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2,309 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Confirmation of diagnosis of dystrophinopathy, documented by clinical exam and
dystrophin DNA mutation analysis
- Ambulatory male subjects between the ages of 7-11 years
- Stable dosage of corticosteroids for 3 months prior to entry (Screening/Baseline Day
0) and during treatment period
- Able to follow instructions and give assent
- Able to complete nonsedated MR
Exclusion Criteria:
- Presence of metallic orthopedic hardware in the lower extremity that could affect
MRI/MRS measurements
- Routine MRI exclusion criteria such as the presence of a pacemaker, cochlear implant,
or cerebral aneurysm clip
- Subjects not capable of cooperating during MR examination
- Known hypersensitivity to L-arginine
- Exposure to another investigational agent, investigational supplements, growth hormone
within 3 months prior to entry (Screening/Baseline Day 0) or during treatment period
- Subjects must not be taking L-arginine for at least 4 weeks prior to entry (Day 0)
- Subjects who are non-ambulatory or with daytime ventilatory dependence
Male
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
Subject must be at most 11 Years | Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids | NCT01388764 | Entailment |
5,692 | 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:
- Turner syndrome by karyotype
Exclusion Criteria:
- Thyroid abnormality
- Glucocorticoid treatment
Female
Accepts Healthy Volunteers
| Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy | NCT00825617 | Entailment |
1,006 | 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:
- Chronic (lasting a long time) primary osteoarthritis knee pain, one or two side with
stage II Kellgen-Lawrence, for more than 3 months with Visual Analogue Scale (VAS)
more than 4
- Good knee deformity, no limit range of motion
- Participant who has signed the informed consent form
Exclusion Criteria:
- Skin disease that prevents the use of the transdermal system or which could affect the
absorption of fentanyl or local tolerability
- History or suspicion of alcohol or drug abuse within the past 5 years
- History of cardiac, nervous system or respiratory disease which in the investigator's
judgment prevents participation in the study because of the potential for respiratory
depression
- Confusion, reduced level of consciousness, or concomitant psychiatric disorder which,
in the opinion of the investigator, could prevent participation in the trial
- Participants who do not understand or speak Thai
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.
| Efficacy and Safety Study of Transdermal Therapeutic System (TTS) Fentanyl in Participants With Osteoarthritis Knee Pain | NCT01742897 | Entailment |
6,581 | 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:
- Diagnosis of congenital haemophilia A or B with inhibitors development against FVIII
or FIX, respectively
Exclusion Criteria:
- Prophylactic administration of any haemostatic drug within 3 last months prior to
entering the trial.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
| Efficacy of NovoSeven® in Bleeding Prophylaxis in Hemophilia | NCT00108758 | Contradiction |
2,711 | 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:
- Clinical diagnosis of a primary unilateral inguinal hernia
Exclusion Criteria:
- Medically unfit for surgical repair
Male
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
| Isolation of the Spermatic Cord in Mesh Inguinal Hernia Repair | NCT01391455 | Entailment |
1,985 | 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. Aged 18-75 years；
2. Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach
or esophagogastric junction, including: papillary adenocarcinoma, tubular
adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet
ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
3. Clinical stage cT1N0M0, cT1N1M0, cT2N0M0；
4. The gastric primary lesion is located in the body or fundus of stomach or the
esophagogastric junction. It is expected that total gastrectomy with D1+/D2 lymph node
dissection achieves R0 resection (multiple primary cancers are also applicable)；
5. BMI(Body Mass Index)<30 kg/m2；
6. No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
7. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy,
etc.；
8. Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or
1；
9. Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
10. Sufficient vital organ functions；
11. Signed informed consent.
Exclusion Criteria:
1. Preoperative examination indicates disease stage cStage II or above；
2. Women during pregnancy or lactation；
3. Suffer from other malignant tumors within 5 years；
4. Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring
systemic treatment；
5. Severe mental illness；
6. Severe respiratory disease；
7. Severe liver and kidney dysfunction；
8. History of unstable angina or myocardial infarction within 6 months；
9. History of cerebral infarction or cerebral hemorrhage within 6 months；
10. Continuous application of glucocorticoid within 1 month (except for topical
application)；
11. Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.)
；
12. The patient has participated in or is participating in other clinical studies (within
6 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.
Subject must be at most 75 Years | The Safety of Totally Laparoscopic Versus Laparoscopy-Assisted Total Gastrectomy. | NCT04351321 | Entailment |
5,802 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Patients presenting with a clinical picture that assumes the diagnosis of erosive oral
lichen planus (bilateral, more or less symmetrical erosive lesions with lacelike
network of slightly raised gray white lesions (reticular pattern), and a histological
findings that confirms the diagnosis (liquefaction degeneration of the basal cell
layer with irregular-saw teeth like rete pegs.
Exclusion Criteria:
- Systemic disorders such as hematological diseases, severe cardiovascular diseases,
treatment with any drugs that could cause Lichenoid reaction.
- Pregnancy or active breastfeeding
- Patients who had lesion/lesions with dysplasia
- Patients who received topical treatment for Oral Lichen planus in the last 2 weeks
(Lee et al., 2013) or systemic treatment for OLP in the past 3 months.
- Platelet count < 150,000/mm3; Hgb < 11 g/dl.
- Immunosuppressed patients
- Patients receiving therapy with anticoagulants and use of non-steroidal
anti-inflammatory drugs in the 5 days before taking the blood sample.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus | NCT03293368 | Entailment |
5,789 | 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:
- Age 18 or older, both genders
- History of recurrent aphthous ulcers with 4 or more episodes per year
Exclusion Criteria:
- History of salivary gland disease including Sjogren's disease, parotitis, and
sialolithiasis
- History of benign or malignant salivary gland tumor
- History of celiac disease, ulcerative colitis or Crohn's disease
- Patients on medications that affect salivary flow such as anti-depressants and
anti-cholinergic medications
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Salivary Catecholamines in Aphthous Stomatitis (Canker Sores) | NCT00556686 | Contradiction |
5,859 | 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:
- Subjects who seek medical advice in primary care for symptoms thought to be GERD
related (GERD is a condition which develops when the reflux of stomach content causes
troublesome symptoms and / or complications).
Exclusion Criteria:
- Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the
last 3 months prior to Visit 1.
- A history of severe esophagitis or known other complications, with alarm symptoms
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 | Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients | NCT00444275 | Contradiction |
2,283 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Completion of ataluren treatment in the previous Phase 2a study (Protocol
PTC124-GD-004-DMD).
- Ability to provide written informed consent (parental/guardian consent if
applicable)/assent (if <18 years of age).
- Confirmed screening laboratory values within the central laboratory ranges.
- In participants who are sexually active, willingness to abstain from sexual
intercourse or employ a barrier or medical method of contraception during ataluren
administration and the 6-week follow up period.
- Willingness and ability to comply with scheduled visits, drug administration plan,
study procedures, laboratory tests, and study restrictions.
Exclusion Criteria:
- Treatment with systemic aminoglycoside antibiotics within 3 months prior to start of
study treatment.
- Treatment with warfarin within 1 month prior to start of study treatment.
- Known hypersensitivity to any of the ingredients or excipients of the study drug
(Litesse® UltraTM [refined polydextrose], polyethylene glycol 3350, Lutrol® micro F127
[poloxamer 407], mannitol 25C, crospovidone XL10, hydroxyethyl cellulose, vanilla,
Cab-O-Sil® M5P [colloidal silica], and magnesium stearate).
- Exposure to another investigational drug within 2 months prior to start of study
treatment.
- History of major surgical procedure within 1 month prior to start of study treatment.
- Ongoing immunosuppressive therapy (other than corticosteroids).
- Ongoing participation in any other clinical trial (except for sub-studies specifically
approved by PTC Therapeutics).
- Clinically significant symptoms and signs of congestive heart failure (CHF) (American
College of Cardiology/American Heart Association Stage C or Stage D).
- Prior or ongoing medical condition (for example, concomitant illness, psychiatric
condition, behavioral disorder, alcoholism, drug abuse), medical history, physical
findings, electrocardiogram findings, or laboratory abnormality that, in the
Investigator's opinion, could adversely affect the safety of the participant, makes it
unlikely that the course of treatment or follow-up would be completed, or could impair
the assessment of study results.
Male
No healthy subjects accepted to join the trial.
| Phase 2a Extension Study of Ataluren (PTC124) in Duchenne Muscular Dystrophy (DMD) | NCT00759876 | Contradiction |
1,432 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Subjects must be scheduled for non-urgent appointment at primary care practice
including annual wellness visits and routine follow-up appointments.
- Subjects must be over the age of 18
- Subjects must be able to give informed consent
- Subjects must have no solid food for 4 hours prior to the procedure, and only clear
liquids for 2 hours prior to the procedure.
Exclusion Criteria:
- Subjects with current symptoms of dysphagia
- Subjects with any history of intestinal strictures, prior GI surgery, or history of
intestinal Crohn's disease.
- Subjects with current symptoms of fever, nausea or sore throat at the time of the
appointment.
- Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting | NCT02445027 | Contradiction |
161 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Males between 18-75 years of age
- Two fasting serum testosterone levels <300 ng/dL
Exclusion Criteria:
- Previous use of the study drug
- History of prostate or breast cancer
- Prostate-Specific Antigen (PSA) ≥3 ng/mL
- Subject is sexually active and not willing to use adequate contraception
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Clinical Trial to Evaluate the Efficacy and Safety of Testosterone Gel in Adult Hypogonadal Males | NCT02149264 | Entailment |
6,365 | 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. Signed informed consent, demonstrating that the subject understands the procedures
required for the study and the purpose of the study
2. Healthy, ambulant male or female subjects 18 years of age to 65 years of age
3. Positive test for COVID-19 by RT-PCR at screening
4. Subjects must agree to practice at least one highly effective method of birth control
for the duration of the study. This includes condoms with spermicide, oral birth
control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects
not of reproductive potential will be exempt (e.g. post-menopausal, surgically
sterilized)
5. Subjects must agree they will do their best to attend the treatment facility daily for
10 days
Exclusion Criteria:
1. Refusal to sign informed consent form
2. Negative test for COVID-19 by RT-PCR at screening
3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea,
shortness of breath, temperature > 38 degrees; pleuritic pain, or frequent cough.
4. Known drug allergy to any of the investigational medications
5. Currently taking medication with known drug interactions with investigational
medications (listed in appendix)
6. Prescription or other antiviral medications
7. Any comorbidities which constitute health risk for the subject
8. Pregnant or lactating females;
9. weight < 110lb;
10. porphyria
11. established retinal disease
12. Inability to attend daily for 10 days
13. Any contraindications for treatment with hydroxychloroquine
1. Hypoglycemia
2. Known G6PD deficiency
3. Porphyria
4. Anemia
5. Neutropenia
6. Alcoholism
7. Myasthenia gravis
8. Skeletal muscle disorders
9. Maculopathy
10. Changes in visual field
11. Liver disease
12. Psoriasis
13. History of QT >500msec
14. History of torsades de pointes
14. Anemia from pyruvate kinase and G6PD deficiencies
15. Abnormal EKG with QT prolongation acquired or from birth
16. History of jaundice or high fevers prior to developing COVID-19
17. Treatment with any of the medications listed in Appendix II
18. Treatment with any anti-epileptic medication
19. Treatment with any other drug not listed that affects the QT 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.
Subject must be at most 65 Years | A Study of Combination Therapies to Treat COVID-19 Infection | NCT04459702 | Entailment |
833 | 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 had to have a documented diagnosis of osteoarthritis of their knees.
- Patients had to be between 50 and 70 years inclusive.
- Patients had to have X-ray evidence of osteoarthritis of their knees.
Exclusion Criteria:
- Patients with another rheumatological condition other than osteoarthritis.
- Patients who were unable to understand the concepts, assessment and treatment
involved.
- Patients who had received a cortisone injection into the knee in the previous 30 days.
- Patients for whom CSWD or hydrotherapy has been contraindicated.
- Patients who have had either CSWD or hydrotherapy in the past.
- Patients who had undergone a surgical procedure on either lower limb in the past 6
months.
- Patients who were receiving other physiotherapy treatment.
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.
Subject must be at most 70 Years | An Examination of the Value of Shortwave Diathermy and Hydrotherapy for Patients With Osteoarthritis of Their Knees | NCT00726492 | Entailment |
5,084 | 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:
- Female
- 65 years or older
- Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score <= -2.5 at spine or
hip) or prior fragility fracture BMD T-score <=-1.5 in at least one of the anatomic
sites including lumbar spine, total hip, and femoral neck sites
- Postmenopausal
- Low levels of vitamin D as measured 25-hydroxyvitamin D
- Has fallen at least once within the past 12 months
Exclusion Criteria:
- Unable to stand or sit upright for at least 30 minutes
- Has a bone disorder other than osteoporosis
- Contraindication to the use of FOSAVANCE
Female
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262) | NCT00692913 | Contradiction |
6,423 | 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
CRITERIA RELATED TO THE POPULATION:
- Male or female subject having signed a written informed consent for his/her
participation to the study
- Subject with a phototype II to IV according to the Fitzpatrick scale
- Subject affiliated to a social security system or health insurance, or is a
beneficiary
- For woman of childbearing potential use of an effective method of contraception, as
assessed by the investigator for at least 4 weeks before inclusion in the study
For acne of the face subgroup and its associated control: Male or female, 18 to 30 years
old included
For atopic dermatitis of the upper limb subgroup and its associated control: Male or
female, 20 to 50 years old included
For vulgar plaque psoriasis subgroup and its associated control: Male or female, 20 to 55
years old included
For telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its
associated control: Male or female, 30 to 55 years old included
For seborrheic dermatitis of scalp subgroup and its associated control: Male or female, 20
to 45 years old included
CRITERIA RELATED TO DERMATOSIS:
For subjects of the acne of the face subgroup :
-Subjects with mild to severe acne on the face with a GEA (Global Acne Evaluation) score of
2 to 4 on a rating scale ranging from 0 (no injury) to 5 (very severe)
- Subject presenting on the face, at least one zone:
- Lesional in immediate border of a papule
- Peri-lesional near inflammatory lesions (papule, about 1 cm)
- Subject presenting on the inner side of the forearm a reference zone without lesion
For subjects in the atopic dermatitis subgroup of upper limbs:
- Subject with atopic dermatitis on the upper limbs, mild to moderate with SCORAD
(SCORing Atopic Dermatitis) between 15 and 40 included with:
•A dryness score ≥ 2 on a scale ranging from 0 (absent) to 3 (severe)
- Subject having at least one inflammatory flare of atopic dermatitis on the upper limbs
in the 2 years before the day of inclusion
- Subject presenting on the upper limb (hand excluded) at least one zone:
•Lesional defined by the signs of target SCORAD between 3 and 12:
• Erythema from 1 to 3
• Dryness ≥2
• Oedema / papule from 0 to 3
- Lesions oozing or crusting 0
- Excoriation of 0
- Lichenification from 0 to 3 On a scale ranging from 0 (absent) to 3 (severe)
- Peri-lesional near the lesion zone (about 1cm)
- Subject presenting on the inner side of the forearm a reference zone without lesion
For vulgar plaque psoriasis subgroup
- Subject with mild to moderate erythematous-squamous plaque psoriasis whose IGA
(Investigator Global Assessment) score is between 2 and 3, on a rating scale ranging
from 0 (clear) to 5 (very severe)
- Subject with on the upper limb (hand excluded) or lower limb at least one zone:
- Lesional:
- Without fissure and without crust
- With erythema score ≥ 1 on a scale ranging from 0 (absent) to 3 (severe)
- With desquamation score between 1 (mild) and 2 (moderate) on a scale ranging from
0 (absent) to 3 (severe)
- With an oedema score of 0 (absent) on a scale ranging from 0 (absent) to 3
(severe)
- Peri-lesional:
- Without fissure and without crust
- Near the lesion zone (about 1 cm)
- Subject presenting on the inner side of the forearm a reference zone without
lesion
For telangiectasic erythrocouperosis papule of the face (rosacea) subgroup
- Subject with telangiectasic erythrocouperosis and papule of the face mild to moderate
with an IGA score between 2 and 3 on a rating scale ranging from 0 (absent) to 4 (severe)
- Subject presenting on the face at least one zone:
• Lesional: immediate border of the papule with a persistent erythema score ≥ 1 on a
rating scale ranging from 0 (absent) to 3 (severe)
• Peri-lesional:
• Near inflammatory lesions (papule, about 1 cm)
• Ranging of at least 1 point less in the erythema score compared to the lesion zone
- Subject presenting on the inner side of the forearm a reference zone without lesion
For seborrheic dermatitis of scalp subgroup :
- Subject with mild to moderate seborrheic dermatitis with an IGA score between 2 and 3
on a rating scale ranging from 0 (absent) to 4 (severe)
- Subject presenting on the scalp at least one zone:
- Lesional:
- with erythema score ≥ 1 on a scale of 0 (absent) to 3 (severe)
- with clinically visible scales
- Peri-lesional:Near the lesion zone (about 1 cm)
- Subject presenting on the inner side of the forearm a reference zone without lesion
- NON INCLUSION CRITERIA
CRITERIA RELATED TO THE POPULATION:
- For woman of childbearing potential: pregnant or breastfeeding
- Subject unable to understand the information given including study procedures (for
linguistic or psychiatric reasons) and to give his/her consent in writing
- Subject who, in the judgement of the investigator, is not likely to be compliant with
study-related constraints and requirements
- Subject who has forfeited his/her freedom by administrative or legal award or is under
guardianship
- Subject who is in a position likely to represent a conflict of interest and/or is a
family member of any people involved in the conduct of the study (secretary, nurse,
technician…) of the investigational site
- Subject who is currently participating, who plans to participate or who has
participated in another clinical study liable to interfere with the study assessments
according to the investigator's assessment
CRITERIA RELATED TO DERMATOSIS AND CUTANEOUS CONDITION:
- Subject with premature cutaneous aging linked to a genetic disease
- Subject with solar erythema in at least one zone under study
- Subject with a tattoo, scar or other dermatological sign on at least one study zone
that may interfere with the study according to the investigator's assessment
- Subject with autoimmune disease
- Subject with any type of complication on at least one study area (excoriation type,
primary, viral, fungal or parasitic bacterial infection, etc.) according to the
investigator's assessment
Criteria for control subgroups:
- Subject with a dermatosis or any type of lesion on the zone corresponding to the
lesional, peri-lesional zone or reference zone of the associated subgroup dermatosis likely
to interfere with the study according to the investigator's assessment
Criteria for chronic inflammatory dermatitis:
For subjects of the acne of the face subgroup:
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on
the face that could interfere with the study according to the investigator's assessment
For subjects in the atopic dermatitis subgroup of upper limbs:
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on
the upper limb (s) to the study likely to interfere with the study according to the
investigator's assessment
For vulgar plaque psoriasis subgroup
- Subject with an isolated palmo-plantar form of psoriasis
- Subject with an isolated form of cutaneous psoriasis other than in plaque (in gout,
pustular, erythrodermic or inverted elbow creases (psoriasis of the mucous membranes))
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on
the upper limb (s) and/or lower limb(s) to the study likely to interfere with the
study according to the investigator's assessment
For telangiectasic erythrocouperosis papule of the face (rosacea) subgroup
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on
the face that could interfere with the study according to the investigator's assessment
For seborrheic dermatitis of scalp subgroup :
- Seborrheic dermatitis under medical treatment
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on
the scalp likely to interfere with the study according to the investigator's
assessment (in particular contact eczema or alopecia)
CRITERIA RELATED TO TREATMENTS AND PRODUCTS
For all subjects :
- Oral intake of isotretinoin or acitretin (oral vit-A and derivatives) within the 6
months prior to the inclusion visit or the day of the visit
- Local retinoid treatment on at least one study zone, which may interfere with the
results of the study according to the investigator's assessment within the month
preceding the inclusion visit or the day of the visit
- Phototherapy treatment in at least one study zone within 4 weeks prior to the
inclusion visit or the day of the visit
- Topical or oral treatment established or modified during the previous weeks or to be
established or modified during the study, which may interfere with the results of the
study according to the investigator's assessment ( for example modifying the cutaneous
characteristics: treatment inducing pigmentation), keratolysis, ...)
- Anti-inflammatory treatment (steroidal or nonsteroidal) taken daily and repeatedly for
more than 5 consecutive days during the week preceding the inclusion visit
- Application of any topical vitamin D-derived treatment on at least one study zone
within 3 weeks prior to the inclusion visit or the day of the visit
- Application of dermocorticoid topical or immunomodulatory topical treatments
(tacrolimus), antifungals, local antibiotics on at least one study zone in the 3 weeks
prior to the inclusion visit or the day of the visit
- Application of water, product or topical treatment on at least one zone under study
after the last wash the day before the visit
- Application of water, topical product or make-up on at least one zone the day of the
inclusion visit
For seborrheic dermatitis of scalp subgroup and its associated control :
- Use on the scalp of any product that can be active on squamous conditions, rinsed or
posed (anti-dandruff, anti-fungal shampoo, vinegar rinse, essential oils ...) within 2
weeks prior to the inclusion visit or the day of the visit
- Any technique to change the color or condition of the hair (coloring, discoloration,
permanent, smoothing / straightening, ..) performed within 2 weeks prior to the
inclusion visit or the day of the visit
- Washing of the scalp done within 2 days before the inclusion visit or the day of the
visit
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Use of the SpiderMass for in Vivo Analysis of the Skin in Five Chronic Inflammatory Dermatosis | NCT04472546 | Entailment |
6,432 | 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:
- Between the ages of 18-70
- No systemic illness
- No other inflammatory dermatoses except for rosacea
- No smoking
- Not using any topical, systemic treatment and sunblock at least a month for rosacea or
other condition
Exclusion Criteria:
- Systemic illness
- Other inflammatory dermatoses except for rosacea
- Smoking
- Using any topical, systemic treatment and sunblock for rosacea or other condition
- Type 4 rosacea patient (only ocular involvement)
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 70 Years | Demodex Density, Immune Response and Oxidative Stress in Rosacea Patients | NCT02556827 | Entailment |
3,214 | 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:
- Has provided written informed consent;
- Between the ages of 18-75 years (inclusive);
- Body weight ≥ 40 kg;
- Meets the revised European criteria proposed by the American-European Consensus Group
for primary Sjögren's Syndrome at screening. These criteria include 3 of the following
4 items:
- ocular symptoms;
- oral symptoms;
- Schirmer's I test showing less than 6 mm of wetting per five minutes in at least
one eye, or filamentary keratitis on slit lamp examination, or positive lissamine
green staining; or
- diminished salivary production (unstimulated whole salivary flow rate ≤ 1.5 mL/15
min); PLUS, either:
- a positive test for serum SS-A and/or SS-B antibodies, or
- focal lymphocytic sialadenitis, with a focus score ≥ 1.0 per 4 millimeters
^2(mm^2) on minor salivary biopsy.
- Stimulated salivary flow of ≥ 0.1 mL/minute (min) (at screening);
- Has one or more of the following systemic manifestations of Sjögren's Syndrome that
are not life-threatening:
- fatigue (as measured by > 50 mm on a 100 mm VAS);
- joint pain (as measured by > 50 mm on a 100 mm VAS);
- peripheral neuropathy (documented by nerve conduction velocity study);
- interstitial lung disease (documented by radiography and/or altered pulmonary
function tests;
- leukocytoclastic vasculitis;
- renal tubular acidosis;
- interstitial nephritis;
- severe parotid swelling;
- other extraglandular manifestations causing organ system dysfunction.
- If taking prednisone (or equivalent corticosteroid), the dose must be ≤ 10 mg/day and
stable for at least 4 weeks prior to Screening;
- If taking hydroxychloroquine, the dose must be stable for at least 12 weeks prior to
Screening;
- If taking a cholinergic stimulant (e.g. pilocarpine, cevimeline), the dose must be
stable for at least 4 weeks prior to Screening;
- Subjects must agree not to become pregnant or to impregnate a female. Because of the
risk involved, participants and their partners (if of reproductive potential) must use
two methods of birth control. They must continue to use both methods until 6 months
after stopping study drug. Two of the birth control methods listed below may be
chosen:
- Hormonal contraception;
- Male or female condoms with or without spermicide;
- Diaphragm or cervical cap with a spermicide;
- Intrauterine device (IUD).
Exclusion Criteria:
- Has an active infection excluding superficial cutaneous fungal or viral infections;
- Has a chronic or persistent infection that might be worsened by immunosuppressive
treatment (e.g., human immunodeficiency virus [HIV], hepatitis B, hepatitis C, or
tuberculosis);
- History of TB or positive intradermal skin test for purified protein derivative (PPD);
positive Mantoux test defined as 10 mm of induration (size of raised bump, not
redness), or equivalent positive TB test result, as per country clinical standards,
during the screening period. Subjects whose PPD induration is ≥ 5 mm but < 10 mm are
eligible for the study if they had a negative chest x-ray during the screening period.
There must be no other clinical evidence of TB on physical examination of the subject.
Note: Subjects who have had prior adequate prophylaxis treatment for latent TB with an
appropriate course of isoniazid or equivalent, per country standards, are not excluded
from study participation. PPD should not be administered within 6 weeks of a
live-virus vaccine;
- History of recurrent significant infections or occurrence of a serious local infection
(e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within
twelve weeks prior to Day 0;
- Receipt of live vaccine within six weeks prior to Day 0;
- History or presence of primary or secondary immunodeficiency;
- History of any life-threatening allergic reactions;
- Is a pregnant or nursing female;
- Ongoing anticoagulant therapy, which is a contraindication for labial salivary biopsy
or tonsil biopsy;
- Concurrent use of anticholinergic agents, such as tricyclic antidepressants,
antihistamines, phenothiazines, antiparkinsonian drugs, anti-asthmatic medications, or
gastrointestinal (GI) medications that cause xerostomia in more than 10% of patients;
- Treatment with any of the following within the defined period prior to Screening:
- 2 years for rituximab;
- 24 weeks for cyclophosphamide;
- 8 weeks for azathioprine, cyclosporine, methotrexate, or mycophenolate mofetil;
- 4 weeks for intravenous immunoglobulin;
- 4 weeks for etanercept;
- 8 weeks for adalimumab;
- 12 weeks for infliximab.
- Prednisone (or equivalent corticosteroid) > 10 mg/day;
- A definite diagnosis of RA, SLE, systemic sclerosis, or dermatomyositis;
- A history of alcohol or substance abuse within 12 months of the screening visit;
- A history of head and neck radiation therapy, sarcoidosis, or graft-versus-host
disease;
- A history of malignancy, except for a resected basal or major squamous cell carcinoma,
cervical dysplasia, or in situ cervical cancer Grade I, within the last five years;
- Severe pulmonary disease as manifested by one of the following at Screening:
- Resting oxygen saturation < 92%;
- Force vital capacity (FVC) < 50% predicted;
- Diffusion lung capacity for carbon monoxide (DLCO) < 50%;
- Abnormal laboratory results for the following parameters at the screening visit:
- Absolute neutrophil count (ANC): < 1,500/mm^3;
- Platelets: < 100,000/mm^3;
- Hemoglobin: < 9 grams (g)/deciliter (dL);
- Serum creatinine: ≥ 2.0 mg/dL;
- AST: > 1.5x upper limit of normal, or
- ALT: > 1.5x upper limit of normal.
- A psychiatric disorder rendering the subject incapable of providing informed consent;
- Plans for foreign travel to countries other than Canada or Western Europe within the
treatment period;
- Inability or unwillingness to follow the protocol;
- Any condition or treatment that, in the opinion of the investigator, places the
subject at an unacceptable risk as a participant in the trial;
- Rochester substudy subjects who meet the following criteria are disqualified from
enrolling in the tonsil biopsy substudy if they:
- Have any side effects to local anesthetics (e.g., lidocaine);
- Have any side effects to silver nitrate;
- Do not have tonsils;
- Are not able to go 48 hours without any NSAIDS;
- Are not able to go 2 weeks without acetylsalicylic acid (aspirin).
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 | Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome | NCT01552681 | Entailment |
728 | 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:
- 1. Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to
ACR criteria, diagnosed at least 6 months previously; 3. Pain in either knee
originates in the knee (not referred pain from other sites, such as hip or back) and
no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee
OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose
per day, for not less than 10 days out of the 14 days preceding the screening visit
and also within the 24 hours preceding the screening visit; 5. Be able to tolerate
rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up
to a maximum of 6 tablets (3 grams) per day for the duration of the study
Exclusion Criteria:
- 1. Partial or total replacement of either knee joint, past or planned/expected during
study duration.
2. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis,
hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however,
common risk factors, such as obesity and past meniscectomy or ligament rupture and repair,
are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid
arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or
laboratory values indicative of such disease with subsequent diagnosis by a physician; 4.
Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin,
other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene
glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the
rescue medication
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.
| Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA) | NCT01967550 | Contradiction |
5,526 | 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:
1. Diagnostic criteria for Giant Cell Arteritis Age at disease onset >50 years (required)
1. New onset or new type of localized pain in the head
2. Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased
pulsation, unrelated to arteriosclerosis of cervical arteries)
3. ESR of >40mm in the first hour by the Westergren method
4. Abnormal artery biopsy (i.e. temporal artery biopsy showing vasculitis characterized
by a predominance of mononuclear cell infiltration or granulomatous inflammation,
usually with multinucleated giant cells)
5. Large Vessel Vasculitis (LVV) by angiogram or biopsy not explained by something else
Inclusion Criteria:
2. Diagnostic criteria for Takayasu's Arteritis
1. Age at disease onset <50 years
2. Claudication of extremities
3. Decreased brachial artery pulse (one or both arteries)
4. Blood pressure difference of >10mm Hg between the arms
5. Bruit over subclavian arteries or aorta
6. Arteriogram abnormalities compatible with TAK (includes conventional dye angiography
or MR angiography or CT angiography)
Inclusion Criteria:
3. Diagnostic criteria for Polyarteritis Nodosa Major criteria (not explained by other
causes) felt by investigator to be due to vasculitis
1. Arteriographic abnormality
2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
3. Mononeuropathy or polyneuropathy
Minor criteria (not explained by other causes) felt by investigator to be due to vasculitis
1. Weight loss > 4 kg
2. Livedo reticularis, cutaneous ulcerations, or skin nodules
3. Testicular pain or tenderness
4. Myalgias
5. Diastolic blood pressure > 90 mm Hg
6. Elevated BUN or serum creatinine levels
7. Ischemic abdominal pain
Isolated cutaneous Polyarteritis Nodosa 1. Biopsy-proven cutaneous PAN
Inclusion Criteria:
4. Diagnostic criteria for Granulomatosis with Polyangiitis (Wegener's) (GPA) and
Microscopic Polyangitis (MPA)
- Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to
classification criteria or definitions, have not been developed for GPA & MPA.
- For diagnosis of GPA meets at least 2 of the following 5 modified ACR criteria:
1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood
2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities
3. Urinary sediment with microhematuria or red cell casts
4. Granulomatous inflammation within the wall of an artery or in the perivascular
area on biopsy
5. Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for
either PR3- or MPO-ANCA
- For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA:
1. Necrotizing vasculitis, with few or no immune deposits, that affects small
vessels (i.e., capillaries, venules, arterioles)
2. Necrotizing arteritis involving small- and medium-sized arteries may be present
3. Necrotizing glomerulonephritis is very common
4. Pulmonary capillaritis often occurs
Inclusion Criteria:
5. Diagnostic criteria for Eosinophilic Granulomatosis with Polyangiitis
(Churg-Strauss)
1. Asthma
2. Peak peripheral blood eosinophilia of >10% of total WBC
3. Peripheral neuropathy attributable to vasculitis
4. Transient pulmonary infiltrates on chest imaging studies
5. Paranasal sinus abnormalities or nasal polyposis
6. Eosinophilic inflammation on tissue biopsy
If patients have 4 of the above 6 criteria but lack clearcut documentation of
small vessel vasculitis, they are also eligible for enrollment.
