cyrilzakka/clinical-trials huggingface dataset:
SME(Sharing, Mind & Enjoyment) App for Adolescents

SME (Sharing, Mind, Enjoyment) App, A Pilot Project is part of the Community-based Mental Wellness Project for Adolescents and Adults, which aims at promoting sharing, mind and enjoyment and enhancing mental wellbeing. The Mental Wellness Project is financially supported by the Health Care and Promotion Fund from Food and Health Bureau and led by the School of Public Health, University of Hong Kong (HKU). This project primarily aims to promote the SME related behaviors of adolescents through the App. The evaluation will be conducted during the programme implementation stage. The effectiveness of the intervention, as well as the level of participation and ratings for the intervention, will be evaluated.

A cluster randomized controlled trial design was adopted. The major subjects of SME (Sharing, Mind, Enjoyment) App Pilot Project RCT Study are 300-500 middle school students. Two schools will be recruited and randomized to each group. Schools will either be assigned to app intervention group or waitlist control group. The students in the intervention group will use the App for one month. Daily and Weekly tasks related to SME will be assigned through the App, and information related to mental health will be provided. The waitlist control group will be able to use the App after we finish all the assessments.

There will then be 4 assessments (pre-intervention, immediate post-intervention, one month and three months after) to evaluate the effects of the intervention programme. In the assessments, students will be asked to complete a questionnaire to measure the changes in SME (sharing, mind and enjoyment) related behaviors, changes of knowledge and attitude towards the anxiety disorder, changes of happiness and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Students (major subjects) (intervention group and control group):

  1. Chinese speaking
  2. Intact verbal and hearing abilities for interpersonal communication
  3. Reading and writing abilities for questionnaire completion
  4. Can use the smartphone
  5. Form 1 to 4 students
* Parents (intervention group):

  1. Chinese speaking
  2. Intact verbal and hearing abilities for interpersonal communication
  3. Reading and writing abilities for questionnaire completion
  4. Can use the smartphone
  5. With at least one child between form 1 to 4
* School principals/teachers/community partners (intervention group):

  1. Principals/teachers of intervention school or staffs of Tung Wah Group of Hospitals in partnership with HKU research team, who organize plan or implement the project
  2. Adults aged 18 or above
  3. Chinese speaking
  4. Intact verbal and hearing abilities for interpersonal communication
  5. Reading and writing abilities for questionnaire/individual in-depth interviews completion

Exclusion Criteria:

* Students who cannot read Chinese
Evaluating Pancreatic Tumors in Patients With Zollinger-Ellison Syndrome

This protocol concerns the approach to the localization, diagnosis of MEN1 and management of the tumor and the tissue samples in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor, investigations for MEN1 the subsequent management of the tumor and tissue samples for research.

This protocol concerns the approach to the localization and management of the tumor in patients with Zollinger-Ellison syndrome. It details the diagnostic imaging tests to be used to localize the tumor and the subsequent management of the tumor.

Eligibility Criteria:
* INCLUSION CRITERIA:

New patients will be evaluated initially as described in the protocol entitled, "Diagnostic evaluation of patients with suspected abnormalities of gastric secretion" (89-DK-0005).

Only those patients that are being treated under the protocol entitled, "Medical Therapy of Zollinger-Ellison Syndrome" (protocol # 89-DK-0015) will be entered into this tumor localization and management protocol.
Effect of Tegoprazan or RAPA114 on Pharmacokinetic of Atorvastatin in Healthy Adult Volunteers

This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.

\[Pharmacokinetic Assessments\] : Blood concentration of atorvastatin, 2-OH atorvastatin

* Primary outcome: AUCτ, Css,max of atorvastatin
* Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin, metabolic ratio

\[Sefety Assessments\]

: Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test

Eligibility Criteria:
Inclusion Criteria:

* Healthy male adults aged 19 to 55 years (inclusive) at the time of his consent.
* Body mass index (BMI) ≥ 19.0 and ≤ 27.0 kg/m2 at screening.
* Decides to participate voluntarily in the trial after being fully informed of and understanding the study completely, and provides the written informed consent to participate in the trial and to comply with the trial-specific requirements.
* Has the ability and willingness to participate in the entire period of clinical trial.

