cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Pharmacokinetic (PK), Bioavailability & Food Effect of MR902 Compared With Immediate Release (IR) Morphine Sulphate Oral Solution

A study to assess bioavailability of a single dose of MR902 and to assess the effect of food on absorption

Volunteers will receive a single dose of the investigational drug on 2 occasions and a reference drug on 1 occasion. Volunteers will be randomised to one of two groups, each group receiving a different dose strength of MR902 in fed and fasted state.

The study involves a screening visit 21 days before first dosing and 3 overnight stays in 3 study periods, and a post-study medical visit.

Volunteers will receive naltrexone to reduce anticipated opioid side effects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
* Body weight ranging from 55 to 100 kg and a BMI ≥ 18.5 and ≤ 30.0.
* Willing to eat all the food supplied throughout the study.
* The subject's primary care physician has confirmed within the last 12 months of first dosing that there is nothing in their medical history that would preclude their enrolment into a clinical study.

Exclusion Criteria:

* Female subjects who are pregnant or lactating.
* Any history of drug or alcohol abuse, misuse, physical or psychological dependence.
* Any history of conditions that might interfere with drug absorption, distribution, metabolism or excretion.
* Use of opioid or opioid antagonist-containing medication in the past 30 days.
* Any history of frequent nausea or vomiting regardless of etiology.
* Any history of seizures or symptomatic head trauma.
* History of respiratory depression, hypoxia or elevated carbon dioxide levels in the blood.
* History of paralytic ileus, gastrointestinal disease or other clinically significant gastrointestinal problems.
* Participation in a clinical drug study during the 90 days preceding the initial dose in this study.
* Any significant illness during the 4 weeks preceding entry into this study.
* Use of any medication including vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose or during the course of this study (with the exception of the continued use of HRT and contraceptives).
* History of smoking within 60 days of IMP administration and refusal to abstain from smoking during the study.
Acute Effects of Exercise at Different Temperatures in Allergic Rhinitis Patient

The purpose of this study was to determine the effects of exercise at different temperatures on nasal blood flow and symptoms in allergic rhinitis patients.

Fifteen patients with allergic rhinitis aged between 18 and 35 years who had a positive skin prick test to house dust mite (D. pteronyssinus). The experiment was a crossover design in which each participant was given aerobic exercise by ergometer in two difference temperatures room : 25 degree celsius and 34 degree celsius. Rhinitis symptoms, nasal blood flow, heart rate, and oxygen saturation were measured before, during exercise at 15, 30, and 45 minutes, and after exercise at 0, 15 and 30 minutes in each temperature. Moreover, blood pressure, peak nasal inspiratory flow, pulmonary functions, respiratory muscle strength, and fractional exhaled nitric oxide were measured before and after exercise at 0, 15 and 30 minutes in each temperature.

Eligibility Criteria:
Inclusion Criteria:

* Subjects had a clinical history of persistent rhinitis, and had positive skin prick test to house dust mite (D. pteronyssinus)
* Persistent allergic rhinitis
* Subjects with known asthma, chronic rhinosinusitis, Lung cancer and Emphysema diseases were excluded.
* BMI 18.5 - 24.9 kg/m2
* Subjects will ask to abstain from taking antihistamine for at least 5 days, leukotriene receptor antagonist for at least 1 week, and nasal steroids for at least 2 weeks prior to the start of the experiment.
* Subjects will ask to abstain from taking any form of dietary supplement during the experiment.
* Subjects had no exercise training program (not exercise regularly or not exercise for 30 minutes or more at least 3 times per week during the past 6 months)

Exclusion Criteria:

* Accident that are unable to continue the research, such as accidental injury or illness, etc.
* Participants did not voluntarily participate.
Plasma Immunity of Mild SARS-CoV-2 Omicron and Delta Pandemic in Thailand

The investigators assessed the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation.

The investigators aimed to assess the effect of treatment for COVID and immunity of the volunteers who admitted to the home isolation. The investigators compared the population between the age groups 12-18 years, 18-45 years and over 45 years to monitor the symptoms of coronavirus patients treated in home isolation and long-term symptoms including factors related to the patient's recovery in the past, present, and future.

