cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
* Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months
* Screening HBV DNA ≥ 2000 IU/mL
* A negative serum pregnancy test is required for females (unless surgically sterile or \> 2 years post-menopausal)

Key Exclusion Criteria:

* Cirrhosis
* Inadequate liver function
* Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
* Received antiviral treatment for HBV within 3 months of screening
* Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
* Significant cardiovascular, pulmonary, or neurological disease
* Women who are pregnant or may wish to become pregnant during the course of the study
* Received solid organ or bone marrow transplant
* Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
* Use of investigational agents within 3 months of screening
* Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
* Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
* History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
* Documented history of yeast allergy
* Known hypersensitivity to study drugs, metabolites or formulation excipients
* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Individuals under evaluation for possible malignancy are not eligible

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Virtual Visitation in Intensive Care Unit Study

The purpose of this study is to identify the efficacy of virtual visitation in Intensive Care Unit on patients and their caregivers during COVID-19 Pandemic.

After being informed about the study, all patients who meet the eligibility requirements will be randomized in a 1:1 ratio to intervention group (Virtual visitation once a day) or Control group (Phone interviews once a day).

Eligibility Criteria:
Inclusion Criteria:

* Patients who are expected to stay in the intensive care unit for more than 48 hours
* Patients with a RASS score of -2 or higher

Exclusion Criteria:

* Patients who discharge or die within 48 hours of admission to ICU
Bortezomib in Treating Patients With Chronic Myelogenous Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have chronic myelogenous leukemia in chronic or accelerated phase.

OBJECTIVES:

* Determine the efficacy of bortezomib, in terms of response rate, duration of response, and survival of patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic or accelerated phase.
* Assess the toxicity of this drug in these patients.

OUTLINE: Patients receive bortezomib intravenous (IV) over 3-5 seconds twice weekly on weeks 1-2. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 5-30 patients will be accrued for this study within 15-30 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Philadelphia (Ph) chromosome-positive chronic myelogenous leukemia (CML) in chronic or accelerated phase, defined as having any of the following:

  * Peripheral blood (PB) or bone marrow (BM) blasts at least 10% but less than 30%
  * PB or BM blasts and promyelocytes at least 20%
  * PB or BM basophils at least 20%
  * Progressive splenomegaly (at least 10 cm confirmed twice at least 4 weeks apart or 50% increase in splenomegaly over 4 weeks)
  * Clonal evolution defined as the presence of additional cytogenetic abnormalities other than the Ph chromosome
  * Thrombocytopenia (platelet count less than 100,000/mm\^3) unrelated to therapy
  * Hemoglobin less than 7 g/dL unrelated to therapy or bleeding
* Failed prior treatment with imatinib mesylate or intolerant, unable, or unwilling to receive it
* Ineligible for higher-priority or higher-efficacy regimens or protocols
* No blastic phase CML

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

* At least 18 weeks

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Bilirubin no greater than 1.5 mg/dL

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min

Other:

* No other concurrent illness that would preclude study entry
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No more than 2 prior cytotoxic regimens in addition to imatinib mesylate and/or hydroxyurea
* At least 4 weeks since prior chemotherapy and recovered
* Concurrent hydroxyurea and/or anagrelide allowed during first 2 courses

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered

Surgery:

* Not specified

Other:

* See Disease Characteristics
* See Chemotherapy
* At least 24 hours since prior imatinib mesylate
* No other concurrent investigational agents
Regadenoson for Acute Vasoreactivity Testing in Pulmonary Hypertension

The purpose of this study is to see if Regadenoson may offer improved ease of use, single dose administration, and better tolerance for testing for pulmonary hypertension than iNO. You will be screened to make sure Regadenoson is safe for you with a clinical evaluation, blood tests, and an ECG.

Pulmonary hypertension (PH) is an increase of blood pressure in the pulmonary vascular system that could cause shortness of breath, dizziness, leg swelling and heart failure. .

The diagnosis of PH requires confirmation of elevated pulmonary pressures.. Right heart catheterization (RHC) is a procedure to determine the diagnosis of PH. .

This research study is looking at the effect of intravenous infusion of the medication Regadenoson on pulmonary vasodilator response compared to the inhaled nitric oxide (iNO) response. iNO is the current standard of care practice.

The purpose of this study is to see if Regadenoson may offer improved ease of use, single dose administration, and better tolerance for testing for pulmonary hypertension than iNO. You will be screened to make sure Regadenoson is safe for you with a clinical evaluation, blood tests, and an ECG.

You will be asked to sign this informed consent form. Then, you will undergo right heart catheterization as part of your clinical care. Those who are positive for pulmonary hypertension will then undergo Regadenoson infusion and a inhaled iNO. Prior to the infusion, subjects will be asked if they have had in the last 12 hours any caffeine-containing foods or beverages, caffeine-containing medications such as theophylline 12 hours prior. Vital sign measurements will be taken to measure your heart. For those subjects that have low heart volume they will be given 500 cc of normal saline in their IV. Vital sign measurements will be taken again to make sure your heart volume is in the normal range. The doctor will administer Regadenoson 0.4 mg intravenously and this will cause your heart rate to increase. The doctor will be taking heart measurements 90 seconds, 5 minutes, 10 minutes, and 20 minutes after administration. Approximately 30 minutes after the Regadenoson has been administered you will be given iNO by facemask for 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old
2. Diagnosis of RHC-proven PH

   * Mean pulmonary artery pressure (mPAP) \> 25 mmHg
   * Pulmonary vascular resistance (PVR) \> 3 woods units
   * Pulmonary capillary wedge pressure (PCWP) \< 15 mmHg).

Exclusion Criteria:

1. Second- or third-degree AV block or sinus node dysfunction
2. Known hypersensitivity to adenosine or regadenoson
3. Systolic blood pressure \< 90mm Hg
4. Active bronchospasm
5. Autonomic dysfunction as defined by prior diagnosis of:

   * Postural Orthostatic Tachycardia Syndrome (POTS)
   * Neurocardiogenic Syncope (NCS)
   * Neurally Mediated Hypotension (NMH)
   * Vasovagal Syncope
6. Hypovolemia
7. \> 40% Left main coronary stenosis
8. Moderate or \> valvular stenosis
9. Pericarditis/pericardial effusions
10. \> 70% carotid artery stenosis
11. Positive urine pregnancy test
Colorectal Cancer Screening Assessment Study

This study, led by the American Samoa Community Cancer Coalition's INdigenous Samoan Partnership to Initiate Research Excellence (INSPIRE) and the UH Cancer Center's project team including Dr. Cassel, will utilize a community-based and culturally relevant process to assess the uptake of fecal occult blood testing (FOBT) using tailored colorectal cancer patient education materials for those with inadequate health literacy. Our primary outcomes include: 1) process to develop "suitable" and "comprehensible" health promotion materials for populations in English and Samoan with various health literacy levels, 2) commitment to use the FOBT Colocare home kit, and 3) use of a FOBT Colocare home kit.

Utilizing the Behavioral Model of Health Services Use as a conceptual framework and the evidence-based program "Against Colorectal Cancer in Our Neighborhoods" (ACCION) for the Latino population in Texas as a guide, the proposed study will conduct a randomized controlled trial of Indigenous Samoan participants (N=312), age≥ 50 recruited using Respondent-Driven Sampling (RDS). This design will compare use of non-tailored instruction for completing ColoCare FOBT home-kits (N=156) versus the experimental condition, using a ColoCare FOBT home-kit with instructions tailored to low health literacy and to enhance CRC-Knowledge Attitudes and Behavior (KAB) - (N=156). Our goal is to test the influence of tailored materials on timely completion of CRC screening using the ColoCARE FOBT.

Eligibility Criteria:
Inclusion Criteria:

1. Resident of America Samoa
2. Over age 50
3. Have not been diagnosed or treated for colon cancer
4. Is not high risk for CRC by having family history or diagnosed with irritable bowel syndrome
5. Can read and speak English and Samoan (can provide written informed consent)
6. Have a home address and working phone
7. Is willing to provide information on their health behaviors

Exclusion Criteria:

* persons who indicate they speak or read and write Samoan or English less than well
A Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Malignant Lymphoma (0683-030)

The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral vorinostat in patients with malignant lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients who relapsed after complete or partial response, or ineffective in previous chemotherapy

Exclusion Criteria:

* Patients with history of chemotherapy, antibody therapy, radiotherapy, during the previous 4 weeks (6 months for radioisotope-labeled antibody)
* Any uncontrolled concomitant illness
* Are pregnant or breast-feeding
* Serious drug or food allergy
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injections of PG-102 (MG12) in Healthy Adult and Obesity Participants.

This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, combined single (Part A) multiple (Part B, C) ascending dose, phase 1 study to investigate the safety, tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102(MG12) in healthy adult participants.

This study will be conducted in 3 Parts (Part A, B and C), with up to 5 cohorts in each part.

Part A (SAD):

In Part A, subjects will receive a single dose of study drug, and the safety and efficacy of PG-102(MG12) will be evaluated in healthy subjects.

Part B (MAD):

In Part B, subjects will receive once-weekly doses of the study drug for 4 weeks, and the safety and efficacy of PG-102(MG12) will be evaluated in otherwise healthy overweight adult subjects.

Part C (MAD):

In Part C, obese participants will receive five repeated subcutaneous doses of the study drug, and the safety and tolerability of PG-102 (MG12) will be assessed across two cohorts based on prior safety data from Part B.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants, aged 18 to 65 years inclusive at the time of signing informed consent
2. Body mass index (BMI) of 18 to 30kg/m2 (inclusive) for Part A, Body mass index (BMI) of 25 to 30kg/m2 (inclusive) for Part B and Body mass index (BMI) 30 kg/m² or higher for Part C

\[Exclusion Criteria\]

1. History of administration of prescription drugs, herbal medicines, over-the-counter drugs, or vitamin supplements within 10 days prior to the study or history of the following drugs and/or other foods within 90 days prior to screening:

   * Drugs that affect body weight (such as obesity medications, psychiatric drugs, beta blockers, diuretics, contraceptives, female hormones, proton-pump inhibitors (PPIs), H2 receptor antagonists, health functional foods/supplements, and formulas designed for weight control).
   * Drugs that have the potential to impact blood sugar, liver fat, and intestinal microorganisms (including GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, thiazolidinediones (TZDs), fish oil, polyunsaturated fatty acids (PUFA), and ursodeoxycholic acid (UDCA)), as well as individuals who are currently using insulin.
2. History of gastrointestinal diseases (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of clinical trial drugs.
3. History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy.
4. History of surgical treatment for obesity within 2 years (example: bariatric surgery, gastric banding etc) or gastrointestinal procedures for weight loss (including LAP-BAND®), or uncontrolled gastrointestinal disorders at Screening (e.g., peptic ulcer, gastroesophageal reflux disease).
Virtual PREHAB Study for Patients Undergoing TAVI

Nova Scotians are aging and many are becoming frailer. People with frailty are more likely to live in worse health and do not recover well from major events, such as open heart surgery. Many people are also too frail to receive open heart surgery. Less invasive procedures called transcatheter aortic valve implantation, or TAVI, are provided for the frailest patients. While TAVI is life-saving, frailer patients are less likely to survive in better health after their operation. Patients in Nova Scotia can also wait up to 3-6 months for their operation where they become frailer or can die before receiving TAVI. The investigators believe that it is important to support these individuals to improve their frailty and overall health before their operation.

Center-based cardiac rehabilitation is offered to patients after, but not before TAVI to improve their health. Center-based preoperative cardiac rehabilitation (i.e., PREHAB) can safely improve the function of frail patients who received open heart surgery. However, many patients cannot come to a center-based PREHAB because of transportation requirements to access the program. Another option is to support these patients with virtually delivered PREHAB, where they can stay in their homes. However, this possibility has not been studied.

For this study, virtual PREHAB will be delivered using the virtual cardiac rehabilitation program in Nova Scotia to patients before TAVI. This intervention will be delivered by healthcare providers who routinely care for TAVI patients, including a medical director, program lead, nurse, physiotherapist, and dietician. Ther goal of this study is to determine if it is feasible and safe to use virtual PREHAB to reduce frailty before TAVI. This research fits with Research Nova Scotia's priorities to improve patient outcomes in those with significant long-term health conditions, and to provide accessible, safe, and quality virtual healthcare to patients so they can thrive after their operation.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre
* Informed written or verbal consent

Exclusion Criteria:

* New York Heart Association or Canadian Cardiovascular Score of 4
* Severe functional limitations
* Cognitive impairment that impacts consenting ability
* Significant language barrier
* No internet or telephone access that precludes virtual PREHAB participation
Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China

This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Toddlers 12-18 months of age who have previously participated in study M37P2.

Exclusion Criteria:

* Prior Hib booster administration.
* History of serious reaction(s) following vaccination.
* Vaccination within 14 days of study vaccination.
* Known or suspected immune impairment.
* For additional entry criteria please refer to the protocol.
Impact of Postoperative Medical Equipment Removal/insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit

A lot of observationnal studies describe parental stressors in PICU/PCICU, but none studied, prospectively, the links between medical equipment removal/insertion and anxiety modulation.

The primary objective is to identify the impact of medical equipment removal/insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via VAS).

A lot of observationnal studies describe parental stressors in Paediatric Intensive care Unit, but none studied, prospectively, the links between medical equipment removal or insertion and anxiety modulation.

The primary objective is to identify the impact of medical equipment removal or insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via Visual Analog Stress Scale.

Parents will fill out questionnaire upon arrival in the Intensive care unit when reaching the bedside of their hospitalized child right after the elective cardiac surgery. Then after each equipment removal or insertion they will be asked to fill out again the same questionaire.

Eligibility Criteria:
Inclusion Criteria:

* parents/legal tutor of minor patient (congenital cardiopathy) with elective hospitalization in PCICU for surgical procedures

Exclusion Criteria:

* Parents no french speaking
* child hospitalized for Cardiac Catheterization
* child hospitalized for Berlin Heart insertion
* child hospitalized for heart transplantation
Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model

This is a Phase I, randomised, double-blind, placebo-controlled, 4-way crossover study to investigate the PD effects, safety, tolerability and PK/PD correlation of two single oral dose levels of IP2015 compared to 300 mg pregabalin and placebo in healthy male subjects using the ID capsaicin model.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male, with a skin type compatible with capsaicin measurements.
* Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, clinical laboratory evaluations.
* Subject must be in good general health with a skin type compatible with the measures, and without significant skin allergies, pigmentary disorders, or any active dermatological conditions that might interfere with the conduct of the study.

Exclusion Criteria:

* Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion (ADME) of drugs, or with the completion of treatment according to this Protocol.
* Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic, or renal disorder).
* Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated to confirm eligibility or judged to be clinically irrelevant for healthy subjects.