cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effect of Omeprazole on the Pharmacokinetics of BMS-986205 in Healthy Participants

The purpose of this study is to assess the effect of multiple dose administrations of Omeprazole on the pharmacokinetics of BMS-986205.


Eligibility Criteria:
Inclusion Criteria:

* Health male and female participants (not of childbearing potential) as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) greater than or equal to (\>=) 80 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2)
* Body mass index (BMI) of 18.0 kilogram per meter square (kg/m\^2) to 32.0 kg/m\^2
* Women participants must have documented proof that they are not of childbearing potential

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding
* Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years
* Concomitant use of strong inhibitors or strong inducers of CYP3A4
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
Detection and Neurological Impact of CerebroVascular Events In Noncardiac Surgery PatIents: A COhort EvaluatioN

The NeuroVISION Study will characterize the incidence, impact, and risk factors of covert stroke in adults undergoing noncardiac surgery. We will determine the incidence of acute covert stroke using an MRI study of the brain in the days following noncardiac surgery. We will characterize the epidemiology and the impact of covert stroke in patients undergoing noncardiac surgery, and its association with cerebral deoxygenation.

At the University of Wisconsin a planned sub study of NeuroVISION is being conducted aiming to enroll 100 patients with additional cognitive testing, MRI sequences and a preoperative MRI scan.

At Hamilton Juravinski Hospital, Hamilton General Hospital, Auckland City Hospital and Prince of Wales Hospital a planned sub study of NeuroVISION (PAFS - Perioperative Atrial Fibrillation and Postoperative Stroke) is being conducted aiming to enroll 400 participants. The purpose of this sub-study is to determine the prevalence of AF(Atrial Fibrillation) before surgery (i.e. "background" AF), as well of the incidence of AF after surgery using the Icentia CardioSTAT "patch-like" single lead heart rhythm monitor.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years old
* An anticipated hospital stay of at least 2 days after elective noncardiac surgery that occurs under general or neuraxial anesthesia
* Written informed consent for potential participation prior to noncardiac surgery

Exclusion Criteria:

* Contraindication to MRI (e.g. implanted devices not safe for MRI studies, claustrophobia)
* Unable or unwilling to attend the follow-up appointments
* Documented history of dementia
* Residing in a nursing home
* Undergoing carotid artery surgery or intracranial surgery
* Unable to complete neurocognitive testing due to language, vision or hearing impairment
* Unable to communicate with the research staff due to language barriers
* Patients who do not undergo their research MRI study after surgery
* Patients who do not complete a baseline MoCA questionnaire
* Patients who suffer an acute overt clinical stroke after the index surgery, but before their research MR study
* Previously enrolled in the NeuroVISION Study.
Comparative Study of Opioid-Free Anesthesia Versus Opioid Anesthesia in Patients Undergoing Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is an effective surgical approach for the treatment of gallbladder disorders such as cholecystitis, gallbladder stones or gallbladder polyps. Although the surgical technique for the treatment of cholecystitis with laparoscope shows some gains compared to open surgery, postoperative complications such as abdominal incision pain, nausea and vomiting, or other complications are still challenging issues.

Thus, there is a need to study and evaluate new non-opioid pain medications after laparoscopic cholecystectomy as part of an opioid reduction strategy.the aim of the study is To compare the effectiveness and safety of opioid-free anesthesia versus opioid-based anesthesia in patients undergoing laparoscopic cholecystectomy, focusing on pain management, postoperative recovery, and incidence of adverse effects.

Anesthesia requires a full spectrum of drugs, from which an anesthetic plan can be applied to achieve the desired level of sedation, analgesia, amnesia, muscle relaxation, and reflex abolition.

Opioid administration as a bolus dose or continuous infusion is commonly used by anesthesiologists in major and day care surgeries. Using of opioids during anesthesia is associated with various opioid-related adverse effects such as respiratory depression, opioid-induced hyperalgesia, nausea and vomiting, urinary retention, paralytic ileus, and the risk of cognitive and sleep dysfunction , This negative side effect profile of opioids may cause delayed recovery and discharge of patients from the post-anesthesia care unit as well as unanticipated hospital readmissions.

The emergence of opioid-free anesthesia was prompted by the adverse effects of opioids and the ongoing opioid epidemic.

Opioid-free anesthesia is a multimodal anesthetic and analgesic without the use of opioid drugs and can play a crucial role in enhanced recovery after surgery.

Eligibility Criteria:
Inclusion Criteria:

* o Adults aged 18-65 years.

