Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of melatonin in outpatients infected with covid-19

Conditions: COVID-19

Summary: this study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with covid-19.

this study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in outpatient adult patients suspected to be afflicted with covid-19. participants will be enrolled as outpatients within 72 hrs of onset of covid-19 symptoms. the study will evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm as assessed by cumulative incidence of serious adverse events (saes), cumulative incidence of grade 3 and 4 adverse events (aes), and/or discontinuation or temporary suspension of the investigational medication (for any reason). additionally, the study will aim to evaluate the clinical efficacy of melatonin as compared to placebo as assessed by hospitalization, covid-19 related symptoms and mortality. the ultimate goal is to determine in an adequately powered study if the anti-inflammatory and antioxidant actions of melatonin can reduce the severity and prevent progression of covid-19 when started in mild disease.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female adult ≥18 years of age at time of enrollment. * women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. * subject provides written informed consent prior to initiation of any study procedures. * understands and agrees to comply with planned study procedures. * agrees to the collection and storage of saliva samples per protocol. exclusion criteria: * severe chronic liver disease * severe chronic kidney disease or requiring dialysis * pregnancy or breast feeding. * allergy to the study medication * currently taking melatonin * currently taking high dose (\>500 mg/day) vitamin c

Keywords: melatonin covid-19 sars-cov-2
a phase i study to evaluate the oral absorption of nepadutant in infants

Conditions: Infantile Colic; Infantile Functional Gastrointestinal Disorders

Summary: the purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. oral absorption is evaluated through the drug recovery in urine.

this trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/kg given as one single dose as oral solution) in infants divided in three age strata (from 6 to 24 weeks old). oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers. safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.

Eligibility criteria:
inclusion criteria: subjects will be eligible for inclusion in the study if they meet all of the following criteria: * infants with a history consistent with a diagnosis of colic or other functional gastrointestinal disorders * age \>6 weeks and \< 24 weeks * at least 44 weeks post-conceptual age at enrolment * normal growth * informed consent by parents (one or both) or legal guardian * caregiver available to be trained in collection and storage of used diapers * caregiver available to record feeding episodes and defecations on the diary exclusion criteria: subjects will be excluded from the study if they meet any of the following criteria: * clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), haematological, severe dermatological or neurological pathology or other diseases; * previous major surgery or blood loss * intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.

Keywords: infantile colic abdominal cramps colicky pain functional gastrointestinal disorders
study evaluating ins018_055 administered orally to subjects with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Summary: the goal of this clinical trial is to learn about ins018_055 in adults with idiopathic pulmonary fibrosis (ipf). the primary objective is to evaluate the safety and tolerability of ins018_055 orally administered for up to 12 weeks in adult subjects with ipf compared to placebo.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥40 years based on the date of the written informed consent form 2. diagnosis of ipf as defined by american thoracic society/european respiratory society/japanese respiratory society/latin american thoracic association guidelines 3. in a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ecg, and laboratory evaluation 4. subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for ≥ 8 weeks prior to visit 1 meeting all of the following criteria during the screening period: 1. fvc ≥40% predicted of normal 2. dlco corrected for hgb ≥25% and \<80% predicted of normal. 3. forced expiratory volume in the first second/fvc (fev1/fvc) ratio \>0.7 based on pre-bronchodilator value exclusion criteria: 1. acute ipf exacerbation within 4 months prior to visit 1 and/or day 1, as determined by the investigator 2. patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study 3. female patients who are pregnant or nursing 4. abnormal ecg findings

Keywords: pulmonary fibrosis idiopathic pulmonary fibrosis fibrosis pathologic processes lung diseases, interstitial lung diseases respiratory tract diseases
systemic immunomodulatory effects and pharmacogenetics of atorvastatin in early atherosclerosis

Conditions: Inflammation

Summary: the purpose of the study is to test whether atorvastatin (also known as lipitor) has anti-inflammatory effects in people with no known heart disease or high cholesterol. we also are investigating whether or not genetic differences between people plays a role in the drug response.

all subjects received 16 weeks of atorvastatin after a two week run in. key dependent variables were the 16 week value minus the baseline value (post run-in). last observation carried forward was used for missing values. the key comparisons are for two groups oatp1b1 reduced carriers and on-carriers and their association with cytokines and lipids. secondarily, we were interested in changes over the 16 weeks for the pooled sample, irrespective of genetics.

