Kornimate/medical-research-clean huggingface dataset:
prevention of traveler's diarrhea

Conditions: Diarrhea

Summary: the prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). the very attractive prospect of preventing travellers' diarrhea without systemic antibiotics has fueled interest in probiotics for this purpose. however, not all probiotics are identical, and the results of studies conducted with a particular agent cannot be generalized to indicate that any probiotic agent would be successful in the same clinical situation. probiotics such as lactobacillus gg have been shown to reduce the incidence of diarrhea in travelers in randomized controlled trials. in contrast, another lactobacillus preparation, non-viable lactobacillus acidophilus, showed no benefit over placebo in a randomized, double-blind, controlled trial of 174 travelers. the reasons for this are unclear, but could be related to the fact that the bacteria were not viable or a peculiarity of the strain selected for testing.


Eligibility criteria:
inclusion criteria: * healthy bikers * able to pass the amazonia forest by bike exclusion criteria: * none predifinied
study to evaluate efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia - Heterozygous

Summary: this was a pivotal phase iii study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (hefh) and elevated low density lipoprotein cholesterol (ldl-c).

this was a two-part (1 year double-blind inclisiran versus placebo / 1 year open-label inclisiran) multicenter study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (hefh) and elevated low density lipoprotein cholesterol (ldl-c) on stable standard of care background lipid-lowering therapy. the primary objective was to demonstrate superiority of inclisiran compared to placebo in reducing ldl-c (percent change) at day 330.

Eligibility criteria:
inclusion criteria: * heterozygous familial hypercholesterolemia (hefh) diagnosed either by genetic testing or on phenotypic criteria * fasting ldl-c \>130 mg/dl (3.4 mmol/l) at screening * fasting triglycerides \<400 mg/dl (4.5 mmol/l) at screening * on maximally tolerated dose of statin (investigator's discretion) with or without other lipid-lowering therapy; stable for ≥ 30 days before screening exclusion criteria: * homozygous familial hypercholesterolemia (hofh) * active liver disease * secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome * previous treatment with monoclonal antibodies directed towards pcsk9 (within 90 days of screening) * recent and/or planned use of other investigational medicinal products or devices

Keywords: heterozygous familial hypercholesterolemia (hefh) ldl-cholesterol (ldl-c) adolescents pediatric small interfering ribonucleic acid (sirna)
kp-10 and insulin secretion in men

Conditions: Kisspeptin Action on Insulin in Healthy Normal Men; Kisspeptin Action on Insulin in Obese Diabetic Men

Summary: induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear. the present study was designed to investigate the role of kp-10 on insulin secretion in adult healthy and obese men with insulin resistance. the aim of selection of obese persons for the present study was to investigate the effect of acute kp-10 administration in a metabolically challenged condition where the pancreatic beta cells are already highly activated. the long-term objective of this study was to understand the physiological role of kisspeptin signalling in the regulation of insulin secretion in human health and disease.


Eligibility criteria:
inclusion criteria: * normal bmi * normal renal function * normal liver function * normal blood count exclusion criteria: * disease history * diabetes * other trauma
crossover bioequivalence study of irbesartan hydrochlorothiazide 300/25 mg tablets under fed conditions

Conditions: Hypertension

Summary: the objective of this study was to prove the bioequivalence of roxane laboratories' irbesartan and hydrochlorothiazide 300 mg / 25 mg tablets under fed conditions


Eligibility criteria:
inclusion criteria: 1. male and female subjects between the ages of 18 and 45 years (inclusive). 2. voluntary consent to participate in the study. 3. body mass index (bmi) between 18 and 30 (inclusive). 4. female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), iud, or vasectomized partner (6 months minimum). 5. no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: 1. a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results. 2. a history of allergic or adverse responses to irbesartan and hydrochlorothiazide, or any comparable or similar product. 3. subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation. 4. subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation. 5. subjects must not have made a plasma donation within 14 days of study initiation. 6. participation in a clinical trial within 30 days prior to study initiation. 7. use of any over-the-counter (otc) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study. 8. use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy. 9. treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, maoi, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study. 10. smoking or use of tobacco products within 6 months prior to or during the study. 11. female subjects who are lactating. 12. positive serum pregnancy test for female subjects. 13. positive blood screen for hiv, hepatitis b or hepatitis c. 14. positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.
advancing discussions using a video-based support tool about end-of-life care

