linjc16/ctgov huggingface dataset:
European Multicentre Study of Human Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Today there is accumulating evidence from animal experiments that regeneration can be induced after a spinal cord injury (SCI). Consequently in the near future, new therapeutic approaches to induce some regeneration will be included in the treatment of patients with SCI. The aim of this proposal is to provide the required clinical basis for the implementation of novel interventional therapies. The establishment of combined clinical, functional and neurophysiological measures for a qualitative and quantitative assessment of spinal cord function in patients with SCI at different stages during rehabilitation represents a basic requirement to monitor any significant effect of a new treatment. Therefore, several European Paraplegic Centres involved in the rehabilitation of acute traumatic SCI patients build up a close collaboration for standardised assessment. The aim is to get knowledge about the natural recovery after spinal cord lesion in a larger population of patients in the sense of a historical control group and to bring new standardised assessment tools to the clinical setting.

Official Title
-----------------
European Multicentre Study of Human SCI

Conditions
-----------------
Spinal Cord Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single event traumatic or ischemic para- or tetraplegia First EMSCI assessment possible within the first 6 weeks after incidence Patient capable and willing of giving written informed consent Exclusion Criteria: Nontraumatic para- or tetraplegia (i.e. discusprolaps, tumor, AV-malformation, myelitis) excl. single event ischemic incidences Pre-known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent Peripheral nerve lesions above the level of lesion (i.e. plexus brachialis impairment) Pre-known polyneuropathy Severe craniocerebral injury

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 |
| --- | --- | --- |
| Spinal Cord Independence Measure (SCIM) | Score from 0 to 100 points; the higher the score, the higher the independence of the patient | Change in course from 2 weeks at 48 weeks | 
| International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI score) | Score from 0 to 112; the higher the score, the better the neurological status of the patient | Change in course from 2 weeks at 48 weeks | 
| Walking Index for Spinal Cord Injury (WISCI) | Score from 0 to 20; the higher the score, the better the walking ability of the patient | Change in course from 2 weeks at 48 weeks | 
| 10 Meter Walk Test (10mWT) |  | Change in course from 2 weeks at 48 weeks |
the Effect of a Red Rice Nutrition Supplement on Cholesterol Levels

Study Overview
=================
Brief Summary
-----------------
In this study the investigators investigate the effect of a red rice product on plasma lipids in a sample of physicians and/or their family members. After a baseline measurement of cholesterol, HDL, LDL and TG, participants are randomised to receive a commercially available red rice product or placebo. After a period of 8 weeks, lipid levels are measured again.

Official Title
-----------------
The Effect of a Commercially Available Red Rice Nutrition Supplement on Serum Lipids

Conditions
-----------------
Cholesterol Level, HDL Level, LDL Level, TG Level

Intervention / Treatment
-----------------
* Dietary Supplement: red rice supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: total fasting cholesterol > 200mg/dl

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: red rice<br>commercially available red rice nutritionial supplement | Dietary Supplement: red rice supplement<br>* patricipants take a red rice supplement or placebo daily for 8 weeks<br>|
| Placebo Comparator: placebo<br>placebo capsules | Dietary Supplement: red rice supplement<br>* patricipants take a red rice supplement or placebo daily for 8 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting cholesterol, LDL, HDL, TG level |  | 8 weeks |
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.

Official Title
-----------------
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

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

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: Vildagliptin Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood glucose criteria must be met Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 22-45 Diagnosis of type 2 diabetes for at least 8 weeks Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of serious diabetic complications Evidence of serious cardiovascular complications Significant laboratory abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

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: Vildagliptin<br> | Drug: vildagliptin<br> <br> * Other names: LAF237;|
| Placebo Comparator: Placebo<br> | Drug: Vildagliptin Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile after 52 weeks of treatment |  |  | 
| Patients with HbA1c <6.5% at 12 weeks |  |  | 
| Patients with HbA1c <6.5% at 52 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Coefficient of failure for HbA1c between 24 weeks and 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Sildenafil Citrate of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of sildenafil citrate on endometrial development in women with history of recurrent implantation failure after IVF

Detailed Description
-----------------
sildenafil citrate may increase endometrial thickness in women with recurrent IVF failure attributed to poor endometrial development

Official Title
-----------------
Effect of Sildenafil Citrate on the Outcome of in Vitro Fertilization After Multiple IVF Failures Attributed to Poor Endometrial Development

Conditions
-----------------
IVF Failure

Intervention / Treatment
-----------------
* Drug: Sildenafil Citrate
* Drug: matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) cases of infertility, older than 20 years of age and not older than 40 years. (2) Body mass index (BMI):20-29. (3) women have experienced two or more implantation failure attributed to inadequate endometrial development. Exclusion Criteria: (1) Uterine abnormalities (e.g. septate, bicornuate and fibroid uterus, Asherman Syndrome). (2) Any contraindication to sildenafil citrate or any of the components of its formulation including: Concurrent use of organic nitrites and nitrates. Severe hepatic impairment. Severe renal impairment. Hypotension. Recent stroke or heart attack.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil citrate<br> | Drug: Sildenafil Citrate<br>* 25 mg orally, 4 times per day for 21 days<br>* Other names: Silden 25 mg tablet, EIPICO, Inc, Cairo, Egypt;|
| Placebo Comparator: placebo<br> | Drug: matching placebo<br>* orally, 4 times per day for 21 days<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness measures | we will measure endometrial thickness by US in women with recurrent implantation failure | 21 days |
Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

Study Overview
=================
Brief Summary
-----------------
This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis (EoE) is characterized by abnormal esophageal structure and compliance compared to non fibrostenotic EoE and that distinctive cellular and molecular profiles predict the fibrostenotic phenotype. This study aims to define and assess the changes that occur in the structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along with characterizing the histologic and molecular patterns in fibrostenotic EoE.

Official Title
-----------------
Fibrostenotic Eosinophilic Esophagitis: Endoscopic, Histologic and Molecular Characterization and Evaluation of Clinical Assessment Tools

Conditions
-----------------
Eosinophilic Esophagitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo a clinical upper endoscopy with biopsy Exclusion Criteria: Known connective tissue disorder Increased risk of bleeding Inflammatory bowel disease, celiac disease, eosinophilic gastroenteritis, or any autoimmune disease Other esophageal disease including known achalasia; history of caustic ingestion, esophageal surgery esophageal stricture for other known reason or other esophageal injury. Use of oral or intravenous steroids in the preceding 60 days. (Swallowed topical fluticasone, budesonide, etc not included as exclusion criteria.)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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 |
| --- | --- | --- |
| Stricture, as measured by endoscopic assessment |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased esophageal distensibility, as determined by EndoFlip |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eosinophilic Esophagitis, Esophageal Stricture
Low-Cost Contingency Management for Hispanic Outpatients - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness of a lower-cost contingency management (CM) procedure in Hispanic substance abusing outpatients. Thirty individuals meeting DSM-IV criteria for substance dependence receive one of two conditions: (a) standard treatment, or (b) standard treatment plus prize CM. Using a cross-over design, CM is implemented in a community-based outpatient clinic and compared with non-CM in the same clinic. The participating clinic is randomly assigned to receive either the CM or non-CM phase first; 15 weeks after the final participant in one phase is enrolled, a one-week washout period occurs, followed by a switch to the other phase. Patients initiating outpatient treatment during the non-CM phase receive standard treatment and submit urine and breath samples 2/week during Weeks 1-6 and 1/week during Weeks 7-12. Patients initiating treatment during the CM phase also receive standard treatment and the same breath and urine monitoring. In addition, they earn the opportunity to win prizes for coming to treatment and for submitting negative breath and urine samples. Follow-up interviews are conducted at 1,3,6 and 9 months following intake during which substance use and psychosocial functioning are assessed.

Official Title
-----------------
Low-Cost Contingency Management for Hispanic Outpatients

Conditions
-----------------
Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age > 18 years current DSM-IV substance dependence. Exclusion criteria: have a serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination have dementia (<23 on the Mini Mental State Exam; Folstein et al. 1975) DSM-IV diagnosis of pathological gambling plans to move from the Hartford are within 9 months.

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Contingency management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  | baseline and each follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contingency management, substance abuse
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

Detailed Description
-----------------
The study is a prospective, controlled, randomized, single-blind, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will be 1:1 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters: National Institute of Health Stroke Scale (NIHSS) at baseline (stratify <10, 11-18) Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify <5 hrs, or ≥5 hrs).

Official Title
-----------------
Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)

Conditions
-----------------
Cerebrovascular Accident

Intervention / Treatment
-----------------
* Device: NeuroFlo™ catheter
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic stroke NIHSS between 5-18 Time from symptom onset less than 14 hours Exclusion Criteria: Hemorrhagic stroke Certain types of heart disease Kidney disease Other conditions the doctor will assess

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: NeuroFlo™ catheter<br>* 45 minute treatment<br>|
| Active Comparator: 2<br> | Other: Control<br>* ASA Guidelines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of the NeuroFlo device and procedure will be compared to medical management alone |  | 90 days | 
| Efficacy will be assessed using a global outcome score |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute improvement in neurological function |  | 24 hours | 
| Stroke Impact Scale |  | 30 & 90 days | 
| Hospital length of stay |  | Varies | 
| Patient disposition upon discharge will be compared |  | Varies | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute, ischemic, stroke, randomized, device, treatment
Minimally-Invasive Isolated Limb Perfusion

Study Overview
=================
Brief Summary
-----------------
The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.

Detailed Description
-----------------
Isolated limb perfusion (ILP) and isolated limb infusion (ILI) are treatment options for patients with in-transit metastases of melanoma and locally advanced extremity sarcomas. There are several advantages for each method, but if the well-established effects of ILP could be combined to the minimally invasive approach of ILI, the results could be maximized and adverse events, related to open approach, minimized. A new method for vascular approach (MI-ILP) will be evaluated in a phase I feasibility study. Percutaneous vascular access of the ipsilateral side will be performed by ultrasound guided technique and connected to an extracorporeal oxygenation system. Perfusion will be conducted in the same way as for open ILP. Outcomes, technical details and complications will be recorded prospectively.

Official Title
-----------------
Minimally-Invasive Isolated Limb Perfusion

Conditions
-----------------
Isolated Limb Perfusion

Intervention / Treatment
-----------------
* Other: Minimal-invasive isolated limb perfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient scheduled for treatment with isolated hyperthermic perfusion Age over 18 years. Signed informed consent Exclusion Criteria: Re-perfusion Lymph node metastases Severe atherosclerosis

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 |
| --- | --- |
| MI-ILP<br> | Other: Minimal-invasive isolated limb perfusion<br>* Minimal-invasive isolated limb perfusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion to open surgery | Number of minimal-invasive procedure that will be converted to open surgery (per cent) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | Clinical response rate according to WHO criteria. | 3 months | 
| Complications | Complications according to Clavien-Dindo | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
isolated limb perfusion
Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.

Official Title
-----------------
Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Study on the Efficacy and Tolerability of a 8-week Treatment With Budesonide vs. Mesalazine vs. Placebo in Patients With Lymphocytic Colitis

Conditions
-----------------
Lymphocytic Colitis

Intervention / Treatment
-----------------
* Drug: Budesonide
* Drug: Mesalamine
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Symptoms and signs of indication of lymphocytic colitis Exclusion Criteria: Infectious diarrhoea, Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease Pregnancy or breast-feeding, Participation in an other clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Budesonide | Drug: Budesonide<br>* 9 mg per day<br>|
| Experimental: B<br>Mesalazine | Drug: Mesalamine<br>* 3 g per day<br>|
| Placebo Comparator: C<br> | Other: Placebo<br>* 0 g per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinical remission |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with histological improvement |  | 8 weeks |