linjc16/ctgov huggingface dataset:
Effect of Ankle-foot Orthoses on Balance Confidence

Study Overview
=================
Brief Summary
-----------------
The patients at our Prosthetics and Orthotics Outpatient Clinic who have had an ankle-foot orthosis for at least one year will fill in the Activities-Specific Balance Confidence Scale (ABC Scale) for wearing the orthosis and for not wearing the orthosis. They will also answer a mini survey about falls in order to determine whether they have fallen within the last 6 months.

Detailed Description
-----------------
The effect of the orthosis will be estimated as the difference between the two ABC Scale scores. The ABC Scale score and individual items will be compared between the fallers and the non-fallers.

Official Title
-----------------
Effect of Ankle-foot Orthoses on Patients' Confidence in Balance-related Activities

Conditions
-----------------
Peripheral Nerve Disease, Peripheral Nerve Injury Lower Limb, Poliomyelitis, Cerebral Palsy, Multiple Sclerosis

Intervention / Treatment
-----------------
* Device: Ankle-foot orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients at our Prosthetics and Orthotics Outpatient Clinic having an ankle-foot orthosis for at least 1 year Exclusion Criteria: insufficient cognitive ability to fill in the ABC Scale

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fallers<br>The patients who had fallen during the 6 months prior to the study onset | Device: Ankle-foot orthosis<br>* Ankle-foot orthosis of any type (unilateral or bilateral, standard or carbon fiber, for support or correction)<br>|
| Non-fallers<br>The patients who had not fallen during the 6 months prior to the study onset | Device: Ankle-foot orthosis<br>* Ankle-foot orthosis of any type (unilateral or bilateral, standard or carbon fiber, for support or correction)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABC Scale | Activities-Specific Balance Confidence Scale (ABC Scale) will be filled in for the confidence without the orthosis and confidence with the orthosis. The ABC Scale is a 16-item self-report measure in which patients rate their balance confidence for performing activities. Each item is rated on a scale from 0 (no confidence) to 100 (complete confidence). Overall score is the average rating across the items. | At day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankle-foot orthoses, lower limbs, rehabilitation outpatients, balance confidence, falls
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model

Study Overview
=================
Brief Summary
-----------------
This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.

Detailed Description
-----------------
Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4). This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Official Title
-----------------
A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: SAGE-217 high dose
* Drug: Placebo
* Drug: SAGE-217 low dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits Subject is a healthy, ambulatory volunteer Subject meets sleep Qualification criteria Exclusion Criteria: Subject has a medical history of suicidal behavior, epilepsy, eating disorders, sleep disorders, or circadian rhythm disorders Subject has worked a night shift or flown >1 time zone within 30 days prior to Screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAGE-217 high dose<br>SAGE-217 | Drug: SAGE-217 high dose<br>* high dose<br>|
| Experimental: SAGE-217 low dose<br>SAGE-217 | Drug: SAGE-217 low dose<br>* low dose<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency, as determined by polysomnography (PSG) |  | 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability, as assessed by adverse events |  | 36 days | 
| Safety and tolerability, as assessed by vital signs |  | 29 days | 
| Safety and tolerability, as assessed by clinical laboratory data |  | 29 days | 
| Safety and tolerability, as assessed by ECG |  | 29 days | 
| Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS) |  | 29 days |
Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease

Study Overview
=================
Brief Summary
-----------------
This research study will help us learn more about how chronic graft-versus-host disease affects the skin, hair and nails. We are interested in knowing if hair and nail problems predict worse disease. This information may help us treat patients like you in the future.

Detailed Description
-----------------
At the initial visit, participants will have a complete examination of their skin, hair and nails. We will also test muscle strength and movement by moving the participant's arms, legs and neck. Photographs will be taken of the skin, hair and nails of they are abnormal. Blood tests will be done to check the liver and blood cell count. The participant and their legal guardian will answer questions about how the participant feels and about their health. Participants will then be scheduled for follow up visits at 3 months, 6 months, and 12 months. At each subsequent visit the following will be done: A complete examination of the skin, hair and nails; a test of muscle strength; photographs will be repeated; blood tests to check liver and blood cell counts; and questions about how the participant feels and about their health.

Official Title
-----------------
The Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease

Conditions
-----------------
Graft vs Host Disease, Chronic Graft vs Host Disease, cGVHD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received hematopoietic stem cell transplant Meet the diagnostic criteria for cutaneous cGVHD Exclusion Criteria: Previous HSCT (other then the current HSCT)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adnexal involvement | To determine if adnexal involvement predicts worse severity and/or prognosis in chronic GVHD. This will be measured by administration of systemic therapy other than steroids. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adnexal, hair and nail, chronic graft vs host disease, children
Hearing Loss and Osteoporosis

Study Overview
=================
Brief Summary
-----------------
To compare the audiological profiles in postmenopausal women with and without osteoporosis and to examine the pattern of hearing loss in osteoporotic patients. postmenopausal women will be separated as normal, osteopenic and osteoporotic according to bone mineral densitometry results. The evaluation of hearing test will be done in these groups and the results will be compared between the groups.

Official Title
-----------------
Audiological Profiling in Postmenopausal Women With Osteoporosis

Conditions
-----------------
Hearing Loss, Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Other: Audiological profiling and bone mineral densitometry measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 45-60 years postmenopausal women Exclusion Criteria: Women over 60 years old, acute or chronic otitis media, ear surgery, use of ototoxic drugs, congenital hearing loss, previous long-term steroid use, malignant or benign neoplasm of the brain, Patients with a history of exposure to noise were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| study group<br>women with hearing loss and osteoporosis will develop the study group. | Other: Audiological profiling and bone mineral densitometry measurement<br>* bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.<br>|
| control group<br>women who have hearing loss but have no osteoporosis will constitute the control group. | Other: Audiological profiling and bone mineral densitometry measurement<br>* bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hearing test results | hearing test results will be examined; Hearing loss result: test passed or test will be recorded as not passed. | 1 week | 
| bone mineral densitometry measurements | bone mineral densitometry measurements of patients with hearing test. those with bone loss will be evaluated as osteoporosis. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone mineral density, Postmenopause
Renal Sympathetic Denervation in Mild Refractory Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the benefit of renal sympathetic denervation in patients with mild refractory hypertension

Official Title
-----------------
Renal Sympathetic Denervation in Patients With Mild Refractory Hypertension

Conditions
-----------------
Refractory Hypertension

Intervention / Treatment
-----------------
* Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
* Other: Sham procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory hypertension: 3 or more antihypertensive agents of different classes (including a diuretic) at optimal dosage without change in the 4 weeks preceding randomization Systolic blood pressure of 135-149 and/or diastolic blood pressure of 90-94 mmHg (ABPM mean daytime values) No change in blood pressure medication within 6 months after randomization Age 18 to 75 years Informed consent Exclusion Criteria: Blood pressure outside range mentioned above Renal, aortic or pelvic anatomy unsuited for renal sympathetic denervation Estimated glomerular filtration rate <45 mL/min/1.73 m² (modification of diet in renal disease formula) Unstable angina pectoris Myocardial infarction within 6 months prior to randomization Planned surgery or cardiovascular intervention within 6 months after randomization Severe heart valve disease Severe comorbidities with limited life expectancy Pregnancy Participation in another trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal sympathetic denervation<br>Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA) | Device: Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)<br> <br> |
| Sham Comparator: Sham procedure<br>Sham procedure mimicking the renal sympathetic denervation procedure in the experimental arm | Other: Sham procedure<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systolic blood pressure (ABPM mean value) |  | 6 months |
The Prognostic Significance of a Fragmented QRS Complex After Primary Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
To investigate the prognostic significance of a fragmented QRS (fQRS) complex in a patient who had undergone primary percutaneous coronary intervention (PCI).

Conditions
-----------------
Fragmented QRS, Primary PCI, MACE

Intervention / Treatment
-----------------
* Other: primary pcı


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chest pain that continued longer than 30 minutes and with ≥ 2 mm ST elevation in ECG at least in two adjacent derivations were diagnosed with an acute STEMI. In all patients, at least two-fold increases were seen in serum CK-MB levels compared to normal values.Having acute STEMI for the first time was stipulated for inclusion in the study. Exclusion Criteria: Subjects with known allergies to aspirin and clopidogrel, inadequate echocardiographic images, malignancy, a previous cerebrovascular event, renal dysfunction (creatine level > 2.5 mg/dl), a previous MI, or a history of cardiogenic shock as well as those who refused to participate in the study were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fragmented QRS positive<br>fQRS at 48 hours after Primary PCI | Other: primary pcı<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events | the presence of a fQRS at 48 hours after primary PCI is a significant parameter in predicting adverse cardiovascular events; |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Q Wave and QRS distortion for predicting major adverse cardiac events | the presence of a fQRS is a more sensitive and specific parameter in predicting development of adverse cardiovascular events than Q wave and QRS distortion; and compared to Q wave, fQRS correlated more significantly with the presence of a scar |  |
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to diabetes mellitus

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent Male or female of all ages Diagnosis of diabetes mellitus based on blood glucose and/or hemoglobin A1C Exclusion Criteria: Refusal to sign informed consent form History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetes Mellitus<br>Patients with diabetes mellitus | Other: No intervention<br>* There is no intervention for this study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized with diabetes mellitus | Three years |
Mass Balance Study of JTZ-951 in Subjects With End-stage Renal Disease on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
A mass balance study to determine the routes and rates of elimination of radioactivity, to determine total radioactivity in plasma and whole blood over time and compare levels to JTZ-951 and drug-derived entities in plasma and to determine pharmacokinetic (PK) parameters of JTZ-951 and its metabolite(s).

Official Title
-----------------
A Phase 1, Open-label, Single Dose, Mass Balance Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of 14C-JTZ-951 in Male Subjects With End-stage Renal Disease Receiving Hemodialysis

Conditions
-----------------
Anemia of Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: JTZ-951, 14C-JTZ-951


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with end stage renal disease on hemodialysis Post-dialysis body weight >45.0 kg BMI between 18.0 and 40.0 kg/m2 (inclusive) Exclusion Criteria: Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.0 × upper limit of normal (ULN), or total bilirubin >1.5 × ULN at the Screening Visit Subjects who have hepatobiliary disease or condition (such as biliary cirrhosis) Subjects with positive test results for HBsAg (hepatitis B surface antigen), HCV antibody or HIV antibody Subjects with known history of liver failure or liver surgery Subjects with a history or current clinically significant chronic or acute blood loss

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JTZ-951, 14C-JTZ-951<br>Single oral administration on Day 1; 10 mg JTZ-951, 100 μCi of 14C-JTZ-951 | Drug: JTZ-951, 14C-JTZ-951<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioactivity concentration in urine, feces and dialysate |  | maximum 20 days | 
| Radioactivity concentration in whole blood and plasma |  | maximum 20 days | 
| Plasma concentrations of JTZ-951 and its metabolite |  | maximum 20 days | 
| Cmax (maximum concentration) |  | maximum 20 days | 
| tmax (time to reach maximum concentration) |  | maximum 20 days | 
| AUC (area under the concentration-time curve) |  | maximum 20 days | 
| t1/2 (elimination half-life) |  | maximum 20 days | 
| Number of adverse events |  | maximum 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
JTZ-951, Pharmacokinetics, 14C-JTZ-951, Mass balance, Time course