cyrilzakka/clinical-trials huggingface dataset:
Effects of High-Intensity Interval Training Exercise in Adolescents With Hepatosteatosis

This is a research study about how short-term exercise intervention affects adolescents with a disease called non-alcoholic fatty liver disease (NAFLD).

The study investigators want to learn more about the effect of a type of exercise on non-alcoholic fatty liver disease (NAFLD), and on markers of health (for example, liver, heart, and overall health) and how the body uses energy in teenagers. The exercise we are studying is called high-intensity interval training, or HIIT. Some participants in this study will receive a 4-week exercise program, and the others will not.

Eligibility Criteria:
Inclusion Criteria: Initial Enrollment

* Ages 13-18 years (inclusive) for both sexes
* Any ethnic/racial background
* English speaking competence
* Teenagers ages 13-15 weighing more than 145 pounds OR teenagers ages 16-18 weighing more than 170 pounds
* Low risk to participate in an exercise program as determined by "The Physical Activity Readiness Questionnaire for Everyone"
* Late stages of puberty (i.e., Tanner stage IV or V) based on Tanner Staging.

Inclusion Criteria: Control or Exercise Group

* Presence of Non-Alcoholic Fatty Liver Disease (NAFLD) as determined by FibroScan Controlled Attenuated Parameter (CAP) score
* Confirmed lack of diabetes as determined by Oral Glucose Tolerance Test (OGTT)
* Confirmed eligibility per medical history

Exclusion criteria:

* Pre-pubertal or early stages of puberty
* Pregnancy
* Confirmed lack of NAFLD in the past 6 months via biopsy or MRI
* Presence of an implantable medical device or metal objects in the body (a contraindication for FibroScan and/or MRI)
* High-risk to participate in an exercise program as determined by "The Physical Activity Readiness Questionnaire for Everyone"
* Unable to cooperate with study procedures and tests including genetic or physical conditions impacting mobility over the past year
* Having known chronic illnesses/disorders that may independently affect study outcome measures: type 1 diabetes mellitus, type 2 diabetes, neurologic (e.g., epilepsy), developmental (developmental delay, autism spectrum disorder), endocrine (Cushing's, growth hormone deficiency), hepatic (other than NAFLD), autoimmune, cardiac and renal disorders
* Current history of poorly-controlled asthma.
* Taking any of the following medications that can affect study outcome at the time of enrollment: insulin, metformin, or any other anti-diabetics, antipsychotics, oral steroids, and anabolic drugs (growth hormone replacement therapy, testosterone, and oxandrolone).
* Adolescents who have a history of claustrophobia.
* Adolescents who need sedation in order to complete MRI.
* Adolescents determined ineligible by the study investigator or delegated staff.
Myeloid Mutations Register in R/R CML

The aim of the study is to know the percentage of ABL mutations in patients with chronic myeloid leukemia that relapsed or are refractory to tyrosine-kinase inhibitors measured with a myeloid mutations panel by NGS.


Eligibility Criteria:
Inclusion Criteria:

* CML diagnosis by the WHO 2016 criteria
* Failure to reach cytogenetic response of Ph chromosome of 36 to 95% at 3 months or BCR/ABL \<10% at 6 months of treatment with TKI
* Progression or relapse of the disease after previous response to treatment with TKI
* Validation of adherence to treatment
* Inform consent

Exclusion Criteria:

* Lack of information to complete the register
* Failure to response achievement due lack of adherence to treatment
A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers

The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and circulation around the wound.


