linjc16/ctgov huggingface dataset:
Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin combined with thiopurine on preventing postoperative endoscopic recurrence in Crohn's disease, compared with thiopurine. The primary endpoint is the rate of endoscopic recurrence at 6 months.

Official Title
-----------------
Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial

Conditions
-----------------
Crohn Disease

Intervention / Treatment
-----------------
* Drug: Rifaximin
* Drug: Azathioprine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis; Enrolled patients must have one or more risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking. Exclusion Criteria: Severe comorbidities; With a stoma; With malignancy; Pregnancy; Intolerant of thiopurine drugs; With contraindication of using rifaximin or thiopurine drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin and Thiopurine<br>Prescribed Rifaximin (600mg, twice daily) combined with Azathioprine (2.0-2.5mg/kg/day) for 3 months after surgery, and then Azathioprine monotherapy (2.0-2.5mg/kg/day) for the next 3months. | Drug: Rifaximin<br>* Antibiotics<br>Drug: Azathioprine<br>* immunomodulator<br>|
| Active Comparator: Thiopurine<br>Prescribed Azathioprine (2.0-2.5mg/kg/day) for 6 months after surgery. | Drug: Azathioprine<br>* immunomodulator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of incidence of endoscopic recurrence | Endoscopic recurrence was defined by a score ≥i2 according to endoscopic recurrence score developed by Rutgeerts et al. | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effect | Adverse effect of Rifaximin | 6 months after surgery |
Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine the cardiovascular function/ cardio respiratory interaction on spontaneous breathing trials in patients with prolonged weaning.

Official Title
-----------------
Examination of Cardiovascular Function/ Cardio Respiratory Interaction on Spontaneous Breathing Trials in Patients in the Prolonged Weaning

Conditions
-----------------
Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: Spontaneous breathing trial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: legal Age (≥18 years) written informed consent Prior to study participation patient in prolonged weaning with NYHA I-II and an actual positive Ventilator Screening test: PaO2 ≥ 60 mmHg at FiO2 ≤ 0.4 PEEP ≤ 8 cmH2O Glasgow Coma Scale > 13 Temp. < 38°C Hb > 80-100 g/L less requirement on catecholamines (<0.1µg/kg/min) and on these patients are already performed a spontaneous breathing trial with following result: abortion this spontaneous breathing trial < 30min, but possible > 10min reason for an abortion was NOT hypercapnia Exclusion Criteria: weaning patients are assigned on Group 1-2 patient with heart failure (NYHA III-IV) and/ or other cardiac comorbidity acute NSTEMI (non-ST-segment elevation myocardial infarction) pregnancy and breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| spontaneous breathing trials<br>spontaneous breathing trials in patients with prolonged weaning | Other: Spontaneous breathing trial<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline measurement (Modus CPAP-PS) in patient with prolonged weaning | under pressure support Ventilation are determined some measurement (e.g. breathing rate) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention measurement in patient with prolonged weaning | 20 min breathing without mechanical ventilation | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weaning TTE, patients in prolonged weaning
Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro). Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.

Official Title
-----------------
An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With an Implant-Supported Prosthesis Retained by Astra Tech Dental Implants, Fixture Micro-Macro in Patients With Poor Bone Quality

Conditions
-----------------
Jaw, Edentulous, Poor Bone Quality

Intervention / Treatment
-----------------
* Device: Fixture MicroThread (Micro-Macro)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 - 75 years of age Bone quality class III or IV, (according to Lekholm & Zarb16) Willing to give signed informed consent Exclusion Criteria: Need for bone augmentation of the maxilla Tobacco smoking more than 5 cigarettes/day Any systemic disease or condition that would compromise post-operative healing and/or osseointegration Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration Unable or unwilling to return for follow-up visits Bruxism or other parafunctional activity

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Fixture MicroThread (Micro-Macro)<br>* Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival |  | Continuously during 5,5 years after implant placement |
Understanding the Mental Health of Migrant Workers During the COVID-19 Outbreak

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the mental health impact of the COVID-19 pandemic on international migrant workers by (1) documenting mental health symptoms among migrant workers and (2) identifying risk and protective factors during the pandemic.

