linjc16/ctgov huggingface dataset:
A Timeline Study of Alcohol Use and Its Relationship to Insomnia

Study Overview
=================
Brief Summary
-----------------
This study is an epidemiological and descriptive study of the lifetime relationship of insomnia to alcohol problems.

Official Title
-----------------
A Timeline Study of Alcohol Use and Its Relationship to Insomnia

Conditions
-----------------
Insomnia, Alcohol Problem

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be between the ages of 18-70, may be male or female, and from any ethnic background. Individuals must have the capacity to give IRB-approved study consent. Subjects must at least have a lifetime history of being heavy alcohol drinkers (i.e., drinks approximately 21 alcoholic drinks or more per week). Alternatively, subjects are eligible if they meet criteria for a lifetime history of either alcohol dependence or alcohol abuse. Overall, a subject must meet at least one of these alcohol criteria: a lifetime history of heavy drinking, alcohol abuse or alcohol dependence. Subjects must have a complaint of chronic insomnia, reporting either six or less hours TST, on average at least three times per week. Exclusion Criteria Potential subjects with a lifetime diagnosis of Bipolar Affective Disorder, Schizophrenia, Borderline Personality Disorder, dementia of any type, or epilepsy will not be admitted to the study. Subjects will be excluded with a diagnosis of any other substance dependence syndrome other than alcohol dependence, nicotine dependence, and/or caffeine dependence. However, individuals may have a history of episodic abuse of cannabis, cocaine, sedatives/hypnotics and opiates, amphetamines, and hallucinogens. Also, subjects may be on prescription benzodiazepine or related sedative/hypnotic therapy. Any condition or treatment of a condition that is likely to confound the experimental design or the results will be prohibited by the PI.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alcohol Problem First<br>Alcohol Problem precedes Insomnia | |
| Insomnia First<br>Insomnia Precedes Alcohol Problem | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the temporal relationship between insomnia and alcohol dependence, alcohol abuse or heavy drinking and determine if this relationship affects the severity of alcohol use. |  | Visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the utility of 3 sleep disorder instruments: the ISI, the SDQ-8 & the ESS in an inpatient or outpatient population of subjects reporting insomnia with a lifetime history of alcohol dependence, alcohol abuse or heavy drinking. |  | Visit 1 |
Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty. A Prospective Randomized Study

Study Overview
=================
Brief Summary
-----------------
Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty.

Official Title
-----------------
Comparison Between i Pack Block and Post Tibial Nerve Block

Conditions
-----------------
Postoperative Analgesia

Intervention / Treatment
-----------------
* Procedure: Adductor canal block with Ipack block or selective tibial nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty • Patients aged 40-80 years with a body mass index of 18-36 kg/ m2 and an American Society of Anesthesiologists functional status of I-III Planned use of regional anesthesia Exclusion Criteria: • Patients younger than 40 years old and older than 80years. Hepatic or renal insufficiency. Patients undergoing general anesthesia. Allergy or intolerance to one of the study medications. BMI > 36 Diabetes ASA of IV Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adductor canal block with Ipack block<br> | Procedure: Adductor canal block with Ipack block or selective tibial nerve block<br>* Ultrasound guided<br>|
| Active Comparator: Adductor canal block with selective tibial nerve block<br> | Procedure: Adductor canal block with Ipack block or selective tibial nerve block<br>* Ultrasound guided<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption | 24 hours | 24 hours post operative |
Prospective Multicenter Study With the Endomina® Triangulation Platform

Study Overview
=================
Brief Summary
-----------------
This registry is designed to further assess on a larger scale safety and efficacy of the endomina® device and tissue apposition accessories (TAPES) when used in the frame of real life routine clinical practice

Detailed Description
-----------------
This is a single arm prospective, multi-center international, open-label, non-interventional, , post-market study. This registry is designed to further assess on a larger scale safety and efficacy of the endomina® and TAPES devices. Patients in need of endoscopic gastroplasty will be enrolled and followed-up for 36 months following hospital routine practice.

