linjc16/ctgov huggingface dataset:
Kinetic Biomarker for Chronic Lymphocytic Leukemia Prognosis

Study Overview
=================
Brief Summary
-----------------
This project will attempt to validate the utilization of a stable isotope kinetic biomarker (KineMarkerTM) as a predictive test for disease progression in early stage chronic lymphocytic leukemia (CLL).

Detailed Description
-----------------
Chronic Lymphocytic Leukemia (CLL), the most common leukemia in the western world, is characterized by a pathological expansion of leukemic B cells. The clinical course of CLL is remarkably heterogeneous; some patients have relatively aggressive disease requiring early treatment, others have highly indolent disease that does not require current anti-leukemia therapy until many years after diagnosis. Current staging systems have not been able to predict which patients in early or intermediate risk stages will undergo disease progression and which will undergo an indolent course. Universal treatment of all patients with early stage disease has been shown to be more harmful than beneficial. As such, early identification of patients who will have more aggressive disease soon after diagnosis has been a major goal in CLL research. In response to this need for a reliable prognostic marker, KineMed is investigating the use of CLL kinetics as a biomarker for subsequent disease progression. This test assesses B-Cell kinetics directly through an in vivo kinetic measurement of tumor DNA synthesis and catabolism by combining 2H2O labeling and state of the art analytic instrumentation.

Official Title
-----------------
A CLL Research Consortium (CRC) Phase II Study of Kinetic Biomarker for Chronic Lymphocytic Leukemia (CLL) Prognosis

Conditions
-----------------
Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age clinical diagnosis of chronic lymphocytic leukemia diagnosis within previous 3 years Stage 0, I, or II disease willingness and capacity to give informed consent Exclusion Criteria: current or prior cll treatment serious co-morbid medical condition patient likely to need treatment in the next 16 weeks pregnancy

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CD5, chronic lymphocytic leukemia, biomarker, prognosis, apoptosis, neoplasm/cancer diagnosis, stable isotope, diagnosis evaluation, outcomes, CD19
Mood Effects of Serotonin Agonists Extended

Study Overview
=================
Brief Summary
-----------------
In this study we are examining the effects of repeated very low doses of serotonin agonists on mood individuals with negative mood.

Detailed Description
-----------------
Here, we are examining the effects of four repeated low doses of lysergic acid diethylamide (LSD), compared to placebo, administered to healthy adults at 3-4 day intervals, on mood, cognitive performance and responses to emotional tasks

Official Title
-----------------
Mood Effects of Serotonin Agonists Extended

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Serotonin agonist - 13ug
* Drug: Serotonin agonist - 26ug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English fluency High school level education BMI between 19 and 30 Exclusion Criteria: Diagnosed medical condition women who are nursing, pregnant, or plan to become pregnant within 3 months History of psychotic disorder or family history of psychotic disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Drug will be administered in solution form<br>|
| Experimental: Serotonin agonist 13ug<br>13ug of serotonin agonist | Drug: Serotonin agonist - 13ug<br>* 13ug lysergic acid diethylamide<br>* Other names: LSD;|
| Experimental: Serotonin agonist 26ug<br>26ug of serotonin agonist | Drug: Serotonin agonist - 26ug<br>* 26ug lysergic acid diethylamide<br>* Other names: LSD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASS-21 | The primary outcome measure is the depression anxiety and stress scale (DASS) 21. This self-report measure contains 21 items and the range of scores for depression is 0-42, anxiety 0-42, and stress 0-42. Our primary outcome measure is total depression scale ratings during session 5, with lower scores indicating lower ratings of depression. | End of session 5, approximately 2 weeks from baseline |
Coronary Artery Disease and Renal Failure Registry

Study Overview
=================
Brief Summary
-----------------
It is the aim of the multi-centric and prospective registry to analyze in patients with CAD the impact of different grades of renal failure on the outcome and course of the patients and to correlate these with clinical variables. In particular, the registry has the following objectives: prospective consecutive assessment of all patients with coronary artery disease and renal failure in the participating hospitals of the registry evaluation of the outcome and course of patients with regard to their different stages of renal failure at baseline analysis of the impact of different therapeutic strategies on acute and long-term outcomes identification of clinical risk factors, novel biomarkers and genetic markers for an unfavorable long-term outcome

Official Title
-----------------
Coronary Artery Disease and Renal Failure Registry

Conditions
-----------------
Coronary Artery Disease, Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and men >= 18 years of age Patients with actually performed interventional coronary angiography and there a documented coronary heart disease, defined as at least one documented stenosis >= 50 % in at least one main coronary vessel (Main steam; RCX; RIVA; RCA) European/Caucasian descent (European/Caucasian parents and grandparents) Availability of an urine, serum- and EDTA blood sample of the patient Documented consent of patients for handling of personal medical data, including a genetic analysis Exclusion Criteria: Patients who have been already recruited into this registry Patients with organ transplantations, apart from kidney transplantations Immunosuppressive therapy, apart from immunosuppressive therapy after kidney transplantation Patients with polycystic renal disease Pregnant and breastfeeding patients Known malignant tumor

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 |
| --- | --- |
| Group 0 (Controllgroup)<br>eGFR >= 90 ml/min/1.73m^2 and no proteinuria | |
| Group 1<br>eGFR >= 90 ml/min/1.73m^2 and proteinuria | |
| Group 2<br>eGFR 60 - 89 ml/min/1.73m^2 | |
| Group 3<br>eGFR 30 - 59 ml/min/1.73m^2 | |
| Group 4<br>eGFR 15 - 29 ml/min/1.73m^2 | |
| Group 5<br>eGFR < 15 ml/min/1.73m^2 or requiring dialysis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| manner of death | cardiac death; non-cardiac death; death of unknown cause | two years |
Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

Study Overview
=================
Brief Summary
-----------------
This study aims to identify the expression signature of miR-181a, miR-196a and miR-21 in plasma of SLE patients and difference in their expression among groups with different systemic lupus erythematosis disease activity index (SLEDAI) scores.

Official Title
-----------------
Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

Conditions
-----------------
Systemic Lupus Erythematosis

Intervention / Treatment
-----------------
* Drug: Cyclophosphamide
* Drug: Hydroxychloroquine
* Drug: Hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult systemic lupus erythematosis patients Exclusion Criteria: Patients younger than 18 years, patients with other autoimmune diseases or malignancy.

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?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Healthy volunteers | |
| Active Comparator: Patients<br>SLE patients further divided into mild and severe patients | Drug: Cyclophosphamide<br> <br> Drug: Hydroxychloroquine<br> <br> Drug: Hydrocortisone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MicroRNAs expression level |  | 3 months |
Cardiac Auscultation Using Smartphones

Study Overview
=================
Brief Summary
-----------------
The investigators performed a proof-of-concept study enrolling subjects with normal and pathologic heart sounds. Heart sound was recorded by auscultation on the skin of the chest wall using three smartphones: Samsung Galaxy S5 and Galaxy S6, and LG G3 . Recorded heart sounds were processed and classified by a diagnostic algorithm using convolutional neural networks.

Detailed Description
-----------------
Heart sound recording was done by researchers who were familiar with the use of the app and understand the principles of cardiac auscultation. Reference heart sounds were recorded using an electronic stethoscope (3M™ Littmann® Electronic Stethoscope Model 3200). Study devices included Samsung Galaxy S5 (model SM-G900), Galaxy S6 (SM-G920), and LG G3 (LG-F400).

Official Title
-----------------
Cardiac Auscultation Using Smartphones: a Proof-of-concept Study

Conditions
-----------------
Cardiovascular Physiological Phenomena

Intervention / Treatment
-----------------
* Diagnostic Test: Heart sound recording using smartphone application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects who gave informed consent subjects who are 18 years old or older and had performed ECG and echocardiography during the previous 6 months. Exclusion Criteria: subjects with impairment of cognition

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Heart sound recording using smartphone application|Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of CPstethoscope in interpretation of heart sounds | specificity, sensitivity, negative predictive value, positive predictive value | 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart sounds, smartphone, application
Vascular Occlusion and Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass resistance training alone. The investigators speculate this training strategy could be beneficial in patients with rheumatoid arthritis.

Official Title
-----------------
Effects of Strength Training With Vascular Occlusion in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

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

Intervention / Treatment
-----------------
* Other: vascular occlusion with exercise trainig
* Other: high intensity resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female with rheumatoid arthritis Disease activity scores > 2.6 use of anti-TNF-alpha drugs for at least 8 weeks Exclusion Criteria: BMD < 20 kg/m2 fibromyalgia cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low intensity with vascular occlusion<br> | Other: vascular occlusion with exercise trainig<br>* twelve weeks of resistance training with vascular occlusion twice a week<br>|
| Experimental: high intensity resistance training<br> | Other: high intensity resistance training<br>* twelve weeks of resistance training twice a week<br>|
| No Intervention: no exercise training<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength |  | twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | twelve weeks |
Effect of Natural Antioxidant Supplement on Sperm DNA Fragmentation

Study Overview
=================
Brief Summary
-----------------
Observational study to see the effect of use of natural Antioxidant supplement on sperm DNA fragmentation. Subjects will take the natural antioxidant for 3 months prior to repeat testing.

Detailed Description
-----------------
Male patients will be recruited based on having a high DNA fragmentation (chromatin >16) no other severe male factor infertility (>5million/ml, count, > 10%motility and >1% morphology) and sufficient ejaculate sperm for ICSI (no surgically removed sperm or history of vasectomy reversal). Patients will be provided the natural antioxidant supplementation by the sponsor. Patients will take 1 capsule orally 3 times a day for a full 12 weeks. Sperm DNA structure will be re-assessed after completion of 12 weeks of antioxidant to compare to baseline sperm DNA structure collected prior to starting regimen of supplement daily

Official Title
-----------------
Observation Study of the Effect of Use of Natural Antioxidant Supplement on Sperm DNA Fragmentation

Conditions
-----------------
Observe Effect of Antioxidant on Sperm DNA Fragmention

Intervention / Treatment
-----------------
* Dietary Supplement: Natural Antioxidant supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Sperm Chromatin >16%, sufficient ejaculate sperm for ICSI Exclusion Criteria: Severe male factor infertility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment group<br>Male patients exposed to antioxidant for 12 weeks | Dietary Supplement: Natural Antioxidant supplement<br>* 1 capsule orally three times a day for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm DNA fragmentation | Direct comparison of sperm DNA fragmentation pre and post natural antioxidant exposure | 12 weeks |
Extension Study of Pimecrolimus Cream in Pediatric Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of Pimecrolimus cream will be evaluated in Japanese pediatric patients with atopic dermatitis. This study is a 6-month extension study following core study. THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Official Title
-----------------
A Clinical Study Continued From the Confirmatory Study to Validate the Efficacy and Safety of Pimecrolimus Cream in Pediatric Atopic Dermatitis Patients

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Pimecrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator Patients whose guardians have given written informed consent to participation in this study Exclusion Criteria: - Patients who failed in treatment compliance in the core study Patients who had a major violation of the protocol in the core study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pimecrolimus<br>* Pimecrolimus cream 1 %<br>* Other names: Elidel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by adverse events (AEs) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of flares during 26 weeks of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic dermatitis, ASM981, pimecrolimus
Alternate Day Buprenorphine Administration, Phase XII - 17

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if six times daily buprenorphine dose is effective in achieving 120 hour buprenorphine dosing.

Official Title
-----------------
Alternate Day Buprenorphine Administration, Phase XII

Conditions
-----------------
Opioid-Related Disorders

Intervention / Treatment
-----------------
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

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
Intervention Model: Crossover Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buprenorphine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  |  | 
| Opioid withdrawal |  |  | 
| Opioid agonist effects |  |  | 
| Dose choice |  |  |
Effect of Controlled Adverse Environment (CAE) on Tear Film Stability

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of the controlled adverse environment (CAE) on Mean Break-Up Area in subjects diagnosed with Dry Eye Syndrome.

Detailed Description
-----------------
Single-Center, Pilot, controlled adverse environment (CAE) Study. This is a single-center, one visit, pilot, CAE study. Dry Eye Subjects (N=30) who qualify will undergo tear film video recording, fluorescein staining, and break up time before CAE exposure and after CAE exposure. All subjects will undergo baseline dry eye assessments including fluorescein staining, breakup time, conjunctival redness and tear film video recording. Subjects who qualify will then undergo CAE exposure for 90 minutes. At the end of CAE exposure subjects will undergo dry eye assessments again.

Official Title
-----------------
A Single-Center Study Evaluating the Effect of the Controlled Adverse Environment (CAE) on Tear Film Stability Using the OPI 2.0 System, Ocular Protection Index (OPI), Tear Film Break-Up Time (TFBUT) and Mean Break up Area by Region (MBA) in Patients Diagnosed With Dry Eye Evaluated During Their Natural Blink Pattern

Conditions
-----------------
Keratoconjunctivitis Sicca

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age & either sex, any race Willing and able to follow all instructions Positive history of dry eye disease Use or desire to use drops for dry eye within the past 6 months Exclusion Criteria: Have planned surgery during trial period Female currently pregnant, planning a pregnancy or lactating Use of disallowed medications Have ocular infections, or ocular conditions that could affect study parameters Have used an investigational drug or device within 30 days of start of study Female that is currently pregnant, planning a pregnancy or lactating

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

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 |
| --- | --- | --- |
| change in tear film break up area |  | change from baseline in tear film break up area at 30 minutes post-CAE at study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Fluorescein Staining |  | change from baseline in staining at 30 minutes post-CAE | 
| Change in Tear film break up time (TFBUT) |  | change from baseline in tear film break up time at 30 minutes post-CAE | 
| Change in Conjunctival Redness |  | change from baseline in conjunctival redness at 30 minutes post-CAE |