linjc16/ctgov huggingface dataset:
The International Registry for Leigh Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a database containing clinical and laboratory information for patients with Leigh syndrome. The goal is to provide a greater understanding of Leigh syndrome allowing further characterization of this disease.

Detailed Description
-----------------
Leigh syndrome, also known as juvenile sub-acute necrotizing encephalopathy, is a progressive neurodegenerative disorder associated with dysfunction of mitochondrial oxidative phosphorylation (OXPHOS). First described in 1951 by British neuropsychiatrist Archibald Denis Leigh, the condition has evolved from a post mortem diagnosis to a clinical entity with characteristic radiologic and laboratory findings. Leigh syndrome is a rare and heterogeneous disease, finding a substantial number of patients to study is difficult. The lack of natural history data in Leigh syndrome and the small number of patients included in clinical reports thus far has limited the ability to fully comprehend the progression of this disease and assess prognostic factors. A Leigh syndrome database will help improve our understanding of this rare disease leading to an improved ability to predict outcomes and/or improve treatment paradigms. Collecting natural history data on Leigh syndrome and integrating this information into a database will be useful in understanding the course of the disease and identifying trends.

Official Title
-----------------
The International Registry for Leigh Syndrome

Conditions
-----------------
Leigh Syndrome, Leigh Disease, Leigh's Necrotizing Encephalopathy, Subacute Necrotizing Encephalomyopathy, Subacute Necrotizing Encephalomyelopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All participants with a diagnosis of Leigh syndrome will be invited to participate Exclusion Criteria: People without Leigh syndrome

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 100 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 |
| --- | --- |
| Leigh syndrome<br>All people diagnosed with Leigh syndrome. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypical characteristics of Leigh syndrome | The goal of this project is to collect longitudinal data on the natural history of Leigh syndrome. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leigh Syndrome, Leigh Disease, Leigh's Necrotizing Encephalopathy, Subacute Necrotizing Encephalomyelopathy, Subacute Necrotizing Encephalomyopathy
Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection

Study Overview
=================
Brief Summary
-----------------
To compare early drain removal versus output-based drain removal, assessing the following end-points: Clinical : risk of seroma and infection, woundhealing, duration of wound care and drain output versus volume of seroma. Quality of life : drain-induced pain, discomfort due to seroma or drain, sleep disturbance and implications on daily activities. Cost-effectiveness

Official Title
-----------------
Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection on Clinical Outcome and Quality of Life in Breast Cancer Patients

Conditions
-----------------
Draining Wound, Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Early-drain removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for breast cancer surgery with placement of suction drainage Female or male Age > 18 years All stages of disease (inclusion is independent of TNM-classification) Exclusion Criteria: Patients scheduled for breast cancer surgery without placement of suction drains No informed consent: Patient refuses participation OR is not able to give a written 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 |
| --- | --- |
| No Intervention: Output-based<br> | |
| Active Comparator: Early-removal<br> | Procedure: Early-drain removal<br>* Drain removal at hospital discharge<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Improve the quality of life, wich will be measured by a questionnaire with some specific questions. | 3 weeks |
Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement.

Detailed Description
-----------------
Inclusion Criteria Age under 19 years Pregnant women will be excluded. This will be confirmed by self-report Exclusion Criteria Age under 19 years Pregnant women will be excluded. This will be confirmed by self-report

Official Title
-----------------
Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: 19 gauge
* Procedure: 22 gauge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who are referred to Florida Hospital Center for Interventional Endoscopy for a EUS FNA for core biopsy (19 gauge needle biopsy) who have needle dysfunction (This occurs in about 10% of patients) Exclusion Criteria: Age under 19 years Pregnant women will be excluded. This will be confirmed by self-report

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Active Comparator: 19 gauge<br>Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle. | Procedure: 19 gauge<br>* Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle<br>|
| Active Comparator: 22 gauge<br>Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle. | Procedure: 19 gauge<br>* Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle<br>Procedure: 22 gauge<br>* Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 22 gauge needle | Compare the quality of core tissue specimens obtained between a 19G and 22G needle by evaluating the ability to perform molecular marker studies or immunohistochemistry studies between samples obtained. | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
19 gauge, 22 gauge, core tissue
Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis

Study Overview
=================
Brief Summary
-----------------
Single center observational study to compare the relationship between atrial fibrosis and potential ablation targets from CARTOFINDER.

Detailed Description
-----------------
A total number of 30 patients will undergo catheter Ablation for persistent AF. Pre-procedural cardiac MRI will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. CARTOFINDER-guided mapping will be performed during the ablation procedure followed by AF ablation. The individual relationship between atrial fibrosis and potential ablation targets will be accessed.

Official Title
-----------------
Catch me if You Can - the Individual Relationship Between Potential Ablation Targets From CARTOFINDER and Myocardial Fibrosis

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing their 1st AF ablation procedure for persistent atrial fibrillation (AF) as per recent Heart Rhythm Society (HRS) consensus document Able to understand and willing to sign the Informed Consent Form. Age ≥18 years. Exclusion Criteria: Contraindication for DE-MRI with a full dose of Gadolinium-based contrast agent. Previous left atrial ablation or surgical procedure Renal failure with CrCl <60 ml/min Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception Mental or physical inability to take part in the study Uncontrolled hypertension Morbid obesity (BMI > 35), or inability to be placed in MRI due to body mass.

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 |
| --- | --- | --- |
| AF recurrence | recurrence of atrial fibrillation after catheter ablation | 12 months |
ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Study Overview
=================
Brief Summary
-----------------
This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.

