linjc16/ctgov huggingface dataset:
Physical Activity Behavior of Rheumatoid Arthritis Patients and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare physical activity behaviour of rheumatoid arthritis patients with healthy matched controls.

Official Title
-----------------
An Observational Study of Physical Activity Behavior of Swiss Rheumatoid Arthritis Patients and Healthy Matched Controls

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (RA patients): Rheumatoid arthritis Functional classes I, II and III Age 40 to 80 years Stable disease activity Stable DMARDS last 3 months Exclusion Criteria (RA patients): Functional classes IV Inflammatory flare

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| RA patients<br>Patients with Rheumatoid Arthritis | |
| Healthy subjects<br>Healthy subjects matched for age and sex | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | PAFQ | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional status | HAQ | Up to 4 weeks | 
| Pain | VAS | Up to 4 weeks | 
| Fatigue | VAS | Up to 4 weeks | 
| Disease activity | DAS 28 | Up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, physical activity
Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance

Study Overview
=================
Brief Summary
-----------------
Cystatin C, a protease inhibitor produced by most nucleated cells, is freely filtered by the kidneys, and its plasma assay reflects the GFR. Compare, in HIV patients, the predictive performance of 11 formula to estimate GFR based on assay plasma cystatin C with that of the MDRD formulas.

Official Title
-----------------
Measurement of Glomerular Filtration Rate (GFR) in HIV Patients: Single-center Study Comparing the Accuracy of Estimators of GFR Versus Iohexol Plasma Clearance

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: iohexol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients infected with HIV, and included in the cohort NADIS Exclusion Criteria: Patient with a known allergy Patients treated with metformin Patients with severe hepatic impairment defined as a TP spontaneously below 50% Patients with a history of dysthyroidism Patient with active neoplasia other than skin cancer Degradation recent (not older than 3 months) in renal function defined as the deterioration of GFR over 25%. Estimated GFR less than 15 mL/min/1, 73m2 Pregnant or lactating Subjects under the protection of justice

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

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: iohexol plasma clearance<br>patients had received iohexol for measuring GFR | Drug: iohexol<br>* 10 ml de l'iohexol (300 mgI/ml)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient with a predictive performance range -30% to +30% | for each estimator :predictive performance calculated by [(DFG estimé* - DFG mesuré par iohexol**)/DFG mesuré par iohexol]X100 | day 0 |
Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. The study will investigate whether changing light distribution pattern from on-axis' (i.e., directed along the eye's visual axis to the fovea) to off-axis (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.

Detailed Description
-----------------
Eligible enrolled subjects will be exposed to 4 different lighting conditions in addition to one dark control condition. There will be 5 study session and each one will last for 90 minutes and will be separated by one week. Subjects will collect 3 saliva samples, each one 30 minutes apart for melatonin levels during each study session.

Official Title
-----------------
Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment and Alzheimer's Disease

Conditions
-----------------
Mild Cognitive Impairment, Alzheimer Disease

Intervention / Treatment
-----------------
* Device: Lighting Intervention Blue light
* Device: Lighting Intervention Green light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild cognitive impairment age matched healthy control macular pigment density either < 0.3 or > 0.5 Exclusion Criteria: extensive brain vascular disease Parkinson's disease bipolar disorder seasonal depression diabetes high blood pressure obstructing cataracts macular degeneration diabetic retinopathy use of melatonin supplements use of beta blockers use of sleep medications use of antidepressant medication

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lighting Intervention Blue<br>Blue light (λmax = 451 nm) on and off axis | Device: Lighting Intervention Blue light<br>* Custom made lighting fixture that will deliver the blue lighting intervention<br>|
| Experimental: Lighting Intervention Green<br>Green light (λmax = 522 nm) on and off axis | Device: Lighting Intervention Green light<br>* Custom made lighting fixture that will deliver the green lighting intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in melatonin levels | Saliva samples will be collected for melatonin analysis | one sample will be collected every 30 minutes during each 90 minute study session up to 5 weeks |
D-Serine Monotherapy for Schizophrenia

Study Overview
=================
Brief Summary
-----------------
N-methyl-D-aspartate receptor (NMDAR) agonist, added to classical or atypical antipsychotic medication, has reduced negative, depressive, and cognitive symptomatology. We will be investigating the effect of D-serine, (DSR), a selective and potent NMDAR agonist, as monotherapy for treatment resistant schizophrenics. 40 subjects on stable doses of risperidone will be randomized under double-blind conditions into a treatment group, which will receive D-serine 2100 mg, or a control group, which will continue to receive risperidone. Treatment will continue for 14 weeks. Symptoms and side effects will be rated biweekly with the CGI, PANSS, BPRS, SAS, AIMS, and UKU. Before and after the trial subjects will undergo neuropsychological assessments. Baseline and post-trial levels of amino acids relevant to glutamatergic neurotransmission (glutamate, glutamine, aspartate, glycine, serine, alanine) will be assessed. The primary outcome measures of the study will be the PANSS total scores and the positive and negative symptom cluster scores.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: D-serine 2100 mg daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria for chronic schizophrenia Treatment resistant aged 18-70 Two months on stable risperidone dose PANSS positive symptom cluster score >20 PANSS negative symptom cluster score >22 Exclusion Criteria: Substance abuse Concurrent DSM IV axis I disorder Serious medical disorder Concurrent drug therapy that can obscure the effect of risperidone or DSR.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: D-serine 2100 mg daily|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, NMDA, D-serine
Cardiovascular Disease Risk in Women With Endometriosis

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that estrogen suppression impairs endothelial dysfunction in endometriosis.

Detailed Description
-----------------
Our scientific premise is that in women with endometriosis, elevated cardiovascular disease risk is the result of endothelial dysfunction and chronic systemic inflammation through lectin-like oxidized low-density lipoprotein receptor-1 (LOX-1) receptor activation. This cardiovascular disease risk is exacerbated by standard estrogen suppression treatments.

Official Title
-----------------
Mechanisms and Interventions Addressing Accelerated Cardiovascular Disease Risk in Women With Endometriosis

Conditions
-----------------
Endometriosis

Intervention / Treatment
-----------------
* Drug: Elagolix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young women between the ages of 18 and 45 years (Controls); Young women between the ages of 18 and 45 years with endometriosis. Exclusion Criteria: Subjects who smoke Subjects who have diabetes, Subjects with sleep apnea or BP>140/90 will be excluded. Women with endometriosis and severe acute pain requiring immediate treatment will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 cohort clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients without endometriosis<br>Control subjects will be healthy women, with regular menses every 26-34 days. Subjects will be excluded if they have any symptoms of endometriosis, including severe dysmenorrhea or progressive cyclic pelvic pain or prior surgery showing evidence of endometriosis | Drug: Elagolix<br>* Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.<br>|
| Experimental: patients with endometriosis<br>Endometriosis will be diagnosed by history of the disease seen at the time of prior surgery or will be diagnosed by classic clinical symptoms of the disease (cyclic progressive pelvic pain) using prior surgical report reviewed by Dr. Taylor. | Drug: Elagolix<br>* Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow Mediated Vasodilation Microvascular skin blood flow analysis | Blood flow velocity will be measured using the Sonoscope S2 ultrasound imaging system. | 2 minutes | 
| Microdialysis perfusions | Following recovery from the microdialysis probe insertions we will measure resting skin blood flow (SkBF). | 15 minutes |
Study Evaluating the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal Asian women.

Official Title
-----------------
A Multicenter, Double Blind, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Bazedoxifene in Postmenopausal Asian Women

Conditions
-----------------
Postmenopause, Osteoporosis

Intervention / Treatment
-----------------
* Drug: bazedoxifene BZA-20


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy Asian women 45 years of age or older who are at least 1 year postmenopausal Subjects must qualify for one of the following categories (a or b): Greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors Equal or greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor Exclusion Criteria: One (1) or more osteoporotic vertebral fractures (T4 - L4) BMD T-score at the lumbar spine or femoral neck less than -2.5 Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bazedoxifene BZA-20|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent change from baseline in lumbar spine bone mineral density (BMD) after 6 months of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional BMD evaluation including total hip, femoral neck and trochanter at 6 months |  |  | 
| Serum bone markers at 3 and 6 months |  |  | 
| Lipid profile at 3 and 6 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postmenopausal, women, SERM, osteoporosis
Evaluation of an Acceleration-Based Prosthetic Knee Locking Mechanism for Reducing the Risk of Falling in Transfemoral Amputees

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a new automatic prosthetic knee locking mechanism will improve gait characteristics during an induced controlled trip and reduce fear of falling.

Conditions
-----------------
Transfemoral Amputees

Intervention / Treatment
-----------------
* Device: Locking mechanism for prosthetic knee


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: transfemoral amputees Independent ambulation with a prosthesis Full cognitive and cooperative ability to follow simple instructions No orthopaedic or neurologic impairments present, that are unrelated to the amputation at the time of the trial Exclusion Criteria: Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions Orthopaedic or neurologic impairment, un-related to the amputation Pregnant woman Weight exceeding 100 kg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transfemoral amputees<br>Locking mechanism for prosthetic knee (no trade mark provided) | Device: Locking mechanism for prosthetic knee<br> <br> |
| No Intervention: Healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D angles of the ankle, knee, hip and pelvis |  | One day |
Study of 24 Hour Blood Pressure and the Association to Complications to Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (BP) in patients with type 1 diabetes. The investigators wish to gain knowledge on the relation between central and peripheral 24 hour BP and a possible association to late complications in diabetes.

Official Title
-----------------
Central and Peripheral 24h BP and the Association to Autonomic Neuropathy and Diabetic Nephropathy in Type 1 Diabetic Patients

Conditions
-----------------
Type 1 Diabetes, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes more than 18 years of age Exclusion Criteria: End Stage Renal Disease (ESRD) dialysis other kidney disease than diabetic nephropathy

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| type 1 diabetes<br> | |
| non-diabetics<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory blood pressure (AMBP) | The participants are seen once (cross-sectional) and we measure AMBP in order for us to investigate any association between AMBP and other parameters such as age, duration of diabetes, albuminuria status and other diabetic complications. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetic late complications | The participants are only seen once and are at this visit, asked in regards to complications, and the electronic patient medical record is rewieved in regards to complications. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nocturnal blood pressure dip, complications, ambulatory blood pressure
Customized Acoustic Stimulation for the Treatment of Tinnitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of a customized sound therapy in reducing tinnitus loudness and increasing the residual inhibition.

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Other: Customized sound
* Other: Regular Masker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Male or female Tinnitus present for 6 months or more Adequate command of English Exclusion Criteria: Active illicit drug use, alcohol dependence Treatable cause of tinnitus History of psychosis Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Other: Customized sound<br>* treatment with customized sound therapy<br>|
| Active Comparator: Control<br> | Other: Regular Masker<br>* treatment with white noise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score of tinnitus loudness |  | 0, 1 minute; 1 hour; 1, 2, 4 and 6 months | 
| Change in score of tinnitus annoyance |  | 0, 1 minute; 1 hour; 1, 2, 4 and 6 months | 
| Change in residual inhibition |  | 1 minute; 1 hour; 1, 2, 4 and 6 months | 
| Change in score of Tinnitus Handicap Inventory (THI) |  | 0, 1, 2, 4 and 6 months |
A Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to determine if blunt needle use during cesarean section closure protects against glove perforation and percutaneous injury to the surgeon and surgical assistant. A secondary objective was to determine physician satisfaction with blunt needles during the surgery.

Official Title
-----------------
A Randomized Trial of Blunt Needles for the Reduction of Needlestick Injuries During Cesarean Section

Conditions
-----------------
Glove Perforations, Needlestick Injuries

Intervention / Treatment
-----------------
* Device: Sharp needle
* Device: Blunt needles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Pregnant Undergoing a cesarean section Exclusion Criteria: Under age 18 Non-English speaking

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sharp Needles<br>Sharp needles to close uterus, fascia and skin during cesarean section | Device: Sharp needle<br> <br> |
| Active Comparator: Blunt Needles<br>Assignment to blunt needles to close uterus, fascia and skin during cesarean section | Device: Blunt needles<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of observed glove perforations | review post-op | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician satisfaction with the needle assignment | Rating scale 1-5 (1 being least satisfied and 5 being very satisfied); review post-op | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Needlestick injuries, Glove perforations, Blunt Needles, Glove perforations of surgeons, assistants, Needlestick injuries of same