linjc16/ctgov huggingface dataset:
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the advantages of single trocar cholecystectomy over standard laparoscopic cholecystectomy.

Official Title
-----------------
Comparison of Single Trocar Cholecystectomy to Standard Laparoscopic Cholecystectomy

Conditions
-----------------
Cholelithiasis

Intervention / Treatment
-----------------
* Procedure: Single trocar cholecystectomy
* Procedure: Standard laparoscopic cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-60 symptomatic cholelithiasis ASA 1-2 Exclusion Criteria: pregnancy morbid obesity with BMI>35 other gallbladder pathology like polyps or tumor history of upper abdomen laparotomy suspected choledocholithiasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single trocar<br>Patients will undergo cholecystectomy by the single trocar approach | Procedure: Single trocar cholecystectomy<br>* Patients with symptomatic cholelithiasis will be operated using the single trocar surgery approach<br>|
| Active Comparator: Standard lap cholecystectomy<br>Standard lap choly | Procedure: Standard laparoscopic cholecystectomy<br>* Patients with symptomatic cholelithiasis will undergo a standard laparoscopic cholecystectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and efficacy of a novel approach to minimally invasive surgery techniques. |  | Continuous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess pain associated with the single trocar approach |  | Continuous | 
| To assess scar formation associated with single trocar approach |  | Continuous | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholelithiasis, cholecystitis
Youth Throwers Respond to Stretching

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to document the rates of youth baseball player demographics, incidence of arm pain, usage of different pitch types, and degree of internal rotation contracture in the throwing versus the non-throwing shoulder. We followed a subgroup of players for a year to see if a particular stretch would help reduce the internal rotation contracture.

Detailed Description
-----------------
Introduction: Overhead throwing can cause contracture of the shoulder posterior-inferior glenohumeral ligament which can lead to injuries such as superior labral tears. We show that instruction on stretching can favorably alter progression of posterior contractures. Methods: 1261 male baseball players ages 7-15 completed a questionnaire and shoulder examinations. Measurements of rotation of both shoulders were made with the subjects in the supine position with the scapula stabilized. Glenohumeral internal rotation deficit (GIRD) was calculated. Pitch type and player position, among other variables, were recorded. The prospective cohort was 175 players who were examined twice a year apart. Players with excessive GIRD (exGIRD) were given stretching instruction, and the control group was those without exGIRD who were not given instruction. Change in GIRD as a result of this intervention was documented.

Official Title
-----------------
Shoulder Posterior Capsular Contracture in Youth Baseball Players: It Can be Improved by Stretching

Conditions
-----------------
Shoulder Posterior Capsular Contracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male baseball player ages 8 to 15 Exclusion Criteria: female (suspected hormonal/gender influences on capsular elasticity) prior throwing arm surgery

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 15 Years

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

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 |
| --- | --- | --- |
| Degree of decrease in internal rotation contracture of the shoulder | GIRD is the Glenohumeral Internal Rotation Deficit. It is the difference in the internal rotation of the throwing shoulder compared to the non-throwing shoulder | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder, posterior inferior glenohumeral ligament, posterior capsule, capsular contracture, baseball, throwing injury
Clinical Proteomic Research for the Brain

Study Overview
=================
Brief Summary
-----------------
The study of plasma and urine proteomic profiles in patients with ischemic brain injury is important to better understanding of the mechanisms by which thrombolytic agents or other therapy affects clinical outcomes. The purpose of this study is to study the proteomic profile of patients with ischemic brain injury and compare it to control subjects without ischemic brain injury, subjects with other chronic neurologic diseases or systemic vascular diseases, and pre- and post- therapy which may be associated with, or predictive of, therapeutic outcome. The investigators hypothesize that there is a unique set of proteins expressed in serum and urine in patients with ischemic brain injury that may provide a more complete understanding of ischemic brain injury pathophysiology. Ultimately, this study may provide information of direct relevance to the medical care of a large proportion of patients with ischemic brain injury and other neurologic diseases in the future. And proteomic proteomic profile may provide important information about the roles of specific biomarkers. Perhaps the prevention of ischemic injury related complications.

