linjc16/ctgov huggingface dataset:
Phase I Study of Adenoviral Vector Mediated Gene Transfer for Ornithine Transcarbamylase in Adults With Partial Ornithine Transcarbamylase Deficiency

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the safety, feasibility, and potential efficacy of intravascular adenoviral vector mediated gene transfer in the liver in adults with partial ornithine transcarbamylase deficiency.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a dose escalation study. Patients undergo a femoral arterial placement of a hepatic intraarterial catheter. Patients then receive adenoviral vector mediated gene transfer intravascularly over 30 minutes. Cohorts of 3 patients each receive escalating doses of adenoviral vector until the maximum tolerated dose is determined. Patients are followed at 3, 5, 7, 8, 15, and 29 days, at 2 months, and then every 3 months thereafter. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Ornithine Transcarbamylase Deficiency Disease

Intervention / Treatment
-----------------
* Genetic: Adenoviral Vector-Mediated Gene Transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of partial ornithine transcarbamylase deficiency Female heterozygote with abnormal allopurinol challenge or underlying defect in either N15 urea or N15 glutamine OR Male with childhood/adulthood onset OR Family history of 2 affected children Stable for at least 1 month prior to study Plasma ammonium levels less than 50 micromoles --Prior/Concurrent Therapy-- Concurrent alternate pathway therapy to control hyperammonemia allowed --Patient Characteristics-- Hepatic: No history of liver disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No high level of neutralizing antibodies to the adenovirus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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 |
| --- |
|Genetic: Adenoviral Vector-Mediated Gene Transfer|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
-----------------
genetic diseases and dysmorphic syndromes, inborn errors of metabolism, ornithine transcarbamylase deficiency, rare disease, urea cycle disorder
Relationship Between Cardiopulmonary Exercise Testing and Ca-P in Chronic Kidney Disease (CKD)

Study Overview
=================
Brief Summary
-----------------
Reductions in exercise capacity associated with exercise intolerance augment cardiovascular disease risk and predict mortality in chronic kidney disease. This study utilized cardiopulmonary exercise testing to (a) investigate mechanisms of exercise intolerance; (b) unmask subclinical ca and p and vitamin D abnormalities that may precede cardiovascular disease in chronic kidney disease.

Detailed Description
-----------------
Cardiopulmonary exercise testing will carry out in Stage 3-5 chronic kidney disease patients ; estimated glomerular filtration rate <60 ml/min/1.73 m2) and biochemistry will be added (Ca P Via D PTH FGF23).

Official Title
-----------------
Evaluation of the Relationship Between Cardiopulmonary Exercise Testing (CPET ) Abnormalities and Ca-P Status in CKD Stage3-5

Conditions
-----------------
Ckd-Mbd

Intervention / Treatment
-----------------
* Diagnostic Test: CPET


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD Patients with GFR <60 non-dialysis age<18 Exclusion Criteria: HTN not signing consent active coronary disease

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 |
| --- | --- |
| CKD Stage 3<br>CKD patients with GFR between 30-60cc/min | Diagnostic Test: CPET<br>* CPET<br>|
| CKD Stage 4<br>CKD Patients with GFR 15-30 cc/min | Diagnostic Test: CPET<br>* CPET<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calcium x phosphorus change in stage 3-5 | CaxP change | 12 MONTHS | 
| CPET score change | Evaluation of CPET score change | 12 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function change | GFR change | 12 MONTHS |
Preliminary Study of Feasibility of Arthrodesis Scapula-humeral Under Arthroscopy

Study Overview
=================
Brief Summary
-----------------
Arthrodesis shoulder blade/humerus under arthroscopy. Implementation of an external fixative spray at the proximal level in the thorn of the scapula and distal in the diaphysis humerus.

Detailed Description
-----------------
This trial is about the arthrodesis shoulder blade/humerus under arthroscopy. The main aim of this study is to be able to carry out a fusion scapula-humeral supplements in 6 months. It is required to provide the benefice risk over to reduce the hospitalisation 48 hours.

