linjc16/ctgov huggingface dataset:
Gastric Procedures for Obesity

Study Overview
=================
Brief Summary
-----------------
This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.

Official Title
-----------------
Phase II Study of Comparing Outcomes of Laparoscopic Sleeve Gastrectomy, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Gastric Banding to Treat Morbid Obesity

Conditions
-----------------
Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: morbid obese patients aged from 18-65, BMI > 40 kg/m2 or BMI> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc. Exclusion Criteria: psychiatric illness, substance abuse, previous gastrointestinal surgery, and any patient who transfers from laparoscopic to convention procedure.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LSG<br>Laparoscopic Sleeve Gastrectomy | |
| LRYGB<br>Laparoscopic Roux-en-Y Gastric Bypass | |
| LAGB<br>Laparoscopic Adjustable Gastric Banding | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Weight | Change of body weight in Kilograms measured at follow-up visits two year after surgery | baseline to 2-year postoperation | 
| Change in BMI | Patients' weight and height were measured at follow up visit 2 years post operation. BMI was calculated using the formula: weight (kg)/height(meter)^2 | from baseline to 2-year postoperation |
Application of Genomic Techniques and Image Processing Using Artificial Intelligence to Obtain a Predictor Model Risk of Melanoma

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to develop a predictive model of risk of developing melanoma. The investigators will used artificial intelligence techniques to analysed images patterns obtained by clinical and dermoscopic pictures. The investigators want to defined a new predictive risk model obtained from genetic information and image analysis of pigmented lesions. This model could help to discriminate more accurately those patients who are most likely to develop melanoma in a high-risk population.

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age; Followed up patients in the Pigmented Lesions Unit at Reina Sofia University Hospital with high risk of developing melanoma (First-degree family/personal history of familiar melanoma and/or melanocyticnevi above 50 and/or dysplastic or atypical nevi); All nevi for which there is at least one dermatoscopy registry will be included. Exclusion Criteria: not enough data in the patient clinical history; located lesions on the face, scalp, mucous membrane or on acral área; nodular or metastatic melanoma diagnosis type V or VI of Fitzpatrick phototyping scale

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 |
| --- | --- | --- |
| Number of participants with Melanoma |  | Three years |
Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

Study Overview
=================
Brief Summary
-----------------
A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

Detailed Description
-----------------
the SOAL questionnaire is a validated Patient Reported Outcomes (PRO) questionnaire in English language. The aim of this study is to develop a new tool in french language and to evaluate incidence and the specific impact of swallowing disorders on the quality of life of patients after Total PharyngoLaryngectomy.

Official Title
-----------------
Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

Conditions
-----------------
Pharyngeal Cancer, Swallowing Disorder, Larynx Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total PharyngoLaryngectomy Age ≥ 18 years old Read, write and understand the French language Exclusion Criteria: Patient under guardianship, deprived of liberty, safeguard of justice Refusal to participate in research

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SOAL- VF | Patient reported outcome measure | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SOAL, patient reported outcomes
Sleep Duration Required to Restore Performance During Chronic Sleep Restriction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.

Detailed Description
-----------------
The purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. Inpatient sleep and performance data will be collected from healthy volunteers.

Official Title
-----------------
Sleep Duration Required to Restore Performance During Chronic Sleep Restriction

Conditions
-----------------
Sleep, Sleep Deprivation, Insufficient Sleep Syndrome

Intervention / Treatment
-----------------
* Behavioral: Sleep:wake 1
* Behavioral: Sleep:wake 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Prescription medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep:wake 2<br>Sleep and wake durations for arm 2 for inpatient portion of protocol. .There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 1. | Behavioral: Sleep:wake 2<br>* Sleep and Wake durations for arm2<br>|
| Experimental: Sleep:wake 1<br>Sleep and wake durations for arm 1 of the inpatient portion of the protocol. There are a variety of sleep and wake durations during the protocol; some of these are longer and some are shorter and some are the same as in arm 2. | Behavioral: Sleep:wake 1<br>* Sleep and Wake durations for arm 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor Vigilance Task (PVT) performance | PVT metrics are reaction time. It is measured when the participants are awake during the inpatient portion of the protocol. | PVT during waking for arms 1 and 2 during the 32-day inpatient portion of the protocol | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inpatients, Health Normalcy, circadian rhythm
Transcranial Ultrasound in Clinical SONothrombolysis

Study Overview
=================
Brief Summary
-----------------
This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

Official Title
-----------------
A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 With Continuous Ultrasound Administration in Subjects With Acute Ischemic Stroke Receiving Treatment With Intravenous Tissue Plasminogen Activator

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: MRX-801
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke Occlusion demonstrated by transcranial Doppler ultrasound Eligible for tPA Exclusion Criteria: Right to left cardiac shunt Moderate to severe COPD Uncontrolled hypertension

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MRX-801|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic intracranial hemorrhage |  | 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recanalization of occluded artery |  | 120 minutes | 
| Independent outcome (modified Rankin Scale 0-2) |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Ischemic Stroke, Microbubbles, Transcranial Doppler ultrasound, TIBI, Symptomatic Intracranial Hemorrhage, modified Rankin Scale, Recanalization, Perflutren
Creatine Supplementation in Pediatric Rheumatology

Study Overview
=================
Brief Summary
-----------------
Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in healthy and elderly people. The investigators speculate that creatine supplementation could have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting and bone mass loss.

