linjc16/ctgov huggingface dataset:
Acceptability Dermacyd Delicata - New Fragrance - Lactoserum - Hygiene

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety of the gynaecological formulation in normal and usual usage condition.

Official Title
-----------------
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata New Fragrance

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: lactoserum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral skin in the tested region Exclusion Criteria: Pregnancy or breastfeeding women Use of antiinflammatory or immunosuppression drugs Topical medication use at the tested region Active cutaneous gynaecological disease Personal history of allergic disease at the area to be treated Allergic or atopic history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events and its association with the drug in study |  |  |
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).

Detailed Description
-----------------
Up to 15 patients over the age of 18 years with a diagnosis of LEMS are eligible to enroll if they are medically stable. They may receive 3,4 diaminopyridine in addition to other treatments and standard of care investigations for LEMS under supervision of the primary investigator. Safety laboratory studies and EKGs will be obtained. The study has been approved by the University of Pittsburgh IRB. There is a local Data-Safety Monitoring Board. The investigator has a hold on enrolling new subjects.

Official Title
-----------------
Treatment of Lambert-Eaton Syndrome With 3,4 Diaminopyridine

Conditions
-----------------
Lambert-Eaton Myasthenic Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of LEMS Over 18 years old Medically stable If female and premenopausal, have a negative urine pregnancy test prior to starting the 3,4 DAP, and, if premenopausal, be willing to practice an effective form of birth control such as double-barrier contraception during the study Exclusion Criteria: Known sensitivity to 3,4 DAP History of past or current seizures History of severe asthma Believed by the investigator to be unable to comply with the protocol Unable to provide informed consent

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 3,4 diaminopyridine|3,4 diaminopyridine up to 80 mg daily in divided doses|

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
-----------------
Lambert-Eaton myasthenic syndrome, 3,4 diaminopyridine
Novel Risk Factors of Atrial Fibrillation in Patients With Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure.

Detailed Description
-----------------
Atrial fibrillation (AF) is the most common cardiac arrhythmia in clinical practice. Chronic Heart failure (CHF) has become a major clinical and public health problem. Both AF and CHF often co-exist and complicate each other's administration.Several risk factors have been demonstrated to be associated with the risk of AF in Patients with CHF. Lopez et al. found that higher levels of low-density lipoprotein cholesterol (LDLc) and total cholesterol were associated with a lower incidence of AF independently of other risk factors from the Atherosclerosis Risk in Communities (ARIC) study. Thus the purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure. This study maybe provide a novel opinion on the prevention of AF in patients with CHF.

Official Title
-----------------
Study to Evaluate Association of Blood Lipid Levels With Atrial Fibrillation Incidence in Patients With Chronic Heart Failure

Conditions
-----------------
Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of chronic heart failure Exclusion Criteria: Use of statins

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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 |
| --- | --- |
| Heart failure<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with newly emerging atrial fibrillation as assessed by electrocardiogram |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality |  | three years | 
| Worsing heart failure assessed by decreased NYHA class and left ventricular ejection fraction |  | three years | 
| rate of rehospitalization |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipids, Atrial Fibrillation, Heart Failure
Endocarditis Registry of the University Hospital of Cologne (ER-UHC)

Study Overview
=================
Brief Summary
-----------------
As recommended in the Guidelines on the prevention, diagnosis, and treatment of infective endocarditis (IE) patients with IE should be evaluated and managed by a multispecialty team including an cardiologist, infectious disease specialist, and cardiac surgeon. Our registry is a prospective, national registry of patients with IE. From January 2013 data from endocarditis board were prospectively recorded using standard definitions during the hospitalization. Patient demographics, clinical, laboratory, and imaging data at the time of IE diagnosis, as well as treatment outcomes were entered into the ER-UHC database.

Detailed Description
-----------------
The primary endpoint will be the 1 year all-cause mortality after treatment begins of IE. We will use 1 year all-cause mortality as the primary endpoint because it has been demonstrated that a period of at least 6 months is necessary to offset the early postoperative mortality related to valve surgery. We also looked at all-cause in-hospital mortality as a secondary endpoint.

Official Title
-----------------
Endocarditis Registry of the University Hospital of Cologne (ER-UHC)

Conditions
-----------------
Infective Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with patients with definitive infective endocarditis Exclusion Criteria: childs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| All-cause mortality | 1-year all-cause mortality | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhospital all-cause mortality |  | 1 month |
Integrated Novel Clinical Decision Support System (CDSS) in a Computerized Physician Order Entry System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the impact of CDSS by knowing the prescribers actions to the CDSS, also the influence of prescribing error announced by pharmacists.

Detailed Description
-----------------
To assess the sensitivity of the CDSS which could identify some specific prescribing errors (ex: duplication of drugs, dosage that exceed the maximum dose,prescribes drugs that have drug-drug interactions). To identify what kind of drugs are most likely to cause duplication use by the physicians, and what kind of drugs are most likely to exceed the maximum dosage, also to know what kind of drugs are most likely to cause drug-drug interaction that physicians encounter during prescribing. To evaluate the percentage of physician acceptance of the prescribing errors identify by the CDSS. What's the impact of CDSS on pharmacist announced prescribing error.

Official Title
-----------------
Integrated a Novel Clinical Decision Support System (CDSS) in a Computerized Physician Order Entry System

Conditions
-----------------
Evaluate the Impact of the CDSS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The prescriptions which induced the alert windows pop out. Exclusion Criteria: The prescriptions which not induced the alert windows pop out.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| accepted<br>The suggestions provided by the CDSS which were accepted by the physicians. | |
| denied<br>The suggestions provided by the CDSS which were denied by the physicians. | |

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
-----------------
CDSS, prescribing error, prescribing errors influenced by CDSS, CPOE
Twin A Breech External Cephalic Version Intervention Trial (TWEXIT)

Study Overview
=================
Brief Summary
-----------------
A prospective study assessing the use of external cephalic version for the management of Twin A breech presentation in twin pregnancy.

Detailed Description
-----------------
The primary goal of the study is to determine the success rate of Twin A external Cephalic Version in our obstetric clinic and to determine new favorable sonographic criteria associated with a successful attempt that have not been investigated before.

Official Title
-----------------
Twin A Breech External Cephalic Version Intervention Trial

Conditions
-----------------
Breech Presentation, Twin; Complicating Pregnancy

Intervention / Treatment
-----------------
* Other: External Cephalic Version


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of the written consent of the patients. The patients must be over 18 years old . No limit in the ability to consent. Exclusion Criteria: Age under 18 Limited ability to consent Placenta previa Fetal abnormalities

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: External Cephalic Version|External Cephalic Version Twin A|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of external cephalic version Twin A | Mean Percentage (Range 0-100) - Successfully performed external cephalic Versions / Total number of participants | 4 hours after external cephalic version | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal weight | Measurement in grams | 30 Minutes before external cephalic version | 
| Fetal Doppler Umbilical Pulsatility Index | Index mesurent /Ratio | 30 Minutes before external cephalic version | 
| Fetal Doppler Umbilical Resistance Index | Index mesurent /Ratio | 30 Minutes before external cephalic version | 
| Incidence of pathological cardiotocogramm | Numerical percentage | 60 Minutes after external cephalic version | 
| Incidence of emergency delivery | Numerical percentage | 60 Minutes after external cephalic version | 
| Incidence of bleeding | Numerical percentage | 60 Minutes after external cephalic version | 
| Incidence of contractions | Numerical percentage | 60 Minutes after external cephalic version | 
| Incidence of rupture of membranes | Numerical percentage | 60 Minutes after external cephalic version | 
| Pain scores | Numerical score: Pain scale Linkert score. (0-10 with 10 being extremely painful) | 60 Minutes after external cephalic version | 
| Mode of Delivery | Type of delivery (vaginal or caesarean) | 6 weeks after delivery |
Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin

Study Overview
=================
Brief Summary
-----------------
This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their current diabetic regimen.

Official Title
-----------------
An Exploratory MRI Study in Type 2 Diabetic Subjects: A Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Measurement of Fluid Volumes by MRI in the Lower Extremities of Subjects Receiving Pioglitazone

Conditions
-----------------
Non-Insulin-Dependent Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Must have been diagnosed with Type 2 diabetes at least three months prior to screening. Must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months. Must have a Body Mass Index (BMI) of between 24 and 35. If female, the subject must be post-menopausal. HbA1c levels must be between 7% and 10%. Subjects must be eligible for MRI scanning (ie, no metal implants, pacemaker, etc). Exclusion criteria: Suffer from claustrophobia. Use of tobacco, nicotine, or illegal drugs of abuse. Use of caffeine within two days prior to each study visit. HIV, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease. Use of drugs or medications that affect the levels of fluid in the body, such as diuretics.

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in interstitial fluid volume in the lower extremities as measured by MRI. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessments of other indicators of fluid volume changes, including labwork evaluation, fluid compartment volume measurement, direct measurement of the calf. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pioglitazone, diabetes, fluid
DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Study Overview
=================
Brief Summary
-----------------
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.

Official Title
-----------------
A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

Conditions
-----------------
Plantar Fasciitis

Intervention / Treatment
-----------------
* Biological: daxibotulinumtoxin type A
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent, including authorization to release health information Skeletally mature, male or female patients 18 to 65 years of age with diagnosis of plantar fasciitis Persistent heel pain for more than three months Women of child bearing potential must have a negative urine pregnancy test (UPT) at Screening Visit and must use an effective method of birth control during the course of the study Exclusion Criteria: Previous surgery on the midfoot or hindfoot Neuromuscular disease Systemic muscle weakness Planning a pregnancy during the study Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: daxibotulinumtoxinA (DAXI) for injection<br>DAXI for injection | Biological: daxibotulinumtoxin type A<br>* Intramuscular injection<br>* Other names: DAXI;|
| Placebo Comparator: Placebo<br>Placebo Intramuscular injection | Biological: Placebo<br>* Intramuscular injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the visual analog pain score for the foot |  | 16 weeks |
Efficacy and Safety of Lanthanum in Controlling Serum Phosphate Levels in Subjects With End Stage Renal Disease Who Require Treatment for High Levels of Phosphate in Their Blood

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test how well higher doses of lanthanum carbonate reduce the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease.

Official Title
-----------------
A Phase IIIb, Multi-center, Two-Cohort, Randomized Study, With an Open-Label Run-In and a Long-Term Extensions Phase, Assessing an Extended Dose Range of Lanthanum Carbonate in End Stage Renal Disease Subjects Receiving Hemodialysis

Conditions
-----------------
Kidney Failure, Chronic

Intervention / Treatment
-----------------
* Drug: Lanthanum carbonate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with ESRD who currently require treatment for hyperphosphatemia Women of childbearing potential must have a negative serum beta HCG pregnancy test and must agree to abstain from sexual activity or to use acceptable contraceptives from the time of informed consent throughout the study Exclusion Criteria: Treatment with compounds containing calcium, aluminum or magnesium for use as a phosphate binder Hypocalcaemia Treatment-naive to any phosphate binder with a serum phosphorus < 5.5 mg/dL Any significant gastrointestinal surgery or gastrointestinal disorders

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: Lanthanum carbonate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dialysis serum phosphate levels after 4 and 8 weeks of treatment |  | 4 & 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | 8 weeks | 
| Quality of Life |  | 8 weeks | 
| Subject/physician satisfaction and preference questionnaires |  | 8 weeks |