cyrilzakka/clinical-trials huggingface dataset:
Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea

Multicenter, open-label, controlled, randomized clinical study to evaluate the efficacy and safety of Racecadotril in infants, children and adolescents with acute diarrhea


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent from one of the parent(s)/caregiver(s) or subject informed assent
* Children and adolescents, both genders, age from 3 months to \< 18 years of age
* Confirmed diagnosis of acute diarrhea (defined as the passage of three or more unformed or liquid stools within the last 24 hours and lasting for less than three days)
* Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection, an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide

Exclusion Criteria:

* Known allergy to Racecadotril or any of its ingredients
* Subjects suffering from renal or hepatic impairment
* Subjects who need treatment for diarrhea other than ORS alone
* Subjects with fever \> 39 degrees Celsius
* Subjects with bloody and/or purulent stools
* Subjects suffering from antibiotic-associated diarrhea, chronic diarrhea or iatrogenic diarrhea
* Subjects with alternating bouts of diarrhea and constipation
* Diarrhea due to exacerbation of chronic gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel disease or pancreatic exocrine insufficiency
* Cystic fibrosis or coeliac disease
* Subjects suffering from prolonged or uncontrolled vomiting
* Subjects with rare hereditary problems of fructose or galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome or sucrase isomaltase insufficiency or primary or secondary lactase insufficiency
* Subjects having received antibiotic treatment at any time within 30 days prior to inclusion into the study
* Subjects having received antidiarrheal drugs 48 hours prior to inclusion into the study
* Subjects with severe dehydration required for intravenous/parenteral rehydration
* Subjects who have reported angioedema with angiotensin converting enzyme inhibitors (such as captopril, enalapril, lisinopril, perindopril, ramipril)
* Subjects with combined diseases or medical situations that would prevent to be enrolled depending in the judgment of the investigator
* Intake of experimental drug within 30 days prior to study start
* Subjects with contraindications to ORS or for whom warnings/precautions of ORS apply
* Adolescents (≥ 60 kg) not able to swallow capsules
* Pregnancy and lactation
The Safety and Effectiveness of Gatekeeper Training in First Nations Communities

Gatekeeper training is where people in the community are trained to recognize and identify those who are at risk for suicide and assist them in getting care. Gatekeeper training has been widely implemented around the world. There are two types of gatekeepers: 1) Designated gatekeepers - individuals who have been trained in helping professions (medicine, psychology, social work, nursing), and 2) Emergent gatekeepers - individuals who are not in caregiving roles (family members, police, teachers, clergy). Applied Suicide Intervention Skills Training (ASIST) has been implemented in Manitoba. However, a recent randomized controlled trial in First Nations community members (emergent gatekeepers) from the Swampy Cree Tribal Council (Northwestern Manitoba) demonstrated that the training had no positive impact on self-reported gatekeeper skills or behavior. Also, compared to a resilience retreat, the ASIST training was associated with a slightly higher likelihood of reporting suicidal ideation. The demonstrated lack of efficacy and the possibility of adverse effects associated with this training program in this vulnerable group have raised concerns about the safety and efficacy of ASIST. There were several key limitations of the previous study. First, the study only recruited community members (emergent gatekeepers), therefore findings may not be generalizable to designated gatekeepers (clinicians, nurses, counselors). Second, the study had a small sample size (n=55) and may have not been large enough to detect small effects that are often associated with educational interventions. Finally, the increase in distress in the ASIST trained group may not have been directly related to the training. To overcome the above limitations, we aim to conduct a larger evaluation of the safety and effectiveness of gatekeeper training that is occurring in Manitoba First Nations, Inuit and Metis communities. Based on previous work that suggests designated gatekeepers are more likely to benefit from gatekeeper training than emergent gatekeepers, we will examine these groups separately.

Hypotheses: 1) ASIST will be associated with an increase in gatekeeper skills and behaviors; 2) ASIST will have a stronger impact on designated gatekeepers than emergent gatekeepers; 3) ASIST will not be associated with an increase in suicidal ideation or distress.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* currently living or working in First Nations, Inuit, or Metis communities in Manitoba
* 16 years of age or older

Exclusion Criteria:

* does not speak English
* \<16 years of age
Effect of Lithium Therapy on Long COVID Symptoms

This study will assess low-dose lithium's effects on several different symptoms experienced by long COVID patients.

