cyrilzakka/clinical-trials huggingface dataset:
A Community-based Social Networking Intervention to Increase Walking in Dog Owners

The present study aims to initially test a community dog walking intervention that addresses individual, interpersonal and community factors associated with dog walking. The study will be conducted in two cities, Worcester and Lowell, as a collaboration between investigators from UMass Medical School and UMass-Lowell.

This is a group randomized trial where 8 communities in Worcester and Lowell (4 per city) will be randomly assigned to the 6-month dog walking intervention or a standard, self-help, print-based physical activity control condition. Dog owners (N=120; 15 per community) will be recruited. The intervention includes a social networking website, monthly newsletters, twice monthly neighborhood dog walks and community events. The intervention will: 1) educate owners about the benefits of dog walking to themselves and their dog, 2) teach strategies for regular dog walking, 3) teach dog walking tips and provide dog training seminars, 4) promote self-monitoring and goal setting for dog walking, 5) provide social networking opportunities for dog owners and 6) promote a sense of community via participation in neighborhood dog walks and community events. Intervention feasibility will be assessed by measures of implementation success, including recruitment and retention rates, website use, intervention satisfaction and attendance at neighborhood walks and community events. Initial efficacy will be assessed via change in weekly steps measured via a pedometer from baseline to 6-months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will own a dog that is in good health and considered a household pet, be a Worcester or Lowell resident, be aged \> 21 years old and have home internet access. Participants with cardiovascular disease, diabetes or other chronic health condition are eligible with permission from their PCP to participate.

Exclusion Criteria:

Participants will be excluded for any of the following:

1. Inability or unwillingness to give informed consent
2. Plans to move out of the area within the study period
3. Participated in a focus group during the developmental phase
4. Another household member is participating in the study
5. Pregnant or planning a pregnancy in the next six months
6. Condition that inhibits exercise (e.g., unable to walk unaided, or cannot walk 1/4 mile without stopping)
7. Incapable of engaging in physical activity as assessed by the Physical Activity Readiness Questionnaire
8. Self-report engaging in \> 150 minutes of moderate and vigorous intensity physical activity per week.
9. The participant's dog has a history of biting a human or has not received a rabies vaccination.
Quality Project to Evaluate and Validate the FAST-O Rating Scale

The purpose of this project is to test the reliability of the FAST-O Rating Scale in patients at acute wards or psychiatric intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute psychotic symptoms attending the acute ward or psychiatric intensive care unit

Exclusion Criteria:

* Not applicable
Transplantation of Autologous Mesenchymal Stem Cell in Decompensate Cirrhotic Patients With Pioglitazone

Liver cirrhosis (LC) is the final destiny in chronic liver disease. Liver transplantation is the only effective therapy available to these patients. However, limited number of donors, post surgical complications, immunological rejection, and financial considerations are it's essential problems. The immuomodulatory impact of MSCs in fibrosis was confirmed, and several clinical studies have applied MSCs to eliminate the progression of fibrosis. In this research the investigators will study the affect of MSCs and Pioglitazone in the process of fibrosis.

BM Aspiration will be done twice (6 months interval) from the iliac crest according to standard procedures under general anesthesia and is collected (200ML) in plastic bags containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be collected by centrifugation in Ficoll-Paque density gradient. MNCs will be cultured in T150 flasks. Cells will be expanded in several subcultures.MSCs will be injected (6 months interval) via portal vein under sonography monitoring.Each patient will receive 30mg Pioglitazone daily for 24 months. After cell therapy, patients are followed up every week for 6 months, and laboratory data are analyzed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 Years cirrhotic patient
* Approved cirrhosis by elastografy ,biopsy, sonography

Exclusion Criteria:

1 - Portal vein thrombosis 2-Hepatic encephalopathy, score 3\&4 3-ALT \& AST 3times more than normal 4-Serum Cr more than 1/5mg/dL 5-(Anti-HIV +) (Anti-HCV+) (HBS-Ag+) 6-Hepatocel carcinoma 7- Primary sclerosing cholangitis (PSC) 8- Esophageal varices grade 4 9-Addiction 10-Child Score B,C
A Trial of SHR-1905 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.

