linjc16/ctgov huggingface dataset:
Gabapentin for the Treatment of Tinnitus

Study Overview
=================
Brief Summary
-----------------
The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory were enrolled.

Official Title
-----------------
Gabapentin for the Relief of Idiopathic Subjective Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Drug: Gabapentin (Neurontin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, between the ages of 18 and 70 Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month's duration or greater Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory. Exclusion Criteria: The symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. Patients who have used these drugs within 30 days of screening will not be enrolled. Impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male Ccr = (140 -age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter); and adult female Ccr = [(140 - age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter)] X 0.85,whereCcr indicates creatinine clearance. Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone Patients with any serious or unstable medical or psychiatric condition. Patients whose ability to give informed consent is in question.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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: Gabapentin (Neurontin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Handicap Inventory Score from Baseline to Week 8 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory Score from Baseline to Week 8 |  |  | 
| Brief Symptom Inventory Score from Baseline to Week 8 |  |  | 
| Epworth Sleepiness Scale Score from Baseline to Week 8 |  |  |
Pilot Study of APD209 in Cancer Cachexia

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To assess the efficacy of APD209 in adult patients with active cachexia associated with advanced malignancy and not caused by simple starvation. Secondary Objective: To assess the safety of APD209 in patients with advanced malignancy and active cachexia.

Official Title
-----------------
Open-Label, Pilot Phase I/II Study of the Efficacy and Safety of APD209 in Patients With Cachexia and Advanced Malignancy

Conditions
-----------------
Cancer-related Cachexia

Intervention / Treatment
-----------------
* Drug: APD209


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Involuntary loss of weight of >= 2% in 2 months or >= 5% in 6 months, and ongoing in recent weeks, without (or with successfully treated) secondary causes of impaired oral nutritional intake (simple starvation).

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: APD209<br> | Drug: APD209<br>* Oral tablets twice per day for 56 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle size and function |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cachexia, neoplasms
A Prospective Analysis of Biofilm in Urinary Catheters Study

Study Overview
=================
Brief Summary
-----------------
To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc urine sample would also be collected from the same subject, and analyzed.

Detailed Description
-----------------
After obtaining informed consent, concurrent with the changing of the Foley catheter in the clinic, would be obtaining a 30 cc. sample of urine which would also be fast frozen and stored in a -81 degree freezer until shipped to the Venter clinic on dry ice.

Official Title
-----------------
A Prospective Anaylsis of Biofilm in Urinary Catheters Study

Conditions
-----------------
Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 18 years of age. Subject is attending weekly office visits at SW Wound Care Center as an out- patient. Subject must have an indwelling Foley catheter. Subject is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment. Subject is willing and able to comply with all specified care and visit requirements. Exclusion Criteria: 1. Subject refuses to participate in the study. 2. Subject is expected to be non-compliant. 3. Subject is a resident in a nursing home, or institutionalized. 4. Subject is pregnant. 5. Subject has a Legally Authorized Representative -

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 |
| --- | --- | --- |
| To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. | the proteomics, metabolomics and metagenomics (omics) data will be analyzed and integrated in order to understand the microbial population dynamics and the interactions with the human subject host responses which may include antibacterial defenses, local inflammation, immune tolerance towards bacteria | Over a period of 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Standard Foley Catheter
ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. ITGA4 gene (CD49d) encodes a member of the integrin alpha chain family of proteins and is considered a negative prognosticator in CLL with aggressive course and short time to treatment. The aim of the study: is to investigate ITGA4 gene expression pattern and to explore its methylation heterogeneity in CLL.

Official Title
-----------------
ITGA4 Gene Methylation Status in Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed CLL. Exclusion Criteria: ▪ Patients previously diagnosed as CLL and received treatment before. Patients with other solid tumors.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient group<br> | |
| control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ITGA4 gene expression pattern and its methylation heterogeneity in chronic lymphocytic leukemia | Detection of ITGA4 gene expression and ITGA4 gene methylation in blood samples in patients with chronic lymphocytic leukemia, Briefly, total RNA and genomic DNA extraction from fresh peripheral blood samples by Real-time -RT-polymerase chain reaction system (RT-PCR) will be carried out. Rate of ITGA4 gene expression and its methylation will be recorded. | 1 year following the startpoint of the study |
Sonication of Explanted Breast Implants for Detection of Subclinical Infection

Study Overview
=================
Brief Summary
-----------------
Objective. Capsular contracture is a frequent complication after breast implantation with unclear etiology. Summary Background Data: Microorganisms may trigger chronic periimplant inflammation with subsequent capsular fibrosis. Study Hypothesis: The investigators hypothesize that with sonication adherent microorganisms can be detected on removed implants . Methods: In a prospective multicentre study all breast implants explanted are collected to be analyzed by sonication. The resulting culture results are correlated with patient, surgical and implant characteristics.

Detailed Description
-----------------
The study is performed in order to find a correlation between the degree of capsular fibrosis and presence of biofilm bacteria on the surface of the implant.

Conditions
-----------------
Implants, Breast

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or more Undergoing breast implant removal for any reason at one of the participating center Explantation of breast implant performed between February 2006 and March 2009 Exclusion Criteria: Obvious contamination of the breast implant in the operating room or during transportation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Removed breast implants for any reason<br> | |

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
-----------------
Breast implants, capsular contraction, sonication, biofilm, Complications, surgery
Rehabilitation in Subjects With Moderate Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
The study is a single-center randomized, unblinded, placebo-controlled study to investigate the effect of pulmonary rehabilitation in subjects with moderate chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Early Detection and Rehabilitation of Subjects With COPD - Rehabilitation in Moderate COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Behavioral: Pulmonary rehabilitation
* Behavioral: conventional care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of moderate COPD. Motivation for Pulmonary rehabilitation. Exclusion Criteria: Comorbidity contraindicating rehabilitation. Participation in pulmonary rehabilitation within the last year. Cognitive disorders limiting the ability to participate in physical training and education sessions.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary rehabilitation<br>A standardized 7 week rehabilitation program, including physical training and education. | Behavioral: Pulmonary rehabilitation<br> <br> |
| Placebo Comparator: Control<br>Conventional care | Behavioral: conventional care<br> <br> |

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
-----------------
Effect of Pulmonary rehabilitation., Exercise capacity, Quality of life
Chemomechanical Caries Removal Using Papain Gel

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of a papain-based gel in caries removal.

Detailed Description
-----------------
Twenty children with at least two carious molar teeth without pulpal involvement participated in this randomized clinical trial. A total of 40 teeth were randomly divided into two treatment groups: group A, papain-based gel; and group B, conventional technique. Data collection included the time required for caries removal, need for local anesthesia, degree of discomfort, changes in the number of viable bacteria, and clinical evaluation of glass ionomer-cement restorations 6-month post-treatment.

Official Title
-----------------
Chemomechanical Caries Removal Using a Papain-Based Gel: A Randomized Clinical Trial

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Procedure: Chemomechanical Caries Removal
* Procedure: Conventional method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with active caries without pulpal involvement in two deciduous molar teeth participated in the trial. The caries were located on the occlusal surface. Exclusion Criteria: Children with pathological process of the dental tissue, with pulpal involvement

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHEMOMECHANICAL CARIES REMOVAL<br>Dental caries removal using papain based gel | Procedure: Chemomechanical Caries Removal<br>* Chemomechanical Caries Removal Using A Papain-Based Gel<br>|
| Active Comparator: conventional method<br>Dental caries removal using rotatory instrument | Procedure: Conventional method<br>* Dental caries removal using rotatory instrument<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| restauration evaluation | the restauration will be assessed by clinical examination for detection the current caries | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discomfort or pain | The Faces Pain Scale was used to evaluate the need for local anesthesia during the procedure. The child was asked to choose a face matching the intensity of his or her pain experience during the procedure. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental caries, caries removal, chemomechanical caries removal
Effect of Bariatric Surgery on Kidney Function

Study Overview
=================
Brief Summary
-----------------
Primary hypothesis: A large reduction in weight is not associated with a change in accurately measured glomerular filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma clearance (51Cr-EDTA)). Secondary hypothesis: A large reduction in weight is associated with a greater change in estimated GFR (The Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR. Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately measured GFR.

