linjc16/ctgov huggingface dataset:
Study of Cerebral MRI Anomalies in Mutated Transthyretin Amyloidosis Patients

Study Overview
=================
Brief Summary
-----------------
Transthyretin amyloidosis (aTTR) initially described as a rare disease, became the most serious hereditary polyneuropathy of adult onset and family screening has made it possible to identify and follow up many asymptomatic patients and carriers of the mutation in the TTR gene. Considered as a systemic disease with involvement of target organs (the heart, the eye, the kidney and peripheral nervous system), it seems to be more complex for neurologists according to recent publications raising the issue of central nervous system involvement. Indeed, TTR amyloid deposits seem to be correlated with the duration of the disease. These deposits can cause cortical damage by different mechanisms: direct TTR toxicity or as a result of pathology related to cerebral amyloid angiopathy (intraparenchymal or subarachnoid hematomas, small infarcts, hemosiderin). A small number of mutations in the TTR gene cause a rare phenotype of systemic amyloidosis, the oculoleptomeningeal form, characterized by clinical neurological symptoms: progressive dementia, epilepsy, ataxia, spastic paraparesis, stroke-like episodes. Hypothesis of the work: the central nervous system involvement is probably underestimated on the radiological description in patients with TTR mutation.

Official Title
-----------------
A Comprehensive Retrospective Study of Cerebral MRI Anomalies in Mutated Transthyretin Amyloidosis Patients

Conditions
-----------------
Transthyretin Amyloidosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients followed at the University Hospital of Nîmes between 2017 and 2021 for a TTR neuropathy with proven mutation, having benefited from a brain MRI. Exclusion Criteria: Patients without TTR neuropathy with proven mutation, or who did not have a brain MRI.

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 |
| --- | --- |
| group patients<br>Patients followed at the University Hospital of Nîmes between 2017 and 2021 for a TTR neuropathy with proven mutation, having benefited from a brain MRI. | Other: No intervention,<br>* pure observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical-radiological characterization | Presence of signs of chronic bleeding on brain MRI (Yes/No) | Baseline |
Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The study aim is to establish a consecutive population of newly referred type 2 diabetes mellitus patients and among these to describe the degree of macrovascular disease by evaluating left ventricular systolic and diastolic function (echocardiography), myocardial perfusion (single-photon emission computed tomography (SPECT)), the peripheral vascular perfusion (strain gauge toe blood pressure measurements and a ultrasound scan of the a. carotis communis). Further, the degree of microvascular disease will be evaluated (glomerular filtration rate assessment, fundus photography and biotesiometry). Finally the cohort will be followed the next two years to assess the prognostic value of the above-mentioned parameters

Official Title
-----------------
Prevalence of Macrovascular Disease in Type 2 Diabetes Mellitus: Left Ventricular Diastolic Dysfunction, Myocardial Ischemia and Peripheral Vascular Insufficient

Conditions
-----------------
Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥ 20 years. Fasting C-peptide > 300 pmol/l. Exclusion Criteria: Verified medical history of macrovascular disease (stroke, myocardiac infarct, coronary revascularisation or strain gauge toe blood pressure < 30 mmHg). Suspected short lifespan because of malignant disease or end-stage kidney disease. Pregnancy or planned pregnancy during the study period. Body weight > 150 kg. Physical or mental disability not enabling participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 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
-----------------
Type 2 diabetes mellitus, Macrovascular disease, Diastolic dysfunction, Intima media thickness, Single- photon emission computed tomography (SPECT)
Inflammatory Cardiomyopathy Baseline Cohort (SFB/TR19)

Study Overview
=================
Brief Summary
-----------------
cohort of cardiomyopathy patients (suspected or validated inflammatory cardiomyopathy) recruited at baseline by the SFB-TR19 project. Standardized protocols used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of various biosamples for biobanking purposes.

Official Title
-----------------
Inflammatory Cardiomyopathy Cohort of the SFB/TR19 [Kohorte Entzündliche Kardiomyopathien Des Sonderforschungsbereichs/Transregio 19 (SFB/TR19)]

Conditions
-----------------
Cardiomyopathies, Heart Failure

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected inflammatory cardiomyopathy at baseline 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation|None, observation only|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular events | Hospitalization (HF based. all-cause), interventions (ICD, pacemaker), myocardial infarction | 1-year follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LVEF | Left ventricular ejection fraction at time of follow-up | 1-year follow-ups | 
| VO2peak | Exercise capacity by CPET | 1-year follow-ups | 
| QOL | Quality of life by questionnaire (Minnesota Living with HF questionnaire) | 1-year follow-ups | 
| Mortality | Mortality (HF-related, CVD, all-cause) | 1-year follow-ups | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, cardiomyopathies, myocarditis
Feasibility of Telemedicine Medical Abortion

Study Overview
=================
Brief Summary
-----------------
This pilot study is designed to obtain data on the safety, acceptability, and feasibility of providing abortion by direct-to-patient telemedicine and mail.

Official Title
-----------------
TelAbortion: Medical Abortion by Direct-to-patient Telemedicine and Mail

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Drug: medical abortion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: desires abortion Exclusion Criteria: medically ineligible for procedure

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant people<br> | Drug: medical abortion<br>* medical abortion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 2 years |
Bioefficacy of Phenolic Acids

Study Overview
=================
Brief Summary
-----------------
The objective is to demonstrate the effect of phenolic acids on endothelial function.

Official Title
-----------------
Effect of Phenolic Acids on the Human Vasculature

Conditions
-----------------
Endothelial Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: phenolic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, Men and women Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening Exclusion Criteria: Any food allergy Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg Pregnancy or lactating women Regular consumption of cholesterol-lowering or antihypertensive medication Smokers Inability to restrain from caffeine/tea and alcohol for 12hrs prior to study visits (intake1 day before screening measurements (and 1 day before each visit) Not restrain the intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study. Excessive alcohol intake defined as > 280 g per week for men and >210g per week for women
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: phenolic acid + maltodextrin<br>phenolic acid + maltodextrin; | Dietary Supplement: phenolic acid<br>* phenolic acid<br>|
| Placebo Comparator: Maltodextrin<br>Maltodextrin | Dietary Supplement: phenolic acid<br>* phenolic acid<br>|
| Active Comparator: flavanol + maltodextrin<br>flavanol + maltodextrin | Dietary Supplement: phenolic acid<br>* phenolic acid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment |  | After 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from predose in blood pressure at 0.5h |  | After 30 min |
Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

Study Overview
=================
Brief Summary
-----------------
Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with alcoholic hepatitis. The liver might play an important role in this stress-catabolism by increasing the production of urea during the inflammatory process. The purpose of this study is to examine the regulation of urea synthesis in patients with alcoholic hepatitis and to study the effect of the anti-inflammatory drugs prednisolone and pentoxifylline on this regulation.

Official Title
-----------------
Effects of Prednisolone and Pentoxifylline on the Regulation of Urea Synthesis in Alcoholic Hepatitis

Conditions
-----------------
Alcoholic Hepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcoholic hepatitis (alcohol intake (> 40g/day in 6 months), bilirubin > 80 μmol/l) Exclusion Criteria: Severe bacterial infections Other chronical inflammatory diseases Cancer Other catabolic diseases Treatment with prednisolone or pentoxifylline within the last 8 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Alcoholic Hepatitis<br>Patients with alcoholic hepatitis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Hepatic Nitrogen Clearance |  | At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and biochemical measures of inflammation |  | At inclusion, after approximately 3 month and if severe alcoholic hepatitis also after 14 days medical treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, Urea Synthesis, Catabolism, Nitrogen balance
ARENA - Project Atrial Fibrilation Rhine-Neckar Region

Study Overview
=================
Brief Summary
-----------------
ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation. The study design includes three study arms: ARENA Intervention: This project will examine the effectiveness of population education. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether there are any complications. ARENA Migration: ARENA migration aims to examine whether a targeted population education can improve the care of people with a Turkish migration background.

Detailed Description
-----------------
ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation. The study design includes three study arms: ARENA Intervention: This project will examine the effectiveness of population education and other measures to provide care for patients with atrial fibrillation. In the end of the control phase (1 year recruitment of approximately 10,000 patients), there will be a wide publicity, informing about the disease. ARENA Medication: ARENA records the patient's complete medication at all survey times (up to two weeks after recruitment and follow up). This allows an accurate assessment of interactions between individual substances. In addition, attempts are being made to determine drug concentrations of anticoagulants directly by the blood of the patient. Therefore, patients are provided with kits, which they can use to apply a drop of blood from your fingertip to a filter paper. The aim is to examine the patient's adherence and to analyze whether there are any complications. ARENA Migration: The Metropolregion Rhein-Neckar is characterized by a high proportion of people with a Turkish migration background. ARENA migration aims to examine whether a targeted population education can improve the care of this patient group.

Official Title
-----------------
Af Register RhEin NeckAr - Projekt Vorhofflimmern Rhein Neckar

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to participate Atiral fibrilation 18 years or older Exclusion Criteria: Not willing to participate

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 |
| --- | --- | --- |
| Number of Prevented strokes in participants |  | 10 years |
Sun Protection Factor Assay (344/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment-Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987521
* Drug: SPF control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-106)<br>Drug: SPF control<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213

Official Title
-----------------
A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)

Conditions
-----------------
Glaucoma, Open-Angle

Intervention / Treatment
-----------------
* Device: OMNI® Surgical System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Participated in, received treatment, and completed Protocol #06213 Exclusion Criteria: Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate washout, place the subject at risk of significant vision loss during the study period (e.g., wet age macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Pre-operative washout of ocular hypotensive medications with post-washout DIOP of 21-36mmHg | Device: OMNI® Surgical System<br>* The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.<br>|
| Cohort B<br>Pre-operative washout of ocular hypotensive medications with pre-operative medicated IOP ≥18 mmHg and on 1 to 5 hypotensive medications | Device: OMNI® Surgical System<br>* The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure (IOP) | Change in unmedicated mean diurnal IOP (DIOP) | 24months | 
| Change in number of medications | Change in the number of ocular hypotensive medications | 24months |
Effect of Dilatation and Curettage on the Endometrial Receptivity

Study Overview
=================
Brief Summary
-----------------
Effect of dilatation and curettage on the endometrial receptivity and pregnancy outcome in patients with recurrent implantation failure

Official Title
-----------------
Effect of Dilatation and Curettage on the Endometrial Receptivity and Pregnancy Outcome in Patients With Recurrent Implantation Failure

Conditions
-----------------
Embryo Implantation

Intervention / Treatment
-----------------
* Procedure: D&C
* Procedure: ICSI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients had at least 3 failed trials of IVF-ET with day 5 fresh blastocyst transferred At least 10 high-grade embryos were obtained in the previous trials Level of AMH more than or equal 1.1 ng/ml. Age: Less than or equal to 35 years Exclusion Criteria: Patients with uterine pathology e.g. myoma , Asherman syndrome, Septum ,adenomyosis Hydrosalpinx Endometriosis patients with diagnosed autoimmune diseases affecting pregnancy e.g. S.L.E.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

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

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: D&C<br> | Procedure: D&C<br>* Dilatation and curettage<br>Procedure: ICSI<br>* Intra Cytoplasmic Sperm Injection<br>|
| Other: No D&C<br> | Procedure: ICSI<br>* Intra Cytoplasmic Sperm Injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth Rate |  | 9 months |