In this double-blind, placebo-controlled study, 50 patients with long COVID will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. After the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. Study visits will occur at baseline and after the three-week double-blind study phase.

Eligibility Criteria:
1. Documented or self-reported positive test for COVID-19 ≥4 weeks prior to enrollment.
2. No fever for ≥4 weeks prior to enrollment.
3. Reports fatigue and/or brain fog (i.e. concentration or memory impairment) for ≥4 weeks prior to enrollment on the PASC-Specific Symptom questionnaire beginning after infection with COVID-19.
4. Fatigue Severity Scale (FSS) score ≥28 or Brain Fog Severity Scale (BFSS) score ≥28 at baseline.
5. Beck Depression Inventory II score \<24.
6. No change in any psychoactive or steroid medications for ≥30 days.
7. No plan to change any psychoactive, steroid or diuretic medication for ≥5 weeks and not planning on obtaining a COVID vaccine within the next 5 weeks.
8. Not using any long COVID therapies felt to be worsening the patient's symptoms or starting a long COVID therapy within the next 5 weeks.
9. No history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to COVID-19 infection.
10. No active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator.
11. No use of tobacco or marijuana products for \>6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use.
12. Not receiving or applying for disability payments or workman's compensation for long COVID.
13. Not pregnant or nursing or planning to get pregnant over the next two months.
Effects of Core Stabilization Approach on Patients With Upper Extremity Injuries

The purpose of the study is to determine the effects of the addition of core stabilization exercises to a traditional upper extremity rehabilitation program in upper extremity injuries.

Abnormal movement patterns are one of the most challenging problems during rehabilitation of the patients with upper extremity injuries. They usually decrease the functional status of the upper extremity and prevent isolated muscle activations. Dysfunction of the kinetic chain system plays an important role in the development of these movement patterns. Thus, multi-segmental rehabilitation strategies has recently gained considerable importance in upper extremity rehabilitation. Core stabilization is one of the most popular rehabilitation approaches preferred to enhance functional stability of the kinetic chain system and dynamic postural alignment during activities. The purpose of this study is to determine the effects of core stabilization approach on functional status of the upper extremity and the amount of abnormal movement patterns. In addition, the factors affecting the abnormal movement patterns will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic distal segment injuries (elbow and wrist)
* Patients in their subacute stage.

Exclusion Criteria:

* Multiple joint problems
* Bilateral extremity problems
* Reflex sympathetic dystrophy
* Trunk and lower extremity problems
* Non-union fractures
* Malignant ans systemic diseases
Arachidonic Acid Metabolism in Carotid Stenosis Plaque in Diabetic Patients

Diabetes is associated with an increased risk of cardiovascular complications, as a reflection of the chronic inflammatory status. Monocytes-macrophages in diabetic subjects present impaired arachidonic acid metabolism. Moreover, atheromatous plaques in diabetic subjects seem to be significantly enriched in 2-AA-LPC (2-arachidonoyl-lysophosphatidylcholine) and are more inflammatory and more likely to rupture than are plaques in non-diabetic subjects. We therefore hypothesize that this vulnerability of atheromatous plaques in diabetic subjects could be explained by impaired 2-AA-LPC metabolism within the plaque.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided explicit consent
* Patients older than 18 years
* Patients about to undergo surgery for carotid stenosis
* Haemoglobin ≥ 7g/dl at the time the sample is taken
* Respect the maximum volume of blood taken (treatment + research) in 30 days

SPECIFIC TO DIABETICS

- Patients with type 1 or 2 diabetes diagnosed more than 6 months earlier

Exclusion Criteria:

* Patients under guardianship
* Patients without health insurance cover
* Pregnant or breast-feeding women
Safety Study of Tecadenoson to Treat Atrial Fibrillation

Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels when given alone and in combination with a beta-blocker (esmolol) in patients with atrial fibrillation to control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic effects when given alone and in combination with beta-blocker (esmolol).


