cyrilzakka/clinical-trials huggingface dataset:
Gastric Neuromuscular Function in GERD

Bodysurface gastric mapping (BSGM) will be used to assess gastric neuromuscular function in healthy controls and patients with medical refractory gastroesophageal reflux disease (GERD).

Participants will undergo BSGM for 4-hours in addition to high resolution manometry (HRM), pH-impedance monitoring, and gastric emptying breath test.

This is a clinical trial of a non-invasive BSGM medical device (Gastric Alimetry) in patients with medical refractory GORD and healthy controls to determine the differences in gastric electrical activity, and correlate with adjacent measurements of gastro-esophageal function.

Patients referred to the Functional Gut Clinic for standard care investigation of GORD with HRM and pH-impedance monitoring will be recruited. Healthy volunteers will be recruited via advertisement.

All patients and healthy volunteers will undergo BSGM at the research site, which lasts around 4.5 hours. After a 0.5 hour baseline, subjects will undergo HRM and pH-impedance monitoring concomitantly. A test meal of porridge with C13 labelled octanoic acid will be consumed with BSGM and breath samples recorded for 4.0 hours after meal completion. The HRM catheter will be removed after 1.0 hour from finishing the test meal whist the pH-impedance monitoring will continue for the remainder of the site visit and for the remainder of the 24-hour study period whilst the subject is at home to quantify reflux.

Eligibility Criteria:
Healthy controls

Inclusion Criteria:

* Aged 18-70 years old
* BMI 18-35
* Able to understand written and spoken English
* Able to provide written consent
* Able to understand risks and benefits

Exclusion Criteria:

* Antacid use (e.g. PPI, H2RA or Gaviscon) within last 12-months
* Active use of other medications known to impact gastric motility
* Upper GI symptoms including but not limited to heartburn, regurgitation, epigastric pain, nausea and bloating
* Significant medical condition
* History of skin allergies or hypersensitivity
* Active abdominal wounds or abrasions, fragile skin
* Current pregnancy
* Vulnerable group e.g. prisoners/cognitive impairment/institutionalised individuals
* Regular cannabis users (unable to abstain for 7-days)
* Opioid user
* Unable to use a tablet device

GORD patients

Inclusion Criteria

* Referred for 24-hour pH-impedance monitoring
* Aged 18-70 years old
* BMI 18-35
* Able to understand written and spoken English
* Able to provide written consent
* Able to understand risks and benefits

Exclusion Criteria

* Systemic or metabolic disorder known to cause gastric dysmotility other than diabetes (e.g. scleroderma, multiple sclerosis, hyperthyroidism).
* History of upper GI surgery or hiatal hernia (\>5cm, paraesophageal, or 'large' on endoscopy report)
* Diabetic and on insulin
* Proven mechanical bowel obstruction
* History of skin allergies or hypersensitivity
* Active abdominal wounds or abrasions, fragile skin
* Current pregnancy
* Vulnerable group - prisoners/cognitive impairment/institutionalised individuals
* Regular cannabis users (unable to abstain for 7-days)
* Opioid user
* Unable to use a tablet device
Managing Non-acute Subdural Hematoma Using Liquid Materials：a Chinese Randomized Trial of MMA Treatment

MAGIC-MT study is multi-center, prospective, randomized (1:1) controlled trial designed to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.

The objective of this study is to show that additional MMA embolization with Onyx in patients with non-acute symptomatic subdural hematoma(SDH) results in reduced hematoma recurrence in surgically treated patients/ reduced hematoma progression in conservatively managed patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptomatic non-acute SDH with mass effect (i.e., chronic or subacute SDH)

   1. Mass effect refers to a shift in midline structure or deformation of local cerebral cortex due to SDH.
   2. Symptomatic defined as neurological symptoms, such as headache, short-term cognitive dysfunction, language disorder or aphasia, gait instability, decreased muscle strength, sensory disturbances, epileptic seizure, etc.
2. Age ≥18 years;
3. Pre-morbid mRS score 2;
4. Informed Consent Form (ICF) signed by patient or guardian.

