Kornimate/medical-research-clean huggingface dataset:
screening for patients admitted to ain-shams university hospitals for sars-cov-2 (covid19)

Conditions: Coronavirus Disease 2019 (COVID19)

Summary: the objective of this study is to screen the patients seeking hospitalization in ain shams university hospitals and identify a cost effective tool for continuing screening the patients all through the epidemic period

study setting: ain-shams university hospitals. it is a campus including the following main hospitals: gynecology and obstetrics, oncology, pediatrics, psychiatry, internal medicine, surgical, cardiothoracic and geriatrics. study population: all patients needing admission in ain-shams university hospitals are eligible for the study. sample size: there is no incidence data published till now. only the confirmed detected cases have been reported. we assumed that the community cases are around 10 times that of detected cases. it was estimated to be 1900 patients with 95% confidence level given the frequency of positive screening 0.05% with precision ± 0.1%. 10 the patients will be enrolled in the study using consecutive sample till the sample size is achieved. study methods: every enrolled patient will be subjected to: 1. an interview questionnaire including personal data ( age, gender, residence , contact details ) , epidemiological data (history of contact to a covid-19 case, history of travel), clinical data history ( fever, cough, sore throat) 2. reverse transcription polymerase chain reaction (rt-pcr) 3. antibody igm-igg test for sars-cov-2 statistical analysis: data will be validated, cleaned and entered in spreadsheet. spss program will be used for analysis. qualitative data will be presented in frequency and related percentage. quantitative data with normal distribution will be presented in mean and standard deviation or median and interquartile for non-normally distributed data. incidence of positive screening test among the total will be calculated with 95% confidence interval. comparison between groups will be done using relevant suitable parametric or non-parametric tests. a "p" value of 0.05 is decided to be the level of significance. risk ratios will be calculated for estimation of risk with 95% confidence interval. cost per one positive detected screening test will be calculated (total cost / total positive cases). the direct and indirect costs will be calculated by the laboratory department. ethical considerations: the protocol will be submitted for approval by the university ethical research committee. the objectives and methods of the research will be explained to the participants. an informed consent will be obtained from subjects willing to participate in the research and the subjects are free to withdraw from research anytime. confidentiality of the data will be highly secured. positive cases will be reported to the ministry of health and population (mohp). the guidelines of isolation and treatment protocol of mohp will be followed.

Eligibility criteria:
inclusion criteria - all hospitalized patients in ain-shams university hospitals. exclusion criteria: - those who refuse to participate in the trial
low dose radiotherapy in covid-19 pneumonia

Conditions: COVID; SARS (Severe Acute Respiratory Syndrome)

Summary: moderate to severe cases of sars-associated ards based on inclusion/ exclusion criteria and the decision made in multi- disciplinary team are treated with 0.5 gy whole lung radiation.

sars-associated ards (acute respiratory distress syndrome) is the most fatal outcome of covid-19 systemic infection. to overcome the uncontrolled inflammation leading to ards and respiratory failure, several drugs have been investigated in this situation with the most promising results coming from anti-inflammatory agents that directly or indirectly inhibit il-6 and its counterparts of inflammation. low dose radiation, as opposed to high dose, has documented anti-inflammatory effects that are exercised through various mechanisms including decrease in pro-inflammatory cytokines such as il-6. in this pilot clinical trial, the patients are carefully selected according to inclusion /exclusion criteria and the clinical judgement of the multi- disciplinary team.their diagnostic ct scan will be used to plan an ap/ pa radiotherapy treatment to both lungs and the set-up positioning information is obtained from anatomical landmarks. the patient will be referred for a fraction of 0.5 gy to both lungs and for the next 28 days the clinical para-clinical and radiologic variables of disease severity will be monitored closely. should the patient's clinical course indicate and the multi- disciplinary team approves, they may be subjected to another fraction of 0.5 gy to a maximum of 1 gy in two fractions at least 72 hours apart. all the patients will also receive the standard national protocol of covid-19 management. a total of 5 patients will be enrolled in the rt arm, providing favourable results seen in the first set of patients, the team will decide on recruiting a larger number for a phase ii clinical trial.

Eligibility criteria:
inclusion criteria: * confirmed covid-19 diagnosis ( pcr or serologic or radiographic) * presence of pulmonary involvement ( defined by p/f ratio or niv need) * less than 3 days since the onset of ards * age \> 60 years * ↑ il-6 ( if available) * ↑ crp exclusion criteria: * lack of informed consent * inability to transfer to the radiation unit * hemodynamic instability * septic shock and organ dysfunction * severe ards p/f ratio ≤ 100 mmhg * history of cardiac failure * contraindications to radiation

Keywords: low dose lung radiotherapy covid-19 anti-inflammatory
rifaximin in patients with gastroesophageal variceal bleeding

Conditions: Cirrhosis; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage

Summary: the purpose of the study is to evaluate the safety and efficacy of rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection. however, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.

Eligibility criteria:
inclusion criteria: * 18 y.o. ≤age≤75 y.o.; * cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric n- butyl-cyanoacrylate injection). exclusion criteria: * age \ 75 y.o.; * never had the variceal bleeding episode before; * do not have endoscopic treatment; * combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment); * known infection after endoscopic treatment (fever, microbial cultures positive, et al.) * massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics. * acute variceal bleeding within 5 days. * refuse to participate
lynx: a novel mobile app to support linkage to hiv/sti testing prep for young men who have sex with men

Conditions: HIV; Sexually Transmitted Diseases; Risk Reduction; Pre-Exposure Prophylaxis

Summary: this study is testing the acceptability and feasibility of a highly interactive mobile application (app) to promote hiv/sexually transmitted infection (sti) testing and uptake of pre-exposure prophylaxis (prep) among young men who have sex with men (ymsm).

using the information-motivation-behavior skills (imb) model, we have developed lynx, a highly interactive mobile app to promote accurate risk perception and increase hiv/sti testing and linkage to prep among young men who have sex with men (ymsm). key components of the app include sex pro (a personalized hiv risk score), a sex diary to facilitate accurate data collection; hiv/sti testing information and reminders; access to home hiv/sti testing options; a geospatial-based locator of hiv/sti testing sites and prep clinics; prep information and videos; and online prep navigation. this study is part of the itech nih u19, which has an overall goal to develop innovative technology-focused interventions addressing the hiv prevention and care continuum for youth.

Eligibility criteria:
inclusion criteria: * no hiv test in the past 3 months (self-reported). * not known to be hiv-infected (self-reported). * not currently taking prep (self-reported). * owns an apple operating system (ios) or android mobile phone and willing and able to download the lynx app onto their phone. * willing and able to attend an in-person baseline visit in the tampa or chicago area. * able to understand, read, and speak english. * participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months * participants ages 19-24: self-report evidence of high risk for acquiring hiv infection including at least one of the following: 1. at least one episode of condomless anal sex with an hiv-positive or unknown hiv status male or transfemale partner during the last 6 months; or 2. anal sex with 2 or more male and/or transfemale partners during the last 6 months; or 3. exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or 4. sex with a male or transfemale partner and has had an sti during the last 6 months. exclusion criteria: * currently enrolled in another hiv intervention study * prior enrollment in an hiv vaccine trial with receipt of experimental vaccine product * enrollment in an earlier phase of lynx study * any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Keywords: prep hiv testing sti testing mobile app technology young men who have sex with men
prevention trial assessing paper-tape in endurance distances ii (pre-taped ii)

Conditions: Blister of Foot

Summary: friction foot blisters are one of the most common and often debilitating complaints of all athletes, and hikers and runners in particular. blistering rates in the literature of outdoor hikers range from 7%-54%. this study's aim is to build on pre-taped i, and determine whether applying paper tape to the areas of the foot where blisters historically occur in endurance runners can prevent the incidence of friction blisters.

participants will be ultra-endurance athletes competing in racing the planet's 250 mile/7 day 4 desert events in 2014 (jordan, gobi, madagascar, and atacama. a convenience sample will be used, with full consent signed before inclusion into the study, with participants being informed that study inclusion is entirely optional and will not affect medical care. randomization will be conducted for each participant, a coin will be flipped to determine which foot is to be taped, heads - right foot, and tails, left foot. the non-taped foot will be used as a control. the runner's normal sock/shoe system will be used to reflect natural wilderness conditions. participants will have demographic data collected prior to the race, including age, gender, country of origin, number of marathons run prior, pack weight, and sock type. the study endpoint occurs when a hot spot or blister develops on either the treated or untreated foot. runners will be instructed to treat suspected blisters or hot spots as they normally would, and to inform the study administrators the same day for visual inspection and final questionnaire to determine if they develop blisters or hot spots, whether they applied or re-applied tape themselves, removed tape, and the reasons for these actions. participants will have tape applied to area(s) prone to blister on 1 foot, if no blister history, 1 area will be randomly assigned. the tape will be left on the selected foot until a blister or hot spot develops on either foot or the end of the race, whichever comes first. at that point, the study is over and the participant can continue or stop taping at their choice. if participants are prone to blisters or hot spots in particular areas, 1" paper tape applied to that site on trial foot. however, if the participant has no previous blister or hot spot experience, a site will be randomly assigned by picking a piece of paper out of a bag with the site written on a piece of paper (heel, toe, instep, head of 5th metatarsal). therefore, a single participant can have more than 1 site on an individual foot.

Eligibility criteria:
inclusion criteria: any runner who are enrolled in an rtp 4 deserts event, all runners who are 18-75 years old all runners who speak or read english. the study will be enrolling only those who speak or read english, so they can fully understand and have knowledgeable consent to the study enrollment protocols. exclusion criteria: any blisters, broken blisters, or hot spots present on either foot at the time of initial taping as determined by visual foot inspection by a enrolling researcher. the runner allergic to paper-tape.
a study of sodium oligomannate (gv-971) in participants with mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of gv-971 in mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * mild to moderate ad per nia-aa. * history of cognitive and functional decline over at least 1 year. * mmse scores between 11 and 24 (inclusive) at baseline. * brain mri scan show the highest possibility of ad. * have a study partner/caregiver. exclusion criteria: * diagnosis of a dementia-related central nervous system disease other than ad. * major structural brain disease as judged by mri. * a resting heart rate of \< 50 beats per minute (bpm) after 5 minutes of rest in sitting or supine position. * major medical illness or unstable medical condition within 6 months of screening. * concomitant use of acheis and/or memantine within 30 days before first mmse score, and during the study. * inadequate hepatic function. * inadequate organ and marrow function. * ecg clinically significant abnormalities.
impact of (neo)adjuvant therapy associating anthracyclines and taxanes with or without trastuzumab on skeletal muscle in breast cancer patients

Conditions: Breast Cancer

Summary: this is an interventional, prospective and monocentric study. this study includes the evaluation before and after (neo)adjuvant therapy of : * one group of patients receiving anthracyclines and taxanes * a second group of patients receiving anthracyclines, taxanes and trastuzumab.


Eligibility criteria:
inclusion criteria: for group 1 without trastuzumab : * patients must be ≥ 18 years old * patients with breast cancer stage i to iii * patients who will receive (neo)adjuvant anthracyclines and weekly taxane, without trastuzumab * patients must have a social security coverage * patients able to speak, read and understand french for group 2 with trastuzumab : * patients must be ≥ 18 years old * patients with breast cancer grade i to iii * patients who will receive (neo)adjuvant anthracyclines and weekly taxane, with trastuzumab * patients must have a social security coverage * patients able to speak, read and understand french exclusion criteria: * history of cancer * previous chemotherapy * patients with known chronic pathology (musculoskeletal disorders, autoimmune, vascular or neuromuscular disease) * pacemaker implantation * contraindication to physical condition evaluation * contraindication to local anesthesia required for microbiopsy * patients \< 18 years old or patients ≥ 18 years old under guardianship, or supervision * psychiatric, musculoskeletal or neurologic disorders * women that are pregnant or breast-feeding
nutritional supplementation in head and neck cancers

Conditions: Malnourishment; Nutritional Deficiency; Undernutrition

Summary: the purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.

this will be an randomized, open label, parallel assignment study during cancer treatment (baseline - week 7 for primary endpoint) comparing multimodal oral nutrition therapy versus standard care. starting at week 8, all patients receive the intervention arm until study ends at week 14. patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention). the primary objective is to assess a multimodal nutrition therapy with two medical foods (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment.

Eligibility criteria:
inclusion criteria: 1. patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up. 2. male or female 3. ≥18 years of age 4. histopathologically confirmed primary squamous cell carcinoma of the oral cavity and oropharynx, larynx or hypopharynx, who have agreed to receive radical intent radiotherapy as primary treatment or adjuvant treatment post-surgery, with or without platinum chemotherapy 5. capable of volitional oral nutritional intake at baseline. 6. a diagnostic ct image taken with a maximum of 30 days before initiation of radical intent radiotherapy. if the ct scan history in the patient's clinical record does not include a study within this window, a baseline non-contrast enhanced ct abdomen will be conducted. 7. an eastern cooperative oncology group performance status of ≤ 2 exclusion criteria: 1. fed by nasogastric tube, gastrostomy or total parenteral nutrition 2. cancer of the nasopharynx, thyroid or salivary gland 3. life expectancy \<6 months. 4. a known hypersensitivity / allergy to the investigational product or to any ingredient in their formulations (e.g. milk/lactose, fish). 5. enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures. 6. patients with untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted). 7. poorly controlled chronic illnesses or other inflammatory diseases (e.g. copd, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis). 8. in the investigators' opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, crohn's disease, etc.)

Keywords: nutritional support oral nutritional supplements
study of modified process hib/hep b vaccine in infants (v121-019)(completed)

Conditions: Haemophilus Influenzae Type B; Hepatitis B

Summary: to determine if there is an improvement in the immune response to hbsag (hepatitis b virus) in healthy infants using a modified process in a combination haemophilus influenzae, type b/hepatitis b vaccine and a currently licensed haemophilus influenzae, type b/hepatitis b vaccine


Eligibility criteria:
inclusion criteria: * healthy 2-month-old full term infants born to non-hbs ag (hepatitis b virus) carrier mothers exclusion criteria: * birth mother known to be a carrier of hepatitis b virus (hbsag+) or known carriers ever living in close contact with the subject * history of previous hepatitis b infection; history of vaccination with any hepatitis b vaccine * recent (\ =38.1°c/\>=100.5°f) * known or suspected hypersensitivity to any component of recombivaxhb™ or comvax™ (e.g., aluminum, yeast) * recent administration (w/i 3 months prior to study start) of hepatitis b immune globulin (hbig), serum immune globulin, or any other blood-derived product * receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period; * known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids); * any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits

Keywords: haemophilus influenza, type b and hepatitis b
development of a face valid executive functioning task

Conditions: Parkinson's Disease

Summary: the purpose of this study is to develop a task to measure executive thinking skills that can be performed in a laboratory setting, but has clear parallels to the thinking demands of real life situations, and can be administered to patients such as those with parkinson's who have difficulty moving.


Eligibility criteria:
brief inclusion criteria parkinson's disease (pd) group: * must have definite pd * have clear benefit from levodopa brief exclusion criteria pd group and control: * hx of stroke * head injury * visual loss

Keywords: parkinson's disease
reverse walking with and without whole body vibration in children with cerebral palsy

Conditions: Cerebral Palsy

Summary: to determine the effects of reverse walking with and without whole-body vibration on postural balance in children with cerebral palsy.

current study concluded that reverse walking with and without whole body vibration were effective in improving postural balance, reach and quality of life in cerebral palsy children. however (whole body vibration+ reverse walking) provides more clinical benefits than reverse walking alone in improving postural balance, side reach and quality of life. whereas both techniques were equally effective in improving forward reach in cerebral palsy children.

Eligibility criteria:
inclusion criteria: aged 6-12 years * confirm diagnosis of cerebral palsy * gmfcs level i \& ii * both genders (28) exclusion criteria: * o visual impairment * patients who can't follow command * hearing impairment * malignancy * infection (such as osteomyelitis) * inflammatory arthritis * lower extremity bones fracture * cardiovascular disease * traumatic cases

Keywords: postural balance
efficacy and safety of biib111 for the treatment of choroideremia

Conditions: Choroideremia

Summary: the objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of biib111 in participants with choroideremia (chm).

this study was previously posted by nightstarx ltd. in october 2020, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * are willing and able to give informed consent for participation in the study. * have a documented genetically-confirmed diagnosis of chm. * have active disease clinically visible within the macular region in the study eye. * have a bcva of 34-73 etdrs letters (equivalent to worse than or equal to 6/12 or 20/40 snellen acuity, but better than or equal to 6/60 or 20/200 snellen acuity) in the study eye. key exclusion criteria: * have a history of amblyopia in the eligible eye. * have had previous intraocular surgery performed in the study eye within 3 months of visit 1. * have any other significant ocular or non-ocular disease/disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study. * have participated in another research study involving an investigational product in the past 12 weeks or received a gene/cell-based therapy at any time previously. * are unwilling to use barrier contraception methods, or abstain from sexual intercourse, for a period of 3 months, if treated with aav2-rep1. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: nightstarx nsr-rep1 gene therapy aav rep1 timrepigene emparvovec