Kornimate/medical-research-clean huggingface dataset:
efficacy of racecadotril in acute watery diarrhea in children

Conditions: Acute Diarrhea; Acute Gastroenteritis

Summary: the purpose of this study is to determine the effect of racecadotril in acute watery diarrhea in children. the investigators will evaluate the effect of product versus placebo.

background: treatment of acute diarrhea is based on the following various oral rehydration management guidelines. lately other drugs currently under investigation as antisecretory drugs to shorten the diarrheal episode and can be used safely in children. objectives: to evaluate the effect of racecadotril in the treatment of children under 5 years of age with acute diarrhea. methods: a randomized clinical trial, controlled, double-blind. the investigators will have two groups of patients: one group will receive racecadotril plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of stools by day, weight of stool, nutritional state.

Eligibility criteria:
inclusion criteria: * acute watery diarrhea exclusion criteria: * severe malnourishment * severe dehydration * systemic infections * coinfections

Keywords: acute diarrhea racecadotril children
safety study evaluating the adrenal suppression potential of product 0405 in pediatric subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the aim of the trial is to assess adrenal suppression potential when pediatric subjects are administered product 0405 for the treatment of atopic dermatitis

treatment medication will be administered topically, twice a day for 4 weeks.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of atopic dermatitis * good health with the exception of atopic dermatitis * percent body surface area minimum requirements exclusion criteria: * subjects who are pregnant, nursing, or planning a pregnancy

Keywords: atopic dermatitis
trial of safety and efficacy of rasagiline in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: als is a disorder that weakens motor strength and lung function. rapid loss of motor neurons in the brain and spinal cord of als patients causes the symptoms of increasing weakness and loss of muscle function. while there are drugs to help relieve symptoms of als, there is no cure for als. rasagiline is a drug with possible neuroprotective characteristics. neuroprotective means that the nervous system may be protected against weakening. it is known that rasagiline has possible neuroprotective characteristics and it is approved for use for patients with another disorder, the effectiveness of rasagiline for patients with als has not been tested.

the specific aim of this screen study is to determine whether rasagiline is safe in this patient population and if the drug has the potential to slow als disease progression

Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of laboratory-supported probable, probable, or definite als, according to a modified el escorial criteria, by the study investigator (appendix iv). 2. 21 to 80 years of age inclusive. 3. vc greater or equal to 75% of predicted at screening and baseline. 4. onset of weakness within 3 years prior to enrollment. 5. if patients are taking riluzole for als, they must be on a stable dose for at least thirty days prior to the baseline visit. 6. women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test. 7. willing and able to give signed informed consent that has been approved by the institutional review board (irb). exclusion criteria 1. requirement for tracheotomy ventilation or non-invasive ventilation for \> 23 hours per day. 2. patients on sympathomimetic agents. this includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine. 3. patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen, flexeril. 4. patients on fluoxetine or fluvoxamine. 5. patients taking amitriptyline \> 50 mg/d, trazodone and sertraline \> 100 mg/d, citalogram \> 20 mg/d or paroxetine \> 30 mg/d. 6. diagnosis of other neurodegenerative diseases (parkinson disease, alzheimer disease, etc). 7. clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days. 8. history of renal disease. 9. history of liver disease. 10. current pregnancy or lactation. 11. limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures. 12. history of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols. 13. vc \< 75% of predicted. 14. receipt of any investigational drug within the past 30 days. 15. women with the potential to become pregnant who are not practicing effective birth control.
the effect of a mediterranean diet intervention on cancer-related fatigue and mitochondrial function during chemotherapy

Conditions: Cancer

Summary: this study will assess the feasibility of delivering an 8-week mediterranean diet intervention as well as the intervention's preliminary efficacy on cancer-related fatigue among patients undergoing chemotherapy, compared to usual care. in the first 4 weeks of the intervention, we will provide the participants with food and educate them on the principles and components of the mediterranean diet, while in the second 4 weeks participants will prepare their own food. in addition, we will evaluate changes in metabolism and mitochondrial function during 4 weeks of chemotherapy and determine how adherence to a mediterranean diet modulates these changes during these 4 weeks. the hypothesis is that the intervention will promote adherence to the mediterranean diet. the second hypothesis is that adherence will be associated with alleviation of fatigue and improvements in metabolic and mitochondrial function.


Eligibility criteria:
inclusion criteria (participants must...): * have a diagnosis of cancer, * be scheduled to receive chemotherapy and have at least 6 weeks remaining, * be able to speak english, * be willing to adhere to study procedures, and * be able to provide written informed consent. exclusion criteria (participants must not...): * be on enteral or parenteral nutrition, * be pregnant, * have distant metastases, * have a brain tumor, * have any plan to get radiation to the head, * have specific dietary needs that a mediterranean diet cannot meet (e.g., allergies to nuts, gluten intolerance), or already be following the mediterranean diet (i.e., have a score ≥10 on a modified 14-item mediterranean diet questionnaire).

Keywords: nutrition diet
l-carnitine as an osmo-metabolic agent for peritoneal dialysis

Conditions: End-Stage Renal Disease

Summary: a major challenge of peritoneal dialysis (pd) therapy is the development of glucose-sparing strategies able to provide an efficacious ultrafiltration (uf) profile. study hypothesis is to evaluate the possibility to formulate pd solutions containing l-carnitine as an osmotic agent to partially replace glucose.


Eligibility criteria:
inclusion criteria: * age ≥18 years * have a diagnosis of esrd and have been on automated peritoneal dialysis (glucose 1.5 or 2.5 % w/v) for at least 3 months * be in a stable clinical condition during the four weeks immediately prior to screening period as demonstrated by medical history, physical examination and laboratory testing * have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with investigators) * have not experienced peritonitis episodes in the last 3 months * have kt/v urea measurement \> 1.7 per week in a previous test performed within 6 months that should be confirmed at baseline visit * have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at baseline visit * have a d/p creatinine ratio at peritoneal equilibration test (pet) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at baseline visit * have a d/p glucose ratio at peritoneal equilibration test (pet) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at baseline visit * be treated by the participating clinical investigator for a period of at least three months * have understood and signed the informed consent form. exclusion criteria: * have a history of drug or alcohol abuse in the six months prior to entering the protocol * be in treatment with androgens * have diabetes mellitus (as defined by the american diabetes society, objectively documented by a fasting plasma glucose and hba1c determinations) * have clinically significant abnormal liver function test (sgot, sgpt, and gamma-gt \> 2 times the upper normal limit) * have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc) * have a history of congestive heart failure and clinically significant arrhythmia * have an history of epilepsy or any ncs disease * have malignancy within the past 5 years, including lymphoproliferative disorders * have any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug, particularly if patient's life expectancy is less than 1 year * have a history of l-carnitine therapy or use in the month prior to entering the protocol * have used any investigational drug in the 3 months prior to entering the protocol * be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means

Keywords: peritoneal dialysis l-carnitine esrd
percutaneous tracheostomy with covid-19

Conditions: Tracheostomy

Summary: coronavirus disease 2019 (covid-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.

different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. one of these methods is the aerosol box.to share our experiences of percutaneous tracheostomy performed with aerosol box in covid-19 patients. patients who underwent percutaneous tracheostomy between march 2020 and june 2020 in the pandemic intensive care unit were evaluated retrospectively.the study is designed as a clinical trial study. this study was performed in faculty of medicine hospital's intensive care unit which is located in canakkale province turkey.

Eligibility criteria:
inclusion criteria: * who underwent percutaneous tracheostomy with covid-19(+) exclusion criteria: * patients who do not give informed consent or do not want to participate in the study * coagulopathy, thrombocytopenia

Keywords: reanimation
to evaluate the safety and performance of the ams activheal silicone foam and the activheal silicone foam lite dressing.

Conditions: Wound

Summary: to demonstrate the safety and performance of both ams activheal silicone foam and ams activheal silicone foam lite dressings to both the patient and clinician in managing both chronic and acute wounds.

this pmcf study has been set up to investigate and assess residual risks in relation to the ce-marked ams activheal silicone foam and silicone foam lite dressing . the purpose of this study is primarily to collect clinical follow-up data on the ams activheal silicone foam and silicone foam lite dressing , as ce-marking was based on equivalence. the data and conclusions obtained from this study will be used to provide clinical evidence of safety and effectiveness for the clinical evaluation process.

Eligibility criteria:
the patient population of this evaluation will consist of patients with either a chronic or acute wound of various wound types, according to the intended use of both the ams activheal silicone foam and activheal silicone foam lite dressing, and they meet study eligibility criteria. inclusion criteria: 1. males or females, age 18 years or above. (females must not be pregnant and if of reproductive age should be using contraception). 2. subjects who are able to understand and give informed consent to take part in the evaluation. 3. no local or systemic signs of infection, including new pain or increasing pain, erythema, local warmth, swelling, purulent discharge, pyrexia (in surgical wounds, typically five to seven days after surgery), delayed wound healing, abscess or malodour. 4. none to high levels of exudate exclusion criteria: 1. patients who decline the invitation to take part. 2. patients who are known to be non-compliant with medical treatment, 3. patients who are known to be sensitive to any of the dressing components. 4. broken/ damaged or prone to blistering peri wound skin. 5. presence of a clinically infected wound as determined by the presence of three or more of the following clinical signs: peri wound, erythema, pain between dressing changes, malodourous wound, abundant exudate, oedema, abscess, cellulitis, purulent discharge, discolouration, friable granulation tissue which bleeds easily. 6. patients who have a current illness or condition which may interfere with wound healing in the last 30 days which may interfere with wound healing (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse.) 7. life expectancy of \<6 months.

Keywords: silicone foams chronic wounds acute wounds
the effect of azithromycin in the treatment of chronic periodontitis

Conditions: Chronic Periodontitis

Summary: the aim of this study is to investigate the effects of azithromycin (systemic and locally) on the clinical and microbiological parameters of periodontal in patients with chronic periodontitis.

the double-blind, placebo-controlled clinical trial that is carried out in eighty patients who referred to the department of periodontology, isfahan school of dentistry. main inclusion criteria were: 1) patients with moderate to severe chronic periodontitis 2) at least twenty teeth 3) age over 18 years. main exclusion criteria were: 1) history of allergy to the macrolide group 2) history of antibiotic therapy within the 4 months ago 3) the lack of patient cooperation. for all patients is initially performed scaling and root planning (srp). oral health education is given to all patients. after one month, patients are randomly divided into four equal groups (two test groups and two control groups). azithromycin(azm) 250 milligram (mg) capsules, two times a day (bid), for three days will be given to a test group. in the other test group, 1% azm gel is locally injected into the periodontal pockets in single-root teeth. placebo capsules with the same dose and frequency will be given to a control group. in the other control group, placebo gel is injected in the same places. clinical parameters included pocket depth (pd), clinical attachment level (cal), papillary bleeding index (pbi), and periodontal disease index (pdi), which are recorded at baseline (before srp), at 1, 2, 3 and 4 months after treatment. using polymerase chain reaction (pcr), microbiological assessment of the percentage of porphyromonas gingivalis (p.g) and actinobacillus actinomycetemcomitans (a.a) are randomly done for 40 patients (10 patients from each group) at baseline and at 3 months after the treatment.

Eligibility criteria:
inclusion criteria: 1. patients with moderate to severe chronic periodontitis 2. at least twenty teeth 3. age over 18 years exclusion criteria: 1. with systemic diseases that affect periodontal conditions such as: diabetes, blood disorders and diseases of immune system 2. history of antibiotic therapy within the 4 months prior to study 3. history of allergy to the macrolide group of antibiotics 4. smoking 5. the lack of patient cooperation 6. history of periodontal treatment during the 4 months prior to the trial 7. pregnancy 8. lactating females 9. patients treated with drugs such as: anti-acid, warfarin and cyclisporine 10) alcohol use.

Keywords: chronic periodontitis, azithromycin, srp
effects of viscous fibre containing foods on satiety (gel form)

Conditions: Obesity

Summary: the purpose of this study is to assess whether low caloric, low energy density, konjac food products are effective in appetite regulation when administered as caloric replacements. it is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food products will have comparable satiety scores, decreased postprandial glucose response, and will not significantly affect subsequent food intake.


Eligibility criteria:
inclusion criteria: * healthy, non-smoking males and females * aged 18-70 years * bmi between 18 - 29.9 kg/m² * non-dieters (1-10 score on stunkard eating inventory) exclusion criteria: * known reported history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, celiac disease/gastrointestinal disease, or aids * weight change of +/- 3kg in the last 2 months * alcohol intake \>2 drinks/day * inability to consume kjm-g meals * any condition which might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results * non-compliance with experimental procedures or safety guidelines
translating a heart disease lifestyle intervention into the community

Conditions: Obesity; Hyperlipidemia; Hypertension; Pre-diabetes; Diabetes

Summary: translating a heart disease lifestyle intervention in the community study will evaluate the feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle intervention to improve the cardiovascular health of underserved south asian (indian, pakistani, bangladeshi, nepali, and sri lankan) americans. participants in this study will be randomly assigned to either a group to receive heart disease prevention classes or to another group where they will receive written materials about heart disease prevention.

south asian individuals were recruited from a community based organization in chicago and randomly assigned to the print health education group or the saheli intervention.

Eligibility criteria:
inclusion criteria: * south asians between 30 and 60 years * have at least one chd risk factor: obesity (body mass index \> 25 kg/m2- cutoff for obesity in south asians), hyperlipidemia, hypertension, pre-diabetes, or diabetes. exclusion criteria: * inability to speak english, hindi, or urdu * history of clinically evident cvd (e.g. heart attack, stroke) * pregnant, lactating, or planning to become pregnant during the study period * conditions that inhibit moderate intensity physical activity * systolic blood pressure ≥190 or diastolic blood pressure ≥105; triglycerides ≥ 400 * using insulin for diabetes * significant medical or psychiatric co-morbidities * plans to move out of the area within 2 years * family/household member enrolled in study

Keywords: south asians diabetes physical activity coronary heart disease lifestyle
intermittent theta-burst stimulation to target irritability in adults with asd

Conditions: Autism Spectrum Disorder

Summary: this study aims to demonstrate the feasibility, tolerability, safety and preliminary efficacy of 6 weeks of fmri-guided itbs delivered to personalized regions of the prefrontal cortex (pfc) in adults with asd in reducing irritability in adults with asd.


Eligibility criteria:
inclusion criteria: 1. diagnosis of asd or asperger's based on dsm-5 criteria as confirmed by a qualified clinician (including dr. fung), and if necessary the administration of autism diagnostic interview-revised (adi-r) and/or autism diagnostic observation schedule-generic (ados-g) 2. age 22 to 55. 3. adults who are physically healthy. 4. no significant current psychosocial stressors per history. 5. full scale iq \> 50. 6. abc-i score of 18 or greater. 7. if the participant is taking medication, they must be stable on this medication regiment for at least 4 weeks prior to baseline and agree to stay on these medications for the duration of the trial exclusion criteria: (f) pre-term birth (\<34 weeks' gestation) (g) low birth weight (\<2000 g). (h) dsm-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or schizophrenia. (i) current use of benzodiazepines. (j) use of other medications that modulate the gaba(a) receptor within 4 weeks of scanning (8 weeks for fluoxetine). (k) history of alcoholism or substance abuse. (l) active medical problems such as unstable seizures, congenital heart disease, endocrine disorders. (m) significant sensory impairments such as blindness or deafness. (n) contraindication for mri. (o) pregnancy. (p) evidence of genetic syndrome.
a french non interventional multicentric cohort study in patients with colorectal dysplasia

Conditions: Hyperplasia; Dysplasia

Summary: the main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions. it will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion. also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments). the main criterion evaluation will be the surgical and endoscopic rates during the time. the treatments offered such as surgical, endoscopic ones or none of them will be followed. finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

a replay centralized pathological lesion slides corresponding to the different lesion will be done

Eligibility criteria:
inclusion criteria: * intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia * compliant patient * endoscopic follow possible * no settler cancer * no serious pathology such as cancer exclusion criteria: * settler cancer * serious pathology such as cancer * no compliant patient * endoscopic follow not possible

Keywords: abnormal histological colorectal lesions