linjc16/ctgov huggingface dataset:
Walking, Spontaneous Physical Activity and Lipid Oxidation After Dietary Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether walking exercise after dietary treatment of obesity is associated with a decrease of the daily spontaneous physical activity and\or with an increase of the time spent in sedentary activities. Our hypothesis is that the practice of walking as an exercise during the phase of weight stability following the dietary treatment of obesity leads to a reduction of spontaneous physical activity and\or to an increase in the time spent in sedentary activities.

Detailed Description
-----------------
The subjects of this study will be randomised in 2 groups: A group with usual follow-up and a group with usual follow-up associated with recommendations to introduce a program of walking achieving gradually 2000-2500 kcal/week.

Official Title
-----------------
Influence of Walking on Spontaneous Physical Activity and on Lipid Oxidation Following Dietary Treatment of Obesity

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

Intervention / Treatment
-----------------
* Behavioral: walking activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women from 18 to 50 year-old In phase of weight stability BMI<40kg/m² Exclusion Criteria: History of bariatric surgery Diabetes Suspicion of obstructive sleep apnea syndrome

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: walking activity|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily time of moderate physical activity, inactivity and total physical activity measured by a portable monitor of physical activity |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily energy expenditure and respiratory quotient during a stay in a respiration chamber |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Weight loss maintenance, Spontaneous physical activity, Lipid oxydation, Walking
NYC Heart Follow-Up Study 2010

Study Overview
=================
Brief Summary
-----------------
This surveillance project will assess NYC population sodium intake using the gold standard measurement of 24-hour urine collection. This surveillance project is a critical component of a larger initiative, coordinated by NYC, to reduce sodium intake nationwide through voluntary industry reductions in processed food sodium content. The project will assess current population sodium intake, against which population intake changes at three years can be assessed

Official Title
-----------------
Baseline 24 Hour Urine Collection in Population-based Sample of NYC Adults

Conditions
-----------------
Sodium

Intervention / Treatment
-----------------
* Other: Surveillance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 Years Exclusion Criteria: Pregnant, breastfeeding or lactating; past or current dialysis

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NYC adults<br> | Other: Surveillance<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urinary sodium |  | 24-hour period |
Special Survey Long-term Treatment With Tiotropium on COPD

Study Overview
=================
Brief Summary
-----------------
Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.

Official Title
-----------------
Special Survey Long-term Treatment

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of Chronic Obstructive Pulmonary Disease Patients were expected to use the product for long period of time Exclusion Criteria: Patients with glaucoma Patients with micturition disorder due to prostatic hyperplasia etc. Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product

Ages Eligible for Study
-----------------
Minimum Age: 20 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 Patients With Adverse Events (AEs) | Number of patients with AEs | Pre treatment and 52 weeks after the treatment | 
| Number of Patients With Adverse Drug Reactions (ADRs) | Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation. | Pre treatment and 52 weeks after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Rate of Comprehensive Evaluation | Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator. Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided comprehensive evaluation. comprehensive evaluation was classified into 3 category, improve No change+Aggravated and Unassessable by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of Improvement in total number of analyzed patients | 52 weeks | 
| Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks | Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation | Pre treatment and 52 weeks after the treatment |
Univation® X Follow-Up Study

Study Overview
=================
Brief Summary
-----------------
The study is designed as a monocentric, prospective, observational, comparative follow-up study based on two previously treated patient groups. The first group consists of patients treated with the patient-specific unicondylar knee implant iUni®. For that group, 30 patients will be included in the study and analyzed. The final follow-up after 24 months has already been documented by the study center. Compared to that, a consecutive series of 50 Univation® X patients will be invited for a 24 months follow-up in 2018. In total, it is planned to include 80 retrospective patients for that historical control study design. The products under investigation were used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF).

Official Title
-----------------
Prospective Observational 2 Year Follow-up on a Retrospective Cohort of Primary Unicompartmental Knee Arthroplasty (UKA) Patients Treated With Univation® X or iUni®.

Conditions
-----------------
Unicompartmental Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: Primary Unicompartmental Knee Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent UKA in 2015/2016 (using one of the products under investigation) Signed informed consent Exclusion Criteria: pregnancy patients < 18 years

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 |
| --- | --- |
| Univation® X<br> | Device: Primary Unicompartmental Knee Arthroplasty<br>* Primary implantation of an unicompartmental knee implant<br>|
| iUni®<br> | Device: Primary Unicompartmental Knee Arthroplasty<br>* Primary implantation of an unicompartmental knee implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee joint function | Knee Society Score | 2 years after primary implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 2 years after primary implantation | 
| axis justice position | radiological analysis | preoperative and until discharge from hospital (within 1 week postoperatively) | 
| radiolucent lines | radiological analysis | 2 years after primary implantation | 
| tibial slope | radiological analysis | 2 years after primary implantation |
High Resolution Imaging for Analysis of MVNT

Study Overview
=================
Brief Summary
-----------------
MVNT (multinodular and vacuolating neuronal tumor of the cerebrum) is a benign, recently discovered, neuronal lesion, the incidence of which is unknown. It seems to predominate in the temporal lobes and presents a characteristic MRI appearance: multiple subcortical nodules, developed at the white substance / gray substance junction, of variable size, well limited, in iso-hyposignal T1, hypersignal T2 and hypersignal FLAIR. The articles describing this entity report the lack of scalability in MRI during patient monitoring, going in the direction of the benignity of the lesion. The diagnosis sometimes remains uncertain with current MRI sequences, and the patient risks undergoing invasive surgery to remove a lesion that is actually benign. Hence the importance of developing the most precise diagnostic criteria possible. The contribution of advanced MRI techniques, such as ultra-high resolution sequences in the characterization of these lesions, has not yet been studied.

Official Title
-----------------
High Resolution Imaging for Analysis of Multinodular and Vacuolating Neuronal Tumor of the Cerebrum

Conditions
-----------------
Benign Neuronal Desease

Intervention / Treatment
-----------------
* Other: cerebral MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years of age Prospective inclusion of all patients with suspected MVNT on a first exploratory MRI: at least the 2 major criteria associated with at least 1 minor criterion will be required to fit into the definition of suspected MVNT: Major criteria : Multinomodular clustered appearance Franc hypersignal FLAIR/T2 Minor criteria : No mass effect Hyposignal T1 Having received informed information about the study and having given express consent to participate in the study Exclusion Criteria: Contraindication to MRI Patient benefiting from a legal protection measure Pregnant or breastfeeding woman Secondary exclusion criteria: - No characterization MRI done

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 |
| --- |
|Other: cerebral MRI|Patients who agree to participate in the study will perform an MRI with ultra high resolution sequences added by the research MRI of control will be done at one year and two years|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the proportion of patients with a central T2 / FLAIR hyposignal visible on standard sequences and on ultra-high resolution sequences. | Among the patients with confirmation of the diagnosis of MVNT (Multinodular and Vacuolating Neuronal Tumor) on the characterization MRI | Day 1 |
Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy as compared to placebo. This study is aimed at supporting the regulatory approval in China of vildagliptin as combination therapy with sulfonylureas in the treatment of type 2 diabetes.

Official Title
-----------------
A Multicenter, Double-blind, Randomized, Parallel-group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50mg qd to Placebo as add-on Therapy to Glimepiride in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy.

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

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of T2DM by standard criteria Patients who have received a stable dose of SU for at least 12 weeks prior to Visit 1 HbA1c ≥7.5% to ≤ 11.0% at Visit 1 and Visit 3 (Week -1) Age: ≥18 to ≤ 80 years at Visit 1. BMI ≥ 20 and ≤ 40 kg/m^2 at visit 1. Exclusion Criteria: FPG ≥ 270mg/dl (15.0 mmol/L) at Visit 1 or Visit 3 (Week -1) Severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between Visit 2 and Visit 4) Other protocol-defined inclusion/exclusion criteria may apply

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vildagliptin<br> | Drug: vildagliptin<br> <br> |
| Placebo Comparator: placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Fasting Plasma Glucose |  | 24 weeks | 
| Safety and tolerability (Frequency of adverse events, serious adverse events, and notable laboratory abnormalities) of add-on therapy with vildagliptin 50 mg qd to glimepiride as compared to pbo |  | 24 weeks | 
| Responder rates - proportion of subjects reaching predefined HbA1c targets |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, vildagliptin
Health Belief Model Based Education on Human Papilloma Virus Infection and Vaccination

Study Overview
=================
Brief Summary
-----------------
To evaluate impact of Health Belief Model Based Education on Human Papilloma Virus Infection and Vaccination among University Students

Detailed Description
-----------------
In this randomized controlled study, it aims to evaluate impact of Health Belief Model based virtual education on Human Papilloma Virus Infection and Vaccination among University Students.

Official Title
-----------------
The Impact of Health Belief Model Based Education on Human Papilloma Virus Infection and Vaccination Among University Students: A Randomized Controlled Trial

Conditions
-----------------
Human Papilloma Virus, Health Behavior

Intervention / Treatment
-----------------
* Other: Virtual Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: University students aged 18 years or over Exclusion Criteria: University students have been received HPV vaccine

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education received group<br>Health belief model based education on HPV infection and vaccination | Other: Virtual Education<br>* health belief model based virtual education<br>|
| No Intervention: Control Group<br>No virtual education | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline assessment of knowledge level on Human Papilloma Virus (HPV) Infection and Vaccination at first day | The scale consists of 10 items. A higher score represents a higher knowledge level. | baseline and next day after the education (at first day) | 
| Change from baseline score of Human Papilloma Virus (HPV) Infection and Vaccination Health Belief Model Scale at first day | The scale consists of 14 items. The construction of the scale consists of perceived severity (n=4 items), perceived susceptibility (n=2 items), perceived benefit (n=3 items), perceived barriers (n=5 items). A 4-point Likert scale was used to assess each item. | baseline and next day after the education (at first day) |
Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.

Official Title
-----------------
A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: BMS-986141 Form A Tablet
* Drug: BMS-986141 Form B tablet (low dose)
* Drug: BMS-986141 Form B tablet (high dose)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments Body mass index 18.0 kg/m2 to 32.0 kg/m2 females must be of non-childbearing potential Exclusion Criteria: known bleeding or coagulation disorders acute or chronic medical illness history of nausea or chronic diarrhea that lasts over 4 weeks history of periodontal disease or gingivitis which required treatment other exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Single oral dose BMS-986141 Form A tablet under fasting conditions | Drug: BMS-986141 Form A Tablet<br>* tablet<br>|
| Experimental: B<br>Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions | Drug: BMS-986141 Form B tablet (low dose)<br>* tablet<br>|
| Experimental: C<br>Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions | Drug: BMS-986141 Form B tablet (high dose)<br>* tablet<br>|
| Experimental: D<br>Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions | Drug: BMS-986141 Form B tablet (high dose)<br>* tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct |  | 4 weeks |