linjc16/ctgov huggingface dataset:
Giant Cell Arteritis - Optimization of Diagnostics

Study Overview
=================
Brief Summary
-----------------
Giant cell arteritis - Optimization of diagnostics

Detailed Description
-----------------
A prospective study. Investigating the use of ultrasound, temporal artery biopsy, biomarkers and 18F-fluorodeoxyglucose positron emission tomography-computed tomography for establishing a diagnosis of giant cell (temporal) arteritis.

Official Title
-----------------
A Head-to-head Comparison of Ultrasound Versus Temporal Artery Biopsy in the Diagnosis of Giant Cell Arteritis

Conditions
-----------------
Giant Cell Arteritis

Intervention / Treatment
-----------------
* Diagnostic Test: Giant cell arteritis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical suspicion of giant cell arteritis Meets the American College of Rheumatology Criteria: Age at disease onset => 50 years New headache Temporal artery abnormality Elevated erythrocyte sedimentation rate >=50 mm/hour Abnomal artery biopsy Exclusion Criteria: Active cancer Use of steroid for more than a week (the prior 6 months)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Giant cell arteritis|Ultrasound 18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography Temporal artery biopsy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Giant cell arteritis | Clinical verification of giant cell arteritis diagnosis as evaluated with a combination of ultrasound, biopsy and PET/CT. | Week 26 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Temporal artery biopsy,, Giant cell arteritis, Ultrasound, 18F-FDG PET/CT
Effect of the Membrane Blue Dual® Dye on the Retinal Sensitivity in Macular Hole Surgery

Study Overview
=================
Brief Summary
-----------------
The idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years. This hole causes an acute decline linked to a central scotoma. The only treatment is surgical. The surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. To be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. The inner limiting membrane (ILM), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. After closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. This sensitivity decrease could be induced by the dyes used during surgery. This effect has not been studied clinically for recent dyes (Membrane Blue Dual®, Brilliant Blue®, Acid Violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models. It would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. Only microperimetry can observe this decrease in retinal sensitivity. This is a noninvasive technique that explores the macular visual field. It is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.

Official Title
-----------------
Pilot Study of the Effect on the Retinal Sensitivity of the Membrane Blue Dual® Dye Used for Peeling of the Internal Limiting Membrane in Macular Hole Surgery

Conditions
-----------------
Macular Hole Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years lower idiopathic macular hole inferior or equal to 600 micron millimeter undergoing macular hole surgery Exclusion Criteria: Myopia > -3 diopters pregnant women no Health Insurance coverage refusal to participate in the study

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 |
| --- | --- | --- |
| change in retinal sensitivity | change from baseline sensitivity at 1 month after macular hole surgery | change from baseline sensitivity at 1 month after macular hole surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inner limiting membrane, Microperimetry, surgical's dye
A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

Study Overview
=================
Brief Summary
-----------------
To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.

Detailed Description
-----------------
Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).

Official Title
-----------------
A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

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

Intervention / Treatment
-----------------
* Drug: Ritonavir
* Drug: Nelfinavir mesylate
* Drug: Saquinavir
* Drug: Delavirdine mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV RNA >= 5000 copies/ml by Amplicor assay. Signed, informed consent from parent or legal guardian for patients less than 18 years old. Previous treatment with antiretrovirals.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Ritonavir|nan|
|Drug: Nelfinavir mesylate|nan|
|Drug: Saquinavir|nan|
|Drug: Delavirdine mesylate|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
-----------------
HIV-1, Drug Therapy, Combination, HIV Protease Inhibitors, RNA, Viral, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients

Study Overview
=================
Brief Summary
-----------------
This study will investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's Patients.

Official Title
-----------------
An Open-label Extension to a 52-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study in Patients With Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106.

