linjc16/ctgov huggingface dataset:
International Weight Control Registry

Study Overview
=================
Brief Summary
-----------------
The IWCR is a global scientific study aimed at better understanding the opportunities and barriers for reducing the prevalence of obesity by collecting information from people who have experience with weight management in their everyday lives. The investigators seek to gather information on a wide range of weight management experiences, ranging from weight loss and weight loss maintenance to weight gain and inability to lose weight.

Official Title
-----------------
International Weight Control Registry

Conditions
-----------------
Weight Loss, Overweight, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The IWCR is open to anyone 18 years or older who is considering weight loss, is actively engaged in weight loss, or has previously attempted weight loss (including successful and unsuccessful attempts) Exclusion Criteria: Minors, below the age of 18 Adults who are not able to give informed consent online and complete online surveys

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight change |  | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight Loss Maintenance, Obesity Management
Effect of Cabergoline on Weight and Glucose Tolerance

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine receptor agonist, on body weight and blood glucose in healthy obese adults. This is a randomized double-blind placebo controlled study. Twenty subjects each will be randomly assigned either placebo or cabergoline for 16 weeks. The effect of treatment on body weight and blood glucose and insulin levels will be compared in the treatment versus the placebo arm.

Official Title
-----------------
Randomized Controlled Pilot Study of the Effect of Cabergoline on Body Weight and Glucose Tolerance in Healthy Obese Adults

Conditions
-----------------
Body Weight, Impaired Glucose Tolerance in Obese

Intervention / Treatment
-----------------
* Drug: Cabergoline
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 - 55 years BMI 30 -40 Exclusion Criteria: diabetes, clinically significant medical condition, use of medications that effect blood glucose or body weight

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>placebo pill | Other: placebo<br>* 1 pill twice weekly<br>|
| Active Comparator: cabergoline<br>cabergoline pill | Drug: Cabergoline<br>* cabergoline 0.5 mg twice weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose |  | 16 weeks |
Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study

Study Overview
=================
Brief Summary
-----------------
Double - Blind, Randomized, single centered study. The purpose of this study is to assess the feasibility of minocycline vs. placebo, added to atypical antipsychotic medications, for positive symptoms in adults suffering from schizophrenia.

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Minocycline
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women 20-65 years of age. Primary DSM-IV diagnosis of Schizophrenia based on SCID for schizophrenia and confirmed by two senior psychiatrists. Patients who scored moderate (4) or higher on at least three of seven positive items in PANSS Initiated on treatment with atypical anti-psychotic medication. Capable and willing to provide informed consent Able to adhere to the treatment schedule Able to read, hear, write and speak the local language. Has signed a written informed consent to participate in the study Exclusion Criteria: Patients with acute, unstable, significant, or untreated medical illness besides schizophrenia including alcohol and drug dependence, or depression. Current suicidal ideation or history of a suicide attempt in the past 3 years Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse. or women who are breastfeeding Subjects who were taking a known contraindication to minocycline treatment. Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry. Subjects who were under compulsory hospitalization.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Minocycline<br> | Drug: Minocycline<br>* minocycline 200 mg/day orally in two divided doses for the second week. From weeks 3 to weeks 5, minocycline 400 mg/day orally in two divided doses.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* placebo 200 mg/day orally in two divided doses for the first week. placebo 200 mg/day orally in two divided doses for the second week. From weeks 3 to weeks 5, placebo 400 mg/day orally in two divided doses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive symptoms | Positive symptoms: The change in Scale for the Positive and Negative Syndrome Scale (PANSS) score from baseline to the end of the study and the change in Clinical Global Impression Scale (CGI). | from baseline to the end of the study (day 56) |
Diagnostic Accuracy of Fine Needle Aspiration in Parotid Tumors

Study Overview
=================
Brief Summary
-----------------
Liberal use of fine needle aspiration biopsy of parotid gland masses is controversial. All information regarding this procedure has been retrospective. Our objective is to evaluate prospectively the diagnostic accuracy of the test, alone and when associated to clinical and/or radiologic data.

