linjc16/ctgov huggingface dataset:
A Phase IV Study of BMS-232632 in HIV+ Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to learn if BMS-232632 administered as Atazanavir/ritonavir (ATV/RTV) is superior to an anti-retroviral regimen including Lopinavir/ritonavir (LPV/RTV), as assessed by an increased brachial artery flow-mediated vasodilatation (FMD), in HIV-infected patients. The safety of this treatment will also be studied.

Official Title
-----------------
A Phase IV, One-arm, Open-label, Multicenter Study Evaluating Effect of Treatment Change to Atazanavir/Ritonavir on Brachial Endothelial Function of HIV Infected Patient Receiving Function in HIV Infected Patient Receiving Potent Antiretroviral Combination Therapy

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Atazanavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Documented Metabolic Syndrome by at least 3 of the following parameters: Abdominal obesity, assessed by waist circumference (for men >103 cm, for women >88 cm). Triglycerides > 150 mg/dl. HDL cholestrol (for men <40 mg/dl, for women <50 mg/dl). Blood pressure > or equal to 130/85 mm Hg. Fasting serum glucose > or equal to 110 mg/dl. HIV RNA < 50 copies/mL. IP within 3 months prior to selection. Exclusion Criteria: -Treated Metabolic Syndrom

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate a significant increase in brachial artery FMD after a 24-week ATV/RTV treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in FMD from ref. value after a 12-wk ATV/RTV treatment period. |  |  | 
| The proportion of pts w/ virologic rebound after a 24-wk ATV/RTV treatment period. |  |  | 
| The proportion of pts w/ metabolic syndrome after a 24-wk ATV/RTV treament period.- |  |  |
Can a Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone?

Study Overview
=================
Brief Summary
-----------------
Meniscus does not always heal when sutured. The investigators will make small holes in the meniscus before repair to promote more bleeding. The investigators expect that will help the meniscus to heal better.

Detailed Description
-----------------
RCT study to evaluate the effect on trephination together with meniscal repair on meniscus healing after repair.

Official Title
-----------------
A Simple Trephination Increase the Heeling Potential for All-inside Meniscal Repair in the Vascular Zone

Conditions
-----------------
Rupture; Meniscus, Bucket Handle

Intervention / Treatment
-----------------
* Procedure: trephination
* Procedure: Normal meniscal repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults who have a meniscus repaired. Exclusion Criteria: Meniscus not fit for repair. Patients not fit for the repair regime. Arthrosis > stadie 2 (ICRS). Prior attempt of repair of the meniscus.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trephination<br>A 1 x 10 mm pricker are used for the trephination of the meniscus before normal meniscal repair. | Procedure: trephination<br>* Artroscopic meniskal repair with trephination.<br>|
| Placebo Comparator: Normal meniscal repair<br>standard operation. Normal meniscalrepair. | Procedure: Normal meniscal repair<br>* Artroscopic meniskal repair without trephination.<br>* Other names: Normal meniscal suture with FastFix device.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Questionnaire | Primary outcome are differences between the to arms in the most relevant subgroup Function, sports and recreational activities in the KOOS questionnaire. | 4 month | 
| KOOS Questionnaire | Primary outcome are differences between the to arms in the most relevant subgroup Function, sports and recreational activities in the KOOS questionnaire. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical meniscus healing |  | 4 month |
Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach

Study Overview
=================
Brief Summary
-----------------
This study was designed to investigate the analgesic effect of bilateral superficial cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The investigators hypothesized that bilateral superficial cervical plexus blockade would reduce the patient's pain score by more than 10 (on a VAS scale of 0 100) compared to a placebo group and control group.

Official Title
-----------------
Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Procedure: Bilateral superficial cervical plexus block
* Procedure: placebo
* Procedure: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class 1 or 2 adult patients scheduled for robot-assisted endoscopic thyroidectomy Exclusion Criteria: Patient refusal Bleeding diathesis Allergies to local anesthetics Patient unable to read consent form (Foreigner, illiterate) Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B<br>Group B = Nerve block group | Procedure: Bilateral superficial cervical plexus block<br>* Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml<br>|
| Placebo Comparator: Group L<br>Group L = Local wound infiltration group | Procedure: placebo<br>* Procedure: Bilateral superficial cervical plexus block with normal saline 20ml<br>|
| Active Comparator: Group C<br>Group C = Control group | Procedure: Control group<br>* Procedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue pain score |  | Immediate post-operation (at recovery room) (day 1) |
Percutaneous Transluminal Forceps Biopsy

Study Overview
=================
Brief Summary
-----------------
To evaluate during a 7 months period the efficacy, safety and accuracy of percutaneous transluminal forceps biopsy combined with transhepatic biliary drainage in patients with biliary stricture

Detailed Description
-----------------
Biological parameters of liver function, histopathology of specimens, comparison with others clinical and pathological data (imaging follow up, percutaneous biopsy, surgical biopsy, endoscopic biopsy) were recorded Comparison between pathological findings of surgery or endoscopy or percutaneous biopsy and specimens coming from biliary forceps biopsy follow up of the patient 12 months after biopsy Evaluation of complications, accuracy

Official Title
-----------------
Percutaneous Transluminal Forceps Biopsy Combined With Transhepatic Biliary Drainage in the Management of Patients With Obstructive Jaundice: Efficacy, Safety and Accuracy

Conditions
-----------------
Biliary Stricture, Biopsy Wound, Oncology

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biliary strictures without histology available Exclusion Criteria: Pregnant patients Children

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

| Intervention/Treatment |
| --- |
|Procedure: biliary biopsy|biliary biopsy through a percutaneous approach during a percutaneous biliary drainage|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of PTBD | Efficacy of PTBD : bilirubinemia after PTFB at Day 7 | 7 days | 
| accuracy for percutaneous biliary biopsy (PTFB) | Accuracy of PTFB : percentage of true positive and true negative results by pathologists | from baseline up to 1 month | 
| incidence of PTFB-related adverse events | Number of patients with PTFB related adverse-events as assessed by Society of Interventional Radiology Standards of Practice Committee classification | up to 1 month after procedure |
Down Syndrome and Continuous Positive Pressure Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and tolerability of Continuous Positive Pressure for SAOS in Down Syndrome patients.

Official Title
-----------------
Follow-up of the Therapeutic Coverage by Continuous Positive Pressure of the Obstructive Sleep Apnea Syndrome for Down Syndrome Patients

Conditions
-----------------
Down Syndrome, Obstructive Sleep Apnea Syndrome

Intervention / Treatment
-----------------
* Device: Continuous Positive Pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Down Syndrome patients with an Obstructive Sleep Apnea Syndrome more than 18 years old Exclusion Criteria: predictable non-compliance of device non-compensated cardiopathy non-stable thyroxin treatment non-stable diabetes

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPC<br>Night time device for positive pulmonary pressure | Device: Continuous Positive Pressure<br>* Nighttime continuous positive pressure device, to be used every day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on psychometrical and dementia scales after a 3-month treatment period (and if possible, after 12 months) |  | 0 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | 0, 3 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down Syndrome, Obstructive Sleep Apnea Syndrome, Continuous Positive Pressure, Hypersomnia
Registry Experience at the Washington Hospital Center, Des - Taxus Liberte Versus Xience V

Study Overview
=================
Brief Summary
-----------------
Multicenter, retrospective registry to collect 9-12 month follow-up data to evaluate major adverse cardiac events in patients whom have undergone percutaneous coronary intervention and received either Taxus Liberte or Xience V.

Official Title
-----------------
Registry Experience at the WAshington Hospital CenteR, DeS - Taxus Liberte vs Xience V

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older, both genders Underwent PCI with Taxus Liberte (alone) or Xience (alone) Exclusion Criteria: Underwent PCI with a non-Taxus Liberte or Xience V DES during the same procedure Received both Taxus-Liberte and Xience-V during the same index procedure Patients not taking, or unable to take, dual antiplatelet therapy (aspirin plus clopidogrel or prasugrel).

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 |
| --- | --- |
| Xience V<br>Those who have only received a Xience V stent | |
| Taxus Liberte<br>Those who have received only a Taxus Liberte stent | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events, | A composite of all-cause death, Q-wave myocardial infarction, and target vessel revascularization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent thrombosis |  | 1 year | 
| Target vessel revascularization |  | 1 year | 
| Cardiac death |  | 1 year |
Vitamin D Supplementation for the Prevention of Acute Respiratory Infections: a RCT in Young Finnish Men

Study Overview
=================
Brief Summary
-----------------
Vitamin D intervention effects on the prevention of acute respiratory tract infections among Young Finnish Men

Official Title
-----------------
Vitamin D Supplementation for the Prevention of Acute Respiratory Tract Infection: a Randomized, Double-blinded and Plasebo Controlled Trial Among Young Finnish Men

