linjc16/ctgov huggingface dataset:
Information or Physical Activity for Chronic LBP

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a specific fear-reducing information with symptom-based exercise

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: Fear-reducing Information
* Behavioral: Symptom-based exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Daily LBP, dominating over possible pain in leg or other joints/muscles Pain og > 4 (scale 0-10) for more than 4 months Exclusion Criteria: Cancer, inflammatory disease, previous back surgery, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Fear-reducing Information|nan|
|Behavioral: Symptom-based exercise|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study

Study Overview
=================
Brief Summary
-----------------
COMPASS is a status and intervention study for the self-monitoring of blood glucose (SMBG) in type 2 diabetic patients with insulin treatment. This multi-centre, open-label prospective study will assess the use and frequency of SMBG and blood glucose control and its influencing factors with the help of Accu-Chek Integra glucometer. Patients with type 2 diabetes mellitus who have received more than 3 months of insulin therapy are eligible to participate in this study. The anticipated duration of the study is 6 months.

Official Title
-----------------
Accu-Chek missiOn: SMBG in Patients With diAbetes on inSulin Study (COMPASS) - Multiple Center, Open, and Non-randomized Study

Conditions
-----------------
Diabetes Mellitus Type 2

Intervention / Treatment
-----------------
* Device: Accu-Chek Integra Glucometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type II diabetes mellitus patients who have received insulin treatment for more than 3 months Patients willing to sign written informed consent form Patients who meet the criteria for the first cross-sectional investigation and have an HbA1c < 7% will receive the second cross-sectional investigation Exclusion Criteria: Patients unable or unwilling to comply with the requirements of the protocol

Ages Eligible for Study
-----------------
Maximum Age: 70 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: A<br> | Device: Accu-Chek Integra Glucometer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change between the baseline and end of study |  | From baseline to month 6 | 
| Successful rate of blood glucose control (the proportion of patients with HbA1c <7%) |  | From baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SMBG frequency change between the baseline and the end of the study |  | From baseline to month 6 | 
| Relationship between SMBG frequency change and blood glucose control |  | From baseline to month 6 | 
| To evaluate the change of quality of life in the 6 months by the health questionnaire SF-36 |  | From baseline to month 6 |
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fasting condition.

Detailed Description
-----------------
This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr.Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules (manufactured by Merck & Co., Inc., USA) in 44 healthy, adult, human subjects under fasting conditions.

Official Title
-----------------
A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co.Inc., USA Under Fasting Conditions

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

Intervention / Treatment
-----------------
* Drug: Omeprazole
* Drug: Prilosec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who provided written informed consent. Subjects who were healthy within 18-45 years of age, weighing at least 50 kg. Body mass index of ≥ 18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg. Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I). Subjects with normal ECG, chest X-ray (PA view) and vital signs. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. Test product, dose, mode of administration and batch number

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omeprazole<br>Omeprazole Delayed Release Capsules of Dr. Reddy's laboratories limited | Drug: Omeprazole<br>* Omeprazole Delayed Release Capsules 40 mg<br>* Other names: Prelosec 40 mg;|
| Active Comparator: Prilosec<br>Prilosec® 40 mg of Merck & Co.Inc. | Drug: Prilosec<br>* Prilosec® 40 mg of Merck & Co.Inc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on Cmax and AUC parameters |  | 5 months |
Pharmacogenomic Study (Adjuvant Chemotherapy)

Study Overview
=================
Brief Summary
-----------------
To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile. To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant chemotherapy.

Official Title
-----------------
Pharmacogenomic Study to Predict Toxicity and Response in Gastric Cancer Patients Treated With Adjuvant Chemotherapy

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gastric cancer patients treated with adjuvant chemotherapy 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| adjuvant chemotherapy<br>Patients enrolled on to the adjuvant XP trial + patients who received adjuvant chemotherapy following curative resection of gastric cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| germline polymorphisms in xenobiotic metabolism genes in toxicity profile |  | 36 months |
MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.

Official Title
-----------------
MK0431 (Sitagliptin) Phase III Clinical Study -Pioglitazone add-on Study for Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: sitagliptin phosphate
* Drug: Comparator: sitagliptin phosphate (MK0431)
* Drug: Comparator: pioglitazone
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Have Type 2 Diabetes Mellitus On Diet/Exercise Therapy And Pioglitazone As Monotherapy Exclusion Criteria: Patients Have Type 1 Diabetes Mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Experimental: 1<br>MK0431 + pioglitazone | Drug: sitagliptin phosphate<br>* Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks<br>* Other names: MK0431;Drug: Comparator: pioglitazone<br>* pioglitazone once daily for 52 weeks<br>|
| Placebo Comparator: 2<br>Placebo/MK0431 + pioglitazone | Drug: Comparator: sitagliptin phosphate (MK0431)<br>* Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks<br>* Other names: MK0431;Drug: Comparator: pioglitazone<br>* pioglitazone once daily for 52 weeks<br>Drug: Comparator: placebo (unspecified)<br>* Placebo once daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12 | Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Fasting Plasma Glucose at Week 12 | Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication. | 12 Weeks |
Pilairo Lab Market Research

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to observe the Pilairo mask in a lab setting.

Detailed Description
-----------------
The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.

