linjc16/ctgov huggingface dataset:
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.

Official Title
-----------------
A Phase 3, International, Multicenter, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: natalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).

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: natalizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Predictive Factors of Chemoresistance in Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Epithelial ovarian cancer (EOC) has a poor prognosis. EOC management requires debulking surgery and chemotherapy based on taxol and carboplatine. Initial response is often good, but most often a recurrence occurred in the first 18 months. Early recurrence signs chemoresistance and palliative treatment. The study of predictive clinical or biological factors is required to adapt therapeutic and develop new treatments.

Official Title
-----------------
Study of Predictive Factors of Chemoresistance in Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Procedure: Cancer treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient > 18 years of age patient with histological proven epithelial ovarian cancer Exclusion Criteria: patients who can not give their own consent patients without ovarian cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients with epithelial ovarian cancer<br>Cancer treatment | Procedure: Cancer treatment<br>* Chemotherapy and laparoscopic surgery<br>* Other names: Carboplatin, Taxol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemoresistance defined by clinical recurrence |  | 6 months after the end of chemotherapy | 
| Chemoresistance defined by biological recurrence |  | 6 months after the end of chemotherapy | 
| Chemoresistance defined by radiological recurrence |  | 6 months after the end of chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, chemo resistance, predictive factors, cohort study, bio bank
Hand Held Nitrous Oxide Delivery Device

Study Overview
=================
Brief Summary
-----------------
To study the safety and efficacy of Hand Held Nitrous. A device that delivers 120 seconds of up to 72% nitrous oxide and ambient air.

Detailed Description
-----------------
This study assesses the Hand Held Nitrous Oxide Deliver Device which is intended to be used in nitrous oxide sedation systems by delivering a limited 16 grams of nitrous oxide over a total of 120 seconds of inhalation time. The device creates short term minimal sedation by delivering a maximum 72% USP grade nitrous oxide / 28 % ambient air combination which quickly drops to under 33% nitrous oxide / 67% ambient air in 60 seconds and stays steady until all the gas is expelled.

Official Title
-----------------
Safety and Efficacy of Hand Held Nitrous, a Device That Delivers 16 Grams of Nitrous Oxide Over 120 Seconds of Inhalation Time.

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Other: There are no other inteventions.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing a painful office procedure or exam Exclusion Criteria: Women that are Pregnant Children under three years of age

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand Held NitrousTM<br>There are no other interventions to this device | Other: There are no other inteventions.<br>* This device gives patients the opportunity to receive nitrous oxide where no such opportunity exists. There is no other intervention available that creates immediate short term minimal sedation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study measures the types of complications (if any) associated with the use of small set amount of nitrous oxide. | This is a short acting device that delivers a small amount of nitrous oxide. The patient responds quickly and recovers quickly (approximately 6 minutes). | The patient is under observation for the length of the procedure or until baseline parameters are met (under 10 minutes). No followup is required. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimal Sedation nitrous oxide
Renal Colic Fast Track Pathway in the Emergency Department.

Study Overview
=================
Brief Summary
-----------------
Validation of a high-resolution, fast track pathway that combines the use of laboratory tests at the Point-of-Care Testing (POCT) and Point-of-Care ultrasound (POCUS) versus the classical pathway, in which blood samples are sent to the central laboratory and comprehensive radiological exams ordered, being equally effective, at a lower cost of care and time of stay in the emergency department.

Official Title
-----------------
Randomised Controlled Trial to Assess a Renal Colic Fast Track Pathway in the Emergency Department Using Point-of-care Ultrasound and Point-of-care Testing.

Conditions
-----------------
Renal Colic

Intervention / Treatment
-----------------
* Diagnostic Test: Point-of-Care ultrasound and testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First renal colic episode Need of analgesia Oral tolerance Exclusion Criteria: Hemodynamic instability Fever Anuria Abdominal trauma Chronic renal failure Active oncologic disease Kidney transplant or monorenal patient

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point-of-care Testing and Ultrasound pathway<br> | Diagnostic Test: Point-of-Care ultrasound and testing<br>* Point-of-Care ultrasound + Point-of-Care blood gas testing<br>|
| No Intervention: Classical pathway<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the Emergency Department |  | 24 hours | 
| Adverse events |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of conclusive exams in the Point-of-Care intervention arm. |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Colic, Point-of-Care ultrasound, Point-of-Care testing
Cord Blood Transplantation in Severe Aplastic Anemia

Study Overview
=================
Brief Summary
-----------------
This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an HLA identical donor;

Detailed Description
-----------------
This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an Human Leucocyte Antigen (HLA) identical donor; 26 patients will be recruited, according to a one step Fleming design

Official Title
-----------------
A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse After Immunosuppressive Therapy

Conditions
-----------------
Relapse, Hereditary Diseases, Acquired Aplastic Anemia, Absence of an HLA Identical Donor

Intervention / Treatment
-----------------
* Procedure: Cord Blood Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 3-55 years old inherited aplastic anemia (with severe aplastic anemia criteria) or acquired aplastic anemia in relapse or treatment failure after immunosuppressive therapy without clonal evolution Karnovsky Index >= 60% Informed consent Exclusion Criteria: HLA identical donor

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cord Blood Transplantation<br> | Procedure: Cord Blood Transplantation<br>* One or 2 cord blood units containing alone or both together more than 4x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients for acquired Severe Aplastic Anemia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft versus host disease |  | 2 years | 
| Infectious episodes |  | 1 year | 
| treatment related mortality |  | 100 days | 
| overall survival |  | 5 years | 
| adverse events |  | 1 year | 
| karnofsky scale |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe aplastic anemia, cord blood transplantation
The Effect of Education on Patient Compliance

Study Overview
=================
Brief Summary
-----------------
With patient education, the compliance with glaucoma medications will increase.

Detailed Description
-----------------
We divided glaucoma patients into two groups; one watched a video the others did not. We checked their intraocular pressures before and after the intervention to see if there was a difference

Official Title
-----------------
The Effect of Patient Education on Glaucoma Medication Compliance

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Behavioral: American Academy of Ophthalmology Glaucoma Educational Tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma patients coming in for routine examination Exclusion Criteria: If glaucoma was unstable and treatment regimen required a change

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: American Academy of Ophthalmology Glaucoma Educational Tape|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on glaucoma educational test |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, compliance, intraocular pressure, video
Evaluation of CRISPR-based Test for the Rapid Identification of TB in Pulmonary Tuberculosis Suspects

Study Overview
=================
Brief Summary
-----------------
This observational Mycobacterium tuberculosis (MTB) diagnostics evaluation study is a prospective study of pulmonary TB suspects who are undergoing sputum or bronchoalveolar lavage fluid (BALF) evaluation for pulmonary TB. The sensitivity and specificity of the CRISPR-based assay will be compared to clinical diagnosis, conventional culture methods and Xpert MTB/RIF assay on same batch specimens.

Official Title
-----------------
Evaluation of CRISPR-based Test for the Rapid Identification of Mycobacterium Tuberculosis Complex in Pulmonary Tuberculosis Suspects

Conditions
-----------------
Tuberculosis, Pulmonary

Intervention / Treatment
-----------------
* Diagnostic Test: CRISPR-based Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected pulmonary TB. Ability and willingness of candidate or legal guardian/representative to provide informed consent. Men and women age equal to or greater than 18 years. Exclusion Criteria: Either receipt of ≥48 cumulative hours OR three or more doses of anti-TB treatment within 180 days prior to completion of second sputum collection for Xpert testing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Pulmonary Tuberculosis Suspects<br>Individuals with suspected TB infection | Diagnostic Test: CRISPR-based Test<br>* CRISPR-based Test performed on sputum or BALF in TB suspects.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay positive and/or MGIT culture positive for M.tuberculosis. |  | week 0 | 
| Proportion of clinically diagnosed TB participants with CRISPR-based test MTB positive in sputum/BALF who are Xpert MTB/RIF Assay negative and/or MGIT culture negative for M.tuberculosis. |  | week 0 | 
| Proportion of clinically diagnosed non-TB participants with CRISPR-based test MTB positive in sputum/BALF. |  | week 0 |
Continuous NMB in PCAS

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to test the hypothesis that continuous NMB could improve outcome in cardiac arrest patients treated with therapeutic hypothermia.

