linjc16/ctgov huggingface dataset:
Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire

Study Overview
=================
Brief Summary
-----------------
The study aims to develop and test a user-friendly, accessible approach to sleep assessment which can function as an initial triage of targeted sleep conditions, such as insomnia, insufficient sleep syndrome, sleep apnea syndromes/snoring, and circadian sleep/wake disorders, within the clinical and community population. Specifically, this study will test the validity and reliability of a self-rated, digitized, and cost-effective diagnostic measure with sufficient sensitivity to accurately assess/diagnose common sleep conditions and/or risk for these conditions. Such an approach, would allow for faster assessment of common sleep conditions and disorders, and provide clinical knowledge to the individual, the physician, and if required insurance companies, as to those persons who need more immediate attention or treatment for their sleep condition.

Official Title
-----------------
Evaluation of the Reliability and Validity of a Diagnostic Sleep Disorders Questionnaire

Conditions
-----------------
Sleep Apnea Syndromes, Insomnia, Insufficient Sleep Syndrome, Circadian Rhythm Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 21-65 years who are referred to the sleep clinic at Carmel Medical Center and who are capable of filling out an electronic questionnaire in Hebrew. Exclusion Criteria: Patient age <21 years or >65 years. Women who are pregnant or breastfeeding. Nighttime shift-workers. Persons who are unable to provide consent due to mental incapacity. Persons referred for evaluation by Ministry of Transportation (for licensing purposes).

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Sleep disorders diagnosis and severity of diagosis | Dayzz diagnostic sleep questionnaire (dDSQ): Insomnia, insufficient sleep syndrome, circadian sleep/wake disorders, risk for sleep apnea, snoring | 30-60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep disorders, assessment, diagnosis
Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

Official Title
-----------------
A Multicenter, Open-label, 52-Week Extension Study to Evaluate the Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia

Conditions
-----------------
Primary Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Milnacipran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have completed or discontinued prematurely from lead-in study, MLN-MD-14, tolerating a minimum daily dose of 50mg milnacipran Exclusion Criteria: Can not tolerate a minimum daily dose of 50mg milnacipran Significant risk of suicidality Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 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: Milnacipran<br>oral administration, twice daily dosing | Drug: Milnacipran<br>* maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of Patients who experience one or more treatment emergent adverse event (TEAE) | Baseline (Visit 1) to Week 53 (Visit 9) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibromyalgia, Pediatric Fibromyalgia, Adolescent Fibromyalgia, milnacipran, Savella, loss of therapeutic response, Forest Research Institute, Pain, Fatigue, Serotonin Norepinephrine Reuptake Inhibitors
Shoe Inserts for Treating Osteoarthritis of the Knee

Study Overview
=================
Brief Summary
-----------------
This trial will test shoe inserts for the treatment of knee osteoarthritis, the most common form of knee arthritis. Those with disease on the inner (medial) aspect of the knee will be studied.

Official Title
-----------------
Randomized Trial of a Wedged Insole for Treatment of Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Device: Shoe Insert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medial knee osteoarthritis Pain No foot problems Lives in Boston, Massachusetts Metro area

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Shoe Insert|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
-----------------
Biomechanics
Linear Growth Study (0476-097)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: MK0476, montelukast sodium / Duration of Treatment : 56 Weeks
* Drug: Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty) Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists) Exclusion Criteria : Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 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: MK0476, montelukast sodium / Duration of Treatment : 56 Weeks|nan|
|Drug: Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1 |  |  | 
| Beta-agonist use |  |  | 
| Oral corticosteroid rescues for asthma |  |  | 
| Discontinuations due to asthma |  |  | 
| Peripheral blood eosinophil count |  |  | 
| Markers of bone turn-over |  |  |
Wound Vitality Markers in Forensic Pathology

Study Overview
=================
Brief Summary
-----------------
The purpose is to determine intrinsic properties of various immunohistochemical markers (FVIIIra, CD15, CD30, tryptase, TNFα, IL-1β, TGFα et TGFβ1) for diagnosis of vital wound, alone and in association (evaluation of sensibility with surgery wounds and evaluation of specificity with post-mortem wounds). Secondary purposes are to measure the minimum time to obtain a positive labeling in vital wounds, and to evaluate inter-observer reproducibility of vitality diagnosis with different markers. Expression of microRNA miR 9, miR 21 et miR 198 will be also studied.

Official Title
-----------------
Wound Vitality Markers in Forensic Pathology

Conditions
-----------------
Wound

Intervention / Treatment
-----------------
* Other: Abdominoplasty with exeresis of cutaneous tissue
* Other: Collection of cutaneous tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alive persons: - Abdominoplasty Deceased persons: - Medico-scientific autopsy for diagnosis Exclusion Criteria: Alive persons: Fragmented sample with non-visible banks Cutaneous pathology Deceased persons: Persons under protection Medico-legal obstacle Cutaneous pathology

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 |
| --- | --- |
| Vital wounds<br>from abdominoplasty of alive persons | Other: Abdominoplasty with exeresis of cutaneous tissue<br> <br> |
| Post-mortem wounds<br>from autopsy of deceased persons | Other: Collection of cutaneous tissue<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility of markers for vitality diagnosis |  | baseline | 
| Specificity of markers for vitality diagnosis |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum time to obtain a labeling (between incision and devascularization) |  | baseline | 
| Coefficient of inter-observer correlation of vitality diagnosis (for reproducibility analysis) |  | baseline | 
| Expression level of miR 9 by qRT-PCR |  | baseline | 
| Expression level of miR 21 by qRT-PCR |  | baseline | 
| Expression level of miR 198 by qRT-PCR |  | baseline |
Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore patient perspectives on Advance Care Planning (ACP) prior to cardiac surgery, including perceptions of benefits, drawbacks, and barriers to ACP.

Detailed Description
-----------------
In this study, we plan to interview 40 patients who are scheduled to undergo cardiac surgery about their perspectives on preoperative ACP and discussion of their values, goals of care, and preferences for prolonged care in hospital prior to having surgery. We plan to conduct and audio record one-on-one interviews that are structured around standard questions about ACP. After recordings are completed, we plan to conduct an analysis of the interviews to find common themes and ideas that participants have about preoperative advance care planning. These results will help us understand whether patients value and wish to participate in advance care planning prior to major surgery, and will help to guide the structure and content of preoperative advance care plan programs in the future.

Official Title
-----------------
Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing cardiac surgical procedures that involve a sternotomy, thoracotomy, or cardiopulmonary bypass for any indication. Age > 18 English-speaking Exclusion Criteria: Emergency surgery, regardless of indication or procedure Minor/percutaneous cardiac procedure Lack of decisional capacity due to dementia or other neurocognitive dysfunction Previously decided upon advance care directives Still considering surgery or not yet booked for an operation

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 |
| --- | --- | --- |
| Interview | Patient perspectives and attitudes regarding advance care planning (ACP) with a focus on patient values and goals prior to cardiac surgery. | 30-35 Minute interview | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advance Care Planning
Oral Taxane in Combination With Pemetrexed (Alimta) in Patients With Recurrent Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
A phase I-II dose ranging study of BMS-275183 (oral taxane) in combination with pemetrexed (Alimta) in patients with recurrent Non-Small Cell Lung Cancer (NSCLC). The safety and efficacy of this combination will be studied.

Official Title
-----------------
Phase I Alimta Combination With BMS-275183 (Oral Taxane)

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Oral Taxane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced or metastatic pretreated NSCLC Measurable disease Adequate hematologic, hepatic and renal functions. ECOG Performance Status 0-2 Exclusion Criteria: Inability to swallow capsules Recent significant cardiovascular disease Women who are pregnant or breastfeeding

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oral Taxane|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
-----------------
NSCLC - non-small cell lung cancer
Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients

Study Overview
=================
Brief Summary
-----------------
This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation.

Detailed Description
-----------------
This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation. The investigators compared the median values of DE and DTF in the group of successfully extubated patients and the group of patients who needed reintubation. Our study compared the utility of DTF and DE to predict extubation success.

Official Title
-----------------
Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients

Conditions
-----------------
Accuracy of DE and DTF in Prediction of Extubation Success

Intervention / Treatment
-----------------
* Diagnostic Test: comparaison between DE and DTF in prediction of extubation success


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were mechanically ventilated for more than 48h and meeting all criteria for extubation patients without history of neuromuscular disease, or severe chronic respiratory failure Exclusion Criteria: patients who needed reintubation for upper airway obstruction or neurological or hemodynamic instability

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 |
| --- |
|Diagnostic Test: comparaison between DE and DTF in prediction of extubation success|diaphragm ultrasound and measurement of DE and DTF in patients meeting all extubation criteria during spontaneous breathing trial|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extubation success | comparaison between DE and DTF values in successfully extubated patients | 48 hours after extubation |
Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study was conducted to investigate the effects of daily supplementation of fermented red ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2 diabetes.

Detailed Description
-----------------
This study was a 4 weeks, randomized, double-blind, placebo-controlled trial. Forty-two subjects with IFG or type 2 diabetes were randomly allocated to 2 groups to consume placebo or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal tolerance test were assessed before and after the intervention.

Conditions
-----------------
Impaired Glucose or Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: Fermented Red Ginseng
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-75 years with fasting glucose 100 140 mg/dL at least two of the following Exclusion Criteria: Lipid metabolic disorder Acute or chronic inflammatory disease Taking medication of corticosteroid within 4 weeks of the study Cardiovascular disease (arrhythmia, heart failure, myocardial infarction or patient with pacemaker) Allergic or hypersensitive to any of the ingredients in the test products Participation in other clinical trials within 2 months Abnormal hepatic liver function or renal disease (acute/chronic renal failure or nephrotic syndrome) Taking medication of lipid phosphates within 3 months of the study etc,

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented red ginseng<br> | Dietary Supplement: Fermented Red Ginseng<br>* Fermented red ginseng 2.7g/day for 4 weeks<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo 2.7g/day for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose profiles during meal tolerance test | Fasting and postprandial glucose profiles during meal tolerance test were assessed before(baseline) and after the intervention | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipid profiles | Change in lipid profiles were assessed before(baseline) and after the intervention | 4 weeks |