria:
- Anything that would place the individual at increased risk or preclude the
individual's full compliance with or completion of the study.
- Contraindication to IVF
- Clinical indication for preimplantation genetic diagnosis (PGD) (i.e., screening for
single gene disorder, chromosomal translocation, or any other disorders requiring
detailed embryo genetic analysis)
- Fewer than 4 mature oocytes retrieved (will not randomize)
- Male partner with non-obstructive azoospermia
- Male partner with any Karyotype other than 46,XY
- Male partner with history of spinal cord injury
- Male partner with Kallman's syndrome
- History of chronic oligomenorrhea
- History of hydrosalpinges or adnexal mass
- History of endometrial insufficiency (max endometrial thickness < 7mm)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Fresh Vs Frozen Surgical Sperm in IVF | NCT03361982 | Contradiction |
3,986 | 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:
[Visit 1, 2 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.
1) Over 50 years of age 2) Less than 30 minutes of morning stiffness 3) Crepitus on active
motion 4) 4 bony tenderness 5) Bony enlargement 6) 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.
[Visit 6, 7 Inclusion criteria] 1. 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.
1. Over 50 years of age
2. Less than 30 minutes of morning stiffness
3. Crepitus on active motion
4. 4 bony tenderness
5. Bony enlargement
6. Nopalpable warmth of synvium 2. At Re-screening visit, someone who diagnosed with
Kellgren & Lawrence Grade I~III by the radioactive examination.
3. 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.) 4. Patient who are confirmed for Responder
by efficacy at visit 5.
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. 1) Patients who
were injected HA at the target knee joint or other parts of knee joint in recent 9
months.
2) Patients who were injected steroids into the intra-articular knee joint in recent 3
months 3) Patients who were administrated steroids systemically by the oral medication
(But, except inhalation) 4) Patients who were administerated Osteoarthritis nutrition such
as glucosamine/chondroichin sulfate or physical therapy or herbal remedy(acupuncture,
yellowish swelling, moxa cautery) for the purpose of pain relief in recent 2 weeks 5)
Patients who have administerated steroid/No-steriod NSAIDs or other pain relief drugs
(patch or other external medicine) in recents 2 weeks except Acetaminophen or below
300mg/day of Asprin 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. Pregnant and lactating women 22. Patients who were injected other investigational
product over a time within 30 days before participated in this clinical trail.
23. Besides that, the patients who have difficulty to be participated in this clinical
trial continuously by Principle Investigator (PI)'s decision.
- Exclusion criteria for Re-injection is except for 13-1) Re-injection date is followed
by visit 7.
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.
| Clinical Trial of YYD302 (Phase3) for Treatment of Osteoarthritis of the Knee | NCT03561779 | Entailment |
337 | 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:
- Age of women <43 years at the time of stimulated IVF
- Replacing early cleavage embryos or blastocysts after thawing
Exclusion Criteria:
- Requiring hormonal replacement cycles
- Use of donor oocytes or embryos
- Undergoing preimplantation genetic testing
- Presence of hydrosalpinx not corrected surgically prior to FET
- Refusal to join the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 42 Years | Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET | NCT03859921 | Contradiction |
3,950 | 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:
- Patients > 18 years with diagnosis of OA or RA according to the criteria of the
American College of Rheumatology (ACR).
Exclusion Criteria:
- Patients with precedents of fractures; carrying patients of chronic diseases who limit
them in the functional capacity.
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.
| Mexican Initiative of Patients With Osteoarthritis and Rheumatoid Arthritis (IMPACTAR) | NCT02124031 | Entailment |
5,361 | 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:
- Signed informed consent
- Age 18 years or older
- Absence of significant medical conditions
- Patients with healthy or effectually treated periodontal conditions
- Candidate for single tooth replacement in the anterior maxilla
Exclusion Criteria
- General contraindications for dental and/or surgical treatments
- Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid
therapy
- Inflammatory and autoimmune disease of oral cavity
- Uncontrolled diabetes
- Pregnant or lactating women
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Dimensional Soft and Hard Tissue Alterations Following Single Tooth Extraction in the Anterior Maxilla - A Prospective Clinical Study | NCT02403700 | Contradiction |
727 | 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:
- Subject has been taking an NSAID at least 15 of the past 30 days for index knee pain
- Grades 2 or 3 OA as defined by the Kellgren and Lawrence Grading System of the medial
tibiofemoral joint (joint space narrowing in the medial compartment > lateral
compartment as assessed by x-ray) using the Altman Atlas of OA7. This must be
documented with a report from an x-ray of the study joint taken either at screening or
within 1 year prior to screening
- Subject meets American College of Rheumatology (ACR) clinical classification criteria
for osteoarthritis of the knee, defined by the following: Knee pain and at least 3 of
the following: oAge >50 oMorning stiffness <30 minutes oCrepitus on active motion
oBony tenderness oBony enlargement oNo palpable warmth of synovium.
Exclusion Criteria:
- Subject has a documented history of an allergic reaction (hives, rash, etc.) or a
clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids
including oxycodone
- Significant pain outside the index knee, including significant hip or back pain that
can not be distinguished from OA pain or that interferes with ability to walk.
(Patients with bilateral knee OA will be allowed into the study. The index knee should
be defined as the more painful knee
- Predominantly patellofemoral knee osteoarthritis in the index knee as assessed by
clinical examination
- Subject who are unable to discontinue all formulations of prior analgesics other than
acetaminophen during the Washout Period of the study, or who are anticipated to be
unable to discontinue rescue medication for 24 hours prior to the respective visits.
(Low dose aspirin may be taken for cardiac prophylaxis
- Excessive signal knee joint laxity indicative of functional ligamentous deficiency
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.
Subject must be at most 70 Years | Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib. | NCT00484718 | Contradiction |
4,689 | 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:
1. 18 years of age or older
2. Pelvic pain and/or abnormal uterine bleeding. (this is specific for Arm. 1 of this
study)
3. If you have had or are scheduled to have both a pelvic MRI (magnetic resonance
imaging) and a pelvic ultrasound with 6 months of the time of enrollment. (this is
specific to Arm 2 of this study).
-
Exclusion Criteria:
1. If you are post-menopausal(have not had a period in at least one year's time).
2. If you have been diagnosed with gynecological malignancy such as uterine, endometrial,
cervical or ovarian cancer.
3. If you are unable or unwilling to sign the informed consents
4. If you are unable to undergo the research study exams -
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography | NCT01992718 | Entailment |
6,168 | 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:
- Covid-19 patient admitted to the infectious unit
Exclusion Criteria:
- patients who do not agree to sign informed consent, or participating in other studies.
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 95 Years | Monitoring COVID-19 Patients' Lung Fluid Using Impedance Technique | NCT04406493 | Contradiction |
6,433 | 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. | Inclusion Criteria:
- 18 years or older
- Skin types I, II, III
- No previous laser or IPL treatment for the condition
Exclusion Criteria:
- Younger than 18 years old
- Skin types IV, V, or VI
- Pregnant or lactating women
- Previous laser or IPL treatment for the condition
- Recent exposure to sun or sun-beds
- Treatment with oral retinoid within 6 months
- Tendency to produce hypertrophic scars or keloids
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Pulsed Dye Laser and Intense Pulsed Light (IPL) for the Treatment of Telangiectasia and Skin Redness | NCT00206921 | Entailment |
1,857 | 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:
- Adult females and males over 45 years of age with dyspeptic symptoms (epigastric pain,
bloating and epigastric discomfort)
Exclusion Criteria:
- Patients who require surgery or immediate follow-up treatment for major symptoms,
including hematemesis, melena, acute epigastric pain
- Patients who previously underwent upper gastrointestinal surgery
- Patients with diabetes
- Pregnant women
- Subjects who refuse to participate or are unable to give consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Gastropanel for Gastric Atrophy and Cancer Risk Assessment | NCT02114411 | Entailment |
1,905 | 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:
- diagnostic gastroscopy, age over 18, danish speaking,
Exclusion Criteria:
- use of beta blocking or any other heart rate modulating drug, antithyroid drugs
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.
| Stress Response Using Thin and Standard Size Endoscopy. | NCT00273130 | Entailment |
1,120 | 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' selection criteria and enrollment plan:
We will enroll subjects from either cardiovascular clinics or inpatients from the National
Cheng Kung University Hospital from 2018 to 2021 after the signature of inform consent from
patients and their families. The major enrollment criteria include one of the flowing
diseases or conditions:
A. Coronary artery disease:
1. History of myocardial infarction
2. Coronary artery disease with computer tomography angiography image study with at least
one vessel luminal stenosis >70%
3. Coronary artery stents implantation by hospital-based image database
4. Thallium-201 scan positive/treadmill test positive with additional 2 risk factors,
including
1. Diabetes mellitus
2. Hypertension
3. Dyslipidemia
4. Family history of sudden death, coronary bypass surgery, cerebral vascular
attacks (CVA), premature myocardial infarction
5. Smoking behaviors
B. Congestive heart failure with reduced ejection fraction
1. Echocardiography left ventricular ejection fraction <40%
C. Hypertrophic cardiomyopathy:
1. Left ventricle interventricular septum（IVS) >15 mm
2. Left ventricle mass index> 200gm
3. Apical hypertrophy noted on the report with 4 chamber view
D. Atrial fibrillation
1. Recorded by Holter continuous EKG
2. Recorded by standard 12 leads complete EKG
E. Pulmonary hypertension
1. Echo with systolic pulmonary pressure (sysPAP)> 40 mmHg
2. Diagnosis of idiopathic pulmonary hypertension
3. Under pulmonary hypertension medication
F. Fabry's disease
1. α-Galactosidase (a-GAL) enzyme deficiency
2. Genetic disorder
G. Patient with only risk factors (<3 risk factors), recognized as the comparison group
(>500 cases)
1. Diabetes mellitus
2. Hypertension
3. Dyslipidemia
4. Family history of sudden death, coronary bypass surgery, cerebral vascular attacks,
premature myocardial infarction
5. Smoking behavior
Exclusion Criteria:
- Patients unwilling to be enrolled
- Concentration of DNA collection was inadequate after 3 times of collection
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.
