linjc16/ctgov huggingface dataset:
Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis

Study Overview
=================
Brief Summary
-----------------
This study aims to provide an estimate of the incidence of paraneoplastic neurological syndromes and autoimmune encephalitides in France between the years 2016 and 2018. The study will describe the incidence of antibody subtypes and regional variations.

Official Title
-----------------
Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis in France Between 2016 and 2018

Conditions
-----------------
Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Clinical diagnosis of Paraneoplastic Neurological Syndrome (PNS) or Autoimmune Encephalitis (AE) made by the referring physician to the national center for PNS and AE in Lyon between 2016 and 2018 Exclusion Criteria: Data on location of diagnosis missing Patients diagnosed out of the mainland French territory Patients for whom insufficient data was available
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paraneoplastic neurological syndromes patients<br>Patients tested for Paraneoplastic neurological syndromes (PNS) and Autoimmune Encephalitis (AE) with a lumbar puncture, with detection of an antibody or negative, but with PNS clinically diagnosed. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and prevalence of diagnosed Paraneoplastic Neurological Syndromes (PNS) and Autoimmune Encephalitis (AE) between 2016 and 2018. | Comparison between general population of the French counties and the cohort of PNS to calculate incidence and prevalence. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Location (city) of diagnosis | Name of city where the diagnosis of Paraneoplastic Neurological Syndromes (PNS) or Autoimmune Encephalitis (AE) was made. | 1 hour | 
| French general population of each counties | Person years for each region | 3 years |
Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects Under General Anesthesia

Study Overview
=================
Brief Summary
-----------------
The primary aim is to utilize near-infrared spectroscopy (NIRS) in patients under general anesthesia to measure changes in brain blood flow in the bilateral somatosensory cortices and the prefrontal cortices in response to noxious stimulation.

Official Title
-----------------
Assessing the Cortical Response to Noxious and Auditory Stimuli Using Near Infrared Spectroscopy in Subjects Under General Anesthesia

Conditions
-----------------
Anesthesia, Pain

Intervention / Treatment
-----------------
* Drug: Remifentanil
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 12-30 years of age Structurally normal heart Right-handed English-speaking Exclusion Criteria: Unable to cooperate or understand the study Neurologic disease Diabetes mellitus Syndrome of greater than minor severity. Smoker Scalp or hair does not permit sufficient optical light detection Unable to keep his/her head still for a period of 200 consecutive seconds

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 30 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Normal saline infusion | Drug: Normal saline<br> <br> * Other names: Placebo;|
| Active Comparator: Drug lower dose<br>Remifentanil infusion | Drug: Remifentanil<br> <br> * Other names: Ultiva;|
| Active Comparator: Drug higher dose<br>Remifentanil infusion | Drug: Remifentanil<br> <br> * Other names: Ultiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilization of NIRS to measure changes in oxyhemoglobin and deoxyhemoglobin in the somatosensory and prefrontal cortices in response to noxious stimulation, and whether these changes are reduced or eliminated by remifentanil. |  | During surgical procedure |
Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the bioequivalence of divalproex sodium 125 MG delayed release tablets.

Official Title
-----------------
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions

Conditions
-----------------
Seizures

Intervention / Treatment
-----------------
* Drug: Divalproex Sodium
* Drug: Depakote DR Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant findings on physical examination, medical history or laboratory tests on screening Exclusion Criteria: Positive test for HIV or Hepatitis B and C History of sensitivity to valproic acid or related compounds

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

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

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Divalproex Sodium 125 MG Delayed Release Tablets Sandoz | Drug: Divalproex Sodium<br> <br> |
| Active Comparator: 2<br>Depakote 125 MG DR Tablets Abbott Laboratories USA | Drug: Depakote DR Tablets<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA Guidelines |  | 9 Days |
Real-life Evaluation of the Daivobet® Gel Applicator

Study Overview
=================
Brief Summary
-----------------
This study aims to describe the patient population being treated and evaluate their treatment adherence and treatment outcomes during treatment of scalp psoriasis with Daivobet® gel Applicator for 4 weeks.