Official Title
-----------------
Pilairo Lab Market Research

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: CPAP mask ( Pilairo)
* Procedure: Other CPAP mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apnea Hypopnea Indea >15 from diagnostic study Minimum 18 years of age Exclusion Criteria: Inability ot give informed consent History of intolerance to CPAP Anatomical or physiological conditions making CPAP therapy inappropriate

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pilairo mask<br>Pilairo nasal pillows mask during CPAP titration | Device: CPAP mask ( Pilairo)<br> <br> |
| Active Comparator: Other CPAP mask<br>Other CPAP mask during CPAP titration | Procedure: Other CPAP mask<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technician Experience With Mask | Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience. | One night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Mask Interventions During the Night | Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort. | One night |
Surgery Versus No Surgery for Osteoarthritis (OA) of the Knee

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to discover whether arthroscopic surgery is helpful in controlling the symptoms of osteoarthritis of the knee.

Detailed Description
-----------------
Although arthroscopic surgery has been widely used for osteoarthritis of the knee, scientific evidence to support its efficacy is lacking. This study will compare optimized physical and medical therapy alone with arthroscopic treatment in addition to optimized physical and medical therapy.

Official Title
-----------------
Arthroscopic vs. Non-surgical Treatment of Osteoarthritis of the Knee

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Procedure: Arthroscopic surgery
* Other: Physical and medical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic or secondary osteoarthritis of the knee with Grade II to IV radiographic severity as defined by the modified Kellgren and Lawrence classification Exclusion Criteria: Patients with inflammatory or post-infectious arthritis Those who had undergone previous arthroscopic treatment for knee osteoarthritis Those with isolate Grade III to IV medical compartment osteoarthritis with greater than 5 degrees of varus deformity.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic Surgery<br>Arthroscopic surgery optimized with physical and medical therapy | Procedure: Arthroscopic surgery<br>* Arthroscopic surgery to treat unresolved symptoms of osteoarthritis of the knee<br>Other: Physical and medical therapy<br>* Treatment with physical and medical therapy alone<br>|
| Active Comparator: Physical and medical therapy<br>treatment with physical and medical therapy alone | Other: Physical and medical therapy<br>* Treatment with physical and medical therapy alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function, pain and quality of life based on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health utility using the Standard Gamble Technique |  | 24 months |
Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.

Detailed Description
-----------------
Invasive pulmonary aspergillosis (IPA) is a life-threatening infection in immunocompromised patients. The poor prognosis of the disease is partly attributed to difficulties encountered with the diagnosis of this infection. Invasive sampling procedures are often precluded in these patients. In addition, conventional diagnostic techniques lack sensitivity. Recently there has been increasing interest in the investigation of the lungs by noninvasive means including measurement of biomarkers in exhaled breath (e.g. NO) and those found in the cooled and condensed exhalate,termed EBC. It has been demonstrated that a measurable fraction of the EBC in healthy subjects is derived from aerosolized airway lining fluid. The presence of biomarkers for IPA will be investigated in EBC of patients with IPA, compared to controls.

Conditions
-----------------
Invasive Pulmonary Aspergillosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalisation in the hematology or intensive care department age > 16 years informed consent proven or probable IPA (EORTC/ MSG criteria) galactomannan positivity in BAL or serum Exclusion Criteria: age < 16 years

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Invasive pulmonary aspergillosis (IPA)<br>Patients with proven or probable invasive pulmonary aspergillosis (IPA) (EORTC/MSG criteria) or putative IPA (Blot et al. Am J Respir Crit Care Med 2012) | |
| Controls<br>Patients without signs of infection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The identification of biomarkers for invasive pulmonary aspergillosis (IPA) in exhaled breath condensate (EBC) |  | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
invasive pulmonary aspergillosis, exhaled breath condensate
Impact of a Computer-Assisted SBIRT Program in an HIV Care Setting

Study Overview
=================
Brief Summary
-----------------
The goal of this research is to assess the impact of the screening, brief intervention, and referral to treatment (SBIRT) intervention strategy for harmful substance use among HIV-positive people.

Detailed Description
-----------------
The specific aims of the study are: To assess the feasibility of conducting SBIRT using (1) a patient self-administered intervention embedded in a web-based Personal Health Record (PHR) compared to (2) a provider-administered SBIRT intervention guided by the Electronic Medical Record (EMR) during clinic appointments. To examine the acceptability of web-based PHRs to conduct and communicate SBIRT compared to EMR-activated SBIRT conducted by clinic staff, from the perspective of the patient and the provider. To assess the impact of SBIRT on risky drug and alcohol use in an HIV/AIDS population and subsequent effects on sexual risk behaviors and antiretroviral therapy (ART) adherence.

Official Title
-----------------
Impact of a Computer-Assisted SBIRT Program in an HIV Care Setting

Conditions
-----------------
Substance Use

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age confirmed prior HIV+ serostatus ability to provide informed consent to be a participant over a 6 month period English or Spanish speaking Exclusion Criteria: Inability to answer questions with interviewer assistance. Not receiving primary care in clinic.

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 |
| --- | --- |
| myHERO SBIRT<br> | |
| clinician administered SBIRT<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced substance use among HIV-positive people |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technological innovation to improve the quality of medical care |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, harmful substance use