| Artificial Intelligence With Deep Learning and Genes on Cardiovascular Disease | NCT03877614 | Entailment |
1,117 | 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 a typical or atypical hypertrophic cardiomyopathy (HCM) confirmed by
imaging modalities (echo and MRI) and/or genetic tests or a relative history of HCM
- Left ventricular obstruction during exercise on treadmill (above 50 mmHg)
- Positive response to leg lifting test (obstruction reduction above 20 mmHg) at rest or
in early recovery phase
- Daily symptoms as shortness of breath during exercise (NYHA2-3), non coronary chest
pain, dizziness
- Correct ultrasound windows quality
- Sinus rhythm
- Optimal medical treatment
- For women, pregnancy test or contraception
- Written consent form obtained
Exclusion Criteria:
- Previous treatment by BX1514M
- Extra-cardiac pathology with life expectancy below than 1 year
- No capability of consent form written
- Pregnancy women
- Secondary hypertension hypertrophy, secondary valvular disease hypertrophy
- Permanent atrial fibrillation
- Severe ventricular arrhythmia without Implantable Cardioverter Defibrillator (ICD)
- Severe coronary disease
- Severe non stabilized hypertension
- Severe cardiopathy (ejection fraction below 40% or demonstrated elevated end diastolic
pressure or pulmonary pressure above 60 mmHg)
- Bradycardia
- Narrow angle glaucoma
- Vascular prethrombotic diseases
- Vascular spams
- Thyrotoxicosis
- Pheochromocytoma
- Severe renal failure (<30ml/mn)
- Patients at risk of urinary retention secondary to prostatic severe disease
- Raynaud's disease
- Non selective Monoamine Oxidase Inhibitors (MAOIs), iproniazid, nialamide or
ephedrine, methylphenidate, phenylephrine, pseudoephedrine or digitalic
- Procedures modifying the peripheral venous return
- Participation to other research 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 80 Years | Hypertrophic Cardiomyopathy Symptom Release by BX1514M | NCT02590809 | Entailment |
6,179 | 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. Ambulatory male or female outpatients ≥ 50 years of age who have laboratory-confirmed
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined
by qualitative PCR (reverse transcriptase (RT)-PCR), or other commercial or public
health assay approved by regulatory authorities as a diagnostic test for COVID-19
(inclusive of SARS-CoV-2 antigen testing or other approved rapid testing platforms) in
any specimen ≤ 5 days prior to randomized treatment.
2. Asymptomatic with no constitutional COVID-19 illness (evident symptoms), specifically
no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache
that is unrelated to pre-existing conditions (example, migraine), sore throat that is
unrelated to other pre-existing medical conditions (example, allergies,
gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with
previous medical condition, or evidence of pneumonia at Screening.
3. Pulse oximetry peripheral oxygen saturation (SpO2) (oxygen saturation) on room air >
94% (i.e., 95% to 100%) at Screening.
4. National Early Warning Score (NEWS) ≤ 2 points at Screening.
5. Subject provides informed consent (ICF) prior to initiation of any study procedures.
Exclusion Criteria:
1. Subjects who are admitted to hospital or for whom hospital admission is being planned
at the time of Screening.
2. Subjects requiring any form of oxygen supplementation at Screening.
3. Concurrent or planned treatment with other agents with actual or possible direct
antiviral activity against SARS-CoV-2 including remdesivir.
4. Prior, concurrent or planned treatment with monoclonal antibodies (mAbs) against
SARS-CoV-2
5. Have participated in a previous SARS-CoV-2 vaccine study OR outside of a study have
received any SARS-CoV-2 vaccine of any kind.
6. Have a history of convalescent COVID-19 plasma treatment at Screening.
7. Fever (temperature >38.0° C [>100.4° F]), requirement for antipyretics to reduce
temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at
Screening.
8. Clinical evidence of any significant acute or chronic disease that, in the opinion of
the investigator, may place the subject at undue medical risk for study treatment.
9. The subject has had a known (documented) history of serious anaphylactic reaction to
blood, any blood-derived plasma product or commercial immunoglobulin, or has known
selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
10. Decompensated congestive heart failure or renal failure with fluid overload. This
includes currently uncontrolled congestive heart failure New York Heart Association
Class III or IV stage heart failure.
11. Subjects for whom there is limitation of therapeutic effort such as "Do not
resuscitate" status.
12. Currently participating in another interventional clinical trial with investigational
medical product or device.
13. Subjects with known (documented) thrombotic complications to polyclonal intravenous
immune globulin (IVIG) therapy in the past.
14. Subject has medical condition (other than COVID-19) that is projected to limit
lifespan to ≤ 1 year.
15. Subject has history of drug or alcohol abuse within the past 12 months.
16. Women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to
practice a highly effective method of contraception (oral, injectable, or implanted
hormonal methods of contraception, placement of an intrauterine device or intrauterine
system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male
sterilization, or true abstinence) throughout 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 50 Years old.
| A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients | NCT04847141 | Contradiction |
626 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- adult patients of > or equal 18 years
- genetic hemochromatosis
- undergoing a therapeutic blood withdrawal
- health insured
- non-obese (body mass index <30Kg/m²)
Exclusion Criteria:
- pregnancy
- transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters
- clinical signs of active exhalation
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.
| Respiratory Variations For Assessing Blood Withdrawal | NCT03066414 | Contradiction |
1,311 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Children and adolescents with Noonan's syndrome with a height < -2 SD and no
progressive cardiopathy
Exclusion Criteria:
- Age < 3 years
- Height ≥ -2 SD
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 15 Years | Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome | NCT00452725 | Contradiction |
6,801 | 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:
- Ability to provide written informed consent
- Age ≥18 years
- Presence of a nonsense mutation as the sole disease-causing mutation in the FVIII or
FIX gene
- At least 20 prior treatments with FVIII or FIX concentrates
- Willingness and ability to comply with scheduled visits, drug administration plan,
study restrictions, and study procedures
Exclusion Criteria:
- Known hypersensitivity to any of the ingredients or excipients of the study drug
- Any history of prior anti-FVIII/FIX inhibitors
- Unable or unwilling to forego prophylactic FVIII/FIX concentrate use during the
screening and on-study periods (Note: Participants were allowed use of FVIII/FIX
concentrates for treatment of bleeding episodes while on study)
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study of Ataluren (PTC124) in Hemophilia A and B | NCT00947193 | Entailment |
6,712 | 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:
1. All children ages 6 months - 18 years with hemophilia A or B
2. Hemophilia subjects with and without a history of hemarthroses including target joints
( joint of interest) and joints without documented bleeds( control joints)
3. Hemophilia subjects with a history of inhibitor to FVIII or FIX and documented
hemarthroses
4. History of hemarthroses more than 4 weeks prior to study enrolment to allow for
resolution of hemarthroses which could affect detection of synovial and cartilage
changes
Exclusion Criteria:
1. Bleeding disorder subjects without a diagnosis of hemophilia
2. Hemophilia subjects with any underlying illness such as liver or renal disease or any
systemic illness such as diabetes or any other chronic illness apart from the
hemophilia
3. Hemophilia subjects on medications which could increase bleeding risk such as non
steroidal anti inflammatory agents, anti seizure medications apart from factor
concentrates
4. History of hemarthroses within the 4 weeks prior to study enrolment
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 18 Years | Ultrasonography in Hemophilic Joint Disease and Serum Markers | NCT02634918 | Contradiction |
5,315 | 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:
- Healthy ambulatory postmenopausal (≥ 5 years) women from 50 to 85 years of age
(inclusive) with a diagnosis of osteoporosis
- The women are to have a bone mineral density (BMD) T score ≤ -2.5 and > -5.0 at the
lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and
radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic
vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip,
femoral, or tibial fracture within the past 5 years. Postmenopausal women older than
65 who meet the above fracture criteria but have a T score ≤ -2.0 and > -5.0 may be
enrolled. Women older than 65 who do not meet the fracture criteria may also be
enrolled if their T score is ≤ -3.0 and > -5.0
- Normal physical exam, vital signs, electrocardiogram (ECG) and medical history
- Laboratory tests within the normal range including serum calcium, PTH(1-84), serum
phosphorus and alkaline phosphatase
Exclusion Criteria:
- History of more than 4 mild or moderate spine fractures or any severe fracture
- Abnormality of the spine or hip that would prohibit assessment of bone mineral density
(BMD)
- Unexplained elevation of serum alkaline phosphatase, history of bone disorders (such
as Paget's disease) or a diagnosis of cancer within the last 5 years (with the
exception of basal cell or squamous cancer of the skin)
- History of thyroid, parathyroid, or adrenal disorders, or malabsorptive syndromes or
any chronic or recurrent diseases or disturbances that would interfere with the
interpretation of study data or compromise the safety of the patient
- Prior treatment with parathyroid hormone (PTH) or parathyroid hormone-related peptid
(PTHrP)
- Prior treatment with bisphosphonates, fluoride, or strontium within the past five
years or treatment with androgens, anabolic steroids, corticosteroids or selective
estrogen receptor modulators within the past 12 months (except hormone replacement
therapy)
- Prior treatment with an investigational drug within the past 12 months
- History of nephrolithiasis or urolithiasis within the past five years, or history of
osteosarcoma at any time
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women | NCT01343004 | Entailment |
5,671 | 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:
- Body Mass Index ≥ 25 - ≤ 34.9 kg/m2.