Conditions: Traumatic Injury

Summary: the purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults


Eligibility criteria:
inclusion criteria: * english or spanish speaking * admitted to any level of care following trauma exclusion criteria: * prisoners * existing do not resuscitate (dnr)/do not intubate (dni) * patients admitted while on hospice * patients not expected to survive over 24-48 hours
follow-up after surgery for colorectal cancer

Conditions: Colorectal Cancer; Quality of Life

Summary: the currently developed implementation study aims to evaluate if a patient-led home-based follow-up approach is successful, improves quality of life, reduces anxiety and lessens fear of cancer recurrence during the years after surgical treatment of colorectal cancer (crc).

as the available literature implies that intensive postoperative surveillance has no impact on (cancer-specific) survival outcomes in patients after curative intent surgery for crc, critical appraisal of the current follow-up practice and guidelines is needed. although patients in the referenced randomized controlled trials were included roughly 5 - 15 years ago, treatment for recurrent colorectal cancer has seen little to no change since then. therefore, efforts to improve the current standard of follow-up in patients with crc should focus on ameliorating quality of life and cost-effectiveness, rather than survival. it provides an opportunity to support patients emotionally, to evaluate treatment effects and complications, and to inform them on their individual prognosis. this is especially true considering the growing importance of value based healthcare and patient reported outcomes in medicine. the investigators therefore propose a patient-led home-based follow-up approach. this follow-up strategy primarily consists of carcinoembryonic antigen (cea) level monitoring at home, but additional counselling/diagnostic testing remains possible if desired by patients. in this way the investigators hope to meet the individual needs of patients during follow-up and to improve quality of life outcomes, while achieving equal or greater societal cost-effectiveness.

Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal adenocarcinoma without distant metastasis and treated with curative intent surgical resection less than 6 months ago * scheduled or currently undergoing postoperative surveillance according to national guidelines * written informed consent by the patient exclusion criteria: * patients with a severely complicated postoperative course, needing in hospital follow-up longer than 6 months postoperatively * patients enrolled in other studies that require strict adherence to any specific follow-up practice with regular imaging - yearly or more frequent - of the abdomen and/or thorax * patients with comorbidity or other malignancy that requires imaging of the abdomen and/or thorax every year or more frequent * inability to complete the questionnaires due to illiteracy and/or insufficient proficiency of the dutch language

Keywords: patient-led home-based
human empowerment aging and disability (head): new technologies for neurorehabilitation

Conditions: Rehabilitation; Technology; Telerehabilitation; Nervous System Diseases

Summary: congenital or acquired neurological disorders could lead to consistent motor and cognitive disabilities. the continuity and persistency of a tailored home rehabilitation protocol after recovery is crucial to prevent disease aggravation or relapses. the integration of a web-based new technology in home rehabilitation programme can constitute a functional low cost resource by offering patients off-line (and on-line) monitoring and by proposing new motivating ways of rehabilitation through high tech tools such as serious games.


Eligibility criteria:
inclusion criteria: * age range 18-85 * parkinson disease (pd - mild to moderate) in stable treatment for at least 3 months * multiple sclerosis (ms) without relapses in the last 3 months (edss ≤ 6) * post stroke ( ≥ 6 months after the acute event) exclusion criteria: * mini mental state examination \< 20 * limited range of motion * severe pain * severe deficit of visual acuity or auditory perception or communication and severe dysmetry
polyethylene bag: a way of preventing hypothermia during central venous catheter placement in preterm neonates?

Conditions: Preterm Neonates

Summary: particular attention is paid to thermal management of preterm neonates in neonatal intensive care units because of the major risk of morbidity associated with hypothermia. percutaneous central venous catheter placement is essential to ensure adequate caloric intake and intravenous administration of treatments, but this procedure can cause major body temperature variations, responsible for complications in these neonates, as convection incubator function is impaired during opening of the incubator, which can be prolonged (30 minutes to 2 hours) depending on the technical difficulties encountered during catheter placement. in parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal transport is now clearly defined and ensures stability or even a considerable temperature gain during transfer immediately after birth. in the light of several clinical cases, the use of a polyethylene bag during central venous catheter placement appears to be effective to prevent body temperature loss in preterm neonates. no data are currently available concerning the value of this method of prevention of hypothermia during this type of procedure. preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or sheet could be useful during this procedure by significantly reducing heat loss caused by convection and evaporation. however, compensation phenomena such as generalized vasoconstriction to cold in preterm infants are very poorly described, but can induce a functional conflict between mechanisms ensuring maintenance of homeostasis and those involved in maintenance of blood pressure.


Eligibility criteria:
inclusion criteria: * premature newborn child = 32 weeks of gestational age * 7 days of life * normothermic (core temperature between 36.5 and 37.5 ° c) * stable on a hemodynamically manner * need the installation of a central catheter ktec exclusion criteria: * parental refusal * hypothermia (temperature \< 36.5 ° c) * hyperthermia (temperature \> 37.5 ° c) * heart disease and malformation syndromes life-threatening * hemodynamic instability ( catecholamine vasoconstrictor and vasodilator ) * breakdown by oscillation

Keywords: hypothermia central venous catheter placement polyethylene bag
does vitamin d improves sustained virologic response (svr) in genotype 2,3 chronic hepatitis c patients?

Conditions: Hepatitis C

Summary: standard therapy for chronic hepatitis c virus (hcv) is (peg/rbv) combination therapy obtaining sustained virologic response (svr) in 80% of naïve patients with genotype 2,3. studies rarely address the issues of improving host factors. the current study examines 1. whether adding vitamin d, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks) 2. whether vitamin d levels predictes negative treatment outcome.

standard therapy for chronic hepatitis c virus (hcv) is (peg/rbv) combination therapy obtaining sustained virologic response (svr) in 80% of naïve patients with genotype 2,3. studies rarely address the issues of improving host factors. the current study examines whether adding vitamin d, a potent immunomodulator, could improve viral respons.the working hypothesis is that adding vitamin d to conventional peg/rbv therapy for naïve, genotype 2,3 patients with chronic hcv infection significantly improves rvr, evr, and svr

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age, * chronic genotype 2,3 hcv infection, traetment naive * negative sero for hbv, hdv and hiv viral infections * absolute neutrophil count of \>1500 per cubic millimeter, a platelet count of \>90,000 per cubic millimeter * normal hemoglobin level exclusion criteria: * decompensated liver disease (cirrhosis with cp score \>9) * another cause of clinically significant liver disease * hepato cellular carcinoma * psychiatric disorder * chronic heart failure * pregnant women * uncontrolled diabetes with retinopathy * arythmia * active cad * positive sero for hbv, hdv and hiv viral infections or other autoimmune liver disease

Keywords: vitamin d hepatitis c genotype2,3 svr naive rvr rate evr rate svr rate
a study of my008211a in adult patients with paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the main purpose of this study is to evaluate the efficacy of my008211a in adult patients with pnh , showing signs of active hemolysis, in china.

the purpose of this study is to determine whether my008211a is efficacious and safe for the treatment of pnh patients who are naive to complement inhibitor therapy, including anti-c5 antibody.

Eligibility criteria:
inclusion criteria: * male and female participants ≥ 18 years of age, bmi≥18 kg/m2，with a diagnosis of pnh confirmed by laboratory tests, according to the pnh diagnostic criteria in the chinese guidelines for the diagnosis and treatment of rare diseases (2019 edition) , and flow cytometry with clone size ≥ 10%. * mean hemoglobin level \<100 g/l. * ldh \> 1.5 x upper limit of normal (uln) * vaccination against neisseria meningitidis infection is required prior to the start of study treatment. if not received previously, vaccination against streptococcus pneumoniae and haemophilus influenzae infections should be given. exclusion criteria: * patients with reticulocytes \<100x10\^9/l; platelets \<30x10\^9/l; neutrophils \<0.5x10\^9/l. * were using a complement inhibitor before the first administration of my008211a tablets or had discontinued a previous complement inhibitor for less than five half-lives or 120 days, whichever was the longest. * history of recurrent invasive infections caused by encapsulated organisms, e.g. meningococcus or pneumococcus. * known or suspected hereditary complement deficiency * previous bone marrow or hematopoietic stem cell transplantation. * previous splenectomy. * a history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
pemf vs laser for stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: stress urinary incontinence, or involuntary urine leakage during activities like coughing, laughing, or exercise, is a common condition that impacts quality of life for many women. pelvic floor muscle training is often used to treat stress incontinence, but additional therapies may enhance outcomes. this randomized controlled trial will compare two physical therapy modalities, pulsed electromagnetic field (pemf) therapy versus laser acupuncture, along with pelvic floor training for improving stress urinary incontinence in 60 adult women. the study will evaluate their effects on pelvic floor muscle strength, severity of urine leakage, and quality of life. we hypothesize that pemf and laser acupuncture will both improve stress incontinence, but pemf will be more effective based on greater pelvic floor stimulation. the study aims to provide evidence on these physical therapy options so that optimized treatment plans can be developed for women with stress urinary incontinence.


