cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Single-Dose Pharmacokinetics of Rilzabrutinib (PRN1008)

This is a single-dose study to assess the effect of mild or moderate Hepatic Impairment (HI) on the Pharmacokinetics (PK) of rilzabrutinib as well as to evaluate the safety and tolerability of rilzabrutinib in subjects with HI.


Eligibility Criteria:
Inclusion Criteria:

* Hepatic Impaired Subjects:

  * Non-smoking or light smoker (not exceeding 5 cigarettes per day), adult male or non-pregnant, non-lactating female, 18-75 years of age, inclusive, at screening.
  * Weight ≥ 50 kg, at screening.
* Healthy Subjects:

  * Non-smoking or light smoker (not exceeding 5 cigarettes per day), healthy, adult males and non-pregnant, non-lactating females, 18-75 years of age, inclusive, at screening.

Subject must be matched for age (within ± 10 years), and sex of the matched subject with hepatic impairment.

--Weight ≥ 50 kg at screening.

Additional inclusion criteria might apply.

Exclusion Criteria:

* Hepatic Impaired Subjects:

  * Pregnant or lactating female.
  * Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 millimeters of mercury \[mmHg\] and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate \< 45 or \> 100 beats per minute (bpm). Measurements may be repeated once in order to determine eligibility.
* Healthy Subjects

  * Pregnant or lactating female.
  * Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or resting pulse rate \< 45 or \> 100 bpm. Measurements may be repeated once in order to determine eligibility.

Additional exclusion criteria might apply.
A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis

The objective of this study is to evaluate the safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis over a 26-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female aged 18-55 years inclusive at screening
* Patients who have a definite diagnosis of relapsing-remitting Multiple Sclerosis

Exclusion Criteria:

* Multiple Sclerosis course other than relapsing-remitting multiple sclerosis
* History of malignancy
* History of clinically significant chronic disease of the immune system (other than Multiple Sclerosis)
* Inability to undergo Gd-enhanced MRI scans
* Diagnosis of diabetes mellitus (type I or type II)
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers

Maintenance of analgesia during a patient stay in the hospital has been an important area of investigation after demonstrating a direct correlation between level of sedation and mortality in the ICU setting. This study will investigate the use of accelerometers in determining patient sedation level.

The goal of the study is to use accelerometers to track patient movement while under sedation in the ICU. Analysis of patient movement may reveal objective means to measuring patient level of sedation. Average length of stay is estimated to be one week.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the neuro ICU at University of Minnesota

Exclusion Criteria:

* Unable to wear accelerometer device
Efficacy and Safety of Leningrado 5 Association in the Treatment of Hypertension

The purpose of this study is to evaluate the efficacy and safety of Leningrado 5 association on the treatment of hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years or more;
* Participants diagnosed with hypertension, not controlled by monotherapy and/ or lifestyle modification;

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* BP ≥ 180/110 mmHg;
* Participants with BMI (body mass index) ≥ 40 Kg/m2;
* Previous diagnosis of secondary hypertension;
* History of Target Organ Injury;
* History of cardiovascular, hepatic and renal disease;
* History of gout, Diabetes Mellitus and hypokalemia;
* Current medical history of cancer;
* Current smoking;
* History of alcohol abuse or drug use;
* Pregnancy or risk of pregnancy and lactating patients;
* Known allergy or hypersensitivity to the medicines components used during the clinical trial;
* Participation in clinical trial in the year prior to this study.
The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

The use of mesh in the repair of umbilical hernias is a gold standard. The best location of the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the surgery.

This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene for preperitoneal use), will be used in this multicentric trial, to evaluate the best procedure in terms of efficacy, safety and postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent from the patient or his/her legal representative
* primary umbilical hernia requiring elective surgical repair
* diameter between 0 and 3 cm

Exclusion Criteria:

* no written informed consent
* incisional hernia at the level of the umbilicus
* recurrent umbilical hernia, as they have to be considered an incisional hernia
* emergency surgery (incarcerated hernia)
* pregnancy
* non-compliance
Study to Determine the Effect of Synbiotics in Patients With Pre-diabetes

The aim of this study is to examine the effect of Metabolic Rheostat™ and Butyrate Ultra on blood glucose levels after a liquid meal challenge in patients with prediabetes. In addition, the study also aims to look at the effect of Metabolic Rheostat™ and Butyrate Ultra on weight, HgbA1c, fasting glucose, cholesterol, triglycerides, inflammation markers, and hormones.

This is a double blinded, pilot placebo-controlled trial of two interventions compared to placebo to determine the effects individually of Metabolic Rheostat™ and Butyrate Ultra daily consumption for 8 weeks on glucose homeostasis in subjects with prediabetes. The entire study will last 10 weeks including screen. The study will include 20 subjects with prediabetes treated with Metabolic Rheostat™; 20 subjects with prediabetes treated with Butyrate Ultra and 20 subjects with prediabetes treated with placebo. Participants will take 6 capsules daily, two capsules three times per day 30 minutes prior to each meal for 56 days.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects with pre-diabetes.
2. Age\> 18 years
3. Ability to understand and the willingness to sign a written informed consent.
4. Willing and able to comply with trial protocol and follow-up.

Exclusion Criteria:

1. Current use of any other investigational agent.
2. Current use of any agent for treatment of diabetes.
3. History of adverse effects, intolerance, or allergic reactions attributed to any medications.
4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
5. Abnormal blood analysis for complete blood count (CBC), hepatic and renal injury tests.
Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing

This study investigated the effectiveness of virtual reality (VR) distraction, compared to book distraction and no distraction, in reducing pain and anxiety during a medical procedure in a pediatric population: the skin prick test. Although this test has many advantages and is considered to be minimally invasive, it causes anxiety and painful discomfort in children. This study concerns children aged 4 to 7 years consulting for an allergic test. Outcome measures include pain score, level of anxiety, VR measures, and satisfaction questionnaires.

The use of skin prick tests is considered a gold standard in the evaluation of allergic reactions. These tests involve depositing a drop or small amount of the allergen on the skin and pricking the skin to let the allergen penetrate the epidermis. Although this test has many advantages and is considered to be minimally invasive, it causes anxiety and painful discomfort for children. Managing pain and anxiety during skin prick testing is essential to prevent long-term adverse effects, especially in the case of future needle-stick interventions. To our knowledge, the studies investigating distraction methods effect on reducing anxiety and pain during skin prick tests in childrenremain limited. No study has yet investigated the value of VR as a distraction tool in this field.

We postulate a greater decrease in child pain and child and parent anxiety in the RV and book conditions compared to the control group. We also postulate a larger effect for the RV group compared to the book group. In the VR group, we postulate the absence of an increase in post-immersion cybersickness symptoms. In last, we postulated a good satisfaction to distractions proposed, with a best score for RV distraction.

Eligibility Criteria:
Inclusion Criteria:

* speaking French regularly,
* requiring a skin prick test

Exclusion Criteria:

* have an epilepsy disorder
* have blindness
The Effect of the Release of the Intrathoracic Fascia on Thoracic Rotation Mobility

Testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility.

Subjects in the experimental group will undergo a technique for stretching the intrathoracic fascia. Before and after, a measurement will be performed with a goniometer, to see if there is a difference in thoracic rotation mobility.

Subjects in the placebo group get a different technique, where the hands of the therapists are simply placed on the thorax, but no manoeuvre will be performed. Before and after, there is a measurement in thoracic rotation mobility.

Data will be compared and statistical analyse will be done to see of there is a difference in rotation. So the hypothesis that stretching intrathoracic fascia has an effect on thoracic rotation mobility, will be accepted or rejected.

Eligibility Criteria:
Inclusion Criteria:

* Subjects between the age of 18 and 65
* Both men and women

Exclusion Criteria:

* Structural disease of cervical or/and thoracic spine and/or head and/or thorax
* Acute mobility restriction of cervical and/or thoracic spine
* Acute and/or intense pain
* A history of trauma and/or operation on cervical and/or thoracic spine
* Treatment for cancer like chemo or radiation
* Baby's and children
* Elderly people
Optimize RV Follow-up Selective Site Pacing Clinical Trial

The purpose of the Optimize RV Follow-Up study is to determine the long-term effect of selective site pacing. Selective site pacing refers to which area of the right ventricle the lead is placed. The goal of selective site pacing is to improve how the heart contracts when paced.

The Optimize RV Follow-Up Selective Site Pacing Clinical Trial is open to subjects that were previously enrolled in the Optimize RV Selective Site Pacing Clinical Trial.

Eligibility Criteria:
Inclusion Criteria:

* Subjects enrolled in the Optimize RV study (version 3, dated 6 March 2007)
* Subjects or legal guardians who are willing and able to sign an Informed Consent (and Authorization to use and Disclose Health Information Form, if applicable)

Exclusion Criteria:

* Subjects who have a device that was programmed outside the Optimize RV programming requirements
* Subjects implanted with and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
* Subjects who are pregnant or nursing
Relative Bioavailability of Olodaterol and Fluconazole

This clinical trial is intended to investigate a possible effect of the CYP 2C9 inhibitor fluconazole on the bioavailability of olodaterol


Eligibility Criteria:
Inclusion criteria:

Healthy male and female volunteers
Functional MRI in Lupus Nephritis

The primary objectives of the study are as follows: To develop and optimize a renal functional magnetic resonance imaging (MRI) protocol consisting of Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen- Level-Dependent MRI (BOLD-MRI), Arterial Spin Labeling MRI (ASL-MRI), Phase Contrast MRI (PC-MRI), and T1rho-MRI; To compare renal functional MRI cross-sectional readouts between normal healthy volunteers (NHV) and lupus nephritis (LN) participants.

The secondary objectives of this study are as follows: Explore whether renal functional MRI techniques discriminate between renal inflammatory activity and damage in lupus nephritis (LN); To examine whether renal functional MRI measurements correlate with laboratory features of renal involvement and renal function in participants with lupus nephritis (LN).


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a documented diagnosis of systemic lupus erythematosus (SLE) according to current American Academy of Rheumatology (ACR) criteria. At least 4 American Academy of Rheumatology (ACR) criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti-Sm, or anti-double stranded DNA antibody.
* Must have a standard of care renal biopsy for lupus nephritis performed or scheduled within +/-7 days of Day 1.

Key Exclusion Criteria:

* Has a metal device affected by magnetic resonance imaging (MRI )(e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator), or has potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) that would be a contraindication for magnetic resonance imaging (MRI).
* History of renal transplant.
* Subjects with uncontrolled diabetes or other condition that may result in significant renal disease.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Physical Activity Program Implementation in Hospitalized Positive COVID-19 Older Adults

Our hypothesis was that physical activity program will be acceptable and may counteract physical and mental decline among older adults hospitalized in COVID-19 unit

The 30 second chair test, balance with joint-feet and semi-tandem stance, and 4 meters comfortable walking test were evaluated. Depending on their score, a specific physical activity (PA) program was selected and explained. The program was printed, explained and left in the room. This intervention included 5 different PA programs.

Final evaluation (one day before leaving the unit) recording physical performance (same physical tests used for inclusion evaluation), Hospital Anxiety and depression (HAD) score, Activities Daily Living (ADL) and self-satisfaction of the program.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 75 years and over
* Hospitalized in a French COVID-19 geriatric unit
* Positive COVID-19 infection made by Real-time Polymerase Chain Reaction COVID-19 or suspected on thoracic lesions on computerized tomography.

Exclusion Criteria:

* Exclusion of patients of palliative care,
* Severe dementia or Mini Mental State Examination (MMSE) \[14\] below 18/30
* Acute COVID-19 complication.
* Activities of Daily Living \< 2/6
Motivational Program on Physical Activity in Cardio-respiratory Patients: an RCT Study

According to actual scientific evidence, the interventions on the general population aiming at regular physical activity are one of the most efficient strategies for health improvement. Regardless of this evidence, there is a large part of the elderly population does not adhere to the recommendations of the international guidelines on daily physical activity.

This is even more evident in patients with chronic respiratory and cardiological disease because exercise exacerbates existing symptoms of breathlessness.

This study aims to evaluate the impact of an in-hospital motivational program dedicated to increasing physical activity. With the data of an electronic wristwatch that keeps records of movement, the health professionals incentive an increase in physical activity leading to long term behavioural changes (evaluated by the number of steps per day) in hospitalized patients with COPD and HF, which already perform a standard rehabilitation program (14 sessions).

There are studies in the literature that have reported, in comparison with healthy subjects, a lower level of physical activity in COPD patients; other studies associate less physical activity with increased risk of hospitalization and mortality, which is even more evident considering patients with chronic respiratory diseases. In the same way, patients with Heart Failure (HF) reduce their activity and exercise capacity increasing hospitalization and mortality.

With more fatigue and dyspnoea, a vicious circle is created, with a consequent further reduction of levels of physical activity and worsening of symptoms.

Therefore, it is necessary to provide augmented physical activity in rehabilitation hospital environments.

Rehabilitation is a way to encourage and support patients to achieve their best physical condition. At present, COPD and HF patients admitted in rehabilitative cardio-respiratory wards dedicate a limited amount of time to physical activity, when referred to the entire day of hospitalization, whereas the rest of their time is spent in a sedentary condition. Thus, it is difficult to imagine that an actual change in the patients' lifestyle can be obtained by such a cardio-respiratory rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years, both of genders;
* Scheduled time of hospitalization of at least 14-16 days;
* Ability to walk by themselves, with safety (SPPB \>10);
* Hospital admission with a diagnosis of COPD (GOLD III-IV, B-D), with or without respiratory failure, or HF (NYHA II-III), sufficiently stabilized with a specific pharmacological therapy
* Possession of a smartphone and ability to use the app for health tracking.

Exclusion Criteria:

* Significant symptoms of the primary disorder, not properly stabilized;
* Hemodynamic and clinic instability;
* Musculoskeletal issues or other types (neurological, orthopedical...), which involve an important limitation in physical exercise performance;
* Medical comorbidities with a life expectancy shorter than one year;
* Clinical signs of cognitive impairment (MMSE \< 25).
Stem Cell Therapy in Incurable Neurological Disorders

The purpose of the study was to analyze the benefit of autologous mononuclear cell therapy in incurable neurological disorders.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed cases of incurable neurological disorders
* age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia
* pregnancy
* lactation
Registry of COVID-19 Patients at AOUI Verona

The registry of COVID-19 patients was designed to collect epidemiolgical, demographic, clinical, anamnestic and outcome information together with serological and microbiological samples from COVID-19 patients admitted at the University Hospital of Verona (Azienda Ospedaliera Universitaria Integrata, AOUI Verona). All SARS-CoV 2 positive patients admitted and able to give an informed consent are included, irrespectively of age and gender.

Anamnestic data are collected at the enrollment, while all the other clinical and epidemiological information are retrieved retrospectively from patients' medical records and electronic health records.

Serological and microbiological samples (blood samples, fecal samples and nasal/rectal swabs) are collected within 48 hours after admission and during the hospital stay, according with routine internal procedures.The biological samples are stored at the University Laboratory for Medical Research (Laboratorio Universitario di Ricerca Medica, LURM).

A dedicated database has been created and implemented to collect all the above mentioned information.

Eligibility Criteria:
Inclusion Criteria:

* PCR for SARS-CoV 2 positive on NPS swab or high suspicion of SARS-CoV 2 with ongoing swab;
* All ages;
* All genders;
* Informed consent obtained.

Exclusion Criteria:

* Failure to obtain the informed consent.
Comparing the Efficacy of the Alcohol Help Centre and Check Your Drinking to a no Intervention Control Condition

Alcohol is one of the leading contributors to premature mortality and disability. Most people with alcohol problems will never seek treatment. There is a need to develop alternate ways to help problem drinkers outside of formal treatment settings.

One promising strategy is Internet-based interventions for problem drinkers. Our recently completed RCT comparing a brief (Check Your Drinking; CYD) versus an extended (Alcohol Help Centre; AHC) Internet intervention for problem drinkers found that, while there was a reduction in drinking across time for both interventions, there was no significant (p \> .05) difference in reductions in drinking between the two interventions. Based on these results, it is not justifiable to say that either intervention 'worked' as there was no comparison condition of participants who received no active intervention. The current trial proposes to address this limitation by conducting an RCT comparing the CYD, AHC, and a no intervention control condition.

Participants will be recruited through Amazon's MTurk crowdsourcing platform. Participants identified as problem drinkers based on an initial survey will be invited to complete another survey in 6 months time. Those who are interested will be randomized to receive access to the Check Your Drinking screener (CYD condition), Alcohol Help Centre (AHC condition) or a feedback questionnaire (control condition). At six-months post-baseline, the MTurk portal will be used to send invitation emails that contain a link to the follow-up survey. The primary hypothesis to be tested is that participants receiving access to the AHC intervention will report a greater reduction in AUDIT-C scores and in number of drinks in a typical week than participants in the CYD intervention. Further, participants in the CYD condition will report a greater level of reduction AUDIT-C scores and in number of drinks in a typical week between the baseline survey and six-month follow-up as compared to participants in the no intervention control condition.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
* Typically consumes 15 or more drinks per week,
* Willingness to complete a 6-month follow-up survey

Exclusion Criteria:None

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