General Exclusion Criteria:
- Inability to give informed consent and to sign the consent form
- Enrolled in VCRC protocols 5502, 5503, 5504, 5505, 5506, 5522, or 5523
- Unwilling to provide blood for DNA collection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
| One-Time DNA Study for Vasculitis | NCT01241305 | Entailment |
4,541 | 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:
- BMI < 35
- Premenopausal
- Uterine size <20 gw
- Willingness to participate to the research
- Uterine fibroids with typical symptoms
- Maximum of 4 treated fibroids
- Dominant fibroid >2.5cm
- >50% of the fibroid is treatable
Exclusion criteria
- Unspecified pelvic tumours or ovarian masses, PID
- Major corrective surgery to uterus (simple myomectomy excluded)
- Major uterine anomalies
- Unability to calculate the volume of uterine fibroids
- Marked uterine calcification
- Marked scarring of the lower abdomen
- Suspicion of malignancy
- Marked general health problem contraindicating MRI
- Claustrophobia
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU) | NCT02914704 | Contradiction |
5,013 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
- Existing unilateral or bilateral VIN DBS for ET, non-demented (MMSE>24), and must have
a documented suboptimal tremor suppression on two successive visits (compared to the
baseline post-operative improvement at 6 months following ET DBS surgery). For
bilateral cases, the most affected tremor side will be studied.
Exclusion Criteria:
- No diagnosis of Essential Tremor
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 | Physiology, Imaging and Modeling of Essential Tremor | NCT03811405 | Entailment |
1,464 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion criteria: - patients with diagnosed dysphagia "of any causes"
- sufficient proficiency in german
- voluntary participation
Exclusion criteria: - insufficient knowledge of the german language
- cognitive limitations
- reduced general state of health
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 | Translation of the Sydney Swallow Questionnaire and Validation of the German Version | NCT01965964 | Entailment |
3,667 | 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:
- Able to demonstrate the necessary abilities (English language, literacy) needed to
provide informed consent without the assistance of another person (e.g., a proxy,
spouse, family member or other support person)
- Self-reported low back pain (acute, subacute or chronic) at the time of examination
and enrollment
Exclusion Criteria:
- Weight > 300lbs
- Spinal Pathology or conditions contraindicating study procedures or compromising
participant safety
- Inflammatory arthropathy involving the spine (e.g. Ankylosing spondylitis, Rheumatoid
arthritis)
- Spinal fracture in the past 6 months
- Other conditions requiring referral (e.g. self-reporting alcohol/substance dependence
or abuse, unstable spinal segments, and cauda equina syndrome)
- Pregnant or planning to become pregnant within the next 5 weeks
- Unable to tolerate study procedures safely
- Altered Mental Capacity
- Sensitivity to adhesives used in the study
- Uncontrolled hypertension
- Co-morbidity requiring simultaneous clinical management that compromises ability to
deliver study procedures or assess the participant's heath status or poses as a
scheduling burden
- Retention of legal advice or seeking a health-related insurance claim
- Compliance concerns (e.g. scheduling conflicts, moving from the quad city area,
unwilling to undergo required study procedures or receive treatment from study
doctor(s))
- Quebec Task Force Classification of 10 or 11: (chronic pain syndrome,
visceral/infectious source of LBP)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | measurINg forceS durInG cHiropractic Treatment | NCT02409797 | Contradiction |
5,989 | 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:
- diagnosis of typical GERD
- partial responder to a stable standard clinical symptoms control dose of PPI therapy
- body mass index ≤ 32 kg/m2
Exclusion Criteria:
- exclusively atypical symptoms of GERD
- symptoms that have been shown not to be associated with GERD
- erosive oesophagitis
- treated with a dose of PPI greater than the dose indicated for clinical symptom
control of GERD
- hiatus hernia > 3 cm
- current diagnosis of co-existing psychiatric disease
- known clinical significant allergy or known hypersensitivity to drugs
- is pregnant or breast-feeding
- has received sodium valproate or topiramate within 30 days of Screening
- has a history of a significant medical condition that may affect the safety of the
patient or preclude adequate participation in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD) | NCT00810485 | Entailment |
4,496 | 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:
- Age 19-40 years
- Mean menstrual cycle 28-38 days
- Good general health
- Generally normal sleep-wake regimen
- Motivated for free participation
Exclusion Criteria:
- Low cooperation
- Medications known to interfere with hormone release
- Clinically evident endocrine abnormalities including the signs of
- Hyperandrogenism
- Travel over several time zones during two months prior the study
Female
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 40 Years | Effect of Bright Light on Sex Hormones and Ovulation in Humans | NCT00327366 | Contradiction |
1,703 | 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:
- Participants include young and healthy women between the ages of 18-30, who have not
engaged in strength training for the last 6 months.
Exclusion Criteria:
- Subjects will be excluded from the study if they have any condition that preclude them
from taking part in the exercise testing procedures or the 24 week exercise program or
if they fail to obtain the required amount of training sessions.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | High Intensity Strength Training & Bone Mineral Density in Young Women | NCT01482130 | Entailment |
5,076 | 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:
1. Has the subject given informed consent according to local requirements before any
trial-related activities? A trial-related activity is any procedure that would not
have been performed during the routine management of the subject.
2. Is the subject a female?
3. Is the subject 65 years old or above?
4. Is the subject postmenopausal (more than 5 years), in the judgement of the
investigator?
5. Does the subject have primary osteoporosis, with a lumbar spine T score ≤ -3.0 SD, or
a lumbar spine T-score ≤ -2.5 SD and previous fragility fracture[1], with a minimum of
two evaluable lumbar vertebrae?
6. Does the subject have a life expectancy of > 2 years?
7. Does the subject have a clinical indication to receive PTH(1-84) and is able to
self-inject (or to have PTH(1-84) injection by a helper)?
All inclusion criteria must be answered "yes" for a subject to participate in the trial.
[1] Definition of fragility fracture in the scope of the study: Bone fractures that occur
as a result of a fall from standing height or less. That is, fractures resulting from
mechanical forces that would not ordinarily cause fractures in a healthy person.
Exclusion Criteria:
1. Is the patient currently taking any of the following treatments: bisphosphonates,
selective estrogen receptor modulators or hormone replacement therapy (if the patient
discontinues any of these treatments at the screening visit, the question can be
answered NO and the patient can be included)?
2. Has the subject received, during her lifetime, strontium, fluoride or calcitonin > 3
months in total?
3. Has the subject ever been treated with teriparatide or PTH(1-84)?
4. Is the subject taking any other medication known to affect bone metabolism in the
opinion of the investigator?
5. Has the subject ever received radiation therapy to the skeleton?
6. Has the subject ever been treated for a bone malignant disease?
7. Is the subject suffering from any known clinically significant diseases affecting
calcium metabolism, including metabolic bone diseases such as hyperparathyroidism,
Paget's disease, osteogenesis imperfecta, or osteomalacia?
8. Does the subject have any known history of hypersensitivity to parathyroid hormone or
any of the excipients in the drug?
9. Does the subject have an elevated serum calcium (total serum calcium value >10.2
mg/dl) after at least 14 days of a 1000 mg calcium and 800 IU vitamin D3
supplementation?
10. Does the subject have a clinically significant elevation of serum alkaline phosphatase
judged by the investigator?
11. Does the subject have an impaired kidney function with creatinine clearance <30ml/min
(indirect measurement by serum creatinine)?
12. Does the subject have a severe hepatic impairment, defined as > 9 Child-Pugh score?
13. Has the subject participated in a clinical trial with an Investigational Medicinal
Product (IMP) during the last 30 days?
14. Does the subject have a bilateral hip replacement?
All exclusion criteria must be answered "no" for a subject to participate in the trial.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES) | NCT00583518 | Contradiction |
3,618 | 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:
- All patients age 18+ presenting with epistaxis that requires an ENT consult that had a
first attempt at treatment by an emergency physician.
Exclusion Criteria:
- Patients will be excluded based on the presence of a hypo-coagulable state. Including
patients actively taking anti-coagulant medications or other patients with either
acquired or hereditary bleeding disorders.
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.
| Management of Persistent Epistaxis Using Floseal Hemostatic Matrix | NCT02488135 | Entailment |
1,030 | 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:
- Female - 50 years of age or older
- Knee pain on most days of the week
- Less than 30 minutes of morning stiffness
- Bony enlargement
- Bony tenderness to palpation
- Signs of inflammation
- Able to safely climb 2 flights of stairs without aid
- Visited a family physician within the last 12 months
Exclusion Criteria:
- Any other forms of arthritis
- Osteoporosis
- History of patellofemoral symptoms
- Active non-arthritic knee disease
- Knee surgery
- Use of cane or walking aid
- Unstable heart condition
- Neurological conditions
- Skin allergy to medical tape
- Hip or ankle injuries in past 3 months
- Any injuries that would prohibit participation in yoga
- Ipsilateral hip or ankle conditions
- Currently receiving cancer treatment
- Currently pregnant
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Yoga as an Intervention for Women With Knee Osteoarthritis | NCT02146105 | Entailment |
6,328 | 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:
- Laboratory confirmed SARS-CoV-2 using currently available laboratory testing
techniques (e.g.,RT-PCR, Immunoglobulin M (IgM) /IgG) or clinical history compatible
with a COVID-19 like illness(fever, cough, shortness of breath).
- Negative participants with no known prior COVID-19 diagnosis or COVID vaccine
- At least 7 years of age
- Participants are eligible to provide semen and breast milk samples if they are 18
years of age or older
Exclusion Criteria:
- Age <7
- Intercurrent conditions that in the opinion of the investigator would confound the
findings of 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 7 Years old.
| Determinants of SARS-COV2 (COVID-19) Persistence After Convalescence | NCT04448145 | Entailment |
6,520 | 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 with FVIII activity < 1% normal
- Weight > 3.5 kg at the time of baseline study evaluation
- Informed consent, approved by appropriate Institutional Review Board/Independent
Ethics Committee, has been administered, signed, and dated
Exclusion Criteria:
- Prior exposure to clotting factor concentrates or blood products
- Other chronic disease
- Currently participating in another investigational drug study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Hemophilia Inhibitor Previously Untreated Patient Study | NCT01652027 | Contradiction |
342 | 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:
- Having ≤ 2 IVF/ICSI cycles
- Total sperm count and motility are normal (WHO, 2010)
- Antagonist protocol
- Agree to have ≤ 2 embryos transferred
- Not participating in another IVF study at the same time
Exclusion Criteria:
- In-vitro maturation (IVM) cycles
- Using frozen semen
- Poor fertilization in previous cycle (≤ 25%)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| ICSI Versus Conventional IVF in Non-male Factor Couples | NCT03428919 | Contradiction |
1,702 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
1. Self identified South Asian (Asian Indian, Bangladeshi, Pakistani, Sri Lankan)
residents of Harris, Fort Bend, Brazoria and Galveston counties.
2. 18 years of age or older
3. Those who speak the languages (including English) that had been identified as most
frequently used in Houston's South Asian community by the Community Advisory
Committee.
Exclusion Criteria:
1. None
2. Sri Lankans who participated in Protocol 2006-1047.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Health and Cancer Issues in the South Asian Community | NCT00479830 | Entailment |
1,218 | 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:
Inclusion/Exclusion criteria for Part A
- Must provide informed consent
- Males and females, age 18 years and older
- Evidence of lung disease by at least one of the following:
1. symptoms consistent with pulmonary disease;
2. chest X-rays and/or chest CT consistent with lung disease;
3. pulmonary function tests consistent with lung disease;
4. lung biopsy consistent with lung disease;
5. family history of lung disease;
6. diseases of organs with known association with lung disease; and
7. individuals suspected of having lung disease based on history and/or physical
examination
- Undergoing fiberoptic bronchoscopy as dictated by their standard clinical care
Exclusion Criteria:
- Patient refuses consent.
Patients enrolled in Part A of the protocol will not undergo screening procedures/tests.
These patients are undergoing a fiberoptic bronchoscopy as dictated by their standard
clinical care and additional samples will be taken for research purposes.
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.
| Lung Disease Collection (Qatar): Evaluation of the Lungs of Individuals With Lung Disease | NCT00504738 | Entailment |
4,519 | 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:
- Patients suffering from benign uterine pathology (uterine fibromatosis, abnormal blood
loss, complex hyperplasia with atypia, uterine prolapse) with indication for total
uterine hysterectomy
- Uterine size </= than 15 cm
- American Society of Anesthesiologists (ASA) class < 3
- Patient's informed consent
- No actual pregnancies or pelvic inflammatory disease
- No previous major abdominal surgical procedures
Exclusion Criteria:
- Suspected neoplastic pathology
- Patients not eligible for surgery
Female
| Can 3D Laparoscopy Improve Surgical Performances in Surgeons in Training? | NCT04209036 | Contradiction |
5,473 | 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:Clinical diagnosis of Menorrhagia
- Must be able to swallow tablets
Exclusion Criteria:
- Endometrial abnormality
- Pelvic infection
- Pregnancy
- Breast Feeding
- Requirement for birth control
- Known intolerance/lack of effect of tranexamic acid
Female
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 50 Years | The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders | NCT00904709 | Entailment |
6,028 | 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. Subject age ≥ 18 years old
2. Subject received an explanation about the nature of the study and agrees to provide
written informed consent.
3. The subject was referred for pH monitoring procedure to detect acid reflux for at
least one of the following reasons:
- Burning substernal chest pain (heartburn)
- Regurgitation of food or stomach contents
- Dysphagia
- Epigastric pain
- Non-erosive reflux disease (NERD)
- Chest pain
- Cough
- Hoarseness
- Asthma
- Lower pharyngeal irritation, need to clear throat
Exclusion Criteria:
1. Subject has a cardiac pacemaker or other implanted electromedical device.
2. Subject has any condition, which precludes compliance with study and/or device
instructions.
3. Women who are either pregnant or nursing at the time of screening, or are of
child-bearing potential and do not practice medically acceptable methods of
contraception.
4. Subject suffers from life threatening conditions
5. Subject currently participating in another clinical study which may interfere with
study objectives, per physician discretion
6. Subject has prior abdominal surgery other than uncomplicated procedures that would be
unlikely to lead to bowel obstruction based on the clinical judgment of the
investigator
7. Subject is schedule to undergo MRI examination within 30 days from pH monitoring
procedure.
8. Subject has known bleeding diathesis, strictures, severe esophagitis, varices and or
obstructions
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.
| Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance (Encore) | NCT01788085 | Entailment |
3,672 | 29 | A 57-year-old man comes to the emergency department due to constipation. His last bowel movement was 2 days ago. He complains of spending about 30 minutes once attempting to defecate. He also has lower back pain. There is no history of trauma. The pain is not relieved with over-the-counter pain medications. His vital signs are within normal limits. Examination shows low back pain that is worse with back flexion and raising of the legs; it radiates into his left leg. Pinprick in the perianal area does not cause rapid contraction of the anal sphincter. The rest of the neurologic examination is normal. He is suspected of Cauda Equina syndrome and referred to a spinal MRI. | I'm a 57 year-old-man, and I had to go to the ER because I couldn't go defecate. My last trip to the toilet was 2 days ago, and I tried too many times, during 30 min, to get my poop to get out. I also have terrible lower back pain. The doctor did not notice any trauma. I tried to get the pain away using over-the-counter medications, but it simply did not work! Back in the ER my vitals were normal. My pain was even more intense with back flexion, and when I raised my legs, it radiated into my left leg. The doctor did an anus exam where he had to pinch it and it was not reacting! However the rest of my neurologic exam was normal. The doctor suspects a Cauda Equina syndrome and referred me to a spinal MRI. | Inclusion Criteria:
Patients:
• Patients ≥5 years of age undergoing surgery at Mbale Regional Referral Hospital, who
receive post-operative care in one of four main surgical wards, with a family carer
prepared to participate in the trial intervention.
Carers:
- All carers will be included in the trial if they feel they are capable of performing
and documenting the basic vital signs provided they agree to participate in the trial.
- The ability to speak English, Luganda, Lugisu, Ateso or Lugwere
- The ability to read a digital clock (to measure vital signs)
- Numeracy sufficient to write numbers on the basic observation chart
Exclusion Criteria:
Patients:
- Refusal of informed consent.