Detailed Description
-----------------
This is a prospective diagnostic test study. Inclusion criteria are all consecutive patients with parotid gland masses referred for treatment at our center, from January 2003 to December 2007. The gold standard for the diagnosis of malignancy is the surgical pathology report of the parotidectomy specimen. Cytologist and pathologist will be blind. Diagnostic accuracy is determinded by Bayesian analysis.

Official Title
-----------------
Accuracy of Fine Needle Aspiration Biopsy in the Pre-Operative Diagnosis of Malignancy in Patients With Parotid Gland Masses

Conditions
-----------------
Parotid Gland Neoplasms

Intervention / Treatment
-----------------
* Procedure: aspiration biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with parotid gland masses

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>fine needle aspiration biopsy of the parotid gland mass | Procedure: aspiration biopsy<br>* fine needle aspiration biopsy of the parotid gland masses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of malignancy |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific histopathologic diagnosis |  | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parotid gland neoplasms
Diabetic Retinopathy and Visual Function Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.

Detailed Description
-----------------
The purpose of this study is to evaluate possible mechanisms of central visual loss in patients with diabetes mellitus. The visual loss of interest to be investigated is that associated with macular edema (prior to and following laser photocoagulation treatment) and that associated with panretinal photocoagulation. The evaluation will be performed with psychophysical testing, i.e., static perimetry and contrast sensitivity function. Of particular interest, the mechanisms of visual loss associated with macular edema (prior to and following laser photocoagulation) will be further investigated. Photoreceptor-mediated visual loss will be assessed by measurements of the Stiles-Crawford effect. Visual loss mediated by post-receptoral retinal changes will be assessed by measuring the Westheimer spatial desensitization/sensitization effect.

Official Title
-----------------
Diabetic Retinopathy and Visual Function Study

Conditions
-----------------
Diabetic Retinopathy, Macular Degeneration, Vision, Subnormal

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with diabetic retinopathy that has not been previously treated are eligible for the study. Patients who have had laser photocoagulation (either focal or scatter) are not eligible.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Macular Edema, Diabetic Retinopathy, Macular Edema, Photocoagulation, Psychophysical Testing, Stiles-Crawford Effect
The Effect of Sitagliptin in Type 2 Diabetes Mellitus With Inadequate Glycemic Control (MK0431-118)

Study Overview
=================
Brief Summary
-----------------
to assess the effect of treatment with Sitagliptin (MK0431) on HbA1c (Hemoglobin A1c) and the safety and tolerability of Sitagliptin.

Official Title
-----------------
Open-label, Non Placebo-Controlled Study To Verify the Effect of Sitagliptin In Adult Patients With Type 2 Diabetes and Inadequate Glycemic Control

Conditions
-----------------
Diabetes Mellitus Non-insulin-dependent

Intervention / Treatment
-----------------
* Drug: sitagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either: Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months) Or On A Single AHa

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>sitagliptin | Drug: sitagliptin<br>* Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks<br>* Other names: MK0431;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in HbA1c (Hemoglobin A1c) at Week 18 | Glycosylated hemoglobin (HbA1c) was to be measured as the percentage of hemoglobin that has glucose bound to it; however, the study was terminated early therefore no laboratory tests were performed, and no outcome data was collected. | Baseline and Week 18 |
Effects of a Peripheral Nerve Block on Biomarkers of Pain and Inflammation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of a local anesthetic nerve block on markers of inflammation and pain after a sunburn. This is important because it may provide information regarding the way that nerve blocks help with the treatment of pain and in particular provide preemptive analgesia.

Official Title
-----------------
Effect of Peripheral Nerve Block on Inflammatory and Nociceptive Biomarkers in a UV-B Burn Model in Humans

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: femoral nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Between 18 and 50 years of age 2. Fluent in English language 3. Provide written informed consent 4. Skin pigmentation type II or III&#xA; Exclusion Criteria:1. Current use of prescription drugs interfering with study objective 2. Use of over-the-counter analgesic/anti-inflammatory drugs within 48h of study participation 3. Current acute or chronic pain conditions 4. Significant medical conditions including psychiatric, neurological, and dermatological diseases 5. Pregnancy 6. Allergies to study drug(s) 7. Concomitant participation in other study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: femoral nerve block|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the effect of a preemptive peripheral nerve block on the hyperalgesic response to an artificially induced sunburn. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the effect of a preemptive peripheral nerve block on the release of pro-inflammatory cytokines. |  |  |
Study of Doxorubicin in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
This was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.

Official Title
-----------------
A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study Of Doxorubicin Hydrochloride Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Sun Pharma Advanced Research Company Limited, India, And Caelyx® (Doxorubicin Hydrochloride) Liposome Injection, 2 mg/ml (50 mg/m2 Dose) of Schering-Plough, Belgium, in Patients With Metastatic Breast Cancer/Advanced Ovarian Cancer, Under Fed (Normal Breakfast) Conditions.

Conditions
-----------------
Breast Cancer and Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: SPARC-08-038
* Drug: Ref-08-038


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. Patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years. Subjects who had no evidence of underlying disease Subjects who had signed written consent form Exclusion Criteria: Females who were pregnant, breastfeeding, or are likely to become pregnant Subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results Subjects deemed uncooperative or noncompliant Smoking or consumption of any nicotine products

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC-08-038<br>2 mg/ml | Drug: SPARC-08-038<br>* 2 mg/ml intravenous infusion<br>Drug: Ref-08-038<br>* 2 mg/ml intravenous infusion<br>|
| Active Comparator: Ref-08-038<br> | Drug: SPARC-08-038<br>* 2 mg/ml intravenous infusion<br>Drug: Ref-08-038<br>* 2 mg/ml intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum measured plasma concentration |  | 336 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the plasma concentration versus time curve from time 0 to infinity |  | 336 hours |
Cerebrovascular Autoregulation During and After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The cerebrovascular autoregulation (AR) is impaired in patients with hepatic encephalopathy. Patients with the indication to liver transplantation mostly have mild to severe hepatic encephalopathy. Transplantation should recover the encephalopathy. The aim of the study is to investigate the AR during liver transplantation, with the questions if the AR is impaired at the beginning of surgery and if there are changes in AR. For follow up the AR will be measured at the first days after transplantation at the ICU.

Detailed Description
-----------------
The cerebrovascular autoregulation (AR) will be measured using transcranial doppler and calculating the index of autoregulation Mx. This measurement is continuous with online calculation. So, the possible changes over the whole time of surgery can be detected. Furthermore, the measurement of AR at the ICU will be performed daily at the same time over a measurement period of 60 Minutes and the time course of AR after liver transplantation will be described.

Official Title
-----------------
Cerebrovascular Autoregulation During and After Liver Transplantation

Conditions
-----------------
Encephalopathy, Hepatic, Cerebrovascular Disorders, Liver Failure

Intervention / Treatment
-----------------
* Other: No interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver transplantation age > 18 years Exclusion Criteria: sepsis preexisting cerebral diseases traumatic brain injury pregnancy

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 |
| --- | --- |
| Liver transplantation<br>Patients with liver failure and liver transplantation | Other: No interventions<br>* No intervention is planned in this study<br>* Other names: No intervention is planned in this study;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of cerebrovascular autoregulation during liver transplantation | Measuring cerebrovascular autoregulation during the whole liver transplantation and compare the index of AR at the beginning with index of AR Mx after reperfusion of the transplantated liver | During the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of cerebrovascular autoregulation after liver transplantation | Meaurement of cerebrovascular autoregulation daily for the first 4 days and calculating a time course | First 4 days after transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
encephalopathy, hepatic, autoregulation, cerebrovascular, liver failure, liver transplantation