Official Title
-----------------
Real-life Evaluation of an Applicator, as a New Mode of Administration of Daivobet® Gel, on Adherence to Treatment and SAtisfaction of Patients With PSOriasis

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: calcipotriol/betamethasone dipropionate gel in Applicator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Dermatologist or general practitioner has decided to initiate treatment with Daivobet® gel Applicator Exclusion Criteria: Indication not within the approved labelling in France Contraindication for treatment with calcipotriol or betamethasone dipropionate Informed consent to participate in the study has not been obtained

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 |
| --- |
|Drug: calcipotriol/betamethasone dipropionate gel in Applicator|Topical treatment of scalp using applicator device. The study as such is non-interventional as the intervention has been decided prior to and independently from the inclusion of the patient in the cohort to be observed.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morisky Medication Adherence Scale-8 | Degree of adherence to prescribed treatment | 2 weeks | 
| Morisky Medication Adherence Scale-8 | Degree of adherence to prescribed treatment | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient opinion on Applicator usability | 5-point Likert scale | 4 weeks | 
| Patient overall satisfaction | 4 point Likert scale | 4 weeks | 
| Patient Global Impression of Improvement | 7 point Likert scale | 2 weeks | 
| Patient Global Impression of Improvement | 7 point Likert scale | 4 weeks | 
| Investigator's opinion on the properties of the Applicator | 5 point rating scale | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis vulgaris, scalp, topical, applicator, device
Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
To assess the safety and tolerability of ascending single oral doses of SAM-315, an investigational drug, in healthy adult subjects. To obtain a preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-315, an investigation drug, administered to healthy adult subjects.

Official Title
-----------------
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Adult Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SAM-315


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men and women of nonchildbearing potential aged 18 to 45 years Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels must be within the upper limit of normal for eligibility. Exclusion criteria: Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results. Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours and, grapefruit, grapefruit-containing products is prohibited 72 hours before study day 1.

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SAM-315|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics and pharmacodynamics |  |  |
Effects of Acetazolamide and CO2 Inhalation on Exercise-induced Periodic Breathing in Heart Failure

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of CO2 inhalation and acetazolamide treatment on exercise-induced periodic breathing in patients with chronic stable heart failure. Patients will be given CO2 (2%) during a constant workload exercise. Patients will be also evaluated by maximal cardiopulmonary exercise test without and with acetazolamide acute and chronic treatment.

Conditions
-----------------
Chronic Heart Failure

Intervention / Treatment
-----------------
* Drug: acetazolamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic heart failure in stable clinical condition exercise-induced periodic breathing Exclusion Criteria: comorbidities NYHA class IV

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Acetazolamide<br> | Drug: acetazolamide<br>* i.v. 500 mg of acetazolamide for the acute study and 500 mg of acetazolamide p.o. t.i.d. for two days<br>* Other names: Diamox;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suppression of periodic breathing |  | two days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| suppression of sleeping apnea |  | two days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure,, exercise, periodic breathing,, acetazolamide
Follow up by General Practitioner After Self-poisoning

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.

Detailed Description
-----------------
Patients hospitalized after an episode of self poisoning will be randomly assigned into intervention an control groups. The intervention is close follow up by general practitioner six months. Both groups will receive treatment as usual.

