linjc16/ctgov huggingface dataset:
Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.

Official Title
-----------------
Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Drug: Atorvastatin 80mg
* Drug: Mesalamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Exclusion Criteria: Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Patients taking immunosuppressives or biological therapies

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group<br>This group will take mesalamine 1 g three times daily | Drug: Mesalamine<br>* Mesalamine<br>|
| Active Comparator: Atorvastatin group<br>This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily. | Drug: Atorvastatin 80mg<br>* Atrovastatin is one of the most effective drugs used to reduce intracellular cholesterol synthesis. it exerts numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement and immunomodulation independent of its basic lipid-lowering properties<br>Drug: Mesalamine<br>* Mesalamine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in health related quality of life | HRQL questionnaire will be assessed according to bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in serum and fecal inflammatory biomarkers | The secondary endpoint is estimated by changes in serum IL-18, and fecal calprotectin. | 6 months |
Metabolic Syndrome and Vitamin D Level in Old People

Study Overview
=================
Brief Summary
-----------------
In 2012, a cross-sectional survey sampling 1,966 community-dwelling old people was conducted. Structurized questionnaires were interviewed face-to-face by well-trained staffs. An overnight fasting blood were obtained for biochemistry parameters.

Official Title
-----------------
Inverse Relationship Between Metabolic Syndrome and Vitamin D Level in Old People Without Vitamin D Deficiency

Conditions
-----------------
Elderly, Metabolic Syndrome, Vitamin D Deficiency, Ostreocalcin, Insulin Resistance, Obesity, Osteoporosis, Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 65-year-old Exclusion Criteria: excluding empty houses, death, non-ambulatory subjects (subjects with significant disabilities, such as handicapped cerebral vascular accident, cancerous cachexia, unstable chronic diseases or psychiatric disorders, severe arthritis or inflammatory disease), uncomfortable anorexia by any medications, and non-reachable subjects

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

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 |
| --- | --- | --- |
| Osteoporotic fracture rate | Vertebra, non-vertebra, major fracture | 5 year |
Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.

Detailed Description
-----------------
Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.

Official Title
-----------------
Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery

Conditions
-----------------
Prostatectomy

Intervention / Treatment
-----------------
* Device: Levita Magnetic Surgical System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age Subject is scheduled to undergo elective prostatectomy surgery Exclusion Criteria: Significant comorbidities Subjects with pacemakers, defibrillators, or other electromedical implants Subjects with ferromagnetic implants Clinical history of impaired coagulation Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use Subject is not likely to comply with the follow-up evaluation schedule Subject is participating in another clinical trial

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levita Magnetic Surgical System<br>Levita Magnetic Surgical System use of surgical tool | Device: Levita Magnetic Surgical System<br>* Device for use as a surgical tool.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and types of tools required to retract the prostate during procedure | Ability to adequately retract the prostate to achieve an effective exposure of the target tissue. Adequate retraction is achieved if it is not necessary to replace the Levita Magnetic Surgical System with another instrument to retract the prostate during the procedure. | During planned prostatectomy procudure | 
| Incidence of device related adverse events (safety) | All adverse events will be recorded and allocated as to relatedness to device, procedure or other. | Through 30 days post prostatectomy procedure. |
An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention

Study Overview
=================
Brief Summary
-----------------
The investigators will compare the differences in the scores between the baseline questionnaire (at diagnosis) and the second questionnaire (at treatment) in the RADS II patients that enrolled in pre-treatment trials versus those that don't.

Official Title
-----------------
An Innovation During the Surgical Wait; Evaluation of the Opportunity for Intervention

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Quality of Life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years of age Diagnosis of BI-RADS 4 and 5 (highly suspicious for carcinoma) on an initial imaging >2cm area of disease Provide informed consent Exclusion Criteria: Previous neo-adjuvant therapy Patients with recurrent disease

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quality of Life, tissue collection<br>All participants will complete the GAD-7 and Cancer Locus of Control Scale - Course of Illness Subscale questionnaires and additional tissue will be collected at the time of the diagnostic biopsy. | Other: Quality of Life<br>* All participants recruited will complete a questionnaire prior to their breast biopsy and then again approximately one week before their surgery. The questionnaire is focused on the level of anxiety patients experience during the wait time between diagnosis and surgery. Additional tissue will be collected at the time of the diagnostic biopsy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | To determine if there are improvements in the measurements of anxiety through quality of life questionnaires completed at 2 different time points when participating in a window of opportunity trial verses not participating in a window of opportunity trial. | up to 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast
Health Promotion of People With Disabilities

Study Overview
=================
Brief Summary
-----------------
This research is meant to evaluate the effectiveness of two different prevention programs for post-acute management of rheumatoid and osteo-arthritis

Detailed Description
-----------------
Park Nicollet Clinic and the Institute for Clinical Systems Integration (ICSI) have developed evidence-based care guidelines and intervention strategies including degenerative joint disease. Included in these guidelines are risk factors for increased limitations, obesity and physical activity. The aims of this research are to modify well-established weight management techniques and physical activity promotion interventions according to ICSI recommendations, implement the interventions in a diverse patient population, demonstrate the short and long term impact of the interventions. The approach will be an individual randomized controlled trial of 400 patients, 200 each in a coach-supported intervention, 200 in a self-directed intervention.

Official Title
-----------------
Intervention Research Grants to Promote the Health of People With Disabilities

Conditions
-----------------
Rheumatoid and Osteoarthritis

Intervention / Treatment
-----------------
* Behavioral: Weight control and physical activity promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical visit 11/1/2003 to april 30/2004 diagnosis code rheumatoid arthritis or lower extremity osteoarthritis saw a provider that consented to have patients invited to participate consented to being contacted for research Exclusion 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?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Weight control and physical activity promotion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height weight: BMI |  |  | 
| Healthy physical activity levels: 20 minutes of physical activity 4+ days/week |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improved weight status |  |  | 
| improved diet |  |  | 
| decreased pain |  |  | 
| reduced depression |  |  |
Venous Thromboembolism in DM1

Study Overview
=================
Brief Summary
-----------------
The risk for venous thromboembolism (VTE) in DM1 and in other inherited myopathies, which can lead to chronic immobilization, are unknown. The purpose of this study is to evaluate incidence of VTE in cohort of patients presenting with DM1 with a comparison to a group of other inheritable myopathies and to a community-based population.

Detailed Description
-----------------
A cohort of more that 2,800 adult patients admitted to our Institutions between January 2000 and November 2014 with genetically proven myopathy will be retrospectively included. Any information relative to their demographic and genetic characteristics, their muscular functional status and the occurrence of VTE will be collected. Statistical analysis will be performed to estimate the incidence of venous thromboembolism in this population, to identify predictors of VTE, and to compare its incidence to a community-based population.

Official Title
-----------------
Incidence and Predictors of Venous Thromboembolism in Myotonic Dystrophy

Conditions
-----------------
Venous Thromboembolism, Pulmonary Embolism, Deep Vein Thrombosis, Myopathy, Myotonic Dystrophy 1

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Genetically proven myopathy Admission in our institutions from January 2000 to November 2014 Exclusion Criteria: Patient refusal

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 |
| --- | --- | --- |
| Any episode of pulmonary embolism and/or deep vein thrombosis, diagnosed according to 2011 AHA guidelines on venous thromboembolism management |  | 14 years |
Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy

Study Overview
=================
Brief Summary
-----------------
the aim of the present study is to evaluate safety and efficacy of tranexamic acid versus vaginal misoprostol in reducing intraoperative blood loss during abdominal myomectomy

Official Title
-----------------
Evaluating Safety and Efficacy of Tranexamic Acid Versus Vaginal Misoprostol in Reducing Intraoperative Blood Loss During Abdominal Myomectomy

Conditions
-----------------
Myomectomy

Intervention / Treatment
-----------------
* Drug: intravenous tranexamic acid
* Drug: vaginal misoprostol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: symptomatic fibroids candidate for abdominal myomectomy Exclusion Criteria: myomas candidate for laparoscopic or hysteroscopic myomectomy and allergy or contraindications to misoprostol or tranexamic acid
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Experimental: intravenous tranexamic acid<br>patients were given a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision plus one vaginal placebo tablet 1 hour before skin incision | Drug: intravenous tranexamic acid<br>* patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.<br>|
| Active Comparator: vaginal misoprostol<br>patients will be given one vaginal misoprostol tablet (200 mcg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision | Drug: vaginal misoprostol<br>* patients will be given one vaginal misoprostol tablet (200 mcg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision<br>|
| Placebo Comparator: placebo<br>patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision | Drug: placebo<br>* patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative blood loss | intraoperative blood loss will be estimated during open myomectomy in mL | one hour |
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients

Study Overview
=================
Brief Summary
-----------------
The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.

Detailed Description
-----------------
The ARIES C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile associated disease (CDAD). The objective of this study is to establish diagnostic accuracy of ARIES C. difficile Assay through a multi-site, method comparison on prospectively collected, left-over, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Official Title
-----------------
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients

Conditions
-----------------
Gastroenteritis, Infectious Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The specimen is from a patient suspected of having C. difficile associated disease (CDAD). The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site. Exclusion Criteria: The specimen is preserved. The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
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 |
| --- | --- | --- |
| Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). |  | Within the first year of sample collection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARIES Clostridium difficile
Pregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study

Study Overview
=================
Brief Summary
-----------------
There are no prospective studies of pregnancies for the diseases studied here in (Heredity Hemorrhagic Telangiectasia, Marfan syndrome, primary lower limb lymphedema, superficial arteriovenous malformations, and cerebro-spinal arteriovenous malformations) although complications of these can present life-threatening health problems for the mother and her baby. The purpose of this National prospective study is to obtain greater insight into obstetrical complications associated with rare maternal vascular genetic disorders in order to improve prevention and to reduce risk of death. In this context, experts and patient associations consider that there is a need to make real progress in the formulation of recommendations based on scientific data.

Official Title
-----------------
A National Prospective Cohort for Pregnancies in Patients With Rare Vascular Anomalies: COGRare5 Study

Conditions
-----------------
Vascular Anomaly, Osler Rendu Disease, Marfan Syndrome, Lymphedema Primary, Arteriovenous Malformations, Cerebrospinal; Disorder

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged ≥ 18 years and ≤45 years at the time of inclusion Pregnant and/or having given birth less than 1 month (≤ 30 days) Clinically and/or radiological and/or molecular biology diagnosis of a rare vascular disease before or during pregnancy or one month after delivery. Having been informed of all pertinent aspects of the study and provided oral non-opposition. Exclusion Criteria: Any person not fulfilling the inclusion criteria or refusing to take part in the study. Major under legal protection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Interview of women with a rare vascular disease through a phone questionnaire about severe and specific obstetrical complications during and after pregnancy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of obstetrical complications among patients with rare vascular anomalies. | The primary effectiveness endpoint is the occurrence of specific and serious obstetrical complications during and after the pregnancy period among patients with rare vascular anomalies. The questionnaire consists in collecting obstetric complications (interview time is about 15 minutes) every 3 months during and after pregnancy. | Maximum 21 months |