Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of nitazoxanide for post exposure prophylaxis of covid-19

Conditions: covid19

Summary: the primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of covid-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.

the primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of covid-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease. subjects that pcr is negative after having direct contact with symptomatic subjects and diagnosed with covid-19 (pcr positive) will be randomized to receive nitazoxanide tid or placebo tid for 7 days.

Eligibility criteria:
inclusion criteria: * informed consent from patient or legal representative. * subject of both genders (male and female not pregnant and not breastfeeding) aged 18 years or over; * subject that lives in a vulnerable community; * subject that were in direct contact with confirmed cases of sars-cov-2 infection, as they live or work directly with index patients; * not showing symptoms compatible with covid-19 and and that do not have a positive rt-pcr test in a nasopharyngeal swab sample before randomization; * participant capable of understanding and fulfilling all activities planned for the study; * in use of an acceptable method of contraception throughout the study. exclusion criteria: * participating in another rct in the past 12 months; * positive pcr result for covid-19 during screening; * history of infection confirmed by sars-cov-2; * present symptoms suggestive of sars-cov-2 infection; * presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to: * hiv or htlv virus infection; * chronic hepatitis c (hcv) treated with direct antiviral drugs; * liver failure; * severe renal failure, including dialysis; * present hypersensitivity to the study product (nitazoxanide), as well as to related compounds; * concomitant administration of drugs that may interact with the product under study (nitazoxanide); * participants who underwent treatment with antivirals and / or antiparasitic drugs in the last 30 days; * subject in antineoplastic treatment with chemotherapy or radiation therapy; * subject with severe autoimmune diseases in immunosuppression; * transplanted participants; * pregnant or lactating women; * any other clinical condition that is deemed by the investigator to be an imminent risk to the health and life of the subject.
effects of losartan on hepatic fibrogenesis in chronic hepatitis c

Conditions: Chronic Hepatitis C; Liver Fibrosis

Summary: there is evidence on the beneficial effects of the administration of angiotensin ii type 1 (at1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis c with mild fibrosis. the purpose of this study is to investigate the effect of long-term administration of oral losartan, an at1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis c and fibrosis f2-f3 (metavir score).


Eligibility criteria:
inclusion criteria: * age between 35 and 65 years * chronic hepatitis c with intermediate fibrosis (f2-f3 in metavir score). * non-responder or contraindication to antiviral therapy. exclusion criteria: * any other cause of liver disease * hiv positive * alcohol consumption * arterial hypertension * creatinine \> 1.5mg/dl * treatment with at1 receptor antagonists or angiotensin converting enzyme inhibitors in the past 12 months. * antiviral therapy in the past 12 months * contraindications to oral losartan

Keywords: hepatitis c, chronic
reconstruction of diffusely diseased left anterior descending with left internal mammary artery on-lay patch or saphenous vein patch without endarterectomy by opening the whole wall of the diseased segment(s) has less risk and fewer complications compared to endarterectomy technique

Conditions: LAD (Left Anterior Descending) Coronary Artery Stenosis

Summary: the objective of this study is to compare different surgical strategies for management of severely diseased lad artery during cabg i.e. lima on-lay patch vs. saphenous vein patch and the distal in situ lima and saphenous vein graft (lima+ svg).

total myocardial revascularization is the primary aim of coronary artery bypass grafting (cabg) . conventional cabg does not attain sufficient myocardial revascularization in severely diseased left anterior descending coronary artery (lad). coronary endarterectomy for severely atherosclerotic lad was first introduced by bailey and his coworkers , but it has a higher risk of morality and poor outcomes. the reconstruction of lad with saphenous vein or left internal mammary artery (lima) combined with endarterectomy was described by fundaro and others surgeons for better long-term patency of lima graft and to avoid the drawbacks of endarterectomy. reconstruction of diffusely diseased lad with lima on-lay patch or saphenous vein patch without endarterectomy by opening the whole wall of the diseased segment(s) has less risk and fewer complications compared to endarterectomy technique. however, the superiority of lima path versus saphenous vein patch is still controversial. in addition, the lima patch is occasionally not available as a bypass to lad, for example with relatively shorter lima due to enlarged left ventricle, difficulty in harvesting the proximal lima, accidental injury of the lima pedicle during harvesting, calcification of the middle or distal lima or mismatching between the lad and distal lima. to overcome this, an end-to-end anastomosis with the distal in situ lima and saphenous vein graft (svg) was performed to establish a composite graft to bypass the lad.