Eligibility criteria:
inclusion criteria: * 18+ years old * normocholesterolemic exclusion criteria: * cardiovascular disease or risk equivalents * malignancy * active alcohol abuse * contraindications to statins * interacting drugs * chronic anti-inflammatory drugs
mirna and myokines in patients with pah

Conditions: Pulmonary Arterial Hypertension

Summary: the overall objective of this study is to fulfill the pilot study (mirna and myokines acutely-expressed during exercise) goal to investigate the excretion of skeletal muscle-derived mirna and myokines in patients with pulmonary arterial hypertension during acute exercise that are biologically active and modulate skeletal muscle function during exercise. pulmonary arterial hypertension (pah), is characterized by the proliferation of endothelial and smooth muscle cells within the precapillary pulmonary vasculature, if untreated results in increased pulmonary vascular resistance and death. the hallmark perivascular infiltrates in pah contain inflammatory macrophages and lymphocytes resulting in endothelial dysfunction and involves the dysregulation of distinct inflammatory mechanisms. idiopathic pah (ipah) and scleroderma-associated pah (ssc-pah), are related by similar clinical and pathophysiologic features. patients with pah experience a central cardiovascular limitation to exercise. despite effective treatment with pulmonary vasodilators, many resting pah (rpah) patients continue to experience exercise intolerance. pah is increasingly acknowledged as a systemic disease, beyond abnormalities of the pulmonary vasculature. although other contributions to exercise intolerance in pah exist, skeletal muscle dysfunction significantly impacts exercise tolerance. the molecular mechanisms behind skeletal muscle dysfunction in pah remain unclear. provocative testing with invasive cardiopulmonary exercise testing challenges the cardio-pulmonary-vascular and skeletal muscle systems and elicits a cascade of physiologic events not measurable at rest. myokines are circulating mediators released from skeletal muscle in an endocrine-like fashion in disease and health influencing many factors but not limited to systemic inflammation, immunity and endothelial function. myokines have not been well described in pah. preliminary data indicate that myokines play important, yet still undescribed, roles in this disease. micrornas (mirnas) are small non-coding rna molecules, which negatively regulate gene expression via repressing translation and degrading messenger rnas through sequence-specific binding. there is a growing literature regarding the biological activity of extracellular mirnas in pah and in aerobic exercise. mir-126 has been implicated in skeletal muscle dysfunction in pah, while mir-133 is skeletal muscle-specific but unlike mir-126 it is not yet implicated in skeletal muscle dysfunction in pah.


Eligibility criteria:
inclusion criteria: * patients undergoing a rhc/icpet procedure at the upmc presbyterian hospital catheterization lab. * 18 years of age or older * able to read and understand the informed consent. * subjects who have signed the icpet registry consent. exclusion criteria: * pregnant women * people under 18 * who are unable to read and understand the informed consent. * subjects prescribed anticoagulant therapy
caries management by risk assessment in children

Conditions: Dental Caries

Summary: the goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical trial in the university of california, san francisco (ucsf) tenderloin community pediatric dental clinic. the investigators hypothesize that the regimen will help to reduce new cavities in children who are at risk for dental cavities.


Eligibility criteria:
inclusion criteria: 1. patients of record at the ucsf pediatric dental clinic, or the ucsf tenderloin community pediatric dental clinic, and must be: 2. patients of record at the tenderloin community and ucsf pediatric dental clinics 3. 5-9 years old 3. be able to give informed assent, consent and answer questionnaires in english, spanish or chinese by parents or guardian 4. be unlikely to move from the area during the study period 5. be willing to participate regardless of group assignment and comply with all study procedures exclusion criteria: persons with: 1. prolonged antibiotic use in the past three months. 2. dental needs outside of the community pediatric clinics, such as care provided in specialty clinics

Keywords: dental caries children mutans streptococci lactobacilli cariogenic bacteria
experimental study with pretest/posttest groups which the intervention group have the system which sends reminder notifications directing them to the website containing bse training along with the illustrations created for the practice prepared by the researcher on the determined ideal day

Conditions: Breast Self-Examination; Breast Cancer; Nursing Caries; Cancer; Awakening Early