Exclusion Criteria:

1. Radiographic imaging indicating massive cerebral infarction with corresponding symptoms;
2. Required craniotomy or craniotomy with small bone flap to remove SDH;
3. Emergency SDH removal/drainage;
4. Bilateral SDH with unknown origin of symptoms;
5. Anatomical variations that may affect the safety of MMA embolization (e.g., prominent middle MMA-ophthalmic artery anastomosis);
6. Intractable coagulation dysfunction or abnormal platelet count and function (pre-operative International Normalized Ratio \[INR\] \> 1.5 and/or platelet count \< 80109/L);
7. Contraindications to cerebral angiography, such as allergy to iodinated contrast agents, renal insufficiency (GFR \< 30 ml/min), etc.;
8. Computed tomography (CT) or magnetic resonance imaging (MRI) showing intracranial space-occupying lesions;
9. Pregnancy or planning to become pregnant;
10. Serious or fatal coexisting disease that may prevent improvement of conditions or completion of follow-up;
11. Life expectancy \< 1 year;
12. Recent operation unrelated to this study or investigators believe that they will be at higher risks if antiplatelet and/or anticoagulant drugs are discontinued;
13. Inability to complete follow-up as required by the protocol;
14. Patients participating in other clinical trials;
15. Prior surgery or interventional therapy on target SDH;
16. Inability to complete MMA embolization before trepanation and drainage.
Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy

The purpose of this study is to determine the efficacy, safety, and population pharmacokinetics and determinants of drug responses to buspirone in children with autism using a randomized, double blind, cross over study in children ages 2 to 6 years.

Autism is a neurodevelopmental disorder defined as qualitative impairment in social interaction and communication and restrictive stereotype patterns of behavior, interests and activities. Pharmacological agents are being increasingly used off label in very young autistic children, and there is virtually no data regarding the pharmacokinetics, safety or efficacy of these agents in young children.

The approach in this study differs from pharmacotherapy studies of autism carried out thus far in several ways:

* the rationale underlying our approach is based upon an attempt to alter synaptic plasticity during postnatal development, focusing on very young children
* are integrating our drug trial with a PG study evaluating whether buspirone response is related to expression of genes involved in serotoninergic neurotransmission
* will assess these variables together with in vivo assessment of serotonin synthesis capacity with PET.

This is a prospective, randomized, double blind, crossover study where children will be stratified by age into two groups. Treatment will last for 12 weeks with dosing twice a day. Parent ratings, cognitive tests and blood sampling will occur throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

* Meet study definition for the diagnosis of autistic disorder
* Age 2 to 6 (male or female)
* Informed Consent

Exclusion Criteria:

* Clinical or lab evidence of renal or hepatic disease
* Treatment with any medication known to alter the activity of the CYP3A4 enzyme including ketoconazole, itraconazole, grapefruit juice, erythromycin, clarithromycin, cimetidine, verapamil, diltiazem, rifampin, phenytoin, phenobarbital, or carbamazepine within the previous 3 months
* Use of centrally acting drugs during the 6 weeks prior or during the study
* Presence or history of neurological disorders, including seizure disorders
Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin

To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between 18 to 55 years of age inclusive with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal range or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or a double barrier and have a negative pregnancy test at Screening and Day 0 for each Dosing Period. Female subjects of non-childbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy
* Be willing to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the clinical protocol

Exclusion Criteria:

* History of hypersensitivity to aspirin (ASA), Nonsteroidal Antiinflammatory Drugs (NSAIDs), acetaminophen and similar pharmacological agents or components of the products
* Eighteen to twenty year olds with a viral infection, with or without fever, at the time of dosing - Syndromes of asthma, rhinitis or nasal polyps
* Females who are pregnant or lactating
* Have taken ASA, ASA-containing products, acetaminophen or any other NSAID (Over the counter (OTC) or prescription) 7 days prior to dosing or during the treatment period, other than trial treatment
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (e.g., nicotine patch, nicotine gum)
Alpha-Glutathione-S-Transferase (AlphaGST) and MARINA Index in Metabolic-Dysfunction-Associated-Steatotic-Liver-Disease (MASLD)

AlphaGST represents a liver enzyme whose serologic levels progressively increase in alcoholic and viral chronic hepatitis according to the worsening of liver fibrosis. However, its diagnostic and prognostic usefulness in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease has never been explored.

The investigators aimed to assess the alphaGST levels in Metabolic-dysfunction-Associated-Steatotic-Liver-Disease patients affected by different stages of liver fibrosis, and, by using a new-designed "Metabolic Abnormalities Related to lipids- Insulin resistance-AlphaGST levels" (MARINA) index, to evaluate its role as a novel non-invasive tool in the disease staging stratification, identification of the advanced fibrosis and prediction of 5-years acute cardiovascular events occurrence.

The investigators enrolled 30 ehalthy controls and 200 metabolic dysfunction-associated steatotic liver disease patients (Training cohort) (TrC). As a validation cohort (VlC), between January 2018 and May 2019, 60 MASLD patients were consecutively enrolled (Validation Cohort - VlC) All Metabolic-dysfunction-Associated- Steatotic-Liver-Disease patients received an ultrasound-guided percutaneous liver biopsy for the disease staging. Liver stiffness measurement, NAFLD fibrosis score, Fibrosis-4, and body mass index-aspartate aminotransferase/Platelet Ratio-Diabetes scores as well as the MARINA index were determined. Naïve-acute cardiovascular events patients were subsequently followed up over 5 years to record acute cardiovascular events occurrence.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* MASLD diagnosis

Exclusion Criteria:

* presence of chronic inflammatory diseases
* acute or chronic kidney diseases
* rheumatoid arthritis, systemic lupus erythematosus, or other major systemic inflammatory diseases or tumors
* ongoing infections
* alcohol or drug abuse history
* other etiologies of chronic liver damage
* previous hepatocellular carcinoma diagnosis
* use of hepatoprotective drugs
* decompensated liver cirrhosis (Child-Pugh B and Child-Pugh C) at the moment of the enrollment or in the previous 12 months
* psychological/psychiatric problems that could have invalidated the informed consent
Chocolate Dynamic Vessel Analysis

The study aims at evaluating the effect of dark chocolate consumption on anatomy and functionality of retinal blood vessels by comparing these same parameters after milk chocolate consumption.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 years or older
* Healthy volunteers
* No vascular diseases
* No ocular diseases
* Volunteers capable of understanding informed consent

Exclusion Criteria:

* Patient unable to follow the instructions
* Patient unable to come back for follow-up
* opacity of lens, cornea, or vitreous
* Allergies that contraindicate pupil dilation
* Eye diseases
* Myopia greater than -8.0 Diopter (D),
* Hyperopia greater than 5.0 D
* Astigmatism greater than -3.0 D
Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing

The purpose of this study is to examine whether administering metolazone 60 minutes prior to furosemide increases urine output compared with administering metolazone and furosemide concomitantly. Participants will have equal chance of being assigned to each group.

Diuretic resistance is common among patients with acute decompensated heart failure, and one strategy for overcoming this phenomenon is sequential nephron blockade with loop plus thiazide-type diuretics. Metolazone is an oral thiazide-type diuretic commonly used for this purpose. Due to its delayed absorption, some clinicians suggest that metolazone be given 30-60 minutes prior to the loop diuretic. However, the efficacy and safety of such a strategy has not been investigated despite its added complexity. The purpose of this study is to investigate whether pre-dosing with metolazone confers a difference in efficacy and safety compared to administering it at the same time as furosemide.

Eligibility Criteria:
Inclusion Criteria:

* Admission within 48 hours for acute decompensated heart failure with at least one symptom and one sign of volume overload
* Receipt of loop diuretic prior to admission
* Plan to administer furosemide 120 - 160 mg IV bolus twice daily over the next 24 hours with additional diuresis deemed necessary
* If patient is concurrently administered intravenous vasodilator or inotrope, the dose of vasodilator or inotrope must be stable for 6 hours prior to enrollment with a plan to continue the same dose for the 24 hour duration of this study

Exclusion Criteria:

* Metolazone prescribed prior to admission
* Receipt of continuous intravenous infusion of furosemide
* Cirrhosis or end stage renal disease
* Non-English speaking patients
Effects of Bisphosphonates and Nutritional Supplementation After a Hip Fracture

The study hypothesis is that nutritional supplementation together with bisphosphonates have a better preserving effect on bone mineral density (BMD) after hip fracture than bisphosphonates alone and that nutritional supplementation given postoperatively for 6 months preserve lean body mass in elderly hip fracture patients.

Inclusion criteria: Men and women, ≥ 60 years of age with a recent fracture of the femoral neck or trochanter, admitted to any of the four University hospitals in Stockholm, Sweden. Patients are randomized into three groups by sealed enveloped technique in blocks by 12, thus assuring that each center had an equal distribution of patients in the three treatment groups. Patients randomly assigned and followed for 12 months. Each center with a doctor in charge and a trial nurse. The trial nurse in collaboration with the doctor are responsible of the randomization procedure and that blood samples are taken in the morning of the first weekday after inclusion at the ward and further that the dual-energy X-ray (DXA) and all estimates are done during hospital stay.The pharmacological treatment and nutritional supplementation starts as soon as the patients are circulatory stable, able to take food by mouth and are able to sit in an upright position one hour after taking the tablets.Patients are examined at baseline with a follow up at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Recent fracture of the femoral neck or trochanter
* Without severe cognitive impairment
* Ambulant before fracture
* BMI ≤ 28

Exclusion Criteria:

* Abnormal parameters regarding liver i.e. S-Alanine aminotransferase (S-ALAT) and S-Aspartate aminotransferase (S-ASAT) ≥ twice as normal
* Abnormal parameters regarding kidney i.e. S-Creatinine \> 130 µg/L
* Primary hyperparathyroidism, osteogenesis imperfecta, Paget´s disease
* Myeloma
* Lactose intolerance
* Dysphagia
* Esophagitis
* Gastric ulcer
* Malignancy
* Diabetes with nephropathy or retinopathy
* Active iritis or uveitis
Which Place for High Flow Oxygen in ICU ?

Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who need only oxygen support, usually received low flow oxygen (\< 15 Liters / min), as well as in respiratory weaning. Now new devices can be used. They provide high flow oxygen with different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2), allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of this study is that the high flow oxygen enable more efficient oxygen administration than conventional oxygen. In addition, it would improve the effectiveness of the ventilation of the patient, through flushing the dead space.

The investigators hypothesized that when using high flow oxygen therapy, respiratory failure is relieved, as well as ventilation failure, so accessories are less stressed muscles, and this can be demonstrated by the electromyography (EMG) of sterno-mastoid..

Eligibility Criteria:
Inclusion Criteria: patients with respiratory failure.

* Spontaneously breathing patient requiring administration at least 40% oxygen, or,
* Patient under mechanical ventilation, during respiratory weaning.

Exclusion Criteria:

* Facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients.
* Neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.
Registry Study on Rare Cancers in Korea

This study aims to determine the participation rate of patients with registered rare cancers in clinical research.

Data collection includes:

* Clinical characteristics (diagnosis, treatment information, primary/metastatic sites, staging, gender/age)
* Survival information (diagnosis date, recurrence date, death date, disease progression)
* Pathological information (diagnosis, genomic information)

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥19 years
* Confirmed rare cancer
* Life expectancy ≥3 months

Exclusion Criteria:

-Serious or unstable medical/psychiatric conditions
Multisite Implementation of COMPRENDO

COMPRENDO (ChildhOod Malignancy Peer Research NavigatiOn) is a multi-site randomized clinical trial (RCT) that uses a Hybrid Type 1 design, to test the effects of a clinical intervention on patient-level outcomes, while exploring multilevel implementation factors that can inform real-world setting implementation. This study will test the impact of COMPRENDO, a peer-navigation intervention, vs. usual care on accrual to childhood cancer therapeutic clinical trials and parental informed consent outcomes. COMPRENDO will be delivered by trained peer navigators in 4 visits. A mixed methods (surveys, individual interviews) implementation evaluation will examine implementation factors that can inform the use of peer navigation in clinical practice, integrating data from clinicians, navigators, administrators, and parents pre and post the RCT.

Aim 1:

Test the effectiveness of COMPRENDO vs. usual care to increase clinical trial accrual in a multisite RCT.

Aim 2:

Determine the impact of COMPRENDO vs. usual care on parental outcomes (informed consent, comprehension, voluntariness, decision-making self-efficacy, satisfaction with informed consent and decisional regret).

Aim 3:

Evaluate multisite implementation of COMPRENDO, focusing on acceptability, feasibility, and fidelity. We will use mixed methods with a minimum of 50 stakeholders: 22 clinicians, (17 oncologists, 3 psychologists, 2 social workers), 4 navigators, 4 administrators and 20 parents to identify implementation factors.

Within each site, eligible participants will be randomized 1:1 to the intervention vs. usual care (informed consent discussion with the oncologist only), resulting in ≈200 participants randomized to each arm.

Eligibility Criteria:
Participants (n≈400) will be parents of Hispanic children (0-17 years) with newly diagnosed cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes) and eligible for a therapeutic clinical trial who meet the following inclusion criteria:

* are a Hispanic parent/primary legal guardian;
* has a child aged 0 to 17 y with a new diagnosis of cancer or cancer-like disease (histiocytic disorders or myelodysplastic syndromes);
* has a child who is eligible for a therapeutic cancer clinical trial;
* will participate in an informed consent discussion for the therapeutic clinical trial;
* has an understanding of written and spoken English or Spanish;
* has signed the consent form for the proposed COMPRENDO study.

Parent Exclusion Criteria:

* second malignancy/relapse;
* diagnosed at an outside institution;
* potential transfer of care to another institution within the next 4 months;
* previously on a clinical trial;
* does not understand written and spoken English or Spanish;
* not Hispanic.

Stakeholder Inclusion Criteria:

Clinicians and parents of children with cancer who have participated in IC discussion for a cancer therapeutic clinical trial.

Stakeholder Exclusion Criteria:

Clinicians and parents of children with cancer who have not participated in IC discussion for a cancer therapeutic clinical trial.