- Identification of potential participant >24hours after operative procedure has taken
place
Carers:
• Refusal of 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 5 Years old.
| Family SuppleMented pAtient monitoRing afTEr suRgery: A Pilot Trial | NCT04341558 | Entailment |
2,400 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Patients with > 20% deficit in isometric quadriceps and/or hamstrings strength
- Patients willing to complete at least 9 BFRT training sessions
- Patients willing to provide informed consent (or parental consent)
Exclusion Criteria:
- Pregnancy
- History of varicose veins
- History of blood clots or active blood clot
- Taking oral contraceptives
- History of heart attack
- Unstable cardiac disease
- Taking heart failure medication
- Uncontrolled hypertension (> 140/90)
- Uncontrolled tachycardia (> 100 bpm)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| BFRT for Severe Lower Extremity Muscle Atrophy | NCT04357184 | Entailment |
4,515 | 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. Are capable of giving informed consent and complying with study procedures;
2. Are between the ages of 18 and 55 years, inclusive;
3. Female subjects have a negative serum hCG or urine pregnancy test result at screening
and Day -1, and meet one of the following criteria:
1. Using a medically acceptable form of birth control for at least 1 month prior to
screening (3 months on oral contraceptives) [e.g., hormonal contraceptives (oral,
patch, injectable or vaginal ring), implantable device (implantable rod or
intrauterine device), or a double barrier (e.g., diaphragm, cervical cap, oral,
patch or vaginal hormonal contraceptive, condom, spermicide, or sponge)]
2. Surgically sterile, with documentation, for at least 3 months prior to screening
by one of the following means:
- Bilateral tubal ligation
- Bilateral salpingectomy (with or without oophorectomy)
- Surgical hysterectomy
- Bilateral oophorectomy (with or without hysterectomy)
3. Postmenopausal, defined as the following:
- Last menstrual period greater than 12 months prior to screening
- Postmenopausal status confirmed by serum follicle stimulating hormone (FSH)
and estradiol levels at screening;
4. Considered healthy by the Investigator, based on subject's reported medical history,
full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
5. Normal renal function as determined by Investigator following review of clinical
laboratory test results;
6. Non-smoker or no more than 2 tobacco-containing including nicotine replacement
products in last 6 months;
7. Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive and body weight not less than 50
kg; Subjects with BMI between 30 and 32 kg/m2 may be allowed to participate with the
sponsor's approval;
8. Willing and able to adhere to study restrictions and to be confined at the clinical
research center;
9. Male subjects with female partners of child-bearing potential must agree to use
condoms for the duration of the study and until 12 weeks after dosing with the study
drug and must refrain from donating sperm for this same period;
10. Ability to swallow and retain oral medication.
Exclusion Criteria:
1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal,
endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic,
immunologic, lipid metabolism disorders, or drug hypersensitivity as determined by the
Investigator;
2. Pregnant (as determined by pregnancy test result) and breastfeeding women;
3. Current and/or recent history (<30 days prior to screening and/or <45 days prior to
randomization) of a clinically significant bacterial, fungal, parasitic, or
mycobacterial infection;
4. Current clinically significant viral infection;
5. Evidence of latent or active tuberculosis, as well as recent exposure or live
vaccinations
6. History of malignancy, with the exception of cured basal cell or squamous cell
carcinoma of the skin;
7. History of pancreatitis or gall stones;
8. History of unexplained syncope, symptomatic hypotension or hypoglycemia;
9. Family history of long QTc syndrome; History or presence of an abnormal ECG, which, in
the investigator's opinion, is clinically significant. QTcF interval >440 msec for
males and >460 msec for females;
10. Resting pulse <45 bpm or >100 bpm at screening, only with Day -1 as PI judgement;
11. History of unstable ischemic heart disease or uncontrolled hypertension (blood
pressure >140/90 mm Hg at screening, only with Day -1 as PI judgement);
12. History of stomach or intestinal surgery, except that appendectomy and/or
cholecystectomy will be allowed;
13. History of chronic diarrhea, malabsorption, unexplained weight loss, food allergies or
intolerance;
14. Poor venous access;
15. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C antibody;
16. Donated or lost >500 ml of blood in the previous 3 months;
17. Taken any prescription medications within 7 days or 5 half-lives (whichever is longer)
of the first dose of study drug;
18. Hospital admission or major surgery within 6 months prior to screening;
19. A history of prescription drug abuse, or illicit drug use within 9 months prior to
screening;
20. A history of alcohol abuse according to medical history within 9 months prior to
screening;
21. A positive screen for alcohol or drugs of abuse at screening or Day -1;
22. An unwillingness or inability to comply with food and beverage restrictions during
study participation;
23. Use of over-the-counter (OTC) medication within 7 days, and herbal (including St
John's Wort, herbal teas, garlic extracts) within 7 days prior to dosing (Note: Use of
acetaminophen at <2 g/day is permitted until 24 hours prior to dosing);
24. Current treatment or treatment within 30 days or 5 half-lives (whichever is longer)
prior to the first dose of study medication with another investigational medication or
current enrollment in another investigational drug protocol;
25. Hemoglobin, WBC, or platelet count below the lower reference limit of the testing
laboratory. Absolute neutrophil count <2000 cells/uL;
26. Any condition or finding that in the Investigators opinion would put the subject or
study conduct at risk if the subject were to participate 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 55 Years | A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study of TLL018, With Food Effect, in Healthy Participants | NCT04243083 | Contradiction |
3,957 | 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:
Meets the diagnosis criteria of knee osteoarthritis. Age between 45 and 70 years. Meets
imaging examination X-ray Kellgren and Laerence classification standards grade I-III.
Patients who meet the criteria for early or mid-term stage of knee osteoarthritis.
Discontinue use of pain medications and hormone drugs during the trial. The patient's vital
signs are stable, can read his own medical history, and can cooperate with the relevant
examination and treatment.
Signed the informed consent voluntarily.
Exclusion Criteria:
Seriously patients with surgical indications Associated systemic arthropathies, e.g.
rheumatoid arthritis and gout Heart failure Bleeding diathesis Liver failure knee
arthroplasty There are diseases that may seriously endanger life, such as cardiovascular
and cerebrovascular diseases, renal and liver failure, hematopoietic system diseases, etc.
Patients with mental illnesses that cannot be completed or are not suitable for treatment
and examination Patients who received treatment including traditional Chinese medicine,
western medicine, acupuncture, massage and physiotherapy within the past month Patients on
steroids History of intra articular injection of steroid within last six months Joint
irrigation or arthroscopy has been performed within the past year Have had knee
arthroplasty At the same time participate in other studies
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 38 Years old.
Subject must be at most 70 Years | Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients | NCT03599180 | Entailment |
655 | 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:
- Mother-infant pairs, between 35 weeks and 41 completed weeks of pregnancy, planned to
deliver through vaginal or Elective lower segment cesarean section(ELSCS)
Exclusion Criteria:
- Women with multiple gestation
- Complications like pregnancy induced hypertension (PIH), Gestational diabetes Mellitus
(GDM), Pre/Eclampsia, placental insufficiency, suboptimal CTG (late deceleration,
variable deceleration)
- Rh-isoimmunization
- Chronic maternal illnesses (hypertension, cardiomyopathies, chronic renal diseases,
haemoglobinopathies
- Pre-existing risk factor for postpartum haemorrhage, like polyhydramnios, previous PPH
- Infants with antenatal diagnosis of congenital malformations of any system (CVS, GIT,
RENAL CNS ,RESP), anomalies or syndromes
- Emergency caesarean section (EmLSCS)
- Need for neonatal resuscitation at birth and NICU admission due to causes not directly
related to the intervention trial.
Criteria 1 to 6 will be applied before randomization and criteria 7 and 8 assess after
randomization.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 3 Months | Effect of Timing of Umbilical Cord Clamping on Haematological and Clinical Outcomes of Infants | NCT01081977 | Contradiction |
4,770 | 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:
- mild to moderate sensorineural hearing loss
- tinnitus (THI > 20)
- first user
Exclusion Criteria:
- profound hearing loss
- conductive hearing loss
- THI < 20
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| The Influence of the Sound Generator Combined With Conventional Amplification for Tinnitus Control: Blind Randomized Clinical Trial | NCT01857661 | Entailment |
672 | 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:
- Apparently healthy male volunteers (21 - 45 years old)
- C-reactive protein (CRP) < 5 mg/L
Exclusion Criteria:
- Blood donation or significant blood loss (e.g. surgery) within the past 4 months
- Regular intake of iron and other nutrient supplements within the past 4 months
- Regular intake of medication except oral contraceptives
- Acute or recent inflammatory or infectious symptoms
- Chronic gastrointestinal disorders or metabolic diseases
- Smoking
- Coeliac disease or gluten-related disorders
- Iron deficiency anemia (Hb < 14 g/dL for males) with serum ferritin concentration < 30
ng/mL)
- Non-iron deficiency anemia (serum ferritin concentration within normal range (30 - 300
ng/mL for males) but low hemoglobin (< 14 g/dL for males)
- Iron overload conditions (serum ferritin concentration > 300 ng/mL for males)
- Known hereditary disorders of iron metabolism
Male
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | Effect of Red Meat Intake on Occurrence of Serum Non-transferrin Bound Iron (NTBI) | NCT03019393 | Contradiction |
6,493 | 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:
- Subjects must be between 18-70 years old
- Subjects with papulopustular rosacea graded moderate to severe (2 or 3) according to
the physician global Assessment, and with lesions on the cheeks.
- Prior stop of any topical treatment antibiotic, retinoid, corticoid or other topical
treatment for rosacea at least 1 month before the start of the study
- Prior stop of any systemic treatment (antibiotic) two month before the start of the
study and for isotretinoin at least 6 months
- Last laser treatment, by lamp, laser or LED, at least 3 months before the start of the
study
- Subjects must be abble to lie for more than 30 minutes
- Patient able to understand and sign the informed consent form
- Affiliation to a social security scheme
Exclusion Criteria:
- Women of child bearing/reproductive potential
- Other skin disease or abnormality of the face which could interfere with the
evaluation of the different criteria evaluated or with the realization of the RF
- Contraindications to radiofrequency: presence of a defibrillator or pacemaker, dental
on the cheeks, dental equipment or metallic orthopedic next to the treated area, skin
cancer on the face, progressive systemic disease, uncontrolled hypertension
- Immunosuppression by HIV (determined by examination) or treatment with
immunosuppressive
- Tattoos or permanent makeup on the face
- Excessively tanned skin to sunlight, ultraviolet or with tanning creams during the
last 2 weeks
- Subject carrying cochlear implants or open wound or in the process of healing
- Minor patient or under tutorship
- Cyanoacrylate or doxycycline allergy
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 70 Years | RosaC-RF : Bipolar Radiofrequency vs Doxycycline in Rosacea | NCT02204254 | Entailment |
2,906 | 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:
- Consecutive patients diagnosed with definite, probable, or probable laboratory
supported ALS
- Disease duration from first symptoms between 6-24 months to exclude slow and fast
progression
- ALSFRS-R ≥ 30
- FVC (%predicted) ≥ 70%
Exclusion Criteria:
- Other medical conditions, like cardiac insufficiency and lung disorders or others
conditions limiting exercise training;
- Heavy smoking habits with laboratorial evidence of significant bronchial constriction;
- Signs of associated dementia or psychiatric disorders.
Note: None of the patients were on tube feeding, invasive or non-invasive mechanical
ventilation at admission of study protocol (T1).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients | NCT03326622 | Entailment |
6,898 | 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:
Inclusion Criteria for All Subjects:
- Male or female aged 50 to 85 years, inclusive.
- Female subjects must be documented by medical records or physician's note to be either
surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal
ligation) or post-menopausal for at least 1 year (ie, 12 consecutive months with no
menses without an alternative medical cause) or, if they are of childbearing
potential, must commit to use a barrier contraception method or to abstinence for the
duration of the study and must have negative serum and urine pregnancy tests.
- Male subjects and their partners of childbearing potential must commit to the use of
two methods of contraception, one of which is a barrier method (ie, condom), or to
abstinence for the study duration.
- Male subjects must not donate sperm for the study duration.
- Willing and able to participate in all study procedures.
Inclusion Criteria for Healthy Subjects:
- Written informed consent must be obtained before any assessment is performed.
- Medically healthy with no clinically relevant finding on physical examination,
laboratory profiles, VS, or ECG at screening and upon reporting for the [18F]APN-1607
Imaging Visit.
- No cognitive impairment based on neuropsychological battery and as judged by the
Investigator.
- No first-degree family history of early-onset AD or other neurological disease
associated with dementia (prior to age 65).
- Has a clinical dementia rating (CDR) score of 0.
- Has a MMSE score ≥ 27.
- The subject has an appropriate informant who agrees to accompany the subject to
screening to provide information for the CDR. In the event that the informant cannot
accompany the subject to screening, the interview may be performed via phone, at the
discretion of the site Investigator.
Inclusion Criteria for Subjects with MDAD:
- Written informed consent must be obtained before any assessment is performed.
- Must meet all of the clinical criteria for MCI according to NIA-AA criteria, including
lack of functional impairment sufficient to warrant a diagnosis of dementia.
- Has a CDR score = 0.5.
- Has an MMSE score between 24 and 30, inclusive.
- Has a positive screening amyloid PET scan.
- Medications taken for symptomatic treatment of AD must have been stable for 30 days
prior to screening and through completion of the neuropsychological battery.
- The subject has an appropriate informant to accompany subject for CDR testing and any
visits, if required for subject or staff comfort or safety.
Inclusion Criteria for Subjects with AD Dementia:
- Written informed consent must be obtained before any assessment is performed. If in
the Investigator's opinion the patient lacks capacity to consent, participation is
only possible if the subject has a legally authorized representative (LAR) or
responsible next of kin and that individual provides written informed consent in
accordance with the local regulations and guidelines and the guidelines of the
independent ethics committee (IEC) or institutional review board (IRB). When written
informed consent is provided by a LAR or responsible next of kin, the patient's assent
must also be obtained and documented.
- Has a diagnosis of AD dementia according to NIA-AA criteria, including significant
impairment of activities of daily living.
- Has a CDR score ≥ 0.5 at screening.
- Has a MMSE score between 10 and 26, inclusive.
- Medications taken for symptomatic treatment of AD must have been stable for 30 days
prior to screening and through completion of the neuropsychological battery.
- Has a positive screening amyloid PET scan.
- Medications taken for symptomatic treatment of AD must have been stable for 30 days
prior to screening and through completion of the neuropsychological battery.
- The subject has an appropriate informant to accompany subject for CDR testing and any
visits, if required for subject or staff comfort or safety.
Exclusion Criteria:
Exclusion Criteria for All Subjects:
- Current or prior history (within the last 10 years) of alcohol or drug abuse.
- Known hypersensitivity to [18F]APN-1607 or its excipients
- Clinically significant active or unstable medical illness or planned surgical
procedures during the study period. History of cancer (other than nonmelanoma skin
cancers or stable, local prostate cancer), unless without evidence of active disease
within the last 3 years and without ongoing medical or surgical therapy.
- Laboratory tests with clinically significant abnormalities or a history or evidence of
clinically significant unstable medical illness.
- Has received any investigational drug or device for any purpose within 30 days of
screening (or 5 half-lives of the drug, whichever is longer), has received a
non-vaccine investigational treatment for AD or other cause of dementia within the
last 3 months (or 5 half-lives of the drug, whichever is longer), or received a
passive vaccine for the treatment of AD or other cause of dementia within the last 6
months, or has ever received an active vaccine for the treatment of AD or other cause
of dementia.
- Prior participation in other research protocols or clinical care in the last year in
addition to the radiation exposure expected from participation in this clinical study,
such that radiation exposure exceeds local guidelines, eg, above an effective dose of
50 mSv in the US.
- Pregnant, lactating or breastfeeding.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal,
hematological, neoplastic, endocrine, alternative neurological, immunodeficiency,
pulmonary, or other disorder or disease.