Official Title
-----------------
Early Loop-Recorder in Suspected Arrhythmogenic Syncope

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Device: Use of an Implantable Loop Recorder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes Exclusion Criteria: Indication for the implantation of a pacemaker Indication for the implantation of an implantable cardioverter defibrillator Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular [LV] outflow stenosis, decompensated heart failure) Contraindication for a diagnostic procedure requested by the study protocol Enrollment in another study Circumstances or comorbidities which do not allow enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Use of an Implantable Loop Recorder|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of diagnostics per patient until final cardiac diagnosis has been made |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of diagnostics until final diagnosis has been made |  |  | 
| Rate of correct cardiac diagnoses |  |  | 
| Comparison of time needed to make a diagnosis |  |  | 
| Comparison of pre-syncopes and syncopes occuring in both groups after enrollment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Syncope of uncertain etiology, Repeated presyncopes
Improving Antibiotic Prescribing Practices in Mexican Primary Care Clinics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to improve antibiotic prescribing practices of Mexican primary care physicians for patients seeking care for acute respiratory tract infections (ARIs). The investigators will employ a combination of qualitative and quantitative methods to develop and evaluate a patient education and physician decision-support intervention. Hypothesis 1: The investigators will identify barriers and facilitators of appropriate antibiotic use for ARIs that can be addressed through patient education and physician decision-support. Hypothesis 2: The proportion of patients who report desire for antibiotics as a very important reason for seeking care will decrease from 50% to 30% following exposure to the educational intervention; and 90% (95% confidence interval: 80% to 100%) of patients will report that they trust the information provided by the computer. Hypothesis 3: Antibiotic prescribing for adults with uncomplicated acute bronchitis will decrease from 80 percent to 40 percent following the introduction of a real-time clinical decision support tool.

Official Title
-----------------
Improving Antibiotic Prescribing Practices in Mexican Primary Care Clinics

Conditions
-----------------
Acute Respiratory Tract Infections

Intervention / Treatment
-----------------
* Behavioral: Computer kiosk Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults age 18 years or greater Exclusion Criteria: mental disability; severe illness

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer Kiosk Eduction<br> | Behavioral: Computer kiosk Education<br>* computerized patient education; guidelines for physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antibiotic prescription rate |  | 4 months |
Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial

Study Overview
=================
Brief Summary
-----------------
AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection. Aim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients. 100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy

Official Title
-----------------
Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions

Conditions
-----------------
Anogenital Human Papillomavirus Infection, Condyloma Anal

Intervention / Treatment
-----------------
* Drug: Imiquimod 5% cream
* Drug: Placebo cream
* Procedure: Fulguration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to understand and willingness to sign and date a written consent document Male and female patients >= 18 years of age Negative urine/serum pregnancy test Indication for surgical therapy of anal HPV lesions Exclusion Criteria: Participation in another clinical study with experimental therapy Diagnosis and therapy of HPV associated lesions in the last 12 months Known intolerance of hypersensitivity to Imiquimod Women who are pregnant of lactating

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br>Imiquimod 5% cream therapy Fulguration | Drug: Imiquimod 5% cream<br>* Patients receive topical Imiquimod therapy for 12 weeks.<br>* Other names: Aldara;Procedure: Fulguration<br>* Surgical Excision and Fulguration of condyloma<br>|
| Placebo Comparator: Placebo Arm<br>Placebo cream therapy Fulguration | Drug: Placebo cream<br>* Patients receive topical Doritin therapy for 12 weeks<br>* Other names: Doritin;Procedure: Fulguration<br>* Surgical Excision and Fulguration of condyloma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in recurrence rates between the two arms | Recurrence is evaluated by clinical examination (proctoscopy) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 (cluster of differentiation 4) cell count | Influence of CD4 cell count in the subgroup of HIV positive patients | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Condylomata acuminata, Fulguration, Imiquimod
A Phase 1b, Single Center, Clinical Study to Investigate the Safety and Biological Responses to Baminercept in Patients With Chronic HCV Hepatitis.

Study Overview
=================
Brief Summary
-----------------
Erstes Safety Trial mit Baminercept in chronischen HCV Patienten. Untersuchung des potentiell antiviralen, antiinflammatorischen Effekts sowie Modulation der hepatischen Gen-Expression. 10 Patienten, open label, 10 Wochen Therapie. Sequentielles Enrollement der ersten 4 Patienten. Trial with medicinal product

Conditions
-----------------
Chronic HCV Hepatitis C

Intervention / Treatment
-----------------
* Drug: Baminercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Informed consent Age 18-60 years Chronic HCV infection Non responder (to Peg-IFN alpha2/Ribavirin containing therapy) Elevated ALT Liver biopsy at screening without sings of (pre-)cirrhosis Compensated liver function Absolute neutrophil count > 1500 / mm3 at screening Hemoglobin > 10 g/dL at screening Calculated creatinine clearance of > 60 cc/min at screening Normal TSH at screening Exclusion criteria: HBV infection Evidence for concomitant liver disease other than HCV hepatitis Evidence for a HCC Alpha-fetoprotein >20ng/ml Autoimmune Disease ANA > 1/320, documented in the last 6 months HIV 1/2 infection ALT and AST >3x ULN, alkaline phosphatase >2,5x ULN Known hypersensitivity or allergy to Baminercept Other clinically significant concomitant disease states Known or suspected non-compliance to study protocol, drug or alcohol abuse Infections other than HCV hepatitis Clinically important chest x-ray abnormality at screening Body mass index (BMI) > 30kg/m2 Concomitant systemic immunosuppressive/-modulating therapy Treatment with anticoagulants Receipt of live vaccine within 4 weeks prior to study start Symptomatic hypogammaglobulinemia with history of recurrent infections Subjects with a history of malignant disease Treatment with other investigational products or participation in an interventional clinical trial within the last 3 months Pregnancy or Breastfeeding Inability or refusal to practice a safe contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

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