linjc16/ctgov huggingface dataset:
Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course

Study Overview
=================
Brief Summary
-----------------
Chart review.

Detailed Description
-----------------
A chart review will be completed on patients with multiple sclerosis to determine potential early characteristics that might be helpful in defining aggressive onset MS and predicting subsequent disease course and disability

Official Title
-----------------
Aggressive Onset Multiple Sclerosis: A Practical Definition and Study of Its Clinical Course

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Two or more relapses in the preceding year and 2 or more gadolinium enhancing lesions on brain MRI scan or a significant T 2 lesion burden or One relapse if it results in sustained EDSS of 3.0 along with 2 or more gadolinium enhancing lesions or significant T2 lesion burden ( T2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location) Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 89 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 |
| --- | --- |
| Aggressive onset MS<br>Two or more relapses in the preceding year and 2 or more gadolinium enhancing lesions on brain MRI scan or a significant T 2 lesion burden or One relapse if it results in sustained EDSS of 3.0 along with 2 or more gadolinium enhancing lesions or significant T2 lesion burden ( T2 lesion burden being determined by factoring the number of lesions, the size of the lesions and lesion location) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability outcome will be determined based on EDDS. | Disability outcomes will be determined based on EDDS at last visit. EDSS at last follow up will be compared to EDSS at start of respective therapies and grouped into 3 categories: EDSS improved, EDSS no change and EDSS worsened. Multivariate logistic regression will be used to test individual variables that could potentially influence the outcome, including treatment, age at onset, gender and race. | at the last visit (average time frame from baseline to last follow up visit expected to be 36 months) |
Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

Study Overview
=================
Brief Summary
-----------------
To evaluate the using of a commercial product of dried human amniotic membrane sterilized by gamma irradiation for the treatment of skin ulcer.

Detailed Description
-----------------
Dried human amniotic membrane patches were obtained from National center for radiation research and technology, Egypt, under commercial name REGE pro.

Official Title
-----------------
Using of Irradiated Amnion Dressing for the Treatment of Skin Ulcer

Conditions
-----------------
Ulcer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients have unhealing ulcer Exclusion Criteria: must stop other line of treatment
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of ulcer | REGE pro decreased size of ulcer after second treatment | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain | Patients response revealed reduction of pain at the time of application. One week post application, a questionnaire were collected from patients; about 95% of them ensured that pain was controlled. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Skin ulcer, Human amniotic membrane, Treatment
Perioperative Hyperoxygenation and Wound Site Infection Following Surgery for Acute Appendicitis

Study Overview
=================
Brief Summary
-----------------
Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.

Conditions
-----------------
Acute Appendicitis

Intervention / Treatment
-----------------
* Other: Oxygen delivery
* Other: Oxygen administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consent was given 15 years old or older Underwent acute appendicitis Exclusion Criteria: Lack of follow up Younger than 15 years Not eligible according to physician decision

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Post op care<br> | Other: Oxygen delivery<br> <br> Other: Oxygen administration<br> <br> |
| Active Comparator: Oxygen administration- different %<br> | Other: Oxygen administration<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the lactic acid bacteria  Lactobacillus acidophilus (LA5) and Bifidobacterium animalis subsp. lactis (BB12) is effective as maintenance treatment in ulcerative colitis.

Official Title
-----------------
Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ulerative colitis ording to well-known diagnostic criteria and remission for at least one month, and with at least one relapse within the last year. Exclusion Criteria: Pregnancy and lactating Serious underlying disease other than UC Former gastrointestinal resections Medication for UC other than mesalazine Known allergic reactions towards compounds in the study drug. Expected lack of compliance due to mental state or language problems

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

| Intervention/Treatment |
| --- |
|Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with relapse at 12 month. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days to relapse. |  |  | 
| Presence and concentrations of the probiotic bacterial strains in stool. |  |  | 
| Safety and tolerance of the probiotic mixture. |  |  |
Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design. Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg & Metformin tablet 500mg

Official Title
-----------------
Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: metformin tablet, metformin gum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men ranging in age from 18-40 Good general health as determined by medical history, physical examination, ECG, Blood pressure, and clinical laboratory tests (hematology & clinical chemistry) obtained within 14 days prior to the start of the study. BMI >18&<30. Willing and able to abide by the dietary requirements of the study. Willing and able to give written informed consent in a manner approved by the Ethics Committee. Exclusion Criteria: History of known or suspected clinically significant hypersensitivity to any drug. Any protocol-required laboratory test abnormality that is considered clinically significant. Mentally unstable or incompetent. Any illness during the week before.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: metformin tablet, metformin gum|500 mg, 250 mg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet). |  | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect on blood glucose levels as well as safety and tolerability of one time administration of the Metformin Gum and Metformin tablet. |  | 45 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmaceutical preparations
Immune Response in Peripheral Blood of Patients With Colon Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in the immune system that may help kill cancer cells. PURPOSE: This laboratory study is looking at anticancer immune responses in the peripheral blood of patients with colon cancer.

Detailed Description
-----------------
OBJECTIVES: Quantify T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) from the peripheral blood of patients with colon cancer. OUTLINE: This is an open-label study. Patients undergo blood collection at time of follow-up, surgery, thoracentesis, paracentesis, or leukapheresis (≤ 5 times per year). Blood is analyzed for tumor peptides (carcinoembryonic antigen and MUC1), circulating cytokines, and lymphocyte response by ELISA, ELISPOT, or intracellular flow. PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

Official Title
-----------------
Immune Studies of Peripheral Blood From Patients With Malignant Disease Gastrointestinal Tract

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: immunoenzyme technique
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of colon cancer PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: immunoenzyme technique|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitation of T cells specific for tumor peptides (carcinoembryonic antigen and MUC1) |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent colon cancer, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer
Hand Function in Patients With Poly- or Dermatomyositis

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the hand function in patients with poly-and dermatomyositis and compare this to healthy individuals and norm values and secondly if hand function correlates to activity performance and health related quality of life. The study is a cross-sectional study. To assess hand function the investigators will measure grip force with Grippit and arm/hand mobility using EPM-ROM scale. The activity performance will be measured with Myositis Activities Profile and health related quality of life will be assessed with SF-36. The investigators' hypothesis is that hand function is reduced in comparison to the healthy population and that hand function affects both activity performance and health related quality of life.

Official Title
-----------------
Hand Function, Health Related Quality of Life and Activity Performance in Patients With Polymyositis or Dermatomyositis.

Conditions
-----------------
Polymyositis, Dermatomyositis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with definite or probable polymyositis or dermatomyositis (according to criteria by Bohan and Peter) were included in the study Exclusion Criteria: Other diseases or injuries that could affect arm/hand mobility and grip force for example other rheumatological or neurological disease.

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polymyositis, Dermatomyositis, Grip force, Quality of life, Activity performance
Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.

Official Title
-----------------
A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: SCA-136 50mg/day
* Drug: SCA-136 150 mg/day
* Drug: SCA-136 300mg/day
* Drug: Risperidone 4mg/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects between >=20 and =<65 years of age Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90) Total PANSS score >=70 and =< 120 Exclusion Criteria: Subjects who are hospitalized against their will Current Axis I primary psychiatric diagnosis other than schizophrenia A score of 3 on CDSS question 8 which pertains to suicide

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: 1<br>Lowest dose | Drug: SCA-136 50mg/day<br> <br> |
| Experimental: 2<br>Middle dose | Drug: SCA-136 150 mg/day<br> <br> |
| Experimental: 3<br>Highest dose | Drug: SCA-136 300mg/day<br> <br> |
| Active Comparator: 4<br>Positive Control | Drug: Risperidone 4mg/day<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale PANSS |  | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calgary Depression Scale for Schizophrenia CDSS |  | 6 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute, Schizophrenia, Phase2a, Vabicaserin
Effects of Ramadan Fasting on Endothelial Function

Study Overview
=================
Brief Summary
-----------------
Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .

Detailed Description
-----------------
All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits. The week before Ramadan (Pre-R). the last week of Ramadan (R). the last week of the month following Ramadan (Post-R). Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent. All patients benifit of an endothelial peripheral arterial tonometry (Endo-PAT) test .

Official Title
-----------------
Effects of Ramadan Fasting on Endothelial Function

Conditions
-----------------
Fasting, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: Reactive hyperemia-peripheral arterial tonometry Index (RHI )


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient intending to fast Ramadan. Exclusion Criteria: Age < 18 years old Hemodynamic instability. Myocardial infarction requiring urgent revascularization. Parkinsonism: tremor problem. Refusal, communication problem.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| participents who has the intention to fast Ramadan<br>subjects with at least two cardiovascular risk factors according to Framingham classification or with out any risk . | Diagnostic Test: Reactive hyperemia-peripheral arterial tonometry Index (RHI )<br>* RHI was assessed by RH-PAT using the EndoPAT2000 system .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Reactive Hyperemia Index (RHI) | RHI is calculated for each participant in the day of iclusion , then it is recalculated in the two others visits. | the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ramadan Fasting, Endo-pat
Newborn Thermal Care Practices: A Community Based Program to Prevent Hypothermia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to train mothers/caretakers on how to prevent their babies from becoming too cold.

Detailed Description
-----------------
This study is designed to determine domiciliary care knowledge, attitudes and practices regarding essential newborn care, with a focus on newborn thermal control; develop behavior change communications to promote prevention, early recognition and effective management of newborn hypothermia, evaluate impact and cost-effectiveness of education/behavior change communications delivered by Community Health Workers and Community Health Promoters/Change Agents on essential newborn care practices, including care-seeking; prevalence, recognition and management of hypothermia, including adaptation, safety and utility of Kangaroo Mother Care; and neonatal morbidity and mortality; evaluate the feasibility and acceptability of using LCT ThermoSpot device in rural communities to enhance mothers' recognition and management of neonatal hypothermia; determine the influence of the neonatal hypothermia indicator (ThermoSpot) on recognition of and response to newborn hypothermia and health-seeking behavior of the caregivers; develop algorithms for recognition and management of hypothermia to inform neonatal IMCI and verbal autopsy protocols and gain insight into the potential roles of various cadres of workers in providing neonatal health services at the community level and inform the development of models of community-based essential newborn care.

Official Title
-----------------
Newborn Thermal Care Practices in Rural India: A Community Based Program to Prevent and Improve Recognition and Management of Hypothermia

Conditions
-----------------
Hypothermia

Intervention / Treatment
-----------------
* Behavioral: Newborn Thermal Care Practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uttar Pradesh Newborns at home Exclusion Criteria: Hospitalized babies
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Newborn Thermal Care Practice|nan|

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
-----------------
Newborn, Hypothermia, India, Maternal/Child Health, Infant, Kangaroo Mother Care