cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with vedolizumab and with placebo in the treatment of participants with moderate to severe UC. This study will consist of two parts, Part A and Part B. Part A will test the induction of clinical remission and Part B will test the durability of clinical remission.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UC
* Confirmation of moderately to severely active UC, defined by the Mayo Clinic Score
* Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment (i.e., azathioprine, 6-mercaptopurine, methotrexate, or tumor necrosis factor \[TNF\] inhibitors \[maximum of 2 prior TNF inhibitors\]) and/or corticosteroid treatment
* Use of highly effective contraception as defined by the protocol

Exclusion Criteria:

* History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year; or primary sclerosing cholangitis
* History of cancer as defined by the protocol
* Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders (excluding UC)
* Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
* Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis or toxic megacolon within 12 months prior to screening
* Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
* Current fistula or history of fistula, pericolonic abscess and stricture (stenosis) of the colon
* History or current evidence of unresectable colonic mucosal dysplasia or history of high-grade colonic mucosal dysplasia
* Prior treatment with UTTR1147A
* Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents
* Prior treatment with rituximab
* Use of prohibited therapies, as defined by the protocol, prior to randomization
* Congenital or acquired immune deficiency
* Evidence or treatment of infections or history of infections, as defined by the protocol
Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery

The investigators will test the hypothesis that transcutaneous electrical nerve stimulation (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary Arterial Bypass Graft Surgery (CABG).

Thirty-eight patients will be randomized to a (4 times/day; 30 min/session) for 5-day program of TENS (n = 20) or to placebo-TENS (P-TENS, n = 18) applied on cervical region (C7-T4). Acute sympathetic stimulation by cold pressor test (CPT), Maximal voluntary contraction (MVC), Femoral blood flow (FBF) and femoral vascular conductance (FVC) will be measured as primary outcome pre and post-CABG, even as the 6-minute walk test (6-MWT), Inspiratory and expiratory muscle strength (PImax and PEmax) and β-endorphin as a secondary clinical parameters. In addition, amount of opioid analgesic and pain intensity also will be measured throughout at first 24 hours after CABG (immediately, 6, 12 and 24 hours).

Eligibility Criteria:
Inclusion Criteria:

* a previous history of more than 1 vessel coronary artery disease,
* lifelong abstinence from tobacco, and
* formal indication for CABG, according to established guideline.

Exclusion Criteria:

* Patients older than 70 years of age, with chronic renal failure, or with unstable angina in the 48 h prior to CABG, moderate or severe valve disease, complex cardiac arrhythmias, stroke, and/or inability to exercise the lower limbs.
Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects.


Eligibility Criteria:
Inclusion Criteria:

- Is obese with a body mass index (BMI) ≥30 kg/m\^2 to ≤45 kg/m\^2, or is overweight with a BMI ≥27 kg/m\^2 to \<30 kg/m\^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis)

Exclusion Criteria:

* Has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start
* Has received AC2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®) or calcitonin
* Has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, before study start
* Has donated blood within 2 months before study start or is planning to donate blood during the study
Long-Term Assessment of Safety and Physical Function With AMG 108 in RA

The purpose of this study is to assess long-term safety of SC AMG 108 in the treatment of RA


Eligibility Criteria:
Inclusion Criteria:

* Only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll.

Exclusion Criteria:

* Subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.
Constipation Fiber Trial

This study examines the effects of dietary fiber in the treatment of functional childhood constipation.

This is a 4-week double-blind, placebo-controlled study to examine the effects of dietary fiber in treating functional childhood constipation. The addition of fiber is anticipated to allow children to have more normal stool consistency and frequency.

All participants will be asked to take a snack bar twice daily and will be randomized in a 1:1:1 ratio to fiber 1, fiber 2 or placebo snack bar groups. All participants will be asked to take low-dose Miralax to avoid worsening of constipation in all groups.

Eligibility Criteria:
Inclusion Criteria:

* 2-16 years of age with functional constipation as defined based on the Rome III criteria

Exclusion Criteria:

* Constipation attributable to organic and anatomic causes or intake of medication
* Children who had previous surgery of the colon or anus
* History of allergy/intolerance to components of snack bar (e.g. celiac disease)
Virtual Hypertension Management Pilot

Investigators are examining the quality improvement impact of providing patients with a an electronic health record-connected blood pressure cuff. Investigators will give half of patients already eligible for hypertension management within a clinical pharmacist panel, the ability to upload their blood pressure data into Stanford's electronic health record.