Official Title
-----------------
Clinical Proteomic Research on the Brain

Conditions
-----------------
Ischemic Brain Injury, Stroke, Healthy Individual, Patent Foramen Ovale (PFO), Neurovascular Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Case Inclusion and Exclusion Criteria: Inclusion Criteria: Ischemic brain injury within 12 hours of symptom onset; Including primary ischemic brain injury from embolism or arterial occlusion or secondary due to increased ICP after trauma, subarachnoid hemorrhage. Exclusion Criteria: Patients who are hemodynamically unstable for venipunctures; Anemic patients (hemoglobin < 11); Children; Pregnant women. Controls Inclusion and Exclusion Criteria: Inclusion Criteria: Healthy adults without any neurologic or systemic disease; Inpatient or outpatient adults with a chronic stroke (greater than 3 months) or chronic neurologic disease such as neurodegenerative disease, movement disorder, demyelinating disease; Inpatient or outpatient adults with systemic vascular disease. Exclusion Criteria: Patients who are hemodynamically unstable for venipunctures; Anemic patients (hemoglobin < 11); Children; Pregnant women.
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 |
| --- | --- | --- |
| Clinical Outcome and Biomarker Outcome |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Foramen Ovale, PFO, Stroke, Ischemic Brain Injury, Neurovascular Disease
Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents

Study Overview
=================
Brief Summary
-----------------
Work requirements for medical trainees result in substantial sleep loss. Sleep loss has been associated with increased levels of certain inflammatory hormones that could have negative impact on blood vessel function. The purpose of this study is to determine the effects of sleep loss on blood hormone levels and blood vessel function in medical trainees.

Detailed Description
-----------------
Context: Sleep loss is associated with increased blood levels of interleukin-6 (IL-6) and C-reactive protein (CRP). Medical residents are often deprived of normal sleep during extended work shifts, but the effects of work-related sleep loss on biomarkers of vascular inflammation and function are unknown. Objective: We sought to test the hypothesis that sleep loss during extended work shifts during medical training is associated with increased circulating levels of pro-inflammatory biomarkers and evidence of vascular dysfunction. Design: Outcome measures were assessed after extended 30-hour work shifts and non-extended 6-hour work shifts in a single-blind, randomized crossover design. Setting: University hospital medical intensive care unit Patients or Other Participants: Twenty-two healthy medical residents were studied during a medical intensive care unit rotation. Main Outcome Measure(s): Sleep related cytokines (interleukin-6 and tumor necrosis factor), serum markers of vascular inflammation (C-reactive protein), and flow-mediated dilation in the brachial artery.

Official Title
-----------------
Effects of Sleep Loss on Endothelial Function and Cytokine Levels in Internal Medicine Residents

Conditions
-----------------
Sleep Deprivation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical resident in MICU rotation Non-smoker Body mass index <28 kg/m2 Exclusion Criteria: Systolic blood pressure >140 mmHg; Diastolic blood pressure >90 mmHg Known history of diabetes mellitus, hypertension, hyperlipidemia Known history of acute or chronic inflammatory or infectious disease Known history of sleep disturbance unrelated to work Pregnancy

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation Mediators [D23.469], Cardiovascular Physiologic Phenomena [G09.330.553]
Transvaginal vs Transabdominal Ultrasound Guided Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
Embryo transfer is the last step in the IVF process. it is now recognized that this step should be done carefully and that it affects success rates. in recent years, sonographic guidance appears to increase success rates.

Detailed Description
-----------------
Embryo transfer is the last step in the IVF process. it involves the insertion of a soft catheter through the uterine cervix. It is now recognized that this step should be done carefully and that it affects success rates. The embyos should be carefully deposited in the cavity. special care should be given to avoid touching the uterine fundus during the procedure. In recent years, sonographic guidance appears to increase success rates.

Official Title
-----------------
Transvaginal or Transabdominal Ultrasound Guided Embryo Transfer- Which is Better?