Official Title
-----------------
Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial

Conditions
-----------------
Suicidal and Self-injurious Behaviour

Intervention / Treatment
-----------------
* Behavioral: Follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self Poisoning (according to the WHO definition) Ability to fill out questionnaire Exclusion Criteria: Hospitalization into psychiatric ward Unknown address or ID Not registered with General Practitioner If institutionalized or in jail.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follow up<br>Close follow up from written guidelines, supervision provided. | Behavioral: Follow up<br>* Follow up, consultations with general practitioner, written guidelines, supervision.<br>* Other names: General Practitioner;|
| No Intervention: Usual Treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal behaviour | Beck Cepression Inventory, Beck Hopelessness scale, Beck Suicide Ideation Scale | 3 and 6 months | 
| Suicidal behaviour | Beck Depression Inventory, Beck Hopelessness scale, Beck Suicide Ideation Scale | 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment | Contacts with GP, and health care services, satisfaction with treatment GP (EUROPEP) | 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Hopelessness, Suicidal ideation
A Study of ND0801 in Attention Deficit/Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
A multicenter, open label, escalating dose study to assess the tolerability and the safety and to explore the efficacy and the pharmacokinetics of ND0801 in adult patients with attention deficit/hyperactivity disorder (ADHD).

Official Title
-----------------
A Multicenter, Open Label, Escalating Dose Study to Assess the Tolerability and the Safety and to Explore the Efficacy and the Pharmacokinetics of ND0801 in Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)

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

Intervention / Treatment
-----------------
* Drug: ND0801


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients. Men and women 18-55 years of age. Primary DSM-IV diagnosis of adult ADHD confirmed by senior physician Capable and willing to provide informed consent Able to adhere to the treatment schedule, and withdrawal of ongoing pharmacotherapy for the treatment of ADHD prior to the beginning of the study treatment and during the study drug treatment. Subjects must be able to read, hear, write and speak the local language. Subject has signed a written informed consent to participate in the study. Exclusion Criteria: Unstable or significant medical disorder. Current (within 12 months of baseline) primary or secondary depression. History of substance abuse or dependence within the past 6 months Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features Bipolar disorder Eating disorder Obsessive compulsive disorder Post-traumatic stress disorder Current generalized anxiety disorder Presence of a personality disorder Individuals with a significant other neurological disorder. Use of any investigational drug within 4 weeks of the randomization visit Known or suspected pregnancy Women who are breast-feeding Women of childbearing potential and not using a medically accepted form of contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: ND0801<br> | Drug: ND0801<br>* Confidential<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & Tolerability Evaluation | Safety and tolerability of ND0801 will be based on adverse events reporting by the subjects during the study. | 1 week |
Intrawound Administration of Vancomycin in THA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total hip arthroplasty.

Official Title
-----------------
Serum and Wound Vancomycin Levels Following Intrawound Administration in Primary Total Hip Arthroplasty

Conditions
-----------------
Hip

Intervention / Treatment
-----------------
* Procedure: Intrawound administration of vancomycin after closure of the arthrotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18; Total hip arthroplasty for advanced hip diseases including femoral neck fracture, developmental dysplasia of hip, and osteonecrosis of the femoral head. Exclusion Criteria: Diminished mental capacity Vancomycin allergy Chronic kidney disease stage III and stage IV

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: Intrawound Administration of Vancomycin<br>After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 20ml of normal saline was injected directly into the joint. | Procedure: Intrawound administration of vancomycin after closure of the arthrotomy<br>* After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle.<br>|
| Experimental: Intrawound Administration of Vancomycin combined with epsilon-aminocaproic acid (EACA)<br>After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle. Then 4g (20ml) of epsilon-aminocaproic acid (EACA) was injected directly into the joint. | Procedure: Intrawound administration of vancomycin after closure of the arthrotomy<br>* After closure of the arthrotomy, 1 g of vancomycin powder suspended in 30ml of normal saline was injected directly into the joint with an 18-gauge needle.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-articular vancomycin concentration |  | 2 hours, 8 hours and 24 hours postoperatively | 
| Serum vancomycin concentration |  | 2 hours, 8 hours and 24 hours postoperatively | 
| Renal function | blood urea nitrogen (BUN), creatinine (Cr), GFR | Postoperative Day 1 and Day 3 | 
| Blood loss |  | Postoperative Day 3 |