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of atrial fibrillation in need of treatment for rate control
* Be able and willing to abstain from any antiarrhythmics, including atrioventricular (AV) nodal blocking agents (except for esmolol per protocol), from no later than 8:00 p.m. on the day prior to dosing until completion of the last dose period assessment
* Be able and willing to abstain from xanthine- or chocolate-containing foods, beverages, and medications
* Females must be post-menopausal or sterilized; or if of childbearing potential, must not be breastfeeding and must have a negative pregnancy test at screening and no intention of becoming pregnant during the course of the study. Males and females must be using adequate contraception during the study.

Exclusion Criteria:

* Have a known accessory pathway
* Have active myocardial ischemia or recent acute coronary syndrome
* Have acute or overt heart failure, bradycardia, heart block greater than first degree, or cardiogenic shock
* Have allergies or contraindications to treatment with esmolol or aminophylline, or any of their constituents
* Have a supine cuff systolic blood pressure \< 90 mm Hg
* Be undergoing treatment with theophylline/aminophylline preparations, Trental® (pentoxifylline), or carbamazepine
* Have asthma or other reactive airways disease currently on-treatment
* Have a history of an active or chronic pancreatic disease or clinically significant increased levels of serum amylase or lipase
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years old in Japan, ≥18 years old in other countries
* Pathologically documented unresectable and/or metastatic non-squamous NSCLC
* Has relapsed from or is refractory to standard treatment or for which no standard treatment is available
* For Cohort 1 and Cohort 1a: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent, from an archival tumor tissue sample
* For Cohort 2 only: Participant has any known documented activating HER2 mutation from an archival tumor tissue sample analyzed by CLIA laboratory or equivalent. Note: HER2 mutation documented only from a liquid biopsy sample cannot be used for enrollment.
* Presence of at least 1 measurable lesion assessed by the investigator and based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Is willing and able to provide an adequate archival tumor tissue sample
* Is willing to undergo a tissue biopsy, after the completion of the most recent treatment regimen
* Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

Exclusion Criteria:

* Had been previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors
* For Cohort 1 and Cohort 1a: Has known HER2 mutation
* Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
* Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out due to imaging at screening
* Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females
* Has a medical history of clinically significant lung disease
* Is suspected to have certain other protocol-defined diseases based on imaging at screening period
* Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:

  1. safety or well-being of the participant or offspring
  2. safety of study staff
  3. analysis of results
Biological Treatment of Amyotrophic Lateral Sclerosis

The purpose of this study is to test the safety and effectiveness of an autologous bone marrow-derived stem/progenitor cells infusion in the subjects with diagnosed amyotrophic lateral sclerosis.

Amyotrophic lateral sclerosis (ALS) is a universally fatal neurodegenerative condition that causes weakness leading to paralysis and death. Life expectancy is less that 5 years. The cause is generally unknown and there is no effective treatment. Patients with ALS typically exhibit a progressive paralysis due to the continued loss of motoneurons. Intraspinal injections of bone marrow mononuclear cells have been able to ameliorate the course of ALS in murine models. The purpose of this prospective, nonrandomized, open label, pilot study is to conduct the investigation of the safety and efficacy of infusion of autologous bone marrow-isolated stem/progenitor cells with different selected phenotypes into the subjects with diagnosed ALS. Especially, this clinical trial is designated to test the therapeutic (pro-regenerative and neuro-protective) functions of different stem/progenitor cell populations able to secrete bioactive neurotrophic factors. All patients enrolled will have a documented history of ALS disease prior to study enrollment. Patients diagnosed as early stage of ALS with the duration of disease less than 6 months and patients diagnosed with advanced stage of ALS disease with duration of 6-12 months will be recruited and allocated based on their disease severity to two treatment groups: Group I - patients of early ALS disease stage and Group II - patients of advanced ALS disease. Next, autologous bone marrow-isolated stem/progenitor cells administration to the cerebrospinal fluid at the site of the spinal cord will be performed. Finally, treatment safety, adverse events and exploratory parameters, including electromyographic (EMG) studies, forced vital capacity (FVC), functional rating scale (FRS) and maximum voluntary isometric contraction-arm (MVIC-arm) evaluation, to establish ALS progression rate will be recorded throughout the duration of the post-treatment follow up period.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of the ALS disease before the cell transplantation (diagnose established following the El Escorial criteria for definite ALS)
* good understanding of the protocol and willingness to consent
* patient is mentally intact and psychologically stable
* signed informed consent

Exclusion Criteria:

Concomitant of other systemic disease or diseases:

* inflammation (high protein or lymphocytosis in the CSF), active infections.
* diabetes,
* cardio-vascular disorders,
* cancer,
* autoimmune diseases
* renal failure,
* impaired hepatic function.
* subject is a respiratory dependent.
* subject unwilling or unable to comply with the requirements of the protocol.
* patient has been treated previously with any cellular therapy.
The Effects of Carbohydrates in Irritable Bowel Syndrome

Food and their components are often reported as gastrointestinal (GI) symptom triggers in patients with IBS. The current interest in dietary management in IBS, has largely focused on the negative effect of poorly absorbed and subsequently fermented carbohydrates (FODMAP - Fermentable Oligo-, Di-, Mono-saccharides And Polyols). These unabsorbed carbohydrates can generate GI symptoms through osmosis, with increased amount of fluid in the gut lumen, and via modification of gut microbiota composition and function (fermentation and production of gas).

Studies assessing diets low in FODMAPs have shown promising results in symptom improvement in some IBS patients, but not in all. The low FODMAP diet, as it is used today, is restrictive and difficult for patients to accommodate in their daily life. Moreover, the effect of this diet on microbiota composition and function is not defined, and there are also concerns that restrictive diets may lead to nutritional inadequacy.

Fructan is a specific FODMAP which is built of fructose polymers. Examples of foods that contain fructans are wheat, onion, garlic and banana. The daily dietary intake of fructans varies approximately between 3 and 6 grams. Fructans are potential triggers of GI symptoms in IBS however, they are currently also used as prebiotic supplements. A recent systematic review and meta-analysis concluded that low dosages of fructans do not worsen GI symptoms, but they do increase the beneficial bifidobacteria. It remains unclear whether the potential benefits of fructans outweigh the potential harmful effects in patients with IBS.

The investigators are aiming to assess the effects of fructans, as well as predictive factors and mechanisms involved, and to compare with placebo in IBS patients. The investigators will assess GI symptom severity, visceral sensitivity, intestinal gas production, gut immunity and microbiota, and metabolites produced in the gut.


Eligibility Criteria:
Inclusion Criteria:

* IBS according to ROME IV criteria (with diarrhoea)

Exclusion Criteria:

* Celiac disease or any other gastroenterology disease (such as inflammatory bowel disease, celiac disease, microscopic colitis, diverticulitis, radiation enteritis).
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastric bezoar.
* Appendicectomy and cholecystectomy \<3 months.
* Heart-, liver-, neurological-, or current psychiatric disease, diabetes, obesity (BMI\>30), other disease or surgery to the abdomen that affected intestinal function.
* Implantable or portable electro-mechanical medical devices, e.g. pacemakers.
* Swallowing disorders/dysphagia to food or pills.
* Allergy or intolerances to foods.
* Compliance to a special diet (including vegan, vegetarian, gluten-free or low FODMAP diet).
* Pregnant or breast feeding.
* Usage of antibiotics within 4 weeks prior to inclusion
* Usage of alcohol more than 14 units per week.
* No new pharmacological treatment during the study period.
* Medications: laxatives, neuromodulators or opioids (morphine, codeine, tramadol...)
Feasibility of Online Based Mindfulness Interventions During COVID-19 Outbreak

The investigators had designed weekly mindfulness sessions (details see intervention below), which is free-of-charge and will be made available to general public who feel distressed during the outbreak of COVID-19. Face-to-face delivery of mindfulness interventions was not possible due to mandatory quarantine. The investigators hypothesize that this intervention is feasible and acceptable by the participants. As secondary outcomes, the investigators also hypothesize that the intervention can reduce stress, depressive and anxiety symptoms and enhance participants' sense of coherence

This will be a quasi-experimental study. Participants will be invited to fill in an online informed consent and questionnaire around 2 days before each mindfulness online session and another set of questionnaire immediately after each session (see outcome measures). Participants will be identified by their e-mail and therefore serial data could be obtained.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of old,
* able to speak and communicate in Cantonese
* can read Chinese or English (because they will be asked to fill in an online questionnaire).

Exclusion Criteria:

* actively suicidal,
* currently abusing restricted psychoactive substances
* diagnosed to have an active psychotic disorder and self-reported active psychotic symptoms (including schizophrenia, bipolar disorder and dementia).