cyrilzakka/clinical-trials huggingface dataset:
Avatar-Led Digital Therapeutic for Aiding Smoking Cessation in Sexual and Gender Minority Young Adults

This trial assesses the acceptability and preliminary efficacy of Empowered, Queer, Quitting, and Living (EQQUAL) smoking-cessation intervention for sexual and gender minority young adult smokers. The prevalence of tobacco use among sexual and gender minority (SGM) young adults is more than twice as high as non-SGM young adults, suggesting that existing SGM-related disparities in tobacco use will persist well into the foreseeable future unless sustained efforts are undertaken to address them. EQQUAL is an online smoking cessation intervention designed specifically for SGM young adult smokers, and may help them quit smoking.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive self-guided, online quit smoking program, called EQQUAL Program A.

ARM II: Participants receive self-guided online quit smoking program, EQQUAL Program B.

Eligibility Criteria:
Inclusion Criteria:

* DEMOGRAPHIC CRITERIA:
* Participants must self-identify being between 18 and 30 years of age
* Participants must self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)
* Participants must currently reside in the United States, with a United States (US) mailing address, and anticipate remaining in the US for the duration of the study (3 months)
* SMOKING CRITERIA:
* Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
* TREATMENT ACCESSIBILITY:
* Participants must self-report having at least weekly Internet access for the next three months
* Participants must self-report being willing and able to stream audio and video online for this study
* Participants must self-report current use of a personal email account
* Participants must self-report current use of text messaging
* OTHER CRITERIA:
* Participants must self-report that they are interested in participating in the study for themselves (versus \[vs\] someone else)
* Participants must self-report that they have not participated in one of our prior smoking cessation studies
* Participants must self-report that they are comfortable reading, writing, and speaking English
* Participants must self-report that they understand and agree to the conditions of compensation
* Participants must self-report that they are not currently incarcerated
* Participants must be willing to use the assigned intervention program, complete the study assessments, and consent to participate in this study
* Participants must be willing to upload a photo of themselves (face visible)

Exclusion Criteria:

* Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
* Participants must not be a member of the same household as another research participant
* Having a Google voice number as their sole phone number
Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®

This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
* FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC \<70%
* Pre-bronchodilator

Exclusion Criteria:

* Current respiratory tract disorder other than COPD
* History of asthma or rhinitis
* Significant or unstable cardiovascular disorder
Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration

A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

This study has a randomized, open-label, two-treatment, one-sequence, multiple drug administration design. The purpose of this study is as follows; To investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects aged 70 - 84 years
* A body mass index (BMI) in the range of 18.5 kg/m2 - 29.9 kg/m2.
* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.

Exclusion Criteria:

* Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator
Hip Replacement in a High Volume Community Hospital: Effect on Length of Stay and Hospital Cost

The investigators propose to evaluate and compare the percentage of patients who are able to be discharged in less than 3 days after undergoing total hip arthroscopy through either a direct anterior or posterior approach, utilizing the identical post operative protocol. The investigators also propose to evaluate the costs associated with the two different approaches to hip replacement in the same group of patients. Post operative resource utilization, discharge disposition, and pain medicine requirement will also be evaluated.

The investigators hypothesize that a higher proportion of patients treated with the direct anterior approach for hip replacement will be able to leave the hospital in less than 3 days when compared with a less invasive posterior approach. Secondly, decreased length of stay associated with the procedure may reduce hospital costs.

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive single surgeon series of patients who have undergone primary uncemented hip replacement at our institution through either a posterior approach or direct anterior approach on a fracture table. Posterior approach patient - most recent patient prior to March, 2010, compared with consecutive recent anterior approach patients with minimum of 6 month follow-up.
2. Diagnosis of osteoarthritis, inflammatory arthritis, or avascular necrosis.
3. No previous surgery on affected hip.
4. Age 40-90 at time of surgery

Exclusion Criteria:

1. Patient not permitted to bear full weight after the procedure, per post operative instructions
2. Hip replacement performed for acute fracture.
3. Previous hip surgery.
Comparing the Cost Savings Potential of Orogastric Tubes in Laparoscopic Sleeve Gastrectomy

Comparing the operation times and staple loads used between the use of multiple tubes and a bougie versus a one-step suction callibrated system in laparoscopic sleeve gastrectomy.

In this study we are comparing the cost/savings of using a bougie with a one-step suction callibrated system in laparoscopic sleeve gastrectomy. We will be looking at OR time and staple usage. This study is not affecting the treatment of the patients in any way. The surgeons would be using the devices regardless of the study. We are simply looking at procedure information after the fact.

Eligibility Criteria:
Inclusion Criteria:

* Patient and surgeon have both agreed that a sleeve gastrectomy is a procedure that they want performed.

Exclusion Criteria:

-
Inpatient Mortality Prediction Algorithm Clinical Trial (IMPACT)

Through the mapping of retrospective patient data into a discrete multidimensional space, a novel algorithm for homeostatic analysis, was built to make outcome predictions. In this prospective study, the ability of the algorithm to predict patient mortality and influence clinical outcomes, will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the participating units will be eligible.

Exclusion Criteria:

* All patients younger than 18 years of age will be excluded.
INSPIRE Trial for Skin and Soft Tissue Infections

The INSPIRE Skin and Soft Tissue Infection trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with skin and soft tissue infection is infected with a resistant pathogen.

Note: enrolled "subjects" represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.


Eligibility Criteria:
Facility Inclusion Criteria:

1. HCA Healthcare hospitals admitting adults for skin and soft tissue infection
2. Facility use of MEDITECH as their electronic health record system

Facility Exclusion Criteria:

-

Note: unit of randomization is the hospital, however the computerized physician order entry (CPOE) alert intervention will calculate risk estimates for adults age \>=18 admitted to non-intensive care unit wards and who are ordered to receive extended-spectrum antibiotics for skin and soft tissue infection.
Different Bowel Preparations for Colonoscopy In Children

THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN.

THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING

COLONOSCOPY IS AN ESTABLISHED DIAGNOSTIC AND THERAPEUTIC TOOL IN A VARIETY OF GASTROINTESTINAL TRACT CONDITION AFFECTING CHILDREN AND ADOLESCENTs. FOR EXAMPLE: INFLAMMATORY BOWEL DISEASE, COLONIC POLYPS OR LOWER GASTROINTESTINAL TRACT BLEEDING.

THE IDEAL PREPARATION SHOULD BE OF LOW VOLUME, PALATABLE AND SUCCESSFUL IN COMPLETE COLON CLEANOUT.

PRIMARY AIMS OF THIS WERE TO COMPARE THE EFFICACY AND ACCEPTANCE OF FOUR METHODS OF BOWEL CLEANSING BEFORE COLONOSCOPY IN CHILDREN. SECONDARY AIMS WAS TO COMPARE THE SAFETY PROFILE OF THIS METHODS.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective colonoscopy in our Institution between 2 and 18 years of age were recruited for this study.

Exclusion Criteria:

1. requirement for urgent colonoscopy,
2. bowel obstruction,
3. known or suspected hypersensitivity to the active or other ingredients,
4. clinically significant electrolyte imbalance,
5. prior intestinal resection,
6. known metabolic, renal and cardiac disease
COVID-19 Booster Readiness Survey

The purpose of this administrative survey is to inform health system logistics by assessing the attitudes towards towards the bivalent COVID-19 boosters held by healthcare workers (HCWs) at a large, rural health system. It will also test, prospectively, the effect on interest in the bivalent COVID-19 booster of different framing approaches in a survey question sent to employees of a large, rural health system.

The Food and Drug Administration has authorized two bivalent COVID-19 boosters with the expectation that the Centers for Disease Control will soon recommend them. The researchers plan to survey the HCWs at a large, rural health system on their attitudes on the bivalent booster.

This survey will gather data on HCWs' interest in a bivalent booster, reasons for hesitancy, risk perception about COVID-19 infection and its complications, and prior COVID-19 infection and vaccination.

Respondents will also be randomly assigned to see different versions of the question asking if they are interested in a bivalent booster with different framing approaches, such as protection of the self or protection of patients (for patient-facing employees). Information on prior vaccination and perceptions of risk will also be gathered and used as covariates in the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Employee at the health system
The Effect of Sildenafil Citrate on Frozen Embryo Transfer Cycles

to investigate the value of adding sildenafil citrate during endometrial preparation in patients undergoing frozen-thawed embryo transfer and its effect on endometrial thickness and pregnancy rates.

