linjc16/ctgov huggingface dataset:
A Study of Combivir Plus Abacavir Plus 141W94 in Patients Who Previously Have Used Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effectiveness of Combivir plus abacavir plus 141W94 in patients who previously have used anti-HIV drugs.

Detailed Description
-----------------
In this open-label study antiretroviral-experienced patients receive Combivir (3TC/AZT tablet) plus 1592U89 (abacavir) and 141W94 twice daily for 48 weeks.

Official Title
-----------------
Combivir, 1592U89, 141W94 Triple Antiretroviral, Experienced Patient Trial

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

Intervention / Treatment
-----------------
* Drug: Lamivudine/Zidovudine
* Drug: Abacavir sulfate
* Drug: Amprenavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: CD4 count greater than 50 cells/mm3. HIV RNA less than 50,000 copies/ml. No active AIDS (excluding CD4 count less than 200 cells/mm3). Ability to comply with dosing schedule and protocol evaluations. Prior Medication: Allowed: AZT or non-nucleoside reverse transcriptase inhibitors (NNRTIs). Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Active AIDS (not excluding CD4 count less than 200). Malabsorption syndrome affecting drug absorption. Serious medical condition that would compromise safety of the patient. Concurrent Medication: Excluded: AZT or NNRTIs. More than 1 week treatment with any protease inhibitor. Enrollment in any other investigational drug protocol. Patients with the following prior conditions are excluded: History of clinically relevant pancreatitis or hepatitis within the past 6 months. Required: Antiretroviral therapy with either single or double reverse transcriptase inhibitors.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lamivudine/Zidovudine|nan|
|Drug: Abacavir sulfate|nan|
|Drug: Amprenavir|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
-----------------
Drug Therapy, Combination, Patient Compliance, Anti-HIV Agents, abacavir
Improving Methadone Maintenance Treatment Compliance and Outcomes in China

Study Overview
=================
Brief Summary
-----------------
China faces the challenge of dual epidemics of drug use and HIV/AIDS. In responding to concerns of high rates of HIV/AIDS and other medical consequences among heroin users, China has recently implemented methadone maintenance treatment (MMT) programs nationwide. One problem noted with this rapid expansion is that the dropout rates from MMT have been high. The proposed study will adapt a motivational incentives (MI) intervention developed in the United States for use in Chinese MMT settings and will pilot test its effectiveness in improving treatment compliance and outcomes. The study's primary aims are: 1. to adapt a motivational incentives intervention in MMT in China, and 2. to experimentally pilot test the motivational incentives intervention. A secondary aim is to explore factors that may influence the outcomes of MMT that incorporates a motivational incentives intervention. It is hypothesized that the MI intervention can be adapted to Chinese settings and that it will optimize the positive outcomes of MMT in reducing HIV risks among heroin abusers. The collaborative team includes researchers in American and Chinese institutes (UCLA/Johns Hopkins/Washington, Shanghai Mental Health Center, Yunnan Institute for Drug Abuse), officials from national and local Chinese Centers for Disease Control and Prevention, and providers in local MMT clinics in Shanghai and Yunnan.

Official Title
-----------------
Improving Methadone Maintenance Treatment Compliance and Outcomes in China

Conditions
-----------------
Methadone

Intervention / Treatment
-----------------
* Behavioral: contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:adult patients entering the participating MMT clinics during the recruitment period who are dependent on heroin and who are willing to participate in the study. Exclusion Criteria:Patients who are diagnosed with severe mental illness will not be eligible to participate.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: contingency management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Feasibility of the EyeControl Device

Study Overview
=================
Brief Summary
-----------------
The EyeControl device is an eye movement-based communication device in the form of wearable glasses with connected infrared cam-era that tracks the pupil and translates blinks and movements into commands.This study is aimed to demonstrate the safety and feasibility of the EyeControl device in healthy volunteers, and ALS patients in early stages.

Official Title
-----------------
Safety and Feasibility of the EyeControl Device (Eye-based Communication Device) for ALS Patients

Conditions
-----------------
ALS (Amyotrophic Lateral Sclerosis)

Intervention / Treatment
-----------------
* Device: EyeControl device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects 18 to 65 years old Subject with understandable speaking communication Subject fluent in Hebrew (speech and writing skills) Additional inclusion criteria for Stage 2 of the study: Subjects with early stage ALS diagnosis - whose speech capability is unaffected Exclusion Criteria: Subjects with glasses or contact lenses Subjects with eye conditions such as Ptosis, Strabismus And Crossed Eyes Medical history of epilepsy Subjects who according to investigator's judgement, unable to comply with the requirements of this protocol Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device use in Healthy volunteers<br>10 healthy volunteers will be recruited | Device: EyeControl device<br>* Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences<br>|
| Experimental: Device use in ALS patients<br>5 ALS patients in early stages will be recruited | Device: EyeControl device<br>* Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - Successful Performance Rate of Device Features | Ability to successfully perform at least 70% of device features (controlling the application and Free text features) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment - Number of Device Related Adverse Events | number of device related adverse events reported during the use of the device | 2 weeks |
Use of Botulinum Toxin to Treat Psoriasis