Exclusion Criteria:

* A subject with clinically significant disease or history of hepatobiliary, renal, gastrointestinal, cardiovascular, musculoskeletal, endocrine, respiratory, neuropsychiatry or hemato-oncologic system, etc.
* A subject with a history of hypersensitivity reactions to main constituents of or identical affiliation of the investigational products (ex, HMG-CoA reductase inhibitor, gastric acid suppressants), or have allergic diseases that require treatment.
* A subject with a history of genetic myopathy or family history.
* A subject who has participated in other clinical trials and received the investigational products within 180 days prior to the randomization.
* A subject who received any medications or foods that could significantly affect the absorption, distribution, metabolism, or excretion of an investigational product within 30 days prior to the randomization.
* A subject with history of whole blood donation within 60 days, or with blood components or received transfusion within 30 days prior to the randomization.
* A subject with continued consumption of alcohol more than 140 g per week.
* A subject with AST, ALT, or γ-GT levels exceeding 1.5 times of the upper limit of the reference range in the screening test.
* A subject with a calculated glomerular filtration rate of less than 60 mL / min / 1.73 m2 in the screening test.
* A subject with any positive result on serology tests for hepatitis B, hepatitis C, HIV or syphilis in the screening test.
* A subject with galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose malabsorption, etc.
* Male subject who don't have willing to accept medically acceptable contraceptive methods during the course of clinical trial, or who plan to provide sperm.
* A subject who is determined to be ineligible to participate in the clinical trial by the investigator for other reasons.
The Prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center

A retrospective review of the prevalence of Group B Streptococcus Positive Pregnant Patients in an Inner City Tertiary Care Center

This is a retrospective chart review of the prevalence of Group B Streptococcus (GBS) positive patients

Eligibility Criteria:
Inclusion Criteria:

* GBS positive pregnant women

Exclusion Criteria:

* n/a
Should Ranges of Vitamin D be Redefined to Prevent or Treat Viral Infections?

Blood vitamin D levels may be associated with severity of viral infections. To find out If there is a statistically significant relation between blood 25-hydroxy vitamin D (25(OH)D) levels and disease severity, patients with Covid-19 viral infection were investigated.

Purpose:

Vitamin D a steroid hormone has profound effects on human immunity. Active vitamin D, 1,25(OH)2D acts as an immune system modulator, preventing excessive expression of inflammatory cytokines and increasing the 'oxidative burst' potential of macrophages. Epidemiological data has linked vitamin D deficiency to increased susceptibility to acute viral respiratory infections.

There is evidence that some patients with severe COVID-19 experience a cytokine storm with production of large quantities of interleukins, specifically IL-1 and IL-6. Moreover it was hipotiesied that the sufficient vitamin D levels may help to decrease IL-6 levels like tocizulamab which is a potent blocking agent of the IL-6 receptor.

In this observational study, possible relation between the disease and vitamin D levels were investigated in COVİD-19 patients.

Material and Methods:

To find out vitamin D levels and it's relation with the disease severity serum 25-hydroxy-vitamin D levels will be measured in nearly 1100 confirmed COVİD-19 patients. Same patients will also be evaluated for vital signs, laboratory and pulmoner CT findings. Demographic and medical data will also be collected. Statically significant positive or negative results and the comparison of these findings will be presented.

Presenting blood vitamin- D levels and it's possible assosiation with disease severity may inspire new perspectives for future trials spesifically focusing vitamin D levels.

Eligibility Criteria:
To find out vitamin D levels and it's relation with the disease severity serum 25-hydroxy-vitamin D levels, 1100 confirmed Covid-19 patients with available laboratory findings were included.

Exlucion Criterias:

Using immunsuppresan medical treatment. Using vitamin D or replacement history of vitamin D in last 3 months. Patients with malnutrition, immun deficiency, chronic infections, chronic other diseases such as rheumatoid arthritis, ankylosing spondilitis, lupus, hemplegia, paraplegia etc.
PanDirect: Self-care Tools and Telephone Coaching for Depression and Anxiety During Pandemics

During pandemics older adults with chronic physical conditions are a particularly vulnerable population for unmet mental health needs. This is a consequence of a number of factors which include decreased access to their doctors because of restrictions in visits in order to decrease risk of disease transmission and because doctors are seconded to provide medical services in areas of high priority. Since Public Health authorities worry that pandemics may be a reality of the future, this study is being operationalized during the present COVID-19 pandemic in order to see what can be learned about different ways to provide mental health care under such constraints.

The study offers evidence-based approaches to managing feelings of anxiety or depression that may have existed prior to the onset of a pandemic, or that have arisen during a pandemic. It uses principles of cognitive behavioural therapy in which participants are offered self-care tools to help them develop strategies for dealing with their various symptoms. These tools have already been shown by the team to be effective in other contexts in studies DIRECT-sc (Effectiveness of a supported self-care intervention for depression compared to an unsupported intervention in older adults with chronic physical illnesses) and CanDIRECT (Effectiveness of a telephone-supported depression self-care intervention for cancer survivors).