- Waist Circumference ≥ 80 cms.
- Non-smoker.
- BP ≤ 140/90 mm Hg
- FBS ≤ 125 mg/dl
- Hb ≥ 11 g/ dl
- Can abstain from strenuous exercise and alcohol for at least 48 hours.
- Can abstain from caffeine for at least 24 hours.
Exclusion Criteria:
- Participants with history of regular (≥2 times a week) structured exercise (gym,
walking, yoga, etc).
- Inter-arm blood pressure is ≥10 mm Hg.
- Known cases of type II Diabetes Mellitus.
- Known cases of hypertension with or without anti-hypertensive medication.
- Visual or balance problems, or who cannot walk on a treadmill without using the
handrails.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Aerobic Fitness in Overweight and Obese Individuals | NCT03854786 | Contradiction |
422 | 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) Between 18 and 49 years of age (at screening), inclusive.
- 2) Willing and able to provide written informed consent.
- 3) Healthy, based on medical history, vital signs, physical examination, urinalysis,
laboratory evaluations for genital infections and laboratory evaluations for
hematology, liver and renal function.
- 4) HIV-negative as determined by HIV ELISA test at screening.
- 5) In the absence of the use of exogenous hormone(s), have a self-reported regular
menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days
between menses.
- 6) Normal Pap test at screening. (Documentation of normal Pap test results within 12
months prior to screening is also acceptable.)
- 7) Agrees to use effective contraception for the duration of the trial. If hormonal
contraception or intrauterine device (IUD)/ Intrauterine system (IUS) is being used,
it must be have been used for at least 30 days prior to screening, with no planned
change in method during the study. The following forms of contraception (per
self-report) are permitted: same-sex relationship, male or female sterilization, oral
contraceptives, contraceptive implant, contraceptive patch, IUS, IUD
depo-medroxyprogesterone acetate (DMPA; Depo-Provera®).
- 8) Willing to abstain from sexual intercourse/activity including receptive vaginal,
oral, digital, and anal intercourse, and the use of any vaginal products including
tampons, male and female condoms, contraceptive sponges, diaphragms, cervical caps,
douches, lubricants, and vibrators/dildos; starting the Screening Visit (Visit 0)
through the final safety visit (Visit 3/Day 8) in the OL period; and starting 48 hours
before enrollment through the final safety visit (Visit 8/Day 21) in the randomized
period
- 9) Agrees to not participate in any other clinical research for the duration of this
trial.
Exclusion Criteria:
- 1) History of or known sensitivity/allergy to any component of either study product.
- 2) Currently pregnant or breast-feeding, or within 3 months of last pregnancy outcome.
- 3) Participation in any other clinical research trial involving investigational or
marketed products currently or within two months of participation prior to screening,
including any trial of a spermicide, microbicide and/or drug.
- 4) Known bleeding disorder that could lead to prolonged or continuous bleeding with
biopsy.
- 5) Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 3
months. Note: Women with a history of condylomata or genital herpes who have been
asymptomatic for at least six months may be considered for eligibility.
- 6) Positive test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), or
Trichomonas vaginalis (TV) at screening.
- 7) Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract
infection (UTI) at screening. (Participants who test positive at initial screening may
be treated and re-tested once, and reconsidered for screening).
- 8) Presence of any clinically significant genital epithelial findings (e.g. abrasions,
ulcerations, or lacerations, or vesicles) suspicious for STIs at screening.
- 9) History of hysterectomy or menopause.
- 10) Use of excluded contraceptive methods including Nuvaring®, condoms (male or
female), contraceptive sponge, diaphragm, or cervical cap.
- 11) History of gynecological surgery or procedure within past 2 months.
- 12) History of uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction
within the last 3 months, including unexplained break-through bleeding requiring
sanitary protection.
- 13) Known current drug abuse, including illicit drugs, or alcohol abuse.
- 14) Abnormal finding on laboratory or physical examination or a social or medical
condition which, in the opinion of the investigator, would make participation in the
study unsafe or would complicate interpretation of data.
- 15) Unable to comply with study requirements, including but not limited to, attending
all study visits, using the gel as directed, observing abstinence throughout the study
and use of allowable effective contraceptives.
- 16) History of latex allergy.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 49 Years | Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women | NCT02875119 | Contradiction |
1,779 | 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 undergoing upper endoscopy Motivation to participate in the study Signed consent
Exclusion Criteria:
Known gastric cancer Unwillingness or inability to co-operate
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Surveillance of Patients With Precancerous Lesions of the Stomach | NCT03250091 | Contradiction |
5,275 | 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 women between the ages of 46 and 80（cessation of menses for 12 months
for any reason）
- Subjects with osteoporosis diagnosed according to the World Health Organization (WHO)
criteria：they had a BMD T-score of -2.5 or less at the spine or femoral neck；or they
had low bone mass，defined as BMD T-score less than -1.0 and more than -2.5 at the
spine or femoral neck，with the history of fragility fracture(Fracture site included
vertebra, hip,proximal humera, distal radius, distal ulna)
- Subjects signed informed consent voluntarily
Exclusion Criteria:
- Any non-primary osteoporosis skeletal disease
- Subjects with abnormal hepatic function and renal function（alanine transaminase(ALT)
and aspartate transaminase(AST) are 2 times higher than the upper limits of
normal(ULN);plasma creatinine concentration and blood urea nitrogen are more than 1.5
ULN or calculated creatinine clearance less than 60 ml/min）
- Subjects with serum calcium greater than 2.75 mmol/L (11.0 mg/dL) or less than 2.00
mmol/L (8.0 mg/dL)
- Subjects with severe heart disease, blood disease, mental diseases
- Subjects with cancer and other serious progressive disease
- Prior therapy with bisphosphonates within 12 months before trial entry, prior therapy
with parathyroid hormone 1-34 or 1-84, estrogen, selective estrogen receptor
modulators, strontium more than 2 weeks within 6 months, prior therapy with oral or
intravenous glucocorticoid more than 3 months within 6 months
- Subject is hypersensitivity to experimental drugs, comparator drugs and their
metabolites
- Subjects who participated in other drugs or medical devices clinical studies as
subjects within 3 months before this study
- Subjects judged unfit for this study by investigators
Female
No healthy subjects accepted to join the trial.
Subject must be at least 46 Years old.
Subject must be at most 80 Years | Generic Zoledronic Acid Versus Original Zoledronic Acid in Postmenopausal Osteoporotic Women | NCT03158246 | Entailment |
5,608 | 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:
- Women treated in an endocrinology centre specialising in hyperandrogenism at the
university hospital of University Federal of Minas Gerais (Belo Horizonte, Minas
Gerais, Brazil)
- The patients were of reproductive age (range: 18-45 years)
- were overweight or obese (Body mass index ≥ 25.0 kg/m2) and
- signed an informed consent statement
Exclusion Criteria:
- Women who were pregnant,
- were lactating,
- had a diagnosis of hypothyroidism or hyperthyroidism or
- had high physical activity levels were excluded from the sample.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Predictive Equations for Resting Energy Expenditure | NCT02435888 | Contradiction |
1,323 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
- Histologically or cytologically confirmed solid tumor malignancy that is advanced or
metastatic (Stage IIIB or IV) or is surgically unresectable.
- Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain
tumors).
- Documentation of an FGFR1-3 gene mutation or translocation.
- Objective disease progression after at least 1 prior therapy.
- Not eligible or able to participate in any other Incyte-sponsored clinical trial.
Exclusion Criteria:
- Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
- Prior receipt of a selective FGFR inhibitor.
- Current evidence of clinically significant corneal or retinal disorder.
- History of calcium and phosphate hemostasis disorder or systemic mineral imbalance
with ectopic calcification of soft tissues.
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.
| Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) | NCT04003623 | Contradiction |
1,535 | 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:
- children with moderate to severe asthma living in homes with non EPA-certified
woodstove used for heating.
Exclusion Criteria:
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 17 Years | Indoor Woodsmoke PM and Asthma | NCT00807183 | Contradiction |
4,796 | 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:
- The patient suffering from vertigo and dizziness for at least 1 month and
- The ability to walk independently or do their routine tasks will be included in the
study.
- Patients should be capable to complete the questionnaire without any help.
Exclusion Criteria:
- Patients suffering from blindness,
- musculoskeletal abnormalities,
- neurologic disorder, or paralysis in ENT or neurologic evaluation by ENT and
- neurologist will be excluded from the study.
- Also, if the patients are unable to cooperate then, they will also 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 18 Years old.
| Translation of Dizziness Handicap Inventory Scale Into Local Languages of Pakistan | NCT04849078 | Entailment |
753 | 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:
- Age 70+
- Fall in the last 12 months before screening (with or without a fracture)
- Living at home (community-dwelling)
- Men or women
- Mobile with or without walking aid - have to be able to use public transportation to
attend the clinical visits at the trial centre
- Score of at least 27 at the screening Folstein Mini Mental test + normal clock test
- Patient understands the study procedures, alternative treatments available and risks
involved with the study, and voluntarily agrees to participate by giving a written
informed consents.
- Patient meets the entry minimal requirements based on routine clinical laboratory
safety screening tests and the Folstein mini mental status (score 27+ required)
performed at the Screening Visit.
- Patient is willing to perform all study tests, attend all required office visits, and
provide blood and urine samples.
Exclusion criteria:
- Serum calcium adjusted for albumin of > 2.6 nmol/l
- Pathologic fracture in the last year (except for fractures due to osteoporosis)
- Chemo therapy / Radiation due to cancer in the last year
- Treatment which has an effect on bone metabolism (e.g. bisphosphonate, PTH,
calcitonin, chronic cortisone intake > XYmg/day for more than XY month/years (except
for inhalation and sporadic infiltration))
- Oral vitamin D intake of more than 800 IU per day
- Unwilling to stop calcium supplementation and vitamin D supplementation during the
trial (maximal calcium supplement intake 250mg/d; no additional vitamin D
supplementation)
- Severe visual or hearing impairment
- Unwilling or unable to take study medication
- Diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome,
Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy,
epilepsy, recurring vertigo, recurring syncope)
- BMI >= 40
- Estimated creatinine clearance < 15 ml/min (estimated Creatinine Clearance Cockcroft
and Gault)
- Malabsorption syndrome (celiac diseases, inflammatory bowl disease)
- Diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary
hyperparathyroidism
- kidney stone in the last 10 years
- Abnormal indices of calcium metabolism, uncontrolled hypocalcemia.
- Patient heavily consumes alcohol containing products defined as greater than (>) 3
drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
- Patient is unlikely to adhere to the study procedures, to keep appointments, or is
planning to relocate during the study.
- Patients who are planning a stay in a "sunny" location (e.g. winter sun resort) for
more than two months per year
- Medication which has an effect on 25-hydroxyvitamin D level (e.g. certain
anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin))
- M. Paget (Ostitis deformans)
- inflammatory arthritis (e.g. rheumatoid arthritis, reiter syndrome, psoriasis
arthritis)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 70 Years old.
| Zurich Disability Prevention Trial | NCT01017354 | Contradiction |
5,686 | 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:
- Diagnosed with Turner's Syndrome through chromosome analysis
- The chronological age: 2≤AGE≤12
- The yearly growth rate should be less than 6cm; the bone age should be equal or less
than 12; the height ≤ 10th percentile for the heights of their agemates
- Before the adolescence, Tuner stage I (breast)
- Normal thyroid function
Exclusion Criteria:
- Growth hormone was administered for 12 months or longer in the past
- Treated with estrogen or adrenal androgens for 12 months or longer in the past
- Malignancy, CNS Trauma, Psychiatric Disorder
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 12 Years | A Clinical Study to Assess the Efficacy and Safety of DA-3002 | NCT01813630 | Entailment |
3,393 | 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:
- Sensorineural hearing loss
- Veteran-adult onset of hearing
- English as first language
- Eligible for VA issued hearing aids
- Eligible to receive care at one of the three participating VA sites: Nashville,
Tennessee, Mountain Home Tennessee, Bay Pines Florida
Exclusion Criteria:
- Known neurological, psychiatric disorders, or co-morbid disease that would prevent
completion of the study
- Inadequate vision
- Inadequate reading skills
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 | Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids. | NCT00727909 | Contradiction |
5,812 | 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! | Main Inclusion Criteria:
- Patients who completed ALTANA Pharma study BY1023/FK3006 (long-term clinical trial
regarding efficacy and tolerability of Pantoprazole in patients not responding to
treatment with H2-receptor antagonists or omeprazole)
- Written informed consent
Main Exclusion Criteria:
- Concomitant diseases
- Pregnant or nursing female patients; female patients of childbearing potential who are
not using reliable contraception
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708) | NCT00261300 | Contradiction |
3,671 | 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:
- At Visit 1 (study entry) patients must have a medical history and physical and
neurological examinations that support a clinical diagnosis of acute low back pain
that is felt down to the lower leg below the knee with the onset no longer than 30
days before Visit 1
- At Visit 1 patients must report qualifying pain intensity scores
- Patients must be appropriate candidates for treatment with oral opioid pain medication
in the investigator's clinical judgment
- Patients must be able to appropriately verbalize pain characteristics and to complete
all protocol required measurements/assessments without assistance
- Patients must be medically stable on the basis of physical examination, medical
history, vital signs, and clinical laboratory tests performed at screening
Exclusion Criteria:
- History of back (cervical, thoracic or lumbosacral) pain =50% of the time in the 1
year prior to the first visit
- History of any low back pain episode, with the exception of the current acute low back
pain episode, within 3 months prior to the first visit that was greater than mild in
pain intensity, or was associated with disability (e.g., loss of time from work,
family, or activities of daily living), or necessitated the use of an opioid
(narcotic) analgesic including tramadol
- Medical history or physical examination results that suggest the acute low back pain
or any of the neurological symptoms or signs are caused by a serious medical condition
(e.g., fever, chills, unexplained weight loss, bowel or urinary bladder dysfunction or
incontinence, bilateral leg weakness, progressive weakness, paralysis)
- There is a high probability for surgical intervention for the back pain during the
projected time on the study or that there will be an increase in the severity of the
leg pain or deficits
- Had either a surgical procedure involving the spine or intervertebral discs in the
lower back region within 1 year prior to Visit 1 or had >1 surgical procedure(s)
involving the spine or intervertebral discs in the lower back region
- has any painful condition that could interfere with the study assessments or with the
patient's ability to differentiate the pain associated with the acute low back pain
episode from pain associated with another condition
- History of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis
- history of epilepsy or recurrent seizures
- Unable or unwilling to discontinue all prohibited medications at the time of
randomization and during the time of their participation in the study
- Known or suspected history of alcohol or drug abuse based on medical history, physical
examination, urine drug screening, or the investigator's clinical judgment
- History of cancer malignancy within 2 years prior to the first visit, with the
exception of basal cell skin carcinoma
- Have filed or plan to file a worker's compensation claim for any issue related to the
current acute low back pain episode
- Currently involved in litigation or plan to seek legal recourse for any issue related
to their acute low back pain
- Known allergies, hypersensitivity, or intolerance to tapentadol or the comparator
(oxycodone) or any excipients used in their manufacture
- Had previously been enrolled in a tapentadol clinical study
- is pregnant or are breast-feeding
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.
| NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain | NCT00986180 | Contradiction |
194 | 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:
- Men aged 18-35 years
- Ability to understand verbal or written instructions/testing materials in English
- Physically active (as determined by accelerometry and review of a physical activity
log)
- Not taking any prescription medications and/or willing to refrain from all medication
use prior to and throughout the entire study period, unless provided/approved by the
study physician
- Willing to refrain from alcohol, smoking, e-cigarettes or use of any nicotine product,
caffeine, and dietary supplement use throughout the entire study period
- Willing to live on the Pennington Biomedical Research Center inpatient unit for 20
consecutive days
- Meets age-specific US Army body composition standards according to Army Regulation
600-9, which includes estimates of percent body fat based on height, weight, and
circumference measures (neck and waist)
- Total testosterone concentration is within the normal physiological range (300-1,000
ng/dL)
Exclusion Criteria:
- Musculoskeletal injuries that compromise exercise capability
- Diagnosed cardiometabolic disorders (i.e., hypertension, hyperlipidemia, kidney
disease, diabetes, etc.)
- Allergies or intolerance to foods, vegetarian practices, or history of complications
with lidocaine
- Anabolic steroid, human growth hormone, or nutritional testosterone precursor-like
supplement use within the past 6 months
- Will not refrain from smoking (any nicotine product), alcohol, caffeine, or any other
dietary supplement during the study
- Adults unable to consent
- Women
- Prisoners
- Sedentary or engages in insufficient quantities of physical activity per week (aerobic
and/or resistance training as determined by accelerometry and review of a physical
activity log)
- Exceeds age-specific US Army body composition standards according to Army Regulation
600-9
- Previous history of kidney stones unless otherwise approved by the medical
investigator
- Systolic blood pressure > 150 or diastolic blood pressure > 95 mmHg
- Previous history of breast or prostate cancer
- Previous history of Chronic Obstructive Pulmonary Disease or Obstructive Sleep Apnea
- Prostate-Specific Antigen (PSA) > 3ng/ml, Hematocrit > 50%, or positive urine drug
screening
- Based on the investigative team's clinical judgment, a subject may not be appropriate
for participation in the study
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations | NCT04120363 | Entailment |
4,378 | 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:
- >18 years old
- Able to read and understand the English language
Exclusion Criteria:
- Significant corneal scarring
- Taking medications that cause miosis (pupil constriction)
- Patients with no light perception
- Patients unable to open their eyes e.g. due to significant ptosis
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Oscillation of Crystalline and Intraocular Lenses | NCT04274634 | Entailment |
3,908 | 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:
- have the ability to give informed consent
- be 45 years or over
- have complaints of knee pain for 3-6 months with or without radiographically
established OA (K/L scale score ≥ 1)
- have complaints of knee pain for 3-6 months with or without satisfying the
non-radiographic American College of Rheumatology criteria for knee OA
- are willing to undertake knee synovial fluid aspiration
- be able to speak, read, and write in English as all instructions and questionnaires
are designed in the English language
Exclusion Criteria:
- Inability to give informed consent due to cognitive impairment or otherwise -
(capacity levels are already established under General Practitioner care)
- Inability to understand key aspects of the study due to cognitive impairment or
otherwise
- Giving history of additional co-morbidities such as cancer, neurological conditions,
inflammatory joint diseases including rheumatoid arthritis, diabetic neuropathies,
fractures or other conditions causing greater disability than their knee pain
- Acute soft tissue injury to the knee within last 3 months before potential recruitment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Molecular Pathways Involved in Knee Pain | NCT04443452 | Entailment |
246 | 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. Age 18 through 35 years (inclusive) at screening
2. Non-pregnant women in general good health as determined by the site clinician
3. Premenopausal with history of regular menstrual cycles (regular cycles defined as
occurring every 21-35 days when not using hormones and with a variation of typical
cycle length of no more than 5 days)
4. Regular and consistent condom use, prior surgical sterilization by participant or
sexual partner, or heterosexually abstinent since last menses prior to enrollment
5. Able and willing to provide written informed consent to be screened for and to take
part in the study, including willingness to undergo all study-related assessments and
follow all study-related procedures
6. Able and willing to provide adequate locator information
7. HIV-uninfected based on testing performed by study staff at enrollment
Exclusion Criteria:
1. Use of any hormonal or intrauterine contraceptive method within 30 days of enrollment
2. Use of depot medroxyprogesterone acetate (DMPA) within 10 months of enrollment
3. Pregnancy or breastfeeding within 60 days of enrollment
4. Surgical procedure involving the pelvis in the 30 days prior to enrollment (includes
dilation and curettage, cryosurgery and biopsy of the vagina, vulva, cervix, and
endometrium)
5. Internal vaginal use of any device (includes sex toys, cervical caps, diaphragms,
menstrual collection devices, and pessaries; excludes tampons and condoms) or product
(includes spermicide, microbicide, douche, antifungal, steroid, or hormone) in the 30
days prior to enrolment (includes investigational products and devices)
6. New sexual partner within 90 days of enrollment
7. Urogenital infection or suspected infection within 30 days of enrollment including:
symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis;
or cervical infection, including N. gonorrhoea (GC), C. trachomatis (CT), or
mucopurulent cervicitis; syphilis; herpes simplex virus (HSV) lesions, or other sores
(Note: seropositive HSV without active lesions will not be excluded); acute pelvic
inflammatory disease; urinary tract infection; recent exposure to a partner with GC,
CT, Trichomonas, syphilis, or non-gonococcal urethritis (NGU)
8. Any history of immunosuppression (includes diabetes, HIV infection, and chronic
steroid use or other immunosuppressive medications)
9. Antibiotic or antifungal therapy (vaginal or systemic) within 30 days of enrollment
10. Menses or other vaginal bleeding at the time of enrollment* (*Women who have vaginal
bleeding at the scheduled enrollment visit may return at a different date to be
re-examined and possibly enrolled provided they are still within the 90-day screening
window and meet all criteria).
11. Vaginal or anal intercourse within 36 hours prior to enrollment
12. Heterosexual intercourse since last menses that places the participant at risk of
pregnancy (without condom use or sterilization of at least one partner)
13. History of hysterectomy
14. History of malignancy within the pelvis (includes uterus, cervix, vagina, and vulva)
15. Any condition that, in the opinion of the Investigator, would preclude provision of
consent, make participation in the study unsafe, complicate interpretation of study
outcome data, or otherwise interfere with achieving the study objectives
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Expression of IFN-epsilon in the Female Reproductive Tract | NCT02416154 | Contradiction |
2,020 | 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... | Cases of non-metastatic gastric adenocarcinoma (nmGaC) were defined as patients with
microscopically-confirmed first primary invasive adenocarcinoma of the stomach
(International Classification of Diseases for Oncology, Third Edition (ICD-O-3) code: C16)
without distant metastasis. Only those who underwent resection in January 2004 through
December 2016 were included. Cancers of other histology types including squamous cell
carcinoma, gastrointestinal stromal tumor or sarcoma, neuroendocrine tumor or carcinoid,
lymphoma, and germ-cell tumor were ineligible, as were patients with non-gastric cancers
involving the stomach, with benign or in situ tumors, or with other malignancies before
gastric cancer. We further excluded patients with diagnosis based on death certificate only
or autopsy, with missing follow-up period, survival status, or cause of death, or with
unknown metastasis status. Cancers with distant metastasis were excluded since resection is
not routinely recommended for them. Data before 2004 were not included, as the TNM stage
information was unavailable. To minimize the effect of perioperative events on survival, we
excluded patients surviving <1 month. No restrictions were applied to age, and patients ≥80
years only comprised 5% of those receiving both resection and chemotherapy.
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 100 Years | Long-term Heart-specific Mortality in the Presence of Competing Risks Among Patients With Non-metastatic Gastric Adenocarcinoma Undergoing Resection and Chemotherapy | NCT04820569 | Entailment |
2,248 | 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:
- Self-reported arthritis or chronic joint symptoms
- Currently exercising less than 3 times per week
- Plan to be in community for at least 1 year
- Physician release for participation in physical activity
Exclusion Criteria:
- Pregnancy
- Non-English speaking
- Cognitive impairment
- Serious medical condition where exercise is contradindicated
- Severe physical or mental impairment
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 the Active Living Every Day Exercise Program for People With Arthritis | NCT00146367 | Entailment |
37 | 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:
- Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes)
testosterone levels >100 ng/dl and ≤ 300 ng/dL.
- Normal Otolaryngological nasal endoscopy examination.
- Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.
Exclusion Criteria:
- Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex
hormones
- Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12
months
- History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or
sinus surgery.
- History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per
month, abuse of nasal decongestants) or sleep apnea.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Efficacy of an Intranasal Testosterone Product | NCT01252745 | Contradiction |
2,099 | 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:
1. Understand and voluntarily sign an informed consent form.
2. >18 and < 75 years old at the time of signing the informed consent form.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Have a diagnosis of Idiopathic Pulmonary Fibrosis in accordance to American Thoracic
Society guidelines.
5. Persistent cough:
• as defined by a cough that adversely affects the patient's quality of life and has
been present for at least 3 months.
6. Laboratory test results within these ranges:
- Absolute neutrophil count >2 x 103/ul
- Platelet count >100,000 /mm³
- Serum creatinine < 2.0 mg/dL
- Total bilirubin < 1.5 mg/dL
7. Diffusion capacity > 25%predicted
8. Forced vital capacity <80% predicted • AST (SGOT) and ALT (SGPT) < 2 x ULN
8. Able to take aspirin (81 or 325 mg) daily as prophylactic anti-coagulation (patients
intolerant to ASA may use warfarin or low molecular weight heparin).
Exclusion Criteria:
1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
2. Females of child-bearing potential defined as a sexually mature woman who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in
the preceding 24 consecutive months).
3. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
4. Use of any other experimental drug or therapy within 28 days of baseline.
5. Known hypersensitivity to thalidomide or lenalidomide.
6. Any prior use of thalidomide, lenalidomide or pomalidomide (CC-4047).
7. Known positive for HIV or infectious hepatitis, type A, B or C.
8. History of deep venous thrombosis
9. History of pulmonary embolism
10. Use of the following anti-tussive agents must be discontinued 14 days prior to their
baseline visit. -
1. prednisone 2. narcotic anti-tussives 3. baclofen 4. neurontin 11. Treatment for
infection or acute exacerbation within past 3 months
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.
| Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis | NCT01135199 | Entailment |
5,831 | 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:
- 18 years and above
- Attending the medical office and reporting symptoms suggestive of upper
gastrointestinal tract symptoms such as heartburn/regurgitation, abdominal pain,
bloating, belching and nausea/vomiting.
Exclusion Criteria:
- Participating on a clinical trial during the last 3 months.
- Patients not able to read and/or understand the GERD-Q questionnaire.
- Patients already included in the study in other participating site.
- Patients taking PPIs or H2blockers in the l
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.
| Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Tract Symptoms in Egypt | NCT01635959 | Contradiction |
6,911 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Patient and/or study partner (relative) must provide a signed and dated Informed
Consent form prior to any study procedures which will be discussed with the Study
Coordinator.
2. Provision of a letter from the Neurologist/Psychiatrist/Internal Medicine Physician
certifying the diagnosis of Alzheimer's Dementia and patient's ability to consent. If
patient is unable to consent, only the legal guardian/tutor of the patient could
consent in his/her behalf. The guardian/tutor will be required to present the
pertinent legal documentation.
3. Must have a study partner who is able and willing to comply with all required study
procedures.
4. Patient should meet NIA-AA criteria for Alzheimer's disease, any stage.
5. At least 3 months evolution of behavioral symptoms at screening visit.
6. Negative drug screen, except for benzodiazepines if patient has been using them in
stable doses for at least 3 months before screening.
7. All medications used for behavioral symptoms should be in stable doses for at least 3
months before screening.
8. All medications used for other conditions besides behavioral symptoms should be at
stable doses for at least 30 days before screening.
9. Women must be postmenopausal (defined as cessation of menses for at least 1 year) or
surgically sterile (hysterectomy, oophorectomy or bilateral tubal ligation) at the
time of screening.
Exclusion Criteria:
1. Prior adverse reaction to cannabinoids.
2. Prior contraindication or allergy to any component of study product (IGC-AD1):
melatonin, honey, curcumin, ethyl alcohol, vitamin-E TPGS, ascorbic acid, water,
tween-80, and rutin.
3. History of stroke, multiple sclerosis (MS), or epilepsy. History of gastrointestinal
dysfunction not related to Alzheimer's disease (e.g., inflammatory bowel disease or
gastrointestinal cancer)
4. Any clinically relevant neurological disorder capable of producing a dementia syndrome
including Parkinson's disease, stroke, vascular dementia, dementia with Lewy bodies,
frontotemporal dementia, and others.