Official Title
-----------------
Effect of Bariatric Surgery on Kidney Function

Conditions
-----------------
Obese Subjects Who Will Undergo Gastric By-pass Surgery

Intervention / Treatment
-----------------
* Procedure: Gastric by-pass surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, older than 18 years of age Appointed to gastric by-pass surgery on Hvidovre Hospital, Denmark Exclusion Criteria: Withdrawal of surgical indication Severe oedema or ascites

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bariatric surgery<br> | Procedure: Gastric by-pass surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in accurately measured GFR |  | Up to 6 months and 18 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in estimated GFR (as measured by the MDRD formula, the Cockcroft Gault formula, CKD-EPI formula and CKD-EPI with cystatin C formula). |  | Up to 6 months and 18 months after surgery | 
| Change in 24hour blood pressure |  | Up to 6 months and 18 months after surgery | 
| Change in arterial stiffness (as measured by sphygmocor) |  | Up to 6 months and 18 months after surgery | 
| Change in body composition, as measured by Dual-energy X-ray absorptiometry scan (DXA-scan) |  | Up to 6 months and 18 months after surgery | 
| Change in accurately measured GFR compared with change in estimated GFR |  | Up to 6 months and 18 months after surgery |
Ulipristal Acetate 10 mg and Asisted Reproduction

Study Overview
=================
Brief Summary
-----------------
Demonstrate an 15% increase in the rate of clinical pregnancy in women with inoperable intramural fibroids not distorting the uterine cavity within a program OVD, after administration of uPA in a dose of 10 mg orally daily for 12 weeks

Official Title
-----------------
Uterine Fibroids: Impact of Ulipristal Acetate 10 mg on ART Results

Conditions
-----------------
Intramural Fibroids, Uterine Fibroids

Intervention / Treatment
-----------------
* Drug: Ulipristal Acetate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients> 18 and <50 years Patients who undergo a first / second cycle OVD Patients who present within 1-3 intramural myomas> 2 cm and <5 cm that do not distort the cavity, Type 3 and 4 of the FIGO classification (Figure 1). Miomas inoperable for medical judgment or patient desire, you want to avoid the post-surgical time waiting 6 months / 1 year before you can submit to TRA Patients who have undergone previous myomectomy who prefer to avoid having surgery Exclusion Criteria: History of endometrial changes in patients (hyperplasia) Presence of other endometrial pathologies: polyps, scars of previous cesarean complicated adenomyosis foci, suspected adhesions Simultaneous participation in another clinical study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Ulipristal Acetate 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks | Drug: Ulipristal Acetate<br> <br> |
| Placebo Comparator: Control<br>Placebo, 10 mg, Oral administration. Dose: 10 mg per day, single dose, duration 12 weeks | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in the rate of clinical pregnancy |  | 12 weeks |
Phase IV Study of FDA Approved, Once-Daily GRALISE™(Gabapentin) Tablets for the Treatment of Postherpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
Study objective is to assess the safety and effectiveness of once- daily GRALISE in clinical practice

Detailed Description
-----------------
Open Label, single arm, 2wk titration, 6 wk stable dosing, 8 wk of total treatment, 1wk dose tapering

Official Title
-----------------
A Phase 4, Open Label, Study of Safety and Effectiveness of GRALISE™(Gabapentin) Tablets in the Treatment of Patients With Postherpetic Neuralgia in Clinical Practice

Conditions
-----------------
Post Herpetic Neuralgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or Women 18 years or older who are suffering from PHN Exclusion Criteria: Patient is Pregnant or a nursing mother Patient has hypersensitivity to gabapentin Patient has an estimated creatinine clearance of <30 mL/min or is in hemodialysis

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 |
| --- | --- |
| Open Label<br>Cohort by age- - Patients >70 Yrs old | |
| Open label<br>Cohort by age- - Patients < 70 Yrs old | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Study in LOCF VAS | Change from baseline in pain score on visual analog scale (VAS) (intensity scored from No Pain (0mm) to Worst Possible Pain (100mm)) at Week 8 of treatment; last observation carried forward (LOCF) analysis | 8 weeks (Baseline and Week 8) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PHN, Post Herpetic Neuralgia, Shingles, HZ roster