Eligibility Criteria:
Inclusion Criteria:

* Chronic wound in the course of diabetic foot ulcers and/or lower extremity venous ulcers with duration of at least 6 weeks and the wound surface not less than 2 sq. cm and not greater than 15 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study
* Meets criteria for stalled chronic wound defined as less than 50% reduction in wound size after 30 days of standard of care management.
* For chronic venous ulcers, ultrasound demonstrates venous reflux \>0.5 seconds
* Satisfactory blood glucose control - fasting not more than 110 mg%, HbA1c \<6.5%
* Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 \> 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome
* In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb's blood supply as a result of the revascularization procedure documented by ultrasound.
* Ankle-brachial index (ABI) ≥ 0.8

Exclusion Criteria:

* Acute wound with duration less than 6 weeks
* Evidence of active infection or on antibiotics
* Smoker
* For chronic venous ulcers, ultrasound demonstrates venous reflux \<0.5 seconds
* Unsatisfactory blood glucose control - fasting more than 110 mg%, HbA1c \<6.5%
* Poor blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 \< 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome
* Ankle-brachial index (ABI) \< 0.
* Pregnancy
* Known allergy to lidocaine
Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma

The primary objective of this study is to assess the impact of bethanechol therapy on R0 resection rates. The safety objective will be assessment of the safety and tolerability of bethanechol in combination with gemcitabine and nab-paclitaxel. The exploratory objective will be to evaluate genomic biomarkers associated with parasympathetic stimulation in pancreatic cancer, and the ability to reduce tumor growth rate.

The purpose of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. Animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. The chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is FDA approved. Although bethanechol is FDA approved, in this study its use is experimental. The aim of the study is to show that the medication is easy to tolerate and that it shows signs of slowing cancer cell growth. The investigators hypothesize that treatment with bethanechol will alter nerve conduction within tumors by stimulating the parasympathetic nervous system and reduce tumor proliferation, decrease CD44+ expression in cancer cells, decrease tumor growth rate resulting in an improved R0 resection rate.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic Ductal Adenocarcinoma
* Plan for neoadjuvant chemotherapy
* Available diagnostic tissue adequate for biomarker analysis
* Ability to tolerate PO meds and comply with study procedures

Exclusion Criteria:

* Metastatic disease
* Evidence of GI obstruction
* Baseline bradycardia (HR\<55) or hypotension (systolic blood pressure\<90)
* Use of acetylcholinesterase inhibitors
* Medical conditions including: hyperthyroidism, active/symptomatic coronary artery disease, seizure disorder, peptic ulcer disease.
Horizontal Bone Augmentation of Alveolar Ridge

The objective of this randomized controlled clinical trial was to evaluate the effects of particulate xenogeneic bone grafts associated with autogenous bone graft or Leukocyte-and-Platelet-Rich Fibrin (L-PRF) for horizontal alveolar ridge augmentation. Twenty-eight patients presenting edentulous regions and requiring horizontal bone augmentation prior to dental implant placement were included in this study and randomly divided into two groups according to the proposed guided bone regeneration (GBR) treatment.

Fourteen surgical sites corresponding to Group A received bone regeneration with particulate autogenous bone tissue associated with deproteinized bovine bone graft (Bio-Oss Small®; Geistlich AG, Wolhusen, Switzerland). In Group B, fourteen surgical sites were regenerated with deproteinized bovine bone graft (Bio-Oss Small®) associated with L-PRF. In both groups, the grafted region was protected by a collagen membrane (Bio-Gide® Compressed; Geistlich AG, Wolhusen, Switzerland) fixed to the buccal and palatal bone plates using titanium pins.

Cone-beam computed tomography (CBCT) scans were performed preoperatively, immediately after the GBR surgical procedure, after 8 months of GBR healing, and immediately after dental implant placement to measure linear and volumetric changes in the alveolar ridge. At the time of dental implant placement, after an average period of 8 months following the guided bone regeneration procedures, bone biopsies were taken from the grafted area for histological, histomorphometric, and micro-CT analysis.

After a period of 6 months, the dental implants were reopened to receive implant-supported prosthetic rehabilitation. Implant stability was assessed using resonance frequency analysis at the time of implant placement in the grafted area and after an average of 6 months during the reopening surgical stage. Patient pain perception following bone regeneration procedures was assessed using a visual analog scale. All obtained data were statistically analyzed.