Official Title
-----------------
Prospective Multicenter Study to Assess the Safety and Efficacy of the Endomina® Triangulation Platform for Treating Patients Requiring Endoscopic Gastroplasty

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be willing to provide written informed consent Adult patients (between ≥ 18 years (legal age in Europe) and 65 years of age at time of ESG) Patients who require endoscopic gastroplasty and who are selected by multidisciplinary team/investigators to be treated with the endomina® device and accessories according to the Instructions for Use (IFU) Exclusion Criteria: Patients with impaired hemostasis or pre-existing conditions that may lead to fragile mucosa (i.e., any contraindication to suturing the stomach) Any malformation from mouth to esophagus (including pharynx) Any contraindication to general anesthesia, including patients with cardiorespiratory dysfunction or respiratory failure Woman who are pregnant, at the time of the procedure or planning (trying) to become pregnant, or nursing within 12 months after the procedure. Impending surgery 60 days post intervention of the treated section of the GI tract Participation in another clinical study evaluating another medical device, another procedure or a medication that did not reach its primary endpoint

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Safety outcome | Occurrence of Serious Adverse Device Effects at 12 months. | 12 months | 
| Technical success | Technical success defined by the completion of the intended procedure without premature abortion due to technical reasons/device deficiency | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Gastroplasty, Endoscopic gastroplasty, endomina
Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are: To estimate the incidence rate of unexpected adverse events To characterize the bleeding events and assess risk factors of bleeding To identify ancillary baseline variables that may also be associated with adverse outcomes

Official Title
-----------------
Eliquis Safety Surveillance in Japanese Patients With NonValvular Atrial Fibrillation

Conditions
-----------------
NonValvular Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Eliquis


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Patients who are beginning to receive the treatment with this product under the approved indications, dosage, and administration will be included in this study Exclusion Criteria: Patients who are receiving Eliquis outside of its approved indication will be excluded from this study

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 |
| --- | --- |
| Eliquis on Nonvalvular Atrial Fibrilliation patients<br>Patients who are beginning to receive the treatment with Eliquis under the approved indications, dosage, and administration will be included in this study | Drug: Eliquis<br> <br> * Other names: BMS-562247;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of unexpected adverse events |  | Day 1 (At Eliquis initiation) | 
| Incidence rate of unexpected adverse events |  | 12 weeks after initiation | 
| Incidence rate of unexpected adverse events |  | 52 weeks after initiation | 
| Incidence rate of unexpected adverse events |  | 104 week (discontinuation) | 
| Bleeding events and risk factors of bleeding |  | Day 1 (At Eliquis initiation) | 
| Bleeding events and risk factors of bleeding |  | 12 weeks after initiation | 
| Bleeding events and risk factors of bleeding |  | 52 weeks after initiation | 
| Bleeding events and risk factors of bleeding |  | 104 week (discontinuation) | 
| Ancillary baseline variables that may also be associated with adverse outcomes |  | Day 1 (At Eliquis initiation) | 
| Ancillary baseline variables that may also be associated with adverse outcomes |  | 12 weeks after initiation | 
| Ancillary baseline variables that may also be associated with adverse outcomes |  | 52 weeks after initiation | 
| Ancillary baseline variables that may also be associated with adverse outcomes |  | 104 week (discontinuation) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular
MaSS - Maastricht Sarcopenia Study

Study Overview
=================
Brief Summary
-----------------
The objective of this cross-sectional study is to obtain insight in the characteristics (nutritional status and level of physical activity) of sarcopenic compared to non-sarcopenic community-dwelling older people. There is one measurement moment and measurements will take place at the participant's home.

Detailed Description
-----------------
Characterization of sarcopenic older people (demographics, nutritional status, level of physical activity) Prevalence rates of sarcopenia in community-dwelling older people in the Netherlands Insight in differences and/or overlap between sarcopenia versus frailty Insight in the impact of sarcopenia on economic outcomes

Official Title
-----------------
Cross-sectional Study on the Identification and Characterization of Community-dwelling Older People With Sarcopenia

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 65 years old Have given informed consent Understand Dutch language Able to perform a walk test Exclusion Criteria: Older people living in a nursing home Older people with active rheumatoid arthritis, post stroke status with evident lingering symptoms (paralysis, loss of motor functions), diseases of the nervous system like Parkinson and MS, active angina pectoris, dementia Older people in a wheelchair, with ICD or pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sarcopenic vs. non-sarcopenic<br>Participants are classified as sarcopenic/non-sarcopenic according to the criteria of the European Working Group of Sarcopenia in Older People (EWGSOP). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in nutritional status and level of physical activity of sarcopenic participants vs. non-sarcopenic participants, as a measure of a Food Frequency Questionnaire and Mini-Nutritional Assessment Tool and Minnesota questionnaire |  | 1 home visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sarcopenia in community-dwelling older people |  | 1 home visit | 
| Number of sarcopenic participants with frailty as a measure of the FRAIL scale and Fried criteria |  | 1 home visit | 
| Health care costs by sarcopenic vs. non-sarcopenic participants, measured by health care use |  | 1 home visit |
Clinical and Biological Strokes Collection in Reunion Island

Study Overview
=================
Brief Summary
-----------------
Cross-sectional regional multicenter hospital study of all neurological events (stroke, AIT and mimics) for diagnostic and prognostic purposes. Cost of illness study.

Official Title
-----------------
Clinical and Biological Strokes Collection in Reunion Island

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Biological: Biological Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: affiliated to a social security scheme clinical signs suggestive of stroke : hemiparesis or hemiplegia, unilateral sensory disorder, language disorder, balance disorder, dizziness, loss of total or partial bilateral or monocular vision, sudden neurological deficit Exclusion Criteria: current pregnancy Recent clinical history of head trauma patients aged < 18 years old patient under guardianship or curatorship Person deprived of liberty

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>A blood sample (10 ml) will be taken for each patient included in the study | Biological: Biological Collection<br>* A blood sample (10 ml) will be taken for each patient included in the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinico-biological score | area under the diagnostic score curve identifying ischemic stroke, stroke hemorrhagic or mimics. | 24 hours after the stroke |
Olive Oil Phonophoresis and Chronic Low Back

Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate the effect of olive oil phonophoresis on chronic law back pain in female athletes.

Detailed Description
-----------------
This study will enroll 60 female patients suffering from chronic low back pain. the study will run in single blind mode that only patients will kept unaware of treatment. The duration of treatment is 10 days. patients will be assigned randomly to olive oil or placebo group. every day, they will take phonophoresis on lower back using phonophoresis gel as placebo or olive oil as treatment for 10 day. the questionnaires will be filled in baseline visit and day 10. any side effect of drugs or technique will be recorded

Official Title
-----------------
The Effect of Olive Oil Phonophoresis on Chronic Low Back Pain in Female Athletes: a Randomized Controlled Trial

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Dietary Supplement: Olive oil
* Drug: Phonophoresis gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Young female athletes suffering from low back pain for more than three months Exclusion Criteria: Underlying systematic or visceral disease Specific conditions such as neoplasm and fractures, spondylolisthesis Previous low back surgery Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Phonophoresis Gel<br>The Phonophoresis gel will be used as placebo | Drug: Phonophoresis gel<br>* Phonophoresis with base gel for 10 days, daily<br>|
| Experimental: Olive Oil<br>Olive oil will be used as a replacement to phonophoresis gel in this arm | Dietary Supplement: Olive oil<br>* Phonophoresis with Olive oil for 10 day, daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | Low back pain intensity will be measured using McGill questionnaire from 0 (no pain) to 10 (worst). | Change from Baseline in McGill Low Back Pain Scale at day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function | The ability of patients in doing daily activities will be measured using two qualified questionnaires | Change from Baseline in Phycical Function Scale at Day 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Back Pain, Topical Olive Oil, Phonophoresis
Trial of Pemetrexed for Patients With Pancreatic Cancer Which Cannot be Treated With Surgery or is Metastatic

Study Overview
=================
Brief Summary
-----------------
This study with pemetrexed is for patients with metastatic or unresectable pancreatic cancer who progressed after first line chemotherapy with gemcitabine.

Official Title
-----------------
A Phase 2 Trial of ALIMTA in Pretreated Patients With Unresectable or Metastatic Cancer of the Pancreas

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: pemetrexed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological diagnosis of adenocarcinoma of the pancreas that is locally advanced (Stage II, III) or metastatic (Stage IV), as staged by the American Joint Committee on Cancer (AJCC; Protocol Attachment S041.2; Fleming et al. 1997), and not amenable to resection with curative intent. Prior systemic first line chemotherapy with gemcitabine single agent or a combination regimen including gemcitabine (not more than one prior systemic chemotherapy allowed). Uni-dimensionally measurable disease according to the RECIST criteria (Therasse et al. 2000), defined as: At least one lesion that can be accurately measured in at least one dimension, with the longest diameter greater than or equal to 2 cm with conventional techniques or greater than or equal to 1.0 cm with spiral CT scans. Ultrasound and X-ray are NOT allowed to measure or follow lesions. Exclusion Criteria: Prior radiation of equal to or greater than 25% of the bone marrow (Cristy and Eckerman 1987) Prior immunotherapy, biological therapy, and/or hormonal therapy for pancreas cancer. Prior systemic chemotherapy with 5-FU. Patient not yet recovered from the acute toxic effects of the treatment prior to study enrollment. Radiotherapy within the last 4 weeks before study entry

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess tumor response. |  |  | 
| To assess time to event efficacy variables including time to progressive disease and overall survival. |  |  | 
| To characterize the quantitative and qualitative toxicities of pemetrexed in this population of pancreatic cancer patients. |  |  |