The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
3. Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
4. For healthy subjects, no clinically significant abnormalities.
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion Criteria:

1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
2. Severe injuries or major surgeries within 6 months before screening.
3. Subjects with infecious disease.
4. Hyper/Hypotension at screening and at check in.
5. Clinically significant abnormalities in 12-Lead ECG
6. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
7. Positive urine drug screen .
8. Subject who cannot perform venous blood sampling.
9. Known history or suspected of being allergic to the study drugs and their excipients.
10. Use of any medicine within 4-weeks or within 5 half-lives
11. History of alcohol abuse within 3 months prior to the IP administration .
12. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
13. in the investigator's judgment, may increase the risk to the subject
Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients

The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.

Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea.

As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it.

Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged over 50
* Clinically diagnosed benign prostate hyperplasia(BPH)
* 8 ≤ IPSS ≤ 30
* 4 ml/sec ≤ Q max ≤ 15 ml/sec
* minimum voided volume ≥ 125 ml
* Post voided residual volume ≤ 250
* Volunteer who singed on informed consent documents

Exclusion Criteria:

* Past history of surgical procedure experience related to BPH
* Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time
* Past history of taking alpha blocker within 2 weeks before screening
* Past history of acute urinary retention within 3 months before screening
* Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA \< 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy)
* Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture)
* Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)
* Unstable and significant medical condition including below

  * Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening
  * Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening
  * Medically uncontrollable diabetes mellitus, peptic ulcer disease
  * Severe hepatic diseases
  * Past history of renal failure or renal disease (serum creatinine \> 1.4mg/dl)
  * Condition expected serious adverse event due to the investigational drug
* Other conditions considered not eligible for the trial upon investigator's judgement
Heart Patch for Myocardial Infarction COVID-19

Myocardial infarction (MI), as one of the many complications of COVID-19, is one of the contributing patients of patients' death. This study attempts on developing an intervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygen in cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patch developed from amnion bilayer seeded with amnion epithelial stem cells and patient's autologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG) surgery are given heart patch, and then patients condition are observed by ECG, Echo, blood test, and radiology (technetium-99m)


Eligibility Criteria:
Inclusion Criteria:

* Aged 40 - 60 years old
* Ischemic burden \>10% and ischemic gradients red-violet
* Ischemic area is not feasible to be grafted (bypass) due to other conditions such as diffusion and deep intramuscular vascularization
* Ejection fraction \>30-35%
* Euro score \<8

Exclusion Criteria:

* Scanning of Technetium-99 showed black colored ischemic area
* Patients undergoing other procedures other than bypass such as valve repair
* Chronic kidney failure
* Patients have went through several bypass surgeries prior
* Patients are still COVID-19 positive
* Immunocompromised patients
Assessment of Risk Factors and Outcome of Thrombocytopenia in ICU Patients

The many comorbidities in the severely ill patient also make thrombocytopenia very common (∼ 40%) in intensive care unit patients. The risk of bleeding is high with severe thrombocytopenia and is enhanced in intensive care patients with mild or moderately low platelet counts when additional factors are present that interfere with normal hemostatic mechanisms (eg, platelet function defects, hyperfibrinolysis, invasive procedures, or catheters).

The many comorbidities in the severely ill patient also make thrombocytopenia very common (∼ 40%) in intensive care unit patients. The risk of bleeding is high with severe thrombocytopenia and is enhanced in intensive care patients with mild or moderately low platelet counts when additional factors are present that interfere with normal hemostatic mechanisms (eg, platelet function defects, hyperfibrinolysis, invasive procedures, or catheters). Even if not associated with bleeding, low platelet counts often influence patient management and may prompt physicians to withhold or delay necessary invasive interventions, reduce the intensity of anticoagulation, order prophylactic platelet transfusion, or change anticoagulants due to fear of heparin-induced thrombocytopenia.