Eligibility Criteria:
Inclusion Criteria:

* Hypertension as defined by clinical pharmacist usual care panel (2 or more readings of blood pressure \>140/90)

Exclusion Criteria:

* Pregnancy
* Chronic kidney disease III or IV
* Systolic heart failure with ejection fraction \<35%
* Current use of 3 or more anti-hypertension drugs
Analysis of the Effectiveness of Visual Training in Stroke Rehabilitation

The study was a randomized control trial conducted to determine whether VR games incorporated with cognitive engagement within visual training feedback are feasible intervention options in stroke rehabilitation. An investigation has been conducted to assess the efficacy of virtual reality games that enhance hand motor functions to attain long-lasting improvements. Patients were randomly assigned to the experimental and control groups. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week, for a total duration of 6 weeks. Developed four VR-based hand games that include hitting a rolling ball, grasping a balloon, swapping hands, and gripping a pencil.

The field of stroke rehabilitation frequently faces limitations in therapies and struggles to achieve long-lasting improvements in hand motor function. The integration of fully immersive virtual reality (VR) games with visual training feedback significantly improves the efficacy of stroke rehabilitation. Virtual reality (VR) games that incorporate repetitive and particular tasks stimulate the gradual activation of brain pathways linked to motor activities. VR research has the potential to enhance VR intervention games by combining cognitive engagement with visual feedback.

The objective of this study was to develop and evaluate virtual reality games that utilize an approach of cognitive engagement within visual feedback in order to enhance hand-motor capabilities. The study utilized completely immersive virtual reality (VR) games specifically designed for subacute stroke patients. The implementation of fully immersive virtual reality (VR) games as an intervention proved to be highly effective in significantly maintaining the motor recovery of patients who had experienced a stroke in the subacute phase. Stroke patients exhibited enhanced dexterity, heightened range of motion, greater hand strength, and improved grip.

Developed VR games utilize a virtual reality device and are designed to be controlled by hand movements such as flexion/extension, close/open, supination/pronation, and pinch. Patients were randomly assigned to the experimental and control groups. The experimental group received a VR hand game intervention with conventional physical therapy, while the control group only received conventional physical therapy. Each patient's therapy consists of 24 sessions, with each session lasting 4 days per week for a total duration of 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Montreal Cognitive Assessment (MOCA ≥ 21)
* Modified Ashworth Scale (MAS\< 4)
* Fugl-Meyer Assessment (FMA between 25 and 55)
* Age ≥ 18 years
* Stroke patient type (Subacute patients)

Exclusion Criteria:

* Wrist Impairments
* Contractures
* Patients with vestibular issues
* Permanent external fixation
A Sub Study to Evaluate the Study Medication (Etrasimod) Using Wearable Sensors in Healthy Participants

The purpose of this study is to look at how healthy adults process Etrasimod when assessed by wearable sensors. Etrasimod is taken without food and assessments taken by site staff and then by participants after training.

The study is seeking participants who are:

* Aged 18 or older
* Male or female who are healthy as determined by medical assessment
* Body-mass index (BMI) of 16 to 32, and a total body weight \> 50kg.

The study will take up to 9 weeks, including the screening period. Participants will have to stay at the study clinic for at least 2 nights, in each of 2 study periods.

Participants will take Etrasimod as a tablet by mouth without food. Blood samples will be taken both before and after participants take Etrasimod. Participants will also use wearable devices to assess blood pressure, heart rate and take further blood samples. A follow-up phone call will be made 20 to 27 days after the last study period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* BMI 16 to 32 kg/m2
* body weight more than 50kg

Exclusion Criteria:

* Ongoing or past history of significant medical conditions
* Eye disorders such as macular edema or uveitis
* Ongoing or recent infections
* Use of prescription or non prescription medications within 7 days of first dose
* Smoking or using nicotine products equivalent to more than 5 cigarettes per day
* History of severe allergic or anaphylactic reactions
Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients

Multinational, multicentre, randomised, double blind, double dummy, placebo and active controlled, 5-way cross over

To demonstrate the non-inferiority in terms of FEV1 AUC0-12h between a single dose of CHF 1535 via NEXT DPI and CHF 1535 via HFA-134a "extrafine" pMDI in partly controlled adult asthmatic patients