Official Title
-----------------
Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis

Conditions
-----------------
Juvenile Systemic Lupus Erythematosus, Juvenile Dermatomyositis

Intervention / Treatment
-----------------
* Dietary Supplement: creatine
* Dietary Supplement: placebo (dextrose)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis physically inactive stable pharmacological treatment Exclusion Criteria: macroalbuminuria GFR < 30 mL/min/1.73m2 use of oral anticontraceptive agents pregnancy diabetes mellitus hypothyroidism

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: creatine supplementation<br>will receive 5g/d of creatine monohydrate throughout the trial | Dietary Supplement: creatine<br>* 5g/d throughout 12 weeks<br>|
| Placebo Comparator: placebo<br>will receive 5g/d of placebo (dextrose) throughout the trial | Dietary Supplement: placebo (dextrose)<br>* 5g/d throughout 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength |  | after six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney function parameters |  | after six months | 
| quality of life |  | after six months | 
| muscle function |  | after six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatology, creatine supplementation, quality of life, strength, juvenile systemic lupus erythematosus, juvenile dermatomyositis
A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy

Detailed Description
-----------------
Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection.

Official Title
-----------------
Randomized Controlled Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer (JCOG9501)

Conditions
-----------------
Gastric Neoplasm

Intervention / Treatment
-----------------
* Procedure: Surgery: D2 dissection
* Procedure: Surgery: D2+paraaortic dissection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Preoperatively, histologically proven adenocarcinoma 75 years old or younger forced expiratory volume in one second ≥ 50 % arterial oxygen pressure in room air ≥ 70 mmHg creatinine clearance ≥ 50 ml/min written consent. Intraoperatively Macroscopic T staging is T2-subserosa, T3, or T4 potentially curative operation is possible no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed) peritoneal lavage cytology is negative for cancer cells Exclusion Criteria: Carcinoma in the remnant stomach Borrmann type 4 (linitis plastica) synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma past history of myocardial infarction or positive results of exercise ECG liver cirrhosis, or chronic liver disease with indocyanine green test ≥10%

Ages Eligible for Study
-----------------
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

| Intervention/Treatment |
| --- |
|Procedure: Surgery: D2 dissection|nan|
|Procedure: Surgery: D2+paraaortic dissection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse-free survival |  |  | 
| operative morbidity and mortality |  |  | 
| length of postoperative hospital stay |  |  | 
| quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stomach neoplasms, lymph node excision, abdominal aorta
Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Completely Masked Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effectiveness of a dietary supplement with high dosage of amino acids and vitamins in the treatment of acute and chronic infection of pharyngeal area known as common cold. T

Official Title
-----------------
Amino Acid Composition Reduces Frequency of Common Cold. Results of a Controlled Randomized Completely Masked Trial

Conditions
-----------------
to Improve the Effectiveness of a Amino Acid Dietary Supplement in Chronic Pharyngeal Infections vs Placebo

Intervention / Treatment
-----------------
* Dietary Supplement: amino acid composition
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men and women with at least two episodes of common cold and infection of ear, nose and pharyngeal area. Exclusion Criteria: people with severe infection like pneumonia, patients expecting an in-patient treatment during the trial, pregnant or breast feeding and people not able to understand the procedure of the treatment

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Other: Placebo<br>* placebo contained no amino acids and vitamins and was identical in appearance and solution properties.<br>* Other names: remedy;|
| Active Comparator: amino acid composition<br> | Dietary Supplement: amino acid composition<br>* one single pouch (13g) of amino acid mixture and vitamins diluted into 200 ml of still water. This solution was daily oral taken after a meal.<br>* Other names: Brand name: aminoplus immun;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| outcome of efficacy | For each study day,participants recorded in a diary rectal temperature, symptoms of sneezing, blocked nose or streaming eyes, whether they had problems to swollow and whether they had headache or pain in arms or legs. | 3 month treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| outcome of efficacy | Secondary outcome variables: feel the patient fit and able-bodied. | 3 month treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amino acids, immune system, vitamins, chronic infection, common cold, ear, nose, throat
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia

Study Overview
=================
Brief Summary
-----------------
Assess efficacy and safety of Omacor® 4g with statin treatment for lowering TG levels in subjects with type 2 Diabetes combined with hyperlipidemia

Official Title
-----------------
Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia

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

Intervention / Treatment
-----------------
* Drug: Omega-3-acids ethylesters 90 4g
* Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LDL-C < 100mg/dL, TG > 150mg/dL, patients on statin treatment for at least 6 weeks prior to randomization. Type 2 Diabetes HbA1c ≤ 10.0 Exclusion Criteria: Type 1 Diabetes Patients with PPAR gamma agonist therapy Patients with acute MI, Unstable angina within 6 months History of malignant tumor within 2 years Women with pregnant, breast-feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega-3-acids ethylesters 90 4g, any statin<br> | Drug: Omega-3-acids ethylesters 90 4g<br> <br> * Other names: Omacor Soft Capsule 4g;Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin<br> <br> |
| Active Comparator: any statin<br> | Drug: Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percent change of Triglyceride(TG) |  | from baseline at week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean percent change of Total Cholesterol(TC) |  | from baseline at week 16 | 
| The mean percent change of LDL-C |  | from baseline at week 16 | 
| The mean percent change of HDL-C |  | from baseline at week 16 | 
| The mean percent change of HBA1c |  | from baseline at week 16 | 
| The mean percent change of FPG |  | from baseline at week 16 | 
| The mean percent change of hs-CRP |  | from baseline at week 16 | 
| The mean percent change of PAI-1 |  | from baseline at week 16 | 
| The mean percent change of Apolipoprotein A1 |  | from baseline at week 16 | 
| The mean percent change of apolipoprotein B |  | from baseline at week 16 |