linjc16/ctgov huggingface dataset:
Study of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

Official Title
-----------------
A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: ipilimumab (MDX-010, BMS-734016)
* Drug: Ipilimumab
* Drug: Ipilimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ipilimumab (MDX-010, BMS-734016)<br>* IV solution, IV, 0.3mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.<br>|
| Experimental: 2<br> | Drug: Ipilimumab<br>* IV solution, IV, 3 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.<br>|
| Experimental: 3<br> | Drug: Ipilimumab<br>* IV solution, IV, 10 mg/kg, Q 3 wks for 12 wks then Q 12 wks, 48+ weeks depending on response.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate BORR in patients with previously treated, therapy-refractory or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate progression free survival rate at Week 12 assessment and other timepoints |  |  | 
| estimate disease control rate at various time points |  |  | 
| estimate overall survival |  |  | 
| estimate survival rate at one year |  |  | 
| evaluate health-related quality of life |  |  | 
| obtain pharmacokinetic samples for population PK analysis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage III (unresectable), Stage IV melanoma
Plasma Protein Binding Characteristics of Voriconazole

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the influence of hypoalbuminemia on the protein binding characteristics of the antifungal drug voriconazole in ICU patients.

Official Title
-----------------
Impact of Hypoalbuminemia on Voriconazole Pharmacokinetics in Critically Ill Adult Patients.

Conditions
-----------------
Focus of the Study:Protein Binding Characteristics of Voriconazole.

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treated with voriconazole Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| Patients admitted to the Intensive Care Unit<br>All patients admitted to the Intensive Care Unit, treated with voriconazole are eligible for the study. | Other: Blood sampling<br>* During the treatment of voriconazole, at steady plasma concentrations of voriconazole, one plasma sample and one serum sample are taken.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Overall Protein Binding in the Presence of Different Plasma Albumin Concentrations. | At steady state plasma concentrations of voriconazole, a plasma sample is taken to determine the overall protein binding of voriconazole. Equilibrium dialysis is used, followed by liquid chromatography-mass spectrometry. | At steady state plasma concentration of voriconazole (after day 4 of therapy) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
voriconazole, protein binding, pediatrics, hematology, intensive care, albumin, alpha-1-acid-glycoprotein
Pediatric Bipolar Disorder Study at UCLA

Study Overview
=================
Brief Summary
-----------------
The UCLA Semel Institute for Neuroscience in Los Angeles, CA, is conducting a study looking at similarities and differences in how the brain works between bipolar disorder and attention deficit hyperactivity disorder (ADHD).

Detailed Description
-----------------
Children between the ages of 7 and 17 years old, with a diagnosis of Bipolar I, Bipolar II, or Bipolar NOS, are currently being recruited for this study looking at similarities and differences in how the brain works between bipolar disorder and attention deficit hyperactivity disorder (ADHD). The study involves a comprehensive evaluation at intake, cognitive assessment, EEG, and functional MRI, done over the course of 2 or 3 visits. This study does not provide treatment. However, with participants' consent, the assessment information can be shared with the child's clinician or psychiatrist and a letter with the results from cognitive testing can be prepared, which can be useful in school planning. Referrals for treatment can also be provided.

Official Title
-----------------
Examining Neurocognitive Profiles of Bipolar Disorder and Attention-Deficit Hyperactivity Disorder

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject suffers clinically impairing symptoms of mood lability. Child has resided with primary caretaker for at least 6 months. Caretaker speaks sufficient English to complete all study evaluations and measures. Exclusion Criteria: Lifetime history of mental retardation, autism, or primary diagnosis of psychosis. Subject is pregnant or nursing.

Ages Eligible for Study
-----------------
Minimum Age: 7 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
-----------------
bipolar disorder, child bipolar disorder, adolescent bipolar disorder, pediatric bipolar disorder, fMRI, MRI, EEG, neurocognitive tasks
The Safety and Effectiveness of Different Doses of Vitamin C in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate the tolerance and antiviral effect of oral vitamin C in HIV-infected.

Official Title
-----------------
A Dose Escalation Study to Evaluate Tolerance and Antiviral Effect of Oral Vitamin C in Two Groups of HIV-Infected Adults

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

Intervention / Treatment
-----------------
* Drug: Oral Vitamin C


Participation Criteria
=================
Eligibility Criteria
-----------------
Not applicable - Study withdrawn since 04/23/1996

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: Oral Vitamin C|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.

Official Title
-----------------
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Treatment A
* Drug: Treatment B
* Drug: Treatment C
* Drug: Treatment D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). A positive urine drug screen. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. Pregnant or nursing females.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A - PF-04764793<br>PF-04764793 using inhaler A | Drug: Treatment A<br>* Inhaled, 300/150, single dose<br>|
| Active Comparator: Treatment B - PF-04764793<br>PF-04764793 using inhaler B | Drug: Treatment B<br>* Inhaled, 300/150, single dose<br>|
| Experimental: Treatment C - PF-04764793<br>PF-04764793 using inhaler A | Drug: Treatment C<br>* Inhaled, 300/150, single dose + oral activated charcoal block<br>|
| Active Comparator: Treatment D - PF-04764793<br>PF-04764793 using inhaler B | Drug: Treatment D<br>* Inhaled, 300/150, single dose + oral activated charcoal block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUClast and Cmax |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life. |  | 48 hours |
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy young adult and elderly subjects.To assess the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy young adult and elderly subjects.

