linjc16/ctgov huggingface dataset:
Nephrogenic Systemic Fibrosis With Gadollinum

Study Overview
=================
Brief Summary
-----------------
Recently there is increasing reports of NEPHROGENIIC SYSTEMIC FIBROSIS(NSF) in patients with severe renal failure mainly in patients under dialysis in whom gadollinum is being used. The investigators will evaluate the prevalence and severity of NSF in patients with different degree of renal failure whom underwent imaging with Gadolinum.

Detailed Description
-----------------
NSF is a progressive and potentially fatal disease reported mainly in End Stage Renal Disease (ESRD) patients in whom Gadolinume been used as contrast agent. Skin is the main organ of involvement but other vital organs like myocard,lung,liver may also be involved.Gadollinum is known as a safe contrast in renal disease patients in comparison with conventional nephrotoxic radiocontrast agents,but with increasing reports of NSF with Gadollinum the use of this agent in renal failure patients is under question. We will retrospectively evaluate the occurrence of this complication in all patients with different degree of renal failure whom underwent MRA or MRI with Gadollinum in Tehran Heart Center since 2003 till now and we will describe the severity and distribution pattern of lesions and the relation of this complication to the severity of renal failure.

Official Title
-----------------
The Prevalence and Severity of Nephrogenic Systemic Fibrosis in Patients Whom Underwent Imaging With Gadollinium(MRI/MRA) in University Hospital of Tehran Heart Center in 2003-2008

Conditions
-----------------
Nephrogenic Systemic Fibrosis, Renal Failure

Intervention / Treatment
-----------------
* Drug: gadollinum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal Failure Use of Gadollinum Exclusion Criteria: No consent Age under 18

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>The patients with renal failure in whom Gadollinume has being used | Drug: gadollinum<br>* use of on injection gadollinum Iv for imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of fibrosis |  | after 2 month of exposure with gadollinum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
occurrence of NSF, NSF, ESRD, MRA, MRI, Use of Gadollinum
A Controlled Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

Study Overview
=================
Brief Summary
-----------------
We propose to conduct placebo-controlled trial of the glucocorticoid receptor antagonist mifepristone in Gulf War veterans (GWV) with chronic multisymptom illness (CMI) to examine its effects on physical and mental health and cognitive functioning. In addition, we propose to examine whether HPA axis biomarkers or their response to mifepristone are useful predictors of clinical response.

Official Title
-----------------
A Randomized, Double-blind Placebo-controlled Crossover Trial of Mifepristone in Gulf War Veterans With Chronic Multisymptom Illness

Conditions
-----------------
Chronic Multisymptom Illness in Gulf War Veterans

Intervention / Treatment
-----------------
* Drug: mifepristone
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veteran of the 1991 Gulf War Veteran meets criteria for multisymptom illness Exclusion Criteria: Veteran lacks the capacity to provide consent. Veteran has a major medical or neurological disorder or traumatic brain injury Veteran has morning plasma cortisol level less than 5 mcg/dl or a history of adrenal insufficiency Veteran is taking oral corticosteroids Veteran has a lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder Veteran has been psychiatrically hospitalized or attempted suicide within the previous 2 years Veteran has current suicidal ideation Veteran is pregnant or breastfeeding or plans to become pregnant within the year (male or female) not willing to use appropriate forms of contraception during the study and for at least 90 days post treatment. Women veterans with diseases of the uterus by history or a family history of uterine cancer Known allergy to mifepristone

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone<br>600mg of Mifepristone | Drug: mifepristone<br>* 200 mg po per day x 6 weeks<br>|
| Placebo Comparator: Placebos<br>Placebo | Drug: Placebos<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the health components score of the veterans RAND 36-item health survey (VR-36) |  | baseline, every two weeks, endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive functioning and measures of depression, fatigue and PTSD |  | baseline and endpoint |
Emotional Processing Intervention for Children With TBI

Study Overview
=================
Brief Summary
-----------------
Investigating an emotional processing program, that is modified for use with children, is effective for children with a traumatic brain injury (TBI).

