cyrilzakka/clinical-trials huggingface dataset:
PROmyBETAappGame: a Study to Learn More About the Medication Usage & Patient Reported Outcomes Via the myBETAapp and to Find Out More About the Usage of Game Principles and Game Design Elements (Gamification) in Medical Care of Patients With Multiple Sclerosis Treated With Betaferon

In this study researchers wanted to learn more about the medication usage behavior among multiple sclerosis (MS) patients treated with Betaferon using the myBETAapp which includes the elements to what extent

* taking medication matched the presciber´s recommendation (adherence, compliance),
* treatment for the prescribed duration (persistence) was continued and
* injections were missed. Among MS patients treated with Betaferon using the myBETAapp the study also collected information on the health-related quality of life, treatment satisfaction and satisfaction with treatment support.

The PROmyBETAappGame study was a mixed prospective and retrospective, non-interventional, observational cohort study

Eligibility Criteria:
Inclusion criteria

* Patients aged ≥ 18 years.
* Patients on treatment with Betaferon (every Betaferon box contains a "Mixject" number, which is a product specific number unrelated to the study. Only patients prescribed Betaferon for their MS will be able to use the myBETAapp and participate in the study).
* Patients must be using the myBETAapp.
* Electronic informed consent must be obtained.

Exclusion criteria

- No exclusion criteria for participation in this study were defined.
Non-magnified NBI in Barrett's Oesophagus Neoplasia Detection and Delineation

Endoscopy plays a pivotal role in the management (diagnosis and treatment) of Barrett's related neoplasia. The standard endoscopy is generally done under white light, which is known to be imperfect in detecting early neoplastic lesion. Narrow band imaging (NBI) improves definition of the superficial morphology and vasculature of GI mucosa. Some studies have shown the potential to improve diagnostic accuracy and reduce the number of biopsies required for Barrett's related neoplasia. This can ultimately improve the cost-effectiveness of endoscopic surveillance. The ability to discriminate between healthy and diseased tissue also makes NBI a useful technique for the delineation of lesions to treat with endoscopic mucosal resection (EMR). However not all studies provide evidence of diagnostic utility. Also the majority of these studies have been conducted by expert endoscopists, which makes the results difficult to extend to general endoscopy practice. The limited number of Barrett's specialists in certain areas of the country validates the need for a study to investigate whether there is an objective improvement in detection and delineation of Barrett's neoplastic lesions by less experienced observers. The aim of this study was to determine the utility of non-magnified NBI in non-expert identification of lesions as compared to expert endoscopists as well as the inter-observer agreement among endoscopists on WLE and NBI.

Matched non-magnified white-light endoscopy (WLE) and narrow band imaging (NBI) images of Barrett's oesophagus with and without lesions from the same level will be obtained prospectively. Lesions will be delineated by 3 expert endoscopists and the overlap between all delineations for each image, regarded as the "sweet spot", will be used as the gold standard. The images will then be assessed by a group of non-expert endoscopists (trainees and nurse endoscopists) as well as senior endoscopists with no interest in Barrett's. First, white light images will be assessed, followed by a wash-out period and then NBI. Assessments will be carried out using a computer application designed in MATLAB. Observers will be also asked to complete the following 1) Paris classification of lesion 2) delineation of the lesion on the screen 3) rate the ability to delineate the lesion for each of the two respective imaging modalities (using a Visual analog scale (VAS score 1-10), 4) choice a single point for virtual diagnostic biopsy. Thus, the quantitative interobserver agreement of the delineations for WLE and NBI will be calculated. VAS scores for the ability to delineate the lesion will be compared between WLE and NBI. Rate of inclusion of the biopsy point in the sweet spot on WLE and NBI will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with dysplastic or non-dysplastic BO at least C1 or M2 in length

Exclusion Criteria:

* Reflux oesophagitis (Los Angeles grade ≥C);
Promoting Employment in Persons Living With HIV/AIDS

Many persons living with HIV/AIDS (PLWHA) are unemployed, with estimates indicating rates as high as 60%. This study will examine the efficacy of reinforcing job-acquisition activities for improving employment outcomes in PLWHA who desire to return to the workforce in part- or full-time capacity. In total, this study will randomly assign 144 unemployed PLWHA to one of two interventions. All participants will receive usual unemployment services with an emphasis on specific issues related to HIV/AIDS, plus encouragement for completing activities geared toward employment readiness and acquisition. The enhanced intervention will involve that same treatment plus chances to win prizes for engaging in job-related activities each week. Participants will receive study treatments for 16 weeks and complete follow-up evaluations throughout 18 months. The hypothesis is that participants reinforced for completing job-related activities will transition to employment at higher and faster rates and work more often than those who are not reinforced for job-related activities.

Many persons living with HIV/AIDS (PLWHA) are unemployed, with estimates indicating rates as high as 60%. This study will examine the efficacy of reinforcing job-acquisition activities for improving employment outcomes in PLWHA who desire to return to the workforce in part- or full-time capacity. In total, this study will randomly assign 144 unemployed PLWHA to one of two interventions. All participants will receive usual unemployment services with an emphasis on specific issues related to HIV/AIDS, plus encouragement for completing activities geared toward employment readiness and acquisition. The enhanced intervention will involve that same treatment plus chances to win prizes for engaging in job-related activities each week. Participants will receive study treatments for 16 weeks and complete follow-up evaluations throughout 18 months. Structured evaluations will assess employment outcomes, quality of life indices, physical and cognitive functioning, psychological symptoms, viral loads, and drug use and risk behaviors. The hypothesis is that participants reinforced for completing job-related activities will transition to employment at higher and faster rates and work more often than those who are not reinforced for job-related activities. The investigators also expect the reinforcement intervention will increase quality of life, reduce depressive symptoms, and improve medical outcomes. Compared to the standard care condition, it may also maintain or improve cognitive functioning and medication adherence and reduce risk behaviors that spread infectious diseases. The investigators will evaluate moderators and mediators of key employment and health outcomes, with an emphasis on exploring the extent to which work conditions (temporary, under the table, physically or emotionally demanding jobs etc.) impact psychosocial and physical health.

Eligibility Criteria:
Inclusion Criteria:

* HIV positive
* aged 18+ years
* not working in the formal economy

Exclusion Criteria:

* have a condition that may hinder study participation
Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

The purpose of this study is to see if children and adolescents with poorly controlled type 1 diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be used to check blood sugars.

Adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was \<70 mg/dL or specific criteria indicating SG and YSI were very discordant were met.

Eligibility Criteria:
Inclusion Criteria:

* 12 to \<18 years old
* T1D for at least one year
* Treatment with insulin pump therapy
* A1c ≥9%
* Willingness to comply with study procedures

Exclusion Criteria:

* Current diabetic ketoacidosis
* Hypoglycemia unawareness
* Chronic use of medications that affect recognition of hypoglycemia (e.g., beta blockers)
* Chronic use of medications that mimic symptoms of high or low blood sugars (e.g., decongestants)
* Recent or frequent severe hypoglycemia (2 episodes in the last year; 1 episode in the last 6 months)
* Skin rashes or conditions that may affect CGM placement and wear
24-Hour Intraocular Pressure (IOP) And Blood Pressure Control In Glaucoma And Ocular Hypertension Patients

The purpose of this study is to compare the short-term mean 24-hour intraocular pressure control, 24-hour blood pressure effect and safety of Latanoprost/Timolol fixed combination given once in the evening with placebo once in the morning versus timolol maleate 0.5% given twice daily in patients with ocular hypertension and primary open-angle glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* POAG
* OHT

Exclusion Criteria:

* Advanced glaucoma
* Arterial Hypertension
Elderberry Consumption and Human Health

The objective of this human study is to determine if the metabolic benefits observed with other anthocyanin-rich berries extend to elderberries. To accomplish this, we performed a short-term controlled feeding study in overweight but healthy volunteers in a placebo-controlled crossover clinical trial. Major study endpoints included blood glucose and insulin response to a high-carbohydrate meal challenge, indirect calorimetry, and profiling of the fecal microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Women and Men between 22 and 75 years of age with a body mass index of 25 kg/m2 or above

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Have a body mass index less than 25 kg/m2
* Are younger than 22 years of age, or older than 75 years of age
* Known allergy or intolerance to elderberries
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring a special diet that is not in accord with the diet behavior requested for this study
* Adherence to restrictive (vegetarian or vegan) or extreme (fad \[ex. Ketogenic or Atkins\] or quick weight loss/gain) diet patterns and unwillingness to consume a conventional, omnivorous diet and maintain body weight
* Habitual use of tobacco (including vaping) products in the last 6 months
* Diagnosis or treatment of cancer in the past 3 years
* Crohn's disease or diverticulitis
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives, including blood thinning medications
* Type 2 diabetes requiring the use of medication
* Fasting blood glucose \&gt; 125 mg/dL
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Pilot Study for the Validity of a Content-based Information Provision Tool Aimed at Improving the Hospitalization Experience of Liver Transplant Patients

The investigators aim to evaluate the improvement of the inpatient experience and the usability of a content-based tool (a brochure). This involves consolidating video content for inpatients on a single website and providing access to it via QR codes in a brochure format.

\[Patients\] Considering this as a pilot study, the investigators plan to recruit around 30 participants. Both the experimental and control groups will receive standard care and information, with the experimental group additionally receiving the brochure. Random assignment will be used for the experimental and control groups. Surveys and interviews will be conducted to assess changes in patient experience and usability before and after providing the brochure.

\[Medical Staff\] Among the medical staff involved in the liver transplant surgical process, researchers will select participants based on their degree of involvement with the intervention subjects. After obtaining their consent, interviews will be conducted concerning patient experiences and the brochure.


Eligibility Criteria:
Inclusion Criteria:

\[Patients\]

* Adults aged 18 and over
* Patients who are scheduled to undergo or have undergone liver transplant surgery
* Recruited through a call for research participants and have consented to participate in this study

\[Medical Staff\]

* Adults aged 18 and over
* Medical staff at Samsung Medical Center involved in the post-liver transplant treatment process

Exclusion Criteria:

\[Patients\]

* Individuals who have not consented to participate in this study
* Individuals whose health condition makes it difficult to participate in the intervention
* During the research period, the researcher will check if the brochure content has been shared during surveys or interviews with the research participants (information dissemination). If information dissemination is confirmed, the participant will be excluded from the study.

\[Medical Staff\]

* Individuals who have not consented to participate in this study
* Medical staff not involved in the liver transplant treatment process
Investigating the Pharmacokinetic Characteristics of HIP1402 in Healthy Male Volunteers

To investigate the PK charateristics and the effect of food on the PK in healthy male volunteers who receive HIP1402 capsule in fed versus fasted condition

A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer, age 19\~50 years
2. Weight ≥55kg and ≤90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
4. Subject who has the ability and willingness to participate the whole period of trial

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. History of relevant drug allergies or clinically significant hypersensitivity reaction.
3. Systolic Blood Pressure: lower than 100mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
4. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
5. Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
6. Intake of more than 210g of alcohol per week or who can't abstain from alcohol during the trial.
7. Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
8. Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
9. Subjects who judged ineligible by the investigator.
Skin Glue Versus Suture for Securing Radial Arterial Lines

Prior investigators have evaluated the use of 2-octyl cyanoacrylate (glue) as a method to secure a variety of venous catheters including central/peripheral lines. There is a paucity of research evaluating the use of glue for arterial catheters. The investigators conducted a pilot study to test the null hypothesis that there would be no difference in failure rates between radial arterial lines (r-a-line) secured with glue vs. suture.

This was a prospective, randomized, controlled, trial for which the investigators enrolled a convenience sample of consenting, non-pregnant, adult patients who received an r-a-line in the ICU or ED at a community-based, teaching hospital. After randomization, lines were secured with either silk 0-0 suture or 2-octyl cyanoacrylate and, then, covered by chlorhexidine gluconate dressing. Patients were followed for duration of line placement and for the occurrence of premature line failure. Categorical data were analyzed by chi-square; continuous data by t-tests.

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age
2. Require invasive blood pressure monitoring via radial arterial catheter

Exclusion Criteria:

1. Under 18 years of age
2. Pregnant
Effectiveness of Patient-centered Community Health Worker Support to Help Patients Control Chronic Disease

The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions. Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal. Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.


Eligibility Criteria:
Inclusion Criteria:

* Patient of target practices for at least 1 yr defined as having one office visit within preceding 12 month
* Home ZIP code including ANY of the following: 1. 19104 2. 19131 3. 19139 4. 19143 5. 19146
* 2 or more of the following conditions: 1. Obesity (BMI greater than 30), 2. HTN (ICD9 relating to HTN in EMR), 3. DM (ICD9 relating to DM in EMR), 4. Asthma/COPD and tobacco dependence (ICD9 for asthma or COPD in EMR AND documentation of tobacco use)
* Uninsured, insured by Medicaid or dually eligible for Medicaid/Managed Medicare
* Patients who have scheduled appointments in the future.

Exclusion Criteria:

* Will not provide informed consent for this study.
* Does not have the capacity to provide informed consent for this study.
* Previously enrolled in this study
Comparison of Bone Graft and Photodynamic Therapy in Class II Furcation

This is a surgical comparative clinical trial which aims to assess class II buccal furcation defects treated with Xenograft alone or preceded by antimicrobial photodynamic therapy.

To test the efficacy of photodynamic therapy (Indocyanine green) along with placement of xenograft (Cerabone®-Natural bovine bone grafting material, Botiss biomaterials) to treat a class II furcation defects. The topical study was designed as a randomized controlled, single blinded (patient), split mouth clinical trial with 14 participants. In the control group, the defects were filled with xenograft (Cerabone®) whereas the test group received photodynamic therapy (Indocyanine green) in addition to grafting. Radiovisiography technique was used to observe the possible changes in the furcation region at baseline and 9 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

Systemically healthy subjects Age group of 25-60 years Presence of class II furcation defect on buccal surfaces of mandibular molars as determined by clinical and radiographic evaluation.

Vertical probing depth (VPD) ≥4mm Horizontal probing depth (HPD) ≥4 mm Gingival margin (GM) coronal to or at the level of the roof of the furcation

Exclusion Criteria:

Current and former smokers Administration of antibiotics in the last 6 months History of any periodontal therapy in the past 6 months Known allergic responses to bovine derived graft materials and photosensitizers.

Pregnant and lactating women.
Effects of Ranolazine and Exercise on Daily Physical Activity Trial

The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. The study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Documented CAD diagnosis
* Stable angina ≥ 3 months

Exclusion Criteria:

* Class III or IV heart failure
* Myocardial Infarction or coronary revascularization procedure within 2 months
* QT interval \> 500ms or prescribed medication known to prolong the QTc interval
* Contraindicated Medications
* Metformin dose \> 1700mg/day
* Class Ia, Ic and III anti-arrhythmics
* CYP3A inhibitors
* Simvastatin \>20mg/day
* Severe renal disease (\< 30ml/min creatinine clearance)
* Currently on dialysis
* Lack of transportation to the exercise and testing facilities
* Implanted pacemaker that is not rate responsive
Duration of Immobilization After Rotator Cuff Repair: Its Clinical Impact

The purpose of this study is to determine whether the immobilization period is helpful for the better healing of repaired rotator cuff.

The investigators hypothesis is that the longer immobilization after rotator cuff repair will help the healing of rotator cuff.


Eligibility Criteria:
Inclusion Criteria:

* Medium to large sized cuff tear (2-4 cm)
* Yes subscapular partial fraying or longitudinal split side to side
* Yes acromioplasty
* Yes AC arthritis with mumford procedure
* Yes biceps tenotomy or tenodesis

Exclusion Criteria:

* No arthritic changes of glenohumeral joint
* No combined infection
* No mini-open procedures
* No complete subscapularis tear
* No incomplete repair
* No small tears or side to side repairs without anchors
* No pregnancy