linjc16/ctgov huggingface dataset:
Risk Assessment Tool for Graft Survival in Pediatric Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
Registry study in which data of all pediatric kidney recipients in the Netherlands (registered in the Nederlandse Orgaan Transplantatie Registry) are studied to develop a risk calculator for graft loss.

Detailed Description
-----------------
The pre-transplantation parameters of all recipients are used to do a multivariable regression analysis. The B-coefficients of this analysis will be used to develop a risk calculator that predicts graft survival after transplantation per year of transplantation.

Official Title
-----------------
A Pre-transplantation Risk Assessment Tool for Graft Survival After Pediatric Kidney Transplantation Based on 1425 Dutch Transplantations

Conditions
-----------------
Kidney Transplant Failure and Rejection, Pediatric Kidney Disease

Intervention / Treatment
-----------------
* Other: None, transplantation recipients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric kidney recipients transplantation in the Netherlands signed informed consent Exclusion Criteria: combined transplantation (pancreas-kidney of liver-kidney transplantation) No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: None, transplantation recipients|None, observational|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival | Functioning graft of death with functioning graft. Survival graph: Percentage recipients with a functioning graft over time | Up to 50 years after transplantation |
Experience of Adolescents With Anorexia Nervosa Towards Antidepressants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the experience of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants

Detailed Description
-----------------
In our adolescent psychiatric unit, antidepressant's prescription is common during the care pathway for adolescents with anorexia nervosa. The literature highlights a paradox between scientific data and clinical practice, based on expert consensus. There are a very few qualitative studies in this subject and none of them concern adolescents. The purpose of this qualitative study is to explore the experience and opinion of adolescents suffering from anorexia nervosa confronted with the prescription of antidepressants

Official Title
-----------------
Subjective Experience of Adolescents Suffering From Anorexia Nervosa With Antidepressants

Conditions
-----------------
Adolescents Cared for Anorexia Nervosa at Maison de Solenn

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents aged 12 to 25 Suffering from anorexia nervosa [according to DSM-5 criteria] Has been prescribed for a type of SSRIs antidepressant (still ongoing or interrupted at the time of the interview) Non-opposition to the study Exclusion Criteria: Atypical eating disorder that do not meet DSM-5 criteria for restrictive anorexia nervosa Body Mass Index < 15 Prescribed for another antidepressant than SSRIs

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 25 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 |
| --- | --- |
| Adolescents with anorexia nervosa<br>Adolescents from 12 to 25 year old, cared for anorexia nervosa at the Maison de Solenn (Cochin hospital, Paris, France) et for whom antidepressive agents have been prescribed | Other: Survey<br>* Oral interview and written questions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative data / Experience of taking anidepressants | Subjective experience of adolescents with anorexia nervosa about prescription of antidepressants and their effects will be obtained during the grid interview and through their describing to written questions | At the time of inclusion (Day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia nervosa, Adolescents, Antidepressive agents
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions. Study Design: Single-dose, open-label, randomized two-way crossover.

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

Intervention / Treatment
-----------------
* Drug: Sertraline Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, smoker or non smoker, 18 years of age and older. Capable of consent. BMI>= 19.0 and <30.0 kg/m2 Exclusion Criteria: Clinically significant illness or surgery within 4 weeks prior to the administration of the study medication. Positive testing for hepatitis B, hepatitis C, or HIV at screening. ECG abnormalities or vital sign abnormalities(blood pressure). History of significant alcohol or drug abuse within one year prior to the screening visit. History or allergic reactions to heparin, sertraline or other related drugs. Use of an investigational drug or participation in an investigational study with in 30 days prior to administration of the study medication. Clinically significant history of gastrointestinal pathology, liver or kidney disease, neurological, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic disease. History of seizures, suicide attempt, bipolar disorder or manic episodes. Depot injection or an implant of any drugs with in 6 months prior to administration of study medication. Breastfeeding subject. Positive urine pregnancy test at screening. Female subject of child bearing potential having unprotected sexual intercourse with any non-sterile mail partner within 14 days prior to study drug administration. Acceptable methods of contraception: Intra-uterine contraceptive device(placed at least 4 weeks prior to study drug administration) Condom or diaphragm + spermicide.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sertraline Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation

Study Overview
=================
Brief Summary
-----------------
To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: standard chemotherapy medicine combined with Chinese herbs
* Drug: standard chemotherapy medicine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age > 18 ages Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2. White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L ALT, AST, normal or less than 2 times, bilirubin is normal Serum level in the normal range;Thr ecg is normal Expected survival time≥ 3 months or more; Agreed to the treatment combined traditional Chinese medicine with western medicine Exclusion Criteria: Engaged in other clinical subjects Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor Severe damage of heart, liver and kidney (cardiac function grade 3   4, ALT and/or AST 2 times more than normal , Cr more the normal limit) Mental illness, Refused to partner; Cannot obtain informed 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy combined with compound herbal medicine<br>Standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks combined with compound Chinese herbal medicine for 2 years，which include 15 kinds of Chinese herbs:Thunberg fritillary bulb,antimutangenic ,cimicifuga foetida,astragalus,pinellia ,Radix Ophiopogonis ,Solanum nigrum,Hedyotis diffusa,Prunella vulgaris ,cordate houttuynia,Herba Patriniae,dried orange peel ,Codonopsis,Wolfiporia extensa,Coix seed,Rhizoma Alismatis. | Drug: standard chemotherapy medicine combined with Chinese herbs<br> <br> |
| Active Comparator: Chemotherapy<br>The therapy of standard chemotherapy protocols on phase IIIB/IV non-small-cell lung cancer for 24 weeks | Drug: standard chemotherapy medicine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | 36months | 
| progression-free survival rate |  | 36months |
RAHelp.Org: An Online Self Management Program for Adults With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine the effects of an arthritis self-management program and an online support community delivered via an encrypted, secure web site on psychological well-being, pain, quality of life, global health status, and social supporting in adults with RA.

Detailed Description
-----------------
Arthritis is the leading cause of disability in the United States. More than 7 million persons in this country report limitations in their daily activities due to arthritis. Rheumatoid arthritis alone affects 1 of every 100 persons in the US. Clinic-based self-management programs have been found to be effective in reducing both pain and disability for persons with RA. However, barriers to participation exist such as distance, time, limited transportation, and declining functional status. The Internet is widely used as a source of information about health issues and may provide an opportunity to reduce these barriers and extend consumer access to self-management approaches. It is necessary to determine the efficacy of Internet-delivered self-management programs.

Official Title
-----------------
An Online Self Management Program for Adults With Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Behavioral: Online Self-Management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 or more years of age Rheumatoid Arthritis diagnosed by a rheumatologist Stable medication regimen for 3 months Exclusion Criteria: Previous exposure to arthritis self-management programs Uncontrolled psychiatric comorbidity Uncontrolled medical comorbidity (e.g. active cancer)

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

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>No intervention | |
| Active Comparator: Online Self-Management<br>RAHelp.org | Behavioral: Online Self-Management<br>* Online Self-Management<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis Impact Measurement Scales |  | baseline, 3 mos., 6 mos., 9 mos., 12 mos. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthritis Self-Efficacy Scale |  | baseline, 3 mos., 6 mos., 9 mos., 12 mos | 
| Rapid Assessment of Disease Activity in Rheumatology |  | baseline, 3 mos., 6 mos., 9 mos., 12 mos | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Self-Management, Internet
Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents in Hemodialysis Centers in Croatia

Study Overview
=================
Brief Summary
-----------------
This study is to document the time spent by health care personnel on anemia-related tasks, including preparation, distribution and administration of monopegylated epoetin beta (Mircera) or other erythropoiesis-stimulating agents (ESAs) in patients with end stage renal disease in hemodialysis centers in Croatia. The total average time will be determined for the same number of patients on monopegylated epoetin beta and patients on other ESAs. In addition, qualitative information will be obtained on changes in practice patterns that may have occurred with the introduction of monopegylated epoetin beta.

Official Title
-----------------
Croatian Time and Motion Survey for Anaemia Management With Erythropoietin Stimulating Agents in Haemodialysis Units

Conditions
-----------------
Renal Anemia of Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adult patients Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients Uncontrolled hypertension

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 |
| --- | --- |
| Monopegylated Epoetin Beta<br>Health care personnel performing anemia management tasks for patients using monopegylated epoetin beta. | Other: No intervention<br>* No intervention administered in this study.<br>|
| Other Erythropoiesis Stimulating Agents (ESAs)<br>Health care personnel performing anemia management tasks for patients using other ESAs. | Other: No intervention<br>* No intervention administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Observed Health Care Personnel Time for Anemia Management With Erythropoiesis Stimulating Agents (ESAs) | Health care personnel time (hours/year) includes preparation, distribution and administration of Erythropoiesis Stimulating Agents (ESAs) | Up to 3 months |
Using Sensors to Measure Drug Concentrations in Exhaled Breath

