Kornimate/medical-research-clean huggingface dataset:
effect of gastric balloon in morbid obesity: prospective study

Conditions: Morbid Obesity

Summary: the aim of this study is to compare the efficacy of gastric balloon in weight reduction among two different categories of morbidly obese people.

to study to effect of gastric balloon in weight reduction among those above 35 bmi and those above 45 bmi.

Eligibility criteria:
inclusion criteria: * morbid obesity exclusion criteria: * patient refusal * psychological patients * oesophageal or gastric abnormalities

Keywords: gastric balloon morbid obesity
creation of a bank of biological materials and associated data related to patients with infectious and tropical diseases

Conditions: Infections

Summary: this is the protocol that formalizes the establishment of the tropica-biobank biobank

subjects who will access the department of infectious and tropical diseases for investigations, analyzes or visits on suspicion of infectious or tropical disease, hospitalized patients and/or patients participating in proposed clinical trials from the department will be enrolled. healthy volunteer donors may also be enrolled. the type of samples collected and stored in the biobank consists of human biological matrices liquids and solids, dna, protein extracts or subcellular fractions, bacterial isolates and arthropods taken from patients. the collection of samples takes place through the support of various professional figures (doctor, nurse, laboratory technician, biologist/biotechnologist) together with associated data. the samples are de-identified and protected by an encryption system (through the system computer diagnostic data management of the laboratory of the irccs sacro cuore don calabria) and stored at a temperature of -80°c, in the department's freezers. samples are stored for 40 years. in order to monitor the quality of the samples over the storage time, a selection of samples used as monthly analytical quality controls will be retested periodically (every 10 years). at the end of the storage time, it will be evaluated whether to extend the storage time of the unused biological samples and associated data or if these will be destroyed. in the first case, an amendment to this protocol will be submitted to the cesc for approval, in which will specify the duration of the extension of the conservation of the samples and associated data. in the second case, no further data will be collected on the aforementioned samples, without prejudice to their use of those possibly already collected to determine, without altering them, the results of searches already in progress. the samples will in any case be destroyed if they are not in good condition.

Eligibility criteria:
inclusion criteria: • informed consent (for healthy volounteers also: age \> 18 years, health status ascertained by laboratory tests, electrocardiogram and medical examination) exclusion criteria: * history of alcohol/drug abuse * pregnant or breastfeeding women, unless there are justified and documented needs
plaque psoriasis study in pediatric subjects

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to compare the safety, efficacy and calcium metabolism of up to 8 weeks of treatment with calcitriol 3 mcg/g ointment versus its vehicle, when used twice daily, without occlusion, to treat children aged 2 to 12 years, with plaque psoriasis.


Eligibility criteria:
inclusion criteria: * male or female 2 to 12 years of age * clinical diagnosis of stable mild to moderate plaque psoriasis exclusion criteria: * other forms of psoriasis * hypercalcemia * past history of kidney stones * vitamin d deficiency * other concomitant dermatological disease
nocturnal cyclic enteral nutrition infusion versus continuous infusion of enteral nutrition

Conditions: Critical Illness; Enteral Feeding Intolerance; Nutrition Support

Summary: enteral nutrition is considered the best way to feed those who can´t be fed orally. the standard protocol of administration includes continuous infusion for 24 hours; nonetheless this support is constantly suspended which causes a decrease in the nutrition administered vs the one formulated. therefore this randomized clinical trial attempts to compare de standard administration vs. cyclic infusion during night hours measuring the formulated vs the administered volume of enteral nutrition given to the patient. the control group will be assigned standard 24 hour infusion of enteral nutrition while the experimental group will be assigned cyclic infusion during night hours. the variables include volume formulated, volume given in 24 hours, hours and reasons why the enteral nutrition was suspended, and related complications (abdominal distension, vomiting, and diarrhea).

the trial will be carried at san ignacio university hospital intensive care unit. patients included will be over 18 years old who require enteral nutrition according to their attending or to the nutritional and metabolic support team. 260 envelopes with the specific intervention were created. 130 of them are identified with number 0 which corresponds to no intervention, meaning continuous enteral nutrition infusion during 24 hours. the other 130 are assigned with the number 1 which corresponds to intervention, meaning nocturnal cyclic nocturnal enteral nutrition infusion. envelopes will be randomly assigned sequentially from number 1 to 260, in which envelope number 1 will be assigned for the first patient. each patient´s envelope will be labeled with its name and identification number. according to the information contained in the envelope the specific scheme assigned will be formulated. envelopes will be kept at the nutritional and metabolic support´s office; only research assistant will have access to this information. after 50% of the sample be achieved, there will be a data analysis to review the rate of intolerance to enteral nutrition in both groups. principal investigators will review the entire data after completion of the clinical trial, measuring percentage of enteral nutrition delivered and intolerance to enteral nutrition feeding.

Eligibility criteria:
inclusion criteria: * patients over 18 years old, hospitalized in san ignacio university hospital intensive care unit. * patients with indication on enteral nutrition defined by its attending or by the nutritional and metabolic support team. exclusion criteria: -if patient or legal advocate denies to sign consent to participate in this study.

Keywords: enteral nutrition critically ill continous infusion cyclic infusion
comparison of sutureless vs. standard biological prostheses for surgical aortic valve replacement

Conditions: Heart Valve Prosthesis; Aortic Stenosis; Hemodynamics

Summary: multicenter randomised study which aims to compare sutureless vs. standard bio- prostheses (1:1) among patients undergoing surgical aortic valve replacement in terms of: * 6 -month hemodynamic performance. * 6 month clinical outcomes including all cause mortality, stroke, myocardial infarction, valve reoperation and major/life threatening bleeding * cost effectiveness

this study is aimed to compare clinical and hemodynamic performance of conventional sutured stented bio-prostheses among patients undergoing a surgical aortic valve replacement. the prostheses are not pre specified to be provided by a specific manufacturer, so that any bio prosthesis but transcatheter and scentless aortic valves can be implanted. the estimated sample size is 350 patients. they will be randomised 1:1 to any of the two arms of the study (standard vs. sutureless prostheses). the randomisation will be stratified according to the need for a concomitant coronary artery bypass grafting procedure. six hospitals in madrid (spain) will take part in the study. the period of recruitment will start as soon as june 2019 and is supposed to finish by june 2020 or earlier. the main outcomes of the study will be measured 6 months after the aortic valve implantation

Eligibility criteria:
inclusion criteria: * patients older than 18 * pure aortic stenosis or combined aortic stenosis/regurgitation * aortic annulus \>18 mm and \< 27 mm exclusion criteria: * pregnancy * willing to receive some other prosthesis * concomitant surgery of the ascending aorta or left ventricle outflow tract * endocarditis * emergency * some other concomitant procedure * participation in any other study * previous surgery

Keywords: aortic stenosis heart valve prosthesis hemodynamics sutureless standard aortic valve prosthesis
a study of lxr015-1 in hiv-infected patients

Conditions: HIV Infections

Summary: to determine and compare the safety and tolerability of 3 doses of lxr015-1 in hiv-infected patients.

patients will be randomized to 1 of 3 doses of oral lxr015-1 for 28 days and patients will be monitored for adverse events for the duration of the study. patients will continue to be monitored for least 4 weeks after completion of the dosing.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * cd4 cell count less than 200 cells/mm3. prior medication: allowed: acute therapy for opportunistic infections or serious aids defining infections must be completed at least 28 days before study entry. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * patients that are unable to take adequate oral intake (i.e. unable to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/oral/esophageal discomfort). * patients who have severe diarrhea as defined as \>= 7 stools per day, or acute diarrhea due to a treatable cause. note: * if the patient has cryptosporidia, mycobacterium avium, or cytomegalovirus that is unresponsive to treatment and has less than 7 stools per day, the patient may participate in this study. * patients who have any severe or life-threatening laboratory or clinical abnormality, or are not expected to live for 8 weeks. * patients who have an active opportunistic infection, including tuberculosis, cryptococcosis, or other serious aids defining infections requiring immediate treatment. acute therapy must be completed at least 28 days before study entry. * patients with unexplained elevated temperature \>= 38.5 degrees c that persists for 7 days or more within 14 days before study entry. * patients with malignancy other than squamous or basal carcinomas of the skin. patients with visceral kaposi's sarcoma or lymphoma requiring systemic chemotherapy or radiation treatment will be excluded. patients with kaposi's of the skin or mucous membranes may enroll in this study. * patients, who in the judgment of the investigator are unable to comply with the protocol. concurrent treatment: excluded: radiation therapy. patients with the following prior condition are excluded: a known history of hypersensitivity reaction to soy protein or soy lecithin. note: * this hypersensitivity is identified through medical history, not skin testing. excluded: * systemic chemotherapy. * acute therapy for opportunistic infections or other serious aids defining infections. * intravenous rehydration as treatment for diarrhea. required: patient must be taking a stable regimen (about 8 weeks) of anti-viral, anti-opportunistic infection and/or anti-diarrheal (if patient has diarrhea) medications.

Keywords: dose-response relationship, drug administration, oral acquired immunodeficiency syndrome anti-hiv agents
efficacy and safety of a high dosage compared to the label dosage of somatropin in early pubertal stage children with growth hormone deficiency

Conditions: Growth Hormone Deficiency

Summary: multi-center, randomized, controlled, open-label, phase iii study comparing the effects of two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of treatment, on height velocity in early pubertal children with growth hormone deficiency (ghd). the study will be conducted in italy. approximately 26 subjects will participate in this study, distributed as 13 in the in-label dosage group (group a) and 13 in the doubled dosage group (group b).


Eligibility criteria:
inclusion criteria: * height velocity (cm/y) less than 25th percentile at the time of diagnosis. * diagnosis of ghd * replacement therapy at label dosage (from 0.025 to 0.035 mg/kg/day) must be started at least 1 year before the enrolment in this study, but at most 3 years before enrolment * bone age less than 12 years for girls and less than 14 years for boys. this assessment should be made by the central reader of bone ages, based on the x-ray taken at visit 0. * informed consent obtained from either both of the subject's parents or legal representative. exclusion criteria: * pubertal clinical stage less than 2 and greater than 3 according to tanner score (for male subjects a volume of testicle greater than 15 ml). * any evidence of active malignancy. in case of previous surgical removal of both diencephalic and hypophysial masses, an mri, performed within six months before enrollment into the study, must exclude the growth of residual tumoral tissue. * any known chronic disease such as diabetes mellitus, hepatic disease (defined by elevated liver enzymes 3-fold the upper limit of normal ranges), renal disease with creatinine levels greater than 130 micromol/l, or congestive heart failure. * glucocorticoid therapy in supra physiological doses (inhaled corticoids will be accepted if below 3 puffs/day, for no more than 10 days consecutively). * current or previous therapy with any therapy that may directly influence growth, including growth hormone releasing hormone, estrogens and anabolic steroids.
effects of pulsed magnetic pads on rheumatoid arthritis symptoms in postmenopausal women

Conditions: Rheumatoid Arthritis; Menopause

Summary: the purpose of this study is to determine whether a pulsed magnetic field (pmf) pad will improve symptoms of rheumatoid arthritis (ra) in postmenopausal women. study hypothesis: a pulsed magnetic field pad will effectively reduce the symptoms of ra in postmenopausal women.

ra is a condition characterized by pain, fatigue, sleep disturbances, and mood changes. these symptoms often persist despite the use of nonsteroidal anti-inflammatory drugs (nsaids) and disease modifying antirheumatic drugs (dmards). many women for whom these drugs do not work turn to complementary and alternative therapies, including the use of magnetic devices. although few studies have investigated the effects of low strength pmf pads in persons with ra, evidence suggests that pmf may help relieve pain, inflammation, and fatigue. this study will determine the effects of a pmf device on ra symptoms in postmenopausal women. this study will last 12 weeks. participants will be randomly assigned to one of three groups: active pmf pad treatment, sham pmf pad treatment, or standard of care, which may include drug therapy or physical therapy. participants in the active and sham pmf pad groups will be treated with their assigned pad for approximately 8 minutes, twice a day for the duration of the study. questionnaires and self-report scales will be used to assess pain, fatigue, sleep quality, mood, and inflammation episodes. blood and urine collection will occur to assess levels of stress hormones and certain proteins.

Eligibility criteria:
inclusion criteria: * diagnosis of ra * postmenopausal, defined by no menstrual period in at least 2 years prior to study entry or a hysterectomy * average pain of 2 or greater on a 0 to 10 pain scale * sleep difficulty * stable medication use related to ra for at least 4 weeks prior to study entry exclusion criteria: * diagnoses of lupus, sleep apnea, or restless leg syndrome * high-dose prednisone (more than 10 mg/day) or equivalent * pacemakers or other implanted devices * epilepsy * currently undergoing treatment for cancer

Keywords: magnetics pulsed magnetic pad magnetic field electromagnetic field women pulsed magnetic field
a clinical study of 9mw2821 in subjects with advanced malignant solid tumors

Conditions: Solid Tumors

Summary: this study is a phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9mw2821 administered by intravenous (iv) infusion.


Eligibility criteria:
inclusion criteria: 1. competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (iec/irb/reb) approved informed consent form. 2. male or female subjects aged 18 to 80 years (including 18 and 80 years). 3. eastern cooperative oncology group (ecog) performance status of 0 or 1. 4. histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). 5. for cohort expansion: subjects must submit tumor tissue for nectin-4 expression. 6. life expectancy of ≥ 3 months. 7. subjects must have measurable disease according to recist (version 1.1). 8. adequate organ functions. 9. sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy. 10. subjects are willing to follow study procedures. exclusion criteria: 1. chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, or any other anticancer therapy within 14 days prior to the first dose of study drug. 2. preexisting treatment related toxicity grade ≥ 2 (except alopecia). 3. major surgery within 28 days prior to first dose of study drug. 4. history of uncontrolled diabetes mellitus. 5. preexisting peripheral neuropathy grade ≥ 2. 6. received treatment of nectin-4 targeted adc with mmae payload. 7. any live vaccines within 4 weeks before first dose of study drug or during the study. 8. documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug. 9. other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection. 10. uncontrolled central nervous system metastases. 11. history of another malignancy within 3 years before the first dose of study drug. subjects with curable malignancies are allowed. 12. history of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug. 13. has ocular conditions that may increase the risk of corneal epithelium damage. 14. known sensitivity to any of the ingredients of the investigational product; history of drug abuse or mental illness. 15. any p-glycoprotein (p-gp) inducers/inhibitors or cyp3a4 inducers/inhibitors within 14 days prior to the first dose of study drug 16. use of any investigational drug or device within 2 months prior to the first dose of study drug. 17. condition or situation which may put the subject at significant risk.
comparison between turquoise and blue light in treatment of neonatal jaundice using light emission diodes

Conditions: Uncomplicated Neonatal Hyperbilirubinemia

Summary: the optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. though, previous studies used light tubes, today we use light emitting diodes (led's). the overall aim of this study was therefore to compare the efficacy of turquoise led's versus blue led's for decreasing total serum bilirubin in neonates with gestational age \> 33 weeks and uncomplicated hyperbilirubinemia.


Eligibility criteria:
inclusion criteria: * newborns with gestational age \>33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines exclusion criteria: * haemolytic disease (rhesus and kell blood type isoimmunization, spherocytosis) * liver disease

Keywords: neonatal hyperbilirubinemia phototherapy light emitting diodes blue light turquoise light
impact of vitamin d supplementation on covid-19 vaccine response and igg antibodies in deficient women.

Conditions: COVID-19 Pandemic; D Vitamin Deficiency; Antibody Hypersensitivity

Summary: decreased immunity in individuals causes a decrease in vaccine response, and vitamin d worsens this course. vitamin d is thought to be a vitamin that can strengthen the innate immune response, inhibit the adaptive system, and modulate the vaccine response. the effect of vitamin d intake on antibodies was studied.


Eligibility criteria:
inclusion criteria: * the study consisted of young volunteer women who completed 2 doses of covid-19 vaccines, did not receive the 3rd dose, and spent an average of 65 days over the 2nd dose. participants were included in the study when igm value was negative, igg value was positive, they were not older than 25 years, and serum 25-hydroxy (25(oh)) vitamin d was below 30 ng/ml. exclusion criteria: * in addition, individuals participating in the research who were pregnant, had physician-diagnosed cardiovascular diseases, had kidney or liver failure, and had the chronic obstructive pulmonary disease were not included in the study.

Keywords: covid-19 vaccine antibody igg d vitamin nutrition
a study of an implantable miniature telescope in patients with with end-stage amd

Conditions: End Stage Macular Degeneration

Summary: evaluation of pre and post-implantation management of patients with end-stage age-related macular degeneration (amd) who have been implanted with the implantable telescope (imt) under ce mark indicated use. this study is designed to evaluate in particular the optimal parameters for patient selection for use of this device in routine clinical practice.


Eligibility criteria:
inclusion criteria: ce mark approved indication of use which includes * at least 55 years of age * bilateral visual impairment due to geographic atrophy or disciform scars * evidence of cataract exclusion criteria: * active cnv (or 'wet' amd) * prior cataract or refractive surgery in the study eye

Keywords: macular degeneration visual impairment quality of life implantable telescope
adolescent depression: video ads on instagram

Conditions: Depression; Stigmatization

Summary: the purposes of this study are to test among adolescent viewers the utility of different types of selfie short video-based messaging to: 1. reduce stigma and self-stigma related to depression, and 2. increase treatment-seeking intentions.

intervention videos will each be self-recorded videos (of \~90-second duration) featuring the same underage professional (ages 16) acting as simulated participant. the investigators will post three brief videos ('video ads') to achieve similar exposure among instagram users, 14-18-year-old. the videos are: (a) depression video; (b) depression video adjusted to race experiences, and (c) control videos. all videos will feature by the same black adolescent girl. the investigators intend to assign \~10,000 individuals aged 14-18 in a randomized way, in equal proportions, and stratified by sex and race, to view one of the three videos. outcomes will include: 1. primary outcome: engagement (a composite of likes, shares, comments, and views) 2. secondary outcome: clicks on a designated link at the end of the video ad.

Eligibility criteria:
inclusion criteria: * english-speaking * living in the us * ages 14 - 18 exclusion criteria: * none
management of the sprained ankle by help of nsaid-plaster

Conditions: The Sprained Ankle

Summary: the purpose of this trial is to study the management of the sprained ankle by help of nsaid-plaster. a questionnaire. the effect of rice and rice + nsaid-plaster in the treatment of the sprained ankle, compared by pain-score.


Eligibility criteria:
inclusion criteria: * a sprained ankle, less than 24 hours old, understanding danish, 18 years or older exclusion criteria: * fracture of the ankle, wound around the ankle, allergy of nsaid- pregnancy, daily use of nsaid, gi-bleeding