Official Title
-----------------
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Young and Elderly Subjects

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

Intervention / Treatment
-----------------
* Drug: SAM-531


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Men or women of nonchildbearing potential aged 18 to 45 years Elderly men or women aged 65 years and above as of study day 1. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg. Exclusion criteria: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results. Tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or grapefruit or grapefruit-containing products 72 hours before study day 1, and until the end of the inpatient confinement period. Elderly men or women aged 65 years and above as of study day 1. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SAM-531|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and pharmacodynamics |  |  |
The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.

Official Title
-----------------
A Non-Interventional, Post-Marketing Surveillance Phase IV Study to Asses the Efficacy and Safety of Telmisartan, With the Special Attention on the Influence of Telmisartan on Selected Metabolic Parameters of Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Pritor (Telmisartan , BAY68-9291)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Untreated or ineffectively treated arterial hypertension Exclusion Criteria: Cholestatic disorders and severe hepatic failure Allergy to telmisartan Pregnancy and lactation period

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 |
| --- | --- |
| Arm 1<br> | Drug: Pritor (Telmisartan , BAY68-9291)<br>* Primary care hypertensive patients starting the therapy with Telmisartan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and safety of the treatment with telmisartan reported by the physician |  | At the both of planned control visits. (Approx. interval between visits 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in metabolic parameters in telmisartan treated patients |  | At the both of planned control visits. (Approx. interval between visits 3 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension
Imaging of Islet Transplantation With PET and MRT

Study Overview
=================
Brief Summary
-----------------
Islets of Langerhans intended for clinical transplantation are labelled with a radioactive tracer. The tracer is retained in viable cells of the transplant. At infusion (transplantation) of the islets into the portal vein the tracer can be followed for two hours with positron emission tomography (PET). Imaging and calculations can give estimates of the proportion of surveying islets and the rate of early destruction. Also the distribution of the islets into the liver can be viewed.

Detailed Description
-----------------
Background: It is suspected that the current need for repeated islets transplantation to treat diabetes type I is dependent on an early destruction of the islets when infused into the portal vein. Aim: To trace the fate of the islet at and after infusion into the portal vein. Method: Islets are labelled in vitro with a radioactive tracer that can be measured with positron emission tomography. 10-20 percent of the graft is labelled. Just prior to start of infusion labelled islets are mixed with unlabelled islets (80-90 percent of the graft). The tracer used is FDG and stands for 2-[18F]-2-deoxy-D-glucose. At infusion the patient is placed in the combined computer tomography and PET camera to follow the infusion. The imaging is almost continuous for 2 h at and after infusion. Expected results: Calculations of proportion of surviving islets and rate of destruction. Localisation and distribution of islets in the liver of the recipient.

Official Title
-----------------
Imaging of Islet Transplantation With PET and MRT

Conditions
-----------------
Diabetes Type 1, Islet Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suitable for clinical islet transplantation. Patient on waiting list for islet transplantation within the Nordic Network for Clinical Islet Transplantation Written Informed Concent

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?
-----------------
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
-----------------
Islet transplantation,, coagulation,, graft destruction,, islet imaging
Allergy and Asthma Following Children Who Were Fed Supplemented Infant Formula

Study Overview
=================
Brief Summary
-----------------
Long-term cognitive outcome study of children who participated in randomized trials of LCP-supplemented formula during infancy.

Conditions
-----------------
Allergy, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children previously randomized in a clinical study consuming LCP-supplemented infant formula Exclusion Criteria: children who did not previously participate in a randomized clinical study consuming LCP-supplemented infant formula

Ages Eligible for Study
-----------------
Minimum Age: 5 Days
Maximum Age: 12 Months

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 |
| --- | --- | --- |
| Prevalence of asthma and allergy related diagnosis in medical records during first 3 years of life. |  | after first 3 years of life |
Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)

Study Overview
=================
Brief Summary
-----------------
Dystrophic epidermolysis bullosa is a rare genetic pathology resulting in fragility of the skin and mucous membranes, causing bubbles and wounds following trauma. Scarring is pathological with a tendency to retraction. The gynecological and in particular the vulvovaginal mucous membranes can be affected but no description of any series is available in the literature. Likewise, some of these patients have a sexual and obstetrical life, despite sometimes-severe damage, but again no specific data is available. The investitigator thus wish to carry out a non-interventional multicenter prospective descriptive study. Better knowledge of gynecological semiology in patients with EBD will allow better adaptation of gynecological follow-up, screening for STDs and gynecological cancers, as well as possible specific complications. This study would eventually allow the draw up of recommendations for our gynecologist / obstetrician colleagues.

Official Title
-----------------
Gynecological Follow-up of Patients With Dystrophic Epidermolysis Bullosa (EBD)

Conditions
-----------------
Dystrophic Epidermolysis Bullosa

Intervention / Treatment
-----------------
* Other: Decriptive study of EDB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older with hereditary dystrophic epidermolysis bullosa (dominant or recessive) followed at the Nice University Hospital or at the St Louis Hospital of the APHP. not opposed to participation after being informed of the study Exclusion Criteria: men age < 18years old

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EDB<br>Adult women (> 18 years old) with hereditary dystrophic epidermolysis bullosa (dominant or recessive) followed at the Nice University Hospital or at the St Louis Hospital of the APHP | Other: Decriptive study of EDB<br>* data on EDB will be register<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptve evaluation of the recruited population | Adult women (> 18 years old) with hereditary dystrophic epidermolysis bullosa (dominant or recessive) followed at the Nice University Hospital or at the St Louis Hospital of the APHP. Descriptve evaluation of the recruited population Description of the anatomical and gynecological functional impairment of adult women with dystrophic epidermolysis bullosa. | 12 months |