linjc16/ctgov huggingface dataset:
Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the effect of Clobazam on sleep and daytime alertness in people with Epilepsy.

Detailed Description
-----------------
Many studies show that patients with epilepsy frequently have disrupted sleep, as well as a high level of daytime sleepiness. This may be due to a sleep disorder, nighttime seizures that lead to disrupted sleep, and other abnormalities. Sleep complaints are widely reported among patients with various epilepsy syndromes. Anti-seizure treatments may affect sleep. Effects vary by type of medication and other health issues. Generally, with improvement of seizure control, the sleep cycle improves and becomes more regular. However, some anti-seizure medications have been associated with insomnia. There have been studies that looked at sleep in relation to some anti-seizure medications. However, there are no currently available published reports on the effect of Clobazam (Onfi) on sleep.

Official Title
-----------------
Effects of Clobazam on Sleep and Daytime Function in Patients With Epilepsy

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults aged 18 years or older diagnosis of epilepsy who are being considered for treatment with Clobazam Exclusion Criteria: known untreated moderate or severe sleep apnea major circadian rhythm disorders

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 |
| --- | --- |
| Patients Treated With Clobazam<br>Single group, patients treated with clobazam by their treating physician (no interventions from PI), followed longitudinally for 1 week after reaching effective clobazam dose. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep (Total Sleep Time) in Patients With Epilepsy Treated With Clobazam | The change in total sleep time in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose | 1 week after reaching effective clobazam dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep (Wake After Sleep Onset) in Patients With Epilepsy Treated With Clobazam | The change in wake after sleep onset (WASO) in patients with epilepsy treat with clobazam one week after reaching effective clobazam dose | 1 week after reaching effective clobazam dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
epilepsy, sleep, antiepileptic drugs
Cytokine Gene Polymorphisms in Gastric Diseases

Study Overview
=================
Brief Summary
-----------------
Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. We intended to clarify the association between polymorphisms of pro-inflammatory and anti-inflammatory cytokines, and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who have higher risks for gastrointestinal disease development.

Detailed Description
-----------------
H. pylori infection has close associations with the development of peptic ulcer diseases as well as gastric cancer, gastric adenoma, and gastric MALT lymphoma. The association of the host genetics with the susceptibility to various gastroduodenal disorders has been intensively investigated in the pathogenesis of peptic ulcer and gastric cancer by H. pylori infection . In chronic active gastritis induced by H. pylori infection, activated neutrophils and mononuclear cells produce several pro-inflammatory and anti-inflammatory cytokines. In fact, levels of pro-inflammatory and anti-inflammatory cytokines are elevated in gastric mucosa infected with H. pylori. Cytokine polymorphisms are associated with various inflammatory and autoimmune diseases. Recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. However, the roles of the IL-10 polymorphisms on the pathogenesis of H. pylori-related gastric cancer and peptic ulcer have not been fully elucidated.It is unclear whether pro-inflammatory and anti-inflammatory cytokines polymorphisms were associated with pathogenesis of peptic ulcer and gastric cancer in Japan. Then, we intended to clarify the association between polymorphisms of IL-10 and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in Japan, and to detect the individuals who have higher risks for gastrointestinal disease development.

Official Title
-----------------
Effects of Pro-Inflammatory and Anti-Inflammatory Cytokine Gene Polymorphism on the Development of Gastric Cancer and Peptic Ulcer in Japanese

Conditions
-----------------
Gastric Ulcer, Duodenal Ulcer, Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: IL-1, TNF-alpha, Il-10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: patinets without H. pylori

Ages Eligible for Study
-----------------
Minimum Age: 0 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: IL-1, TNF-alpha, Il-10|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Markers of Vascular Aging and Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of  non-enzymatic post-translational modifications . They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, PTMD) that can accumulate in tissues and be responsible for deleterious effects. The specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated. This project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD could therefore constitute relevant biomarkers in this specific clinical situation. To explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. The concentrations of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed. This should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.

