cyrilzakka/clinical-trials huggingface dataset:
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension

This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
* Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
* Compensated cirrhosis OR Decompensated cirrhosis with no more than 1 prior significant decompensating event
* Severe portal hypertension defined as HVPG ≥12 mmHg
* Subjects who are on NSBB, nitrates, diuretics, lactulose, rifaximin, or statins must be on a stable dose for at least 3 months prior to Day 1
* Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug

Exclusion Criteria:

* Evidence of severe decompensation
* Severe hepatic impairment defined as a Child-Pugh score ≥10
* ALT (alanine transaminase) \> 3 times upper limit of normal (ULN) or AST (aspartate transaminase) \>5 times ULN during screening
* Estimated creatinine clearance \<30 mL/min
* Prior transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure
* Known portal vein thrombosis
* Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy
* Current use of medications that are considered inhibitors of OATP1B1 and OATP1B3 transporters
* Alpha-fetoprotein \>50 ng/mL
* History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QTcF interval of \>500 msec
* History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
* Prior liver transplant
* Change in diabetes medications or vitamin E within 3 months of screening
* Uncontrolled diabetes mellitus (HbA1c \>9%) within 3 months of screening
* Significant systemic or major illness other than liver disease
* HIV infection
* Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening
* If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
* Previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to Day 1
Virtual Reality Pain Study

Investigating pain in hospitalized patients in two groups: virtual reality usage group vs standard of care

Patients will be randomized to either the virtual reality group or the standard of care group. The virtual reality group will use the device over two days. Both groups will answer questionnaires regarding their pain and anxiety. Medical records will be used to look at pain medication usage in both groups.

Eligibility Criteria:
Inclusion Criteria:

* • patients at least 18 years of age,

  * reported pain in last 24 hours ≥ 3 on the Numerical Rating Scales (NRS),
  * patients undergoing surgery,
  * expected hospital length of stay of at least 48 hours,
  * English fluency,
  * willing to comply with study procedures.
  * Hx opioid use

Exclusion Criteria:

* • gross cognitive impairment that would interfere with the ability to consent or complete study procedures

  * current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines,
  * hypersensitivity to flashing light or motion,
  * history of motion sickness or cyber sickness,
  * medical condition predisposing to or current nausea, vomiting or dizziness,
  * stereoscopic vision or severe hearing impairment,
  * injury to eyes, face or neck that impedes comfortable use of virtual reality,
  * cancer related pain,
  * PHQ-9 screen indicating suicidal ideation, patients will be referred to appropriate clinical intervention (see suicide protocol)
  * currently pregnant,
  * current or recent completion of participation in any interventional pain study (with in past 2 months)
  * substance abuse (alcohol or illegal drugs): Alcohol- NIAAA definition of heavy drinking as more than 4 drinks on any day or more than 14 drinks per week for men, more than 3 drinks on any day or more than 7 drinks per week for women. Any illegal drugs including marijuana
The Efficacy and Economics of Exercise Maintenance Post-Cardiac Rehabilitation

The purpose of this study is to develop a new intervention to improve the transition of patients from structured, supervised exercise to self-managed home- or approved community-based exercise programs in an effort to increase maintenance of exercise behaviour post cardiac rehabilitation (CR). The goal of the study is that those receiving the intervention will engage in at least 30 minutes of physical activity at a moderate or vigorous intensity 5 or more days per week, 26, 52 and 78 weeks after CR compared to those in the usual care group. The new intervention will be delivered by trained exercise facilitators (physiotherapists or exercise specialists) and will make use of: small group counseling teleconferences (5 sessions); personal telephone contacts (3 sessions), and community program demonstrations that would facilitate linkages between patients and approved community programs known as Heart Wise Exercise programs available in Ottawa and Toronto. The trial will be conducted at the Minto Prevention and Rehabilitation Centre at the University of Ottawa Heart Institute and the Cardiovascular Rehabilitation and Prevention Centre at the University Health Network (Peter Munk Cardiac Centre \[PMCC\] and Toronto Rehabilitation Institute \[TRI\]) sites. The study has a target enrollment of 604 participants.


Eligibility Criteria:
Inclusion Criteria:

* Patient is currently participating in an on-site CR program of ≥ 8-week duration (to ensure that outcomes are not confounded by exposure to home-based or telephone-based case managed programs)
* Patient has graduated from CR (to ensure that the study is evaluating an intervention to help sustain and improve maintenance of exercise behaviour
* Patient has a documented diagnosis of CAD (to ensure homogeneity of the patient population)
* Patient is 18 years of age or older
* Patient is able and willing to provide informed consent
* Able to walk unaided at 2 mph

Exclusion Criteria:

* Patient has New York Heart Association class III or IV heart failure (because this might interfere with the ability to achieve recommended exercise levels and to ensure homogeneity of the patient population)
* Patient is pregnant, lactating or planning to become pregnant during the study period (because this might interfere with the ability to achieve recommended exercise levels)
* Patient is unable to read and understand English or French
* Planning to leave the province or region in the next 12 months
* Member of the participant's household is already participating in the study
* The participant is unable, in the opinion of the qualified investigator, to participate in unsupervised exercise.
Building CAPACITI for Community-Based Palliative Care

The purpose of this cluster randomized controlled trial is to assess the efficacy of a quality improvement intervention called CAPACITI intended to increase competency among primary care teams to deliver early palliative care. CAPACITI is palliative care training and coaching program for primary care teams, comprised of three, two-month (4 session) modules, each addressing a critical component of implementing a palliative care approach into primary care practice.