Study Overview
=================
Brief Summary
-----------------
The use of blood tests to measure drug concentrations in psychiatric patients is often a crucial part of monitoring and evaluating the course of treatment. Such tests are commonly conducted as part of official protocols, and patients are often tested on a weekly basis. The current study aims to examine the possibility of using a novel, non-invasive device to measure drug concentrations in exhaled breath as an alternative to blood tests. The device, SniffPhone, uses sensors to detect and measure volatile organic compounds (VOCs) in exhaled breath, and features a small and portable design. Sniff Phone has been previously approved for use in clinical trials and has been used successfully to screen for particular types of cancer and other diseases.

Official Title
-----------------
Using Sensors to Measure Drug Concentrations in Exhaled Breath

Conditions
-----------------
Mental Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proper ability to give informed consent Psychiatric patients undergoing treatment at Sheba Medical Center Patients with treatment plans that require therapeutic drug monitoring Exclusion Criteria: Involuntary psychiatric hospitalization Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Detection of drug type and concentration in volatile organic compounds (VOCs) profile | Detection of drug type and concentration in VOCs profile (measured using Sniff Phone) | Up to 6 months | 
| Correlation between drug concentration and volatile organic compounds VOC concentrations | Correlation between drug concentration (as measured in blood test) and VOCs (hexanone acetic acid, heptane, hexanal, 3-heptanone, hexanoic acid, heptanal and nonanal) measured using Sniff Phone. | Up to 6 months |
The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).

Official Title
-----------------
A Single Center, Double-Blind, Randomized, Double Dummy, Placebo-Controlled, Three-Period Crossover Study to Assess the Effects of a mGluR2/3 Positive Allosteric Modulator [AZD8529] Upon Ketamine-Induced Cortical Stimulation and Impairment of Working-Memory Related Activation of the Prefrontal Cortex

Conditions
-----------------
Healthy, Memory Impairment

Intervention / Treatment
-----------------
* Drug: AZD8529
* Drug: Placebo to match AZD8529


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Right handed 12th grade education or equivalent Able to read and write English as primary language Exclusion Criteria: History of head injury Substance abuse or dependence History of claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>180 mg of AZD8529 | Drug: AZD8529<br>* 6 capsules by mouth 1 time 12 to 24 prior to assessments<br>Drug: Placebo to match AZD8529<br>* 6 capsules by mouth 1 time 12 to 24 hours prior to assessments<br>|
| Experimental: 2<br>50 mg AD8529 | Drug: AZD8529<br>* 6 capsules by mouth 1 time 12 to 24 prior to assessments<br>Drug: Placebo to match AZD8529<br>* 6 capsules by mouth 1 time 12 to 24 hours prior to assessments<br>|
| Placebo Comparator: 3<br>Placebo | Drug: AZD8529<br>* 6 capsules by mouth 1 time 12 to 24 prior to assessments<br>Drug: Placebo to match AZD8529<br>* 6 capsules by mouth 1 time 12 to 24 hours prior to assessments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI |  | 3 | 
| Ketamine Infusion |  | 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered Dissociative States Scale (CADSS) |  |  | 
| Positive and Negative Syndrome Scale (PANSS) |  |  | 
| Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy normal volunteers
A Study of a Human Anti-Intercellular Adhesion Molecule-1 Monoclonal Antibody, in Patients With Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This is a first in human study which will assess the safety and tolerability of a monoclonal antibody against ICAM-1 in patients with Multiple Myeloma. The tumour response rate will also be measured.

Official Title
-----------------
A Phase I Dose-Escalation Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of BI 505, a Human Anti-Intercellular Adhesion Molecule 1 Monoclonal Antibody, in Patients With Relapsed/Refractory Multiple Myeloma

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

Intervention / Treatment
-----------------
* Biological: BI-505


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Myeloma with measurable disease after at least 2 previous regimens. Life expectancy > 3 months. Performance status ECOG < 2. Exclusion Criteria: Prior antineoplastic therapy within 4 weeks prior to inclusion. No high dose steroids within 7 days prior to screening. Severe other conditions.

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: BI-505<br> | Biological: BI-505<br>* Anti-ICAM-1 monoclonal antibody given as a i.v infusion every second week for four weeks,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed as Adverse Events, ECG, vital signs and clinical laboratory tests |  | four weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, monoclonal antibody, safety, pharmacokinetic