linjc16/ctgov huggingface dataset:
Iron-Chelating Therapy and Friedreich Ataxia

Study Overview
=================
Brief Summary
-----------------
Friedreich ataxia, an autosomal recessive condition, ascribed to frataxin gene expansion, has been shown to result from an iron- induced injury to the mitochondrial respiratory chain. Buffering free radicals with short-chain quinones (Idebenone) protects the patients against cardiomyopathy but not CNS involvement. Removing CNS iron should limit the impact of the neurological symptoms of the disease.

Detailed Description
-----------------
The current clinical trial is a monocentric open phase1-2 trial in the context of rare diseases framework, aimed to the goal of defining the tolerance/efficacy of the treatment. Inclusion criteria: minimum age: 13 years Follow up in the Dept of Genetics, Hospital Necker-Enfants Malades, Paris, France

Official Title
-----------------
Effect of Iron-Chelating Therapy in Friedreich Ataxia. Study Phase I/II

Conditions
-----------------
Friedreich Ataxia

Intervention / Treatment
-----------------
* Drug: Iron chelating intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Minimum age: 13 years Molecular confirmation of frataxin gene mutation Iron overload evaluation Presence of lactate Echography response to Idebenone treatment Urinary test of pregnancy for girls Sexual abstinence for men Information consent Exclusion Criteria: No disturbance of iron metabolism No response to Idebenone Friedreich not confirmed Polynuclear neutrophils <2 x 109/L or hemoglobin < 8g/dL No participation to other trial Doubt regarding the compliance of the patient to protocol Impossibility to undergo X-ray examination or presence of iron material in the backbone Pregnant women Absence of social insurance.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: 1<br>Iron chelating intervention | Drug: Iron chelating intervention<br>* Iron chelating intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of iron overload at TO and month2 by imagery |  | at months :0, 1 ,2 ,4 ,6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical (monthly) and biological parameter follow- up ( blood count, |  | weekly | 
| plasma iron, ferritin, transferrin and liver enzymes) |  | every months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron-chelating treatment
FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the value of FLT-PET early after initiated chemotherapy in patients with small cell lung cancer, and to determine whether MRI of the brain should be performed routinely in these patients.

Official Title
-----------------
FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Device: FLT-PET
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy proven small cell lung cancer referred for standard chemotherapy oral and written informed consent Exclusion Criteria: metal or electronical devices in the body not compatible with MRI of brain or thorax pregnancy or lactation communication difficulties

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLT-PET/MRI<br> | Device: FLT-PET<br> <br> Device: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 
| Disease free survival |  | 1 year |
Human Repeated Insult Patch Test

Study Overview
=================
Brief Summary
-----------------
Repeated insult patch test on healthy males and females to determine potential contact irritation or contact allergy in the skin

Official Title
-----------------
Human Repeated Insult Patch Test

Conditions
-----------------
Dermatitis, Allergy, Contact Allergy

Intervention / Treatment
-----------------
* Device: NeoMatriX Collagen Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults; Subjects must understand and execute an Informed Consent Form that includes a HIPAA statement; Subjects must be considered dependable and able to follow directions Exclusion Criteria: Subjects who are in ill health; Subjects who are taking medications other than birth control; Female subjects who are pregnant (return positive urine pregnancy test), planning to become pregnant or lactating during the course of the trial; Subjects who have a history of adverse reactions to personal care products, or known sensitivity to the test materials or their constituents including patch materials; Subjects with any active skin disease; Subjects who have heavy alcohol consumption; Subjects with current use or history of repeated use of street drugs; Subjects with a significant past medical history to potentially effect results of study; Subjects with immunization less than 10 days prior to the test patch application;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Collagen Dressing and Comparator<br>NeoMatriX Collagen Dressing and Comparators - positive control and normal saline will be applied to the absorbent pad portion of the exclusive dressing. | Device: NeoMatriX Collagen Dressing<br>* Collagen wound dressing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema at the Patch Test Site is Evaluated for Each Participant | Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitization Reactions | Erythema Scoring Scale with 0 being no visible erythema and 5 being bullous reaction. Allergic Dermal Sensitization Potential - Erythema will be evaluated at the patch site for only the test material (positive and negative control will not be evaluated). Sensitization reactions will be determined at the patch test site after a two week rest period for each participant (similar to a wash-out period). The patch test site will be tested on the same study subject population, but using a virgin test site. | 5 weeks |
Sofosbuvir in Treatment of COVID 19

Study Overview
=================
Brief Summary
-----------------
Sofosbuvir containing treatment in treatment of COVID 19 Egyptian patients

Detailed Description
-----------------
Sofosbuvir containing treatment of COVID 19 Egyptian patients: a randomized-controlled trial

Official Title
-----------------
Sofosbuvir Based Regimens in Treatment of COVID 19 Patients

Conditions
-----------------
COVID

Intervention / Treatment
-----------------
* Drug: sofosbuvir
* Drug: Sofosbuvir ledipsavir
* Drug: Daclatasvir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Covid positive patients. Exclusion Criteria: Contraindication to sofosbuvir or ribavirin.
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: Sofosbuvir and ledipsavir<br>Sofosbuvir and ledipsavir plus standard of care treatment. | Drug: Sofosbuvir ledipsavir<br>* Sofosbuvir ledipsavir once daily<br>* Other names: mpiviropack plus;|
| Experimental: Sofosbuvir and Daklatasuvir<br>Sofosbuvir and Daklatasuvir plus standard of card treatment.. | Drug: sofosbuvir<br>* Sofosbuvir once daily<br>* Other names: Mpiviropack, Sovaldy, soflanork;Drug: Daclatasvir<br>* Daklatasuvir tablets<br>* Other names: daklinza;|
| No Intervention: Standard treatment<br>Standard treatment alone | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with response to treatment | The total number of patients with response to treatment | 1 month |
Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Study Overview
=================
Brief Summary
-----------------
Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette syndrome (TS). Unfortunately, medications are often ineffective and frequently have significant side-effects. This is a pilot therapeutic study using a dietary approach, the modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability, and efficacy of dietary therapy in patients with TS (proof of concept) and to determine whether this intervention is worthy of evaluation in large-scale clinical trials. The modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under investigation for neurological conditions other than epilepsy, including Alzheimer disease, headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and depression.