Summary: h0: among the intervention and control groups of reminder notifications relating to self-examination h01: average breast cancer fear score and h02: there is no difference in the average score of breast cancer health beliefs. h1: among the intervention and control groups of reminder notifications relating to self-examination h11: average breast cancer fear score h12: breast cancer is different in terms of average score of health beliefs

newly enrolled students in the nursing programs at girne american university and eastern mediterranean university will participate in this study as an experimental study with a pretest/posttest control group. the students will receive the same training. contrary to the control group, the intervention group will have the system which will send reminder notifications (via the web base) directing them to the website containing bse training, along with the vector illustration to be created for the concurrent practice prepared by the researcher on the determined ideal day. users will receive a notification twice via the website and email that includes re-examination seven days following the end of their period. depending on the permission they grant to their phones, users will be able to access the bse training materials on the website by clicking on the general reminder notification or the router, using their browsers, and logging in to their accounts. the data on the frequency of bse with the "breast cancer fear scale" and "champion's health belief model scale" will be collected from the users at the end of the three-month period of using the website, which will be developed in order to raise the chances of early diagnosis by encouraging bse.

Eligibility criteria:
inclusion criteria: * who is over 18 years old, * eastern mediterranean university and girne american university, newly enrolled female students in the nursing department of the faculty of health sciences exclusion criteria: * people who do not meet the criteria

Keywords: awareness early diagnosis prevent surgery breast self-examination
i-beam and cruciate tibial components used in total knee replacement

Conditions: Degenerative Arthritis; Osteoarthritis; Rheumatoid Arthritis; Knee Arthritis

Summary: the purpose of this study is to compare the clinical outcomes of using an i-beam or cruciate tibial component in total knee replacement.


Eligibility criteria:
inclusion criteria: * patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment are involved. * patients requiring correction of varus, valgus, or posttraumatic deformity * patients requiring correction of revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. exclusion criteria: * patients with infection, sepsis, or osteomyelitis.
pre-clinical models in gynecological tumors a tissue repository

Conditions: Endometrial Neoplasms; Uterine Neoplasms

Summary: the purpose of this study is to provide a repository for long-term storage of endometrial cancer tumor and normal tissue, ascites and serum. this material will be used in studies to better understand the molecular biology of endometrial cancer.

background and rationale this protocol will create a central repository for banking tumor and other tissues as well as serum from patients with uterine corpus tumors. in addition, this protocol will also serve as a central repository for serum and tissue to healthy post-menopausal and peri-menopausal controls. there will be an "internal" bank. the internal bank will have samples available to unm investigators.

Eligibility criteria:
inclusion criteria: * all patients undergoing hysterectomy, or who have endometrial cancer, and are under routine surveillance. * patients may have received prior hormonal, cytotoxic chemotherapy, irradiation or surgical therapy. * healthy post-menopausal and peri-menopausal women. * a consent form must be signed by the patient prior to study entry. exclusion criteria: study patients: * patients who do not have primary uterine corpus tumors. * patients with less than one gram of tumor tissue available to procurement. controls: * patients unwilling to have their medical records reviewed for height, weight, and general medical history (see attached data sheets).

Keywords: corpus uteri endometrium cancer
surgical capacity in zimbabwean public hospitals

Conditions: Surgery; Anesthesia

Summary: this study aimed to understand how ready zimbabwe's public hospitals are to perform essential surgeries, which are critical for treating a wide range of health issues from emergencies like car accidents to planned procedures such as childbirth by caesarean section. the researchers looked at hospitals across zimbabwe to see what kind of surgery facilities, equipment, and specialists were available.

abstract background: access to surgical care is an essential component of universal health coverage, but surgical capacity is lacking in many low- and middle-income countries. surgical capacity in zimbabwe, a lower-middle income country, is undocumented. the objective of this study was to assess surgical capacity in public hospitals in zimbabwe. methods: a national hospital survey was performed in 2019 using a validated surgical situational analysis tool. the investigators included district, provincial and central hospitals in the public sector across all 10 provinces of zimbabwe. data was collected from key informants using an online survey. information gathered included an inventory of infrastructural components required to perform essential surgical services, a survey of healthcare workers involved in surgical care (the surgical anaesthetic and obstetric workforce); a submission of the number of surgical procedures including bellwether procedures performed over the course of the last year and also surgical sundries and consumables required to perform surgical services.