5. Other possible causes of dementia as: infections of the CNS (e.g. HIV, syphilis) or
Creutzfeldt Jakob disease, subdural hematoma, communicating hydrocephalus, brain
tumors, drug intoxication, alcohol intoxication, thyroid disease, parathyroid disease,
and vitamin B12 or other deficiencies
6. Use of contraindicated medication (see section 6).
7. History of myocardial infarction, severe congestive heart failure, unstable angina,
significant valvular disease, or cardiomyopathy within 1 year of screening.
8. History of cardiac arrhythmias, second or third-degree AV block.
9. History of seizures, schizophrenia, or bipolar disorder.
10. Other condition or clinically important abnormality on vital signs, physical
examination, neurologic examination, laboratory results or electrocardiogram (ECG)
examination that could compromise the study efficacy interpretation or safety of the
subject.
11. Have participated in an investigational drug or device study within 30 days prior to
study start.
12. TCA or opioid use within 30 days before the enrollment.
13. History of alcohol and drug abuse within 2 years of screening.
14. Elevated liver enzymes (AST or ALT ≥3 times upper limit of normal, Total bilirubin≥1.5
times ULN or ALP≥1.5 times ULN).
15. Urine drug screen positive for drug use, except for benzodiazepines if patient was
using them previously and their dose had remained stable for at least 3 months before
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 99 Years | Study of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease | NCT04749563 | Entailment |
894 | 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:
- Patients with unilateral or bilateral knee OA.
- Subjects of 50 years or above
- palpable bony enlargement
- Crepitus on knee motion
- morning stiffness for less than 30 minutes
- Kellgren and Lawrence scale: Grade 1-3
Exclusion Criteria:
- Patients with spinal surgery
- lower extremity arthroplasty
- Severe joint contractures and bony deformities of lower extremity
- Amputation of lower extremity
- Recent trauma to lower extremity
- A cortisone injection to the hip/ knee within previous 30 days
- Patient having mechanical back pain .i.e. lumbosacral radiculopathy and sciatica
- Patient with lower extremity bony deformities either acquired or congenital
- Patient with advanced hip OA.
- Systemic arthritis or rheumatoid arthritis
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.
| Hip Joint Mobilizations and Strength Training in Patients With Knee OA Osteoarthritis | NCT04769531 | Entailment |
3,076 | 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:1. Confirmed genetic diagnosis of fragile X syndrome
2. Age e 14
3. Verbal IQ e 60 Exclusion Criteria:1. Currently taking any anticholinergic medications,
tricyclic antidepressant medications, or diphenhydramine.
2. Presence of cardiac disease or bradycardia (< 60 beats/minute) at initial evaluation.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 14 Years old.
| An Open-Label Trial of Donepezil in Fragile X Syndrome | NCT00220584 | Entailment |
6,252 | 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. Adult 18 years-old and older.
2. Person in employment (on fixed-term or permanent contracts) since (at least) March
17th, 2020, the date of national implementation of containment measures in response to
the COVID-19 pandemic.
3. Signed informed consent.
4. Person affiliated to a French social security regimen in accordance with Article
1121-11 of the French Public Health Code).
Exclusion Criteria:
1. Report of known active SARS-CoV-2 infection within 10 days prior to the date of
signing the consent. Known active SARS-CoV-2 infection is defined as a positive result
on a diagnostic RT-PCR test.
2. Presence of known symptoms suggestive of COVID-19 within 10 days prior to the date of
signing consent: fever, fatigue, dry cough, shortness of breath, loss of taste and/or
smell, headache, body aches, aches and pains, conjunctivitis or colds, digestive
disorders (vomiting, diarrhea).
3. A person who is unable to follow and comply with research procedures due to
geographical, social or psychological reasons.
4. Pregnant or breastfeeding woman.
5. Person deprived of their liberty, incapable or incapable of giving their consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Serological Response to SARS-Cov-2 Virus in Personnel of the Institut Bergonié in the Context of the COVID-19 Pandemic | NCT04426006 | Contradiction |
6,582 | 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 :
For participants rolling over into Arm A
- Participants who have completed the studies EFC16923, EFC16925, Arm B or Arm C of the
current study, or any other potential BIVV001 study.
- Male or Female For participants new to BIVV001 (Arm B and C)
- Participants who have severe hemophilia A, defined as <1 IU/dL (<1%) endogenous FVIII
activity as documented either by central laboratory testing at screening or in
historical medical records from a clinical laboratory demonstrating <1% FVIII
coagulant activity (FVIII:C) or a documented genotype known to produce severe
hemophilia A.
- Previous treatment for hemophilia A (prophylaxis or on-demand) with any recombinant
and/or plasma-derived FVIII, or cryoprecipitate for at least 150 EDs or 50 EDs for
participants aged <6 years.
- Platelet count ≥100 000 cells/μL at screening.
- A participant known to be human immunodeficiency virus (HIV) antibody positive, either
previously documented or identified from screening assessments, must have the
following results prior to enrollment: CD4 lymphocyte count >200 cells/mm³ and viral
load of <400 000 copies/mL
- Male
- Only for Arm B: Chinese participants
- Only for Arm C: planned major surgery within 6 months after Day 1.
Exclusion criteria:
For participants rolling over into Arm A
- Positive inhibitor result, defined as ≥0.6 Bethesda units (BU)/mL.
- Participation in another study. For participants new to BIVV001 (Arm B and Arm C)
- Any concurrent clinically significant liver disease that, in the opinion of the
Investigator, would make the participant unsuitable for enrollment. This may include,
but is not limited to cirrhosis, portal hypertension, and acute hepatitis.
- Serious active bacterial, fungal, or viral infection (other than chronic hepatitis or
HIV) present within 30 days of screening.
- Other known coagulation disorder(s) in addition to hemophilia A.
- History of hypersensitivity or anaphylaxis associated with any FVIII product.
- History of a positive inhibitor (to FVIII) test defined as ≥0.6 BU/mL, or any value
greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs
for inhibitor detection between 0.7 and 1.0 BU/mL, or clinical signs or symptoms of
decreased response to FVIII administrations. Family history of inhibitors will not
exclude the participant.
- Positive inhibitor test (FVIII) result, defined as ≥0.6 BU/mL at screening.
- Treatment with acetylsalicylic acid (ASA) or antiplatelet agents that are not
nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to screening.
- Treatment with NSAIDs greater than the maximum dose specified in the regional
prescribing information within 2 weeks prior to screening.
- Systemic treatment within 12 weeks prior to Screening with chemotherapy and/or other
immunosuppressive drugs (except for the treatment of hepatitis C virus [HCV] or HIV).
- Emicizumab use within the 20 weeks prior to screening.
- Major surgery within 8 weeks prior to screening.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A | NCT04644575 | Contradiction |
2,854 | 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. Able to comprehend and willing to sign an Informed Consent Form (ICF)
2. Males or females 18 years of age or older
3. A diagnosis of familial or sporadic ALS (defined as meeting the possible,
laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS
according to the World Federation of Neurology El Escorial criteria)
4. Maximum voluntary grip strength in at least one hand between 10 & 40 pounds (females)
and 10 & 60 pounds (males)
5. Able to swallow tablets with water
6. Currently taking and tolerating a stable dose of 50 mg BID riluzole
7. Willing and able to reduce daily dose of riluzole to 50mg QD for 5 weeks
8. Not currently taking or willing and able to remain off theophylline-containing
medications during study participation
9. Patient has a caregiver who is capable of observing and reporting patient status
10. Upright Slow Vital Capacity (SVC) >50% of predicted for age, height, and sex
11. Able to perform pulmonary function tests
Exclusion Criteria:
1. Life expectancy <3 months
2. Receipt of investigational study drug within 30 days or 5 half-lives of the prior
agent, whichever is greater, prior to dosing
3. Any prior treatment with CK-2017357
4. Any use of non-invasive positive pressure ventilation (NIPPV), such as Continuous
Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP)
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 18 Years old.
| Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | NCT01486849 | Entailment |
2,541 | 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. Pediatric out-patients diagnosed with AD aged 2 to 15 years at the time of written
informed consent. Diagnosis for AD should be made in accordance with the "Guidelines
for Management of Atopic Dermatitis" by the Japanese Dermatological Association.
2. Mild to moderate clinical symptoms appearing at baseline in areas where the
application of study drug is possible, except the skin of face/head and non-dermal
areas such as mucosa
3. Evaluable skin lesions appearing at baseline. "Evaluable skin lesion" means rash area
of 25 to 100 cm2 in the trunk or extremities, in which at least one of dermal symptoms
(erythema, exudate/eschar, excoriation or lichenification) must be moderate in
severity.
4. Continuous use of an appropriate moisturizer for at least 14 days before baseline
5. Females of child-bearing potential must be negative for pregnancy test at baseline and
are able to practice effective contraception during the study period including the
follow-up period
6. Virile males and females of childbearing potential, who and whose partners consented
to practice contraception throughout the study period after receiving an explanation
using the informed consent form and the separately-prepared assent form
7. Patients whose legally acceptable representatives (caregivers) are able to consent in
writing to participate in the study and who are able to adhere to the protocol
requirements. For patients aged 12 years or older at the time of informed consent,
written consent should be obtained from the patients as well as their legally
acceptable representatives (caregivers). Also for patients aged below 12 years,
written informed consent should be obtained whenever possible.
Exclusion Criteria
1. Use of biological products which may affect the pathological evaluation of AD within 6
months before the start of study treatment
2. Concurrent or recent use of certain topical or systemic medications or phototherapy
without a sufficient washout period, except hydrocortisone butyrate preparations used
in areas which are unsuitable for application of study drug at the discretion of the
investigator
3. Currently has Kaposi's varicelliform eruption, scabies, molluscum contagiosum,
impetigo contagious, psoriasis, connective tissue disorder, or Netherton's syndrome,
etc, which may affect the pathological evaluation of AD
4. Any past history or present illness of serious allergy such as anaphylactic shock,
anaphylactic reaction and anaphylactoid reaction, or any past history or present
illness of drug allergic reaction or hypersensitivity
5. Has active infection that requires oral or intravenous administration of antibiotics,
antifungal or antivirus agents at baseline
6. Currently has an advanced disease or highly abnormal laboratory test result that may
affect the safety of subject or the implementation of the study
7. Difficulty in venous access for blood collection
8. Any past history or present illness of malignant tumor, lymphoma, leukemia or
lymphoproliferative disorder, except non-melanoma skin carcinoma (e.g., squamous cell
carcinoma and basal cell carcinoma) which was completely removed and has not recurred
or metastasized for at least 5 years
9. Scheduled for surgery during the study
10. Concurrently enrolled in another clinical study or used any investigational drug or
device within 30 days before the date of informed consent
11. Ineligible for participating in the study for other reasons, in the judgment of the
investigator or subinvestigator
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 15 Years | A Phase 1/2 Study of E6005 in Pediatric Subjects With Atopic Dermatitis | NCT02094235 | Entailment |
6,987 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Patients fulfilling the National Institute on Aging and the Alzheimer's Association
diagnostic criteria of probable AD dementia or the NINDS-AIREN (National Institute of
Neurological Disorders and Stroke and Association Internationale pour la Recherché et
l'Enseignement en Neurosciences) diagnostic criteria of AD with cerebrovascular
disease (AD + CVD)
- Patients presenting mild or moderate dementia according to the Clinical Dementia
Rating (CDR), i.e., CDR 1 or 2, respectively
Exclusion Criteria:
- Patients treated with ChEI or memantine before study entry
- Patients diagnosed with frontotemporal dementia, dementia with Lewy bodies or vascular
dementia,
- Patients with CDR 3
- Illiterate patients
- Patients with different comorbidities, with signs of clinical decompensation
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 59 Years old.
Subject must be at most 93 Years | Good Rate of Clinical Response to Cholinesterase Inhibitors in Alzheimer's Disease After Three Months of Treatment | NCT02007291 | Entailment |
987 | 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:
- Active complaint of knee pain
- Diagnosis of knee osteoarthritis according to X-ray
- Morning stiffness of less than 30 minutes AND/OR crepitus in active movement
- Ability to read Hebrew
Exclusion Criteria:
- Previous participation in physiotherapy treatment program
- Gout in knee, rheumatoid arthritis, fibromyalgia
- Complaints that appear in a knee which was operated in the past
- Dementia
- Severe limitations in mobility
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.
| Integrated Treatment Program for Osteoarthritis of the Knee | NCT02200107 | Entailment |
1,747 | 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... | DISEASE CHARACTERISTICS:
- Diagnosis of cancer with developing febrile neutropenia
- Neutropenia defined as an absolute granulocyte count of less than 1,000/mm^3,
expected to fall to less than 500/mm^3 within 24 hours, secondary to
administration of chemotherapy and/or radiotherapy within the past 30 days
- Fever defined as an oral temperature greater than 38.5ºC once, or 38°C or greater
on 2 or more occasions at least 1 hour apart during a 12-hour period, and
suspected to be due to infection
- Expected low risk of serious medical complications as predicted by a Multinational
Association for Supportive Care in Cancer risk-index score of greater than 20
- No obvious signs of exit-site or tunnel intravascular catheter infection
- No known or suspected CNS infection
- No known or highly suspected bacterial, viral, or fungal infection
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- No high probability of death within 48 hours before study enrollment (i.e., patients
who are moribund or comatose for any reason with little hope of recovery OR patients
in danger of, or in hepatic stupor or coma)
Hematopoietic
- See Disease Characteristics
- No signs or symptoms of uncontrolled bleeding
Hepatic
- Bilirubin no greater than 3 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 3 times ULN
- AST and ALT no greater than 5 times ULN
- No severe hepatic dysfunction
Renal
- Creatinine no greater than 3.4 mg/dL
- Creatinine clearance at least 25 mL/min
- No renal failure requiring hemodialysis or peritoneal dialysis
Cardiovascular
- No prior symptomatic arrhythmias
- No clinically relevant bradycardia
- No QTc interval prolongation
- No uncorrected hypokalemia
- No signs or symptoms of hypotension (systolic less than 90 mm Hg)
Pulmonary
- No signs or symptoms of respiratory insufficiency
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Able to swallow oral medication
- No contraindication for oral drug intake
- No condition likely to severely impair drug absorption
- No prior immediate or accelerated reaction to penicillin, cephalosporin, or
fluoroquinolone antibiotics
- No known allergy or hypersensitivity to any antibiotics in this study or other
quinolones
- No signs or symptoms of severe dehydration
- No signs or symptoms of shock
- No other signs or symptoms at presentation that would necessitate IV supportive
therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- More than 4 days since prior antibacterial agents except for the following:
- A single (oral or parenteral therapeutic) dose after initial diagnosic work-up
and within the last 8 hours
- Low-dose cotrimoxazole (i.e., no more than 480 mg daily or 960 mg 3 times per
week) prophylaxis of Pneumocystis carinii pneumonia
- More than 30 days since prior investigational drugs
- No prior randomization in this study
- No other concurrent antimicrobial agents
- No class IA or class III antiarrhythmic drugs or other concurrent drugs that prolong
the QTc interval
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.
| Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer | NCT00062231 | Contradiction |
202 | 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:
- Healthy males between the ages of 18 and 65 years of age exhibiting morning
testosterone ≤350 ng/dL.
- All clinical laboratory tests within normal ranges (any clinically significant
deviation of laboratory results will require approval of sponsor)
- Ability to complete the study in compliance with the protocol
- Ability to understand and provide written informed consent
- Agreement to use a condom, and with a fertile female partner, another form of
contraception.
- Agreement to provide a semen sample in the clinic
Exclusion Criteria:
- Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3
months prior to study
- Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen,
anabolic steroid, DHEA, or herbal hormone products during the study
- Use of Clomid in the past year or during the study
- Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment
at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control
will be allowed into the study. Newly diagnosed diabetics need to be treated for at
least 48 hours before being enrolled in the study.
- A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
- Clinically significant abnormal findings on screening examination
- Use of an investigational drug or product, or participation in a drug or medical
device research study within 30 days prior to receiving study medication
- Known hypersensitivity to Clomid
- Any condition which in the opinion of the investigator would interfere with the
participant's ability to provide informed consent, comply with study instructions,
possibly confound interpretation of study results, or endanger the participant if he
took part in the study
- Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome,
primary hypogonadism, vasectomy, or tumors of the pituitary)
- History of breast cancer
- History of prostate cancer or a suspicion of prostate disease unless ruled out by
prostate biopsy, or a PSA >3.6
- History of known hyperprolactinemia with or without a tumor
- Chronic use of medications use such as glucocorticoids
- Chronic use of narcotics
- Subjects known to be positive for HIV
- Subjects with end stage renal disease
- Subjects with cystic fibrosis (mutation of the CFTR gene)
- Subjects unable to provide a semen sample in the clinic
- Subject has a BMI >42 kg/m2
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone) | NCT01386606 | Entailment |
5,462 | 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:
- Women aged 18 to 35 years.
- Women who have freely chosen a low-dose LNG-IUS for the first time as contraceptive
method and it has been successfully inserted previously to invite the woman to
participate in the study.
- Women capable of reading and writing.
- Women who signed the informed consent form.
- Women who are not participating in an investigational program with interventions
outside of routine clinical practice.
- Women without a mental illness and able to make decisions and follow instructions.
- Women without contraindications to a low-dose LNG-IUS according to the local marketing
authorization.
- Women without concomitant medications that may lead to changes in the bleeding pattern
(e.g. antiplatelet and/or anticoagulants).
Exclusion Criteria:
- None
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | The Aim of This Study is to Estimate the Discontinuation Rate of Low-dose Levonorgestrel-releasing Intrauterine System Due to Self-reported Unacceptable Menstrual Bleeding Pattern in Spanish Women Who Are Using it for the First Time How Intrauterine System for Long Acting Contraception | NCT04785950 | Entailment |
1,242 | 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. | Inclusion Criteria:
- male or female subjects 18 years or older
- documented diagnoses of hypertension and of hypercholesterolemia or current therapy
for these conditions
- uncontrolled hypertension (SBP >140 mmHg or DBP >90 mmHg) or cholesterol levels above
their threshold based on their global atherosclerotic risk profile (based on ATP III
assessment)
- ability to give written informed consent
Exclusion Criteria:
- ischemic heart disease, atrial fibrillation, chronic kidney disease and significant
liver disease
- currently prescribed 3 or more drugs to control blood pressure
- currently prescribed 2 or more drugs to control hypercholesterolemia
- participating in other hypertension/hypercholesterolemia studies
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.
| STITCH2 (Simplified Therapeutic Intervention to Control Hypertension and Hypercholesterolemia) | NCT00637078 | Entailment |
3,568 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | Inclusion Criteria:
- erythema migrans in patients > 18 years
Exclusion Criteria:
- pregnancy or lactation
- taking antibiotic with antiborrelial activity within 10 days
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.
| Cytokines and Chemokines in Erythema Migrans | NCT02147249 | Entailment |
5,968 | 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:
- Patient aged from18-50 years who have been diagnosed to have gastric reflux by
gastroenterology departement before the start of treatment, and they also have
sinonasal symptoms.
Exclusion Criteria:
- Pregnant
- Significant nasal cavity malformations
- Oncological pathology
- Other sinonasal 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 50 Years | Gastric Reflux and Sinonasal Symptoms | NCT04105894 | Contradiction |
5,113 | 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 women (postmenopausal for at least two years)
- Men above 50 years
- Treatment for at least two years with denosumab
- Last denosumab injection less than five months ago
Exclusion Criteria:
- Low-energy vertebral fracture at any time
- Low-energy hip fracture within the last 12 months
- BMD T-score < -2,5 (lumbar spine, total hip or femoral neck)
- Alendronate treatment for more than three years prior to denosumab treatment
- Ongoing treatment with glucocorticoids
- Metabolic bone disease
- Hormone replacement therapy
- Cancer
- Estimated glomerular filtration rate (eGFR) < 35 mL/min
- Allergy to zoledronic acid
- Hypocalcaemia
- Contraindications for zoledronic acid according to the SPC
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.
| Treatment With Zoledronic Acid Subsequent to Denosumab in Osteoporosis | NCT03087851 | Contradiction |
5,539 | 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:
- giant celle arteritis with at least 3 ACR criteria including a disgnostic temporal
artery biopsy
- corticosteroid treatment since less than 1 month
- age less than 85 years
- signed informed consent
Exclusion Criteria:
- amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium
infarctus, mesenteric ischemia or other vascular complications related to GCA
- low life expectancy (<2 years)
- corticosteroid treatment since more than 30 days whatever the dosage
- primary corticosteroid resistance defined by persistant symptoms despite prednisone
for more than 15 days
- previous psychiatric troubles induced corticosteroids
- hydroxychloroquine contra-indicated
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 85 Years | Hydroxychloroquine in Giant Cell Arteritis | NCT00430807 | Entailment |
473 | 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:
All pregnant subjects will be recruited under informed consent at Hutzel Hospital. The
study population for both arms of this protocol will involve pregnant women between the
ages of 15 years-old and older at Hutzel Hospital. The ethnic backgrounds are estimated to
involve approximately 60 percent Caucasian and 40 percent African American between both
sides.
- Accurate pregnancy dating criteria.
- Estimated gestational age less than or equal to 20 weeks' gestation.
- Visible fetus with normal heart rate and rhythm.
EXCLUSION CRITERIA:
- Poor visualization of the fetus due to technical factors (e.g. obesity).
- Risk factors that increase risk for not keeping serial ultrasound appointments.
- Desire not to have vaginal ultrasound scans.
Female
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
| Early Pregnancy Evaluation by Three-Dimensional Ultrasound | NCT00342290 | Contradiction |
459 | 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:
- has regular menstrual cycle (24 to 35 days)
- is at low risk of pregnancy (ie, sterilized, in exclusively same-sex partnership, in
monogamous relationship with vasectomized partner, or using non-hormonal IUD)
- is in good general health as determined by a medical history and physical examination
- is not pregnant and does not have desire to become pregnant in the subsequent 36
months
- has had a normal mammogram within the last year (for Part 1 only)
- additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
- has hypertension:
- systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg
- vascular disease
- has current or history of ischemic heart disease
- has history of stroke
- has history of thromboembolic event
- has systemic lupus erythematosus
- positive (or unknown) antiphospholipid antibodies
- severe thrombocytopenia
- has rheumatoid arthritis on immunosuppressive therapy
- has migraine with aura
- has unexplained vaginal bleeding
- has diabetes
- has strong family history of breast cancer (defined as one or more first degree
relatives, breast cancer occurring before menopause in three or more family members,
regardless of degree of relationship, and any male family member with breast cancer),
or current or history of breast cancer, or undiagnosed mass detected by breast exam
- has current or history of cervical cancer
- has severe cirrhosis (decompensated) or liver tumors
- has known significant renal disease
- used Depo-Provera Contraceptive Injection or Depo-subcutaneous Provera 104 (DMPA)
products in the past 12 months
- used any of the following medications within 1 month prior to enrollment:
- any investigational drug
- prohibited drugs per protocol
- oral contraceptives, contraceptive ring or patch
- levonorgestrel intrauterine system (LNG IUS) or contraceptive implant
- used a combined injectable contraceptive in the past 6 months
- less than 3 months since the end of last pregnancy
- currently lactating
- is using or plans to use prohibited drugs per protocol in the next 18 months
- has known sensitivity to MPA or inactive ingredients
- has a plan to move to another location in the next 24 months
- in the opinion of the investigator, potentially at elevated risk of HIV infection (eg,
HIV -positive partner, IV drug use by self or by partner)
- additional criteria apply, please contact the investigator for more information
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Study to Evaluate Suppression of Ovulation and Pharmacokinetics of Medroxyprogesterone Acetate Following Administration of TV-46046 in Women With Ovulatory Cycle | NCT02817464 | Contradiction |
6,506 | 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. | Inclusion Criteria:
1. Male or female subjects ≥18 years of age at the time of consent.
2. Subjects do not have any medical conditions, other than rosacea, that in the opinion
of the investigator, put the subject at unacceptable risk or could interfere with
study assessments or integrity of the data.
3. A clinical diagnosis of moderate to severe (Grade 3 or 4) facial rosacea
(papulopustular (Subtype 2) or mixed erythematotelangiectatic (Subtype 1) and
papulopustular (Subtype 2)) as determined by the Investigator's Global Assessment
(IGA)
4. Have 15-70 papulopustular lesions of rosacea on the face with no more than 2 nodules.
5. Female subjects of childbearing potential are willing to use effective contraceptive
method (s) for at least 4 weeks before Baseline and at least 4 weeks after the last
study product administration or have a sterilized or same sex partner for the duration
of the study. Effective contraceptive methods are: systemic hormonal contraceptives,
intrauterine device or barrier method of contraception in conjunction with spermicide
or agree to sexual abstinence. Hormonal contraceptives must be on a stable dose for at
least 12 weeks before Baseline. Subjects using low dose (≤35 ug ethinyl estradiol)
oral contraceptives must use a second form of birth control (e.g., barrier method such
as condoms with spermicide).
6. Female subjects of childbearing potential must have a negative urine pregnancy test
(dipstick).
7. Subjects who use make-up, facial moisturizers, creams, lotions, cleansers and/or
sunscreens must have used the same product brands/types for a minimum period of 2
weeks prior to Baseline, must agree not to change brand/type or frequency of use
throughout the study and must agree not to use make-up, facial moisturizers, creams,
lotions, cleansers and/or sunscreens on the scheduled clinic visit days before the
visit.
8. Be willing to limit or avoid known personal 'triggers' of rosacea such as spicy foods,
consumption of alcoholic beverages, extended sun exposure, tanning beds, etc., for the
duration of the study.
9. Subjects must be capable of giving informed consent and the written informed consent
must be obtained prior to any study-related procedures.
Exclusion Criteria:
1. Have a history of skin disease, presence of skin condition, scarring or excessive
facial hair the PI believes would interfere with the study.
2. Have moderate or severe rhinophyma, severe telangiectasia or plaque-like facial edema.
3. Have rosacea conglobata or fulminans, corticosteroid induced rosacea or facial
erythrosis other than rosacea.
4. Have ocular rosacea of a severity that requires systemic treatment.
5. Have a history of any adverse reaction to minocycline or other tetracycline class
antibiotic.
6. Have a clinically significant chemistry or hematology value or have an ALT or AST that
is greater than or equal to 2x normal.
7. Have any conditions or factors that the PI believes may affect the response of the
skin or the interpretation of the results.
8. Have a history of symptoms that might be confused with a diagnosis of pseudotumor
cerebri such as severe headaches or visual disturbances inconsistent with a diagnosis
of migraine or have a history of traumatic brain injury with headache and/or visual
disturbances.
9. Have used on the face an over the counter (OTC) topical medication for the treatment
of rosacea within 4 weeks prior to Baseline.
10. Have used prescription topical (on the face) and/or oral antibiotics within 4 weeks
prior to Baseline.
11. Treatment with hormonal therapy or oral corticosteroids that is not on a stable dose
and frequency for at least 12 weeks before Baseline and not stable throughout the
study.
12. Have had a facial procedure such as chemical peel, laser, microdermabrasion or
injections with a dermal filler or neuromodulator within 8 weeks prior to Baseline.
13. Have received photodynamic therapy or phototherapy to the face within 12 weeks prior
to Baseline.
14. Have used an oral retinoid within 6 months or a topical retinoid within 3 months prior
to Baseline.
15. Current drug or alcohol abuse.
16. Female subject who is breastfeeding, pregnant or who is planning a pregnancy during
the study.
17. Participated in any clinical study with exposure to any investigational treatment or
product within the previous 4 weeks to Baseline, or plan on concurrent participation
in other studies.
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.
| Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea | NCT03667222 | Entailment |
5,897 | 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:
- Adults between 19 and 75 years old based on the date of written agreement
- Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA
Grade A-D on the upper gastrointestinal endoscopy
- Those who experienced symptoms of heartburn or acid reflux within the last 7 days
Exclusion Criteria:
- Those who have undergone gastric acid suppression or gastric, esophageal surgery
- Those who with clinically significant liver, kidney, nervous system, respiratory,
endocrine, hematologic, cardiovascular, urinary system disease
- Clinically significant abnormal laboratory values during screening
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 75 Years | Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease | NCT04282954 | Contradiction |
Subsets and Splits