Official Title
-----------------
Pilot Study of the Modified Atkins Diet for Tourette Syndrome

Conditions
-----------------
Tourette Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Modified Atkins diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 12-65 years Tourette syndrome (vocal and motor tics for over a year) > 20 score on the Yale Global Tic Severity Scale Ability to follow instructions and comply with the dietary changes Exclusion Criteria: Secondary tics Underweight (BMI < 5%) Prior use of the Atkins diet for over 2 days High cholesterol or triglycerides Major depression or anxiety disorder Pregnancy Substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 65 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: Modified Atkins Diet<br>Patients are started on the modified Atkins diet at 15 grams per day. | Dietary Supplement: Modified Atkins diet<br>* Low carbohydrate diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tic frequency | Number of tics per day, intensity, severity, will be compared to baseline (pre-diet) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ketosis |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tourette, Atkins, Ketosis, Tic
Study of Colchicine to Prevent the Postpericardiotomy Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether colchicine is safe and effective in the prevention of the postpericardiotomy syndrome.

Detailed Description
-----------------
The postpericardiotomy syndrome is a frequent complication after cardiac surgery affecting from 20 to 40% of patients. The etiology of this complication is a subject of debate. It is commonly believed to be an autoimmune response to pericardial and/or pleural bleeding or surgical trauma. Colchicine is safe and effective in the treatment and prevention of pericarditis and preliminary data have shown that it may be effective also in the primary prevention of the postpericardiotomy syndrome. Comparisons: The study will compare the safety and efficacy of colchicine in the primary prevention of the postpericardiotomy syndrome in addition to optimal standard care.

Official Title
-----------------
Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The COPPS Trial: COlchicine for the Prevention of Postpericardiotomy Syndrome

Conditions
-----------------
Postpericardiotomy Syndrome

Intervention / Treatment
-----------------
* Drug: Colchicine (for 1 month)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the third day after a cardiac surgery operation Age≥ 18 years Informed consent Exclusion Criteria: All evaluated before the surgical operation: Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality Serum creatinine >2.5 mg/dl Serum creatine kinase (CK) over the upper limit of normality or known myopathy Known gastrointestinal or blood disease Pregnant or lactating women or women not protected by a contraception method Known hypersensibility to colchicine Treatment with colchicine at enrolment

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Colchicine (for 1 month)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpericardiotomy syndrome |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-related hospitalization, cardiac tamponade, constrictive pericarditis and relapses |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpericardiotomy Syndrome, Pericarditis, Prevention, Colchicine, Recurrence
Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission.

Detailed Description
-----------------
The primary objective of this study is to use HBP concentration to indicate the presence, or outcome, of severe sepsis (including septic shock) at admission and to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission. The secondary objectives of this study are to separately evaluate the performance of HBP concentration to a) indicate the presence of severe sepsis (including severe sepsis) at admission and b) to predict the outcome of severe sepsis (including septic shock) over 72 hours, in patients with suspected infection following emergency department admission. Further exploratory objectives include evaluating the use of HBP measurement to indicate the outcome of severe sepsis (including septic shock) in patients with suspected infection 12-24 hours after emergency department admission, to compare the use of HBP to other markers of severe infection and to evaluate whether or not different cut-off values are required for the progression and outcome measures.

Official Title
-----------------
Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the HBP Assay to Predict Development of Severe Sepsis in Patients With Suspected Infection Following ED Admission

Conditions
-----------------
Sepsis, Septic Shock, Sepsis With Acute Organ Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age, suspected infection Exclusion Criteria: None

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 |
| --- | --- | --- |
| Measurement of plasma levels of HBP to evaluate patients with suspected infection for their risk of developing severe sepsis | The purpose of this measurement is to assess the clinical validity of plasma levels of HBP for indicating the presence, or outcome, of severe sepsis (including septic shock), over 72 hours, in patients with suspected infection following emergency department admission. The concentration of plasma HBP will be compared to the final clinical outcome of the patient to assess the ability of the HBP level to predict clinical progression. | 72 hours |
Direct Acting Antivirals for HCV Infection in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.

Official Title
-----------------
Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients

Conditions
-----------------
Kidney Transplant; Complications, Hepatitis C, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being a kidney transplant recipient. Having a detectable level of HCV RNA. Having direct acting antivirals for 12 or 24 weeks. Exclusion Criteria: Withdrawing or not providing 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR12 | Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stable Graft Function | Stability of serum creatinine and proteinuria levels of kidney transplant recipients during and after the treatment with direct acting antivirals. | 6-12 months | 
| Stable Serum Trough Levels of Immunosuppressive Agents | Stability of serum trough levels of calcineurin and mTOR inhibitors during the treatment with direct acting antivirals. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
kidney transplant recipients, chronic hepatitis c virus infection, direct acting antivirals, sofosbuvir/ledipasvir