Eligibility criteria:
inclusion criteria: * hospitals were considered eligible if there was any major or minor surgical activity occurring in the facility exclusion criteria: * hospitals dedicated to a non-surgical pursuit * private hospitals

Keywords: global surgery surgical capacity zimbabwe
the use of an engineered glove for the assessment and rehabilitation of manual dexterity in people with stroke.

Conditions: Stroke; Hand Grasp

Summary: stroke often results in impairments of upper extremity, including coordination deficits, reducing of force, weakness and changes in the kinetic and kinematic workspace of fingers with 75% of stroke survivors facing difficulties performing activities of daily living. the ability to oppose the fingertip of the thumb to each fingertip of the same hand is the basis of grasping objects of various sizes and operating tools and assessing and improving distal upper extremity function is of primary goal in the rehabilitation of stroke survivors. moreover, repetitive movement practice seems to be crucial for maximizing therapeutic benefits. recent studies, proposed an engineered glove to assess motor performance during finger-to-thumb opposition movements and to provide objective and reproducible measures. the same tool can be integrated with virtual reality and serious games to provide repetitive practice of activities improving motivation and adherence with therapy. the investigators developed a new integrated glove and virtual reality to facilitate the recovery of hand functionality. the aim of this study is to investigate the feasibility of the engineered glove in the assessment and treatment of hand dysfunction in people with stroke.


Eligibility criteria:
inclusion criteria: * a single stroke, * some movement of the fingers, * any technical and difficulties with wearing the glove on the paretic hand exclusion criteria: * visual or cognitive deficits that would prevent them for performing the task
cardiovascular responses to spartathlon running

Conditions: Disorder Heart

Summary: the aim of this study is to examine the cardiovascular effects of ultramarathon running and their relation to performance.

the purpose of the study is to determine the changes of cardiovascular morphology and function after an ultramarathon race. 50 entrants to the "spartathlon 2017" 246-km running race will participate in the study. cardiac and arterial morphology and function tests will be conducted one day before the race and within 20 minutes of race completion.

Eligibility criteria:
inclusion criteria: * runners at least 18 years old, healthy and sufficiently trained. * runners being accepted to participate in the spartathlon race according to the eligibility criteria (http://www.spartathlon.gr/en/registration-en.html) * runners who will volunteer to be examined pre- and post the race exclusion criteria: * runners with chronic diseases * runners receiving any medication
text-message program to reduce risky sexual behavior in young adult female emergency department (ed) patients

Conditions: Education, Sex

Summary: the us preventative services task force (uspstf) recommends behavioral counseling in the primary care setting for prevention of sexually transmitted diseases, however, screening and counseling rarely occur. text messaging (tm) is increasingly being used as a tool to affect behavior change in patients, but its effect on patients that report at-risk sexual behavior in the emergency department (ed) is unknown. the investigators seek to assess the feasibility of ed-based screening of young adult females for at-risk sexual behavior and enrolling them in a 3 month trial using tm to deliver information and skill building to improve health behavior.


Eligibility criteria:
inclusion criteria: * female * age 18-25 years * audit-c score \> 2 * (drugs or alcohol prior to last sex or no condom with last sex or \> 1 partner in last 3 months) exclusion criteria: * no personal cell phone with sms features * prisoner * pregnant or planning in next 3 months * current or past drug/alcohol treatment or psychiatric treatment
the effects of early life pufa and r-tfa on ad: a systematic review and meta-analysis

Conditions: Allergic Disorder

Summary: the purpose of this study is to evaluate whether early life natural exposure to fatty acid affects the ad risk.

the prevalence of allergic diseases (ad) is rising dramatically worldwide especially in more industrialized countries during the past two decades, representing a substantial disease burden of individuals and health service cost. early life nutritional exposures could modify the gene expression and susceptibility of allergic diseases (ad), yet the effects of early life polyunsaturated fatty acids (pufa) and ruminant trans fatty acids (r-tfa) on ad remain unclear.therefore,the investigators performed the meta-analysis and systematic review to evaluate whether early life natural exposure to pufa and r-tfa affects the ad risk.

Eligibility criteria:
inclusion criteria: * studies needed to provide endpoints of ad, and risk estimates \[odds risk (or), relative risk (rr) or hazard ratio (hr)\] for pufa or r-tfa as the exposure. we included english language articles only, while scanned titles /abstracts of non-english language articles to evaluate agreement with the results published in english. exclusion criteria: * studies were excluded if they didn't report the profile of pufa or r-tfa, or if they targeted participants with medical condition.