Patients who met these conditions entered the study and 110 patients will be divided into two groups 55 patients in each group based on randomized tables.

Group 1: will be given estradiol in form of Cycloprogynova white pills starting dose is one pill t.i.d may be increased to two pills t.i.d according to endometrial thickness in day 9 measured by vaginal ultrasound.

Group 2: will be given sildenafil citrate tablets (50 mg) daily in addition to the above treatment protocol from the first day of the cycle until the day of starting progesterone. It was discontinued 48- 72 hours prior to the embryo transfer.

On the ninth day of the menstrual cycle, the endometrial thickness will be estimated by transvaginal ultrasonography (arranged in a series every other day). The evaluations will be performed by a single investigator.

If the endometrial thickness was more than 8mm, 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.

If the endometrial thickness is less than 8 mm estrogen dosage will be increased to two pills t.i.d and patients would be arranged for follow up every other day for endometrial thickness estimation by transvaginal ultrasound till endometrial thickness is more than 8 mm , then 400 mg of progesterone vaginal suppository and Duphastone tabs twice daily will be administered.

Frozen thawed embryo transfer will be carried out after 5 days (blastocyst stage). Estrogen and progesterone will be continued until two weeks after the embryos are transferred. In cases whom BHCG would be positive, estrogen and progesterone will be continued until the 11th week of pregnancy.

Eligibility Criteria:
Inclusion Criteria:

1. Age under 40 years
2. Subject has high quality frozen embryos

Exclusion Criteria:

1-A history of endocrine diseases. 2. A history of any previous surgery that could compromise the integrity of endometrium.

3. Cardiovascular, renal and liver diseases. 4. Hypotension (blood pressure less than 90/50). 5. A history of stroke or myocardial infarction. 6. A history of previous implantation failure.
Mindful Moms: Mechanisms of Mindfulness-based Cognitive Therapy During Pregnancy and Postpartum

The proposed study seeks to elucidate the mechanisms underlying Mindfulness-Based Cognitive Therapy in pregnancy to improve understanding of how and why this treatment modality enhances well-being, which can then be leveraged to optimize treatment for psychological distress emerging during this vulnerable period.

Pregnancy and postpartum is a period of vulnerability for new or worsening psychiatric symptoms. Mindfulness Based Cognitive Therapy (MBCT) is an effective approach to mitigate pregnancy-related worsening of psychological distress. However, prior research has focused predominantly on symptoms of depression and anxiety, and is it not clear how or why MBCT improves psychological health during the perinatal period. Thus, the goals of this project are to (1) examine whether MBCT improves psychological functioning among pregnant women and whether these improvements persist at three-months postpartum, (2) examine whether improved ability to regulate emotions and behavior accounts for the beneficial effects of MBCT, and (3) determine what demographic, socioeconomic, and psychosocial factors impact treatment engagement and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* pregnancy between 12 and 30 weeks gestation
* reporting at least mild psychological distress (based on self-report)
* access to high-speed internet or cellular network access
* located in the U.S.

Exclusion Criteria:

* current suicidal or homicidal ideation as assessed verbally during screening
* symptom severity necessitating a higher level of clinical care
* current psychosis
* untreated mania
* active substance abuse
* lack of high-speed internet connection or cellular network access
* planning to be traveling without access to internet for more than two weeks in the next 12 months
Validity and Reliability of the Six-minute Peg Board and Ring Test in Patients With Rheumatoid Arthritis

The aim of the study was to evaluate the validity and reliability of 6-PBRT in patients with rheumatoid arthritis and to determine the applicability of the test for this population.

Rheumatoid arthritis (RA) is a systemic, inflammatory disease that causes pain and joint involvement. Pain, loss of range of motion, and decreased muscle strength lead to loss of function in patients with RA. Hand grip and generalized muscle weakness in patients cause decreased upper extremity functions. A study found that the upper extremity functional capacity of RA patients was lower than that of healthy individuals. In routine evaluations of rheumatoid arthritis patients, rough and fine grip strength measurements are made, but these measurements do not provide sufficient information about upper extremity functional exercise capacity. Rehabilitation programs aim to improve upper extremity function, therefore, valid and reliable methods are needed to determine upper extremity function in RA patients and to measure the effectiveness of rehabilitation programs. The six-minute peg board and ring test (6-PBRT) is a valid, reliable, useful, practical and easy-to-apply test that evaluates upper extremity endurance without support in patients with chronic obstructive pulmonary disease and asthma and in healthy individuals (5-7). Studies have determined that the total number of rings in 6-PBRT has a positive relationship with upper extremity daily living activities in COPD and asthma patients. Six-PBRT is frequently used in the evaluation of upper extremity exercise capacity and endurance without support and in determining the effectiveness of rehabilitation programs. The validity and reliability of 6-PBRT, which is used in the evaluation of functional upper extremity exercise capacity in different diseases, has not been investigated in patients with RA. The arm ergometer test is also a gold standard method used to evaluate upper extremity exercise capacity. Therefore, it was planned to use the arm ergometer test as a criterion measure for the validity of 6-PBRT in our study. The aim of this study was to evaluate the validity and reliability of 6-PBRT in patients with rheumatoid arthritis and to determine the applicability of the test for this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis,
* Ages of between 18-75 years,
* Patients who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

* Serious cardiopulmonary, neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions,
* Participated in a planned exercise program in the last three months,
* Cognitive impairment that will cause difficulty in understanding and following exercise test instructions,
* Contraindications to exercise testing or exercise training according to the American Sports Medicine Association will not be included in the study.
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).


Eligibility Criteria:
Patients treated with Tio+Olo:

Inclusion criteria:

1. At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019.
2. Aged ≥ 40 years on the index date.
3. At least one diagnosis of COPD at any time prior to or on the index date.
4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
5. At least one record in the health insurance system database.

Exclusion criteria:

1. Any use of Tio+Olo in free or fixed form within one year prior to the index date.
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.

Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs):

Inclusion criteria:

1. At least one prescription for LAMA+LABA (FDC or free combination) other than Tio/Olo as a new initiation between 1st January 2014 and 31st December 2019.
2. Aged ≥ 40 years on the index date.
3. At least one diagnosis of COPD at any time prior to or on the index date-
4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs.
5. At least one record in the health insurance system database.

Exclusion criteria:

1. Any use of LAMA+LABA in free or fixed form for one year prior to the index date.
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.
Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY

Blockchain technology has gained attention for its decentralized feature and data integrity. The study aims to apply blockchain technology to implement dynamic consent model and evaluate the real-world experience as a form of virtual clinical trial.

The study will simulate a clinical trial that implements dynamic consent module. In this study, two major and three minor protocol amendments will be conducted on the scheduled date. Each subjects will give consent using the dynamic consent platform, METORY, and will be informed when the protocol is amended. The communication only be conducted under the METORY and the real-world experience of METORY would be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who can use METORY (application platform)
* Subjects who completely understand the study and voluntarily decide to participate in the study

Exclusion Criteria:

* Subjects who are not able to use the web or application due to cognitive dysfunction or other reasons
* Subjects who are not able to measure body temperature by themselves
* Subjects who investigators decide not be appropriate for the study for other reasons
Preoperative Maximum Inspiratory Pressure and Outcomes After Interscalene Block in Obese Patients

The study aims to explore if Maximum Inspiratory Pressure can predict postoperative breathlessness in obese patients receiving interscalene blocks for shoulder surgery.

The main question is: does baseline Maximum Inspiratory Pressure have any association with postoperative breathlessness after interscalene blocks in class 2 or higher obese patients (BMI\>35).

Preoperative and postoperative lung volumes, pressures, breathlessness score and respiratory outcomes will be measured on participants already receiving shoulder surgery with interscalene blocks.


Eligibility Criteria:
Inclusion Criteria Groups 1 and 2

* Adults \>18 years of age receiving shoulder surgery with preoperative interscalene block and general anesthesia;
* Speak English;

Group 3

· Adults \>18 years of age receiving cystoscopy or lower extremity procedures receiving general endotracheal anesthesia

Exclusion Criteria All Groups

* Less than 18 years of age;
* currently pregnant;
* currently incarcerated;
* those with significant neuromuscular disease, tracheo-bronchial structural abnormalities, severe respiratory or severe cardiovascular comorbidity;
* those undergoing intra-abdominal or intrathoracic surgeries due to the potential to independently effect breathing
Compassionate Use of Dupilumab

Provide Compassionate Use of Dupilumab

Compassionate Use requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.

Eligibility Criteria: