linjc16/ctgov huggingface dataset:
Observed Actions in Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
The aim of the present protocol is to prove if the observed actions (AOb) will improve the cervical range of motion (CROM) in patients with non-specific chronic neck pain (CNP). This study is a parallel-group double blind randomized clinical. Outcome measures were CROM, and pressure pain detection thresholds (PPDT) with a digital algometer. The follow-up will consist of three evaluations: pre- treatment, post-treatment and 10 minutes after second measurement (motor imagery).

Official Title
-----------------
Influence of the Actions Observed on Cervical Motion in Patients With Chronic Neck Pain. Randomized Controlled Trial

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Other: Actions observed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non specific chronic neck pain Diagnosed by medical specialist Exclusion Criteria: cervical osteoarthritis or polyarthrosis rheumatic disease history of cervical hernia whiplash syndrome surgery on the neck, face or shoulders, systemic disease, medical history of cancer significant trauma that the patient relates to their pain and/or refusal to participate

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effective movement<br>This group will see a 1-minute video showing an individual performing a cervical rotation movement to each side, first 10 times towards the right and then 10 times towards the left. The movement will be performed effectively over the entire course of the cervical path, approximately 80º | Other: Actions observed<br>* Patients observed movements without realize them. After this actions, movements will be imagined by patients<br>|
| Active Comparator: Ineffective movement<br>This group will see a 1-minute video showing an individual performing a cervical rotation movement ineffectively, without achieving the maximum cervical travel, performing approximately 40º. First, 10 movements towards the right will be performed and then 10 towards the left | Other: Actions observed<br>* Patients observed movements without realize them. After this actions, movements will be imagined by patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion degrees |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
observed action, range of motion, mirror neuron
New Dermal Filler for Chin Correction and Augmentation

Study Overview
=================
Brief Summary
-----------------
Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada

Official Title
-----------------
A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multi-center Study to Evaluate Effectiveness and Safety of GP0109 for Augmentation and Correction of Retrusion in the Chin Region

Conditions
-----------------
Chin Augmentation and Correction

Intervention / Treatment
-----------------
* Device: Hyaluronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subject willing to comply with the requirements of the study subject intent to receive treatment for augmentation and correction of retrusion in the chin region subject with mild or moderate (grade 1 or 2) on the GCRS Exclusion Criteria: subjects presenting with know allergy to HA (hyaluronic acid) filler or amide local anesthetics subjects with any previous facial surgery below the nasal line or previous HA filler or collagen below the nasal line within 12 months subjects in any other interventional clinical study within 30 days before baseline

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment Group<br> | Device: Hyaluronic Acid<br>* Injectable gel. Chin correction and augmentation for retrusion<br>* Other names: GP0109;|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator |  | 3 months after baseline |
Welcoming by Design Pilot: Reducing Structural Stigma by Changing Clinic Systems and Architectural Design

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the feasibility and acceptability of implementing clinic system changes and physical structures in Uganda to improve aesthetics, welcome, and privacy to reduce HIV stigma, improve retention-in-care, and improve the patient experience. To evaluate pilot/implementation outcomes, the outcomes of fidelity, feasibility, and acceptability will be assessed prior to intervention. After the changes are done to two HIV interventions clinics, the outcome surveys will assess if the changes were disruptive or impeded the workings of the clinics.

Official Title
-----------------
Welcoming by Design Pilot: Reducing Structural Stigma by Changing Clinic Systems and Architectural Design to Make HIV Clinics More Friendly, Private, and Patient-Centric

Conditions
-----------------
Hiv

Intervention / Treatment
-----------------
* Other: Clinics remodeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 and older Enrolled in the HIV clinics where we are working Able to independently consent for interview, survey, or focus group. Exclusion Criteria: Unable to provide consent Does not speak English or Luganda (local language around Kampala and Entebbe)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventions clinics to be remodeled<br> | Other: Clinics remodeling<br>* changes to the clinics will be planned based on baseline surveys<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability survey | How well an intervention will be received by the target population and the extent to which the intervention meets the needs of the target population and organizational setting. This will be assessed through qualitative evaluation and a quantitative survey from patients and staff. | Baseline | 
| Feasibility | An assessment of the practicality of a proposed idea or project, by assessing recruitment capacity, and ability to complete proposed modifications in clinics. The intervention will be judged feasible if enrollment and metrics can be completed. | baseline | 
| Fidelity to the Intervention | Assesses whether the intervention was delivered as intended, using the intervention plan/checklist | 6-months post intervention | 
| Outcomes survey | assesses if the changes were disruptive or impeded the workings of the clinics. | 6-months post intervention |
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City

Study Overview
=================
Brief Summary
-----------------
Financial incentives for motivating health change have been increasingly employed in various healthcare sectors. They can be a potentially effective approach to promote smoking behavioral change and increase the use of evidence-based counseling and pharmacotherapy. Smoking cessation randomized clinical trials (RCT) incorporating financial incentives have been conducted in different populations; however, there has not been a randomized clinical trial coupled with a financial incentive with Asian American cigarette smokers. The purpose of this pilot study is to examine the feasibility of implementing an incentivized smoking cessation program among Asian American smokers in New York City.

Official Title
-----------------
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City: A Feasibility Study

Conditions
-----------------
Smoking Cessation, Smoking, Cigarette

Intervention / Treatment
-----------------
* Behavioral: Financial Incentives


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asian American current smoker who smokes at least 10 cigarettes daily (verified by a CO level of 8 ppm or above) New York City resident able to complete three month follow-up assessments in person, can provide a telephone number declining the use of Chantix for smoking cessation. Exclusion Criteria: <18 years old pregnant cannot provide a telephone number, non-smokers or smokers that smoke fewer than 10 cigarettes daily, users of e-cigarettes or other tobacco products who are not interested in quitting smoking, marijuana users not a New York City resident unable to complete three month follow-up assessment in person unable to provide written consent agree to use Chantix for smoking cessation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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: Usual Care+Financial Incentive<br>Smoking cessation counseling couples with financial incentives | Behavioral: Financial Incentives<br>* Baseline Interview, 2 Counseling Sessions at baseline and 2 weeks post baseline, and one follow up survey at one month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients recruited by implementing Financial Incentive Smoking Cessation Program among Asian American Smokers | Number of patients who complete incentive program | One Month |
Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections.

Study Overview
=================
Brief Summary
-----------------
The primary objective is to collect data on treatment outcomes (clinical and microbiological cure), safety and tolerability of treatment with cefoperazone/sulbactam in patients with serious intra-abdominal and hepatobiliary infections in Slovakia.

Official Title
-----------------
Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections In Slovakia. An Open, Prospective, Non-Comparative Study.

Conditions
-----------------
Abscess, Intra-Abdominal, Cholecystitis, Wound Infections, Peritonitis, Appendicitis

Intervention / Treatment
-----------------
* Drug: CP-75385-02 Cefoperazone/sulbactam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient of age 18 years or older. Patient with intraabdominal/hepatobiliary infection.? Exclusion Criteria: Patients with known hypersensitivity to penicillins, cephalosporins, cefoperazone or to sulbactam.

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 |
| --- |
|Drug: CP-75385-02 Cefoperazone/sulbactam|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.

Study Overview
=================
Brief Summary
-----------------
The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.

Official Title
-----------------
A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Orlistat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients preparing for gastric bypass surgery Exclusion Criteria: 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: orlistat 60mg<br>Patients assigned to treatment group for up to 6 months of therapy. | Drug: Orlistat<br>* 60mg capsule three times a day for up to 6 months<br>* Other names: Alli;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | Weight loss acheived during time on study up to 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric bypass surgery
Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To establish and compare the diagnostic utilities for hepatocellular carcinoma (HCC) screening tests of (a) HS-AFP, (b) AFP + US,(c) AFP alone and (d) US alone (within HBV carriers between age 40 and 70 years); To establish the cost-effectiveness of the screening tests; To compare tumor sizes, resection rates, and survival rates up to 18 months between those who were screened by HS-AFP those of a historical control group that was not screened.

Official Title
-----------------
Validity and Cost-Effectiveness of a New Screening Test for Hepatocellular Carcinoma

Conditions
-----------------
Hepatitis B Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 40 and 70 years Seropositive for HBsAg Child's A or B Life expectancy of more than 2 years Exclusion Criteria: Non-HBV related cirrhosis History of malignancy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 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 |
| --- | --- |
| JHC<br>AFP > 20 ng/ml and USG positive | |
| Non JHC<br>patient without AFP > 20 or USG negative | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HBV carriers
A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.)

Official Title
-----------------
A Phase I Open-label, Fixed Sequence Study to Determine the Effect of Multiple Intravenous Doses of AZD6765 on the Pharmacokinetics of Oral Midazolam (CYP3A4 Substrate) in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: AZD6765
* Drug: midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 19-30 Exclusion Criteria: Significant result for C-SSRS at screening or baseline Single arm preference for IV procedures

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>midazolam + AZD6765 IV solution | Drug: AZD6765<br>* IV solution<br>Drug: midazolam<br> <br> |
| Active Comparator: 2<br> | Drug: midazolam<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations |  | on Day -1 and Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, physical and neurological examinations, clinical laboratory assessments, 12-lead ECG, C-SSRS, CADSS, and VAS scales) |  | will be collected from the time of informed consent (Visit 1) until completion of the follow-up visit. | 
| Optional Genetic sampling |  | at admission Day -2 | 
| Exploratory - renal biomarkers in urine |  | At admission Day -2 until follow up visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Midazolam, Pharmacokinetics
Nutritional Problems After Lung and Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
Part 1) Bone health after transplantation - possible influence of vitamin K Part 2) Fat metabolism and endocrine parameters - possible predictors for developement of overweight after transplantation

Official Title
-----------------
Nutritional Problems After Lung and Heart Transplantation

Conditions
-----------------
Bone Density, Overweight

Intervention / Treatment
-----------------
* Drug: Vitamin K
* Drug: Vitamin K


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: accepted for transplantation Exclusion Criteria: not accepted for transplantation

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

| Intervention/Treatment |
| --- |
|Drug: Vitamin K|180 micrograms vitamin K daily|
|Drug: Vitamin K|2 capsules daily 180 micrograms vitamin K daily or placebo 1 year|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma vitamin K |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin K, Bone Mineral Density, undercarboxylated osteocalcin
A Compassionate Access Protocol For Those Patients Who Have Completed A4001029

Study Overview
=================
Brief Summary
-----------------
This is a compassionate study to provide continued access to maraviroc for only those subjects completing study A4001029 who are showing clinical benefit. Assessments of safety and tolerability of maraviroc when added to OBT will be continued.

Official Title
-----------------
A Compassionate Access Protocol For Those Patients Who Have Completed A4001029

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Drug: Maraviroc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having completed study A4001029 in Canada and still deriving clinical benefit. Exclusion Criteria: None

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 |
| --- |
|Drug: Maraviroc|150 mg twice per day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Compassionate, CCR5