  * Scheduled for elective laparoscopic cholecystectomy.
  * ASA Physical Status I-III.
  * Provided informed consent.

Exclusion Criteria:

* patients with a history of alcohol or drug abuse.

  * Chronic opioid use or dependence.
  * basal heart rate (HR) ≤ 50 beats/min.
  * Allergies to study medications.
  * Severe renal or hepatic impairment.
  * Pregnancy or lactation.
The Effect of Dry Needling and Prolotherapy on Pain, Function, and Quality of Life in Patients With Cervical Radiculopathy.

Cervical radiculopathy is characterized by neurological dysfunction caused by compression and inflammation of the spinal nerves or nerve roots of the cervical spine. Rolotherapy is a regenerative therapeutic method that consists of injecting irritant solutions into the injured areas.

Hyperosmolar dextrose is the most common agent. Administering proliferant substances can accelerate the tissue healing process by inducing cellular rupture and inflammatory response, leading to collagen deposition, cellular growth factor production, and regeneration. Dry needling used to relieve trigger point release in deep and superficial muscles. Both treatment interventions will apply to cervical radiculopathy patients to measure the effectiveness of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age group between 20-50 years
* Both male and female
* Unilateral pain starting in the cervical spine and radiating to the upper limb.
* Pain aggravated by upper limb movement
* Restricted range of motion of arm

Exclusion Criteria:

* History of Spinal infection
* Spinal Cord Injury
* History of Vertebral tumor and factures
* History of cervical or intracranial surgery
* History of Radiating pain to bilateral upper limb.
Pretreatments of the Skin Prior to PDT

The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT).

The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT). The pretreatments include: microneedling, sandpaper, curettage, ablative fractional laser and non-ablative fractional laser. 17 treatment areas are mapped on the upper back of the participants. Each participant receives each intervention in a random sequence.

Primary outcome measure: PpIX accumulation after 3 hours incubation with MAL. Secondary outcome measures: pain during treatment and skin reactions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, healthy, fair skinned (skin type I-III)

Exclusion Criteria:

* Pregnant women
* Tattoos, moles or scars in treatment area
BMI Development and Risk of Overweight and Obesity in Children

The goal of this observational study is to investigate differences in attained BMI and the proportion of overweight/obesity at school entrance in children who attended kindergartens actively delivering a community-based health promotion and obesity prevention intervention compared to children who attended usual care kindergartens. Further questions it aims to answer are:

* Explore the prevalence of attainted overweight/obesity in children at six years of age, who attended kindergartens delivering intervention compared with usual care kindergartens.
* Explore the development of obesity, overweight and normal weight in children from three-, four- to six years of age, who attended kindergartens delivering intervention.


Eligibility Criteria:
Inclusion Criteria:

* All children with eligible information on one measure of BMI after school entrance

Exclusion Criteria:

* \<7 years of age
Alcohol Biomarkers in Post-Liver Transplant Patients

The aim of this study is to compare the predictive validity and reliability of PEth testing at detecting alcohol use in post liver transplant patients. A prospective cohort study will be used to test the primary hypothesis. Subjects enrolled in the study will be followed for 12 months with biomarker levels drawn at baseline, six and 12 months. The baseline interview will inquire about the previous 30 day alcohol and tobacco use; lifetime and 12 month Diagnostic and Statistical Manual-IV criteria for alcohol abuse and/or dependence; prior alcohol treatment; history of abstinence prior to transplant; co-morbid medical issues; and depression. The six and 12 months interview will focus on previous 30 day alcohol use. The baseline, six and 12 months interviews will be conducted face-to-face at each site. While many patients who receive a transplant do not live near the academic medical center that performed the surgery patient, they normally have a transplant clinic visit 1-2 times per year. Medical records and transplant databases will be assessed to assess the other variables of interest.

Patients who have a positive PEth will be asked to have a confirmatory test performed 10-14 days after a positive result (PEth \>20ng/ml). The rationale for this procedure is to determine the test retest reliability of this marker and as well as being able to correlate levels of drinking with changes in biomarker levels over time. There is limited information on the length of time PEth levels remain elevated in transplant patients after drinking episodes.

Hypothesis H.1. PEth will have a significantly higher "area under the Receiver Operating Characteristic (ROC) curve" in a sample of post-transplant patients who report any alcohol use in the past 30 days compared to the control group.