Official Title
-----------------
Continuous Neuromuscular Blocking Agent for out-of Hospital Cardiac Arrest; Multicenter Randomized Controlled Trial

Conditions
-----------------
Out-of-hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Drug: Esmeron
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (older than 19) OHCA with sustained ROSC Comatose (i.e., not following commands) following ROSC Undergoing targeted temperature management (TTM) Time of enrollment ≤ 6hrs from ROSC Exclusion Criteria: Pre-existing dementia, brain injury, or dependence on others for ADLs (CPC > 3) Traumatic etiology for cardiac arrest Protected population (pregnant, prisoner)

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Rocuronium<br>Patients will receive a bolus dose of 0.6 mg/kg, then a continuous I.V. infusion of 0.3-0.6 mg/kg/hr as per standard intensive care unit practice. | Drug: Esmeron<br>* Neuromuscular Blockade<br>* Other names: Rocuronium;|
| Placebo Comparator: Usual Care<br>Patients will receive 100 mL of normal saline over 5-10 minutes at the beginning of the study in addition to usual care. | Drug: Saline<br>* Normal Saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate levels 24 hours after initiation of study drug |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate change over time |  | 0, 12, 24, 36 hrs | 
| Survival | in-hospital survival | Duration of hospitalization, limit 180 days | 
| Good neurological outcome | Modified Rankin Scale | Duration of hospitalization, limit 180 days | 
| Length of intensive care unit stay |  | Duration of ICU stay, limit 180 days |
Swallowing Function Before and After Surgery for Thyroid Goiter

Study Overview
=================
Brief Summary
-----------------
To date, there have been no comprehensive studies on swallowing function in patients undergoing surgery for multinodular goiter. We hypothesize that 1. Multinodular goiter has significant effect on swallowing function in symptomatic and asymptomatic patients, which can be demonstrated by a standardized questionnaire and a formal swallowing evaluation and 2. Surgery will improve swallowing function as measured post-operatively by these same parameters. Patients with multinodular goiter will be asked to fill out a validated survey (SWAL-QOL) on swallowing function in addition to undergoing a formal swallowing evaluation before and after surgery for multinodular goiter (subtotal thyroidectomy) and compared to patients undergoing total thyroidectomy for follicular cancer and less extensive thyroid surgery for other benign processes (lobectomy or lobectomy plus isthmusectomy).

Detailed Description
-----------------
Detailed description not desired.

Official Title
-----------------
Swallowing Function Before and After Surgery for Thyroid Goiter

Conditions
-----------------
Hypothyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: thyroidectomy Exclusion Criteria: na

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 |
| --- | --- | --- |
| Swallowing Quality of Life | The swallowing quality of life (SWAL-QOL) validated outcomes assessment tool will be used before and one year after surgery to measure changes in swallowing-related QOL in patients undergoing thyroid surgery. The SWAL-QOL is a 44 item tool that asks patients to rate several factors about 10 quality-of-life concepts related to swallowing on a 5 point scale.Data were collected on demographic and clinicopathologic variables, and comparisons were made to determine the effect of surgery on patients' perceptions of swallowing function. A score of 0 represents the least favorable state, and 100 the most favorable. It has been validated and has favorable psychometric properties, including high internal-consistency reliability and reproducibility. The scales of the instrument differentiate patients with oropharyngeal dysphagia from normal swallowers and are sensitive to clinically-relevant differences in dysphagia severity in patients with medically and surgically treated conditions. | One year |
Efficacy of Proton Pump Inhibitors in Gastrointestinal Erosions and/or Ulcers

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to collect the data of clinical efficacy and safety after the usage of bonoprazon and esomeprazole when the patients take NSAIDs more than 2 weeks and have gastrointestinal symptoms who have had gastrointestinal erosions and/or ulcers in the past.

Official Title
-----------------
RCT Using Bonopurazan or Esomeprazole in Patients With NSAIDs-induced Erosions and/or Ulcers

Conditions
-----------------
Gastrointestinal Erosions and/or Ulcers

Intervention / Treatment
-----------------
* Drug: Oral Bonoprazan
* Drug: Oral Esomeprazol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of NSAIDs-induced gastrointestinal Erosions and/or Ulcers who want to take Bonoprazan or Esomeprazole Exclusion Criteria: Patients allergic to Bonoprazan or Esomeprazole

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 99 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Bonoprazan<br>Daily intake of Bonoprazan | Drug: Oral Bonoprazan<br>* To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers<br>|
| Active Comparator: Oral Esomeprazol<br>Daily intake of Esomeprazol | Drug: Oral Esomeprazol<br>* To examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with healing of gastrointestinal erosions and/or ulcers using major forceps |  | Change from Baseline Gastrointestinal erosions and/or ulcers at 2 weeks |