Official Title
-----------------
Arthrodesis Gleno Humeral Under Arthroscopy in the Sequelae of Plexus Brachial Evaluation of the Technical Feasibility

Conditions
-----------------
Arthroscopy Arthrodesis Gleno-humeral

Intervention / Treatment
-----------------
* Procedure: arthroscopy arthrodesis of the shoulder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient having a deficit scapula-humeral mobility Impossibility of being operated for a preserving nervous surgery Patient affiliation with a social security Patient who signed inform consent Exclusion Criteria: Patient with No mobility in all the articulations of the shoulder Callus malunion of the higher end of the humerus or the glen of the scapula Unable to sign an inform consent

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: shoulder arthroscopy arthrodesis<br>The shoulder surgery will be realized under arthroscopy only. | Procedure: arthroscopy arthrodesis of the shoulder<br>* The shoulder surgery will be realized under arthroscopy only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological fusion gleno humeral on side and front view after the 6th month of the arthroscopy interventional | This outcome will be considered like a success if the investigators get a continuous bone matrix between the humeral head and glenoid on the scapula and bone frame continues between the humeral head and the acromion. This evaluation will be done by radiographies. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | The blood loss during and after the surgery will be calculated and will be considered like a success if the total blood loss are less than 600ml. | 3 days |
Role of the Autonomic Nervous System in HIV-Lipodystrophy

Study Overview
=================
Brief Summary
-----------------
The study aims to characterise the influence of the autonomic nervous system activity on the development of the lipodystrophy syndrome in HIV-infected patients by measuring heart rate variability and various metabolic pathways in HIV patients receiving highly active antiretroviral therapy.

Official Title
-----------------
Autonomic Nervous System Activity in the Pathogenesis of the Lipodystrophy Syndrome in HIV-Infected Patients.

Conditions
-----------------
HIV Infections, Lipodystrophy-Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-infection Age above 18 years No AIDS defining event during last 6 months No infection during last 6 weeks No concommitant drug interfering with insulin sensitivity and ANS-activity

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 |
| --- | --- | --- |
Tear Based Sample Collection Breast Cancer Detection

Study Overview
=================
Brief Summary
-----------------
This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.

Detailed Description
-----------------
Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.

Official Title
-----------------
Tear Based Sample Collection for Breast Cancer Detection

Conditions
-----------------
Breast Cancer, Tear, Breast Cancer Female

Intervention / Treatment
-----------------
* Other: Schirmer Strip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individual is an adult woman and has recently been diagnosed with breast cancer. Exclusion Criteria: Individual is excluded if they have already started treatment for the breast cancer diagnosis. Age less than 18 or more than 100 years.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women recently diagnosed with breast cancer who have not undergone any treatment.<br>Tear sample collection | Other: Schirmer Strip<br>* A tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA certified lab. It consists of two parts: tear sample collection using a Schirmer Strip and a clinical lab-developed test that measures protein biomarkers for breast cancer screening.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant tear samples collected. | The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preventative screening, protein biomarkers, lacrimal tear fluid, mammography, ELISA assay, CLIA laboratory, lab developed test, high complexity, tear collection, mammogram, improved patient outcomes, reduce gap in access, health equity, total cost of care, trust from patient, increased compliance, affordable, low cost, non-invasive, women's health and wellness, breast health, breast cancer screening test
Influence of the COVId-19 Pandemic on STRESS, and Screening Procedures (COVISTRESS Screening)

Study Overview
=================
Brief Summary
-----------------
Coronavirus has caused containment of more than a third of the world's population. Some countries have used a major screening strategy. Screening procedures, such as waiting (or resulting) for the test, can be stressful and can attract the most stressed people. However, there is currently no data on the relationship between stress and screening for SARS-CoV2

Detailed Description
-----------------
This is an observational study by REDCap questionnaire® via a flyer deposited in the waiting room of the COVID screening centres. No incentive to complete the questionnaire will be made. The self-survey will assess stress and its relationship to SARS-CoV2 screening procedures, socio-demographic factors or lifestyle habits. This Screening questionnaire includes 31 questions.