Detailed Description
-----------------
The first stage of this project will evaluate the appropriateness of an emotional processing intervention modified for a pediatric population. The researchers will modify the intervention prior to the evaluation by the 15 typically developing children. The second stage of the project will evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI. Emotional processing includes both facial affect recognition and social perception measures.

Official Title
-----------------
The Application and Modification of an Emotional Processing Intervention for Children With Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Behavioral: Emotional Processing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages of 9 and 17. Speak and read English fluently. Healthy Volunteer or Have sustained a TBI at least 1 year ago, that has affected his or her ability to process emotions. Exclusion Criteria: Previous stroke, MS, or neurological injury or disease in the past (like brain tumor or epilepsy) other than TBI. History of significant psychiatric illness (like bipolar disorder, schizophrenia or psychosis). Uncontrolled seizures or other unstable medical complications.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emotional Processing<br>The intervention looks at emotional processing of face interpretation. | Behavioral: Emotional Processing<br>* Processing Emotions of others based on photographs of faces<br>|
| Placebo Comparator: Control intervention<br>The control group is seeing the same faces and are asked questions regarding them. | Behavioral: Emotional Processing<br>* Processing Emotions of others based on photographs of faces<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Facial Identification Task | measure of facial affect recognition | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emotional Processing, Pediatric Traumatic Brain Injury
Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
The investigators are measuring the adherence rates of an oral MS drug that is to be administered twice-daily. The investigators would like to observe any patterns that might indicate factors that greatly affect adherence.

Official Title
-----------------
A Single-center Prospective Measurement of Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients.

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must give written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). Aged 18 at the time of informed consent. Must have a relapsing form of MS. Male subjects and female subjects of child-bearing potential (including female subjects who are not post-menopausal for at least 1 year) must be willing to practice effective contraception (as defined by the investigator) during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. Exclusion Criteria: Progressive form of MS History of severe allergic or anaphylactic reactions or known drug hypersensitivity. Female subjects considering becoming pregnant while in the study. Female subjects who are currently pregnant or breast-feeding. Unwillingness or inability to comply with the requirements of the protocol including the presence of any conditional (physical, mental or social) that is likely to affect the subject's ability to comply with the protocol. Any other reason that, in opinion of the Investigator and/or the Sponsor, the subject is determined to be unsuitable for enrollment in this study.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence rates to Tecfidera |  | over one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Tecfidera(R), Oral medication, Adherence
Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy, safety and tolerability of BYM338 in patients with sporadic Inclusion Body Myositis

Official Title
-----------------
A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BYM338 in Patients With Sporadic Inclusion Body Myositis

Conditions
-----------------
Sporadic Inclusion Body Myositis

Intervention / Treatment
-----------------
* Biological: BYM338
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Males and Females aged 40-80 with a confirmed diagnosis of sporadic Inclusion Body Myositis Exclusion Criteria: Unable to walk at least 3 meters without assistance from another person Use of oral beta agonists, oral corticosteroids, androgens or androgen inhibitors, or intravenous gamma globulin in the last 6 months patients with a history or presence of renal impairment and/or liver disease Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BYM338<br> | Biological: BYM338<br> <br> |
| Placebo Comparator: Placebo<br> | Biological: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of BYM338 on Thigh Muscle Volume by MRI | Change in thigh muscle volume | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of BYM338 on muscle function by 'Timed Get Up and Go' test | Change in muscle function measured on scale by test results | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sporadic Inclusion Body Myositis
Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to assess bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting conditions.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Balsalazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant finding on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enyzme altering drugs. History of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Balsalazide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, 7 day washout |
Migraine in Electrohypersensitive Patients

Study Overview
=================
Brief Summary
-----------------
The investigators propose here by the use of the French version of the migraine disease screening questionnaire (ID Migraine ™) to study the prevalence of migraine disease in a population of electrohypersensitive patients

Official Title
-----------------
Prevalence of Migraine Disease in Electrohypersensitive Patients