Study Overview
=================
Brief Summary
-----------------
Psoriasis vulgaris is a chronic disease in which psoriatic plaques may appear on the knees, elbows, scalp and trunk. Evidence suggests the role of neurogenic inflammation in the pathogenesis of psoriasis. Botulinum toxin has been shown to have an effect on inhibiting neurogenic inflammation. Recently, it was reported that patients who suffered from dystonia and had concomitant psoriasis, when treated with botulinum toxin for dystonia noted a dramatic improvement of their psoriatic lesions. This pilot study will determine the safety and efficacy of botulinum toxin in the management of psoriasis vulgaris.

Official Title
-----------------
Pilot Study on the Safety and Efficacy of Botulinum Toxin Injections in the Treatment of Psoriasis Vulgaris.

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Biological: injection of botulinum toxin type A.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects. Psoriasis vulgaris diagnosis made by a board certified dermatologist involving at least one area that has been intolerant or recalcitrant to at least two forms of recognized topical or systemic treatments in the past. In addition, the subject should have at least a score of 2 for keratoderma and erythema. Signed informed consent. Willing to adhere to protocol. Exclusion Criteria: Immunosuppressed patients, pregnant, secondary skin infections, phototherapy within 4 weeks of the botulinum toxin injection, exposure to any topical or systemic retinoid treatment with the last 12 months, volunteers taking chloroquine and hydroxychloroquine, volunteers on warfarin.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: botulinum toxin<br>injection of botulinum toxin type A | Biological: injection of botulinum toxin type A.<br>* 35 to 100 units injected around a skin lesion (plaque) one time.<br>* Other names: Botox.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psoriasis scoring scale |  | baseline and 3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3mm skin biopsy. |  | baseline and at 3 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis, Botulinum toxin
Giant Cell Tumor of the Bone in Young Patients

Study Overview
=================
Brief Summary
-----------------
single institution cases series review of histological and clinical data of young patient with Giant Cell Tumors

Official Title
-----------------
Giant Cell Tumor of the Bone in Patients Under 15 Years Old: a Single Institution Case-series

Conditions
-----------------
Giant Cell Tumor of Bone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients under 15 years old treated at Rizzoli Institute from 01 January 1982 to 31 December 2018. Diagnosis of giant cell tumor of bone, aneurysmatic bone cysts with solid features and giant cell reparative granuloma. Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis Written informed consent prior to any study-specific analysis and/or data collection Exclusion Criteria: Patients with histological diagnosis different from diagnosis of giant cell tumor, aneurysmatic bone cysts with solid features, and giant cell reparative granuloma. Patients with no available material for additional immunohistochemical and molecular analysis

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- | --- |
| selection and review of 50 cases of young patients with Giant Cell Tumor of bone. | Investigators will review all the medical records, radiological imaging, and histological slides of all cases in order to collect the largest pediatric series. | at baseline (Day0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analysis of H3F3A mutation expression on tissue tumor material | In all cases with enough available material, immunohistochemistry will be performed on tumor tissue material. Histone 3.3 (H3.3) genes, and H3F3A mutation will be analyzed with immunohistochemistry and/or by allele specific-PCR analysis in order to confirm that the lesions are a giant cell tumors of bone occurring in a non-canonic age group (skeletally immature patients). | at baseline (Day0) |
Pravastatin and Protease Inhibitors in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

Detailed Description
-----------------
Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels. Design. randomized double-blind, multicentric. Intervention. Pravastatin versus placebo for 12 weeks. Eligibility criteria. Positive for anti-VIH antibodies, stable antiretroviral therapy including at least one PI for >= 3 months, plasma HIV-RNA level of < 50 copies/mL for >= 3 months before randomization, total cholesterol >= 5.5 mmol/L with LDL-cholesterol >= 3.4 mmol/L on fasting status after three months of standardized dietary advice, written informed consent Outcomes. HIV RNA at 12 weeks

Official Title
-----------------
Pravastatin in HIV-Infected Patients Treated With Highly Active Antiretroviral Therapy

