linjc16/ctgov huggingface dataset:
Autoimmunity in Retinitis Pigmentosa

Study Overview
=================
Brief Summary
-----------------
Using local immune suppression, the trial seeks evidence for the hypothesis that autoimmunity plays a role in the pathomechanism of retinitis pigmentosa.

Conditions
-----------------
Retinitis Pigmentosa

Intervention / Treatment
-----------------
* Drug: twice-daily dosage with 0.5% cyclosporine-A eyedrops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of retinitis pigmentosa Exclusion Criteria: Cataract Extremely low ERG wave amplitude (less than 8% of normal)
Sexes Eligible for Study
-----------------
All

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: twice-daily dosage with 0.5% cyclosporine-A eyedrops|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.

Detailed Description
-----------------
Patients are randomized to receive open-label emtricitabine or ABC in combination with stavudine and efavirenz. Viral load and CD4+ cell counts are compared at Weeks 24 and 48. Patients are followed for 48 weeks.

Official Title
-----------------
A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients

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

Intervention / Treatment
-----------------
* Drug: Abacavir sulfate
* Drug: Efavirenz
* Drug: Emtricitabine
* Drug: Stavudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible if you: Are HIV-positive and generally healthy. Have a viral load of 5,000 copies/ml or more. Have CD4 cell counts of 200 cells/mm3 or more. Are age 18 or older. Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms). Exclusion Criteria You will not be eligible if you: Have ever taken anti-HIV drugs for 3 days or more. Have had certain AIDS-related infections. Have had severe diarrhea within the past 30 days. Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain. Are being treated for active tuberculosis (TB). Are pregnant or breast-feeding. Use illegal drugs or alcohol that make it difficult for you to take study drugs or keep clinic appointments. Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail).

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Abacavir sulfate|nan|
|Drug: Efavirenz|nan|
|Drug: Emtricitabine|nan|
|Drug: Stavudine|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
-----------------
Dideoxynucleosides, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, abacavir, efavirenz
A Phase II Study to Determine the Safety and Efficacy of Second-line Treatment With Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the Second Line Threatment of Advanced Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of second-line treatment with Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the second line treatment of advanced colorectal cancer

Conditions
-----------------
Previously Treated Advanced Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 histologically confirmted advanced colorectal cancer ECOG PS 0-2 expected life span more than 3months normal bone marrow, liver, renal function Exclusion Criteria: 5-FU, oxaliplatin, irinotecan or Metformin Allergic history Lactic acidosis, metabolic acidosis active infection or severe neuropathy

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: FOLFOX6+Metformin/FOFIRI+Metformin<br> | Drug: Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | one year | 
| Overall Survival |  | one year | 
| Number of participants with adverse events |  | one year | 
| Progression Free Survival |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
5FU, Colorectal cancer, Metformin, FOLFOX6, FOFIRI, irinotecan, oxaliplatin
Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting

Study Overview
=================
Brief Summary
-----------------
This study includes an interview with men who have selected watchful waiting or active surveillance for their localized prostate cancer, in lieu of active treatment (such as surgery or radiation). We hope to understand the educational and support needs of men on surveillance so that we can develop a new intervention that will improve quality of life for such men.

Detailed Description
-----------------
Interviews are conducted over the telephone and require approximately 90 minutes to complete. Men interviewed are compensated for their participation in the study.

Official Title
-----------------
Psychosocial and Patient Education Needs of Prostate Cancer Patients Selecting Watchful Waiting

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) male, 2) 18 years or older, with biopsy-proven prostate cancer, 3) diagnosed with localized disease within the last 24 months, 4) have a telephone at the time of enrollment, 5) have an address where they can receive study materials by mail (a street address or post office box), 6) able to speak and understand English; 7) have selected surveillance, rather than active treatment for his prostate cancer. Exclusion Criteria: 1) female 2) no diagnosis of localized prostate cancer 3) completed or undergoing active treatment (e.g., surgery, radiotherapy, etc.) 4) no phone or US mail address 5) unwilling or unable to provide informed consent 6) unable to speak and understand English

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Observational cohort study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life, particularly cancer-specific anxiety and general anxiety |  | One time retrospective interview |
Gastric Volumes After Oral Multimodal Analgesia in the Pre-operative Setting: A Prospective Case Series

Study Overview
=================
Brief Summary
-----------------
To assess possible risk of aspiration with pre-operative oral medications taken with sips of water (100ml).

Official Title
-----------------
Gastric Volumes After Oral Multimodal Analgesia in the Pre-operative Setting

Conditions
-----------------
General Surgery

Intervention / Treatment
-----------------
* Other: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients able to take prescribed oral multimodal analgesia as per standard of care Exclusion Criteria: BMI > 40

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 |
| --- | --- |
| Multimodal analgesia<br>Patients scheduled for general surgery and requiring multimodal analgesia in preoperative period. | Other: Ultrasound<br>* Before and after patient receives oral multimodal analgesia as per standard of care, two ultrasound scans will be performed (10 minutes apart for each time element).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral multimodal analgesia and gastric volume |  | Baseline |
Jewel ACL Post Market Clinical Follow Up Study

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the JewelACL device for ACL reconstruction. The impact of fixation type and autograft augmentation will also be assessed. All adverse events related to the JewelACL device will be recorded. This study is Sponsored by Xiros.

