linjc16/ctgov huggingface dataset:
Aldesleukin in Participants With Metastatic Renal Cell Carcinoma or Metastatic Melanoma

Study Overview
=================
Brief Summary
-----------------
This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.

Official Title
-----------------
Open-label Pharmacokinetic Trial of Aldesleukin (Rh-Interleukin-2 [IL-2]) Administered Intravenously to Subjects With Metastatic Renal Cell Carcinoma or Metastatic Melanoma With Immunologic Correlative Studies

Conditions
-----------------
Metastatic Melanoma, Metastatic Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Aldesleukin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Performance Status Eastern Cooperative Oncology Group: 0 or 1. Adequate organ function. Exclusion criteria: Pregnancy or lactation. Prior treatment with any form of IL-2. Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply

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: Aldesleukin<br>All participants were treated with aldesleukin 600,000 international units per kilogram [IU/kg] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated. | Drug: Aldesleukin<br> <br> * Other names: PRL002;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Area Under the Concentration-Time Curve (AUC) From 0 to 8 Hours (AUC0-8) of Aldesleukin After One Cycle of Therapy |  | From Cycle 1, Day 1 to Cycle 2, Day 15 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metastatic Renal Cell Carcinoma, Metastatic Melanoma, Aldesleukin, IL-2
A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Melphalan, Prednisone and Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed of multiple myeloma. Age > 65 years ECOG <= 3 Written informed consent given at the time of randomization Patients with age <= 65 but not eligible for high dose treatment with stem cells support Exclusion Criteria: ECOG > 3 current neoplasm.. contraindications to use thalidomide peripheral neurophaty

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

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

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

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

Design Details

Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melphalan, prednisone plus Thalidomide<br> | Drug: Melphalan, Prednisone and Thalidomide<br> <br> |
| Active Comparator: Melphalan and Prednisone<br> | Drug: Melphalan, Prednisone and Thalidomide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy | To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment | from 8 to 12 months | 
| To assess the toxicity | To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0 | From 1 to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the Overall Survival (OS) in the 2 arms of treatment | OS was defined as the time from the date of first treatment after diagnosis of multiple myeloma to the date of last follow up examination or the date of death from any cause | From 1 to 60 months | 
| To evaluate the Duration of Remission (DR) in the 2 arms of treatment | DR was defined from the date of Complete Remission, Partial Remission, Minimal response after the completion of MPT or MP cycles to the date of disease progression or the date of last follow up examination | From 8 to 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Elderly patients
Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if metformin therapy prevents fetal macrosomy in gestational diabetes mellitus to the same extent as insulin therapy.

Official Title
-----------------
Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus: a Randomized Controlled Study

Conditions
-----------------
Gestational Diabetes Mellitus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational diabetes mellitus diagnosed between 12-34 pregnancy weeks if normoglycemia is not reached with diet Exclusion Criteria: hypertension with pharmacological treatment or preeclampsia multiple pregnancy liver or kidney disease

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br> | Drug: Metformin<br> <br> |
| Active Comparator: Insulin<br> | Drug: Insulin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of fetal macrosomy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational diabetes mellitus, treatment, metformin
Sleep and Nocturnal Melatonin in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effects of methylphenidate on sleep in adults with Attention Deficit/ Hyperactivity Disorder (ADHD) using polysomnographic parameters.

Detailed Description
-----------------
Previous studies in children with Attention Deficit/ Hyperactivity Disorder (ADHD) have described the effect of stimulants on sleep patterns. However the data on adults with ADHD is sparse. The aim of this study is to investigate the effects of methylphenidate on sleep in adults with ADHD using polysomnographic parameters.

Official Title
-----------------
The Effects of Methylphenidate on Sleep Patterns in Adults With ADHD: An Open Label Polysomnographic Study

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Device: One-night polysomnographic recordings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADHD according to DSM-IV Criteria Positive ASRS questionnaire Exclusion Criteria: Brain damage Brain encephalopathy Borderline IQ Affective disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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: methylphenidate<br> | Device: One-night polysomnographic recordings<br>* One-night polysomnographic recordings before and during methylphenidate treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polysomnographic parameters |  | one- night (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep questionnaire | mini sleep questionnaire | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, Adult
Application of Machine Learning Based Approaches in Emergency Department to Support Clinical Decision Managing SARS-CoV-2 Infected Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to develop a prognostic prediction model based on machine learning algorithms in patients affected by coronavirus disease 2019 (COVID-19), the prediction model will be capable to recognize patient with favorable prognosis or patient with poor prognosis by intelligent systems data analysis.

Official Title
-----------------
Application of Machine Learning Based Approaches in Emergency Department to Support Clinical Decision Managing SARS-CoV-2 Infected Patients

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged over 18 positive for COVID-19 by polymerase chain reaction assay for rhino-pharyngeal swab Exclusion Criteria: Under 18 aged

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 |
| --- | --- |
| training cohort<br>data collection | |
| validation cohort<br>data collection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 clinical course | Data about sex, age, symptoms start date, symptoms, comorbidity, vital parameters, hematochemical blood tests, therapy, oxygen support, radiology, clinical disease progression will be collected. The collected data will be analyzed through a machine learning based approach to predict the prognosis of patients affected by COVID-19. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Application of machine learning algorithms on data of patients affected by COVID-19 | The collected data will be analyzed through a machine learning based approach to establish correlations between collected data and the prognosis of patients affected by COVID-19. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, machine learning, prediction model, convolutional neural network
A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.