Official Title
-----------------
Influence of the COVId-19 Pandemic on STRESS, and Screening Procedures

Conditions
-----------------
COVID-19 Screening

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All volunteers who are screened Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Stress measures | Attitudes and stress related to screening procedure will be measured via questionnaire | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening | Attitudes towards screening will be measured via questionnaire | Day 1 | 
| Sociodemographic characteristics | Age, gender, qualification, personal work status, ethnicity, life characteristics and stress will be assessed by questionnaires | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Screening, Stress
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.

Detailed Description
-----------------
The drug being tested in this study is called Leuprorelin acetate (Leuplin PRO for Injection Kit 22.5 mg). Leuprorelin acetate is being tested to treat people who have prostate cancer. This study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting. The study will enroll approximately 300 patients. • Leuprorelin acetate This multi-center trial will be conducted in Japan.

Official Title
-----------------
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: Leuprorelin acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with prostate cancer will be included. Exclusion Criteria: Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Leuprorelin acetate<br>Usually, for adults, 22.5 mg of leuprorelin acetate is subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants will receive interventions as part of routine medical care. | Drug: Leuprorelin acetate<br>* Leuplin PRO for Injection Kit 22.5 mg<br>* Other names: Leuplin PRO for Injection Kit 22.5 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Events |  | Up to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | Up to Week 24 |
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Study Overview
=================
Brief Summary
-----------------
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can reset participants' sleep/wake rhythm to a more normal rhythm.

Official Title
-----------------
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Conditions
-----------------
Insomnia, Sleep Initiation and Maintenance Disorders, Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment Subjective complaint of sleep disruption, unsatisfactory sleep, early morning awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made by either the potential participant or by the caregiver. Exclusion Criteria: Participation in any other clinical drug trial Liver failure Believed by the investigator to be unwilling or unable to follow the protocol Active liver or coronary disease

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

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: Modafinil<br> | Drug: modafinil<br>* 100-400 mg daily for 4 weeks<br>* Other names: Provigil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal Sleep Length at 1 Month |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Daytime Alertness and Quality of Life. |  |  1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild Cognitive Impairment (MCI), Sleep, Fatigue, Memory
Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Study Overview
=================
Brief Summary
-----------------
The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.

Official Title
-----------------
Adjunctive Lisdexamfetamine in Bipolar Depression

Conditions
-----------------
Bipolar, Depression

Intervention / Treatment
-----------------
* Drug: Lisdexamfetamine
* Drug: Placebo control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will meet DSM-IV-TR criteria bipolar I or II disorder, Exclusion Criteria: Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lisdexamfetamine<br>Drug | Drug: Lisdexamfetamine<br>* Oral; 20-70mg/day<br>* Other names: Vyvanse;|
| Placebo Comparator: Placebo<br>Drug | Drug: Placebo control<br>* Oral; 20-70mg/day<br>* Other names: Sugar pill, fake pill with no active medication;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MADRS score | The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score. | 30-36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bipolar disorder, manic depression, depression, Bipolar I or II
Changes in Pituitary Iron and Volume With Deferasirox

Study Overview
=================
Brief Summary
-----------------
Despite continuing advances in iron chelation therapy, iron toxicity of endocrine glands, particularly the pituitary gland, remains common in patients with transfusion dependent anemias. We would like to establish accurate population norms of pituitary R2 and volume and understand the progression of pituitary iron in transfused patients on Deferasirox.

Official Title
-----------------
Changes in Pituitary Iron and Volume With Deferasirox in Transfusional Iron Overload

Conditions
-----------------
Iron Overload

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently on chronic transfusion therapy. Duration of chronic transfusion >1 year. Age 2 to 25 years On deferasirox monotherapy for the duration of the study. Informed consent from legal guardian and/or patient. On deferasirox for a minimum of 3 months at start of study. Exclusion Criteria: Sickle cell disease or sickle-beta zero genotype. Combination of deferasirox and another iron chelator.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 25 Years

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 |
| --- | --- |
| Chronically Transfusion Patients<br>Patients with transfusion dependent anemia (excluding sickle cell disease), ages 2-25, on Deferasirox chelation therapy, to be monitored over 2 years. | |
| Controls<br>Normal controls, ages 2-25, with no known brain abnormality or endocrine dysfunction. | |

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

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