Conditions
-----------------
In Vitro Fertilization

Intervention / Treatment
-----------------
* Procedure: transabdominal ultrasound
* Procedure: transvaginal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high quality embryos fro transfer Exclusion Criteria: repeated IVF failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abdominal<br>Transabdominal ultrasound guided embryo transfer | Procedure: transabdominal ultrasound<br>* transabdominal ultrasound<br>|
| Active Comparator: Vaginal<br>Transvaginal ultrasound guided embryo transfer | Procedure: transvaginal ultrasound<br>* transvaginal ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction |  | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrasound, IVF, Embryo transfer, Pregnancy rate, female patient undergoing IVF
A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.

Official Title
-----------------
A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

Conditions
-----------------
Insulin Resistance, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Metformin
* Procedure: skin biopsy
* Behavioral: diet and exercise
* Drug: pioglitazone
* Drug: rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT. Family history of type II diabetes. Exclusion Criteria: Critically ill patients, patients will congestive heart failure, renal or liver insufficiency Inability to give consent. History of poor compliance with physician's recommendations

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metformin|nan|
|Procedure: skin biopsy|nan|
|Behavioral: diet and exercise|nan|
|Drug: pioglitazone|nan|
|Drug: rosiglitazone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Dermacyd Teen Care Tangerina Mix - Compatibility

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Teen Care Tangerina Mix.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermal Irritability, Dermal Sensitivity) of Dermacyd Teen Care Tangerina Mix .

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

Intervention / Treatment
-----------------
* Drug: Lactic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin I,II, III e IV Integral skin test in the region Exclusion Criteria: Lactation or gestation Use of Anti-inflammatory and/or immuno-Supression drugs 1 month before the study Personal history of atopy History of sensitivity or irritation for topic products Active cutaneous disease Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lactic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermal irritability will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | Throughout the study |
Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia

Official Title
-----------------
A Multi-Center, Randomized, Blinded, Placebo Controlled, Cross-Over Study to Investigate the Safety and Tolerability of Intravenous VIT-45 in Patients With Iron Deficiency Anemia

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: VIT-45


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects > or = 18 years of age and able to give informed consent Historical laboratory Hgb indicative of anemia within 3 months prior to screening visit Screening Visit laboratory Hgb indicative of anemia Screening Visit ferritin indicative of iron deficiency anemia Exclusion Criteria: Known hypersensitivity to VIT-45 Previously received VIT-45 Parenteral iron in the 4 weeks prior to screening Chronic or serious active infection Malignancy history AST or ALT greater than the upper limit of normal Anticipated need for surgery or initiation of dialysis during the study Pregnant or sexually active females who are not willing to use an effective form of birth control

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VIT-45|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  |  |
ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine if DN-101 plus Taxotere lowers PSA levels, delays or limits disease progression and is safe with minimal side effects.

Detailed Description
-----------------
DN-101 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA). It is a newly formulated pill that contains high amounts of calcitriol, a naturally occurring hormone and the biologically active form of vitamin D. Administration of DN-101 results in much higher blood levels of calcitriol than the body can produce from dietary vitamin D or vitamin D supplements. These higher levels of calcitriol are associated with anti-cancer effects in laboratory models of human cancer. Laboratory models also indicate that calcitriol has synergy with many commonly used chemotherapeutic agents used to treat cancer. Calcitriol, at very low doses, is currently approved for use in patients with chronic kidney failure. DN-101 was specifically designed for cancer and contains 30 times the amount of calcitriol found in the calcitriol pill commercially available today. In order to take an amount of calcitriol equivalent to 1 DN-101 pill, cancer patients would need to swallow 30 pills of the approved, low dose formulation. DN-101 represents a breakthrough in the use of calcitriol in the clinic, because it contains high concentrations of calcitriol and makes it more feasible for patients to stay on regimen.

Official Title
-----------------
A Phase 2/3 Multicenter, Randomized, Double Blind Study of Docetaxel (Taxotere) Plus DN-101 or Placebo in Androgen Independent Prostate Cancer (AIPC)

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

Intervention / Treatment
-----------------
* Drug: calcitriol
* Drug: docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Three rising PSA measurements OR a new metastatic lesion Adequate liver and kidney function Ongoing hormonal therapy No hospitalization for angina, heart attack or congestive heart failure within the last 12 months No kidney stones in the last 5 years

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

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

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: calcitriol|nan|
|Drug: docetaxel|nan|

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
-----------------
Prostate Cancer, Androgen Independent Prostate Cancer