H.2. PEth will have a significantly higher "area under the ROC curve" in a sample of post-transplant patients who report daily alcohol use of \>40 grams/day (three drinks/day) in the past 30 days compared to the control group.

H.3. PEth will have a significantly higher "area under the ROC curve" in a sample of post-transplant patients who report heavy episodic drinking (\>60 grams of alcohol, eight or more occasions in the past 30 days) compared to the control group.

H.4. PEth levels will be \<20 ng/ml in the control sample of 50 post transplant patients who do not have a history of alcohol dependence or alcohol related liver disease.

H.5. The test-retest reliability of PEth will be \>0.90.

Eligibility Criteria:
Inclusion Criteria:

* men and women 18 years and over
* Participant must have received a liver transplant after January 1, 2003
* Participant must be six months or more post-transplant
* Mini-mental status score of greater than or equal to 20
* Participant must be well enough to participate in the research procedures over a 12 month period
* Participant must continue to be followed by the transplant center

Exclusion Criteria:

* Individuals who do not consent
The Effect of Non-nutritive Sucking on Pain During Examination for Retinopathy of Prematurity

Aim: The aim of the study is to determine the effect of non-nutritive sucking on pain during examination for retinopathy of prematurity.

Method: The study is conducted as a randomized controlled trial. The population of the study is premature newborn who treatment in a neonatal intensive unit. The premature newborns divided into two groups as an intervention and control group according to randomization. After the randomization, non-nutritive sucking is applied to the intervention group. No method is applied to the control group.

A topical anesthetic will be applied to all premature newborns 30 seconds before eye examination. Non-nutritive sucking is applied to the intervention group during the examination for retinopathy of prematurity. No method is applied to the control group during the examination for retinopathy of prematurity

Eligibility Criteria:
Inclusion Criteria:

* having an examination for retinopathy of prematurity for the first time,
* age was between 28-35 weeks

Exclusion Criteria:

- having no congenital anomalies
Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults

Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity.

Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. ECC contractions are significantly more damaging to the muscles and produce greater muscle strength, for these reasons there is a greater risk of inducing muscle damage before the muscle is able to adapt.

Parmigiano Reggiano (PR) has some peculiar bromatological characteristics. The proteins contained in it, and in particular the potentially bioactive peptide sequences, can rapidly provide the amino acids necessary to promote muscle growth and repair during exercise. Furthermore, PR can be an important source of fatty acids, of which a significant amount of short-chain fatty acids (SCFA) which are known to have important clinical effects on body composition and metabolic health and can have a systemic anti-inflammatory effect.

Therefore, the central hypothesize is that PR consumed while being engaged in a RET can provide more energy substrates and improve muscle recovery, redcue inflammatory markers and improve lipid metabolism. To date, no studies have studied its function on recovery from exercise nor in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* age \>60 years
* BMI \>18 and \<30 kg/m2
* stable body weight in the past 3 months
* valid medical certifacate for practice of physical activity

Exclusion Criteria:

* diabetes or pre-diabetes as for ADA guidelines
* chronic diseases (cardiovascular, liver, respiratory, cancer, etc)
* acute inflammatory status
* regular practice of intense physical activity (\>2 sessions/week)
* treatment with steroids in the past 3 months
* regular use of \>50g/die of Parmigiano Reggiano
Abdominoperineal Extra-Elevators Rectal Resection for Cancer: Prone Position vs. Supine Position

Prospective multicenter randomized controlled trial comparing the prone vs. the supine position of the perineal time of the Miles operation in patients with advanced rectal cancer.

Primary objective:

- Pathological circumferential resection margin

Secondary objectives:

* 5 year oncological outcomes
* Morbimortality rates
* Surgical specimen quality
* Perineal hernia incidence


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary low lying rectal cancer involving or threatening anal sphincter complex as seen in MRI

Exclusion Criteria:

* American Society of Anaesthesiologists classification of Physical Health (ASA) IV patients
* Locally palliative purpose of the operation
* Age \< 18 years
* Preoperative indication for pelvic exenteration
* Pregnancy
* Lack of patients consent
Effect of Magnesium Supplementation in COPD

Magnesium (Mg) is involved in several pathways that could be affected in chronic obstructive pulmonary diseases (COPDs), namely in the contractility and excitability of neuro-muscolar endothelial cells and low-grade inflammation, a typical state of COPD. In this sense, several randomized controlled trials (RCTs) confirmed a positive role of Mg in asthma since long-period oral supplementation of Mg leads to a clinical and spirometric improvement.