Eligibility Criteria:
Inclusion Criteria:

1. patient with infected with the novel coronavirus disease 2019 (COVID-19) who has been end of self-quarantine at Siriraj Hospital more than 21 days.
2. Thai nationality, able to read and write Thai language
3. able to use telephone and line to communicate

Exclusion Criteria:

1. people who received additional vaccination after leaving quarantine before the day of the immunization test
Remission Factors in Anorexia Nervosa

Anorexia Nervosa (AN) is a complex and multifactorial psychiatric disease that affects mostly women and is characterized by a self-restriction of food intake leading to life-threatening consequences whose underlying mechanisms are largely unexplored. AN encompasses a constellation of risk factors including genetic, biological, neuro-psychological and social factors. Although AN has a prevalence of only 1-3% in the general population, it has the highest mortality rate amongst any psychiatric disorder. Recovery of normal feeding behaviour in patients often requires several months with a large between-patient variability and a high percentage of relapse, which can occur in 35 to 41% of the patients. There is a huge unmet need for optimal understanding of processes underlying relapse. Reward processing abnormalities represents an important hypothesis underlying AN development and perpetuation. We aim to investigate the mechanisms that contribute to the maintenance and chronicity of the disease after inpatient treatment with a longitudinal design across intensive standardized inpatient treatment. We will challenge our hypothesis through brain imaging, neuropsychological, metabolic and genetic approaches. One hundred twenty-five AN female patients admitted for intensive inpatient treatment will be recruited and evaluated: at admission, after weight recovery and at 6 months after discharge with neurocognitive tests (including the Delay Discounting Task), genetic/epigenetic examination, hormonal blood samples (at each visit and repeated sampling around a meal for a 10-patient subgroup) and brain imaging (including fMRI during a Delay Discounting Task for fifty patients). One hundred healthy controls will be also recruited and be subjected to the same study procedures.


Eligibility Criteria:
Inclusion Criteria:

* DMS 5 criteria for Anorexia Nervosa
* BMI \< 18.5 kg/m²
* Being able to consent
* fluent in French
* Being affiliated to a social security scheme or being the beneficiary of such a scheme.
* Having signed the informed consent

Exclusion Criteria:

* Deprived of liberty subject (judicial or administrative decision)
* Refusal to participate
* Presenting an unstabilized serious physical illness or psychiatric disorder compromising the follow up according investigator evaluation
* Contraindication for IRMf
* Pregnant or breast-feeding women
The Bioavailability of Mycoprotein

To evaluate the bioavailability of mycoprotein, compared with a reference animal based protein, in a dose-response manner.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and aged 18-40 y
* BMI between 18 and 30

Exclusion Criteria:

* On medication
* Family history of metabolic disease
* Diagnosed with any metabolic or cardiovascular conditions
* BMI \< 18 or \> 30
Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke

The main purpose of this multicentric, prospective, randomized, placebo-controlled, double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe tool to promote recovery in acute ischemic stroke patients.

124 patients with acute ischemic stroke will be recruited and randomly assigned to real or sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min daily, for 5 consecutive days, starting within 48 hours from the onset of stroke.

The primary outcome will consist of reduction of the expected infarct growth at MR measured in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness, safety and tolerability of pulsed ELF-MF in acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* first onset, mono-hemispheric ischemic stroke in the middle cerebral artery territory;
* onset of symptoms within 48 hours;
* National Institutes of Health Stroke Scale (NIHSS) score between 4 and 25;
* signed written informed consent.

Exclusion Criteria:

* acute intracranial hemorrhage;
* previous ischemic or hemorrhagic stroke;
* lacunar stroke, defined as not involving the cortex and \< 2.0 cm if measured on MRI diffusion-weighted images;
* contraindications to transcranial magnetic stimulation such as implanted metallic parts of implanted electronic devices or other metal in body;
* historical modified Rankin Scale (mRS) \>1;
* other serious or complex disease that may confound treatment assessment;
* women known to be pregnant, lactating or having a positive or indeterminate pregnancy test;
* current participation in another study.
The Efficacy of Hypertonic Dextrose Injection to Anterior Talofibular Ligament Sprain

Anterior talofibular ligament is the most injured ligament in ankle sprain. Investigators will include ankle sprain patients who have ankle pain or instability more than 3 months. Ultrasonography will be done for confirm ligament injury. Participants will be randomized into two groups. Participants in dextrose injection group will accept dextrose 15% injection to tendon and enthesis. In the other hand, subcutaneous sham injection to control group. Pain condition, stability test and function test, will be evaluated in 1 week, 4 weeks and 12 weeks after injection.

Background: Sprains constitute most of ankle injury and 85% ankle sprain is inversion injury. The conventional treatment includes medication, physical therapy, bracing and steroid injection. Anterior talofibular ligament is the most injured ligament in ankle sprain. Although the response of acute ligament sprain is usually quickly, treatment of chronic ligament sprain is difficult. Chronic pain and ankle instability is the most common symptom in chronic ankle sprain. Dextrose prolotherapies been used for treating soft tissue injury such as osteoarthritis, tendinopathy and ligament sprain. However, there is not randomized control trial for hypertonic dextrose injection to chronic ankle sprain.

Methods: Investigators will include 40 ankle sprain patients who have ankle pain or instability sensation more than 3 months. Ultrasonography will be done for confirm ligament injury. Participants will be randomized into two groups. Dextrose injection group will accept dextrose 15% injection to tendon and enthesis. Otherwise, investigators will do subcutaneous sham injection to control group. Investigators will measure pain threshold and peak pressure by algometer, the degree of ankle instability by ultrasound, the proprioception by single leg standing, and foot and ankle questionnaire. The examination will be done before injection, immediately after injection, 1 week, 4 weeks and 12 weeks after injection.To our hypothesis, investigators suggest dextrose prolotherapy injection could decrease pain and improved proprioception.

Eligibility Criteria:
Inclusion Criteria:

1. 20-70 age
2. Chronic ankle sprain more than 3months with chronic ankle pain or instability sensation
3. Ultrasound diagnosed anterior talofibular ligament sprain

Exclusion Criteria:

1. Acute ankle sprain less than 3 months
2. Lower limb fracture history
3. Cognitive impairment
4. Other neurological or muscular disorders
5. Sever pain could not tolerate examination
Effect of Over-the-counter Dietary Supplements on Kidney Stone Risk

The purpose of this study is to ascertain whether certain supplements promote excessive urinary oxalate excretion and increase the risk for calcium oxalate kidney stones. Supplements that enhance urinary oxalate excretion, as a result of their oxalate concentration or from some other mechanism (e.g., providing substrate for oxalate biosynthesis) will be identified by the investigators.

The investigators hypothesize that certain over-the-counter dietary supplements will increase urinary excretion of oxalate as measured in 24-h urine collections. The investigators further hypothesize that the concentration of oxalate in dietary supplements may not be associated with urinary oxalate excretion, suggesting that other nutritional components of the supplements may be exerting an influence over oxalate biosynthesis, oxalate absorption in the gastrointestinal tract, and/or renal oxalate handling. These other factors include the form of oxalate in the supplement (water- vs. non water-soluble) and the supplement's concentration of ascorbic acid.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, no prior personal history of kidney stones

Exclusion Criteria:

* Personal history of kidney stones (by subjects' report); known allergy to any of the dietary supplements to be used in the study (by subjects' report); short bowel; active ulcerative colitis or irritable bowel disease; Crohns or Celiac disease; renal tubular acidosis; current use of topiramate or other carbonic anhydrase inhibitor, steroids, allopurinol, thiazide diuretics, or supplemental ascorbic acid \>250 mg/day.
A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval

Current standard of care is no pretreatment medications before the egg retrieval, and the investigators would like to evaluate if preoperative Tylenol improves procedure and post procedure pain control over the current practice (no pre-treatment). Specifically, this study will compare Tylenol with a placebo when given before retrieval procedures. The investigators believe that if Tylenol can offer better analgesic relief than no pretreatment medications, then it may reduce the amount of narcotics needed by patients during and after the procedure and contribute to better patient satisfaction. . This study will enroll 100 participants all from University of Alabama at Birmingham (UAB).

The current standard of care for oocyte retrieval in IVF involves fentanyl, propofol, as well as oxycodone. However, there exists little data of alternatives to narcotic medications for analgesic purposes in oocyte retrieval procedures. A retrospective study published in 2013 showed potential for NSAID's, specifically ketorolac, to significantly improve pain scores in women undergoing oocyte retrieval. It was also shown that the use of these medications did not significantly alter pregnancy rate, live birth rate, or miscarriage rate in these patients. Few other studies have delved into the question of anesthetics for oocyte retrievals except a prospective study in 2006. This study shows that no significant difference in pregnancy rates of implantation occurs with the use of acetaminophen and diclofenac vs. acetaminophen alone if given post-operatively. However, pain was not measured in this study for either group. Therefore, it is clear that there exists limited data on the subject of analgesics used in oocyte retrievals for in vitro fertilization and that more exploration into alternative medications is required to find the most effective and least harmful option.

Eligibility Criteria:
Inclusion Criteria:

* English Speaking
* Undergoing Transvaginal Oocyte Retrieval Procedure

Exclusion Criteria:

* Acetaminophen allergy
* Opioid dependency
Role of Oral Care in Prevention of Nosocomial Pneumonia Among COPD Patients

Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia.

Infection is a common problem and a major cause of morbidity and mortality for patients in intensive care units (ICUs). Pneumonia is the most common site of infection according to an international study of the prevalence and outcomes of infection in ICUs, which included 13,796 patients. Nosocomial pneumonia (NP) is among the leading causes of mortality in patients in the ICU. Notably, the incidence of nosocomial pneumonia is increasing, and the number of infection-related deaths that follow is also increasing. Thus, preventing nosocomial pneumonia is a cost reducing and life-saving health care practice, especial in ICUs.

