linjc16/ctgov huggingface dataset:
Mindfulness Based Dementia Care Study

Study Overview
=================
Brief Summary
-----------------
Mindfulness based stress reduction (MBSR) refers to a particular type of attention focused on the present moment, non-judgmental awareness, and acceptance of that experience with openness and curiosity. Mindfulness training was designed to enhance the range and use of coping skills, decrease levels of stress, improve mood, and reduce tendencies to react in maladaptive ways 1-3. Investigators are evaluating a new program, called the Mindfulness Based Dementia-Care (MBDC) in caregivers (CG) for dementia, which combines the traditional approaches with education. The overall objective of this study is to evaluate the program and explore the potential benefits of the Mindfulness Based Dementia-Care (MBDC) program. Investigators are conducting a prospective, pre-post, observational study with members participating in the MBDC program.

Official Title
-----------------
MBDC-The Mindfulness Based Dementia-Care Study

Conditions
-----------------
Caregiver Burnout

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be ages ≥ 18 years Must be able to read and understand English Participant of the Mindfulness Based Dementia Care (MBDC) Program Exclusion Criteria: There is no exclusion criteria for this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Change in pre-post scores on the Perceived Stress Scale (PSS) | The Perceived Stress Scale (PSS) scores on a total score. The range of the PSS is 0-40 points. A lower score is indicative of lower stress. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pre-post scores on the Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D scores on a total score. The range of the CES-D is 0-60 points. A higher score is indicative of the presence of more depression symptoms. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mindfulness, Dementia
Using Device Delivering Ophthalmic Solution in a Spray Form Instead of Eye Drops

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to confirm that Vigamox reaches similar aqueous concentration when administered as the commercially available eye drops or as a spray delivered from a proprietary device.

Detailed Description
-----------------
Patients scheduled for elective cataract surgery, will be randomly allocated to receive Vigamox 4 times , 1 hour prior to surgery, either via the experimental device in a spray form, or via the regular, commercially available bottle. Aqueous sample will be collected and submitted to a masked laboratory for measuring Vigamox concentration.

Official Title
-----------------
Pilot Study on Bioavailability of Vigamox Administered as Drops vs. as Spray

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Vigamox delivered via the device in spray form


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for elective cataract surgery Exclusion Criteria: Known allergy to quinolone compounds

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Vigamox via the experiemntal device | Device: Vigamox delivered via the device in spray form<br>* Vigamox delivered 4 times, 1 hour prior to cataract surgery<br>|
| Active Comparator: 2<br>Vigamox drops from the commercially available bottles | Device: Vigamox delivered via the device in spray form<br>* Vigamox delivered 4 times, 1 hour prior to cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqeous concentration of Vigamox |  | one month |
A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.

Official Title
-----------------
A Prospective, Multicenter, Noncomparative, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: ertapenem sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a complicated urinary tract infection Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture Patient is indian and 18 years of age or greater. Exclusion Criteria: Patient had a kidney transplant Patient had been given antibiotic therapy for condition Patient had poor liver function Patient has complete obstruction of urinary tract Patient has history of serious allergy to antibiotics and multivitamins Patient is pregnant Patient not likely to respond to 10 to 14 days of antibiotic therapy Patient not likely to survive 4 week study period

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: ertapenem sodium | Drug: ertapenem sodium<br>* ertapenem sodium as a single dose of 1gm I.V. was infused over a 30 min interval for a minimum of 3 days to a maximum of 14 days.<br>* Other names: Invanz;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability |  | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment |  | 14 days after treatment |
Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how health literacy impacts glaucoma patient adherence (as measured by following up with the doctor) in Tamil Nadu, India. We hypothesize that individuals with better health literacy will have higher rates of follow-up with their ophthalmologist.

Detailed Description
-----------------
Many studies have shown the importance of health literacy on patient adherence in the United States (Juzych, M, et al., 2008; Muir, KW, et al., 2006). Low adherence in glaucoma patients leads to increased intraocular pressure, optic nerve damage, and blindness. To date, no research has been done with health literacy and patient adherence in the developing world. We will use TOFHLA and REALM to assess the health literacy of glaucoma patients in Tamil Nadu, India. We will also survey other demographic information and patient knowledge of glaucoma. This information will be compared with follow-up rates to identify barriers to patient adherence.