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Biological: CAD106


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have completed the core study with no significant safety concerns Exclusion Criteria: Diagnosis of other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression). Diagnosis or presence of an active, uncontrolled seizure disorder and/or cerebrovascular disease. Diagnosis or presence of an active autoimmune and/or with an acute or chronic inflammation. Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAD106<br> | Biological: CAD106<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/tolerability assessments at multiple time points including but not limited to screening, and through to the end of the study to week 66. |  | 66 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect long-term safety information through SAE's collection for two years after completion of the extension study. |  | 2 years | 
| Immune response, cognitive and functional assessments at multiple time points including but not limited to baseline, and through to the end of the study to week 66. |  | 66 weeks | 
| Evaluate the antibody response after 4 additional injections in the Extension study, in patients initially treated with CAD106 in the Core study. |  | 66 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Active immunization, Alzheimer disease, Antibody, Central Nervous System diseases, Neurodegenerative diseases, Vaccine
National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients

Study Overview
=================
Brief Summary
-----------------
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty.

Official Title
-----------------
National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects

Conditions
-----------------
Dwarfism, Pituitary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater) Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk Ability to keep follow-up appointments throughout the study Willingness to remain on therapy until epiphyseal closure is achieved Prior enrollment in NCGS Core Study 85-036 Exclusion Criteria: Treatment with non-Genentech GH preparation Closed epiphyses Active neoplasia Treatment with insulin for diabetes

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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
-----------------
Pubertal Growth Hormone Deficiency
Neurohumoral Control of Intestinal Electrical and Mechanical Activity

Study Overview
=================
Brief Summary
-----------------
A collaborative research project with Dr. Kathleen Keef (Department of Physiology, University of Nevada School of Medicine, Reno, Nevada) studying the role of putative neurotransmitters in human intestine.

Detailed Description
-----------------
Segments of intestine from patients undergoing elective gastric bypass for morbid obesity or resections for non-obstructive neoplasms at the UC Davis Medical Center will be used. Samples will be taken from tissue normally removed and sent to Pathology or discarded. Full thickness segments of intestine (10 mm x 1 mm) will be prepared for recording either intracellular electrical activity or mechanical contraction. The effects of putative non-adrenergic, non-cholinergic neurotransmitters (e.g., nitric oxide) will be studied. The source of the tissue will not be identified either directly or indirectly through identifiers associated with the measured responses.

Official Title
-----------------
Neurohumoral Control of Intestinal Electrical and Mechanical Activity

Conditions
-----------------
Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients having elective bowel resection Exclusion Criteria: Entire resected segment required for pathology Ischemic/necrotic disease
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
-----------------
intestinal, smooth, muscle, GI, motility
Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses

Study Overview
=================
Brief Summary
-----------------
This is a comparative study on the survival and long-term quality of life of Jehovah's witnesses having undergone a cardiac surgery and having refused blood transfusions for religious reasons. This group will be compared with two other groups having no restrictions on this subject. The purpose of the study is to evaluate the impact of this decision on survival and postoperative quality of life, in the long term.

Official Title
-----------------
Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: Cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery with extra corporeal blood circulation Informed consent given Exclusion Criteria: Dementia (must be able to answer the questionnaire) Control group: refusal of blood transfusions

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 |
| --- | --- |
| Jehovah's witnesses<br>Jehovah's witnesses having undergone cardiac surgery between 1991 till 2012. Blood perfusions refused. | Procedure: Cardiac surgery<br>* Cardiac surgery<br>|
| Control<br>Paired control group, twice as big as the experimental group. Pairing criteria: age, sex, type of surgery performed. The control group must accept blood transfusions. | Procedure: Cardiac surgery<br>* Cardiac surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (score) | Score computed with the MacNew Heart Disease health-related quality of life instrument.The MacNew is a valuable tool for assessing and evaluating health related quality of life in heart disease patients. It consists of 27 questions, falling into 3 possible domains: physicial limitation capacity (13 questions), emotional domain (14 questions), social domain (13 questions), symptom related (5 questions). The time frame for the MacNew is the previous two weeks. Scoring of the MacNew is simple: one score in each domain and a global score (4 scores). The maximum possible score in any domain is 7 [high HRQL] and the minimum is 1 [poor HRQL].The global score is calculated as the average over all scored items unless one of the domains is completely missing. | Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed | 
| Survival rate | Survival rate | Evaluated once by means of a phone contact performed in 2016, irrespective of the date the surgery was performed |
Acupuncture for Non-cyclical Breast Pain

Study Overview
=================
Brief Summary
-----------------
Breast pain or mastalgia is a common and troublesome symptom for many women. Whereas cyclical breast pain related to hormonal fluctuations can frequently be treated, non-cyclical breast pain can go untreated due to its various etiologies and non-specific presentation. Acupuncture is an ancient form of Chinese medicine that has been used for centuries to treat a vast array of illnesses and conditions. Research has shown that acupuncture has a link to a release of endorphins and other chemicals in the central nervous system. Thus, it is thought to help relieve pain. To date, there has been minimal research using acupuncture for breast pain. This pilot of 30 women will seek to determine whether four acupuncture treatments over a period of two weeks will significantly lower the level of pain experienced by these participants. Additionally, we will evaluate quality of life measures.

Official Title
-----------------
Acupuncture for the Treatment of Non-Cyclical Breast Pain

Conditions
-----------------
Breast Pain

Intervention / Treatment
-----------------
* Procedure: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Female greater than 18 years non-cyclical unilateral or bilateral breast pain occurring daily, Greater than or equal to 2 on the BPI (average pain question) pain for more than 3 months satisfactory (non-suspicious for malignancy) breast examination within one year of enrollment (need documentation from physician or advanced practice nurse) satisfactory (non-suspicious for malignancy) mammogram and/or ultrasound within one year if Greater than 35 years(need written report to verify) able to return for acupuncture two times a week for two weeks speak and understand English hormone replacement therapy discontinued > 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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: acupuncture<br>four acupuncture treatments over a period of two weeks | Procedure: acupuncture<br>* acupuncture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Four acupuncture treatments over a period of two weeks can improve non-cyclical breast pain |  | two weeks |
Multicenter Study of Safety and Efficacy of Prolgolimab in Patients With Advanced Melanoma in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
Describe the safety, tolerability, efficacy and approaches to prescribing prolgolimab in the standard dosing regimen of 1 mg / kg every 2 weeks in patients with advanced melanoma in routine practice. Prolgolimab (Forteca, formerly BCD 100) is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation.

Detailed Description
-----------------
Describe the safety and tolerability of using Prolgolimab at a standard dosage regimen of 1 mg / kg every 2 weeks. Describe the efficacy of prolgolimab 1 mg / kg every 2 weeks in patients with metastatic or inoperable melanoma in routine practice, based on the following indicators: Progression-free survival (time from first dose of prolgolimab to disease progression or death for any reason); Overall survival (time from receiving the first dose of prolgolimab to death for any reason); Objective response rate (proportion of patients with a complete or partial response to prolgolimab therapy).

Official Title
-----------------
Multicenter Non-interventional Retro- and Prospective Safety and Efficacy Study of Prolgolimab (Forteca - Anti-PD1) in Patients With Advanced Melanoma (FOrteca Real Practice Assessment)

Conditions
-----------------
Advanced Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmed melanoma Advanced stage (unresectable III or metastatic IV) Treated by at least one therapy line including prolgolimab in routine practice - Exclusion Criteria: - Patient participation in any interventional clinical study.

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 |
| --- | --- | --- |
| The incidence of adverse events during prolgolimab therapy | The rate of all grade and grade 3-5 adverse events and the rate of discontinuation of study drug(s) due to adverse events. | 2 years | 
| Objective response rate | The response rate during prolgolimab therapy in patients with unresectable advanced melanoma | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | The median PFS and 24 months PFS rate of patients with advanced melanoma during prolgolimab | 3 years | 
| Overall survival (OS) | The median OS and 24 months OS rate of patients with advanced melanoma | 3 years |