linjc16/ctgov huggingface dataset:
Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.

Study Overview
=================
Brief Summary
-----------------
Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls. Up to date, pediatric data are lacking. The study aims at demonstrating if a correlation exists between the motor deficiency and the muscular deoxygenation in children suffering from neuromuscular disorders.

Detailed Description
-----------------
Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls, as it was demonstrated in Becker muscular dystrophy patients and fascioscapulo humeral muscular dystrophy. Moreover, the deoxygenation kinetics was positively correlated to the functional status and the muscular deficiency severity. However, no pediatric study has been conducted on this topic up to date. The aim of the study is to determine if a correlation exists in children suffering from neuromuscular diseases: between muscular oxygenation and the percentage of the 6 minutes walking test performed in the routine medical care between muscular oxygenation and the total and D1 motor function measure value

Official Title
-----------------
Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.

Conditions
-----------------
Neuromuscular Diseases in Infants, Neuromuscular Diseases in Children

Intervention / Treatment
-----------------
* Other: Muscular oximetry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children from 6 to 18 years-old suffering from a neuromuscular disorder Able to walk, with or without help Exclusion Criteria: Hypoxia secondary to heart or lung disease Visual impairment (<5/10) Parents refusal concerning data storage

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- |
| Muscular oximetry<br>6 minutes walking test performed in the routine medical care with muscle oximetry recording in children suffering from neuromuscular diseases | Other: Muscular oximetry<br>* 6 minutes walking test performed in the routine medical care with muscle oximetry recording<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular oxygenation | Muscular oximetry | 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minutes walking distance | 6 minutes walking distance | 6 minutes | 
| Motor function | Motor function measure (MFM scale) | 25 minutes |
A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From Abdominal Aorta Surgery

Study Overview
=================
Brief Summary
-----------------
Summary Question: Does backward walking offer additional therapeutic value in patients after aortic aneurysm surgery? Participants: The study of backward walking as an addictive physiotherapy procedure was conducted in the group of 65 patients who underwent abdominal aorta surgery. The patients were randomly divided into three subgroups and three various models of physiotherapy were applied. Control group has only routine physiotherapy since therapeutic group I and II have also walking exercises forward in group I and backward in group II respectively.

Official Title
-----------------
A Controlled Trial of Effectiveness of a Backward Walking Program in Patients Recovering From an Abdominal Aorta Surgery

Conditions
-----------------
Abdominal Surgery

Intervention / Treatment
-----------------
* Procedure: forward walking
* Procedure: backward walking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with abdominal aortic aneurysm Age 65-75 years Male sex Stable cardiologic status Absence of neurological disorders Non-symptomatic aneurysm - non-ruptured No pain complaints No motion system impairments Exclusion Criteria: Patients with neurological disorders Unstable coronary heart disease symptomatic aortic aneurysm - dissecans aneurysm Having difficulty in locomotion Having contradiction for starting physical training during the first or second day after surgery Patients with psychiatric disease Lack of patient's compliance with physiotherapist; AND Other medical contraindications

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Backward walking, | Procedure: backward walking<br>* physiotherapy with use a backward walking type of physiotherapy<br>|
| Active Comparator: 1<br>Forward walking | Procedure: forward walking<br>* comparison forward walking vs backward walking in the physiotherapy after after abdominal surgery<br>|

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
-----------------
abdominal aorta surgery, Physical Training, backward walking, physiotherapy
A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.

Official Title
-----------------
A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose Response Study to Evaluate the Safety and Efficacy of Two Different Doses of Abatacept (BMS-188667) Administered Intravenously to Japanese Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Abatacept
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization Exclusion Criteria: no current infection or other evolutive or uncontrolled disease

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abatacept 2 mg/kg<br> | Drug: Abatacept<br>* Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks<br>* Other names: Orencia;|
| Active Comparator: Abatacept 10 mg/kg<br> | Drug: Abatacept<br>* Injection, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks<br>* Other names: Orencia;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Injectio, IV Infusion, Day 1, 15, 29 and every 28 days for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be evaluated using the American College of Rheumatology response rate or ACR 20. This means the respective proportion of patients reaching an improvement of at least 20% of the ACR composite index from baseline. |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR 50 and ACR 70 will be assessed as respectively 50 and 70% improvement of the ACR composite index, quality of life by using SF36 questionnaire, Population Pharmacokinetics, Biomarkers, Immunogenicity |  | at 6 months | 
| Safety (Severity of adverse events, causal relationship to the study drug, outcome, action taken with respect to the investigational product, treatment required) |  | at 6 months |
Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
JJ ureteral stent represents an advance in the management of the upper urinary tract obstruction as it allows the patient to resume his activities although he is stented between the kidney and the bladder. However, in many cases, this JJ stent is not well tolerated and can even be unbearable. This trial evaluates the benefit of tamsulosin (an alpha-blocker) in improving the tolerance of JJ stents compared to low-doses of phloroglucinol.

Official Title
-----------------
Evaluation of the Efficacy of Tamsulosin (Alpha Blockers) Compared to Phloroglucinol in Improving JJ Ureteral Stent Tolerance. A Randomized Controlled Trial

Conditions
-----------------
Non-oncological Indication to Ureteral Stenting

Intervention / Treatment
-----------------
* Drug: Omexel
* Drug: spasfon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 or more. Non-oncological indication to ureteral stenting Informed written consent Exclusion Criteria: 1 Any contra-indication to Tamsulosin or phloroglucinol (renal or hepatic insufficiency, allergy) 2. Pregnancy 3. Patients already treated with alpha blockers

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 |
| --- | --- |
| Experimental: Omexel<br> | Drug: Omexel<br> <br> |
| Active Comparator: spasfon<br> | Drug: spasfon<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the benefit of alpha-blockers (Tamsulosin, group A) compared to phloroglucinol (Spasfon®, group B) as regards patients tolerance to JJ stents |  | 1 month treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of complications |  | after 1 month treatment |
Effect of High Protein, High-calorie Oral Nutritional Supplementation in Malnourished Elderly in Nursing Homes.

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that the administration of a high-calorie high-protein oral nutritional supplement twice a day for three months to elderly malnourished in residents in Spain is associated with improved nutritional status, with an increase in body weight of between 5 and 8%, and an improvement in functional status, with low incidence of complication.

Detailed Description
-----------------
A prospective, multi centric, observational study. The study is conducted in elderly living in nursing homes in Spain.

Official Title
-----------------
Effect of High Protein, High-calorie Nutritional Supplementation in Malnourished Elderly in Nursing Homes. A Prospective, Observational, Multicentric Study (PROT-e-GER Study)

Conditions
-----------------
Other Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Fortimel Complete


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 65 years, Living in nursing homes, Malnutrition treated with an hyper-caloric oral nutritional supplementation (1.3 Kcal / ml) and high-protein (protein 20%). Exclusion Criteria: Tube feeding (nasogastric or gastrostomy) Terminally ill or palliative treatment and residents with life expectancy of less than 6 months Special nutritional requirements (for example by intestinal malabsorption, short bowel residents or specific nutrition for renal insufficiency).

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Fortimel Complete<br>All of the residents included receive ONS | Dietary Supplement: Fortimel Complete<br>* The residents included receive 2 bottle por day.<br>* Other names: ONS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve weight | Difference between the weight of the residents at the beginning and at the end of the study | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPPB scale | Functional status at the end of the study | 3 months | 
| Barthel index | Ability in Activities of Daily Living at the end of the study | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Malnutrition, Disability, Oral Nutritional Supplementation
Corneal Nerve Structure in Sjogren's

Study Overview
=================
Brief Summary
-----------------
Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for ocular symptoms and corneal nerve morphology. We are specifically interested in the relationship between Vitamin D level and aberrations in the morphology of the corneal nerves.

Detailed Description
-----------------
Patients with either suspected or confirmed diagnosis of Sjogren's disease will be recruited to participate. Participation will involve the completion of a brief survey (the OSDI), corneal evaluation with an aesthesiometer, corneal staining with fluorescein and lissamine green, and finally measurement of tear-film breakup time. In addition, participants will have their corneal nerve morphology evaluated with the Heidelberg confocal microscope and finally they will have a blood draw performed to assess vitamin D level.

Conditions
-----------------
Sjogren's Syndrome, Vitamin D Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected or confirmed Sjogren's syndrome 18+ years of age Exclusion Criteria: Any condition that in the opinion of the investigator may confound study results or cause concerns for safety

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Nerve Morphology | Heidelberg Retina Tomograph with the Rostock Cornea Module | one time exam | 
| Vitamin D Level | serum | one time exam at baseline, day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital dye staining | corneal staining | one time exam at baseline, day 1 |
Clopidogrel Resistance in Stroke Patients From Different Ethnicities

Study Overview
=================
Brief Summary
-----------------
Clopidogrel is an anti-platelet agent used to inhibit blood clots. Variation in response to clopidogrel has been reported among different population and may lead to reoccurring ischemic events. The aim of the present study is to evaluate the incidence of clopidogrel resistance in ischemic stroke patients from different ethnicities in Northern Israel and to find different strategies to overcome high platelet reactivity including clopidogrel dose adjustment or the choice of alternative agents. Quantification of platelet aggregation will be determined by vasodilator stimulated phosphoprotein (VASP) assay.

Official Title
-----------------
Prospective Study Evaluating Clopidogrel Resistance in Ischemic Stroke Patients From Different Ethnicities

Conditions
-----------------
Clopidogrel, Poor Metabolism of, Ischemic Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: Quantification of platelet aggregation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent and to be compliant with protocol assessments. Ages 18 and above inclusive Both genders eligible for the study Diagnosis of ischemic cerebrovascular event Exclusion Criteria: Pregnant patients will be excluded Ages below 18 Patients not able to provide informed consent

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Jewish communities<br>Ashkenazi, Sephardi, Ethiopian | Diagnostic Test: Quantification of platelet aggregation<br>* Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay<br>|
| Arab populations<br>Muslim, Christian, Druze | Diagnostic Test: Quantification of platelet aggregation<br>* Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of clopidogrel resistance assessed among the different ethnicities |  | 6 months | 
| Identifying of high-risk subgroups of adverse clinical outcomes |  | 6 to 12 months |
Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy (Craniopharyngioma)

Study Overview
=================
Brief Summary
-----------------
Prospective, open labelled, phase II, monocenter trial to combine partial surgery resection and protontherapy to management paediatric craniopharyngioma.

Detailed Description
-----------------
This study is phase II prospective, open labelled, phase ii, monocenter. The main objective is to evaluate the fractionated high precision radiotherapy with a dose of 59,5 Gy (1,7 Gy daily, 5 fractions per week).

Official Title
-----------------
Phase II Study on the Management of Pediatric Craniopharyngioma by a Combination of Partial Surgical Resection, and Protontherapy

Conditions
-----------------
Craniopharyngioma

Intervention / Treatment
-----------------
* Radiation: Protontherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented craniopharyngioma Age range between 3 and 16 years Landsky performance status > 60 Incomplete surgical resection or simple biopsy Solid and/or cystic aspect on imaging Irradiation performed at the time of presentation or of local progression Signed informed consent by parents or by legal representative (with copy to each participating center) Exclusion Criteria: Previous history of radiotherapy (including stereotactic) administered to the head and neck region Severe vasculopathy Participation to a concurrent study Contra-indication to general anesthesia in children below 5 years Patient non-compliant to a minimum 30 mn immobilisation Patient deprived of freedom or under guardianship Patient not expected to be followed in a long run

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protontherapy<br> | Radiation: Protontherapy<br>* 59,5 Gy (1,7 Gy daily, 5 fractions per week).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control rate at 3 years of a minimally aggressive surgical resection, followed by fractionated high precision radiotherapy |  | at 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual pathway tolerance according to NCI-CTC v3.0 scale |  | through study completion, up to 9 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
craniopharyngioma, protontherapy
Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare the remifentanil requirements in deep versus moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic herniorrhaphy.

Official Title
-----------------
A Double-blind, Randomized Study to Compare the Remifentanil Requirements in Deep Versus Moderate Neuromuscular Blocks During the Surgical Pleth Index-guided Analgesia in Patients Undergoing General Anesthesia for Laparoscopic Herniorrhaphy

Conditions
-----------------
Hernia Abdominal Wall

Intervention / Treatment
-----------------
* Drug: Moderate neuromuscular block
* Drug: Deep neuromuscular block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic hernia repair Exclusion Criteria: patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Moderate NMB group<br> | Drug: Moderate neuromuscular block<br>* maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg<br>|
| Experimental: Deep NMB group<br> | Drug: Deep neuromuscular block<br>* maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remifentanil Infusion Rate | remifentanil infusion using target effect-site concentration to achieve an surgical pleth index of range between 25 and 50 | from pneumoperitoneum to removal of laparoscope, an average of 30 minutes |