The many comorbidities in the severely ill patient also affect platelet homeostasis, and, consequently, thrombocytopenia is very common in critically ill patients treated in the intensive care unit (ICU). Thrombocytopenia is usually defined as a platelet count of \< 150 × 109/L, whereas severe thrombocytopenia is considered as platelet counts \< 50 × 109/L. Thrombocytopenia has six major mechanisms, and it can be induced by hemodilution, increased platelet consumption (both are very common in the ICU after tissue trauma, bleeding, and disseminated intravascular coagulopathy \[DIC\]), increased platelet destruction (ie, immune mechanisms), decreased platelet production, increased platelet sequestration, or by the laboratory artefact of pseudothrombocytopenia .

Eligibility Criteria:
Inclusion Criteria:

* Children and infants aged one month to 18 years admitted to the ICU in period from August 2023 to August 2024 and developed thrombocytopenia documented in laboratory investigation done in PICU.

Exclusion Criteria:

* patients older than 18 years
* Patients diagnosed with congenital thrombocytopenia (TAR syndrome...etc)
Safety of Pediatric COVID-19 Vaccination

This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to \< 16) will be followed post administration of mRNA COVID-19 vaccines.

Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the 7 days following each vaccination using either identical web-based or paper diaries, depending on study participant preference.

At Duke University, Cincinnati's Children Hospital, and Kaiser Permanente Northern California, serum samples will be collected for optional assessment of antibody titers to COVID-19. Each participant who opts in will have baseline (within 3 days of vaccination) serologies obtained and immunogenicity assessment at 28 (+7) days after each dose.

All participants will be followed for 180 days after dose 2 for serious adverse events and adverse events of special interest.


Eligibility Criteria:
Inclusion Criteria:

1. Children ≥ 5 years to \< 16 years of age
2. Receiving first dose or a booster dose of a U.S authorized or approved and recommended COVID-19 vaccine per standard of care
3. Parent/legal authorized representative (LAR) willing to provide written informed consent per local IRB requirements
4. Participant willing to provide assent per local IRB requirements
5. Intention of being available for entire study period and complete all relevant study procedures, including follow-up phone calls
6. English or Spanish literate.

Exclusion Criteria:

1. Current or planned participation in any clinical trial with an investigational product during the study period.\*

   * Per protocol, co-enrollment in observational or behavioral intervention studies are permitted at any time. An investigational product or behavioral intervention permitted at any time. An investigational product may be permitted for therapy of an illness condition that occurs during the study period (e.g., COVID-19 illness)
2. Any condition, which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives.
3. Anyone who is a relative of any research study personnel or is an employee supervised by study staff.
Effect of Metformin Versus Repaglinide Treatment in Non-Obese Type 2 Diabetic Patients Uncontrolled by Diet

Background: Metformin is the first drug of choice in obese patients with type-2 diabetes (T2DM) due to its antiglycaemic as well as its cardiovascular protective potentials. In non-obese T2DM patients insulin-secretagogues are empirically used as first choice. The aim of this study was to evaluate the effect of metformin versus an insulin-secretagogue, repaglinide on glycaemic regulation and non-glycaemic cardiovascular risk markers in non-obese patients with T2DM.

Methods: Single-center, randomised, double-masked, double-dummy, cross-over-study of 96 non-obese (BMI ≤ 27 kg/m2) Caucasian T2DM-patients. After a one month run-in on diet-only treatment, patients were randomised to either repaglinide 2mg three times a day (t.i.d). followed by metformin 1g twice a day (b.i.d.) or vice versa each for a period of four months with a one month wash-out between interventions.


Eligibility Criteria:
Inclusion Criteria:

Type-2 diabetes, defined as:

* Age at onset of diabetes ≥ 40 years
* Fasting serum C-peptide ≥ 300 pmol/l or a non-fasting or glucagon-stimulated serum C-peptide ≥ 600 pmol/l
* No history of ketonuria or ketoacidosis.
* BMI ≤ 27 kg/m2.
* Fasting plasma-glucose ≥ 6.5 mmol/l after at least one month of diet-only treatment.
* HbA1c ≤ 9.5% at ongoing oral anti-hyperglycaemic agents. HbA1c ≥ 6.5% after minimum one month of diet-only treatment.
* Weight-loss of no more than 5.0 kg during the last 6 months prior to enrolment.

