linjc16/ctgov huggingface dataset:
Signs and Symptoms of Genetic Abnormalities Linked to Inherited Heart Disease

Study Overview
=================
Brief Summary
-----------------
Genetically inherited heart diseases (familial cardiomyopathies) are conditions affecting the heart passed on to family members through abnormalities in genetic information. These conditions are responsible for many heart related deaths and illnesses. In this study researchers hope to determine the signs and symptoms (clinical correlation) associated with specific genetic abnormalities causing inherited heart diseases. In order to do this, researchers plan to evaluate patients and family members of patients diagnosed with inherited heart disease. Patients participating in the study will undergo several tests including blood tests, electrocardiograms (EKG), and echocardiograms. Patients may also be asked to undergo an MRI of the heart to provide a clearer picture of it. Patients participating in this study may not be directly benefited by it. However, information gathered from the study may contribute to the medical care, treatment, and prevention of problems for others in the future.

Detailed Description
-----------------
Familial cardiomyopathy (FC) often demonstrates both non-allelic and allelic genetic heterogeneity. We propose to determine the clinical correlates of specific genetic defects which cause FC by identifying and expanding a set of kindreds with identical and distinct molecular defects.

Official Title
-----------------
Clinical Manifestations of Mutations in Genes Linked to Familial Cardiomyopathy

Conditions
-----------------
Cardiomyopathy, Hypertrophic, Familial

Participation Criteria
=================
Eligibility Criteria
-----------------
Individuals with cardiomyopathy referred for evaluation to the NIH.
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
-----------------
Cardiac Hypertrophy, Genetics, Phenotypes, Hypertrophic Cardiomyopathy
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC

Study Overview
=================
Brief Summary
-----------------
Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in first Treatment of NSCLC

Official Title
-----------------
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in First Line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer Stage II Randomized Controlled Trials

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: ABX Combined With Cisplatin
* Drug: Gemcitabine Combined With Cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
1.18 75 years 2.Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer 3.Presence of at least one index lesion measurable by CT scan or MRI 4.Ecog0-1 5.Expected life time longer than 12 weeks 6.Normal laboratory values: leucocyte ≥ 4×109/L neutrophil ≥ 1.5×109/L platelet ≥ 100×109/L Hemoglobin ≥ 10g/L ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis) 7.Signed written informed consent Exclusion Criteria: Patients have used drugs according to protocol Patients were allergic to pemetrexed or cisplatin Patients received radiotherapy or other biological treatment 4 weeks before the trial Uncontrolled hydrothorax or hydropericardium neuropathy toxicity ≥ CTC 3 Severe symptomatic heart disease Active upper gastrointestinal ulcer or digestive disfunction Severe infection or metabolic disfunction Patients with other malignant tumor Uncontrolled brain metastases Patients have accepted other clinical trials Female patients during their pregnant and lactation period, or patients without contraception

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABX Combined With Cisplatin<br>ABX，100mg/m2，d1、8、15，ivgtt,in 30 min，28day one cycle； cisplin 75mg/m2 d1 ivgtt | Drug: ABX Combined With Cisplatin<br> <br> |
| Active Comparator: Gemcitabine Combined With Cisplatin<br>gemcitabine 1000mg/m2，d1、8；cisplatin 75mg/m2 d1 ivgtt,3 weeks one cycle. | Drug: Gemcitabine Combined With Cisplatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS |  | from the first cycle of treatment (day one) to two month after the last cycle | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PFS
Multi-Colored Placido Disk Viability

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show that the multi-colored Placido Disk set-up can get reliable data over long time periods.

Official Title
-----------------
Viability Study of a Multi-Colored Videokeratoscope With Extended Timescale Data

Conditions
-----------------
Dry Eye, Sjogren's Disease, Healthy

Intervention / Treatment
-----------------
* Procedure: Multi-colored Placido disk imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have clinically diagnosed Dry Eye or Sjörgren's syndrome. Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI) Ability to give informed consent Willing to spend time for the study; approximately 30 minutes for a visit Either gender Any racial or ethnic origin Exclusion Criteria: Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s). Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy. Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dry Eye Disease or Sjogren's Disease<br>Capturing images of the tear surface using the multi-colored Placido disk | Procedure: Multi-colored Placido disk imaging<br>* The multi-colored Placido disk instrument records the tear surface using video imaging.<br>|
| Other: Control<br>Capturing images of the tear surface using the multi-colored Placido disk | Procedure: Multi-colored Placido disk imaging<br>* The multi-colored Placido disk instrument records the tear surface using video imaging.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film break-up time | The multi-colored Placido disk will collect images of the tear film with the aim to have usable data for more extended periods of time. This instrument measures tear film break-up time in seconds using a video recording of the tear surface. | up to 3 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
A Biobehavioral Model of Diabetes Risk in Chinese Immigrants

