linjc16/ctgov huggingface dataset:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for TBI

Study Overview
=================
Brief Summary
-----------------
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of traumatic brain injury

Detailed Description
-----------------
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Traumatic brain injury (TBI). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of TBI. Patients with TBI will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Official Title
-----------------
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Biological: AlloRx


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of traumatic brain injury Understanding and willingness to sign a written informed consent document Exclusion Criteria: Active infection Active cancer Chronic multisystem organ failure Pregnancy Clinically significant Abnormalities on pre-treatment laboratory evaluation Medical condition that would (based on the opinion of the investigator) compromise patient's safety. Continued drug abuse Pre-menopausal women not using contraception Previous organ transplant Hypersensitivity to sulfur Seizure disorders
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: Treatment Group (AlloRx)<br>Single intravenous infusion of 100 million cells | Biological: AlloRx<br>* cultured allogeneic adult umbilical cord derived mesenchymal stem cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Traumatic brain injury, stem cell treatment
Place of General Medical During Oncology Care Management

Study Overview
=================
Brief Summary
-----------------
The Purpose of MGPEC_ONCO is to see if patient consult their general practitioner during the management of their cancer, especially before hospitalization. The study concerns not planned hospitalizations in medicine service. Before leaving hospital, the patient completes the survey, other data are taken in patient record

Official Title
-----------------
Place of General Medical During Oncology Care Management

Conditions
-----------------
Oncologic Disorders

Intervention / Treatment
-----------------
* Behavioral: medical questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing oncology treatment or ≤ 1 year of the latest oncology treatments Patient hospitalized in a medical service in an unscheduled way Age > or = 18 years old Patient informed and not opposed to the study Patient able and agreeing to follow all study procédures Patient must be affiliated to a social security system Exclusion Criteria: Patient hospitalized in surgery and continuing care services Patient deprived of liberty or under supervision

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

| Intervention/Treatment |
| --- |
|Behavioral: medical questionnaire|The patient will complete a questionnaire of 10 questions before leaving hospital. This questionnaire concerns the care pathway for hospitalized patients.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients in unscheduled hospitalization | Percentage of patients in unscheduled hospitalization who have seen their general practitioner | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, hospitalization, general practitioner
Psychometric / Validation Study

Study Overview
=================
Brief Summary
-----------------
Data for the study will be collected from therapist across the world. The therapists will share data they have already compiled from their caseload. Data will be stripped of all personal identifiers and personal health information. The TWU SCOPE research team has no contact with clients whose assessment data is being shared for secondary analysis or clinical data repository. For educational and training purposes clients can be videotaped by the therapist who will obtain consent and/or assent from the client. Not every client will be videotaped. The subjects from the data shared by the therapists are from the ages of 0-21, both male and female, and of any ethnicity. The total amount of data collected from all participating therapists will be 500 pieces.

Detailed Description
-----------------
Therapists will be recruited by a TWU SCOPE research team member via email. Therapists who wish to participate will send a data sharing letter to the PI of the study. Once the TWU SCOPE research team has received the data sharing letter, a clinical data packet will then be distributed to the therapist through the U.S. mail or an email will be sent containing a web address link to http://www.myweb.twu.edu/ ttioseco for access to the clinical data packet via the internet. Those therapists who collect ten pieces or more of de-identified data and send them to the TWU SCOPE research team will receive an incentive in the form of a gift card. Flow Chart of Research Study Process Collaborators (share new de-identified data) → databank (new de-identified data input) → data analysis (analysis of new and old de-identified data) → publication/presentation No risks are involved because data collected is without any personal identifiers.

Official Title
-----------------
SCOPE: A Psychometric Study

Conditions
-----------------
To Determine the Psychometric Properties of the Short Child Occupational Profile

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects receiving therapy from participating therapists. Exclusion Criteria: Age over 21.

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| OTs<br>Occupational therapists | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the psychometric properties of the Short Child Occupational Profile Validate SCOPE | To determine the psychometric properties of the Short Child Occupational Profile (SCOPE) and validate the SCOPE. | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCOPE
Long-term Effects of Methadone for Cancer Pain

Study Overview
=================
Brief Summary
-----------------
The methadone is an useful opioid for the cancer pain treatment, mostly used in second or last line during the opioid rotation. The Methadone had an anti-MNDA effect, and clinicians agree that the methadone could have an effect in neuropathic cancer pain. During a previous study the investigators find that the pain was still improving after the week 2, but they had only a small number of patients still included at this stage and they cannot conclude. The investigators decide to follow up systematically all the patients undergoing a methadone treatment for cancer pain, at day 28, to study the hypothesis about the long-term pain improvement.

Official Title
-----------------
Long-term Effects of Methadone for Cancer Pain

Conditions
-----------------
Cancer Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with t methadone for cancer pain in opioid rotation Able to fill the questionnaire Performance status (PS) from 0 to 2 Exclusion Criteria: Patients PS 3 Unable to sign the informed consent

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between EVA pain score at Day 28 and Day 0 | long-term effects of methadone for cancer pain | pain score measure at Day 0 and Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score of neuropathic pain intensity NPSI |  | Day 0 and Day 28 | 
| Change in depression and anxiety score HADS |  | Day 0 and Day 28 | 
| Change in quality of life score QOL C30 |  | Day 0 and Day 28 | 
| Side effect record |  | up to Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
methadone, cancer pain, long term effect
Beta- Probe and Surgery in GEP NET: Evaluation of a New Probe

Study Overview
=================
Brief Summary
-----------------
Radioguided surgery (RGS) with beta- radioisotopes is a novel approach focused on developing a new probe which, detecting electrons and operating with low background, provides a clearer delineation of the margins of lesions with low radiation exposition for surgeons. To validate this procedure, ex vivo specimens of tumours expressing somatostatin receptors, as small-intestine neuroendocrine (SI-NET), will be tested

Detailed Description
-----------------
Small Intestinal neuroendocrine patients, with a positive Ga-68-DOTATOC PET/CT, will receive a small amount of beta- radiopharmaceutical (Y-90-DOTATOC), and then operated, as clinical indicated. Tissue samples will be tested ex-vivo with a beta-probe prototype

Official Title
-----------------
Studio Esplorativo Monocentrico Non Controllato, in Aperto, Volto a Sviluppare e Valutare l'Applicazione di Una Tecnica Innovativa di Rimozione Radioguidata Dei Tumori Neuroendocrini Gastro-entero-pancreatici

Conditions
-----------------
Neuroendocrine Tumors

Intervention / Treatment
-----------------
* Drug: Y90-DOTA-Tyr3-Octreotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SI NET patients, Ga-68-DOTATOC PET/CT positive, proposed for surgery Exclusion Criteria: negative PET/CT; pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Y-90-DOTATOC<br>Patients affected by Small Intestine neuroendocrine tumors | Drug: Y90-DOTA-Tyr3-Octreotide<br>* Patients enrolled for surgery will receive a small amount of Y-90-DOTATOC, in order to check beta- radioactivity by the probe<br>* Other names: Beta- emetting radioisotope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of sensitivity of a beta- probe | after receiving a small amount of radioactivity, patients will be operated and an evaluation of radioactivity on surgical specimens will be evaluated | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
beta- probe, radioguided surgery
Epidemiologic Study to Evaluate the Proportion of Cardiovascular Disease Risk Factors in Korean Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is investigating the proportion of Cardiovascular disease risk factors of hypertensive patients.

Detailed Description
-----------------
Primary endpoint: To evaluate the Proportion of patients with Cardiovascular disease high risk factors Secondary endpoint: To evaluate the Proportion of patients with Cardiovascular disease risk factors, To evaluate the Proportion of patients with Cardiovascular disease, To evaluate Target blood pressure achievement rate according to the proportion of Cardiovascular disease risks

Official Title
-----------------
A Multi-center, Observational, Cross-sectional Study to Evaluate CVD Risk Factors in Korean Hypertensive Patients

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Other: Blood Sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Essential hypertensive patient no less than 18 yeas old Patient who gave informed consent form Exclusion Criteria: Patient was diagnosed as secondary hypertension Patient who have white-coat hypertension

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 |
| --- | --- |
| Hypertension<br>Subject who meet eligible criteria | Other: Blood Sampling<br>* Blood sampling for Fasting Plasma Glucose, Hemoglobin A1C, Cholesterols, Blood Urea Nitrogen, Creatinine<br>* Other names: Blood sampling for cardiovascular disease risk;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with cardiovascular disease high risk factors | Between patients with essential hypertension | 6years, average duration of hypertension | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Cardiovascular disease risk factors | Between patients with essential hypertension | 6years, average duration of hypertension | 
| Proportion of patients with Cardiovascular disease | Between patients with essential hypertension | 6years, average duration of hypertension | 
| Target Blood Pressure achievement rate according to the proportion of Cardiovascular disease risks | Between patients with essential hypertension | 6years, average duration of hypertension |
The (PIVOTAL) Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.

Official Title
-----------------
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)

Conditions
-----------------
ABDOMINAL AORTIC ANEURYSMS

Intervention / Treatment
-----------------
* Device: AneuRx AAA stent graft / Talent AAA stent graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 to 90 years of age Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use Maximum aneurysm diameter of 4-5cm If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion Patient is willing and able to comply with the specified follow-up evaluation Life expectancy at least 3 years Exclusion Criteria: Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use Known co-existing condition with a life expectancy of less than 3 years Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before. Planned conduit procedure for introduction of endograft

Ages Eligible for Study
-----------------
Minimum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Surveillance<br> | |
| Experimental: Early Endovascular Repair<br> | Device: AneuRx AAA stent graft / Talent AAA stent graft<br>* Catheter based stent graft inserted to seal off an abdominal aortic aneurysm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects That Experienced Rupture or Aneurysm Related Death |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aneurysm Growth >0.5 cm | After repair, AAA enlargement by >0.5cm | 1 year | 
| Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up | secondary interventions in those that had successful delivery and deployment by treatment group randomized to. | study termination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AAA, Aneurysm, AneuRx, Talent
Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding

Study Overview
=================
Brief Summary
-----------------
Carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Detailed Description
-----------------
A Randomized controlled trial of carvedilol versus endoscopic band ligation for primary prophylaxis of oesophageal variceal bleeding in cirrhotic patients with arterial hypertension

Official Title
-----------------
Randomized Controlled Trial of Carvedilol Versus Endoscopic Band Ligation for Primary Prophylaxis of Oesophageal Variceal Bleeding in Cirrhotic Patients With Arterial Hypertension

Conditions
-----------------
Esophageal Varices

Intervention / Treatment
-----------------
* Drug: Carvedilol
* Procedure: Endoscopic band ligation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Aged >18 years Cirrhotic patients with arterial hypertension Endoscopic evidence of medium/large-sized esophageal varices Exclusion Criteria: • History of variceal bleeding or previous primary prevention of varices. Portal vein thrombosis or previous porto-systemic shunts as TIPS. Patients on drugs affecting portal pressure (beta blockers, nitrates). Advanced cardiovascular disease including acute myocardial infarction, atrio-ventricular block, congestive heart failure, chronic peripheral ischemia, severe bradycardia. Patients with severe respiratory diseases (COPD, bronchial asthma). Uncontrolled diabetes mellitus Renal impairment Hepatocellular carcinoma Allergy to carvedilol Pregnancy or lactation

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: carvedilol<br>Carvedilol | Drug: Carvedilol<br>* Carvedilol<br>* Other names: carvid;|
| Active Comparator: Band Ligation<br>Band Ligation | Procedure: Endoscopic band ligation<br>* Endoscopic band ligation<br>* Other names: band ligation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with the first variceal bleeding within 1 year | The number of patients with the first variceal bleeding within 1 year | 1 year |