Detailed Description
-----------------
Worldwide, there are an estimated 164 million migrant workers. Although studies have documented how migrant workers have an increased risk of adverse mental health outcomes, little is known about their mental health burden during a large-scale health crisis. In the current COVID-19 outbreak, migrant workers represent 9 in 10 of the COVID-19 cases in Singapore, with 25 dormitories gazetted to contain the spread of the virus. Correspondingly, these measures have placed a spotlight on the mental well-being of migrant workers. In this research protocol, the investigators propose to administer a survey to understand the prevalence and predictors of mental health symptoms amongst migrant workers in Singapore. In particular, prior meta-analyses have identified COVID-19 health concerns, quarantine status, financial instability, exposure to news and misinformation and demographics (i.e., gender, age, education) as risk factors for poor mental health amongst the general population. By assessing these factors amongst the migrant worker population and documenting their impact on migrant workers' mental health, we hope to identify workers in greatest need of support during the ongoing pandemic and provide empirical evidence to guide public health policies.

Official Title
-----------------
Understanding the Mental Health of Migrant Workers During the COVID-19 Outbreak

Conditions
-----------------
Mental Health Issue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥21 years of age Hold a government-issued work permit identifying employment status

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| DASS-21 Scores | Depression, Anxiety and Stress Scale (DASS-21) is a validated 21-item measure that has been widely used during the current COVID-19 pandemic. | single measurement upon study enrolment |
Non-motor Symptoms and Brain Dopamine Transporter Binding

Study Overview
=================
Brief Summary
-----------------
This project aims to clarify the role non-motor symptoms in the development of Parkinson's disease (PD) and to improve diagnostics at very early stages of PD. The project involves multidimensional measures of disease biomarkers together with brain dopamine transporter (DAT) imaging with [123I]FP-CIT single photon emission computed tomography (SPECT).

Official Title
-----------------
Non-motor Symptoms and Brain Dopamine Transporter Binding: An Observational Study in Parkinsonism

Conditions
-----------------
Parkinson Disease, Parkinsonism

Intervention / Treatment
-----------------
* Other: DAT SPECT imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female Age 18-100 years Referred for clinical DAT SPECT in Turku or Helsinki

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Patients with parkinsonism<br>Patients with parkinsonism that are referred for DAT SPECT imaging in Turku University Hospital, Finland or Helsinki University Hospital, Finland | Other: DAT SPECT imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAT SPECT striatal specific binding ratio |  | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinsonism, DAT Dopamine transporter, SPECT
Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Coronary artery bypass grafting (CABG) is a well established treatment modality for patients with coronary artery disease. For 30 years now CABG operations have been performed with the help of the heart lung machine (Cardiopulmonary bypass). However, the heart lung machine is believed to be responsible for many of the side effects and complications seen in patients following CABG surgery. The organs most commonly affected are the brain, blood constituents, lungs and kidneys. In the last few years, stabilising devices have been developed that allow CABG operations to be performed safely without the use of the heart lung machine. Our hypothesis was that CABG done without the heart lung machine may be better tolerated by patients resulting in lower morbidity, increased functional outcome and shorter hospital length of stay. Enrolment into the trial was from 1998 to 2003 and included 300 patients. The last patient was enrolled in June of 2003. The initial results from the study suggest that excellent results can be obtained with both techniques and contrary to others no advantages could be demonstrated in in-hospital outcomes of patients performed without cardiopulmonary bypass (Legare et al. Circulation 2005).

Detailed Description
-----------------
We are now in follow-up to evaluate the medium term and long term outcomes of all 300 patients originally enrolled in above mentioned randomized clinical trial. The follow-up of patients is approved by the Capital Health Research Ethics Board (CDHA-RS/2004-295).

