linjc16/ctgov huggingface dataset:
Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.

Official Title
-----------------
Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Symbicort Turbuhaler 160/4.5


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma for past 6 months and treated with inhaled glucocorticosteroids for at least 3 months. Patients who asthma is classified as uncontrolled or partially controlled as defined by GINA 2006 guidelines. Exclusion Criteria: Patients already on Symbicort SMART treatment. Patients who has respiratory tract infection 30 days before study enrolment.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Symbicort Turbuhaler 160/4.5|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART | Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction | 6 months after each patient was initially treated with Symbicort SMART | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART | Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms | 6 months after each patient was initially treated with Symbicort SMART | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma
A Clinical Pharmacology of KHK4827 in Healthy Volunteers and Subject With Moderate to Severe Psoriasis

Study Overview
=================
Brief Summary
-----------------
This is a randomized, placebo-controlled, ascending single dose study of KHK4827 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous or intravenous administration of KHK4827 in healthy male subjects or moderate to severe psoriasis patients.

Official Title
-----------------
A Randomized, Placebo-controlled, Ascending Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KHK4827 in Healthy Volunteers and Subjects With Moderate to Severe Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: KHK4827


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health volunteers Able to provide written informed consent Healthy male between 20 to 45 years of age, inclusive at the time of screening Additional inclusion criteria apply Psoriasis subjects 20 to 70 years of age, inclusive at the time of screening Active but clinically stable, plaque psoriasis Psoriasis involving ≥10% of the body surface area A minimum PASI score of ≥10 obtained during the screening period Additional inclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KHK4827<br> | Drug: KHK4827<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse events Clinical laboratory test data Vital signs |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma KHK4827 concentrations and pharmacokinetic parameters | To assess PK parameters which include area under the plasma concentration versus time curve (AUC) peak plasma concentration (Cmax) t1/2 CL | 16 time points up to 64 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis
Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effect of NTRA-2112 on intestinal malabsorption in preterm infants.

Detailed Description
-----------------
The study will assess the efficacy and safety of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo

Official Title
-----------------
A Multi-center, Double-blind, Randomized, Three-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants

Conditions
-----------------
Premature Birth of Newborn, Intestinal Malabsorption

Intervention / Treatment
-----------------
* Drug: NTRA-2112
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound Birth weight ≥ 500g Singleton or twin birth Exclusion Criteria 1. Complete enteral feeding

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 5 Days

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NTRA-2112 A<br>NTRA-2112 A - Dose 1 To be administered orally with daily feed for 28 days or until discharge from hospital. | Drug: NTRA-2112<br> <br> |
| Experimental: NTRA-2112 B<br>NTRA-2112 B - Dose 2 To be administered orally with daily feed for 28 days or until discharge from hospital. | Drug: NTRA-2112<br> <br> |
| Placebo Comparator: Placebo<br>Placebo To be administered orally with daily feed for 28 days or until discharge from hospital. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of days to achieve complete enteral feeding |  | 28 days or discharge from hosital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days to achieve discharge from hospital or readiness to discharge |  | 28 days or discharge from hospital | 
| Growth velocity (g/kg/day) |  | 28 days or discharge from hospital |
Micronutrients and Health in Adult Chinese

Study Overview
=================
Brief Summary
-----------------
Adult subjects were recruited from a health examination center. Their fasting blood samples were collected for laboratory analyses of multiple measures including mineral, glucose, lipids, etc.

Conditions
-----------------
Dysglycemia, Dyslipidemia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult volunteer Han population living in Shenzhen City for > 2 y Exclusion Criteria: caught by organic diseases in pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| Cross-sectional<br>a cross-sectional study. | Other: No intervention<br>* No intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| circulation concentration of glucose | Glucose (mmol/L) was measured in less than 4 hours after sample collection | less than 4 hours | 
| circulation concentrations of 4 types of lipids | TG, TC, LDLC, and HDLC (mmol/L) were measured in less than 4 hours after sample collection | less than 4 hours | 
| circulation concentrations of 5 minerals | all samples were stored at minus 75 degrees Celsius until ready for analysis collectively on a ICP-MS machine for calcium, cobalt, iron, selenium, and zinc (ng/ml) | less than 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | body weight (kg) and hight (m) were measured when the volunteers were visiting the health examination center, and the body mass index was calculated later by the formula of body weight/ hight/ hight (kg/m^2). | less than 1 month | 
| circulation concentration of 25OHD | all samples were stored at minus 75 degrees Celsius until ready for analysis collectively with ELISA kits (nmol/L) | less than 3 years |
Progrip Ventral Study for Sublay Repair

Study Overview
=================
Brief Summary
-----------------
A novel concept of self-gripping mesh has been developed to achieve secure and long-term posterior wall reinforcement. ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation. The self-fixation of the mesh to the underlying tissues is instantly achieved at application, limiting or avoiding the requirement of sutures (which can penetrate underlying tissues and damage cutaneous nerves), and providing a near tension-¬free repair. Case series confirmed that Parietex ProGrip™ placed in onlay position allows a safe and painless treatment of incisional hernias and provides secure and efficient fixation mesh. On this basis, larger sizes Parietex ProGrip™ meshes have been developed for larger incisional hernia defect treatment. In order to assess the clinical outcomes following the use of ProGrip™ larger sizes in incisional hernia repair, this mono-center observational study has been initiated.