Official Title
-----------------
Markers of Vascular Aging and Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Biological: blood sample withdrawn


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute coronary heart syndrome included during hospitalization, usual cardiologic follow-up planned in Reims university hospital Exclusion Criteria: <18yo

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acute coronary syndrome<br> | Biological: blood sample withdrawn<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-translational modifications of Proteins quantification assessed by Liquid chromatography-mass spectrometry |  | up to 1 year |
Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.

Official Title
-----------------
Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis, Healthy

Intervention / Treatment
-----------------
* Other: Blood sampling (MS)
* Other: Blood sampling (controls)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center Healthy controls Ability to understand and sign informed consent Exclusion Criteria - All subjects: Other concomitant autoimmune or inflammatory diseases Ongoing treatment with other immunomodulatory medications Previous treatment with rituximab, methotrexate, cyclophosphamide, mitoxantrone, mycophenolate mofetil, or alemtuzumab Pregnancy or lactation Hypersensitivity to ocrelizumab Exclusion Criteria - Healthy Controls: MS First-degree relatives with MS

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Sclerosis<br>Subjects with multiple sclerosis (MS) initiating treatment with ocrelizumab | Other: Blood sampling (MS)<br>* Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment.<br>|
| Healthy<br>Healthy individuals serving as controls to the subjects with MS | Other: Blood sampling (controls)<br>* Blood samples will be collected once at enrollment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocyte Transcriptome Profiling | Changes in messenger ribonucleic acid (mRNA) expression | 12 months | 
| Antigen microarrays | Changes in serum autoantibody immune signatures | 12 months | 
| Serum microRNA profiles | Changes in serum microRNA expression | 12 months |
Leucine Supplementation and Skeletal Muscle Disuse

Study Overview
=================
Brief Summary
-----------------
Leucine supplementation is widely known for promoting strong influence on skeletal muscle remodeling. This study aims to evaluate the effect of leucine supplementation on disuse-induced skeletal muscle atrophy.

Official Title
-----------------
Leucine and Skeletal Muscle Disuse: Clinical Anti-Atrophic Effectiveness and Related Mechanisms

Conditions
-----------------
Disuse Atrophy

Intervention / Treatment
-----------------
* Dietary Supplement: Leucine
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of anterior cruciate ligament injury Physically active Must be able to swallow tablets Non-smokers Do not use nutritional supplements Exclusion Criteria: Post-surgical complications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immobilization and Leucine<br> | Dietary Supplement: Leucine<br>* 7.2 g of leucine during 2 weeks<br>|
| Placebo Comparator: Immobilization and Placebo<br> | Dietary Supplement: Placebo<br>* 7.2 g of alanine during 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle structure (cross-sectional area) |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular signalling pathways (hypertrophy, atrophy, and inflammation) |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leucine, Skeletal Muscle Disuse, Atrophy, Proteolysis
Progression Rate of Pseudoxanthoma Elasticum-associated Choroidal and Retinal Degeneration

Study Overview
=================
Brief Summary
-----------------
This study aims to systematically assess the retest reliability and ability to detect a change of new visual function tests and ophthalmological imaging methods for observing the natural course of pseudoxanthoma elasticum (PXE).

Official Title
-----------------
Progression Rate of Pseudoxanthoma Elasticum-associated Choroidal and Retinal Degeneration

Conditions
-----------------
Pseudoxanthoma Elasticum

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients with Pseudoxanthoma elasticum according to the Plomp criteria or adult patients with a PXE-mimicking phenotype (angioid streaks and peau d'orange [e.g., ENPP1 or GGCX-associated disease]) Best-corrected visual acuity (BCVA): ≤1.0 LogMAR Exclusion Criteria: Inability to give informed consent Claustrophobia Prior surgery (other than anti-VEGF injections, cataract surgery, YAG laser capsulotomy, or laser retinopexy) that - according to the investigator's judgment - may affect visual function assessments (e.g., retinal detachment surgery, glaucoma filtration surgery, or a history of a corneal transplant in the study-eye) Concurrent ophthalmic conditions in the study eye that (according to the investigator's judgment) may contribute to loss of vision, such as clinically significant opacification of the ocular media (corneal dystrophies, cataract), other retinal diseases, or disease of the optic nerve head and visual pathway (including amblyopia) Major surgery planned or other events that (according to the investigator's judgment) could hinder follow-up examinations (e.g., knee replacement)

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: No intervention|According to clinical practice.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the rate of rod-mediated dark-adaptation at the leading disease front (i.e., change in the S2 slope per year) |  | Two years from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bruch's membrane reflectivity |  | Two years from Baseline | 
| Change in choriocapillaris loss |  | Two years from Baseline | 
| Change in steady-state rod and cone sensitivity |  | Two years from Baseline |
Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)

Study Overview
=================
Brief Summary
-----------------
This is a single center collection of discarded biological samples and electronic medical review (EMR) data on patients who are hospitalized with clostridium difficile infections and treated with Fidaxomicin

Detailed Description
-----------------
This single site study will be a clinical research data base of patients hospitalized and diagnosed with Clostridium difficile infection (CDI), treated with Fidaxomicin and willing to allow us to collect discard biological samples for testing and analysis in the investigators lab. An additional blood sample will be obtained if a clinically indicated bronchoscopy is performed as to measure the amount of medication in the BAL. We will also complete a medical record review will also occur.

Official Title
-----------------
Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI)

Conditions
-----------------
Clostridium Difficile Infection (CDI)

Intervention / Treatment
-----------------
* Drug: Fidaxomicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Currently an inpatient at UPMC Presbyterian Diagnosed with an CDI Being treated with Fidaxomicin Exclusion Criteria: not meeting entry criteria

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 |
| --- | --- |
| clostridium difficile infection (CDI)<br>This is a pilot project. Data from electronic medical records will be collected on all patients diagnosed with clostridium difficile infection and who are receiving fidaxomicin as part of their treatment. A total of 50 patients will be enrolled | Drug: Fidaxomicin<br>* patients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI<br>* Other names: clostridium difficile infection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risks factors | Incidence of death as indicated in medical record | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDI episodes | quantified by number of stools in a day as reported in medical record | 1 year |
Hyperthyroidism: Methimazole Plus L-carnitine and Selenium

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the benefits of methimazole treatment in patients with hyperthyroidism, associated with supplementation of L-carnitine and Selenium.

Official Title
-----------------
Association of Methimazole With L-carnitine and Selenium in Patients With Hyperthyroidism

Conditions
-----------------
Hyperthyroidism

Intervention / Treatment
-----------------
* Dietary Supplement: L-carnitine+Selenium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of hyperthyroidism requiring therapy with methimazole Exclusion Criteria: Drug and alcohol abuse; Pregnancy; Medically uncontrolled psychiatric conditions; Interfering therapies (lithium, interferone, TKI, amiodarone)

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: methimazole (control)<br>Patients with hyperthyroidism under methimazole treatment | |
| Experimental: methimazole+L-carnitine+selenium (intervention)<br>Patients with hyperthyroidism under methimazole treatment + supplementation with L-carnitine and Selenium | Dietary Supplement: L-carnitine+Selenium<br>* Supplementation with L-carnitine and Selenium<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperthyroidism symptoms | Improvement of the patients' quality of life through questionnaire | Change from baseline QoL at 6 months of supplementation | 
| Hyperthyroidism symptoms | Improvement of the patients' quality of life through questionnaire | Change from 6-months supplementation QoL at 12 months of intervention (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TRAb | Change in serum TRAb (TSH receptor antibodies) | Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months) | 
| TSH | Change in serum TSH (Thyroid stimulating hormone) | Four time points: baseline; after 3 months of supplementation; after 6 months of supplementation; end of the study (12 months) |