linjc16/ctgov huggingface dataset:
Maternal Oral Hydration and External Cephalic Version

Study Overview
=================
Brief Summary
-----------------
The investigators are carrying out a study of 164 pregnant women, with breech presentation at term who will undergo to external cephalic version. The investigators' goal is to know if oral maternal hydration can increase the successful of external cephalic version

Official Title
-----------------
Maternal Oral Hydration and External Cephalic Version: a Single Blind Randomised Controlled Trial

Conditions
-----------------
External Cephalic Version, Maternal Oral Hydration

Intervention / Treatment
-----------------
* Other: hydration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single gestation breech presentation from 37 to 41,5 weeks without pregnancy complications fetus adequate for gestational age without fetal malformations intact membranes amniotic fluid index between 7 and 24 cm placenta properly inserted Exclusion Criteria: age less than 18 years maternal disease at risk of fluid overload (cardiac disease, renal impairment, moderate or severe preeclampsia or hypertension and diabetes) contraindications for vaginal birth vaginal blood loss uterine contractions

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydration<br>after recruitment the women in hydration group will be invited to drink 2 litres of water,in 2 hours | Other: hydration<br> <br> |
| No Intervention: control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with external cephalic version successful after maternal oral hydration | The primary outcome of the study is to evaluate the successful rate of external cephalic version, after oral intake of two litres of water | The primary outcome will be assessed by ultrasound examination, 5 minutes after ending of the external cephalic version | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amniotic fluid volume | We will assess the amniotic fluid index at recruitment (Baseline). 1 hour after ending of oral intake (2 litres of water), we will revalue the amniotic fluid volume | 1 hour after the end of oral maternal hydration (2 litres) | 
| type of birth | We will record if the woman will give birth by cesarean section or vaginal birth (spontaneous or operative) | at birth |
A Single-blind, Dose-titration Study of KWA-0711 in Patients With Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of titrated KWA-0711 dose in chronic constipation patients.

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: KWA-0711
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who experienced fewer than three spontaneous bowel movements per week for more than 6 months prior to the enrollment. The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation Exclusion Criteria: Patients who have secondary constipation caused by systemic disorder. Patients who have organic constipation. Patients who received intestinal resection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KWA-0711 Dose1<br> | Drug: KWA-0711<br> <br> |
| Experimental: KWA-0711 Dose2<br> | Drug: KWA-0711<br> <br> |
| Experimental: KWA-0711 Dose3<br> | Drug: KWA-0711<br> <br> |
| Experimental: KWA-0711 Dose4<br> | Drug: KWA-0711<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of signs and symptoms associated with constipation | Frequency of Spontaneous Bowel Movements Bowel Movement Timing Stool Consistency Abdominal Assessment QOL Assessment | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Constipation, Constipation, Functional gastrointestinal disorders
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.

Study Overview
=================
Brief Summary
-----------------
Bipolar disorder is a psychiatric illness with clinical characteristics of mixed mania, grandiose delusions, and suicidality. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of patients with bipolar disorder type I or II.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel Group, Placebo-controlled 52 Weeks Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o.(300-1200 mg/Day) as Adjuvant Therapy in the Bipolar Disorder I or II Treatment

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Oxcarbazepine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of bipolar disorder type I or II Exclusion Criteria: Other serious medical conditions Treatment with antiepileptic medications Other protocol-defined inclusion/exclusion criteria may apply.

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: Oxcarbazepine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of remission |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily mood fluctuation |  |  | 
| Time to new maniac/hypomanic episode |  |  | 
| Time to new depressive episode |  |  | 
| Number of relapsed patients at study completion and type/severity of episode |  |  | 
| Change from baseline in functional activity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxcarbazepine, bipolar disorder
Prognostic Biomarkers in Predicting Mortality in Respiratory Patients With Ventilator-Associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate prognostic efficiency RDW and NLR for mortality prediction in respiratory patients with VAP.

Detailed Description
-----------------
Ventilator-associated pneumonia (VAP) is the most common nosocomial infection. VAP continues to be a leading cause of morbidity and mortality in the nosocomial setting. Red cell distribution width (RDW) and neutrophil-lymphocyte ratio (NLR) are prognostic factors to mortality in different diseases.

Official Title
-----------------
Prognostic Biomarkers in Predicting Mortality in Respiratory Patients With Ventilator-Associated Pneumonia

Conditions
-----------------
Ventilator Associated Pneumonia

Intervention / Treatment
-----------------
* Diagnostic Test: complete blood picture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Respiratory failure needs mechanical ventilator support > 48 hrs. VAP was defined as an acute lower respiratory tract infection in mechanically ventilated patient > 48 hrs with a new or progressing infiltrate on chest radiograph and who met at least two of the following clinical criteria: body temperature >38°C or <36°C with no other recognized cause, white blood cell count >10,000 /mm3 or <5000 /mm3, or a macroscopically purulent tracheal aspirate Only the first VAP episode was included Exclusion Criteria: Neutropenia (< 500 cells/ml) before the development of VAP. Conditions are known to influence total and differential WBC counts such as chronic inflammatory conditions, hematologic disorders, history of chemotherapy, or radiotherapy within 4 weeks before enrollment. Conditions are known to affect RDW as anemia due to nutritional deficiency (ie, iron, vitamin B12, and folic acid). Patients with HIV/AIDS

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 |
| --- | --- |
| Respiratory ICU patient<br>patient in RICU that developed ventilator-associated pneumonia | Diagnostic Test: complete blood picture<br>* Measure the red blood cell distribution width (RDW), the neutrophil-lymphocyte ratio (NLR).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Mortality | The number of patients who not Survive after developing ventilator-associated pneumonia in their stay in the Respiratory Intensive Care Unit. | 45 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Red cell distribution width, neutrophil-lymphocyte ratio, Intensive care units, Respiratory
Role of K+ and Ca2+ in Development of Muscle Fatigue

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle fatigue in trained young men.