Official Title
-----------------
Efficacy of Self-fixating Mesh in Ventral and Incisional Hernia Repair

Conditions
-----------------
Primary Ventral and Incisional Hernia Repair

Intervention / Treatment
-----------------
* Device: Parietex ProGrip™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients at participating hospital undergoing incisional hernia repair by using retromuscular placement by open approach. Defect size: 5cm ≤ width*, 10 cm ≤ length ≤ 20 cm

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 |
| --- | --- |
| incisional hernias<br> | Device: Parietex ProGrip™<br>* ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of peri-operative and post-operative complications using Parietex ProGrip™. | Clinical observation: recurrence, wound complications pain, pain/ chronic pain and other postoperative complications | 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description and assessment of the use of Parietex™ ProGrip™ larger sizes meshes at time of surgery |  | End of surgical procedure |
Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.

Study Overview
=================
Brief Summary
-----------------
To investigate the mucosal microbiome in human gastric intestinal etaplasia and duodenal tissue.

Official Title
-----------------
Mucosal Microbiome in Human Gastric Intestinal Metaplasia and Duodenal Tissue.

Conditions
-----------------
Mucosal Microbiome, Gastric Intestinal Metaplasia, Duodenum

Intervention / Treatment
-----------------
* Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for gastroendoscopy examination Aged between 18 and 80 years old Exclusion Criteria: Antibiotic, probiotic or prebiotic usage within 2months,gastric inhibitor usage within 1 month Esophageal, gastric or duodenal cancer or other malignancy History of upper GI tract surgery Coagulopathy or bleeding disorders Allergy to fluorescein sodium Pregnant or breast-feeding (for females) Impaired renal function

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| gastric intestinal metaplasia<br>patients were diagnosed gastric intestinal metaplasia | Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing<br> <br> |
| gastritis<br>patients were diagnosed non atrophic gastritis | Other: endomicroscopy, targeted biopsy and 16s rRNA gene sequencing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The operational taxonomy units in gastric Intestinal Metaplasia and and Duodenal mucosal microbiome |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mucosal Microbiome, gastric intestinal metaplasia, duodenum
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Cancer of the Colon or Rectum

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will evaluate the safety and efficacy of first-line Avastin (bevacizumab) in combination with standard chemotherapy in routine clinical practice in patients with metastatic cancer of the colon and/or rectum. Patients will be followed for the duration of their treatment and a 30-day follow-up after the last dose of study drug.

Official Title
-----------------
Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Bevacizumab in Combination With Standard Chemotherapy Regimens as First Line in Patients With Metastatic Cancer of the Colon or the Rectum

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases At least one measurable metastatic lesion (as per RECIST criteria) Life expectancy of > 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate hematological, renal and liver function Exclusion Criteria: Prior chemotherapy for metastatic disease Clinically significant cardiovascular disease Ongoing treatment with aspirin (325 mg/day) or other medications known to predispose for gastrointestinal ulceration Participation in an investigational trial in the previous 3 months Pregnant or lactating women History of thrombotic or haemorrhagic disorders Evidence of bleeding diathesis or coagulopathy Uncontrolled hypertension Known hypersensitivity to Avastin and any of its excipients, or any of the chemotherapies Evidence of any disease or disorder that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Time to disease progression |  | approximately 3.5 years |
Brody Belt - Alternative Method of Securing a Patient's Urinary Drainage Bag

Study Overview
=================
Brief Summary
-----------------
The Brody belt may help improve quality of life in patients using urinary drainage bags. PURPOSE: This clinical trial studies the Brody belt in improving the quality of life in patients using urinary drainage bags.

Official Title
-----------------
Brody Belt - Alternative Method of Securing a Patient's Urinary Drainage Bag

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Procedure: quality of life
* Procedure: Quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ->18 years old -All patients in the urology clinic at Roswell Park who currently use a urinary drainage bag for a period of at least 7 days prior to signing consent for the study and who are expected to use a urinary drainage tube for an additional period of 4 weeks or more based on the diagnosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brody Belt<br> | Procedure: quality of life<br>* survey<br>|
| Active Comparator: Conventional Urinary Drainage bag<br> | Procedure: Quality of life<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 4 weeks |
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

Study Overview
=================
Brief Summary
-----------------
122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.

Official Title
-----------------
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial

Conditions
-----------------
Delirium

Intervention / Treatment
-----------------
* Dietary Supplement: melatonin
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada. Exclusion Criteria: Life expectancy less than 24 hours, Unable to communicate in English, Unable to take oral medications, Intracranial bleed or known seizure disorder, Markedly sub or supra-therapeutic INR while on warfarin, OR A known allergy to study tablet ingredients.

Ages Eligible for Study
-----------------
Minimum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: melatonin<br>.5 mg (one half of a 1 mg tablet of GNC rapid dissolving Melatonin, natural product number (NPN) 80001380) | Dietary Supplement: melatonin<br>* one half of a 1 mg tablet of GNC rapid dissolving Melatonin, NPN (natural product number) 80001380, available over the counter in Canada<br>|
| Placebo Comparator: placebo<br>half a white placebo tablet | Dietary Supplement: placebo<br>* half a white placebo tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delirious using confusion assessment method (CAM) |  | days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDAS (memorial delirium assessment scale) |  | days |