Eligibility criteria:
inclusion criteria: * adult females aged 18-65 years with stress urinary incontinence * able to comply with study procedures and schedule exclusion criteria: * prior pelvic floor surgery * pregnancy * active urinary tract infection * pelvic organ prolapse \>stage 2 * neurologic disorder affecting urinary function
esophageal motility in reflux induced cough

Conditions: Cough

Summary: to determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough.


Eligibility criteria:
inclusion criteria: 1. adult patients (ages 18-75 years old) 2. cough for more than 8 weeks 3. additional clinical evaluation of cough including a complete pulmonary function test with methacholine challenge and a high resolution ct scan of the chest. 4. ability to understand the purpose and nature of the study 5. willingness to participate and provide consent form exclusion criteria: 1. actively smoke in the preceding 6 months. 2. recent respiratory tract infection (\<4 weeks). 3. drink above the recommended safe alcohol limit (21 units per week). 4. history of respiratory or gastrointestinal malignancies. 5. previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy). 6. subjects with established and significant cardiac, pulmonary, or neurological disorders as deemed by the clinician or study personnel 7. use of angiotensin converting enzyme inhibitors 8. use of h2 blockers or proton pump inhibitors in the seven days prior to reflux testing (impedance/ph), or inability to withhold such medications for the duration of the study 9. women of childbearing potential, using adequate birth control. adequate birth control includes: (i) hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; (ii) barrier methods (such as, a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); (iii) intrauterine device (iud); or (iv) abstinence (no sex). adequate birth control must be maintained for the duration of the study. women not using adequate birth control will be excluded from the study, as funding for the pregnancy tests was not included in the small grant awarded for this study. 10. nursing mothers will be excluded. 11. persons with allergies to citrus will be excluded. 12. inability to understand the purpose and nature of the study 13. unwillingness to participate and provide consent form

Keywords: chronic cough gastroesophageal reflux esophageal motility cough sensitivity
quantifying physical and biochemical factors that contribute to primary graft dysfunction after lung transplantation

Conditions: Primary Graft Dysfunction

Summary: primary graft dysfunction (pgd or lung reperfusion edema) complicates 10 to 20% of lung transplantations and leads to severe early and late postoperative complications. its pathophysiology remains unclear but may involve graft ischemia-reperfusion, increased vascular permeability, pneumocyte dysfunction and finally alveolar flooding that impair gas exchange and blood oxygenation.its substrate, namely extravascular lung water (evlw), can now be clinically measured with minimally invasive intensive care unit monitors (picco2®, pulsion medical systems) that also provides a physical estimate of pulmonary vascular permeability (pvpi). similarly, biochemical correlates of vascular permeability (icam-1) and pneumocyte dysfunction (rage) can now be measured in plasma samples. our study aims at quantifying physical and biochemical markers of pgd and assess their diagnosis and prognosis values.


Eligibility criteria:
inclusion criteria: * lung transplant recipient * age \> 18 years * signed informed consent * social security affiliation exclusion criteria: * age\<18 * pregnancy or lactation * contraindication to femoral arterial catheterization * patient refusal

Keywords: lung transplantation primary graft dysfunction extravascular lung water receptor for advanced glycation endproducts (rage) intercellular adhesion molecule-1 (icam-1)