Conditions
-----------------
Vitamin D Deficiency, Respiratory Tract Infections

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria; Male 18-29 years of age examined as Healthy according to Finnish Military Health Care regulations Exclusion Criteria Female age > 30 yrs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

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

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

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 D3<br>20 mikrog vitamin D3 daily, 3 months | Dietary Supplement: Vitamin D3<br>* 20 mikrog vitamin D3 daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days off duty due to acute respiratory tract infections | The number of Days off Duty recommended by Health care personnel will be calculated in order to show the severity and last of the disease. By that it could be estimated how the disease will effect on duty service. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days off duty due to musculoskeletal disorders | The number of days off Duty because of musculoskeletal disorders will be index for outcome. The index will be compared between plasebo and intervention group | 4 months | 
| Aerobic and muscular fitness | Used test are Cooper-test for aerobic and Finnish military fitness test for muscular fitness performance. The index will be compared between plasebo and intervention group | 4 months |
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.

Study Overview
=================
Brief Summary
-----------------
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Official Title
-----------------
An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B

Conditions
-----------------
Hepatitis B, Chronic

Intervention / Treatment
-----------------
* Drug: peginterferon alfa-2a (40KD) [PEGASYS]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-65 years of age; HBeAg negative chronic hepatitis B; treated with lamivudine for >=6 months; demonstrated lamivudine resistance; compensated liver disease. Exclusion Criteria: severe hepatic dysfunction; previous treatment with antivirals other than lamivudine; immunosuppressant treatment in past 6 months; co-infection with hepatitis A, C, or D virus or human immunodeficiency virus; medical condition associated with chronic liver disease.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: peginterferon alfa-2a (40KD) [PEGASYS]<br>* 180 micrograms sc weekly for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of ALT, and HBV-DNA <10,000 copies/mL |  | Week 96 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of ALT, and HBV-DNA <10,000 copies/mL |  | Weeks 48 and 72 | 
| HBsAg loss and anti-HBs seroconversion |  | Weeks 48, 72 and 96 | 
| AEs and lab parameters |  | Throughout study |
Genetic Influence on Statin Pharmacodynamics

Study Overview
=================
Brief Summary
-----------------
The study intends to investigate whether genetics influence how individuals respond to statins (clinical outcomes and changes in carotid intimal media thickness)

Official Title
-----------------
An Observational Study Investigating Genetic Influences on Clinical Outcomes and Change in Carotid Intimal Thickness in Adults Taking Atorvastatin, Simvastatin, or Lovastatin

Conditions
-----------------
Hyperlipidemia, Hypercholesterolemia, Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recently (within past 3 months) started taking atorvastatin, lovastatin, or simvastatin Exclusion Criteria: concomitant uses of medications, supplements, or OTCs known to interfere with statin metabolism

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 |
| --- | --- |
| statin<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid intimal media thickness (CIMT) | CIMT measurements will be performed at baseline (within 3 months of starting statin) and at 6, 12, 18, and 24 months. Change in CIMT is considered a surogate measure of atherosclerotic progression. | 2 years |
Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether the use of a preoperative antibiotic bowel regimen is associated with a reduced risk of deep organ/space surgical site infection in gynecologic oncology surgery.

Detailed Description
-----------------
This is a retrospective chart review study. Patients who underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist will be identified and their chart reviewed for demographic data of age, race, BMI, comorbidities, and type of surgery. Those patients who had a deep organ/space surgical site infection within 30 days postoperatively will be identified. The numbers of these infections before and after August 2020, at which time all patients moving forwards were prescribed antibiotic bowel preparation, will then be statistically analyzed and compared to see if the institution of the antibiotic bowel preparation was associated with a reduction in surgical site infection.

Official Title
-----------------
Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery

Conditions
-----------------
Surgical Site Infection, Surgical Complication, Gynecologic Cancer

Intervention / Treatment
-----------------
* Other: Diagnosed with Surgical Site Infection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist Exclusion Criteria: Unscheduled surgery Intraoperative consult by a WellSpan gynecologic oncologist

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Antibiotic Bowel Prep<br>Patients who did not receive a preoperative antibiotic bowel preparation | Other: Diagnosed with Surgical Site Infection<br>* As an observational study, this notates patients who were diagnosed with a deep organ/space surgical site infection within 30 days of surgery<br>|
| Antibiotic Bowel Prep<br>Patients who did receive a preoperative antibiotic bowel preparation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection Rates Associated with Antibiotic Bowel Prep | Rate of surgical site infection rate as associated with or without use of antibiotic bowel preparation | 2019-2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgical site infection, gynecologic cancer