Conditions
-----------------
Peritoneal Dialysis, Hyperphosphatemia

Intervention / Treatment
-----------------
* Drug: PA21


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving stable maintenance peritoneal dialysis Peritoneal dialysis patients with hyperphosphatemia Exclusion Criteria: Patients having history of a pronounced brain / cardiovascular disorder Patients having severe gastrointestinal disorders Patients having severe hepatic disorders

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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: PA21<br> | Drug: PA21<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphate concentrations |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Adverse Events |  | 12 weeks | 
| Incidences of Adverse Events |  | 28 weeks | 
| Serum phosphate concentrations |  | 28 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal Dialysis, Hyperphosphatemia
A Safety Extension Study of DR-OXY-301

Study Overview
=================
Brief Summary
-----------------
This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.

Official Title
-----------------
A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 in Women With Overactive Bladder

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Oxybutinyn Vaginal Ring 4mg
* Drug: Oxybutinyn Vaginal Ring 6mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the 12 weeks of treatment in the DR-OXY-301 study Willing to limit medications for overactive bladder to investigational product only Able to understand and complete all study procedures including the required diary

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxybutinyn Vaginal Ring 4mg<br>inserted daily and replaced every 4 weeks | Drug: Oxybutinyn Vaginal Ring 4mg<br> <br> * Other names: DR-3001;|
| Experimental: Oxybutinyn Vaginal Ring 6mg<br>inserted daily and replaced every 4 weeks | Drug: Oxybutinyn Vaginal Ring 6mg<br> <br> * Other names: DR-3001;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported |  | Duration of Study |
IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence

Study Overview
=================
Brief Summary
-----------------
IMPAACT P1107 will describe the outcomes of HIV-infected persons, ages 12 months and older, who undergo transplantation with CCR5Δ32 cord blood stem cells for treatment of cancer, hematopoietic disease, or other underlying disease.

Official Title
-----------------
IMPAACT P1107: Cord Blood Transplantation With CCR5Δ32 Donor Cells in HIV-1 Infected Subjects Who Require Bone Marrow Transplantation for Any Indication and Its Observed Effects on HIV-1 Persistence

Conditions
-----------------
HIV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed HIV-1 infection 12 months of age or older Willing to provide written informed consent Pre-Transplant Cohort: Underlying disease appropriate for stem cell transplant, as determined by the transplant team as part of standard of care. Pre-Transplant Cohort: Availability of an appropriately matched (as determined by the transplant center) CCR5Δ32 cord blood unit (homozygous or heterozygous) and intention to proceed with transplantation. NOTE: Double cord transplants are allowed. If a double cord is used, at least one cord blood unit should be CCR5∆32 (homozygous or heterozygous). Pre-Transplant Cohort: Received a CCR5Δ32 homozygous cord blood or bone marrow transplant within the last two years. Exclusion Criteria: • Received, or planning to receive, more than one CCR5Δ32 homozygous cord blood or bone marrow transplant.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-Transplant Cohort<br>HIV-1 infected participants, enrolled prior to transplant, who receive a heterozygous or homozygous CCR∆32 cord blood transplant | |
| Post-Transplant Cohort<br>HIV-1 infected participants, enrolled within 2 years after transplant, who receive a homozygous CCR∆32 cord blood transplant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Survival and event-free survival at 100 days, Week 26, Week 52, and then every six months until five years post-transplant | Through 5 years post-transplant | 
| Graft versus host disease | Graft versus host disease | Through 5 years post-transplant | 
| Engraftment | Chimerism (≥ 98% of blood cells bearing CCR5∆32) and time to hematopoietic cell and immune recovery | Through 5 years post-transplant | 
| HIV DNA level | HIV-1 proviral DNA levels in peripheral blood | Through 5 years post-transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cord blood transplantation, CCR5Δ32, HIV cure
Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device

Study Overview
=================
Brief Summary
-----------------
Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.

Official Title
-----------------
Validation of a Robust Method for Kinematic Analysis of Ventricular Mechanical Dyssynchrony by Two Dimensional Echocardiography in Patients With Cardiac Resynchronization Devices for Chronic Systolic Heart Failure and Conduction System Disease

Conditions
-----------------
Systolic Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18-110 years Must have a CRT-D (A biventricular pacemaker with defibrillator) Last optimization of their device (CRT-D) must not have been done in the past 3 months Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.) Exclusion Criteria: Less than 18 years of age or greater than 110 years old. Does not have a CRT-D Optimization of their device has occurred in the past 3 months Not on optimal medical therapy for heart failure as listed in the inclusion criteria.

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 |
| --- | --- |
| Systolic Heart Failure, Dyssynchrony, CRT-D<br>Patients with systolic heart failure and dyssynchrony that have a CRT-D that have not been optimized in the past 3 months. | |

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
-----------------
Dyssynchrony, Cardiac resynchronization therapy