linjc16/ctgov huggingface dataset:
Effects of a Zumba Dance Program for Postmenopausal Women With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the effects of a 12-week Zumba dance intervention on fitness, anthropometric and psychometric parameters and eating behavior.

Official Title
-----------------
ZumBeat: Effekte Eines Rhythmusorientierten Aeroben Tanz-Bewegungsprogrammes für Postmenopausale Frauen Mit Metabolischem Syndrom

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Zumba dance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postmenopausal women (Age 45-65) waist of >94 cm or BMI > 30kg/m2 not physically active >1x/week for 20 minutes written consent before the start of the study Exclusion Criteria: involvement in other clinical studies unable to participate at the dance lessons medical contraindications for the intervention or increased risk for exercise participation

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Zumba dance intervention | Other: Zumba dance<br>* Twelve weeks, 3 times weekly 1 hour training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2peak (=peak oxygen consumption) | The VO2peak will be assessed for every participant during a treadmill spirometry at baseline and follow-up using a mask and calibrated gas measuring devices applying a standardized protocol. | VO2peak will be assessed at T1 and T12 (baseline and after 12 weeks of intervention) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiorespiratory fitness, weight, quality of life, depression, menopausal symptoms, exercise barriers, executive functions
Treatment of Patients With Nocturia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.

Official Title
-----------------
A Phase III Randomized, Double Blind, Placebo Control, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia

Conditions
-----------------
Nocturia

Intervention / Treatment
-----------------
* Drug: SER120
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female 50 years or older Nocturia of 6 or more months duration averaging 2 episodes or more per night Exclusion Criteria: CHF Diabetes Diabetes Insipidus Renal Insufficiency Hepatic Insufficiency Incontinence Illness requiring steroids Current or past urologic malignancy Nephrotic Syndrome Unexplained pelvic masses Urinary bladder neurological dysfunction Urinary bladder surgery or radiotherapy Sleep Apnea Pregnant or breast feeding

Ages Eligible for Study
-----------------
Minimum 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
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SER120<br>SER120 | Drug: SER120<br>* SER120<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Number of Nocturic Episodes/Night | Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline | 7 weeks | 
| Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night | Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline | 7 weeks |
Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

Study Overview
=================
Brief Summary
-----------------
To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration).

Official Title
-----------------
Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo Casodex® tablets monotherapy for not less than 12 months
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Adverse event incidence |  | Time since starting Casodex monotherapy, monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of prostate cancer using Tumor marker PSA |  | Time since starting Casodex monotherapy, monthly | 
| Maintenance of sexual function |  | At 3 months since starting Casodex monotherapy, | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Casodex, Monotherapy
Chronic Schizophrenia With Obsessive-Compulsive Symptoms: Comorbidity or a Subtype?

Study Overview
=================
Brief Summary
-----------------
Evaluating the prevalence and characteristics of obsessive-compulsive (OC) symptoms in patients with chronic schizophrenia

Conditions
-----------------
Schizophrenia, Obsessive Compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenic patients Schizophrenic patients with OCD Exclusion Criteria: Organic problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Prospective Randomized Study of Glucocorticoids in the Impact of the Liver Function and the Prognosis After Hepatectomy of HCC

Study Overview
=================
Brief Summary
-----------------
The major drawback of hepatic pedicle clamping is ischaemia-reperfusion injury with impairment of liver function. Perioperative steroid administration has been advocated to reduce liver damage. The aim of this prospective, randomized study was to determine whether steroid administration can reduce liver injury and impact the prognosis

Conditions
-----------------
Some Studies Shows That the Steroid Can Reduce the Injury of the I/R of the Liver

Intervention / Treatment
-----------------
* Drug: Hydrocortisone sodium succinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old diametre of the mass>3cm. hcc

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| steroid,liver function I/R<br> | Drug: Hydrocortisone sodium succinate<br>* 100mg/day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| liver function |  | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
steroid, liver function, prognosis
Drug Drug Interactions of Aspirin and P2Y12-inhibitors

Study Overview
=================
Brief Summary
-----------------
Study Objective: To investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)

Detailed Description
-----------------
Rationale: Opiates reduce the intestinal resorption of orally administered drugs such as paracetamol. Because morphine is often injected to relieve pain in patients with myocardial infarction, it is of particular interest if morphine may decrease the rate of absorption of antiplatelet drugs. Results of this study will provide essential information for the use of morphine and antiplatelet drugs in clinical practice, in particular in myocardial infarction.

Official Title
-----------------
Drug Drug Interactions of Antiplatelet Drugs and Morphine

Conditions
-----------------
Drug Interaction Potentiation, Myocardial Infarction

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers ≥ 18 years of age No intake of NSARs and P2Y12-inhibitors within 14 days before study entry Written informed consent Exclusion Criteria: Known coagulation disorders Relevant impairment of hepatic function (elevated transaminases, ≥ 2 fold) Relevant impairment of renal function Infectious diseases (HIV, hepatitis B and C) Gestation and lactation Clinically relevant abnormal laboratory values Use of medication during 2 weeks before the start of the study, which may affect the validity of the study General contraindications for aspirin (resp. clopidogrel, prasugrel, ticagrelor) and morphine

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine<br>Vendal 5 mg i.v. bolus injection | Drug: Morphine<br>* i.v. bolus injection<br>* Other names: Vendal;|
| Placebo Comparator: Placebo<br>Sodium chloride 0.9% i.v. bolus injection | Drug: Placebo<br>* i.v. bolus injection<br>* Other names: Sodium chloride 0,9%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax |  | 14 days | 
| Cmax |  | 14 days |
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: MK 0773
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a nonsurgical postmenopausal female Subject is neither grossly overweight nor underweight for her height Subject is in good health Subject is willing to avoid excess alcohol and strenuous physical activity during the study Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study Exclusion Criteria: Subject has significant drug allergies Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks Subject is a regular user or past abuser of any illicit drug (including alcohol) Subject drinks excessive amounts of caffeinated beverages Subject has a history of cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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 |
| --- | --- |
| Experimental: Postmenopausal Women- Active Agent Group<br> | Drug: MK 0773<br>* 25 mg oral tablet b.i.d. MK 0773 or 100 mg oral tablet b.i.d. MK 0773, for 12 weeks<br>|
| Placebo Comparator: Postmenopausal Women- Placebo<br>Placebo | Drug: Placebo<br>* Placebo oral tablet b.i.d for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious Clinical Adverse Events |  | From date of enrollment through 12 weeks of study | 
| Number of Participants with Nonerserious Clinical Adverse Events |  | From date of enrollment through 12 weeks of study | 
| Number of Participants with Serious Laboratory Adverse Events |  | From date of enrollment through 12 weeks of study | 
| Number of Participants with Nonserious Laboratory Adverse Events |  | From date of enrollment through 12 weeks of study | 
| Number of Participants Who Discontinued Due to Any Adverse Event |  | From date of enrollment through 12 weeks of study | 
| Number of Participants Who Withdrew Consent and Discontinued the Study |  | From date of enrollment through 12 weeks of study | 
| Least Squares Mean Change in Lean Body Mass |  | From baseline, at 12 weeks |
Determination of Gentamicin Dosing in Neonatal Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.

Detailed Description
-----------------
This study aims to verify dosages of gentamicin for use in Uniject, chosen based on a consideration of gentamicin pharmacokinetics, safety, efficacy, target population body weight, cost, feasibility and acceptability.

Official Title
-----------------
Determination of Gentamicin Dosing in Neonatal Patients for Use in the Uniject Pre-filled Syringe [A Three-site Study at: 1) Dhaka Shishu Hospital, Dhaka Bangladesh; 2) Christain Medical Center, Vellore, India; and 3) Aga Khan University Medical Center, Karachi, Pakistan]

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: Gentamicin in Uniject Pre-filled syringe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infants with culture proven sepsis infants 2000-2499 at birth infants > 2500 gm at birth infants < 2000 gm at birth in study site areas: Pakistan, Bangladesh and India Exclusion Criteria: infants w/o culture proven sepsis

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 28 Days

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gentamicin in Uniject Pre-filled syringe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients 2.0-2.24 kg high peak>12.0: 2/6 patients |  |  | 
| Low peak<4.0: none |  |  | 
| High trough > 2.0: 1/6 patients |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients 2.5-3.0 kg |  |  | 
| High peak>12.0: 2/14 patients |  |  | 
| Low peak <4.0: none |  |  | 
| High trough>2.0:2/14 patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meningitis, neonatal deaths, gentamicin, Uniject, aminoglycoside
Effectiveness and Safety of YVOIRE Y-Solution 540

Study Overview
=================
Brief Summary
-----------------
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection

Official Title
-----------------
A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 Versus YVOIRE Volume Plus in Nasolabial Folds Injection

Conditions
-----------------
Wrinkles in the Nasolabial Folds

Intervention / Treatment
-----------------
* Device: YVOIRE Y-Solution 540
* Device: YVOIRE volume plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3 (moderate) or 4 (severe) on the 5-graded WSRS who sign the written informed consent form Exclusion Criteria: who have received permanent facial implants who have received semi-permanent fillers who have undergone temporary dermal filler treatment within 12 months who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YVOIRE Y-Solution 540<br> | Device: YVOIRE Y-Solution 540<br>* Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.<br>|
| Active Comparator: YVOIRE volume plus<br> | Device: YVOIRE volume plus<br>* Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WSRS responder rate | the proportion of subjects with ≥ 1 grade improvement on the wrinkle severity rating scale (WSRS) score | 24 weeks after the last injection |
Evaluation of Contrast Medium Enhanced Post-mortem CT in Virtual Autopsy

Study Overview
=================
Brief Summary
-----------------
The study aims to compare the value of contrast medium enhanced post mortem CT to classic autopsy.

Conditions
-----------------
Thromboembolism, Vascular Conditions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients dying in the ICU age >18y Exclusion Criteria: relatives refusing to participation in the study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| virtual and classic autopsy<br>Patients where contrast medium enhanced post mortem CT and classic autopsy will be performed. | |
| virtual autopsy only<br>Patients where only contrast medium enhanced post mortem CT will be performed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contrast medium enhanced post mortem CT, virtual autopsy, To evaluate the value of contrast medium enhanced post-mortem CT in virtual autopsy focussing on thromboembolic and vascular conditions