Eligibility Criteria:
Inclusion Criteria:

* Patient's written informed consent obtained prior to any study-related procedures.
* Outpatient male or female aged ≥ 18 years.
* Evidence for "partly controlled" asthma in the 2 weeks before the screening visit
* Under previous inhaled corticosteroids (ICS) treatment at the screening visit
* Forced expiratory volume in the first second (FEV1) ≥ 60% and ≤ 90% of the predicted normal values at the screening visit.
* A documented positive response to the reversibility test at the screening visit, defined as ΔFEV1 ≥ 12% and ≥ 200 mL over baseline, 30 minutes after 400 μg salbutamol pMDI
* Patients free of long-acting beta2-agonists (LABAs) treatment for at least 2 weeks before the screening visit.
* Patients free of short-acting beta2-agonists (SABAs) treatment for at least 6 hours before the screening visit.
* Non-smokers or ex-smokers

Exclusion Criteria:

* Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they are menopausal or are using effective and acceptable methods of contraception.
* Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer.
* History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit) within 1 year before screening.
* Occurrence of asthma exacerbations or respiratory tract infections in the 4 weeks preceding the screening visit.
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* History of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency.
* Diagnosis of restrictive lung disease.
* Patients treated with oral or parenteral corticosteroids in the previous 8 weeks (12 weeks for parenteral depot corticosteroids) before screening visit.
* Intolerance or contra-indication to treatment with beta2-agonists and/or inhaled corticosteroids.
* Allergy, sensitivity or intolerance to study drugs or excipients.
* Significant medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality.
Myfortic - Treatment for Extensive cGvHD

The purpose of this study is to determine whether the response to treatment for extensive chronic Graft versus Host Disease (cGvHD)is improved with the addition of myfortic alongside cyclosporine A and prednisone, compared to the reference treatment of cyclosporine A and prednisone alone.

This clinical trial is a European, multi-center, randomized, double blinded placebo-controlled trial comparing CsA+PDN+MPA versus the reference treatment of CsA+PDN alone + placebo, in patients with extensive chronic GvHD. Randomization will be stratified according to:

* Platelet number (low versus high risk)
* Source of transplantable cells (marrow versus PBSC versus cord blood)

Patients not in progression at 6 weeks post randomization (progression defined as primary failure) will be evaluated for remission (complete or partial) at 3, 6, 9, \& 12 months post randomization

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 60
* Any primary diagnosis requiring treatment by hematopoietic stem cell transplantation
* Recipient of a single allogeneic stem cell transplant (bone marrow or peripheral blood stem cells, or cord blood) minimum 80 days ago
* Received a graft from a related or an unrelated donor
* Conditioning regimen: Myeloablative or non-myeloablative
* Patients suffering a first episode of extensive chronic GvHD, without recurrent disease
* The diagnosis of chronic GvHD requires the following:

  * Distinction from acute GvHD
  * Presence of at least one diagnostic clinical sign of chronic GvHD or presence of at least one distinctive sign confirmed by pertinent biopsy or other relevant diagnostic tests
  * Exclusion of other possible diagnoses
* Receiving a standard prophylaxis regimen for acute GvHD: CsA plus methotrexate, or CSA+MMF for NMA, or a T-cell depleted transplant
* Patient gives written informed consent prior to randomization

Exclusion Criteria:

* Patient age less than 18 years or over 60 years.
* GvHD prophylaxis by tacrolimus plus methotrexate
* Delayed onset acute GvHD following NMA or DLI
* Second allogeneic stem cell transplant
* Not the first episode of chronic GvHD needing systemic immunosuppressive therapy.
* Limited chronic GvHD (Seattle criteria, see Appendix 1)
* Uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient's death within 1 week of randomization
* In the opinion of the investigator, if the patient has significant medical or psychosocial problems or unstable disease status
* Pregnant or lactating females
* Known hypersensitivity to mycophenolic acid
The Effects of the Endocrine System on Endometrial Cancer

Endometrial cancer usually begins in the endometrium, which is the tissue lining of the uterus. Endometrial cancer is the most commonly diagnosed gynaecological malignancy in Australia. It affects 1 in 80 Australian women and there are about 1400 new cases and 260 deaths from the disease every year. Most affected women are aged between 50 and 70 years. The purpose of this study is to investigate the possible role of the endocrine system in the regulation of human endometrial cancer. By looking at the laboratory results of people with endometrial cancer and also those without endometrial cancer we hope to gain a better understanding of how endometrial cancer develops and progresses. This may lead to the development of new, effective therapies for endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* women aged 18 years or older
* having a hysterectomy for the treatment of endometrial cancer, fibroids, chronic pelvic pain or abnormal uterine bleeding
* have provided informed consent
Nitroglycerin to Facilitate Radial Arterial Catheter Insertion in Children

Local nitroglycerin (NTG) was successfully used as a vasodilator to facilitate cannulation of the radial artery. NTG was used in adults by topical application as well as subcutaneous infiltration. Subcutaneous infiltration of NTG resulted in significant vasodilatation, improved palpability of the radial artery, reduced the number of punctures and the time needed for cannulation in adults. Topical NTG was reported to increase radial artery diameter in healthy volunteers without reduction in arterial blood pressure. In pediatric population, there no sufficient evidence for the effectiveness of NTG in improving radial artery cannulation. In a case report on two neonates, topical nitroderm ointment successfully reversed tissue ischemia secondary to radial artery cannulation The aim of this work is to evaluate the use of topical NTG (patch) for increasing the diameter of radial artery, improving the cannulation success, and decreasing catheter-related ischemic complications.

A written informed consent will be obtained from patient's parents or guardians. Randomization will be obtained using computer-generated sequence. Concealment will be obtained using opaque envelopes.

On arrival to the preparing room, patients will be randomized into one of the two groups:

- NTG group or, Control group

Ultrasound examination:

The diameter of radial artery will be measured using a linear, high frequency probe (12 mHz) of Simens machine. Measurement will be obtained in the short axis plane at the point with maximal pulsation. The point will be marked to guide the post-intervention examination. The operator will be an experienced single operator blinded to the study group. Measurements will be obtained in both limbs at baseline (before application of NTG patch application,30 minutes,60minutes after NTG application After induction of anesthesia, radial artery will be punctured by 22-g catheter by an experienced anesthetist

Eligibility Criteria:
Inclusion Criteria:

* children aged between 2 and 5 years scheduled for cardiac surgery

Exclusion Criteria:

* Systolic blood pressure less than 90 mmHg,
* previous radial artery puncture
* abnormal Allen's test
* hypercoagulable states
* coagulopathy
* previous vascular complications
S8809-S9800-S9911-S9704-A Study of Blood and Tissue Samples From Patients With Follicular Lymphoma Treated With Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at blood and tissue samples from patients with follicular lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone.

OBJECTIVES:

* To test for association of polymorphisms in Fc-gamma (Fcγ) receptors IIa (H/R131) and IIIa (V/F158) with progression-free survival and clinical response in patients with follicular non-Hodgkin lymphoma treated with rituximab and CHOP chemotherapy comprising cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone.
* To assess novel polymorphisms in Fcγ receptors for predictive and prognostic significance in patients treated with this regimen.

OUTLINE: Genomic DNA extracted from paired samples of serum and formalin-fixed paraffin-embedded tissue is analyzed for R131H polymorphism in Fcγ receptor IIa and V158F polymorphism in Fcγ receptor IIIa by TaqMan-based assay. The DNA is also analyzed for genotypes corresponding with several other polymorphisms in Fcγ receptors, as determined by the HapMap project. The resulting Fcγ receptor genotypes are then compared with clinical data from the Southwest Oncology Group database to identify associations between particular genotypes and progression-free survival, overall response, and complete response. A multivariate analysis incorporating clinical prognostic variables (e.g., age, stage, serum LDH level, extranodal disease, and performance status) is also performed to determine whether Fcγ receptor polymorphisms are independent predictive or prognostic markers for clinical outcome.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of follicular lymphoma
* Meets either of the following criteria:

  * Previously enrolled on clinical trial SW0G-8809 and treated with chemotherapy alone

    * Excess tissue sections available
  * Previously enrolled on clinical trial SWOG-9800 or SWOG-9911 and treated with a combination of chemotherapy and monoclonal antibody therapy
* Matched serum and tissue samples available from the SWOG Lymphoma Bank

PATIENT CHARACTERISTICS:

* See Disease Characteristics

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics