linjc16/ctgov huggingface dataset:
Healthy Eating & Active Living for Diabetes in Primary Care Networks

Study Overview
=================
Brief Summary
-----------------
The investigators aim to establish the effectiveness of a prescribed, community-based lifestyle modification program for those with recently diagnosed diabetes. The investigators hypothesize that those who enter a 6 month program will report greater levels of physical activity compared to a group who do not enter the program but who continue to receive usual care.

Official Title
-----------------
Healthy Eating & Active Living for Diabetes in Primary Care Networks

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: HEALD
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult, recent type 2 diabetes diagnosis according to a diabetes patient registry, received a referral to a group-based lifestyle program or some provider-based diabetes related education. Exclusion Criteria: physical limitation, cardiovascular contraindication, participation in any other research study

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counselling<br> | Behavioral: HEALD<br>* A six month, two phase pedometer-based walking program. For weeks one and two of phase I, participants will attend a group-based 60 minute education/supervised walking session. They will be asked to set a daily step goal and to attempt to achieve this on a daily basis over three months. Their steps will be recorded in a step log. For weeks one and two of phase II, participants will learn how to increase the speed of a portion of their daily steps and will learn the concept of low glycemic index and how to set dietary goals related to this concept. They will attend two sixty minute group-based education/supervised walking sessions.<br>* Other names: Pedometer-based lifestyle intervention;|
| Active Comparator: Usual Care<br> | Behavioral: Usual Care<br>* Control<br>* Other names: Control, Usual care, off group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity |  | 3 months | 
| Physical Activity |  | 6 months | 
| Physical Activity |  | 12 months |
The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.

Study Overview
=================
Brief Summary
-----------------
To value the accuracy of the dosing algorithm published by the International Warfarin Pharmacogenetics Consortium in Chinese patients after heart valve replacement. To value the accuracy of warfarin pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients.

Detailed Description
-----------------
The dosing algorithm published by the International Warfarin Pharmacogenetics Consortium hadn't been verifying by a standard randomized prospective study in Chinese patients after heart valve replacement. And, warfarin will affect people's coagulation, so that probably increase the drainage. We'll analyse the interaction of patients' PT-INR or drainge and oral warfarin dosing.

Official Title
-----------------
The Pharmacogenetics of Optimal Warfarin Therapy in Chinese Patients After Heart Valve Replacement.

Conditions
-----------------
Heart Valve Disease, Older Than 18-years-old, Without Any Liver or Kidney Diseases

Intervention / Treatment
-----------------
* Genetic: CYP2C9;VKORC1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:atrial fibrillation atrial fibrillation heart valve replacement VTE Exclusion Criteria: severe liver or kidney diseases

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genetic Group<br>Dose (mg/week) = [5.6044 - 0.02614 × Age [in years] + 0.0087 × Height [cm] + 0.0128 × Weight [kg] - 0.8677 × VKORC1 A/G -1.6974 × VKORC1 A/A - 0.5211 × CYP2C9 *1/*2 - 0.9357 × CYP2C9 *1/*3 - 1.0616 × CYP2C9 *2/*2 - 1.9206 × CYP2C9*2/*3 - 2.3312 × CYP2C9 *3/*3 - 0.1092 × Asian race - 0.5503 × amiodarone ]2 | Genetic: CYP2C9;VKORC1<br> <br> |
| No Intervention: Control Group<br>Dose for the first three days after operation will be 4.5mg/d. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The perccentage of time that the INR was in the therapeutic range |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all drainage fluid of every patient |  | 1 week after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
warfarin, Chinese patients, heart valve replacement
Effects of Omega 3 in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to determine the effects of a 3-week fish oil oral supplementation on the metabolic fate and thermogenic effect of an oral glucose load in hemodialysis patients.

Official Title
-----------------
Effets of Fish Oil on Metabolic Fate of an Oral Glucose Load in Patients With End Stage Renal Disease Undergoing Hemodialysis

Conditions
-----------------
Hemodialysis, End Stage Renal Disease

Intervention / Treatment
-----------------
* Behavioral: fish oil supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hemodialysis at least 6 months duration end stage renal disease Exclusion Criteria: - Age < 18 y ou > 75 y Hemodialysis < 6 months Diabetes, obesity allergy to fish Asthma glucocorticoïds, propranolol,, Immunosuppressive drugs, Insulin, Somatostatin erythropoïetin < 3 months Cancer Hemoglobin < 11 g/l disease < 1 month pregnancy respiratory insufficiency intensive sport practice refusal

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: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: fish oil supplementation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma glucose utilization |  |  | 
| glucose-induced thermogenesis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, omega 3 fatty acids, insulin resistance
Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This prospective cohort study examines the impact of perioperative physical activity on postoperative pulmonary complications among esophageal cancer patients.

Official Title
-----------------
Impact of Perioperative Physical Activity on Postoperative Pulmonary Complications and Quality of Life Among Esophageal Cancer Patients: A Prospective Cohort Study

Conditions
-----------------
Esophageal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are diagnosed with esophageal cancer and scheduled to receive curative esophagectomy Patients who are able to read and understand the questionnaire Patients who are able to communicate with research personnel Patients who recognize the purpose of this study and provide written informed consent Patients without treatment for psychiatric disease Exclusion Criteria: Patients who have difficulty for walking Patients with history of other cancer in the last 3 years Patients with neoadjuvant chemotherapy and/or radiation therapy Patients with recurrent esophageal cancer Patients with multiple cancer Foreigner or overseas patients who were not able to regularly participate this study

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Pulmonary complications | Incidence of pneumonia and atelectasis | Within 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of quality of life | The change of quality of life is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core30 (C30). The quality of life scale is transformed into a score 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of quality of life. | Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery | 
| The change of symptom | The change of symptoms is measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) oesophageal cancer module (OES18). The symptom scale is transformed into a score 0 to 100, derived by 4-point Likert scale. A higher score represents a higher level of symptom. | Before surgery(baseline), and 1, 6, 12, 24, 36, 48, and 60 months after surgery |
Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair.

Detailed Description
-----------------
The aim of the present study is to determine whether usage of mesh with larger pores, compared with mesh with smaller pores, would result in decreased rate of chronic pain after open inguinal hernia repair. The patients are randomized into two study gropus receiving mesh with different pore size. Clinical follow-up examination will be performed 1 week, 1 month, 6 months and 3 years after the operation.

Official Title
-----------------
Single-centre Single-blinded Randomised Study Evaluating the Impact of Mesh Pore Size on Chronic Pain After Lichtenstein Hernioplasty

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Device: Optilene LP mesh
* Device: Ultrapro mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years unilateral primary reducible inguinal hernia elective operation consent to participate in the study. Exclusion Criteria: age <18 years irreducible strangulated recurrent hernia inability to understand the questionnaire unwillingness to participate in the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OM group<br>Optilene LP mesh | Device: Optilene LP mesh<br>* Lichtenstein hernioplasty<br>|
| Active Comparator: UM group<br>Ultrapro mesh | Device: Ultrapro mesh<br>* Lichtenstein hernioplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Pain | On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise | 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Pain | On visual analogue scale pain measurement at rest, on coughing, when rising from lying to sitting and during physical effort and exercise | 3-year follow-up | 
| Foreign Body Feeling | The question about foreign body feeling was a yes-or-no question | 6-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, Chronic pain, Mesh, Lichtenstein hernioplasty
Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Congenital Cataract

Study Overview
=================
Brief Summary
-----------------
The purpose of prospective cohort study is to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract(CC) and to explore key factors associated with the rate of change.

Detailed Description
-----------------
Due to myopic shift, it's difficult to select power of IOL implanted in eye with congenital cataract. The developmental profile of refraction among patient with congenital catarat is has not yet been fully characterized. The investigator recruited a large cohort of Chinese CC children.After primary IOL implatation, routine examinations including retinoscopy were completed. Data were analysed to to estimate the rate of change in postoperative change after primary IOL implantation among children with congenital cataract and to explore key factors associated with the rate of change.

Official Title
-----------------
Longitudinal Changes in Refractive Error After Primary IOL Implantation Among Children With Unilateral and Bilateral Congenital Cataract

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: primary IOL implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with uncomplicated surgeries Children with unilateral/bilateral cataract Exclusion Criteria: Corneal diseases Lens luxation Glaucoma Retinal diseases Nystagmus and nanophthalmos

Ages Eligible for Study
-----------------
Minimum Age: 7 Months
Maximum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: primary IOL implantation|implant IOL in capsular bag after cataract extraction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The refraction status (presented as spherical equivalent, SE) | Refractions were conducted with objective retinoscopy after cycloplegia, and performed by experienced optometrists. | up to three years after surgery |
Correlation Between Somatic Growth and Number of Erupted Deciduous Teeth

Study Overview
=================
Brief Summary
-----------------
This investigation seeks to build upon existing evidence that a relationship exists between body mass and timing and the number of erupted teeth.

Detailed Description
-----------------
Alteration in the order of teeth eruption denotes a disorder in normal development of the teeth, rather than delayed or accelerated growth. The more time deviation of teeth eruption from normal, the more possible the presence of a problem in development of teeth. For these reasons having a non-invasive tool such as body mass index to determine if development will be slower than average, could be helpful to the practitioner.

Official Title
-----------------
Correlation Between Somatic Growth and Number of Erupted Deciduous Teeth

Conditions
-----------------
Eruption

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Healthy infants aged 5-36 months. 2-Absence of medical and congenital diseases. 3-Full term infants. 4-Residents of Cairo governorate. Exclusion Criteria: Presence of natal and neonatal teeth.

Ages Eligible for Study
-----------------
Minimum Age: 5 Months
Maximum Age: 36 Months

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 |
| --- | --- | --- |
| number of erupted teeth | the number of erupted erupted teeth will be counted if any part of the tooth appeared | around 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | the index will be counted through the equation | around 2 months |
Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis. In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.

Detailed Description
-----------------
We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo . The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.

Official Title
-----------------
Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: 3,4-diaminopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years and = <60 years Patients with multiple sclerosis clinically defined and with MIFS-SEP score > 44, without deficit sleep and without depression. Patients without treatment by 3,4-DAP since 3 months EDSS score < 6 Exclusion Criteria: ASAT/ALAT > 2 x ULN MADRS >= 20 Abnormality cardiac rhythm Pregnancy Asthma Evolutive affection Renal failure

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3,4-diaminopyridine<br>3,4-diaminopyridine | Drug: 3,4-diaminopyridine<br>* 3,4-diaminopyridine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group. | improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group. | 43 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of safety | evaluation of safety | 43 months | 
| quality of life impact | quality of life impact | 43 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, fatigue, 3,4-diaminopyridine
Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to: 1) find out if pregabalin relieves pain in subjects with painful diabetic peripheral neuropathy; 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day); and 3) find out if changes in nerve function happen during the study.

Official Title
-----------------
A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy

Conditions
-----------------
Diabetic Neuropathy, Painful

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with Type 1 or 2 diabetes Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months Exclusion Criteria: Patients must not be in poor or unstable health.

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve conduction measurements; Pain scores from patient diaries |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with at least a 50% reduction in pain scores; Short-Form McGill Pain Questionnaire; Sleep interference scores from patient diaries; Clinical Global Impression of Change; Patient Global Impression of Change |  |  |
Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.

Official Title
-----------------
Serotonin/Dopamine Antagonism of Cocaine Effect

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Risperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analog mood scales |  |  | 
| POMS |  |  | 
| EPS sx |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine abuse, cocaine addiction