Conditions
-----------------
Skeletal Muscle Fatigue in Humans

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: physical active healthy men aged 18-40 years Exclusion Criteria: smokers allergy towards terbutaline chronic disease

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: terbutaline<br>terbutaline is administered by injection (0.25-0.5 mg Bricanyl, AstraZeneca diluted in 9 ml isotonic saline) | Drug: Terbutaline<br>* K+ transport and Ca2+ release and uptake function are stimulated by administration of terbutaline<br>|
| Placebo Comparator: Placebo<br>placebo is administered as isotonic saline (10 ml) | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in time to fatigue during knee-extensor exercise |  | 1 day |
Pain on Injection of Propofol: a Comparison of Lidocaine and Alkalinized Lidocaine

Study Overview
=================
Brief Summary
-----------------
Aim: The aim of this study was to compare the efficacy of pretreatment 0.5 mg/kg lidocaine and 0.5 mg/kg alkalinized lidocaine for prevention of propofol induced pain. Methods: In this double-blind, placebo controlled study, 300 adults patients ASA I or II, scheduled to undergo elective surgery, were randomly assigned into three groups of 100 each. Group L, recevied 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF), Group A, 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF) and control group received isotonic saline pretreatment in the dorsum of the hand, followed by propofol 30 sec later. A blinded researcher assessed the patient's pain level via a four-point scale.

Conditions
-----------------
Pain on Injection of Propofol,Lidocaine, Alkalinized Lidocaine

Intervention / Treatment
-----------------
* Drug: alkalinized lidocaine
* Drug: Lidocaine
* Drug: Placebo (for alcalinized lidocaine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing elective surgery Exclusion Criteria: allergy to the study drug

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: alkalinized lidocaine & lidocaine<br> | Drug: alkalinized lidocaine<br>* recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)<br>Drug: Lidocaine<br>* 0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),<br>|
| Active Comparator: alkalinized lidocaine &Placebo<br> | Drug: alkalinized lidocaine<br>* recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)<br>Drug: Placebo (for alcalinized lidocaine)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on injection of propofol |  | 5 th minutes after propofol injection |
Lung Bioavailability With Continuous or Discontinuous Nebulization

Study Overview
=================
Brief Summary
-----------------
To compare the continuous and sicontinuous delivery of drug with AKITA.

Official Title
-----------------
EFFECT OF DRUG TARGETING NEBULIZATION ON LUNG DELIVERY

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: AKITA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no lung disease no allergy Exclusion Criteria: smoker

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

Sexes Eligible for Study
-----------------
Male

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous nebulization<br>Continuous nebulization with AKITA | Device: AKITA<br> <br> |
| Experimental: Discontinuous nebulization<br>Discontinuous nebulization with AKITA | Device: AKITA<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung bioavailability by urinary monitoring |  | 24h after the nebulization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the nebulization |  | After the nebulization |
Comparison of Intermittent vs. Continuous Walking in MS

Study Overview
=================
Brief Summary
-----------------
Objective: To compare effects of an intermittent and continuous walking program on walking endurance and fatigue in people with multiple sclerosis (MS).A randomized crossover prospective method was used.The intervention consisted of eight 6-minute-long walks (2x/week for 4 weeks). The continuous condition consisted of 6 continuous minutes of walking. The intermittent condition consisted of three 2-minute bouts with 2-minute rests. After a 4-week detraining period, participants performed the second training condition.

Official Title
-----------------
The Effect of Intermittent vs. Continuous Walking Training on Walking Endurance and Fatigue in People With Multiple Sclerosis: a Randomized, Crossover Trial.

Conditions
-----------------
Multiple Sclerosis, Endurance

Intervention / Treatment
-----------------
* Other: type of walking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive diagnosis of MS Ambulatory for at least 6 minutes with or without an assistive device (e.g. cane, crutches or orthotics) Ability to read, understand, and sign an informed consent form Exclusion Criteria: Evidence of exacerbation in the prior three months as defined by a treating physician Orthopedic or cardiovascular condition that would interfere with ability to walk for 6 continuous minutes, Currently being on an active physical rehabilitation program

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intermittent walking training<br> | Other: type of walking<br>* Subjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over<br>|
| Active Comparator: Continuous Walking Training<br> | Other: type of walking<br>* Subjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre to post change in 6 Minute walk test distance |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale of fatigue | Measurements to be taken at baseline and after each 4 week intervention | 4 weeks |
Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency (28 Week Extension)

Study Overview
=================
Brief Summary
-----------------
This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency

Official Title
-----------------
A 28 Week Extension to a 24 Week Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of Vildagliptin (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Conditions
-----------------
Diabetes Mellitus, Type 2, Renal Insufficiency

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete the core study Exclusion Criteria: Did not comply with core study requirements

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>50mg qd vildagliptin | Drug: vildagliptin<br>* 50mg qd<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 52 weeks of treatment |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency |  | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Test-retest Reliability of a Standard Protocol on the Biodex Dynamometer

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate test-retest reliability of a standard protocol on the Biodex dynamometer in older adults. In addition, the test-retest reliability and validity of an experimental measure of knee extension strength will be assessed in older adults.

Conditions
-----------------
Test-retest Reliability, Validity, Biodex Medical Systems III Dynamometer, Experimental Measure of Knee Extension Strength

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: +65 years old able to perform a maximal strength test on a dynamometer Exclusion Criteria: pathologies that prohibit a maximal strength test on a dynamometer

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |