linjc16/ctgov huggingface dataset:
Efficacy of Metformin in Lean Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Insulin resistance is an important feature of the polycystic ovary syndrome,and patiens are successfully treated with the insulin sensitizing agent metformin. The insulin resistance of lean patients with the syndrome is debated. In this study, we will study the change in insulin resistance, metabolic and hormonal factors after 3 months of metformin treatment in lean PCOS women.

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCOS (Rotterdam criteria) BMI < 27 No medication for 3 months Exclusion Criteria: Pregnancy Lactation Other endocrinologic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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: Metformin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance |  |  | 
| Hormonal factors |  |  | 
| Metabolic factors |  |  |
Effect of Vitamin D in Burn Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.

Detailed Description
-----------------
Vitamin D deficiency often occurs in burn patients, which may include longer hospitalization and respiratory and cardiac complications. The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.

Official Title
-----------------
Effect of Vitamin D in Burn Patients: A Randomized Clinical Trial

Conditions
-----------------
Burn Surgery

Intervention / Treatment
-----------------
* Biological: Vitamin D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vitamin D <30 ng/ml patients undergoing burn surgery Exclusion Criteria: age < 18 years old hypercalcemia renal disease cardiac disease ( EF<40%, MI, angina) respiratory disease (ARDS, pneumonia) intubated patients electrical burn

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D group<br>Vitamin D 200,000 IU (1 cc) IM | Biological: Vitamin D<br>* Vitamine D<br>|
| Placebo Comparator: Control group<br>Normal saline 1 cc IM | Biological: Vitamin D<br>* Vitamine D<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative complications | Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death | Within postoperative 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D level | Serum 25-hydroxy vitamin D level | Within postoperative 14 days |
The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation

Study Overview
=================
Brief Summary
-----------------
To explore carrier and infection status of T.tonsurans tinea capitis and characterize the host-pathogen interaction as it relates to the disease presentation. The general hypothesis for this study is as follows: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.The global outcome of this investigation is to reveal potential new drug targets designed to improve treatment outcomes in these children.

Detailed Description
-----------------
Tinea capitis is an overwhelmingly prevalent disease of childhood estimated to be present in approximately 1 in 20 children at any point in time with an equal number of children serving as carriers of the fungal pathogen. Despite the widespread nature of the disease, the natural course of the infection remains incompletely described. The study will be driven by the following hypothesis: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection. A fungal scalp culture will be acquired from all participants using a brush culture technique. Samples will be collected once a month over a two year time period.

Official Title
-----------------
The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation

Conditions
-----------------
Tinea Capitis

Intervention / Treatment
-----------------
* Procedure: Scalp Brushing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preschool aged children will be eligible. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Scalp Brushing|sterile, soft-head toothbrush massaged on scalp|

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
-----------------
Tinea Capitis
Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.

Official Title
-----------------
Prospective Comparison of Cyanoacrylate Tissue Adhesive (Dermabond) and Suture (Vicryl) for Closure of Cardiac Device Pockets

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Device: Cyanoacrylate tissue adhesive (Dermabond)
* Device: Polyglactin 910 suture (Vicryl)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for implantation of a pacemaker or ICD in the deltopectoral region at Mayo Clinic Hospital in Phoenix. Exclusion Criteria: Allergy to one of the closure materials.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adhesive<br>Cyanoacrylate tissue adhesive. | Device: Cyanoacrylate tissue adhesive (Dermabond)<br>* Skin closure will be performed with cyanoacrylate tissue adhesive.<br>* Other names: Dermabond;|
| Active Comparator: Suture<br>Polyglactin 910 suture. | Device: Polyglactin 910 suture (Vicryl)<br>* Skin closure will be performed with polyglactin 910 suture.<br>* Other names: Vicryl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported Here Are the Number of Participants With Devices That Developed Infection |  | Within 3 months after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pacemaker, cardioverter-defibrillator, ICD, cardiac resynchronization device, cyanoacrylate, suture, Dermabond, Vicryl
Retrospective Study to Determine the Incidence of Bone Fractures in HIV-infected Patients in Spain

Study Overview
=================
Brief Summary
-----------------
Study to determine the incidence of Bone Fractures in HIV infected patients in Spain

Detailed Description
-----------------
Study to know the incidence of bone fractures in HIV patients, determine associate factors to bone fractures, the type of patients with fractures.

Official Title
-----------------
Retrospective Study to Determine the Incidence of Bone Fractures in HIV-infected Patients in Spain

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection Signed ICF Patient that fulfill these: Osteroporosis associated fracture Enough information close to the moment of the fracture Exclusion Criteria: patients with cognitive impairment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fractures<br>Patients in follow up from 1st Jan 1997 to 1st Jan 2012 with any fracture (pathologic) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of HIV patients with bone fractures | To know the incidence of bone fractures in HIV infected patients in Spain | 18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of fractures associated to determine factors | Determine associate factors to fractures | 18 years | 
| Number of patients with fractures | Determine the profile of patients with fractures | 18 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Epidemiology of Klebsiella Pneumoniae in China

Study Overview
=================
Brief Summary
-----------------
Klebsiella pneumoniae is one of the most common pathogens causing both community-onset and nosocomial infection. More worse, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics,outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, outcomes and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.

Detailed Description
-----------------
All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, outcome and the rationality of the current therapy for the Klebsiella pneumoniae infection in China.

Official Title
-----------------
Klebsiella Pneumoniae Infection in China: Epidemiology, Molecular Characteristics, Treatment, and Outcome

Conditions
-----------------
Klebsiella Pneumoniae Infection

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - new confirmed community-onset or noscomial infection of Klebsiella pneumoniae infection Exclusion Criteria: Age<18, or >85 years old; Mixed infection of Klebsiella pneumoniae and other microbes

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Carbapenem-Sensitive K. pneumoniae<br>Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection. | Other: no intervention<br>* no intervention, this is an obervational study.<br>|
| Carbapenem-Resistant K. pneumoniae<br>Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection. | Other: no intervention<br>* no intervention, this is an obervational study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRKP infection | Culture postitive results confirmed the infection of CRKP | 6 months |
The Aim is to Estimate the Total Amount of Insulin-producing Cells in the Pancreas by MRI.

Study Overview
=================
Brief Summary
-----------------
Assess pancreatic beta cell function using MR imaging.

Detailed Description
-----------------
The study was terminated on July 31st, 2007. The study was discontinued, as we have not met the primary end point, differentiation between normal volunteers and subjects with type 1 diabetes mellitus. There were no safety concerns.

Official Title
-----------------
Pancreatic Beta-Cell Mass And Function Quantification By Means Of Perfusion Imaging

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: MR imaging
* Procedure: Glucose clamp
* Drug: Arginine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal Volunteers T1DM and T2DM subjects Exclusion Criteria: Concomitant severe conditions

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MR imaging|nan|
|Procedure: Glucose clamp|nan|
|Drug: Arginine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic perfusion |  |  |
Antabuse in Severe Alcoholism: an Open Controlled Study

Study Overview
=================
Brief Summary
-----------------
Newly detoxified alcoholics (N=60) are randomised to either antabuse (disulfiram) treatment or the control group for a total of 6 months.All patients will receive cognitive behavioural treatment in groups. The hypothesis to be tested is that more of the patients who receive antabuse (disulfiram) will be alcohol free during the 6 months treatment period compared to the control group. The trial is open.

Official Title
-----------------
Antabuse in Severe Alcoholism: an Open Controlled Study

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: antabuse (disulfiram)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcoholism Living in the departments catchment area Exclusion Criteria: Pregnancy Schizophrenia Bipolar disorder Other substance abuse Dementia Anorexia

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antabuse (disulfiram)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients in each group who have not been drinking alcohol after 6 months of treatment. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcoholism, antabuse, disulfiram, abstinence, cognitive behavioural therapy
Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment

Study Overview
=================
Brief Summary
-----------------
Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could be exagerated and could produce greater postoperative opioid consumption and higher pain score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study was to evaluate, in patients with current opioid treatment, the effects of peroperative Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.

Official Title
-----------------
Effects of Intraoperative Nitrous Oxide on Postoperative Pain for Patients With Current Opioid Treatment After Vertebroplasty.

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Procedure: Nitrous oxyde


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: > 18 years old Current opioid treatment > 1 month patients scheduled to undergo vertebroplasty with general anesthesia

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 |
| --- |
|Procedure: Nitrous oxyde|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) and morphine consumption recorded for 48 postoperative hours (every 8 hours). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative and postoperative pressure pain threshold (pressure algometer) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Current opioid treatment, Nitrous oxide, Chronic pain, Opioid therapy, Postoperative hyperalgesia, Acute opioid tolerance
A Study of Prophylactic Treatment for Hand-Foot Syndrome in Patients Treated With Oral Xeloda (Capecitabine).

Study Overview
=================
Brief Summary
-----------------
This 3 arm study will compare the prophylactic effect of topical corticosteroids, Bepantol or placebo on hand-foot syndrome in patients receiving Xeloda for treatment of metastatic breast cancer, metastatic colorectal cancer or adjuvant treatment of colorectal cancer. Patients who have been receiving oral Xeloda for at least 5 days will be randomized to receive prophylactic treatment with either placebo, topical corticosteroids or Bepantol. The anticipated time on study treatment is until disease progression or development of hand-foot syndrome, and the target sample size is 500+ individuals.

Official Title
-----------------
A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Corticosteroids
* Drug: Placebo
* Drug: capecitabine [Xeloda]
* Drug: dexpantenol [Bepantol]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; breast cancer or colorectal cancer patients; treated with oral Xeloda for <=5 days; lack of hand-foot syndrome (palmar-plantar erythrodysesthesia). Exclusion Criteria: existence of clinical symptoms suggesting hand-foot syndrome; use of doxorubicin, 5-FU and/or cytarabine for last 3 months; diabetes mellitus.

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: capecitabine [Xeloda]<br>* As prescribed<br>Drug: dexpantenol [Bepantol]<br>* As prescribed<br>|
| Active Comparator: 2<br> | Drug: Corticosteroids<br>* As prescribed<br>Drug: capecitabine [Xeloda]<br>* As prescribed<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* As prescribed<br>Drug: capecitabine [Xeloda]<br>* As prescribed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand-foot syndrome onset |  | Event driven | 
| QoL C-30 score |  | Weeks 7, 13 and 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Throughout study |