linjc16/ctgov huggingface dataset:
Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)

Study Overview
=================
Brief Summary
-----------------
Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).

Official Title
-----------------
Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for all: Visual acuity normal or corrected to normal Affiliation to a social security scheme (copy of the vital card in support) Signed informed consent Medical examination according to the participation in the MRI examination MMSE score> 23/30 For Parkinson patient: Diagnosis of Parkinson's disease Presence of asymmetric bradykinesia and rest tremor and / or stiffness Hoehn & Yahr Stadium I-II / V Exclusion Criteria for all: Unprotected Majors unable to express their consent Protected Major (Persons mentioned in Articles L1121-5,6 and 8 of the public health code) Significant hearing or motor impairment Past or present neuropsychiatric pathology (except benign epilepsy) Taking narcotics and / or drugs for neurocognitive purposes Existence of a severe condition in general (cardiac, respiratory, hematological, renal, hepatic, cancerous) Any other neurodegenerative pathology or treatment that may affect the oculomotor control For Parkinson patient: Treatment for Parkinson's disease (except the inhibitors of monoaminoxidase B or MAO-B, such as selegiline and rasagiline).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br>MRI exam | Other: MRI<br>* Examine BOLD activity in relation to eye movements measures<br>* Other names: eyetracking;|
| Experimental: Parkinson patient<br>MRI exam | Other: MRI<br>* Examine BOLD activity in relation to eye movements measures<br>* Other names: eyetracking;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI images | Functional and anatomical brain volumes | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye latency | latency (milliseconds) of ocular saccades | 1 hour | 
| eye amplitude | amplitude (degree) of ocular saccades | 1 hour |
Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children

Study Overview
=================
Brief Summary
-----------------
MIMOSA study aims to characterize from behavioral, neurophysiological and neurocognitive perspectives children and adolescents with attention deficit hyperactivity disorder (ADHD), in order to identify a possible biomarker of response to medication treatments. To achieve this aim, in the study children with ADHD (drug naive) are recruited and undergo behavioral and clinical screenings, neurocognitive profile, and neurophysiological evaluation with functional near infrared spectroscopy (fNIRS). ADHD group is evaluated before the beginning of medications, at first dose of medication (only imaging evaluation fNIRS), and after a period of two/three months of continuous treatment with medication.

Official Title
-----------------
Multi Neuro-functional Biomarkers for Monitoring the Effects of Treatments in ADHD Children

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of ADHD according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) criteria; drug naive Exclusion Criteria: presence of intellectual disability, neurological diseases, epilepsy, genetic syndromes and previous treatment with psychoactive drugs

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

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

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

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 |
| --- | --- |
| Experimental: ADHD sample<br>Children with a diagnosis of ADHD | Drug: Methylphenidate<br>* standard therapy for ADHD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD rating scale | Clinical improvement measured with ADHD rating scale, percentage. | 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI-S | Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = normal, not ill; maximun value: 7 = very severely ill ) | 2-3 months |
Chronic Obstructive Pulmonary Disease as a Predictor of Mortality in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
To estimate prevalence of chronic obstructive pulmonary disease (COPD) in cardiac surgery population and establish links between COPD status, as assessed through pulmonary functional tests, and 2-year mortality

Official Title
-----------------
Chronic Obstructive Pulmonary Disease as a Predictor of 2-year Mortality in Patients Undergoing Coronary Artery Bypass Graft Surgery

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent, planned elective coronary artery bypass graft surgery Exclusion Criteria: contraindications to pulmonary functional tests, emergency surgery, recent or ongoing myocardial infarction, angina

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| All-cause mortality |  | Two years |
Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome

Study Overview
=================
Brief Summary
-----------------
This study intends to explore the correlation between cervical microbiome, gut microbiome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.