Subjects with COPD seem to have a reduced bioavailability of Mg probably due to the use of drugs that may increase Mg losses (e.g. beta-agonists and cortisones), to a reduced dietary Mg intake, and heavy smoking. A recent study showed that the administration of endovenous or aerosol Mg sulphate with beta-agonists acutely improve maximum expiratory flow during COPD relapses as well as the prolonged treatment with endovenous sulphate Mg led to a reduction in pulmonary hyperinflation and increase in muscles involved in respiration, with a consequent clinical and instrumental improvement.

These evidences suggest that a chronic supplementation with Mg could improve COPD in clinical and instrumental parameters, but, at the best of our knowledge, no study was available in this sense.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years).
* Moderate-severe COPD (FEV1 between 30-80% of theorical values).

Exclusion Criteria:

* Already taking magnesium or calcium supplementations.
* Severe renal (creatinine clearance\< 30 ml/min) or hepatic decline or presence of other co-morbidities interfering with outcomes (e.g. dementia).
* Hypermagnesemia (serum Mg\>1.85 mmol/L).
Early Recognition of Pulmonary Arterial Hypertension in Myelodysplastic and Myeloproliferative Diseases

Myelodysplastic and myeloproliferative Disease represent conditions with increased risk for pulmonary hypertension. However, the exact prevalence of pulmonary hypertension in these conditions is not known. The effects of pulmonary hypertension on the clinical picture and the symptoms of patients in these conditions needs also further exploration. This exploratory study is designed to describe the prevalence of pulmonary hypertension in the population with such hematologic diseases, and the stages of pulmonary hypertension as well its effect on exercise capacity at time of diagnosis.

For early recognition of pulmonary hypertension exercise doppler echocardiography will be used in all patients. Patients with elevated pulmonary arterial pressure at rest or during exercise (estimated by echocardiography), or with decreased exercise capacity (as a potential sign of pulmonary hypertension) are advised to undergo right heart catheterisation. Cardiopulmonary exercise testing and six-minute walk distance measurement are performed to measure exercise capacity. The described work-up of patients allows precise and objective hemodynamic and clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* myelodysplastic disease or myeloproliferative diseases

Exclusion Criteria:

* known pulmonary hypertension
* relevant pulmonary disease
* relevant left cardiac or valvular disease
* recent major operations
* recent changes in medications
* relevant anaemia
* inability to exercise
Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.

The purpose of this study is to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up.

All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50 per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18-70
* Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks
* 7-day average pain score of at least 4 on VAS scale

Exclusion Criteria:

* Systemic diseases (Diabetes, malignancies, infections, etc.)
* Post-traumatic arthritis
* Patient had intra-articular injection on affected knee in last three months
Bone Marrow Derived Adult Stem Cells for Dilated Cardiomyopathy

A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary injection of progenitor cells compared to placebo injection in patients with Dilated Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo injection


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients with a confirmed diagnosis of dilated cardiomyopathy (NYHA II-III) attending their local 'Heart Failure clinic' who are on optimal heart failure treatment, under supervision from their physician or heart failure nurse specialist, and have no other treatment options
* Patients who are NYHA II that have been hospitalised with a dilated cardiomyopathy related condition
* Coronary angiography will be performed where necessary to confirm the diagnosis and ensure no other conventional treatment options are indicated
* Prior to recruitment to the study patients at risk of ventricular arrhythmia will have undergone electrophysiological assessment and appropriate clinical management (including implantable defibrillator insertion) where indicated (as per NICE guidelines)

Exclusion Criteria:

* NYHA I
* Referral hospitals most recent documented ejection fraction of \>45% (any imaging modality)
* The presence of cardiogenic shock
* The presence of acute left and/or right sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
* Known severe pre-existent left ventricular dysfunction (with a documented ejection fraction of \<10% from referral hospital) prior to randomisation
* Congenital cardiac disease
* Cardiomyopathy secondary to a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia
* Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
* Previous cardiac surgery
* Contra-indication for bone marrow aspiration
* Known active infection
* Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), HTLV or syphilis.
* Chronic inflammatory disease requiring ongoing medication
* Serious known concomitant disease with a life expectancy of less than one year
* Follow-up impossible (no fixed abode, etc)
* Patients with an irregular heart rhythm (AF allowed if paced in a regular rhythm)
* Patients with renal impairment (Creatinine \>200mmol/L)
* Neoplastic disease without documented remission within the past 5 years
* Weight\>140kg
* Subjects of childbearing potential