linjc16/ctgov huggingface dataset:
Four-Drug Combination Treatment in Hiv-Infected Subjects Failing Therapy With Antiretroviral Regimens

Study Overview
=================
Brief Summary
-----------------
This is a 48 week study for HIV-infected patients who have failed several regimens including PI's, NNRTs and NRTIs. Patients will be randomly selected to be in 1 of 4 groups. Three of the 4 groups will contain capravirine in different doses combined with Kaletra and nucleosides and one of the groups will be a combination of Kaletra and nucleosides without the capravirine.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Dose-Ranging Study Of Capravirine (AG1549) In Combination With Kaletra (Trademark) and At Least 2 Nucleoside Reverse Transcriptase Inhibitors in Hiv-Infected Subjects Who Have Failed Antiretroviral Regimens Containing Protease Inhibitors, Nonnucleoside Reverse Transcriptase Inhibitors, and Nucleoside Reverse Transcriptase Inhibitors

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

Intervention / Treatment
-----------------
* Drug: capravirine
* Drug: Kaletra
* Drug: 2 NRTIs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infected male or female at least 18 years of age HIV RNA level >1000 copies/mL at screening Subject has failed regimens that included at least 1 protease inhibitor but not more than 3 protease inhibitors, at least 1 nonnucleoside reverse transcriptase inhibitor, and least 2 nucleoside reverse transcriptase inhibitors Adequate renal function Adequate hematological function Adequate liver function Exclusion Criteria: Women who are pregnant or lactating No previous experience with Kaletra

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capravirine|nan|
|Drug: Kaletra|nan|
|Drug: 2 NRTIs|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the optimal safe and effective dose of capravirine in combination with Kaletra plus at least 2 NRTIs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the relationship of HIV baseline resistance (genotype and phenotype) to virologic outcome |  |  | 
| the population pharmacokinetics of capravirine and lopinavir/ritonavir (Kaletra) using mixed-effects modeling |  |  | 
| the pharmacokinetic drug-drug interactions between capravirine and Kaletra and selected concomitant medications |  |  | 
| changes in subject-reported health status and HIV symptoms using the Medical Outcomes Study - HIV Health Survey (MOS-HIV) and the Symptoms Distress Module (National Institute of Allergy and Infectious Diseases Adult AIDS Clinical Trials Group) |  |  |
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Study Overview
=================
Brief Summary
-----------------
Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media

Official Title
-----------------
Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates

Conditions
-----------------
Otitis Media

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Main inclusion criteria: Children >= 2 months and =< 5 years Spontaneous draining AOM =< 2 days Main Exclusion Criteria: exclusion criteria: Previous operation of the ear Chronic otitis media or tube placement with drainage >= 3 days Chronic disease/immune deficiency

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serotype distribution |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Otitis Media, Serotype distribution
Early Diagnosis and Treatment Standardization of Delirium

Study Overview
=================
Brief Summary
-----------------
Observe the characteristics of delirium patients, searching for early diagnostic methods or finding risk factors Design a guideline for delirium, diagnosis or treatment

Detailed Description
-----------------
The study is consisted of two parts; First, observational study of gastric cancer patients admitted to hospital, diagnosing the presence of delirium or subsyndromal delirium and collecting patient data, including assessment, self-report surveys, and electronic medical records. Second, Designing a guideline for treating delirium patients in Korea using the study data and reviewing other studies, guidelines.

Official Title
-----------------
Early Diagnosis and Treatment Standardization of Delirium

Conditions
-----------------
Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Curable malignant gastric cancer Exclusion Criteria: Gastrointestinal stromal tumor Uncurable cancer

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 |
| --- | --- | --- |
| Delirium Rating Scale-98 | Delirium rating tool, score of 8 for subsyndromal delirium, 15 for delirium | Till 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional assessment of cancer therapy - gastric cancer | Quality of life measuring tool for gastric cancer | Till 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, postoperative, subsyndromal delirium, quality of life
Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP)

Study Overview
=================
Brief Summary
-----------------
Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.

Detailed Description
-----------------
The pilot study purpose is to demonstrate that the tutorial which is a part of the device software, is giving sufficient training for the intended users.

Official Title
-----------------
Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients

Conditions
-----------------
Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Device: ForeseeHome


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capable and willing to sign a consent form and participate in the study Subjects diagnosed as intermediate AMD in at least one eye Age >50 years VA with habitual correction >20/60 in the study eye Ability to speak, read and understand instructions in Hebrew Familiar with computer usage Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP. Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye Participation in another study with the exclusion of AREDS study Patients diagnosed with geographic atrophy (GA)

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>Intermediate AMD Patients | Device: ForeseeHome<br>* human factor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who manage to use the device as in a daily testing |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HMP, PHP, AMD, CNV, HPHP
The Effect of Weight Loss on Ovarian Reserve

Study Overview
=================
Brief Summary
-----------------
Obesity affects on fertility. Obese women have lower pregnancy rate after infertility treatments.They need more doses of hormone during ovarian stimulation, more days for stimulation. During IVF treatment less oocytes are collected and the quality of embryo also harmed. The first line treatment for those women with obesity and infertility is weight loss. The investigators' hypothesis is that weight reduction improves ovarian reserve and fertility treatment outcome.

Detailed Description
-----------------
The investigators have outpatient clinic for obesity and infertility. the patients undergoing program of 3 months with diet and physical activity. Blood sample will take at the beginning of the program and at the end. The blood sample will evaluate for: AMH, Adiponectin, Leptin, CRP, Colesterol, CRP, Smac in addition TVUS will perform to evaluate AFC.

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Dietary Supplement: weight loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing weight loss program Exclusion Criteria: dropp out before comletion the weighy loss target

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| overweight women with infertility<br> | Dietary Supplement: weight loss<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti Mullerain Hormone (AMH)and AFC before and after weight loss | AMH and AFC will measure at the first visit and after 3 months of weight loss program | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MMA, AFC, Ovarian reserve
Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients

Study Overview
=================
Brief Summary
-----------------
General anesthesia (GA) and paralysis are factors which facilitate atelectasis formation, especially in obese patients. Spontaneous breathing can reduce the amount of atelectasis. In this study, the investigators are comaparing obese patients undergoing hip arthroplasty in GA versus spinal anesthesia. Distribution of ventilation during and after anesthesia is assessed by eletrical impedance tomography (EIT).

Official Title
-----------------
Impact of Spontaneous Breathing on Ventilation Distribution in Obese Patients

Conditions
-----------------
Obesity, Hip Arthroplasty, General Anesthesia, Spinal Anesthesia, Atelectasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >30 age 18-85 elective hip arthroplasty in general anesthesia or spinal anesthesia Exclusion Criteria: pregnancy/breastfeeding allergies against drugs used for the anesthesia contraindications for EIT severe cardiac or pulmonary comorbidities unable to consent or understand/follow study

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 |
| --- | --- |
| General Anesthesia<br> | |
| Spinal Anesthesia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arterial pO2 on room air |  | 24hrs | 
| Center of Ventilation | measured by EIT | 24hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Flow |  | 24hrs |
Clinical, Radiographic and Laboratory Analysis of Failures of Joint Replacements

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to more fully understand the reason(s) that joint replacement implants fail and to better identify diagnosis and outcome methods both pre-operatively and post-operatively with revision surgery. Analysis of joint replacement failure will include a through analysis of laboratory, radiographic, implant, surgical and demographic data.

Detailed Description
-----------------
To examine all clinical data in patients with failed total hip and total knee replacements including patient demographics (age, sex, comorbidities, etc.), patient clinical data (history and physical exam and lab findings) and including implant specifications and radiographic findings (for implant type, implant size, implant bearing surface type, position, stability, etc.).

Official Title
-----------------
Defining the Inflammatory Cytokines in Patients With Adverse Reactions to Metal-on-Metal Hip Replacements

Conditions
-----------------
Joint

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age failed hip or knee replacement willing to sign informed consent Exclusion Criteria: none

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Revision,
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months

Study Overview
=================
Brief Summary
-----------------
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

Detailed Description
-----------------
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance. All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

Official Title
-----------------
A Multi-Center, Open-Label Evaluation of the Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Silodosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males in good general health and at least 50 years of age, who have completed SI04009 or SI04010. Exclusion Criteria: Medical conditions that would confound the efficacy evaluation. Medical conditions in which it would be unsafe to use an alpha-blocker. The use of concomitant drugs that would confound the efficacy evaluation. The use of concomitant drugs that would be unsafe with this alpha-blocker.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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: Silodosin<br>Silodosin 8 mg per day with food | Drug: Silodosin<br>* 8 mg daily<br>* Other names: Rapaflo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | All reported adverse events were recorded. Clinically significant abnormal laboratory values or other clinical findings upon examination were also recorded as adverse events. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | The IPSS is a symptom severity scale from 0 to 35 that is derived from a 7 item questionnaire. 0 indicates no symptoms and 35 indicates most severe symptoms. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
benign prostatic hyperplasia, alpha blocker
Comparison of Intra Ocular Pressure After Insertion of the LMA Supreme and LMA Proseal in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The investigators enrolled pediatric patients who are undergoing strabismus surgery. The investigators insert either an I-gel or laryngeal mask airway Supreme and measure the intraocular pressures.

Detailed Description
-----------------
We already know that tracheal intubation increased intraocular pressure. We tried to evaluate the change of the intra ocular pressure increase before, during and after insertion the I-gel and LMA Supreme supraglottic airway devices. We enrolled the pediatric patients who are undergoing to strabismus surgery.

Official Title
-----------------
Intra Ocular Pressure After I-gel and Supreme Insertion

Conditions
-----------------
Intra Ocular Pressure

Intervention / Treatment
-----------------
* Device: I-gel
* Device: LMA Supreme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatrics > 2 years pediatrics < 7 years undergoing strabismus surgery Exclusion Criteria: pediatrics < 2 years pediatrics > 7 years neuromuscular blockage using

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 7 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I-gel intra ocular pressure<br>supraglottic airway device | Device: I-gel<br>* supraglottic airway device without cuff<br>|
| Active Comparator: LMA Supreme intra ocular pressure<br>supraglottic airway device | Device: LMA Supreme<br>* supraglottic airway device with cuff<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra ocular pressure | measurement the intra ocular pressure before, during and after insertion of the device | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vomiting |  | 2 hour | 
| bradicardia |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra ocular pressure, I-gel, LMA Supreme, strabismus surgery
Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term results after transcatheter mitral valve repair

Detailed Description
-----------------
Patients with transcatheter mitral valve repair are followed for 10 years to demonstrate efficacy and safety.

Official Title
-----------------
Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)

Conditions
-----------------
Mitral Valve Regurgitation

Intervention / Treatment
-----------------
* Device: CE certified mitral valve repair systems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mitral valve regurgitation transcatheter mitral valve repair Exclusion Criteria: no written informed consent

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
Interventional Model Description: CE certified mitral valve repair systems
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CE certified mitral valve repair systems<br>CE certified transcatheter mitral valve repair systems | Device: CE certified mitral valve repair systems<br>* Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cerebral and cardiac events | Major adverse cerebral and cardiac events | 10 years |