- Unsuitable veins for repeated venipuncture
- MRI exclusion criteria include: Findings that may be responsible for the neurologic
status of the patient such as significant evidence of cerebrovascular disease (more
than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter
abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent
hyperintense lesion on the fluid-attenuated inversion recovery (FLAIR) sequence that
is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal
pressure hydrocephalus or any other abnormalities associated with central nervous
system (CNS) disease. For subjects with MDAD or AD dementia, there may be evidence of
atrophy compatible with AD.
- Implants, such as implanted cardiac pacemakers or defibrillators, insulin pumps,
cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS
aneurysm clips and other medical implants that have not been certified for MRI, or
history of claustrophobia in MRI.
Exclusion Criteria for Healthy Subjects:
- Meets criteria for a diagnosis of MDAD or dementia or has ever had either diagnosis.
- Has ever received treatment with a drug for cognitive impairment or dementia.
Exclusion Criteria for Subjects with MDAD:
• Meets criteria for a diagnosis of dementia due to AD.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 85 Years | Evaluation of [18F]APN-1607 PET Uptake in Alzheimer's Disease Patients Compared With Healthy Subjects | NCT04141150 | Entailment |
1,559 | 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:
- Diagnosis of carpal tunnel syndrome
- Completion of a nerve conduction velocity study (NCVS) within the past twelve months
or a physician waiver of the NCVS
- Able to type using all fingers on the keyboard
Exclusion Criteria:
- Do not use all of their fingers when typing
- No active symptoms of carpal tunnel syndrome
- Unable to type, or flex and extend the fingers, for whatever reason
- Unable or unwilling to provide informed consent
- Use of pain relievers or medications during study sessions (potentially masking
symptoms of median nerve entrapment)
- Unable to complete the typing activities before their symptoms (swelling associated
with body ailments or metabolism) changed
- Had inconsistent subjective and objective evaluations in the preactivity test
- Threaten or abuse the investigator
- Unable to perform the activity so as to meet the minimal use requirements
- Had such injury as they had no sensation in their hands (i.e. Late stage)
- May suffer further injury (as indicated by their medical history) by attempting the
typing activity
- Had non CTS related metabolic problems and upper extremity neurologic conditions,
current or past, which have similar symptoms to median nerve entrapment, but which
were not due to median nerve entrapment in the carpal canal
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 85 Years | Study Protocol for CTS and Keyboard Controlled Randomized Trial | NCT02101294 | Contradiction |
4,449 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- symptoms of tennis elbow for at least 3 months
- clinical diagnosis of tennis elbow
Exclusion Criteria:
- significant symptom improvement in previous month
- receipt of any active treatment for the condition in the previous month
- currently under the care of another health professional for tennis elbow
- current cervical radiculopathy
- other pathology affecting distal upper limb
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.
| Effectiveness of Microcurrent for Treatment of Tennis Elbow | NCT00817232 | Contradiction |
5,098 | 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 for 5 or more years, defined as no menses for at least 5 years OR at
least 5 years status post bilateral oophorectomy
- Bone mineral density T-score at the hip or spine of -2.0 or less
- Spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA). At the lumbar
spine, there is no evidence of vertebral fracture in at least 3 vertebrae in the L1 to
L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative
joint disease, and sequelae of orthopedic procedures that result in anatomy that is
unsuitable for accurate bone densitometry must be absent from the lumbar spine.)
- At least one hip must be evaluable by DXA (e.g., contain no hardware from orthopedic
procedures)
- In a state of general health allowing for successful completion of the trial
- Agreement to not use any medications to treat osteoporosis during the study
Exclusion Criteria:
- History of prior osteoporotic fracture (unless declined treatment with or was
ineligible for osteoporosis therapy)
- Past treatment with osteoporosis medications, steroids, hormone replacement, as well
as various other medications that affect bone may be exclusionary. (Different
exclusion criteria apply to each bone active drug. For example, any prior use of
intravenous (IV) bisphosphonates is not permitted. By contrast, prior use of hormone
replacement for several years is permitted if it has not occurred within the past 6
months. Please ask the study doctor for details)
- Significant clinical or laboratory abnormalities at the screening visit for the study
that, in the opinion of the investigator, could complicate interpretation of the study
results or pose additional risk to the patient (for example, patients who are
non-ambulatory should be excluded for this reason)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | A Study to Examine the Effects of an Experimental Drug on Postmenopausal Osteoporosis (MK-0822-004) | NCT00112437 | Contradiction |
5,491 | 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:
Patients must meet all of the following criteria in order to be eligible for enrollment:
1. Criteria for diagnosis of giant cell arteritis (GCA), Takayasu's arteritis (TAK),
polyarteritis nodosa (PAN), granulomatosis with polyangiitis (GPA, Wegener's), microscopic
polyangiitis (MPA), or eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss),
as used for the VCRC longitudinal studies
a. Giant cell arteritis: According to the American College of Rheumatology (ACR) criteria
for classification of GCA, meeting at least 2 of the following 5 remaining criteria at the
time of diagnosis of GCA: Age of disease onset >50 years (required) i. New onset or new
type of localized pain in the head ii. Temporal artery abnormality (i.e. temporal artery
tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical
arteries) iii. ESR of >40 mm in the first hour by Westergren method iv. Temporal artery
biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration
or granulomatous inflammation, usually with multinucleated giant cells v. Large Vessel
Vasculitis (LVV) by angiogram or biopsy not explained by something else
b. Takayasu's arteritis: According to an adaption of the American College of Rheumatology
criteria, meeting at least 2 of the following 5 remaining criteria at the time of inclusion
of TAK: Arteriogram abnormalities compatible with TAK (includes conventional dye
angiography or MR angiography or CT angiography) (required) i. Age at disease onset ≤50
years ii. Claudication of extremities iii. Decreased brachial artery pulse (one or both
arteries) iv. Blood pressure difference of >10mm Hg between the arms v. Bruit over
subclavian arteritis or aorta
c. Polyarteritis nodosa: An adaption of the America College of Rheumatology criteria will
be used for the diagnosis of PAN. At the time of inclusion, one major and one minor
criteria or two major criteria or isolated cutaneous PAN must be met.
i. Major criteria (not explained by other causes):
1. Arteriographic abnormality
2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy
3. Mononeuropathy or polyneuropathy ii. Minor criteria (not explained by other causes)
1. Weight loss > 4 kg 2. Livedo reticularis, cutaneous ulcerations, or skin nodules 3.
Testicular pain or tenderness 4. Myalgias 5. Diastolic blood pressure >90mm Hg 6. Elevated
BUN or serum creatinine levels 7. Ischemic abdominal pain iii. Isolated cutaneous
polyarteritis nodosa
1. Biopsy-proven cutaneous PAN
d. Granulomatosis with polyangiitis: Participants can be enrolled if two of the five
modified American College of Rheumatology criteria are met: i. Nasal or oral
inflammation: painful or painless oral ulcers or purulent or blood nasal discharge ii.
Abnormal chest radiograph: nodules, fixed infiltrates, or cavities iii. Urinary
sediment: microhematuria or red cell casts iv. Granulomatous inflammation on biopsy:
granulomatous inflammation within the wall of an artery or in the perivascular area v.
ANCA positivity by enzyme immunoassay for either PR3- or MPO-ANCA e. Microscopic
polyangiitis: The following Chapel Hill Consensus Conference Definitions for MPA need
to be met: i. Necrotizing vasculitis with few or no immune deposits affects small
vessel (i.e., capillaries, venules, or arterioles) ii. Necrotizing arteritis involving
small and medium-sized arteritis may be present iii. Necrotizing glomerulonephritis is
very common iv. Pulmonary capillaritis often occurs
f. Eosinophilic granulomatosis with polyangiitis: An adaptation of the American
College of Rheumatology criteria will be used for the diagnosis of EGPA. At the time
of inclusion, four of the six items must have documented evidence: i. Asthma ii. Peak
peripheral blood eosinophilia of >10% of total WBC iii. Peripheral neuropathy
attributable to vasculitis iv. Transient pulmonary infiltrates on chest imaging
studies v. Paranasal sinus abnormalities or nasal polyposis vi. Eosinophilic
inflammation on tissue biopsy If patients have 4 of the above 6 criteria but lack
clear-cut documentation of small vessel vasculitis, they are also eligible for
enrollment.
2. Baseline normalized score on PROMIS Global Physical Health of 40 or lower.
3. Vasculitis in remission or very low disease activity, as defined by Physician Global
Assessment 0-1 for at least 12 weeks
4. Stable immunosuppressive therapy (including prednisone) related to vasculitis for at
least 12 weeks
5. No change in medications in the past 12 weeks made with the expectation of improving
pain, fatigue, or mood
6. No plan to change medication or a non-pharmacologic treatment regimen likely to affect
pain, fatigue, mood, or vasculitis activity during the next 12 weeks
7. Age of 18 years or older
8. Willingness and ability to comply with treatment and follow-up procedures, including
receipt of weekly phone calls from the study coordinator
9. Willingness and ability to provide informed consent -
Exclusion Criteria:
1. Change in any medication related to control of vasculitis, pain, fatigue, or mood
within the past 12 weeks (medications taken as needed must be in a stable pattern per
the patient's estimation)
2. Use of another investigational agent as part of a clinical trial within 30 days of
enrollment
3. Current use of any opioid agonist including tramadol or suboxone
4. Change in vasculitis activity in the past 12 weeks, as defined by a change in
Physician Global Assessment greater than 1
5. Baseline normalized score more than 40 on PROMIS Global Physical Health
6. New major medical problem or surgery in past 12 weeks
7. Pregnancy or breastfeeding
8. Inability to provide informed consent or comply with study procedures
9. Schizophrenia or bipolar disorder
10. Poorly controlled depression or anxiety, as defined by a score of ≥ 20 on PHQ-9
11. Liver cirrhosis
12. Significant kidney disease, defined as glomerular filtration rate <30ml/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.
| Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | NCT03482479 | Contradiction |
5,898 | 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:
- Patients with functional dyspepsia that fulfill Rome III criteria with inadequate
relief of dyspeptic symptoms
- Age >18
- Provision of written consent
Exclusion Criteria:
- Presence of organic pathology identified by upper endoscopy or other investigations
- Presence of sliding hiatus hernia as defined by flap valve grade IV disruption of
morphology at gastro-esophageal junction
- Concurrent medications that affect gastrointestinal motility
- Presence of acid reflux or heartburn symptoms of more than twice a month
- History of gastric surgery
- H. pylori infection
- Use of PPI or NSAID in the past 4 weeks
- Pregnancy
- Known hypersensitivity to PPI
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.
| BRAVO Study for Functional Dyspepsia | NCT01349413 | Contradiction |
6,255 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients with signed informed consent.
- Patients with a positive PCR test for SARS-CoV-2 or influenza H1N1 test upon emergency
department admission.
- Patients with lung CT within 24hrs of specimen collection for PCR test.
- Patients with complete 30-day follow-up information.
Exclusion Criteria:
- Patients who are unwilling to undergo a lung CT.
- Negative PCR test for SARS-CoV-2 or influenza H1N1 test upon emergency department
admission.
- Patients with a tumor or tumor metastasis on the pulmonary CT.
- Patients with a previous or de novo autoimmune disease diagnosis.
- Patients with a previous or de novo interstitial lung disease.
- Pregnancy.
Elimination Criteria:
- Patients with loss of information on the variables of interest.
- Patients without 30-day follow-up information.
- Patients who chose to withdraw their participation at any time of the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Tomographic Findings in COVID-19 and Influenza H1N1 | NCT04499378 | Contradiction |
1,818 | 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 patients (≥18 years of age) who are undergoing esophago-gastro duodenoscopy
(EGD) for any reason and are consenting to be enrolled in the study during the study
period.
Exclusion Criteria:
- the patients who cannot speak English in Canada, who cannot speak Japanese in Japan,
and cannot speak Persian in Iran.
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.
| Japanese Upper GI Symptoms Compared With Iranian and Canadian Patients Presenting | NCT03868267 | Entailment |
4,206 | 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:
- Diagnosis of cystic fibrosis, confirmed by the sweat test;
- 14 - 25 years;
- Clinical stability;
- Absence of bacterial colonization for 4 weeks;
- Both sexes;
Exclusion Criteria:
- Inability to perform the protocol established by the study;
- Present any intercurrence during data collection;
- Being unable to understand and / or perform procedures.
- Colonization during study participation;
- Patient hospitalization due to worsening of the clinical picture.
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.
Subject must be at most 25 Years | Inspiratory Muscle Training in Individuals With Cystic Fibrosis | NCT03737630 | Contradiction |
6,886 | 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 diagnosed with new or previous mild or moderate Alzheimer's disease diagnosed
by a doctor according to medically-accepted definitions
- Patients living in ordinary households (for example in their own home or in the home
of a family member or friend, not in nursing homes or other long-term care facilities)
Exclusion Criteria:
- Patients who are currently participating in another clinical trial
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| A Survey Study of the Treatment and Outcome Management in Patients Diagnosed With Alzheimer's Disease | NCT00291421 | Entailment |
252 | 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:
- Healthy, women ages 18 to 39yo with BMI <30
- Regular menstrual cycles with duration between 24-35 days
- Completion of screening visit where ovulation will be assessed with blood draw for
progesterone level (must be 5ng/mL or greater)
- Not seeking pregnancy during the study period
- Use of a non-hormonal form of contraception, such as: sterilization (tubal ligation,
Essure), copper IUD (intrauterine device), barrier methods or abstinence
- Must speak English or Spanish
Exclusion Criteria:
- Currently pregnant or breastfeeding
- Severe pelvic organ prolapse or prolapse to any degree that may prevent retention of
the vaginal ring after insertion
- Use of oral contraceptive pills, patches, implants or hormonal intrauterine
contraception in the month prior to screening
- Use of depo medroxyprogesterone within 6 months of screening
- Use of medications that interact with contraceptive steroid hormones: anti-epileptic
medications, rifampin, rifabutin, fosamprenavir, etc
- Medical condition with safety deemed to be category 3 or 4 when using a combined
hormonal contraceptive, as determined by the Center for Disease Control Medical
Eligibility Criteria: current or past history of breast cancer, severe decompensated
cirrhosis, history of deep vein thrombosis or pulmonary embolus, diabetes with
nephropathy/retinopathy/neuropathy or other vascular disease diagnosed more than 20
years ago, current symptomatic gallbladder disease, hypertension, ischemic heart
disease, known thrombogenic mutations, hepatocellular adenoma, malignant hepatoma,
multiple risk factors for atherosclerotic cardiovascular disease, multiple sclerosis
with prolonged immobility, history of peripartum cardiomyopathy, cigarette smoking and
≥35yo, history of complicated solid organ transplant, history of stroke, history of
superficial venous thrombosis not associated with catheter, systemic lupus
erythematosus with positive antiphospholipid antibodies, valvular heart disease
complicated by pulmonary hypertension or atrial fibrillation or bacterial
endocarditis, and acute viral hepatitis
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Application for the Etonogestrel/Ethinyl Estradiol Ring | NCT03120728 | Contradiction |
3,320 | 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:
- A healthy male adult at the age of 20 to 45 (both inclusive) at the time of screening
test.
- Body weight equal to or greater than 55 kg and calculated ideal body weight (IBW)
within ±20%
- An individual who has been given and fully understood detailed explanations about this
study, decides to participate in the study of his own will, and provides written
informed consent to comply with instructions.
Exclusion Criteria:
- History or presence of any clinically significant diseases in the hepatobiliary,
renal, nervous(central or peripheral), respiratory, hemato-oncology, cardiovascular,
urinary, musculoskeletal, immune, ear, nose and throat (ENT), mental, and,
particularly, endocrine systems (e.g., diabetes mellitus, hyperlipidemia, etc.).
- History of any gastrointestinal disease that may affect absorption of the study drug
(Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal
surgeries (except for simple appendectomy or hernia repair).
- Hypersensitivity to MP-513 or drugs containing metformin or other drugs in the same
class as ingredients or to other drugs
- Vital signs in a sitting position corresponding to at least one of the following
criteria: systolic blood pressure ≥ 140 mmHg or < 90 mmHg, or diastolic blood pressure
≥ 95 mmHg or < 60 mmHg.
- Serum creatine > upper limit of reference range
- Required to refrain from food intake for at least 24 hours during the study period due
to surgery or religious reason.
- History or presence of drug abuse.
- Administration of drugs that either induce or inhibit drug metabolizing enzymes, such
as barbitals, within 1 month prior to the first dosing.
- Intake of food or beverage containing grapefruit or cranberry within 1 week prior to
the first dosing.
- Administration of any ethical drugs or traditional Korean herbal medicines within 2
weeks or any over-the-counter drugs or vitamin products within 1 week prior to the
first dosing
- An individual who participated in another clinical trial and was administered any
investigational product within 3 months prior to the first dosing.
- Whole blood donation within 2 months, apheresis donation within 1 month, or blood
transfusion within 1 month prior to the first dosing.
- An individual who drinks excessive amounts of alcohol or who cannot stop drinking
alcohol from 24 hours prior to hospital admission through to hospital discharge.
- Having smoked 10 cigarettes/day or more on average over the past 3 months.
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years | A Study to Evaluate the Effect of Food on Fixed-Dose Combination of MP-513 10 mg and Metformin XR 750 mg | NCT03787043 | Contradiction |
2,073 | 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:
- Thoracocentesis
- Chest X-ray
- CT scanning
- PET-CT scanning
Exclusion Criteria:
- Missing data
- Lung cancer
- Thoracic malignancies
No condition on gender to be admitted to the trial.
Subject must be at least 16 Years old.
| The Value of PET-CT in Pleural Effusions | NCT03272997 | Entailment |
4,662 | 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:
Healthy volunteers will be in excellent health.
Only women with regular menstrual cycles (every 26-35 days) using mechanical (condoms,
diaphragm) or sterilization methods of contraception will be included.
Only women with a negative pregnancy test, normal physical examination and laboratory
results, and a luteal phase progesterone value of greater than 4 ng/mL will be entered into
this study.
Women with endometriosis will be recruited from those with histologically-proven
endometriosis. Except for this diagnosis they will meet criteria for healthy volunteers as
stated above.
Women may participate in the study on more than one occasion, but biopsies may not be
performed in a "baseline" cycle.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 43 Years | Hormonal Effects on the Uterus and Endometrium | NCT00001454 | Entailment |
2,378 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Age 7 or older; must be wheelchair-dependent
- Confirmed Dystrophin mutations based on mutation compatibility with micro-dys cDNA
based on previously published methods.
- Males of any ethnic group will be eligible.
- Ability to cooperate with muscle testing.
- Willingness of sexually active subjects with reproductive capacity to practice
reliable method of contraception (If appropriate).
Exclusion Criteria:
- Active viral infection based on clinical observations.
- Symptoms or signs of cardiomyopathy, including:
- Dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales
at the base of the lungs
- Echocardiogram with ejection fraction below 40%
- Serological evidence of HIV infection, or Hepatitis A, B or C infection
- Diagnosis of (or ongoing treatment for) an autoimmune disease
- Concomitant illness or requirement for chronic drug treatment that in the opinion of
the PI creates unnecessary risks for gene transfer.
- Subjects with AAVrh74 binding antibody titers ≥ 1:50 as determined by ELISA
immunoassay.
- Abnormal laboratory values in the clinically significant range as defined in protocol
or based upon normal values in the Nationwide Children's Hospital Laboratory.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
| Clinical Intramuscular Gene Transfer Trial of rAAVrh74.MCK.Micro-Dystrophin to Patients With Duchenne Muscular Dystrophy | NCT02376816 | Entailment |
4,539 | 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. Females aged below 40 years old.
2. Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic
ultrasonography.
3. Female subject who is:
- using adequate contraception since last menstruation and no plan for conception
during the study.
- non-lactating.
- has negative pregnancy test (urine) within 14 days prior to the study.
4. Informed consent form signed.
Exclusion Criteria:
1. Sensitivity to study product.
2. Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic
pathology).
3. Patient has clinically significant physical disability or abnormal findings on
physical examination or laboratory testing judged by the investigator or
co-investigator.
4. Participation of any clinical investigation during the last 30 days.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 40 Years | Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea | NCT01449305 | Contradiction |
4,013 | 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:
- Symptomatic knee OA for at least 6 months
- Fulfilled American College of Rheumatology clinical criteria for OA of the knee
- Radiographically assessed OA of the knee graded 1-4 according to the Kellgren &
Lawrence scale
Exclusion Criteria:
- Acute septic arthritis
- Patients with an increased tendency to fall
- Lack of physical or mental ability to perform or comply with the treatment procedure
- Diabetes mellitus
- History of pathological osteoporotic fracture
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.
| Measurement of Gait Spatio-Temporal Characteristics in Knee Osteoarthritis Patients | NCT00599729 | Entailment |
4,348 | 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:
- age 18 - 65
Exclusion Criteria:
- regular use of analgesics
- known hypersensitivity of local anaesthetic
- renal-, heart- or liver disease
- known peripheral neuropathy or diabetes mellitus
- local infection on injection site
- circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)
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 65 Years | The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic | NCT02086292 | Entailment |
4,682 | 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:
- Participant must be 18 to 55 years of age inclusive, at the time of signing the
informed consent
- Participants must be overtly healthy as determined by medical evaluation including
medical history, physical examination, laboratory tests, ECG, blood pressure and heart
rate
- Confirmation of the subject's health insurance coverage prior to the first screening
examination/visit
- Body mass index (BMI) within the range 18 and 30 kg/m^2 (inclusive)
- Male participants who are sexually active and female participants of childbearing
potential must use one of the methods of contraception described in this protocol
Exclusion Criteria:
- Incompletely cured pre-existing diseases for which it can be assumed that the
absorption, distribution, metabolism, elimination and effects of the study
intervention will not be normal
- Relevant diseases within the last 4 weeks prior to start of the first study
intervention
- Known severe allergies, non-allergic drug reactions, or multiple drug allergies
- Existing chronic diseases as specified in protocol
- Regular use of therapeutic or recreational drugs
- Suspicion of drug or alcohol abuse
- Smoking equal or more than 10 cigarettes/day
- History of COVID-19; contact with SARS-CoV-2 positive persons or COVID-19 patients
within the last 4 weeks prior admission to the ward or positive SARS-CoV-2 viral RNA
test
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Trial to Learn What Happens to Different Medicinal Forms of BAY2328065 When They Enter the Body and How Safe They Are in Healthy Male and Female Participants | NCT04851483 | Entailment |
3,714 | 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:
- ethnic Chinese;
- aged 50 years or above;
- ability to comprehend Chinese;
- fulfilling any 3 of the following criteria: i. morning stiffness ≤ 30 min; ii.
crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no
palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity
for OA knee diagnosis);
- having knee pain for at least 3 months;
- Knee pain ≥3 on a Likert pain scale from 1-10;
- having a smartphone (or a family member living together having a smartphone) that is
compatible to WhatsApp (it is the investigator's experience in the pilot study that
most of every subject had been used to using WhatsApp for social communication);
- willing to provide informed consent
Exclusion Criteria:
- medical diagnoses or conditions that preclude individuals from active participation
(e.g. bleeding disorders, alcohol or drug abuse);
- knee pain related to other conditions (cancer, fracture, rheumatoid arthritis,
rheumatism) as screened according to the red flags for further investigation or
referral in the NICE 2014 Guidelines for Osteoarthritis of the knee;
- score < 22 in Hong Kong Montreal Cognitive Assessment (HK-MoCA) indicating cognitive
impairment that may prevent understanding of training instructions;
- body mass index over 30, the obese II criteria for Asians (it will be too difficult
for the obese subjects to perform acupressure on the acupoints as physical pressure
reaching the muscle is required);
- presence of skin lesions or infections at the treatment sites;
- ever had knee replacement surgery;
- pregnancy or contemplating pregnancy;
- ever received acupressure or steroid injection for knee pain over the past 6 months
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.
Subject must be at most 70 Years | Self-administered Acupressure for Knee Osteoarthritis in Middle- and Older-Aged Adults | NCT04191837 | Contradiction |
204 | 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:
- Diagnosis of idiopathic hypogonadotropic hypogonadism (IHH) or Kallmann syndrome
(KS)Adult male 18-65 years of age
- Serum testosterone <100 ng/dL
Exclusion Criteria:
- No specific exclusion criteria
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism | NCT00493961 | Entailment |
195 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male, ages 18-68
- Serum total testosterone less than or equal to 275 ng/dL
Exclusion Criteria:
- Significant intercurrent disease of any type, in particular, liver, kidney or heart
disease, uncontrolled diabetes mellitus or psychiatric illness.
- Abnormal prostate digital rectal examination, elevated PSA, AUA symptom score of >15,
and/or history of prostate cancer.
- Hematocrit of <35 or >50%
- BMI >36
- Serum transaminases > 2 times upper limit of normal or serum bilirubin > 2.0 mg/dL
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 68 Years | Pharmacokinetic Study of Oral Testosterone (T) Ester Formulations in Hypogonadal Men | NCT00695110 | Entailment |
544 | 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:
- In-vitro fertilization patients at the investigators' institution, intended to undergo
a transfer of a frozen five-day embryo (blastocyte)
- 18 to 39 years old
- First to third treatment cycle
- Patient has previously had a maximum of four embryos transferred.
Exclusion Criteria:
- Over 40 years old
- Congenital or acquired uterine malformations
- Hydrosalpinx
- Chronic autoimmune diseases
- Embryo intended to be undergo preimplantation genetic diagnosis
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Assisted Hatching in Frozen Blastocysts | NCT03833869 | Contradiction |
5,631 | 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:
- 13-16 years old,
- overweight or obese (weight for height >20% over normality)
Exclusion Criteria:
- mental health problems, long term illnesses.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 16 Years | Promoting Overweight Adolescents Physical Activity | NCT02295761 | Contradiction |
5,352 | 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. | Key Inclusion Criteria: Qualified participants must meet all of the following inclusion
criteria.
1. Female age 30 to 50 years
2. Excessive menstrual bleeding due to benign causes
3. Uterine sounding depth measurement of 6.0 - 12.0 cm
4. A minimum uterine cavity length of 4.0 cm
5. A minimum PBLAC score of ≥ 150 for 1 menstrual cycle (obtained during screening) and
must also have a documented history of excessive menstrual bleeding prior to study
enrollment
6. Endometrial biopsy within 12 months prior to treatment procedure with no abnormal
pathology
7. Premenopausal at screening as determined by FSH measurement ≤ 40 IU/L when age is ≥ 40
years
8. Patient agrees to use a reliable form of contraception during the study and to follow
these requirements: (a) If a hormonal birth control method is used for contraception,
the patient must have been on said method for ≥ 3 months prior to the onset of the
screening menstrual cycle and agrees to remain on the same hormonal regimen through
the initial 12-month post-treatment follow-up (pills, injections, patches, rings,
implants); (b) Patient also agrees to not use hormonal birth control during the first
12-month post-treatment follow-up period if they were not using hormonal birth control
during the 3 months prior to treatment
9. Ability to provide written informed consent
10. Patient is literate and clearly demonstrates understanding on how to use PBLAC after
training
11. Patient agrees to the following during the study: (a) No initiation of hormonal
contraception or any other medical intervention for bleeding; (b) Attend all follow-up
exams through the 36-month follow-up timepoint; and (c) Exclusive use of
study-provided sanitary products and submission of completed PBLAC diaries through the
12-month post-treatment follow-up
Key Exclusion Criteria: Qualified participants must NOT meet any of the following exclusion
criteria.
1. Pregnant, or desires to retain fertility
2. Current or documented history of endometrial hyperplasia
3. Active endometritis
4. Clinically significant or suspected adenomyosis indicated by patient complaints,
imaging, or clinician's judgment
5. Active infection of the genitals, vagina, cervix, uterus, adnexa, or urinary tract
6. Active pelvic inflammatory disease
7. Currently using an intrauterine device (IUD), including Mirena™ device, and unwilling
to remove the IUD
8. Presence of an implantable contraceptive device (e.g., Essure®) protruding into the
uterine cavity
9. Active sexually transmitted disease (STD) at the time of ablation
10. Presence of bacteremia, sepsis, or other active systemic infection
11. Currently on anticoagulants
12. Known clotting defects or bleeding disorders
13. Currently on medications that could thin the myometrium, such as long-term steroid use
14. Previous medical/surgical treatments, or has other conditions, that could lead to
anatomic/pathologic weakness or thinning of the myometrium
15. Any general health, mental health or social situation which, in the opinion of the
investigator, could represent an increased risk for the patient, or the ability of the
patient to complete study requirements
16. Known/suspected abnormal uterine/pelvic anatomy or condition, such as frozen pelvis
17. Abdominal, pelvic or gynecological malignancy
18. Untreated/unevaluated cervical dysplasia, except cervical intrepithelial neoplasia I
(CIN I)
19. Previous endometrial ablation procedure
20. Abnormal or obstructed, or perforated cavity as determined by investigator via
standard clinical practices (e.g., hysteroscopy, saline infusion sonohysterography).
21. Intramural or subserosal myomas > 3 cm in size, or any myoma that distorts the uterine
cavity
22. Any patient who is currently participating or considering participation in any other
research of an investigational drug or device
Female
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 50 Years | Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness | NCT04267562 | Contradiction |
6,123 | 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:
- Individuals who work within a food production, healthcare, research or clinical
organization.
- Asymptomatic as per daily screening.
- No contraindication to performing a NP swab.
Exclusion Criteria:
- Any individual with fever, respiratory or flu-like symptoms will not be eligible.
Symptom positive individuals who were not picked up at entry screening will be
referred to their Occupational Health. Specific symptoms include:
- Fever, chills or headache
- New or worsening cough
- Shortness of breath, difficulty breathing, sore throat or difficulty swallowing
- Runny nose or stuffy nose without another cause (e.g. allergies)
- Nausea/vomiting, diarrhea, stomach pain
- Decrease/loss of taste or smell
- Unexplained fatigue, malaise, muscle aches
- Eye pain or pink eye In addition to those symptoms listed above, individuals
should also be screened for symptoms as per their institutional requirements.
- Enrolled in a COVID-related interventional study (eg. Behavioural or drug study).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| A Research Platform to Screen Healthcare Workers | NCT04574765 | Contradiction |
6,613 | 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 or have a legally authorized
representative provide written informed consent
- Subjects who are 18-55 years of age
- Subjects must be willing and able to comply with study procedures
- HbCO<3% (for smokers only)
Exclusion Criteria:
- Subject or a legally authorized representative is unable to provide written inform
consent.
- Subjects that are considered morbidly obese (defined as BMI > 39.5),
- Subjects with injuries, deformities or abnormalities that may prevent proper
application of the device under test,
- Smokers with COHb levels >3% or subjects who have smoked within two (2) days. Subjects
will be screened for COHb levels of >3% with a Masimo Radical 7 (Rainbow).
- Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu,
pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema,
COPD, lung disease),
- Subjects with known heart or cardiovascular conditions,
- Female subjects that are actively trying to get pregnant or are pregnant,
- Subjects taking blood thinners or medications with aspirin or other antiplatelet
medication in them (applies only to arterial draw study),
- Subjects with Systolic blood pressure >140mmHg,
- Subjects with Diastolic blood pressure >100mmHg,
- Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus
arrhythmia
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | SpO2 System Accuracy Testing With Different Sensors | NCT01613222 | Contradiction |
5,182 | 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:
- At least 7 years post-menopause
- Serum 25OHD level 5 ng/ml to 20 ng/ml
- BMI less than or equal to 40 kg/m2
- Willing to discontinue multivitamins that contain vitamin D during the study
Exclusion Criteria:
- Cancer (except basal cell carcinoma) or terminal illness
- Previous hip fracture
- Hemiplegia (paralysis of one side of the body)
- Uncontrolled type I diabetes or fasting blood sugar greater than 140 mg in type II
- Kidney stones more than twice in a lifetime
- Chronic renal failure
- Evidence of chronic liver disease, including alcoholism
- Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure
severe enough to prevent reasonable physical activity
- Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives,
(e.g. Teriparatide or Fluoride) in the last 6 months
- Previous treatment within the last 6 months with calcitonin or estrogen
- Chronic high dose corticosteroid therapy (more than 10 mg per day) for over 6 months
and not within the last 6 months
- Anticonvulsant therapy
- High dose thiazide therapy (more than 37.5 mg)
- 24 hour urine calcium greater than 290 mg on 2 baseline tests
- Serum calcium exceeding upper normal limit on 2 baseline tests
- Bone Mineral Density T-score less than -3.0 for spine or hip
Female
No healthy subjects accepted to join the trial.
Subject must be at least 57 Years old.
| Vitamin D Supplementation in Older Women | NCT00472823 | Entailment |
4,304 | 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:
absence of sperm cells on 2 spermograms in 3 months interval testicular size has to be
determined in order to categorized in a group to accept surgery-
Exclusion Criteria:
allergy to fluoro deoxyglucose clinical varicocele
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Secretory Azoospermia and FDG (Fluoro Deoxyglucose) PET-CT | NCT02043444 | Entailment |
312 | 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:
- Be healthy women, who are sexually active, at risk for pregnancy, and desiring
contraception.
- Be within the age range of 18 through 35 (inclusive) at enrollment if not in the
subset of women with an age of 36-45 at enrollment (age subset at select sites).
- Be at low-risk for both human immunodeficiency virus (HIV) and sexually transmitted
disease (STD) infection and currently have a single sex partner (≥ 4 months) who is
also at low-risk for both HIV and STD infection.
- Have a negative urine pregnancy test prior to enrollment.
- Have normal cyclic menses with a usual length of 21 to 40 days over the last two
cycles or at least one spontaneous, normal menstrual cycle (two menses) since
delivery, abortion, or after discontinuing hormonal contraception/hormonal therapy.
- Be willing to accept a risk of pregnancy.
- Be willing to engage in at least two acts of heterosexual vaginal intercourse per
cycle.
- Be willing to be randomized to either study treatment.
- Be willing to use the study product as the only method of contraception over the
course of the study (with the exception of emergency contraception (EC)), when
indicated).
- Be capable of using the study product properly and agree to observe all study
directions and requirements.
- Be willing to keep a daily diary to record coital information, product use
information, information about the use of other vaginal products, and sign and symptom
data for both the subject and her partner.
- Agree not to participate in any other clinical trials during the course of the study
with the exception of enrolling in the Amphora™ gel extension study.
- Be willing to give written informed consent to participate in the trial.
Exclusion Criteria:
- Have a history of allergy or sensitivity to spermicides or products containing N-9
(nonoxynol-9).
- Have had three or more urinary tract infections (UTIs) in the past year.
- Have a UTI by urine culture, symptomatic yeast vaginitis, or symptomatic bacterial
vaginosis diagnosed by wet mount unless treated and proof of cure is documented.
- Have a history of any recurrent vaginal infections/disorders (either less than or
equal to four times in the past year or less than or equal to three times in the
previous six months).
- Be pregnant, have a suspected pregnancy, or desire to become pregnant during the
course of the study.
- Have a history of infertility or of conditions that may lead to infertility, without
subsequent intrauterine pregnancy.
- Have any contraindications to pregnancy (medical condition) or chronic use of
medications for which significant evidence of fetal risk exists.
- Have had more than one sexual partner in the last four months.
- Have shared injection drug needles in the past unless has a negative HIV test at least
six weeks since last use.
- Have or have been suspected to have HIV infection.
- Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence
(initial episode) within three months prior to screening.
- Have three or more outbreaks of HSV within the last year.
- Have evidence of Chlamydia trachomatis or Neisseria gonorrhoeae unless she and her
partner complete treatment and proof of cure is documented.
- Have been diagnosed with any other STDs in the six months prior to the Randomization
Visit (with the exception of human papillomavirus (HPV), trichomonas, gonorrhea, adn
Chlamydia).
- Be lactating or breastfeeding.
- Have any clinically significant abnormal vaginal bleeding or spotting within the month
prior to screening.
- Have any clinically significant abnormal finding on pelvic examination or baseline
labs, which in the view of the investigator, precludes her from participating in the
trial.
- Have clinically significant signs of vaginal or cervical irritation on pelvic
examination.
- Have had vaginal or cervical biopsy or vaginal surgery within three months prior to
screening (with the exception of cervical biopsies performed for eligibility
determination).
- Have used vaginal or systemic antibiotics or antifungals within 14 days prior to
screening or enrollment/randomization, with the exception of systemic antibiotics
taken for a UTI and trichomonas diagnosed at screening. Subjects should not have used
systemic antibiotics prescribed at the Screening Visit for a UTI within seven days of
the enrollment/randomization visit.
- Have had a Depo-Provera® injection in the ten months prior to enrollment.
- Have an abnormal Pap test based on the following criteria:
- Pap test in the past 15 months with ASC-US unless:
- less than 21 years of age;
- a repeat Pap test at least six months later was normal;
- reflex HPV testing was performed and was negative for high-risk HPV; or
- a colposcopy (with or without biopsy) found no evidence of dysplasia requiring
treatment or treatment was performed and follow-up at least six months after the
treatment showed no evidence of disease;
- Pap test in the past 15 months with LSIL unless:
- less than 21 years of age;
- a colposcopy (with or without biopsy) found no evidence of dysplasia requiring
treatment or treatment was performed and follow-up at least six months after the
treatment showed no evidence of disease;
- Pap test in the past 15 months with ASC-H, atypical glandular cells, or HSIL unless
colposcopy and/or treatment was performed and follow-up at least six months after the
colposcopy and/or treatment showed no evidence of disease;
- Pap test in the past 15 months with malignant cells.
- Consume (on average) greater than three drinks of an alcoholic beverage per day.
- Have a past history (within 12 months) or current history which, in the PI's judgment,
constitutes of drug abuse (recreational, prescription, or over-the-counter (OTC)).
- Have taken an investigational drug or used an investigational device within the past
30 days.
- Have issues or concerns (in the judgment of the investigator) that may compromise the
safety of the subject or confound the reliability of compliance and information
acquired in this study.
In addition, in order to be eligible to participate in the trial, potential subjects must
state that, to her best knowledge, her sexual partner meets the following criteria:
- Is not infertile.
- Has had untreated chlamydia or gonorrhea in the past six months.
- Has not had more than one sexual partner in the past four months.
- Has no history of allergy or sensitivity to spermicides or products containing N-9.
- Has not been previously diagnosed with or suspected of HIV infection unless he has
subsequently had a negative HIV test.
- Has not been known to have engaged in homosexual intercourse in the past five years
unless he has had negative HIV test results since then.
- Has not shared injection drug needles in the past unless he has had a negative HIV
test at least six weeks since last use.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel | NCT01306331 | Contradiction |
6,464 | 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. | Bilaterally symmetric red skin on cheeks Caucasian Age 18-60 years
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Topical Agent for Treatment of Red Skin | NCT00279890 | Entailment |
130 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Premature appearance of secondary sexual characteristics: girls present with
development of secondary sexual characteristics before 8, with breast induration as
the earliest manifestation.
2. Accelerated linear growth: the annual growth rate is higher than normal.
3. Advanced bone age: the bone age is 1 or years more than the actual age
4. Enlargement of sexual glands: B-mode ultrasonography of pelvic cavity indicates the
volumes of the uterus and ovaries have increased, and multiple ovarian follicles with
a diameter>4mm can be found in ovaries;
5. HPGA functions have been primed; serum gonadotropin and sexual hormone levels reach
pubertal values.
6. Subjects should be willing and able to follow the study protocol during the study
period.
7. Subjects should submit their parents' or guardians' written informed consent before
initiation of the study procedure with non-normal medical care. They should understand
that subjects or their parents/guardians may withdraw the consent at any time without
impairing future medical care. If the child is old enough to read and write, she
should submit a separate consent form.
Exclusion Criteria:
1. Patients with central nervous system diseases and thyroid diseases;
2. Patients with CHA-induced precocious puberty;
3. Patients with poor compliance.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 14 Years | Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty | NCT02920515 | Contradiction |
6,611 | 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:
- This study has 2 Phases. In Phase 1, healthy, non-smoking adult volunteers greater than
18 years of age are invited to participate. In Phase 2, all adult (>18) non-critical
patients and healthy community volunteers visiting the ED at VH and UH are eligible to
participate.
Exclusion Criteria:
Potential participants will be excluded based on the following criteria:
Phase 1:
- greater than 70 years of age,
- current smokers,
- previous history of cardiac disease (e.g., atrial fibrillation, myocardial infarction,
congestive heart failure),
- history of moderate or severe asthma,
- history of seizures,
- history of stroke or transient ischemic attack
- pregnant women
- Patients with any active pulmonary disease such as pneumonia
- Individuals who are unwilling to participate or are less than 18 years old
- Those who are unable to consent
Phase 2
- Critical patients will be excluded from participating
- Individuals who are unwilling to participate or are less than 18 years old will be
excluded
- Those who are unable to consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Calibration and Validation of High Quality Low-Cost 3D Printed Pulse Oximeter | NCT02846974 | Contradiction |
2,074 | 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. Patient ≥ 18 years of age
2. Admitted to ICU in the last 72 h
3. Definite or probable IPF diagnosis defined on 2018 ATS/ERS/JRS/ALAT guidelines or a
possible usual interstitial pneumonia pattern on HRCT without etiology.
4. Definite AE-IPF according to the 2018 revised criteria :
1. Previous or concurrent diagnosis of idiopathic pulmonary fibrosis (if the
diagnosis of IPF is not previously established, this criterion can be met by the
presence of radiologic and or histopathologic changes consistent with usual
interstitial pneumonia (UIP) pattern on the current evaluation);
2. Acute worsening or development of dyspnea typically of less than one-month
duration;
3. Computed tomography with new bilateral ground-glass opacity and/or consolidation
superimposed on a background pattern consistent with a UIP pattern (if no
previous computed tomography is available, the qualifier "new" can be dropped);
4. Deterioration not fully explained by cardiac failure or fluid overload.
5. PaO2/FiO2 ratio < 200 measured on FiO2 1
Exclusion Criteria:
1. Known hypersensitivity intravenous immunoglobulins or rituximab
2. Severe heart failure
3. Active and uncontrolled bacterial fungal or parasitic infection ruled out by at least
one of these two conditions
1. Procalcitonin value at inclusion < 0.25 ng/mL OR
2. Adapted antimicrobial therapy for at least 48 hours at inclusion
4. Positive multiplex PCR for Influenzae A and B, or VRS
5. Deep Veinous Thrombosis or Pulmonary embolism in the last six months
6. Prior exposures to human-murine chimeric antibodies
7. Ongoing treatment with a cellular immunosuppressant (e.g., cyclophosphamide,
methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, etc.)
8. Subject treated with more than 2 boluses of methylprednisolone (total dose > 500mg of
methylprednisolone) or one dose > 10mg/kg in the last 72 hours
9. Uncorrectable coagulopathies or thrombocytopenia < 30000/mm3
10. Active cancer (other than basal cell carcinoma of the skin)
11. Other source of immunosuppression (i.e. HIV infection, solid organ transplant,
lymphoma or leukemia)
12. Pregnancy
13. Patient listed for lung transplantation
14. Patient on ECMO
15. Patient with a do-not-intubate order at inclusion
16. Concurrent participation in other experimental trials
17. Not Affiliation to the French social security
18. Not Written informed consent from the patient or a legal representative if appropriate
19. Hypersensitivity to corticosteroids, cotrimoxazole / atovaquone
20. Patients with severe renal insufficiency (creatine clearance <15ml / 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.
| Therapeutic Plasma Exchange, Rituximab and IV Ig for Severe Acute Exacerbation of IPF Admitted in ICU | NCT03584802 | Entailment |
5,683 | 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:
- Children evaluated for short stature
- Normal weight \ overweight \ obesity
Exclusion Criteria:
- Known GH deficiency
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 6 Years old.
Subject must be at most 16 Years | Growth Hormone Secretion Following the Anaerobic Exercise | NCT01934270 | Entailment |
3,309 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- clinical diagnosis of oculocutaneous albinism
- age over 3 and weight over 25 lbs.
Exclusion Criteria:
- ocular only albinism
- ocular pathology other than albinism
- neurologic disease, history of myocardial infarction, history of clinical depression,
pregnancy
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.
| Vision Response to Dopamine Replacement | NCT01663935 | Entailment |
6,290 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
Patients With confirmed COVID-19
Exclusion Criteria:
inadequate sample of the patients
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 | To Access the Egyptian COVID-19 Whole Genome by NGS and Compare to the International Worldwide Database | NCT04346043 | Entailment |
4,425 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
1. age 18-65 years
2. diagnosis of CLE, confirmed by the PI using clinical symptoms and exam findings of
tenderness over the lateral epicondyle and/or extensor tendon, and pain on 2 extensor
muscle provocation tests
3. self-reported CLE-related pain for at least 6 months
4. self-reported failure of at least 2 of the 3 most common treatments for CLE (a course
of NSAIDS, physical therapy or corticosteroid injections).
Exclusion Criteria:
1. current bilateral CLE
2. a corticosteroid injection in the prior 3 months or prior PrT or PRP for CLE
3. current carpal tunnel syndrome, other elbow pathology, or acute trauma of the
CLE-affected upper extremity
4. self-reported history of bleeding disorders, other hematologic conditions,
inflammatory arthritis, systemic nervous system disease, upper extremity surgeries or
neuropathy
5. current use of opioids for pain
6. anticoagulation or immunosuppressive therapy in the prior month
7. intent to use NSAIDs or steroids
8. known allergy to dextrose, acetaminophen or lidocaine
9. MRI contraindications: non-compatible metal in the CLE-affected upper extremity or
severe claustrophobia
10. unresolved litigation
11. self-reported pregnancy. Pregnant women are excluded from the study because pregnancy
changes the characteristics of connective tissue including ligaments and tendons
associated with CLE and, so, is an unacceptable confounder in this pilot level study.
There is no report however, about dextrose, morrhuate sodium or PrT being harmful to
pregnant women. Therefore we will not draw confirmatory labs to ensure that women of
childbearing age are not pregnant. Rather we will accept self-report on pregnancy
status at the time of consent. If a woman becomes pregnant during the study she will
be dropped from the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Efficacy of Injection Therapy for Lateral Epicondylosis | NCT01476605 | Contradiction |
700 | 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. | No eligibility criteria
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 100 Years | Hemochromatosis and Iron Overload Screening Study (HEIRS) | NCT00005541 | Entailment |
2,910 | 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. | Key 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. Upright Slow Vital Capacity (SVC) >50% of predicted for age, height, and sex
6. Able to swallow tablets with water
7. Willing and able to remain off riluzole for 4 weeks (Part A only)
8. Currently taking and tolerating a stable dose of 50 mg BID riluzole (Part B only)
9. Willing and able to reduce daily dose of riluzole to 50 mg for 4 weeks (Part B only)
10. Willing and able to refrain from caffeine-containing products during study
participation
11. Willing and able to remain off warfarin and theophylline-containing medications during
study participation
12. Has a caregiver who is capable of observing and reporting patient status, and also
assisting in the proper use of nocturnal oximetry equipment
13. Able to perform pulmonary function tests
Key Exclusion Criteria:
1. Life expectancy <3 months
2. Participation in any trial in which receipt of investigational study drug occurred
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. Use of non-invasive positive pressure ventilation (NIPPV) for any part of the day or
night
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.
| A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) | NCT01378676 | Entailment |
5,688 | 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:
- Children with short stature by growth hormone deficiency(GHD) or idiopathic short
stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA)
- Children who has official height record at least 6 months prior
Exclusion Criteria:
- Children with Epiphyseal closure
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.
| Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature | NCT04798690 | Entailment |
5,226 | 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:
- fracture caused by osteoporosis
- fifty years or more of age
- informed consent
Exclusion criteria:
- Physically or mental state that does not participation
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.
| Osteoporosis School | NCT00224991 | Entailment |
764 | 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:
1. Male or female higher than 18 and less or equal to 65 years of age
2. an active life-style, professional or regular casual sport player (people who plays
sport or trains themselves at least 2-3 times per week).
3. diagnosis of knee osteoarthritis will be based upon a standing weight bearing knee
X-ray at Screening or an X-ray performed within 6 months prior to screening. The
radiograms must be classified as a Kellgren and Lawrence Grade I-III for
osteoarthritis of the knee.
4. a knee VAS pain score, within 48 hours before the visit.
5. patients must have had all analgesic/anti-inflammatory drugs discontinued for 2 weeks
prior to Baseline except for acetaminophen.
Exclusion Criteria:
1. Major injury to the contralateral knee or other weight-bearing joint if it would
interfere with the study assessments.
2. Surgical procedure of the studied joint within the previous 12 months prior to
Screening.
3. Ligament reconstruction in the target knee within 1 year
4. Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis
5. Intra-articular or local peri-articular corticosteroid injections to the study
joint/knee within the previous 3 months prior to screening or to any other joint
(beside the study joint) or soft tissue area within the previous month prior to
Screening.
6. Any corticosteroid within the previous month. Steroid inhalants are permitted if the
patient has been on a stable regimen for the past month prior to Screening and remains
on this regimen throughout the course of the trial.
7. Intra-articular hyaluronan in the studied joint within the previous 6 months prior to
Screening.
8. History of allergic reaction to an intra-articular Hyaluronic acid injection
9. Use of glucosamine- or chondroitin sulfate-containing products unless the patient is
on stable doses for at least 4 months prior to Screening and willing to remain on
these stable doses throughout the course of the trial.
10. Patients with X-ray findings of acute fractures, severe loss of bone density,
avascular necrosis and/or severe deformity.
11. Axial deviation of the lower limbs higher than 20 degrees in valgus or varus on
standing X-ray.
12. Symptomatic osteoarthritis of either hip, contralateral knee or spine that may
interfere with functional assessment of the signal knee.
13. Clinically significant medio-lateral and/or anterior-posterior instability.
14. Osteonecrosis of either knee.
15. If patients are receiving or performing physical therapy at Screening, this physical
therapy regimen has not been stable during the one-month preceding Screening and the
patient is not willing to maintain the same regimen throughout the course of the
trial.
16. Patients with Kellgren-Lawrence Stage IV osteoarthritis of the knee (i.e.,in grade IV
large osteophytes, marked narrowing, severe sclerosis, and definite deformity).
17. Hemiparesis of the lower limbs
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Efficacy and Safety of Hymovis ONE® (32mg/4ml) Intrarticular Injection in Active Patients With Knee Overuse Syndrome | NCT04661111 | Contradiction |
6,675 | 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:
- Male
- Severe hemophilia A or moderate hemophilia A
- 1-12 years of age
- Requiring treatment with FVIII
Exclusion Criteria:
- Current or prior inhibitor or familial antecedents of inhibitor
- Surgery required during the study (9 months)
- Positive for HIV
Male
No healthy subjects accepted to join the trial.
Subject must be at least 1 Year old.
Subject must be at most 12 Years | Russian Kogenate Pediatric Study | NCT00632814 | Contradiction |
6,825 | 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%. | - Male, at least 12 years old, with severe hemophilia A undergoing major elective major
surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test
at screening and no past history of inhibitor.
- Previously treated with at least 150 exposure days to any Factor VIII product
- Normal hepatic and renal function tests and no other bleeding disorder
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery | NCT00243659 | Entailment |
3,552 | 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:
- Patients with verified Addison's disease on stable treatment.
Exclusion Criteria:
- Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease,
pregnancy.
- Treatment with glucocorticoids or drugs that interfere with cortisol metabolism
(antiepileptics, rifampicin, St. John's wart).
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 70 Years | Glucocorticoid Treatment in Addison's Disease | NCT01063569 | Entailment |
1,094 | 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:
- Adult patients 40 years of age or older who present to the Emergency Department with
syncope or presyncope.
- Subjects must read and speak English or Spanish.
- Subjects must have a working phone number and fixed address.
Exclusion Criteria:
- Patient who have a syncope mimic such as seizure, stroke, head trauma with loss of
consciousness, altered mental status, hypoglycemia, intoxication, or require an
intervention to restore consciousness.
- Patients who have a new serious diagnosis found in the Emergency Department, such as
death, significant cardiac arrhythmia (see below), myocardial infarction, significant
structural heart disease, stroke (both ischemic and hemorrhagic), pulmonary embolism,
aortic dissection, hemorrhage or anemia requiring blood transfusion, subarachnoid
hemorrhage, cardiopulmonary resuscitation, acute surgical illness, pregnancy, or major
traumatic injury.
- Significant cardiac arrhythmia includes Ventricular Fibrillation, Ventricular
tachycardia (>30 secs), Symptomatic ventricular tachycardia, (<30 secs), Sick sinus
disease with alternating sinus bradycardia and tachycardia, Sinus pause > 3 seconds,
Mobitz type II atrioventricular heart block, Complete heart block, Symptomatic
supraventricular tachycardia (including PSVT, rapid atrial fibrillation/ flutter),
Symptomatic bradycardia (pulse<40), Pacemaker or implantable
cardioverter-defibrillator malfunction with cardiac pauses.
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.
| Practical Approaches to Care in Emergency Syncope | NCT04533425 | Contradiction |
3,979 | 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:
- Symptomatic idiopathic osteoarthritis of the knee for a minimum of six months duration
requiring treatment with either an analgesic or anti-inflammatory agent on a regular
basis (greater than or equal to three days/week) for at least three months.
- A history of osteoarthritis of the knee characterized by pain of at least a moderate
intensity.
- Demonstrated radiographic evidence of mild to moderate osteoarthritis based on the
Kellgren and Lawrence radiographic entry criteria of grade 2 or 3 osteoarthritis.
- Subjects' physical ability was to be either American College of Rheumatology (ACR)
Function Class I or II
- At the baseline visit, subjects must have reported a maximum pain intensity
experienced over the previous 24 hours of at least moderate on a five-point scale of
none(0), mild(1), moderate(2), moderately severe(3), or severe(4) in order to be
enrolled in the study.
Exclusion Criteria:
- Medical history, physical examinations, or radiographs suggestive of other types of
arthritis, pseudogout, collagen vascular disease or fibromyalgia.
- Medical or psychiatric conditions that may influence absorption, metabolism, or
excretion of the study medications or interfere with interpretation of adverse
reactions to the study drug.
- History of allergy, sensitivity, contraindication or non-response to acetaminophen,
rofecoxib, or drugs classified as NSAIDs including aspirin.
- Use of concomitant medications that might interfere with study drug assessments,
including intra-articular corticosteroids.
- Signs of active knee inflammation, morning stiffness of greater than 30 minutes
duration.
- Rheumatoid factor quantitative value greater than or equal to 40 IU/mL or a Westergren
erythrocyte sedimentation rate greater than or equal to 40 mm/hour.
- ACR functional class III or IV, or unable to walk without assistive devices.
- Pregnancy, lactation, or expect to become pregnant within one month of study
completion.
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.
| A Four-Week Study Comparing Acetaminophen Extended Release and Rofecoxib in the Treatment of Osteoarthritis of the Knee | NCT00568295 | Entailment |
426 | 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. Infertile patients with clear fertility desires
2. Diagnosed with thin endometrium or endometrial scarring for whom drugs and surgical
interventions were ineffective
3. 20-42 years old
4. Normal ovarian function or with frozen embryos
5. Willing to actively cooperate with postoperative follow-up
Exclusion Criteria:
1. With abnormal chromosome karyotype
2. With other uterine diseases including large intramural myomas, severe endometriosis,
severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis,
vaginitis and endometritis
3. Systemic diseases: hypertension, diabetes, and so on
4. Contraindications to pregnancy
5. Contraindications to hormone replacement therapy
6. Medical history of pelvic tumors or receiving pelvic radiotherapy
7. Involved in other clinical studies
8. Unable to adhere to the follow-up
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 42 Years | The Efficacy and Safety of Collagen Scaffold Loaded With Umbilical Cord Derived Mesenchymal Stem Cells in Infertile Women With Thin Endometrium or Endometrial Scarring | NCT03592849 | Contradiction |
6,412 | 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:
- Adults age 18 or older
- Tested positive for SARS-CoV-2 by RT-PCR assay using a respiratory tract sample
(either nasopharyngeal swab OR oropharyngeal swab OR nasal aspirate OR
tracheobronchial aspirate OR saliva) collected within 72 hours of randomization
- Stated willingness to give their written informed consent to participate in the study
- Stated willingness to comply with all study procedures and availability for the
duration of the study
- Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to
contraceptive measures during the study and for 7 days following the last dose of
study medication
- Females must be unable to bear children, OR ensure that their male partner is
incapable of fathering a child, OR, if of childbearing potential will strictly adhere
to contraceptive measures during the study and for seven days following the last dose
of study medication
- Females must agree to stop breast-feeding prior to first dose of study drug and
through seven days after completing therapy
- Females must have a negative pregnancy test at screening
- Ability to take oral medication and be willing to adhere to the favipiravir/placebo
regimen
- Subject has access to a smart phone, tablet, or PC
- Minimal baseline severity score for COVID-19-related symptoms: at least two symptoms
with a score of 2 or higher.
COVID-19-related symptoms (excluding changes in the sense of taste or smell) include:
- stuffy or runny nose
- sore throat
- shortness of breath
- cough
- lack of energy or tiredness
- muscle or body aches
- headache
- chills or shivering
- feeling hot or feverish
- nausea
- diarrhea
- vomiting
Exclusion Criteria:
- O2 saturation <94%
- Shortness of breath at rest
- Heart rate ≥ 125 per minute
- Requirement for hospitalization at the time of enrolment
- Participation in another trial or use of any experimental treatment for COVID-19
- Treatment with high steroid dose (excluding stable chronic treatment) or remdesivir
- Evidence of sepsis or organ dysfunction/ failure
- Known infection with a respiratory virus other than SARS-CoV2 (e.g. Influenza) or any
known bacterial infection (affecting the respiratory system or any other system)
- Inability to adhere to study requirements
- For premenopausal women: unwilling or unable to use effective birth control measures
- Known allergy to favipiravir
- Known end-stage kidney disease or requiring hemodialysis or continuous ambulatory
peritoneal dialysis (CAPD)
- Liver impairment greater than Child-Pugh A
- Psychiatric illness that is not well controlled (defined as stable on a regimen for
more than one year).
- Known elevated uric acid levels in the past year or taking uric acid lowering
medications (allopurinol, febuxostat)
- History of hereditary xanthinuria or history of xanthine urolithiasis.
- History of gout or actively being treated for gout.
- Current use of the following medications, which cannot be discontinued for the
duration of the study: pyrazinamide, hydralazine, more than 3000 mg of acetaminophen
per day.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| The Prevent Severe COVID-19 (PRESECO) Study | NCT04600895 | Entailment |
2,409 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Male
- Age 7 years to 100 years
- Ability to ambulate for 10 meters. Assistive devices are allowed.
- Diagnosis of DMD confirmed by at least one the following:
- On stable dose of prednisone, prednisolone or deflazacort for at least 12 months prior
to screening.
- Participants who are on stable dose of any combination of the following compounds
(creatine, glutamine, coenzyme Q10, vitamin E, C or D, JUVEN, arginine, calcium) must
have taken these medications for at least 2 months prior to screening. Subjects are
not required to take these medications to participate in the study.
- All other herbs, supplements or green tea (other than those noted above) have been
discontinued 3 months prior to screening.
- Ability to provide reproducible QMT bicep score with no more than 15% variation
between scores during screening.
- Normal blood clotting ability evidenced by a platelet function assessment (PFA).
Exclusion Criteria:
- Currently enrolled in another treatment clinical trial.
- History of significant concomitant illness or significant impairment of renal or
hepatic function.
- History of impairment of blood clotting ability (as evidenced by increased PT/PTT or
PFA over the upper limit of normal (ULN)).
- Recent cerebral or retinal hemorrhage.
- History of bleeding diathesis or gastric ulcer.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
| Study of Daily Pentoxifylline as a Rescue Treatment in Duchenne Muscular Dystrophy | NCT00243789 | Entailment |
4,611 | 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. Women aged 18-50 years, inclusive
2. General good health, by volunteer history and per investigator judgment
3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
4. History of Pap tests and follow-up consistent with standard medical practice or
willing to undergo a Pap test at Visit 1.
5. Protected from pregnancy by female tubal sterilization
6. Willing to abstain from or engage in intercourse with and without condoms and to
abstain from other vaginal activity as required in the protocol
7. In a mutually monogamous relationship for at least the last four months with a male
partner who:
1. Is at least 18 years old;
2. Has no known risk for STIs;
3. Is willing and able to comply with protocol requirements including sexual
activity/ abstinence and condom use requirements; and
4. Can engage in vaginal intercourse with the participant, with and without condoms,
as specified in protocol
8. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy colposcopy and genital tract sample collection
9. Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol
Exclusion Criteria:
1. History of hysterectomy
2. Vasectomy in male partner
3. Sterility or known history of sperm dysfunction in male partner
4. Within two calendar months from the last pregnancy outcome. Note: If recently pregnant
must have had at least two spontaneous menses since pregnancy outcome.
5. Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera
within the last 120 days
6. Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study
7. Significant gynecological abnormalities (including abnormal vaginal bleeding or
excessive vaginal discharge)
8. Either device does not appropriately fit volunteer, as determined by clinician
9. Inability of the volunteer to insert, position, and/or remove either device, even with
assistance
10. History of sensitivity/allergy to nonoxynol-9 or to silicone or any other component of
Ovaprene™ or Caya, for either the volunteer or her male partner
11. In the last four months, either the volunteer or her male partner diagnosed with or
treated for any STI or pelvic inflammatory disease. Note: Women or male partners with
a history of genital herpes or condylomata who have been asymptomatic for at least six
months may be considered for eligibility
12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
or HIV
13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
vesicles suspicious for a sexually transmitted infection
14. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
15. Known current drug or alcohol abuse which could impact study compliance. (This is
defined as any illicit drug use or more than 15 alcoholic drinks per week)
16. Participation in any other investigational trial within the last 30 days or planned
participation in any other investigational trial during the study
17. History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
18. Abnormal finding on laboratory or physical examination or a social or medical
condition in either the volunteer or her male partner which, in the opinion of the
investigator, would make participation in the study unsafe or would complicate
interpretation of data
19. Nugent score greater than or equal to 7
20. Systemic use in the last two weeks or anticipated use during the study of antibiotics
(other than those used to treat UTI, vaginal candidiasis, or BV diagnosed at Visit 1,
or to treat UTI or vaginal candidiasis after Visit 1) or topical antivirals (e.g.,
acyclovir or valacyclovir). Note: Participants should avoid non-steroidal
anti-inflammatory drugs (NSAIDs) and Tylenol except for occasional use, as in
treatment of headaches or dysmenorrhea.
21. Grade 2 or higher abnormality per the March 2017 update of the Division of AIDS
(DAIDS), National Institute of Allergy and Infectious Disease (NIAID) Table for
Grading of the Severity of Adverse Events or clinically significant lab abnormalities
as determined by the investigator (see Section 13.5 for link to DAIDS table)
22. Inability to achieve adequate cervical mucus in two attempts at the baseline cycle
23. Inadequate sperm in endocervical aspirate during baseline testing without any device,
despite adequate mucus and presence of sperm in vaginal pool
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Safety and Acceptability Study of a Non-Hormonal Ring | NCT03598088 | Entailment |
5,654 | 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:
- Ages 13-17
- Male and female
- Living with at least one parent or guardian who is willing to participate in treatment
- A BMI percentile >85% for gender and age (e.g., overweight or at risk for overweight)
Exclusion Criteria:
- Current psychotic illness
- Current alcohol/drug dependence
- Active suicidality
- Eating disorders (e.g., binge eating disorder)
- History of bariatric surgery
- Medication associated with significant weight changes (e.g., antipsychotics)
- Serious medical or physical conditions resulting in significant weight changes (e.g.,
pregnancy, genetic disorders).
- Complications of obesity that contraindicate moderate physical activity (e.g.
orthopedic disorders)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 17 Years | Parent-Based Treatment for Pediatric Overweight | NCT00807560 | Contradiction |
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