Nosocomial pneumonia (NP) was defined as an infection of the lower respiratory tract that does not exist at the time of admission and does not have an incubation period of infection but occurs 48 hours after admission. The most important cause for the development of nosocomial pneumonia is the oral environment. The oral cavity of ICU patients is an important reservoir for bacteria and provides a habitat for microorganisms that can lead to nosocomial pneumonia. Patients in ICUs acquire pneumonia by aspirating oral bacteria that have been colonized in the oral cavity into the lower respiratory tract. Due to advanced age, limited mobility, illness, and cognitive dysfunction, patients in ICUs often have difficulty maintaining oral hygiene by themselves.

Poor dental hygiene has been linked to respiratory pathogen colonization in ICU patients. Therefore, respiratory pathogens tend to colonize dental plaque and oral mucosa in these populations. Therefore, strategies to eliminate respiratory pathogens from the oral cavity may improve oral hygiene and decrease the development of nosocomial pneumonia. The aim of the present study is to assess value of preventive strategy using chlorhexidine for oral care among non-intubated COPD patients admitted to ICU upon incidence of nosocomial pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as COPD
* admitted to ICU with acute exacerbation
* need for noninvasive ventilatory support including noninvasive ventilation anf high flow nasal cannula

Exclusion Criteria:

* patients refusing to participate
* End stage organ failure (Heart Failure, Liver cell failure and/or Renal failure
Intraoperative Hypocapnia in PROVHILO and PROBESE

To gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation, the 'PROtective Ventilation using High versus LOw PEEP trial' (PROVHILO), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE).

Lung-protective intraoperative ventilation (LPV) has the potential to improve the outcome of surgery patients through a reduction in postoperative pulmonary complications. Use of intraoperative ventilation strategies that use a low tidal volume could result in intraoperative hypercapnia. However, hypocapnia remains surprisingly common during intraoperative ventilation, possibly meaning that anesthesiologists continue to use high, if not too high respiratory rates or tidal volumes.

Previous studies suggested associations between intraoperative derangement of end-tidal carbon dioxide (etCO2) and postoperative outcomes. Indeed, two studies in highly selected patient groups showed associations of intraoperative hypocapnia with prolonged length of hospital stay, in patients undergoing pancreaticoduodenectomy, and in patients undergoing hysterectomy.

To gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation; PROVHILO and PROBESE.

Eligibility Criteria:
Inclusion Criteria:

* Planned for major (abdominal) surgery.
* At risk for postoperative pulmonary complications.

Exclusion Criteria:

* Planned thoracic surgery or neurosurgery.
* Unscheduled surgery (i.e., urgent, or emergent surgeries) were excluded because these patients may have had metabolic abnormalities at the moment of surgery, i.e., metabolic acidosis, for which the anesthesiologist may have adjusted the intraoperative ventilator settings. This may have led to a 'compensatory' low etCO2.
* Patients with etCO2 recordings are missing from the study databases.
Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

The study will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with itraconazole will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
* Able to complete the study as required by the protocol;
* Subjects have no birth plan and voluntarily take effective contraception from 2 weeks before administration to 3 months after the last dose, and the pre-drug serum HCG test for fertility-enabled women must be negative;
* Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 \~ 26 kg/m2 ;
* No clinically significant abnormalities in general physical examination, vital signs, laboratory tests, etc.

Exclusion Criteria:

* Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing.
* Allergic constitution or known allergy to pyrotinib, itraconazole or the excipients;
* History of drug abuse in the past 5 years, or positive for drug abuse screening;
* Alcoholic or often drinkers with drinking amount more than 14 units a week; a heavy smoker; and can't abstain from smoking and alcohol during the study
* Left ventricular ejection fraction (LVEF) \<50% by echocardiography or QTcF ≥ 470 msec by 12 lead electrocardiograph;
* A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system that are not suitable for subjects to participate in the study, as judged by the investigator;
* Any surgery within 6 months before screening;
* Have taken hepatotoxic drugs for a long time within 6 months before screening;
* Subjects who took any clinical trial drugs within 3 months;
* Subjects who took any drugs that change liver enzymes activity within 28 days before dosing; or took any prescription drugs, over-the-counter drugs or vitamins, health products or herbal medicine within 14 days before dosing;
* Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
* Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, or alcohol within 48 hours before dosing; strenuous exercise; or other factors which affect drug absorption, distribution, metabolism, excretion, etc.;
* Other factors that are not suitable for subjects to participate in the study, as judged by the investigator.