Improving access to home-based palliative care can improve patient and system outcomes; however, there is a lack of programs to build capacity among primary care teams to deliver this care. To address this gap, the investigators are offering a quality improvement intervention called CAPACITI. CAPACITI is palliative care training and coaching program for primary care teams, comprised of three, two-month (4 session) modules. Each module addresses a critical component of implementing a PC approach into primary care practice: (1) Identify and Assess; (2) Enhance Communication Skills; (3) Enhance Skills for Ongoing Care (including involvement of family and specialists). Over bi-monthly (one hour) sessions, each CAPACITI module uniquely integrates 3 components: clinical education in the form of expert advice and tips; evidence-based tools; and high-facilitation and expert coaching for adaptation to local context. The study will offer the CAPACITI modules to primary care teams across Canada. Teams that register for a module will be randomized to one of two arms: 1) facilitated learning where the module materials are covered in live webinars, and 2) non-facilitated learning where teams have access to all module materials to use a self-directed approach. The online materials for both study arms will be provided on a learning management system. The investigators will examine the difference between the facilitated and nonfacilitated approaches in teams' abilities to provide a palliative care approach in relation to the content of the module. Ultimately this research program will strengthen the primary care system and increase access to home-based palliative care for patients across Canada.

Eligibility Criteria:
Inclusion Criteria:

* Each team must be comprised of primary care providers, defined as having a minimum of at least 1 of the following: family physician, nurse practitioner, or nurse and practice coordinator (including manager or administrator) that provides primary care. Teams can be a single provider. Teams can also have other team members (e.g. social worker, pharmacist, etc.).
* Each team must be community-based and willing to provide palliative care, defined as managing symptoms, addressing psychosocial needs, educating patients and families, and coordinating care.

Exclusion Criteria:

* Not community-based
* Not willing to provide palliative care
* Outside of Canada
Diffusion Basis Spectrum Imaging of the Prostate

Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age and willing and able to provide informed consent.
* Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")
* Including those men with:

  * an elevated PSA and no prior biopsy
  * an elevated PSA and a negative prior biopsy
* Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")

Exclusion Criteria:

* Patients with any clinical contraindication to MRI

  \*Including but not limited to:
  * Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators
  * Those with cochlear implants
  * Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)
  * Those who cannot lie flat for over 1 hour
* Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)
Using Preoperative Anxiety Score to Determine the Total Dose of Butorphanol for Sedation

Orthopedic surgeries are considered to be discomfortable and the sense of fear and anxiety of patients who already have preoperative anxiety may be aggravated by intraoperative stimulation, which may contribute to postoperative complications. Previous studies have found that high anxiety predicts increased sedative requirements. Therefore, the investigators explored the relationship between anxiety and intraoperative butorphanol requirements and the investigators evaluated the specific sedative requirement which can keep satisfactory sedative state for patients by preoperative anxiety score

A total of one hundred and eighteen patients who were to undergoing lower limb orthopedic procedures with spinal anesthesia were selected，the Amsterdam preoperative anxiety and information scale was used to evaluated the degree of preoperative anxiety one day before the surgery. Patients in preoperative anxiety group were randomly allocated to two groups: butorphanol group (Group A) and physiological saline group (Group B); Patients in non-preoperative anxiety group were also randomly allocated to two groups: butorphanol group (Group C) and physiological saline group (Group D). In Group A and Group C, patients received an intravenous loading dose of 15ug/kg butorphanol 5 min before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the Ramsay sedation score reached 4 points, Group B and Group D received an infusion of the same volume of physiological saline. The sedation scores were recorded 10 min after getting into the operation room and 5, 10, 15, 30min after infusion of butorphanol or physiological saline. The duration when Ramsay sedation score reached 4 points in Group A and C, adverse events and post-operative visual analgesia scale scores were also recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ
* 18-75 years
* Scheduled for elective low limb orthopaedic procedures under spinal anesthesia

Exclusion Criteria:

* central system disease
* cardiovascular disease
* autonomic nervous system disease
* long term use of analgesic, sedative, and anti-anxiety drugs
* psychosis
* a patient with a language communication disorder not willing to cooperate with the experimenter
$100Kitchen and Low-birth-weight Study in Rural Bangladesh

Low-birth-weight (LBW) is a major adverse pregnancy outcome in resource-poor countries. About 28% of all neonatal deaths worldwide are directly attributed to LBW. Exposure to biomass fuel during cooking is associated with LBW. There is unlikely to be any significant change in the use of biomass fuels in the near future, therefore, interventions targeted to reduce the harmful effects on poor pregnancy outcomes is warranted. To address this need, the investigators proposed a locally-made inexpensive prefabricated model of the "100-dollar-kitchen"($100Kitchen) with an improved cookstove for resource-poor settings. The improved cookstove of the $100Kitchen ensure complete incineration of the biomass fuels and thus, provided safeguard to the pregnant women using these fuels. This study has been measured the impact of our '$100Kitchen and improved cookstove' intervention as to whether a pregnant woman residing in a household with a '$100Kitchen and improved cookstove' is less likely to give birth to a LBW newborn. A cluster-randomized controlled trial has been adopted in Shahjadpur sub-district in Bangladesh and 628 and 639 pregnant women at 8-12 weeks gestational age enrolled for each intervention and control area respectively and followed-up through 42-days post-delivery. Birth outcomes have been noted and the newborns have been weighted within 72-hrs of the delivery. Non-invasive maternal blood Carbon Monoxide Hemoglobin saturation (SpCO) level between the intervention and control groups have also been measured.

A single-stage cluster sampling was followed. All the 'mouzas' (revenue villages) in Shahjadpur sub-district were divided into clusters so that each cluster contained a population of about 3,000. This generated 188 clusters. 104 out of 188 clusters-52 clusters for the intervention and 52 clusters for the control group - were randomly selected for the study to enroll the required 1300 pregnant women. Each cluster was then randomly allocated to either the intervention or control group using a computer generated random sequence. The random allocation sequence was generated independently by a statistician, who had no further involvement with the study. Once allocated, in each cluster all the eligible pregnant women were identified, invited, and enrolled during door-to-door visits by the project field staff. The field staff included female health workers, with the help of existing government community health workers such as family welfare assistants. A total of 628 eligible pregnant women were enrolled in the intervention clusters and a total of 639 eligible pregnant women in the control clusters. During the enrolment in the intervention clusters, a $100Kitchen with the improved cookstoves was installed at each of the 628 pregnant women's households following the verbal and written consent of the women and the household head.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women at 8 to 12 weeks gestational age

Exclusion Criteria:

* Pregnant women more than 12 weeks gestational age
PREoperativ Study of Exercise Training

Background Patients undergoing resection for gastro-esophageal (GE)-cancer are subjected to high burden of disease and treatment-specific morbidities with potential detrimental impact on survival and quality of life. Exercise training is a promising strategy to improve physical functional before and after tumor resection, but it is not established if this translates into lower risk of peri- and post-operative complications, improved treatment tolerance.

Objectives:

* To explore the effect a preoperative exercise-training intervention on the risk of treatment failure, defined as the risk of not reaching surgery, in patients diagnosed with operable GE cancer.
* To explore the effect of preoperative exercise training on median time to tumor progression (disease free survival), and overall survival
* To explore the effect of preoperative exercise training on the risk of treatment complications
* To explore the effect of preoperative exercise training on health related quality of life, anxiety and depression,cardiopulmonary fitness, muscle strength, and body composition

Subjects and Methods In total, 310 GE-cancer patients will be included in the study and randomly allocated to pre-operative exercise training (n=155) or usual care control (n=155). All participants will undergo 2 study visits; assessed for cardiopulmonary fitness; muscle strength, body composition; blood sample (50 ml); quality of life by questionnaires; physical function; and blood volume profile.

Quality of life will be assessed by questionnaires by self-report three times (at 12, 24, and 36 months after diagnosis), and we will collect data from medical records regarding mortality and disease recurrence up to 36 months after diagnosis.

Treatment arms:

The intervention-group will be prescribed 2-3 weekly supervised exercise training for a total of 12 weeks before surgery during neo-adjuvant chemotherapy. The control group will follow current usual care guidelines. After surgery during adjuvant chemotherapy, both groups will be referred to municipality-based rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* patients with histologically verified, resectable adenocarcinoma of the esophagus, stomach or gastro-esophageal junction

Exclusion Criteria:

* Deemed inoperable at the point of diagnoses
* Pregnancy
* Any other known malignancy requiring active treatment
* Not eligible for preoperative chemo- or chemoradiotherapy
* Performance status \> 1
* Physical disabilities precluding physical testing and/or exercise
* Inability to read and understand Danish
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation. Participants who were transferring from study 11702 DVT (NCT00440193) to the extension study 11899 (NCT00439725) did not enter the observational period.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
* Other indication for VKA than DVT and/or PE
* The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
Effect of Antidepressants on Back Pain

The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.


Eligibility Criteria:
Inclusion Criteria:

* Chronic back pain (pain on a daily basis for six months or longer)
* Age 18-65
* No major medical illness

Exclusion Criteria:

* medical contraindication to tricyclic antidepressants
* recent alcohol or substance use disorder
* bipolar disorder