Official Title
-----------------
The JewelACL Post Market Clinical Follow Up Study - Multicentre Study of at Least 5 Years Follow up, Looking at Clinical Outcomes in Patients Treated With the JewelACL for Anterior Cruciate Ligament (ACL) Reconstruction

Conditions
-----------------
Anterior Cruciate Ligament Injuries

Intervention / Treatment
-----------------
* Device: JewelACL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years Patients previously implanted with the JewelACL for Anterior Cruciate Ligament (ACL) reconstruction (Primary JewelACL cases only, no revision cases) Exclusion Criteria: Age less than 18 years Any implantations for non-indicated conditions, as stated in the Instructions For Use Instructions for use (IFU) Revision cases

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 |
| --- | --- |
| JewelACL + Autograft (Hybrid)<br>JewelACL + Autograft (Hybrid) | Device: JewelACL<br>* The JewelACL is a polyester scaffold for anterior cruciate ligament (ACL) reconstruction<br>|
| JewelACL only<br>JewelACL only | Device: JewelACL<br>* The JewelACL is a polyester scaffold for anterior cruciate ligament (ACL) reconstruction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Re-ruptures | Number of participants with re-rupture that were implanted with the jewelACL device for ACL reconstruction | Five Year |
Transvaginal Appendectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the feasibility and safety of transvaginal appendectomy and determine and compare the postoperative pain and quality of life after surgery to standard laparoscopic transabdominal appendectomy.

Official Title
-----------------
Transvaginal Appendectomy

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: transvaginal appendectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ultrasound or CT-based diagnosis of acute or chronic appendicitis ASA classification 1 or 2 Exclusion Criteria: BMI >35 on Immunosuppressive meds or immunocompromised on blood thinners or aspirin or abnormal coagulation tests h/o ectopic pregnancy, PID or endometriosis prior open abdominal surgery or transvaginal surgery with diffuse peritonitis evidence of abscess retroflexed uterus non english speaking

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>transvaginal appendectomy | Procedure: transvaginal appendectomy<br>* patient undergoes transvaginal appendectomy<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of transvaginal appendectomy |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 1 year | 
| quality of life |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
appendicitis, surgery, laparoscopy, natural orifice transluminal surgery
Families In Recovery From Stroke Trial (F.I.R.S.T.)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to assess the effects of a psychosocial intervention on functional recovery after stroke.

Detailed Description
-----------------
Prior research shows that, after a stroke, emotional support from friends and family is very important in recovery from stroke. This study was designed to test whether a program of family sessions would lead to a faster recovery for stroke patients and lower stress for their families. The sessions were designed to mobilize the family and close friends of a stroke patient and help them to provide effective support to the patient. The aim of the study was to help patients who have recently had a stroke to achieve greater functional ability. Participants were randomly assigned to either the standard care or the treatment group. Those in the treatment group received standard care plus a maximum of 16 home-based sessions, or family meetings, with a specially-trained clinician. (The majority of participants received 14 or 15 sessions.) The sessions included stroke education, information about services and community resources, assistance with problem solving to aid in gaining independence, help with coping, and emotional support. The study is no longer enrolling patients and the study data has been collected. The data is now being analyzed.

Official Title
-----------------
Psychological Intervention in Stroke Recovery

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: home-based sessions/family meetings with trained clinician


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: patients with ischemic stroke or non-traumatic intracerebral hemorrhage, with residual deficit origin; age 45 or older stroke severity (3-8 on the NIH stroke severity scale); and able to participate in the intervention (due to, for example, ability to communicate or level of social connectedness). Exclusion: patients living outside the greater Boston area; admitted from a nursing home; terminally ill; severely aphasic; significantly cognitively impaired; unable to speak English; and under 45 years of age.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: home-based sessions/family meetings with trained clinician|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
-----------------
stroke, recovery
Effect of Oxygen on Core Temperature

Study Overview
=================
Brief Summary
-----------------
Study of the effect of oxygen on the frequency of central apnea, sleep and body temperature in patients with a cardiac disease

Official Title
-----------------
Effect of Oxygen on Core Temperature

Conditions
-----------------
Cardiac Disease, Cheyne-Stokes Respiration

Intervention / Treatment
-----------------
* Other: Oxygen
* Other: Air from a placebo oxygen delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac disease and Cheyne-Stokes respiration and controls without Cheyne-Stokes respiration Exclusion Criteria: Obstructive sleep apnea
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxygen<br>4 liters of oxygen a minute | Other: Oxygen<br>* 4 liters of oxygen a minute<br>|
| Placebo Comparator: air<br>4 liters of room air | Other: Air from a placebo oxygen delivery<br>* 4 liters a minute of air from a placebo device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Core temperature | This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.core temperatue is measured continuously during this night with ongoing treatment of oxygen or placebo-air | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep stages, apnea-hypopnea index | This is an experitmetal study. Subjects receive oxygen or placebo-air during one night in random order. Outcome measure, i.e.the amount of differernt sleep stages, total sleep time and apnea-hypopnea index is measured during this night with ongoing treatment of oxygen or placebo-air | One day |
Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
Nilotinib vs imatinib in patients with newly diagnosed CML-CP

Detailed Description
-----------------
Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt

Official Title
-----------------
Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Nilotinib 150 MG [Tasigna]
* Drug: Imatinib 400mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic phase CML not received treatment Pts with no heart disease Pts with no abnormal cholesterol level Exclusion Criteria: Any pts treated before with diff. Treatment Pts. With past history of heart problems Pts. With abnormal cholesterol level

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chronic phase CML treated by nilotinib<br>Newly diagnosed | Drug: Nilotinib 150 MG [Tasigna]<br>* Nilotinib vs imatinib in patients with newly diagnosed CML-CP<br>|
| Active Comparator: Chronic phase CML treated by imatinib<br>Newly diagnosed | Drug: Imatinib 400mg<br>* Nilotinib vs imatinib in patients with newly diagnosed CML-CP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years | Overall survival rate in years | 3 years cutoff | 
| Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg | cholesterol level in mg | 3 years cutoff | 
| Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG | heart state by assessment by ECG | 3 years cutoff | 
| Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years | free survival rate in years | 3 years cutoff |