Eligibility Criteria:
Inclusion Criteria:

* a requirement for the placement of one to four dental implants exclusively in the maxilla;
* insufficient horizontal bone remaining for dental implant placement (maximum width of 4mm);
* sufficient vertical bone height for subsequent placement of dental implant(s).

Exclusion Criteria:

* any contraindication for dental implant placement;
* the need for vertical bone augmentation;
* inflammatory or autoimmune disease in the oral cavity;
* use of immunosuppressants, corticosteroids, or bisphosphonates;
* a history of malignancy in the past 5 years;
* smokers;
* patients reporting excessive alcohol consumption;
* decompensated systemic condition;
* uncontrolled periodontal disease;
* insulin-dependent diabetic patients;
* patients with blood-related diseases.
Volatiles in Critical Care After Free Flap Surgery

Patients undergoing complex free flap surgery are randomised to volatile or intravenous sedation in terms of subsequent intensive care sedation, based on the in-hospital standard of care. For study purposes, differences in management (set-up times, change of filters, etc.) will be investigated in relation to accelerated awakening and possibly improved neurocognition after the end of sedation.


Eligibility Criteria:
Inclusion Criteria:

* Free flap surgery
* Patient capable of giving informed written consent

Exclusion Criteria:

* Intolerance to volatile anaesthetics (e.g. malignant hyperthermia).
* Severe obstructive pulmonary disease
* Pre-existing severe neurocognitive disorder
* Age \<18 years (minors)
At-Home Infusion Using Bamlanivimab in Participants With Mild to Moderate COVID-19

This is an open-label, pragmatic, single-dose study using matched controls in participants with mild to moderate COVID-19. Participants will track for developing symptoms while at home and upon reporting of symptoms will test for COVID-19. If positive for COVID-19, a one-time at-home infusion of Bamlanivimab (LY3819253) will be provided by Optum Infusion. Participants will then track for 28 days to assess for any additional medical care needed or if hospitalization was required.


Eligibility Criteria:
Inclusion Criteria:

* UnitedHealthcare member
* confirmed COVID-19 positive
* located in an area where Bamlanivimab (LY3819253) is available for infusion

Exclusion Criteria:

* current (from first symptom report) hospitalization for COVID-19
* prior administration of Bamlanivimab or other COVID-19 therapies
* previous COVID-19 diagnosis
* prior receipt of a COVID-19 vaccine
* not authorized for patient use per the EUA
Understanding the Role of Large Extracellular Vesicles in Lymphomas and Lymphoproliferative Disorders: the "Off the Beaten Track" Liquid Biopsy

This study aims to investigate the role of extracellular vesicles as diagnosic and prognostic biomarkers in patients with lymphomas or lymphoproliferative disorders. In particular, circulating extracellular vesicles, thanks to their cargo of proteins, lipids, and nucleic acids, play a role in the communication between cells. Since it has been described that these vesicles are able to influence also immune cells, the study of their functions may lead to the discovery of new mechanisms underlying this type of diseases.

It is a 3-year monocentric in vitro study on human tissue. 50 patients with aggressive and indolent Non-Hodgkin Lymphomas (Diffuse Large B-Cell Lymphoma (DLBCL; Group A; n=10), Follicular Lymphoma (FL; Group B; n=10), Marginal Zone Lymphoma (MZL; Group C; n=10), Peripheral T-Cell Lymphoma (PTCL; Group D; n=10), Mycosis Fungoides (MF; Group E; n=10)), and patients with Chronic Lymphocytic Leukaemia (CLL; N=10; Group F; n=10), Hairy Cell Leukemia (HCL; Group G; n=10), and Multiple Myeloma (MM; N=10; Group H; n=10) will be enrolled over a period of 24 months. Follow-up: 12 months. Patients will be enrolled at the Complex Operative Unit of Haematology-IRCCS Azienda Ospedaliero-Universitaria di Bologna. The peripheral blood samples of patients (40 ml) will be collected only at diagnosis within normal clinical practice, outside of clinical study protocols, and following the treatment guidelines in use at the Centre. The analysis of the samples will be performed at the Unità Operativa Complessa di Ematologia-IRCCS Azienda Ospedaliero-Universitaria di Bologna in collaboration with the Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' - IRST IRCCS and with the University of Perugia.

Eligibility Criteria:
Inclusion criteria for patients:

* Age ≥ 18 years.
* Patients with WHO 2017-defined diagnosis of indolent and aggressive Non-Hodgkin Lymphoma (specifically Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Peripheral T-Cell Lymphoma, Mycosis Fungoides) or Chronic Lymphocytic Leukemia or Hairy Cell Leukemia or Multiple Myeloma.
* Signed informed consent.

Exclusion criteria for patients:

- Concomitant secondary neoplasia.

Inclusion criteria for healthy donors:

* Age ≥ 18 years.
* Signed informed consent.

Exclusion criteria for healthy donors:

- Healthy donors with neoplasia.
Comprehensive Care Transition: A Trial of an Enhanced Care Transition Process in Dementia

This pilot study examines the impact of an enhanced care transition process vs. usual care for persons with dementia admitted to a transitional unit (hospital or LTC) for management of behavioural and psychological symptoms of dementia (BPSD) with a planned discharge to long term care (LTC) facilities or other hospital units. Deficiencies in discharge processes can contribute to poor outcomes (e.g., readmissions), and there is a dearth of research on how to improve care transitions for persons with BPSD. The investigators aim to improve the care transition process for persons with dementia and BPSD utilizing an enhanced care transition process that will contain up to 6 elements: integrated behavioural care plans, videos, patient specific briefcase containing activities to reduce BPSD, in-person care transition meeting, in-person care demonstration (when possible), and follow up visits with a transition team. The ability to determine the effect of enhanced care transitions on the clinical course of patients with planned discharge to LTC or hospital may allow for improved outcomes and an overall increased efficiency of post discharge care.

The investigators have formulated an enhanced care transition process based on factors that have been documented to support care transitions in other clinical populations (e.g., Coleman, 2003 on persons with continuous complex needs; Viggiano, et al., 2012 on persons with mental health issues), along with novel package elements based on the investigators' experience working with persons with dementia and BPSD. The investigators propose to conduct a preliminary analysis of patient and staff outcomes comparing an enhanced care transition process with a control group receiving usual care. The investigators' proposed enhanced care transition process will contain 5 elements: 1. Unified transfer care document adapted to the post-care transition location 2. Videos of BPSD management to better communicate care provision, 3. Provision to -the post-care transition location a patient specific briefcase containing activities that help to reduce BPSD, 4. In-person care transition meeting between sites, including the family, to transfer knowledge, 5. In person care demonstration (when possible), and 6. Follow-up visits post transition with a transition team (a service already in existence but not consistently used). The investigators hope that with improved communication, discharge locations will be better equipped to manage BPSD, and reduce the likelihood of adverse events for both patients and staff.

Eligibility Criteria:
Inclusion Criteria:

* Patients on behavioural transitional support unit's at Baycrest (Behavioural Neurology Unit, transitional Behavioural Support Unit) who are admitted for behavioural and psychological symptoms of dementia (BPSD)
* Diagnosed with a degenerative dementia
* Over 55 years old at the time of discharge, with a planned discharge to a long-term care (LTC) facility or another hospital unit will be eligible for the study

Exclusion Criteria:

* None
Effect of Different Pranayama Breathing Techniques on Quality of Life in Hypertensive Patients

The purpose of the current study is to compare between the effect of Bhramari pranayama versus Sheetali pranayama on quality of life in hypertensive patients.

People with hypertension have poorer sleep quality, less physical activity and more psychological stress than those with normal blood pressure. It has been shown that sleep affects vitality and health status and that sleep problems affect daily functioning and QOL, and so it can be assumed that in patients with hypertension, sleep problems will have a negative effect on QOL (Uchmanowicz et al., 2019).

Yogic breathing exercises are known as Pranayamas and are considered a form of meditation in itself, as well as a preparation for deep meditation. They promote physical well-being and self-awareness, improve lung and cognitive capacities, reduce blood pressure, anxiety, and other psychosomatic patterns, probably by increasing the parasympathetic tone. Pranayama alone has demonstrated numerous beneficial health effects, including stress relief, beneficial cardiovascular effect, improved respiratory function, and enhanced cognition (Jayawardena et al.,2020 ).

Since there is no study examined effect of Bhramari versus Sheetali on quality of life, physical fitness and stress in hypertensive elderly, this study aimed to examine this comparison.

Eligibility Criteria:
Inclusion Criteria:

- Sixty elderly are selected from both sexes. 2-Their age ranges from 60-75 years old. 3-Hypertensive patients (SBP is 140 -159 mmHg and/or DBP is 90-99 mmHg).

4-Their body mass index (BMI) ranged from \< 30kg/m2. 5-All patients are medically stable.

Exclusion Criteria:

* - patients with cardiac problems e.g. atrial fibrillation, left bundle-branch block, heart failure, Recent myocardial infarction, coronary artery disease, or participation in cardiac rehabilitation following bypass surgery.

  2- Patients with history, symptoms of, and/or laboratory reports suggestive of renal, neurologic, or hepatic complications.

  3-Patients who have difficulty in rolling the tongue for Sheetali practice as stroke or Bell's palsy.

  4- Tongue swelling in case of acromegaly, amyloidosis, Myxedema and tongue cancer.

  5- Tongue pain in case of diabetic neuropathy, mouth ulcers, oral cancer and burn in the mouth.

  6- Chronic smokers and alcoholics. 7- Severe ear infections that interfere with bhramari breathing.
A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER+/HER2+ Breast Cancer.

To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
2. Age at diagnosis ≥18 years and ≤75 years, female.
3. Histologically confirmed diagnosis of Unilateral ER+/HER2+ breast cancer. ER-positivity is defined as \>1% stained cells；HER2-positivity is defined as IHC 3+ or if IHC scored 2+, in-situ hybridisation (ISH) suggests amplified HER2 gene.
4. Tumor diameter \>2 centimeters with the clinical stage being classified as from IIa to IIIc.
5. ECOG ≤ 1, LVEF ≥ 55%.
6. Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥1.5 × 109 / L and platelets ≥100 × 109 / L and hemoglobin ≥90 g/L; for hepatic function, total bilirubin ≤1.5 × UNL, AST and ALT ≤2.5 × UNL; for renal function, SCr ≤1.5 × UNL.

Exclusion Criteria:

1. Evidence of bilateral invasive breast cancer or metastatic disease (M1).
2. Pevious treatment with chemotherapy, hormonal therapy, an investigational drug for any type of malignancy, or radiation therapy.
3. Any of the following exist in the last 6 months: known or suspected congestive heart failure (≥ NYHA II), persistent arrhythmias (≥ grade 2), atrial fibrillation of any grade, coronary / peripheral bypass, symptomatic congestive heart failure, cerebrovascular accidents (including transient cerebral hemorrhage attacks or symptomatic pulmonary embolism).
4. Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol.
5. Active infection or severe symptomatic visceral disease in the last 4 weeks.
6. Patients with HIV infection or known AIDS, or patients with infection of active hepatitis B (HBV DNA ≥1000IU / ml) or hepatitis C (hepatitis C antibody is positive and HCV RNA is above the lower limit of detection of the analytical method).
7. Prior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
8. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
9. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
10. Not eligible for the trial assessed by the investigators of our study.