linjc16/ctgov huggingface dataset:
Prognostic Factors Affecting Duchenne Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
Determination of prognostic factors affecting ambulation of duchenne muscular dystrophy

Detailed Description
-----------------
Duchenne muscular dystrophy is the most common herditary muscular disease , it lead to loss of ambulation in early teenageers . It lead to early death at the mean age of 19 years

Official Title
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Prognstic Factors Affecting Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: any male pt diagnosed as duchenne muscular dystrophy by typical clinical picture &shooting serum CPK level &EMG study or biopsy & age 10 to 18yrs old Exclusion Criteria: female patient ' age below 10 yrs old or above 18 yrs old .patient with autoimmune disease or malignancy

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 18 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ten meter walking test | Questionnaire | 2018 - 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strenght | Questionnaire | 2018- 2019 |
How Smoking Causes COPD: Examination of Immune System Changes

Study Overview
=================
Brief Summary
-----------------
A breathing condition known as chronic obstructive pulmonary disease (COPD) caused by cigarette smoking is a major health problem. The way by which smoking leads to lung disease is uncertain. Recent research done in animals provides a description of specific changes (that is a reduction) in these immune cell types as a result of cigarette smoke exposure. The study you have been asked to participate in is a pilot study to see if similar changes occur in humans who smoke. The purpose of this study is to evaluate this new method of testing blood in 3 groups of 10 people: normal non-smoking subjects, subjects who smoke with no history of lung disease and subjects who smoke and have smoking related COPD.

Detailed Description
-----------------
The mechanism by which smoking leads to damage to lung tissue in susceptible hosts, is uncertain. Recently there has been description of specific changes (that is reduction) in the number and activity of certain key immune cell types - dendritic cells- as a result of cigarette smoke exposure. This work was done in animal models and we would like to develop methods that will allow us to examine if similar changes occur in humans who smoke. Reduced number and activity of dendritic cells would be expected to lead to increased incidence of infection - a common problem in patients with COPD. Since dendritic cells come to the lung from the bloodstream, and one can detect them in the circulation, we will look at the dendritic cells that are present in the peripheral blood.

Official Title
-----------------
How Smoking Causes COPD: Examination of Immune System Changes

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 40 years Healthy Subjects - Non smokers FEV1/FVC > 70% predicted Current Smokers - > 10 pack year smoking history FEV1/FVC > 70% predicted Current Smokers with COPD - > 10 pack year smoking history FEV1/FVC < 70% predicted Able to give informed consent Exclusion Criteria: Healthy Subjects - Reside with smokers History of lung disease Current Smokers - History of lung disease

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, Smoking Related Disease, Immune System Changes
Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults

Study Overview
=================
Brief Summary
-----------------
This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension

Detailed Description
-----------------
Remifentanil is becoming popular for rapid sequence intubation because it has a fast onset and ultra-short half-life. Remifentanil a potent opioid associated to bradycardia and hypotension at high doses.

Official Title
-----------------
Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults

Conditions
-----------------
Bradycardia, Hypotension

Intervention / Treatment
-----------------
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication of anesthesia induction Exclusion Criteria: Protocol violation Monitoring problems

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Supportive Care
Intervention Model: Sequential Assignment
Interventional Model Description: Adaptative clinical trial, Dixon's Up-And-Down Method
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Patients will receive bolus dose of remifentanil before intubation | Drug: Remifentanil<br>* bolus dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic stability during rapid sequence intubation | no bradycardia and no hypotension | from anesthesia induction up to 5 minutes |
Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events

Study Overview
=================
Brief Summary
-----------------
The evaluation of efficacy is performed by laboratory monitoring of bone density and resorption markers and clinical monitoring of bone density improvement. This is a prospective, randomized, parallel group, single blind study of one year treatment with zoledronic acid every 6 months as compared to one year treatment with zoledronic acid every 3 months and to placebo every 3 months in patients with hemoglobin syndromes and risk of skeletal complications.

Official Title
-----------------
Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events

Conditions
-----------------
Thalassemia

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with thalassaemia or sickle cell anaemia and bone density, z-scores < -1.5, in at least one of the examined sites Normal renal function. Urea and creatinine should not exceed > 2-fold the upper limit of normal (< 2 x ULN). Exclusion Criteria: - Other protocol-defined inclusion / exclusion criteria may apply.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density by means of bone densitometry with dual energy x-ray absorptiometry (DEXA) at three body sites (lumbar region, femoral head, wrist) prior to treatment initiation the start and at the end of treatment |  |  | 
| N-telopeptide of type I collagen (NTx) levels, TRACP-5b, with ELISA, prior to the start of treatment initiation and every 3 or 6 months |  |  | 
| Serum Bone alkaline phosphatase, Osteocalcin, OPG and S-RANKL with ELISA, prior to the start of treatment initiation, and every 3 or 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemistry (Ca, P, urea/creatinine, SGOT/SGPT, ALT, γGT), endocrine and cardiac test prior to the start of treatment initiation and at 6 and 12 month. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thalassemia, zoledronic acid, skeletal events
Mindfulness Training for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of mindfulness training (MT) compared to standard Smoking Cessation Therapy (SCT) on smoking cessation and stress provocation in individuals trying to quit smoking.

Official Title
-----------------
Assessing Mindfulness Training as a Mechanistic Probe for Stress-Induced Brain Activation and Relapse Prevention for Tobacco Addiction

Conditions
-----------------
Cigarette Smoking, Tobacco Smoking, Nicotine Dependence, Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Training
* Behavioral: Smoking Cessation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 and 60 Smoking 10 or more cigarettes per day Fewer than 3 months of smoking abstinence in the past year Motivated to stop smoking Exclusion Criteria: Current use of psychoactive medications that have not been at a stable dose for the past six months, are used as mood stabilizers, or are used as smoking cessation treatments. Individuals who are on psychoactive medications that are stable, not mood stabilizers, and not used for smoking cessations are excluded from fMRI sessions but not smoking cessation treatment. Use of another investigational drug within 30 days Any serious or unstable disease within 6 months Meets criteria for substance dependence within the past year Left handed (will be excluded from fMRI only)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Training<br> | Behavioral: Mindfulness Training<br>* 8 sessions of behavioral treatment for smoking cessation<br>|
| Active Comparator: Smoking Cessation Therapy<br> | Behavioral: Smoking Cessation Therapy<br>* 8 sessions of behavioral treatment for smoking cessation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group differences in continuous abstinence |  | during treatment and 6, 12 and 18 weeks after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between group differences in perceived stress |  | 6, 12 and 18 weeks after treatment initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mindfulness, smoking, stress
Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide

Study Overview
=================
Brief Summary
-----------------
The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension.

Official Title
-----------------
Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide

Conditions
-----------------
Essential Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: essential hypertension under candesartan treatment Exclusion Criteria: -

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patient with essential hypertension under treatment with candesartan or candesartan HCT | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate under naturalistic conditions the compliance rate, defined as the number of subjects with regular intake of the prescribed dose of candesartan or candesartan/HCT as judged by the physician at the end of the observational period. |  | app. 3 monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess under naturalistic conditions the subject's reason(s) for being compliant or non-compliant with the intake of the pre-scribed dose of candesartan or candesartan/HCT |  | app. 3 monthly | 
| To assess under naturalistic conditions the subject's reason(s) for withdrawal of the pre-scribed dose of candesartan or candesartan/HCT |  | app. 3 monthly | 
| To assess under naturalistic conditions whether physicians are using procedures to improve the subject's compliance regarding the intake of candesartan or candesartan/HCT and to get insight in the type and effects of these procedures |  | app. 3 monthly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
essential hypertension, ARB, compliance, candesartan
Motivational Incentives for Alcohol Abstinence in American Indian and Native Alaskan Adults

Study Overview
=================
Brief Summary
-----------------
This study examines the impact of a culturally tailored version of contingency management treatment on alcohol in 400 alcohol dependent American Indians and Alaskan Natives. Participants will be recruited from addiction treatment agencies and throughout the community. Those who complete a 4 week induction period will be randomized to receive 12 weeks of contingency management or a non-contingent control condition. Individuals will then be followed for an additional 3-months to assess the long term efficacy of the treatment.

Official Title
-----------------
Contingency Management Treatment of Alcohol Abuse American Indian People

Conditions
-----------------
Alcohol Abuse

Intervention / Treatment
-----------------
* Behavioral: Contingency Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self reported American Indian/Alaskan Native Current alcohol dependence 5 or more standard drink on 1 or more occasions in the last 30 days Ability to read and speak English Ability to provide written informed consent Exclusion Criteria: Illicit drug use greater than alcohol use in the last 90 days A risk of dangerous alcohol withdrawal Any medical or psychiatric condition, such as organic brain disorder, dementia, or psychotic disorder

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contingency Management<br> | Behavioral: Contingency Management<br> <br> |
| No Intervention: Non-Contingent Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in alcohol use as assessed by ethyl glucuronide detection in urine |  | Twice weekly for twelve weeks |
Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities

Study Overview
=================
Brief Summary
-----------------
Recently, three-dimensional scanning of the torso has been proposed as an alternative for two-view chest radiographies and computed tomography to determine the severity of pectus excavatum without exposure to ionizing radiation. The range of three-dimensional scanning systems is broad with even varying systems being used within hospitals. Most of these scanning systems have been validated for accuracy and reproducibility, no comparison between these systems is known. In addition, severity measures of pectus excavatum, as well as other research outcomes, surgical planning techniques, and analysis methods are based on a single imaging system. It is subsequently essential to determine whether different imaging systems can be used interchangeably regarding accuracy and reproducibility. The aim of this study was to assess the reproducibility and accuracy between three commonly used three-dimensional scanning systems.

Official Title
-----------------
Three-dimensional Scanning of the Chest: a Comparison Between Three Different Imaging Modalities

Conditions
-----------------
Chest Wall Disorder

Intervention / Treatment
-----------------
* Other: Three-dimensional scans


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers only Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Three-dimensional scan arm<br> | Other: Three-dimensional scans<br>* All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility | Mean difference between subsequent scans utilizing the same three-dimensional scanning system | 1 month | 
| Accuracy | Mean difference between scans, acquired by different three-dimensional scanning systems | 1 month |
A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment

Study Overview
=================
Brief Summary
-----------------
This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.

Official Title
-----------------
A Multi-center, Open Label, Dose Titration, Exploratory Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: CS-3150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women Aged 20 years or older and 80 years or younger at informed consent Subjects with hypertension (Sitting systolic blood pressure SBP >= 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP >= 80 mmHg and < 110 mmHg) estimated glomerular filtration rate eGFR >= 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2 Exclusion Criteria: Secondary hypertension or malignant hypertension Diabetes mellitus with albuminuria Serum potassium level < 3.5 or >= 5.1 mEq/L Subjects under Insulin treatment Subjects under or pre-planned for hemodialysis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-3150<br>CS-3150 1.25 to 5.0 mg , orally, once daily after breakfast for 12 weeks | Drug: CS-3150<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic and diastolic blood pressure |  | Baseline to end of Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in UACR | Urine Albumin Creatinine Ratio (UACR) | Baseline to end of Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CS-3150, Hypertension, moderate renal impairment, mineralocorticoid receptor antagonist, Japanese