Official Title
-----------------
Microbiome Predicts Pregnancy Outcomes Undergoing Frozen Embryo Transfer: A Multicenter Prospective Observational Study

Conditions
-----------------
Infertility, Microbiome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women receiving assisted reproductive technology treatment, preparing for frozen embryo transfer cycle; Female age: 20-45 years old; Single frozen-thawed blastocyst Transferred Endometrial thickness ≥7mm on the day of luteal transformation Written informed consent. Exclusion Criteria: Women who have pathologies or malformations that affect the pregnancy outcome:genital malformations, intrauterine adhesions, uterine fibroids (>4 cm in diameter or compressing endometrial line), adenomyosis, endometrial polyps; untreated tubal pleura Presence of autoimmune disease; Untreated hyperprolactinemia, thyroid disease, adrenal disease Antibiotic use within the past 7 days; Current or recent (within 3 months) drug abuse, including alcohol and tobacco; Refused or unable to comply with protocol requirements; Participation in any experimental drug study within 60 days prior to screening.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 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 |
| --- | --- |
| Conception positive<br>serum human chorionic gonadotropin ≥10 mIU/mL | Other: no intervention<br>* no intervention in this study<br>|
| Conception negative<br>serum human chorionic gonadotropin <10 mIU/mL | Other: no intervention<br>* no intervention in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conception | Concentration of serum human chorionic gonadotropin ≥10 mIU/mL | 09.01.2022 to 09.01.2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy | detection of a gestational sac in the uterine cavity 3 weeks after conception | 09.01.2022 to 09.01.2024 |
Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.

Official Title
-----------------
Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Lanreotide (Autogel formulation)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient having documentation supporting diagnosis of active acromegaly in one of the following definitions: patient having received neither somatostatin analogue nor dopaminergic agonist within the previous 12 weeks and having an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range, patient being treated with a somatostatin analogue (other than lanreotide autogel) or a dopaminergic agonist when attending the first visit and having at the end of the wash-out period an IGF-1 level at least 1.3 times the upper limit of the age-adjusted normal range. Exclusion Criteria: Patient having had pituitary surgery within the previous 3 months Patient having received radiotherapy for acromegaly disease within the previous 36 months Patient being predicted to require pituitary surgery (adenomectomy) or receive radiotherapy during the study period Patient having received lanreotide autogel at any time before the 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lanreotide (Autogel formulation)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients having a normal (age-adjusted) serum insulin-like growth factor 1 (IGF-1) level at end point (Week 48) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of variation from baseline of the IGF-1 levels expressed as a percentage of the upper limit of the age-adjusted normal range |  |  | 
| Mean growth hormone (GH) levels |  |  | 
| Number of patients having a serum GH level at or below 2.5ng/ml |  |  | 
| Number of patients having a serum GH level at or below 1 ng/ml |  |  | 
| Number of patients with no or reduced clinical signs of acromegaly |  |  | 
| Long-term safety of repeated injections of lanreotide autogel at titrated doses |  |  |
Assessment of Human Herpes Virus Reactivation 6 Post Autologous Stem Cells

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the human herpes virus reactivation 6 post autologous stem cells in 196 patients. The aim of our study was to describe the incidence of reactivation of HHV-6 in patients requiring autologous HSCT and determine the pathogenic role in this target population.

Official Title
-----------------
Assessment of Human Herpes Virus Reactivation 6 Post Autologous Stem Cells , Prospective, Open, Multicenter Study

Conditions
-----------------
Hematologic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients hospitalized in the Hematology Clinic of Saint-Etienne and Clermont-Ferrand and receiving autologous hematopoietic stem cells, according to the decision of the Consultative Meeting Multidisciplinary service; Autologous recipients are included irrespective of causal hemopathy (myeloma, lymphoma, acute leukemia, mainly). Exclusion Criteria: The non-consenting patients or unable to give 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 |
| --- | --- |
| Graft of autologous hematopoietic stem cells<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HHV-6 biological reactivation | HHV-6 biological reactivation (blood viral load) is defined by a detectable viral load HHV-6 and> 450 copies / mL on two occasions one week apart. | 40 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aplasia output or engraftment |  | 40 days | 
| Reconstitution of hematopoiesis |  | 40 days | 
| Disease HHV-6 |  | 40 days |
Hyperapo B and Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
To determine the role of apolipoprotein B and apolipoprotein A1 in the etiology of coronary artery disease.

Detailed Description
-----------------
BACKGROUND: Hyperapo B is a phenotype defined as elevated plasma level of the major apoprotein B of low density lipoproteins in the presence of a normal plasma level of low density lipoprotein cholesterol. It has been demonstrated that hyperapo B is strongly associated with coronary artery disease. In 1984 when the study began, the independence of this association with other risk factors for coronary artery disease such as cigarette smoking, hypertension, and low plasma levels of high density lipoproteins was not known. The study improved knowledge of the pathophysiology of coronary artery disease and of the genetic and biochemical defects of hyperapo B and hypoalphalipoproteinemia. DESIGN NARRATIVE: Interviews were conducted and clinical data collected on each index case and spouse, as well as on first degree relatives. Risk factor data included blood pressure, blood lipid levels, obesity, cigarette smoking, fasting blood sugar and diabetes, hormone use and menopause for women, physical activity, personality scores, and family history. Clinical data included the indications for coronary arteriography, history of use of lipid-lowering agents and insulin, presence of corneal arcus, xanthomata, and xanthelasma, and the electrocardiogram. To determine if the apolipoprotein B gene and the apolipoprotein A1-C3-A4 gene cluster were independent predictors of premature coronary disease, the relation between DNA polymeric sites within the two genes and coronary disease were investigated using cloned DNA fragments as molecular probes. To determine if apolipoprotein B and apolipoprotein A levels aggregated in families and to determine if hyperapo B and hypoalphalipoproteinemia segregated as Mendelian traits, genetic analysis was conducted in the 200 index cases and the 900 first degree relatives. Studies were also conducted on the linkages between hyperapo B and haplotypes of the apolipoprotein B gene, on hyperapo B and the Ag polymorphisms, and on hyperalphalipoproteinemia and haplotypes of the apolipoprotein A1-C3-A4 gene cluster. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Diabetes Mellitus, Obesity, Hypercholesterolemia, Familial

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
ONO-7913 Phase I Study (ONO-7913)

Study Overview
=================
Brief Summary
-----------------
To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.

Official Title
-----------------
An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Biological: ONO-7913


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically or cytologically confirmed advanced or metastatic solid tumors ECOG Performance Status of 0-1 Patients with life expectancy of at least 3 months Exclusion Criteria: Patients with multiple cancers Patients with history of serious allergy

Ages Eligible for Study
-----------------
Minimum Age: 20 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: ONO-7913 as a Single Agent<br> | Biological: ONO-7913<br>* ONO-7913 will be administered by intravenous continuous infusion during the designated time.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicities | Number of participants with a DLT | 28 days | 
| Adverse events | Assessed by the NCI CTCAE v5.0 criteria | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration vs time of ONO-7913 as single dose | PK profile | Up to 24 months |
Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling

Study Overview
=================
Brief Summary
-----------------
This study intends to characterize the affect of sodium and potassium citrate in the diet on renal function.

Official Title
-----------------
Effect of Dietary Sodium and Potassium Citrate on Renal Mineral Handling

Conditions
-----------------
Kidney Stone

Intervention / Treatment
-----------------
* Dietary Supplement: Sodium and Potassium Citrate
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 - 70, approximately equal numbers of men and women studied by endoscopy with complete papillary mapping and grading stone formers Exclusion Criteria: Patients with primary renal diseases or renal impairment (eGFR < 90), or medical conditions such as diabetes, or systemic diseases or medications that alter calcium metabolism Patients with known bladder voiding problems

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Sodium plus Potassium Citrate<br> | Dietary Supplement: Sodium and Potassium Citrate<br>* Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.<br>|
| Placebo Comparator: Low Sodium plus placebo<br> | Dietary Supplement: Placebo<br>* Sodium without Potassium Citrate<br>|
| Experimental: High Sodium plus Potassium Citrate<br> | Dietary Supplement: Sodium and Potassium Citrate<br>* Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.<br>|
| Placebo Comparator: High Sodium plus placebo<br> | Dietary Supplement: Placebo<br>* Sodium without Potassium Citrate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Calcium levels | Amount of calcium in the urine will be measured | 10 days |