Conditions
-----------------
Headache, Migraine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Informed Consent 18 years or older at the time of informed consent With all these criteria : the perception by the subjects of various non-specific functional symptoms the absence of clinical and biological evidence to explain the symptoms the attribution by the subjects themselves of these symptoms to exposure to electromagnetic fields, which are themselves diverse the symptoms are chronic (more than 3 months) the symptoms appear during an exposure to a source of electromagnetic radiation and cease after the exposure is stopped the symptoms are reproducible Exclusion criteria: - age under 18 years old

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 |
| --- | --- | --- |
| Possible migraine attack | With the number of positive response to the French version of the migraine disease screening questionnaire, we are looking for the patients declaring themselves electrohypersensitive if they have had headaches in the last 12 months with characteristics that could evoke a migraine attack. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrohypersensitivity
Study of Pulmonary Infections (Pneumonia) in Kidney Transplant Recipients Admitted to Hospital

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to identify prognosis factors associated with in-hospital complications and assess the epidemiology, management, and outcomes of community-acquired pneumonia in a kidney transplant recipients' cohort. The investigators intend to identify each stay by a national database. Then they will be consulted by 2 clinicians to assert CAP clinical definition. After that radiographic evidence will be reviewed to validate CAP diagnoses. Then clinical data are collected in each center.

Official Title
-----------------
Study of Pulmonary Infections (Pneumonia) in Kidney Transplant Recipients Admitted to Hospital

Conditions
-----------------
Kidney Transplant Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: kidney transplant recipients at least 18 years admitted to hospital for CAP. Non-inclusion criteria were: Exclusion Criteria: incomplete CAP definition hospital-acquired pneumonia another diagnosis explaining the symptoms patients with non-functional kidney graft

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 |
| --- | --- | --- |
| In-hospital complications | In-hospital death, transfer to intensive care units (ICU) and prolonged stays | inhospital stay, an average of 30 days |
Application of Chemical Sensors for Diagnosis of Inflammatory Bowel Diseases and Irritable Bowel Syndrome by Respiratory Samples

Study Overview
=================
Brief Summary
-----------------
Discriminating irritable bowel syndrome (IBS) from inflammatory bowel disease (IBD), especially with mild disease activity, is common clinical challenge. Most of the patients with suspected IBS have to go invasive procedures (colonoscopy/gastroscopy). In order to avoid invasive investigations, there is a search for noninvasive markers with the capacity to distinguish between IBS and IBD. Dr Hossam Haick (Department of Chemical Engineering, Technion) developed a system that combines nano-metals produced in his laboratory with electrical devices (transistors). The combination between a nanomaterial and an electrical transistor induces a change in its electrical behavior upon exposure to the material being examined; that is, a change in its electrical properties. The change in its electrical behavior is translated into a computerized graphic signal. The electronic nose is composed of an air pump, a filter for filtering external contaminants and an array of sensors. Each sensor transmits a signal according to the materials it knows how to identify. Thus, it is possible to characterize most of the substance families characteristic of a certain disease, and the same system is designed for differential diagnosis of different diseases. The purpose of the investigators study is to use the electronic nose to find bio-markers that will help to diagnose IBD and IBS without using invasive procedures. The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50 controls). The patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire. The samples will analyzed in the laboratory of Dr. Haick.

Detailed Description
-----------------
The plan is to collect 200 samples (50 IBS' 50 Crohn's disease, 50 ulcerative colitis and 50 controls). The patients included in the study will undergo an evaluation by a gastroenterologist after signing an informed consent and will answer a questionnaire. The samples will analyzed in the laboratory of Dr. Haick.

Official Title
-----------------
Application of Chemical Sensors for Diagnosis of Inflammatory Bowel Diseases and Irritable Bowel Syndrome by Respiratory Samples

Conditions
-----------------
Inflammatory Bowel Diseases, Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patinets with IBD or IBS Exclusion Criteria: Age under 18 y/o pregnancy, malignant and infectious diseases

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

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