The present study, PanDIRECT (Assisting Family Physicians with Gaps in Mental Health Care Generated by the COVID-19 Pandemic), aims to answer the following questions:

1. Can these tools be used in the community care of mental health problems during pandemics?
2. Are they acceptable to patients?
3. Using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes?
4. Do family practitioners value patient information sent to them at the end of the trial


Eligibility Criteria:
Inclusion Criteria:

* 65+ years old
* consented to be recontacted (participant in a previous study)

Exclusion criteria:

* moderate to severe cognitive impairment (using BOMC a brief cognitive screen) -unable to read in English or French (self-reported); hearing impairment (as judged by research staff);
* currently receiving counseling or psychological therapy (as these treatments may conflict with the self-care interventions)
* currently living in a long term care or other medicalized facility,
* presenting suicidal intent (as identified through the final item of the PHQ-9 which will be asked at screening).
Validity and Reliability of the Turkish Version of the Tele-Pulmonary Rehabilitation Acceptance Scale

The objective of this research is to translate the Tele-Pulmonary Rehabilitation Acceptance Scale into Turkish and assess its reliability and accuracy.

The use of telehealth in pulmonary rehabilitation, also known as telerehabilitation, is a novel approach in healthcare practice. In order to effectively implement telerehabilitation programs, it is important to evaluate how potential users perceive and accept this new type of program. Thus, the aim of this research was to create a measuring tool that could assess the level of acceptance of telerehabilitation among healthcare providers and patients. A group of experts in pulmonary rehabilitation, telehealth, information technology, and scale development have reviewed and confirmed the content validity of the Tele-Pulmonary Rehabilitation Acceptance Scale. This scale is significant because it offers a consistent means of collecting data to measure the level of acceptance towards telerehabilitation among potential users. This study aims to translate and show the consistency and validity of the Tele-Pulmonary Rehabilitation Acceptance Scale in Turkish.

Eligibility Criteria:
Inclusion Criteria:

* Being a patient in need of pulmonary rehabilitation or a healthcare professional working in the field of pulmonary rehabilitation.
* Being a native Turkish speaker.
* Giving consent to participate in the study.

Exclusion Criteria:

* Any disease or condition that prevents reading, understanding, or filling out forms.
* Not giving consent to participate in the study.
Gene Expression in Tissue From Patients With Acute Lymphoblastic Leukemia

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at gene expression in tissue from patients with acute lymphoblastic leukemia enrolled in clinical trial ECOG-2993.

OBJECTIVES:

* Identify genes involved in specific biologic processes or molecular functions that contribute to the mechanisms by which the BCR/ABL tyrosine kinase induces a leukemic phenotype using RNA banked from patients with BCR/ABL-positive acute lymphoblastic leukemia (ALL) enrolled on ECOG-2993.
* Compare patterns of mRNA expression of BCR/ABL fusion protein in patients with B-lineage ALL vs patients with ALL and no cytogenetic abnormalities enrolled on ECOG-2993.
* Determine both shared and differing expression patterns in patients with BCR/ABL-positive and cytogenetically negative ALL with respect to achievement of complete remission and duration of disease-free and overall survival.

OUTLINE: This is a multicenter study.

Total RNA is isolated from stored tissue samples and integrity is verified by reverse transcription-polymerase chain reaction (RT-PCR). cDNA libraries are created from total RNA and gene expression is analyzed via microarray analysis.

Genes of interest are further analyzed by flow cytometry and RT-PCR.

PROJECTED ACCRUAL: A total of 137 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed diagnosis of acute lymphoblastic leukemia
* Tissue banked on protocol ECOG-2993 meeting the following criteria:

  * Leukemic blast cell population immunophenotyped in detail (e.g., including CD25) in ECOG's Immunophenotyping Reference Laboratory
  * Flow cytometric analysis of gated blast cells reveals association with the B-cell lineage
  * Mononuclear cell fraction used for RNA isolation contains 75-99% blasts (median 85%)
  * Negative for TEL/AML1, MLL/AF4, and E2A/PBX1 by qualitative reverse transcription-polymerase chain reaction (RT-PCR)
  * No FLT3 gene mutations
  * BCR/ABL-positive samples meeting the following criteria:

    * Presence of t(9;22)(q34;q11) by standard cytogenetics
    * Detection of either p190 BCR/ABL or p210 BCR/ABL transcripts by qualitative RT-PCR
  * Patients with genetic risk factors must meet the following criterion:

    * Only a normal diploid karyotype is present in ≥ 15 metaphases by standard cytogenetics

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Accuracy and Precision of the True Vie I3 Continuous Glucose Monitoring System: an Open Label, Multi-Center Trial

The purpose of the investigation is to evaluate the performance of the I3 CGM according to the FDA's special controls for iCGM.

Participants will attend a screening visit, 4 clinic visits with Frequent Sampling Testing (FST) at the beginning, 2 in the middle, and end of the I3 CGM sensor wear, and a visit for removal of the I3 CGM. Participants will wear 3 I3 CGM devices for up to 15 days and be instructed to continue their normal daily activities and manage their glucose as usual between in clinic FST per routine care. Participants will not have access to the I3 CGM data for the management of their blood glucose between clinic visits and will continue their usual care including CGM, if they are CGM users.

At the clinic FST visits venous blood samples will be drawn from an intravenous cannula for FST for up to 10 hours for plasma glucose determination. During the clinic visits the investigative site staff will determine the participants' insulin doses and meals and may induce both hypoglycemia and hyperglycemia of up to an hour duration.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with T1DM or T2DM diagnosed for at least 6 months. 2. Individual is 18-80 years old, inclusive, at the time of screening. 3. Must be and have been in stable treatment regimen for at least 1 month with a multiple daily insulin dosing regimen (at least two insulin doses with meals daily) or CSII using at least two bolus doses a day with meals, irrespective of delivery device(s).

Exclusion Criteria:

* 1. History of skin adhesive tolerance issues in the area of sensor placement. 2. HbA1c \> 9%. 3. Insulin meal dosing based on fixed dose regimens. 4. Absence of established correction factor for high glucose. 5. Hematocrit below 10% under the lower limit of the normal range. 6. Body mass index \< 18.5 kg/m2. 7. Inadequate intravenous access on arms. 8. Participant has had a hypoglycemic seizure within the past 6 months prior to enrollment.

  9. Participant has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to enrollment.

  10. Participant has a history of a seizure disorder. 11. Pregnancy, planned pregnancy within the study period, or unwillingness to use reliable contraception during the study period.

  12. Planned MRI, CT scan or diathermia procedure for the duration of the study.
Anakinra for Preterm Infants Pilot

Phase I/II study of anakinra to prevent the impact of perinatal inflammation in extremely premature infants.

With improvements in antenatal and neonatal care over the last 20 years, now infants are born as early as 22 weeks gestation and survive to discharge from hospital. This increased survival comes with increased risk of long term issues such as cerebral palsy and chronic lung disease. There is strong evidence to show these risks are increased due to an underlying inflammatory process initiated around the time of premature birth. This study aims to prove the safety of treating infants born between 24-27+6 weeks gestation with Anakinra, a medication which is similar to an anti-inflammatory molecule the body makes itself called Interleukin 1 Receptor Antagonist (IL-1Ra). Anakinra acts to reduce the inflammatory response and is currently used in adults and children as young as 8 months to manage autoimmune inflammatory conditions. This study looks at the safety of giving Anakinra to babies born extremely premature, over the first 3 weeks of life. Once safety is established, the investigators will conduct a larger trial studying the efficacy of this treatment for reducing the risk of long-term complications caused by neonatal inflammation in extremely preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Born at 24 to 27+6 weeks gestation

Exclusion Criteria:

* Inability of the legal representatives to consent
* Any disease or condition that the investigators judge could confound the trial results; these include, but are not limited to, genetic syndromes, severe cardiac abnormalities, substantial pre-/perinatal compromise (profound/severe hypoxia (SaO2 \<80% for \>3h), congenital diaphragmatic hernia, intrauterine stroke and others.
* Imminent death
Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults

The purpose of this study is to find out more about cognitive functioning in people who are cannabis dependent, relative to people who do not use cannabis, and how their brains process information after one month of not using cannabis. An additional goal is to characterize the severity of cannabis dependence using precipitated and naturalistic withdrawal with a double blind, placebo controlled, single administration of rimonabant. Research assessments occur bi-weekly throughout this 28 day study.


Eligibility Criteria:
Cannabis Dependent Subjects:

Inclusion Criteria:

* males or females 21-30 years of age
* meets Diagnostic and Statistical Manual (DSM-IV) diagnosis of Cannabis Dependence
* willing to be abstinent for 28 days during study
* smokes \< 10 cigarettes per day
* drinks \< 1 (female) or \< 2 (male) per day

Exclusion Criteria:

* active suicide ideation
* meets DSM-IV diagnosis for dependence on other substances other than cannabis
* significant medical disorders
* pregnant women
* meets DSM-IV diagnosis for a major Axis I disorder other than cannabis dependence
* currently taking psychoactive medication
Cobb Angle Measurement of Kyphosis and Scoliosis

Measurement of bone length in subjects diagnosed with kyphosis and scoliosis using the Lunar iDXA x-ray scan.

To determine if bone density scanning (DEXA) and the use of a computer software program can make accurate measurements of the curvature(s) of the spine (Cobb angle)in patients with kyphosis and scoliosis compared to x-rays of the spine.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Have Kyphosis or Scoliosis
* Have had an x-ray of the spine performed within 3 months time

Exclusion Criteria:

* Are unwilling to read and sign this document
* Are pregnant or if you have not had a negative pregnancy test just prior to the iDXA scan.
* Have severe deformities of your back
* Unable to lay on the scanning table for the scan