Study Overview
=================
Brief Summary
-----------------
This prospective, longitudinal study of Chinese American immigrants will examine whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time, and whether such associations are mediated by inflammatory pathways.

Detailed Description
-----------------
It is now well-documented that immigration to the US leads to increased risk for various chronic diseases, including type 2 diabetes. The increased diabetes risk observed among Chinese immigrants has been primarily attributed to changes in diet and weight gain following immigration, but these changes can only partially explain disparities in disease risk. Models of immigrant health suggest that the stress of adapting to life in a new country has a considerable impact on physical health. However, few studies have considered the psychosocial impact of immigration upon biomarkers of health and disease risk. Therefore, this longitudinal study of US Chinese immigrant men and women will examine: (1) whether psychosocial factors (e.g., acculturative stress, social isolation, discrimination) are associated with markers of type 2 diabetes risk over time; and (2) whether the association between psychosocial factors and diabetes risk markers is mediated by inflammatory pathways.

Official Title
-----------------
A Biobehavioral Model of Diabetes Risk in Chinese Immigrants

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese heritage; migration from Asia in adulthood (aged 18 years or older); and age 35-65 years Exclusion Criteria: Current or prior history of diabetes Self-reported conditions of cancer, auto-immune disorders, HIV, or psychiatric illness Use of medications that may impact study outcomes (e.g., steroidal or non-steroidal anti-inflammatory medications) Inability to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | Insulin resistance will be estimated according to the homeostasis model assessment (HOMA) as HOMA = (fasting insulin x fasting glucose) / 22.5 | 24 months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin (HbA1c) | Level of blood sugar | 24-months post-baseline |
Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost Formulation A and Formulation B following 14 days of once daily topical administration in male participants with androgenetic alopecia (AGA).

Detailed Description
-----------------
Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With androgenetic alopecia

Official Title
-----------------
Evaluation of Local Pharmacokinetics and Tolerability of Bimatoprost Applied Topically to the Scalp of Male Patients With Androgenetic Alopecia

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Drug: Bimatoprost 1% Formulation A
* Drug: Bimatoprost 1% Formulation B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with mild to moderate Androgenetic Alopecia of the vertex area of the scalp. Exclusion Criteria: Patients with uncontrolled systemic disease History of significant cardiovascular disease Scarring disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could cause temporary hair loss (eg, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, and genetic disorders) Patients who have received hair transplants or have had scalp reductions Abnormal bone biomarker laboratory results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 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: All Participants<br>Bimatoprost 1% Formulation A solution applied to the left side of the scalp and trunk area and Bimatoprost 1% Formulation B solution applied to the right side of the scalp and trunk area once daily for 14 days. | Drug: Bimatoprost 1% Formulation A<br>* Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.<br>Drug: Bimatoprost 1% Formulation B<br>* Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Concentration in Skin Biopsy Samples |  | Day 14 | 
| Percentage of Participants with at Least 1 Treatment Emergent Adverse Event |  | 28 Days |
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Study Overview
=================
Brief Summary
-----------------
The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).

Detailed Description
-----------------
The Bio-enteric Intra-gastric balloon (BIB) has been shown to be an effective treatment for weight reduction in obese patients. This study will determine the feasibility of using BIB in the treatment of patients with Non alcoholic Steatohepatitis (NASH). It will evaluate the efficacy of the BIB in improving histology of NASH in obese patients.

Official Title
-----------------
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Conditions
-----------------
Non Alcoholic Steatohepatitis

Intervention / Treatment
-----------------
* Procedure: AHA diet plus exercise with BIB placement
* Procedure: AHA diet plus exercise with sham BIB placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 21-65 years of age, Had histological evidence of NASH, Had a BMI of greater than 27kg/m2, and Had failed at least 6 month trial of medical therapy for weight reduction. Exclusion Criteria: Patients with any organic disease of the upper GI tract, Were receiving anti-inflammatory drugs, Anticoagulants or steroids, or Had a history of alcoholism or drug addiction. A hiatus hernia of > 5 cm, an active gastric or duodenal ulcer, and prior or intestinal surgery were considered contraindications to the placement of BIB.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Treatment<br>AHA diet plus exercise with BIB placement | Procedure: AHA diet plus exercise with BIB placement<br>* AHA diet plus exercise with BIB placement for 6 months<br>|
| Sham Comparator: Sham control<br>AHA diet plus exercise with sham BIB placement | Procedure: AHA diet plus exercise with sham BIB placement<br>* AHA diet plus exercise with sham BIB placement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver histology | The primary outcome measure was liver histology before and after treatment. Assessment of disease activity was done with the use of the NAS, which grades steatosis, lobular inflammation and hepatocellular ballooning. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non alcoholic Steatohepatitis, Intra-gastric balloon
Kineret in the Treatment of Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Objective of the study is to gain knowledge about the administration of Kineret in patients with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In the current survey, the investigation of the response rate of Kineret regarding the date of onset of action, the efficacy, as well as the tolerability and safety are of particular interest.

Official Title
-----------------
Kineret in the Treatment of Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: Anakinra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent by the patient Rheumatoid arthritis Previous methotrexate therapy with inadequate response Exclusion Criteria: 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?
-----------------

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score 28 (DAS28) | The DAS28 measures the progress and improvement of Rheumatoid Arthritis. DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS 28 below the value of 2.6 is interpreted as Remission. Both the number of joints with tenderness upon touching and swelling are counted. In addition, the erythrocyte sedimentation rate is measured. Also, the patient makes a subjective assessment of disease activity during the preceding 7 days on a scale between 0 and 100, where 0 is no activity and 100 is highest activity possible. | 0-52 weeks | 
| ACR response | The ACR (American College of Rheumatology) Criteria measures the effectiveness of treatments for Rheumatoid Arthritis. The ACR is reported as % improvement, comparing disease activity at two discrete time points. | 0-52 weeks | 
| Health Assessment Questionnaire | The patients will at each visit complete a questionnaire about their health status and the impairment in usual activities due to the rheumatoid disorder. | 0-52 weeks |
RCT of Psychoeducational Program of Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression

Detailed Description
-----------------
Unipolar depression is a common disorder which may be treated by drugs or psychological intervention. Many patients prefer psychological treatment, but there is a lack of professional skills and methods for effectively dealing with this in the primary health services,where most of the depressed patients are seen.For this reason it is of great importance to develop and test psychological methods which may be applied in the primary health services, as well as in the specialized psychiatric services.In the present study a psychoeducational group method is tested, with trained psychiatric nurses as the most common group leaders. Comparison: People with unipolar depression receiving treatment as usual

Official Title
-----------------
A Randomized Controlled Trial of a Psychoeducational Group Program for Unipolar Depression in Adults in Norway

Conditions
-----------------
Unipolar Depression

Intervention / Treatment
-----------------
* Behavioral: Control with depression course (CWD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Unipolar depression - Exclusion Criteria:Psychosis, other psychiatric disorders, subclinical depression, suicidal ideation, learning disabilities -

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Control with depression course (CWD)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BeckDepression Inventory : A questionnaire with 23 items to measure symptoms of depression |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, psychoeducation, RCT, primary health services
An Investigational Drug Study in Healthy Adult Volunteers in a Model of Insomnia (0928-007)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the safety and effectiveness of an investigational drug for insomnia (a sleep disorder).

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of MK0928 in Healthy Adult Volunteers Participating in a 4-Hour Phase Advance Model of Transient Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: MK0928, gaboxadol / Duration of Treatment: 10 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults who are between the ages of 18 and 64 Exclusion Criteria: Adults who are diagnosed with insomnia

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0928, gaboxadol / Duration of Treatment: 10 months|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-hour advanced polysomnographic (PSG) recording session measuring wake time after sleep onset (WASO) and latency to persistent sleep (LPS); Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily sleep diary for visual analogue sleep quality and number of night awakenings (sNAW) |  |  |