Official Title
-----------------
Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India

Conditions
-----------------
Patient Noncompliance, Health Literacy, Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Better than 20/100 corrected vision in better eye Must live within 50 miles of Aravind Eye Hospital Clinical diagnosis of primary glaucoma Paying patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 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 |
| --- | --- |
| 1<br>Adequate Health Literacy (as determined by TOFHLA) | |
| 2<br>Inadequate Health Literacy (as determined by TOFHLA) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between TOFHLA and REALM and the probability of return for follow-up visit |  | 1 year from enrollemnt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between religion, caste, education, socio-economic status, employment, and available time for doctor visits and the probability of return for follow-up visit. |  | 1 year from enrollment | 
| Association between marital status, number of dependents, family history of glaucoma, travel, need for an escort, understanding of glaucoma, and paying status and the probability of return for follow-up visit. |  | 1 year from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Literacy, Patient Nonadherence, Patient Noncompliance, Follow Up, India, Glaucoma
Evaluation of SCOUT DS in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.

Detailed Description
-----------------
Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.

Official Title
-----------------
An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 18 years Self-reported diagnosis of type 2 diabetes Exclusion Criteria: Not diagnosed with type 2 diabetes Diagnosed with type 1 diabetes Known to be pregnant (Self Reported) Receiving dialysis or having known renal compromise Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

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 |
| --- | --- |
| Those with Type 2 diabetes<br>All subjects have been diagnosed with type 2 diabetes. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of SCOUT DS algorithm for detecting known type 2 diabetes | Collect SCOUT DS and Hemoglobin A1c measurements of subjects with Type 2 Diabetes | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, Adults 18 years and older, Taking Control of Your Diabetes Health Fair
Pharmacokinetics Of Celecoxib Test Formulations

Study Overview
=================
Brief Summary
-----------------
The pharmacokinetics of new formulations of celecoxib are being evaluated. They are expected to provide more favorable bioavailability characteristics than the present commercial formulation.

Official Title
-----------------
A Pilot, Open-Label, Randomized, Crossover, Pharmacokinetic Study Of Enhanced Bioavailability Celecoxib Formulations D1, D2 And D3 In Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Celebrex capsule
* Drug: Test formulation D1
* Drug: Test formulation D2
* Drug: Test formulation D3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female volunteers Body weight BMI 17.5-30.5 Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease Positive urine drug screen

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Celebrex capsule<br>Commercial capsule | Drug: Celebrex capsule<br>* Single dose 200 mg commercial Celebrex capsule<br>|
| Experimental: D1<br>Test formulation D1 | Drug: Test formulation D1<br>* Single dose 150 mg celecoxib as formulation D1<br>|
| Experimental: D2<br>Test formulation D2 | Drug: Test formulation D2<br>* Single dose 150 mg celecoxib as formulation D2<br>|
| Experimental: D3<br>Test formulation D3 | Drug: Test formulation D3<br>* Single dose 150 mg celecoxib as formulation D3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, AUCt, Cmax |  | 1.5 month | 
| Visual inspection of median plasma concentration versus time profiles resulting from each formulation |  | 1.5 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax, half-life |  | 1.5 month | 
| adverse events, laboratory tests, vital signs |  | 1.5 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioavailability, pharmacokinetics, celecoxib
Study of CS-3150 in Patients With Severe Hypertension

Study Overview
=================
Brief Summary
-----------------
To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).

Official Title
-----------------
A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Patients With Severe Hypertension (Grade III)

Conditions
-----------------
Severe Hypertension

Intervention / Treatment
-----------------
* Drug: CS-3150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 20 to 80 years at informed consent Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg) Exclusion Criteria: Patients who are suspected hypertensive emergency Secondary hypertension or malignant hypertension Diabetes mellitus with albuminuria Serum potassium level < 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor) eGFR < 60 mL/min/1.73 m^2.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: CS-3150<br>CS-3150 2.5 to 5mg, orally, once daily after breakfast for 8 weeks | Drug: CS-3150<br>* CS-3150 2.5 to 5mg, orally, once daily after breakfast<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic and diastolic blood pressure |  | Baseline to end of Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time course of systolic and diastolic blood pressure |  | Baseline to end of Week 8 | 
| Proportion of patients achieving blood pressure control |  | Baseline to end of Week 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
severe hypertension, grade III hypertension, mineralocorticoid receptor antagonist
USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY

Study Overview
=================
Brief Summary
-----------------
This study is created in order to refine and reduce the duration between the medical and surgical therapeutic sequences (when the surgery is necessary) in these fragile patients knowing that conventional radiological changes can only be observed with a delay comprised between 3 and 6 months starting from observed clinical changes.

Official Title
-----------------
USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY

Conditions
-----------------
Mandibular Osteoradionecrosis

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic osteoradionecrosis with a PENTOCLO protocol indication (decided in a multi-disciplinary staff). Patient should understand to any protocol-specific procedures performed. Patient who did not object to participate after being informed of the study. Patient should be able and willing to comply with study visits and procedures as per protocol. Patients must be affiliated to a social security system or beneficiary of the same. Patients must be over 18 years old (legal age). Exclusion Criteria: Excluded forms of the disease: mandibular osteoradionecrosis complicated by mandibular fracture and / or hyperalgesic (resistant to analgesic treatment of stage III). Contraindications specific to the treatment under study (allergy to one of the PENTOCLO treatments, contraindication to 18FDG PET-CT). Associated pathology that contra-indicate on of the PENTOCLO treatment. Pregnant woman, declaring likely to be pregnant or breastfeeding. Chilbearing age women must declare not being pregnant and use effective contraception. Impossibility to submit to the medical follow-up of the test for geographical, social or psychological reasons. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or unable to express its opposition to participating in the study.

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 |
| --- | --- |
| Patients included in PENTOCLO protocol<br>We perform a prospective study with inclusions of all consecutive patients with osteoradionecrosis eligible for PENTOCLO. | Other: Data collection<br>* Imaging collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnosis performance of 18-FDG PET-CT | Evaluate the diagnosis performance of 18-FDG PET-CT with the criteria of Mandibular mean FDG uptake compared between the reference test and at 3 months: ΔSUVmean | up to 3 months |
Does DHEA IVF Outcomes in Poor Responders?

Study Overview
=================
Brief Summary
-----------------
This study is a RCT to examine whether DHEA is capable of improving results for poor responders to ovarian stimulation during IVF treatment

Detailed Description
-----------------
Poor responders to ovarian stimulation for IVF may be either predicted or evidenced from previous treatment. The ESHRE criteria for poor responders will be used to select candidates for this trial. A power calculation determined that 200 subjects should be recruited to each arm to receive either DHEA or placebo.

Official Title
-----------------
Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial

Conditions
-----------------
Infertility, Female, Poor Response to Ovulation Induction

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 40 years Markers for poor ovarian reserve (AMH <7 pmol/L(<1.1 ng/ml) and/or AFC< 7) Previous poor response to ovarian stimulation ( ≤3 oocytes with a conventional stimulation protocol) Exclusion Criteria: Women > 42 years Women with premature ovarian failure / premature menopause (FSH>40 U/L). Women already taking DHEA. Patients with a known allergy to the trial drug or any of the active ingredients in the placebo.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, double-blind, placebo controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teatment<br>75mg Dehydroepiandrosterone once daily for minimum ten weeks prior to starting ovarian stimulation | Drug: Dehydroepiandrosterone<br>* 75mg Dehydroepiandrosterone daily<br>|
| Placebo Comparator: Comaprator<br>75mg placebo once daily for minimum ten weeks prior to starting ovarian stimulation | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rates | ultrasound confirmation of a foetus with a heartbeat | at 6-8 weeks gestation |