Conditions
-----------------
HIV Infection, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Pravastatin (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed HIV-1 infection (ELISA confirmed by Western-Blot test) ; Age above 18 years Stable antiretroviral therapy including at least one PI for >= 3 months, Plasma HIV-RNA level of < 50 copies/mL for >= 3 months before randomization, Total cholesterol > = 5.5 mmol/L with LDL-cholesterol > = 3.4 mmol/L on fasting status after three months of standardized dietary advice, signed informed consent Exclusion Criteria: Current AIDS event or infectious disease Tumoral, inflammatory, muscle diseases; kidney or hepatic failure Psychiatric conditions Biological elevated muscular enzymes Chronic alcohol consumption Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pravastatin (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV RNA |  | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid biological markers |  |  | 
| Plasma level of protease inhibitors |  |  | 
| CD4 count at 12 weeks |  |  | 
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV,, protease inhibitors, pravastatin, Treatment Experienced
Outcomes of Surgical Treatment of Patients With Spinal Metastasis in AUH

Study Overview
=================
Brief Summary
-----------------
To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate .

Detailed Description
-----------------
this study monitor what is the results after operative treatment of patients which have secondary metastases in spinal column concerning quality of live for one year and pain and neurology

Official Title
-----------------
Outcomes of Surgical Treatment of Patients With Spinal Metastasis in Assiut University Hospitals

Conditions
-----------------
Spinal Metastases

Intervention / Treatment
-----------------
* Procedure: spinal decompression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years old Patient with tissue proven dx of cancer Exclusion Criteria: Patient younger 18 years old CNS or spinal 1ry tumor

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: spinal decompression|spinal surgery by decompression or fixation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate quality of life after surgery | to evaluate the general condition using 5Q-ED score | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to analyze postoperative pain control , stability and ambulatory statues after surgical treatment of spinal metastases. | evaluation of postoperative pain and neurology and comparing with preoperative data | Baseline |
Biopsy Incisional With Trepan in Periocular Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.

Detailed Description
-----------------
In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.

Official Title
-----------------
Biopsy Incisional With Trepan in Periocular Lesions

Conditions
-----------------
Tumor

Intervention / Treatment
-----------------
* Procedure: Punch Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All lesions were initially examined at the slitlamp, after which lesions with malignant characteristics such as texture, size or color alterations asociated with ulceration, prominent borders or elevated contours, irregular borders, telangiectasias or loss of eyelashes were included. Exclusion Criteria: Lesions with not malignant characteristics
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Punch Biopsy<br> | Procedure: Punch Biopsy<br>* Instillation of anesthetic eye drops. Asepsis Placement of surgical cloths and drapes Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution. Trephination of the most typical area of the lesion with a punch (2mm in diameter) of stainless steel by applying gentle pressure and twisting the trephine until its introduction into the suspicious lesions Removal of the excised tissue with the aid of an insulin needle or conjuntival forceps, the base then bein cut with an number 11 surgical blade<br>* Other names: Biopsy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy, positive predictive value, negative predictive value, sensitivity, specificity |  | In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Punch biopsy,, periocular, tumors.
Long Term Effect of Bariatric Surgery on Pelvic Floor Disorders

Study Overview
=================
Brief Summary
-----------------
Bariatric surgery is increasingly practiced, as it is the most efficient treatment for morbid obesity. More than eighty percent of the operated patients are women. Nethertheless, few is known about gynecologic long-term impact of such surgeries, especially regarding pelvic floor disorders (PFD). This work aims at studying the evolution of PFD in women following a bariatric surgery more than 18 months ago in a French university center Hospital.

Official Title
-----------------
How Bariatric Surgery Impacts Pelvic Floor Disorders Evolution : Analysis on a Cohort From a French Hospital.

Conditions
-----------------
Bariatric Surgery Candidate, Weight Loss

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, aged from 18 to 50 years old the day of their surgery, had a bariatric surgery in Poitiers university hospital center (France), are under french social security system. Exclusion Criteria: to be under guardianship or tutelage measures to express opposition to participate to this 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Questionnaires will be sent by email or by post, in which questions about PFD, obstetrical history or dietetic follow-up will be asked. Some obstetrical issues will be get from women medical files.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of the main PFD | To evaluate the prevalence of the main PFD regarding the efficiency of the bariatric surgery 18 months or more after. The prevalence of PFD will be estimated thanks to the PFDI-20 questionnaire : urinary incontinence : at least one positive answer to questions 16 to 18 of PFDI-20 bowel incontinence : at least one positive answer to questions 8 to 10 of PFDI-20 vaginal prolapse : positive answer to question 3 of PFDI-20 Efficiency of the bariatric surgery will be estimated thanks to the weight registered in the medical file before bariatric surgery and the most recent weight obtained thanks to the questionnaire. Our results will be adjusted for age, menopausal status, obstetrical and surgical history. | minimum 18 months after surgery |