Official Title
-----------------
Randomized Clinical Trial Comparing Coronary Bypass Grafting With or Without Cardiopulmonary Bypass

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Procedure: Coronary bypass surgery without cardiopulmonary bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient suitable for CABG surgery Exclusion Criteria: Emergency, concomitant procedure, low ejection fraction (<20%)

Ages Eligible for Study
-----------------
Minimum Age: 0 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Coronary bypass surgery without cardiopulmonary bypass|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospitalization |  |  | 
| Blood product utilization |  |  | 
| Post operative atrial fibrillation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial infarction |  |  | 
| Mortality |  |  |
Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

Study Overview
=================
Brief Summary
-----------------
To design and create wearable head protection to be worn on a patient's head following a neurosurgical procedure (namely craniectomy and craniotomy

Detailed Description
-----------------
After being given informed consent, all participants will undergo the fitting and trial of a specially designed head protection for 6 weeks. Week 1 participants will be assessed and clinical data obtained on participants condition with the head protection fitted during the same session. Participants will return after 3 weeks for review and adjustment and again at the 6 week interval where they will also be given a questionnaire to fill up regarding their use and comfort.

Official Title
-----------------
Design of Protective Headgear for Patients Who Have Undergone a Craniectomy

Conditions
-----------------
Craniectomy

Intervention / Treatment
-----------------
* Device: Head protection device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects are eligible if they are 21 years or above and have had a DC >30 days, no wounds, able to understand simple commands and have a primary caregiver Exclusion Criteria: Exclusion criteria are patients with severe cognitive impairment, wounds, > unilateral DC, no caregiver

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 99 Years

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

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: Head protection<br>Participants are given a form of head protection | Device: Head protection device<br>* The participants are fitted with a form of head protection over the craniectomy and provide feedback on design, use, and comfort<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Survey | A survey to assess Satisfaction with device | 6 weeks after receiving their head protection fitting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Euro Quality of Life - 5 Dimensions (EQ-5D) | Quality of life survey. The higher the score from 0-5 for each dimension, the higher the quality of life. | 6 weeks after receiving their head protection fitting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
helmet, protection,
Expanded Access for Dasatinib

Study Overview
=================
Brief Summary
-----------------
This is an expanded access designed to provide access to dasatinib for eligible participants.

Intervention / Treatment
-----------------
* Drug: Dasatinib


Participation Criteria
=================

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dasatinib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Assessment of the Efficacy of Vitamin D-fortified Oil in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to plain oil.

Detailed Description
-----------------
Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the two intervention groups: 1.fortified sunflower oil, 2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of oil every day for 2 months. At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is the improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Official Title
-----------------
Formulation of Vitamin D-fortified Sunflower Oil and Evaluation of the Efficacy of Its Consumption in Healthy Adults: a Randomized Controlled Clinical Trial

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

Intervention / Treatment
-----------------
* Dietary Supplement: fortified oil
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 to 60 years healthy subjects no receiving vitamin D or omega-3 supplement in past 3 months Exclusion Criteria: - receiving vitamin D or omega-3 supplement during the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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: fortified oil<br>daily intake of fortified sunflower oil (700IU vitamin D/ 35g) | Dietary Supplement: fortified oil<br>* 35 g fortified sunflower oil<br>|
| Placebo Comparator: control<br>daily intake of plain oil | Dietary Supplement: Placebo<br>* plain oil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-hydroxyvitamin D (nmol/L) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum glucose (mg/dL) |  | 8 weeks | 
| serum triglyceride (mg/dL) |  | 8 weeks | 
| serum total cholesterol (mg/dL) |  | 8 weeks | 
| serum LDL |  | 8 weeks | 
| serum HDL |  | 8 weeks | 
| serum PTH (pg/mL) |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin D, fortified oil