Exclusion Criteria:

* Type-1 diabetes
* Insulin-treated type-2 diabetes
* Secondary diabetes, heart-failure
* Serum-creatinine above the upper limit
* Serum-ASAT elevated more than 3 fold above the upper limit
* Factor II-VII-X decreased below 0.7
* Ongoing coexisting illnesses with a life-shortening prognosis
* Mental retardation or reduced intellectual behaviour
* Pregnancy
* History of drug-abuse or HbA1c\>10.5% at two separate visits with at least one month interval during treatment-periods.
Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin's Lymphomas

Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs), and evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.

This is a multi-center prospective, observational real-world study, targeting patients with B-cell non-Hodgkin's lymphomas. This study is designed to evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting.

This study will mainly focus on the following three cohorts:

Cohort 1: patients diagnosed with CD20-positive diffuse large B-cell lymphoma; Cohort 2: patients diagnosed with CD20-positive follicle lymphoma; Cohort 3: patients on maintenance treatment who have achieved complete remission or partial remission after induction therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as B-cell non-Hodgkin's lymphoma
* Voluntary participation in this study and the signing of an informed consent form
* The researchers assessed that the patient will benefit from the treatment of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs)

Exclusion Criteria:

* Contradictions to any drug in the treatment regimen
* Pregnant or lactating women
* Patients who were not considered suitable for the study by the researchers
Virtual MOUD Treatment- Virtual POC Toxicology

Care for Substance use disorders (SUD) such as Medication treatment of Opioid Use Disorder (MOUD) saves lives and is increasingly delivered virtually. Currently, 60% of VA outpatient addiction treatment occurs over video. However, toxicology testing, a major component of SUD care, currently requires in-person visits. A process for virtual point-of-care toxicology testing is needed. This research will develop a Virtual Point-of-Care Toxicology Testing Process for VA. This Pilot Trial will evaluate the feasibility, acceptability, and proximal effects of the process by evaluating provider and patient testing uptake, qualitative feedback, and health service use.

Care for Substance use disorders (SUD) such as Medication treatment of Opioid Use Disorder (MOUD) saves lives and is increasingly delivered virtually. Currently, 60% of VA outpatient addiction treatment occurs over video. However, toxicology testing, a major component of MOUD care, currently requires in-person visits. A process for virtual point-of-care toxicology testing is needed. The objectives of this pilot project are to develop, feasibility test, and describe the proximal outcomes of a Virtual Point-of-Care Toxicology Testing Process for VA patients in MOUD care.

The process will be evaluated in a pilot trial among providers and patients at VA Connecticut (VACT) and VA Central Western Massachusetts (VACWM). Acceptability will be evaluated through patient and provider semi-structured interviews. Overall feasibility will be determined using a priori benchmarks of utilization. These findings will be used to inform modifications of virtual toxicology testing procedures.

Mixed-methods will be used to develop and evaluate the testing process, which will use an oral-fluid test for common drugs of abuse. The test is FDA approved for at home patient use. Patients will self-administer the test during virtual SUD visits and assess results with providers. In the pilot trial, a single-arm mixed-methods pilot trial will evaluate the process among patients and providers at two VA facilities. Feasibility will be evaluated by examining process uptake. Acceptability will be evaluated through semi-structured interviews with patients and providers based on Consolidated Framework for Implementation Research (CFIR) constructs. Health service use will be evaluated by analyzing data on patient characteristics, test utilization, and treatment contacts extracted from the electronic medical record.

Eligibility Criteria:
Inclusion Criteria:

To participate VA patients must

* be recruited by their provider through a discussion about the project
* be interested in participating after the discussion
* have used VA video-based care at least once
* receive buprenorphine from a VACT or VAWCM provider (50% will have started buprenorphine within the last 3 months)
* have the ability to receive mail from the VA for the purposes of receiving oral fluid test kits)

Exclusion Criteria:

* Veterans must not be receiving inpatient or day-program treatment