Eligibility criteria:
inclusion criteria: * included patients with long-segment diffusely diseased lad, with good ejection fraction and elective surgery. exclusion criteria: * patients with associated valve surgery, left ventricular ef less than 40%, and severe comorbidities (renal or liver failure), preoperative dialysis, and hemodynamic instability, emergency operations were excluded.
development of achilles tendon elongation and its effect on physical function the first year after rupture

Conditions: Achilles Tendon Rupture

Summary: the objective of this study is to examine how elongation of the achilles tendon develops during the first year after rupture among patients with an achilles tendon rupture, and how it affects physical function. the aim is to define a cutoff of acceptable elongation dividing the patients who obtain normal physical function (limb symmetry index \> 90%) from those who do not. patients treated both operatively and non-operatively will be included.


Eligibility criteria:
inclusion criteria: * appointment in the outpatients department within 4 days of injury. * total achilles tendon rupture. * initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury. * the patient must be expected to be able to attend rehabilitation and postexaminations. * the patient must be able to speak and understand danish. * the patient must be able to give informed consent. exclusion criteria: * rupture of the achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae. * previous rupture of the achilles tendon in any of the two legs. * treated with fluorquinolons or corticosteroids within the last 6 months. * in medical treatment of diabetes. * suffers from rheumatic disease. * other conditions prior to the injury resulting in reduced function of any of the two legs. * contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the achilles region of the injured leg. * inability to lie in prone position on the operating table. * terminal illness or severe medical illness: asa (american society of anesthesiologists) score higher than or equal to 3.
circulating tumor cells and treatment de-escalation after neoadjuvant therapy for her2 positive breast cancer

Conditions: Breast Neoplasms; HER2-positive Breast Cancer; Circulating Tumor Cell

Summary: phase ii unicentric randomized trial which will include early her2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. circulating tumor cells will be collected at neoadjuvant therapy baseline. patients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm a) versus trastuzumab + pertuzumab (arm b) in a two factorial design: group a, with her2 positive ctcs and group b, with her2 negative/absent ctcs.

patients with her2 positive breast cancer (hormone receptors positive or negative), which are candidate to neoadjuvant therapy with pertuzumab and trastuzumab will be included. blood samples will be collected at baseline (before neoadjuvant start) for the analysis of ctcs and its positivity for her2 by ihc and ish. patients with pathological complete response will be included in the randomization phase of the study. there will be 2 cohorts: her2 positive ctcs at baseline and her2 negative/absent ctcs at baseline. in each cohort, patients will be randomized in 1:1 ratio for adjuvant trastuzumab versus adjuvant trastuzumab + pertuzumab

Eligibility criteria:
inclusion criteria: * her2 positive breast cancer (hormone receptors positive or negative) * stage i to iii * indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab * breast surgery after neoadjuvant therapy * preserved coagnition * ecog 0-3 * for the randomization phase: pathological complete response (ypt0/yptis and ypn0) * agreement on participation and signature of de icf exclusion criteria: * contradindication for trastuzumab or pertuzumab * adjuvant chemotherapy. hormone therapy is allowed * second primary tumor \< 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer
rct comparing analgesia post-vats with epimorph vs placebo

Conditions: Thoracic Surgery, Video-assisted; Postoperative Pain; Rachianesthesia; Sufentanil; Morphine

Summary: the purpose of the study is to determine if the administration of a mix of sufentanil and morphine in intrathecal is a better analgesia regimen than pca alone in patient post-vats.

this study will compare the need for analgesia (hydromorphone pca) of two groups of patients post-vats. the placebo group will only have a pca for post-operative analgesia, witch is the standard care for patient post-vats. the experimental group will have a intrathecal injection of a mix of morphine and sufentanil before the induction of anesthesia.

Eligibility criteria:
inclusion criteria: * vats * asa 1,2 or 3 * minimum weight of 50 kg * patient able to consent exclusion criteria: * patient refusal * patient unable to understand pca * contraindication to rachianalgesia * zona * pregnancy * over 30 mg of morphine during the last 24 hours * use of pregabalin, gabapentin, doluxetin, amitriptyline or nsai in a context of chronic pain * severe allergic reaction to morphine, hydromorphone, sufentanil or local anesthetic * intubation over 1 hour after surgery (unability to use pca) * high risk of conversion to thoracotomy * unable to perform rachianalgesia due to technical difficulties
study to evaluate the diagnostic value of a combined molecular breast imaging/ breast tomosynthesis modality

Conditions: Breast Cancer

Summary: the purpose of this pilot study is to investigate the potential clinical benefits of combining two new diagnostic tools to provide co-registered anatomical and functional information in the breast in patients with suspected breast cancer.

the purpose of this pilot study is to obtain preliminary data on a new way of imaging the breast that combines the benefits of a 3-d anatomical technique (digital tomosynthesis) with those of a functional imaging technique (molecular breast imaging). combining data from these 2 modalities would provide co-registered functional and anatomical information on the breast, in the same way that pet/ct does today in oncology. this should greatly facilitate the evaluation and biopsy of lesions seen on mbi but occult on conventional mammography.

Eligibility criteria:
inclusion criteria: * over the age of 25 * enrolled in one of the following protocols: irb # 08-005522: evaluation of molecular breast imaging in patients with a high likelihood of ductal carcinoma in situ. 07-004241: molecular breast imaging in the preoperative evaluation of women with biopsy proven breast cancer. 1204-03: evaluation of a small field of view gamma camera for scintimammography in patients with atypical ductal hyperplasia, atypical lobular hyperplasia, and lobular carcinoma in situ. 07-003397: comparison of mri and molecular breast imaging in breast diagnostic evaluation. 17-05: determination of the sensitivity of a dual-headed small field of view gamma camera for the detection of small breast lesions. * digital mammogram at the mayo clinic within the past 30 days exclusion criteria: * they are unable to understand and sign the consent form * they are pregnant or lactating * they are physically unable to sit upright and still for 40 minutes. * recently enrolled on one of the ongoing tomosynthesis vs. mammography studies (rationale - avoid performing duplicate tomosynthesis studies in the same patient)

Keywords: mbi molecular breast imaging breast cancer positive molecular breast imaging scan.
pharmacokinetics of co-administration of seretide 250 diskus (hcp0910) and spiriva capsule for inhalation (hgp1011)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone, salmeterol, and tiotropium after co-administration of hcp 0910 (seretide 250 diskus) and hgp1011 (spiriva capsule for inhalation) which are prescribed concomitantly for the patients with chronic obstructive pulmonary disease (copd).

within 3 weeks prior to the first administration of study drug, volunteers who agreed the participation of this study by their written consent will undergo screening, including physical examination and clinical laboratory test etc, to evaluate whether they are eligible to participate in this study. study drugs will be administered at about 8 a.m. in the morning of the drug administration day, followed by blood collection for evaluation of pharmacokinetics. the same schedule with increased dose will be proceeded after 14-day washout period.

Eligibility criteria:
inclusion criteria: * age between 19 to 45, healthy male subjects (at screening) * body weight between 55kg - 90kg, bmi (body mass index) between 18.0 - 27.0 * volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent exclusion criteria: * volunteer who has past or present history of any diseases such as liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder * volunteer who had drug(aspirin, antibiotics) hypersensitivity reaction * subject who already participated in other trials in 3 months * subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
use of a virtual reality cognitive stimulation programme for breast cancer patients wishing to restart or maintain a professional activity

Conditions: Breast Cancer; Cancer-related Cognitive Difficulties

Summary: the study concerns patients who have been treated for breast cancer, have cognitive problems and are planning to return to work or are currently working and wish to begin cognitive rehabilitation. patients will follow the virtual reality program developed for the study, during the cognitive rehabilitation usually proposed in the establishment, at the rate of a weekly session of 10-15 minute for 6 weeks.


Eligibility criteria:
inclusion criteria: * patients \>18 years of age * patient with breast cancer for whom adjuvant chemotherapy has been administered; maintenance treatments (e.g. trastuzumab, hormone therapy) are eligible, * maximum 2 years after completion of adjuvant treatment, * patients who have cognitive complaints at inclusion (answer yes to the question: 'since your cancer treatment, have you had any difficulties with memory, concentration, etc.?) * patients planning to return to work or who have returned to work in the past year, * signature of informed consent prior to any specific procedure relating to the study, * patient affiliated to a social security system. exclusion criteria: * patients suffering from illnesses or conditions that impair their ability to understand, follow and/or comply with study procedures, * patients with personality disorders and/or psychiatric pathology, * patients deprived of their liberty or placed under the authority of a guardian, * pregnant women

Keywords: virtual reality cognitive rehabilitation
gellan contact study

Conditions: Thermal Injury; Skin Burn

Summary: the primary objective of this study will be to establish the safety of the two different gellan formulations (sheet and fluid gel) following its application to the epidermis of healthy volunteers. this will be compared to a control dressing-- mepitel one (polyurethane net with soft silicone).

this contact study is part of the wellcome trust anti-scarring dressing project to develop a carrier dressing that will be used to deliver therapeutic agents to the skin. a polysaccharide, gellan, has been chosen as the main component of this dressing (the biomembrane)and it can be produced in either a sheet or fluid gel forms. gellan is a widely used material in both the food and medical industry e.g. as a lubricant in eye-drops (e.g. timoptol xe, merck sharp \& dohme, usa). as part of the development of the dressing, the epidermal (skin) response to gellan needs to be evaluated to check its safety. the main objective of this study is to establish the safety of the two different gellan formulations (2% gellan sheet and 2% gellan fluid gel) following application to the epidermis (skin).

Eligibility criteria:
inclusion criteria: * male or female subjects aged ≥ 18 years old * subjects who can provide informed consent exclusion criteria: * subject with existing skin conditions/diseases which may interfere with the aim(s) of the study. examples include pathological fibrosis e.g. scleroderma; pathological thinning e.g. epidermolysis bullosa and collagen disorders e.g. marfan's syndrome * chronic steroid use, history of skin malignancy or chronic papulo-squamous disease (e.g. eczema, pemphigus) and history of steven johnson or tens disease * blemishes, marks (e.g. tattoos, scars or burns,) on the test site(s) which may interfere with assessment on the test site * use of medication which may affect may affect skin response * known allergy to the materials used in the study * known allergy to adhesive plasters or tapes * fitzpatrick skin type vi (due to the difficulty of identifying erythema) * irritated skin on the test site * known pregnancy (confirmed by urine pregnancy test) or lactating * inability to commit to attending all sessions. * participation in another study which may affect the results of this contact study. * any other reason that clinician considers will interfere with the objectives of the study

Keywords: gellan, thermal injury, healthy volunteers, skin
intraluminal peppermint oil and adenoma detection rate in screening colonoscopy

Conditions: Colonic Polyp

Summary: this is a prospective randomized placebo-controlled trial to evaluate the efficacy of peppermint oil spraying into the colonic lumen through the scope channel during screening colonoscopy. the primary outcome is to compare the colonic peristalsis between peppermint oil and placebo. the secondary outcomes compare the procedural time, polyp detection rate, adenoma detection rate, and adverse events.


Eligibility criteria:
inclusion criteria: - participants with age \> 18 years who attended for colorectal cancer screening colonoscopy. exclusion criteria: * participants who had been colectomy * participants who diagnosed of inflammatory bowel disease or polyposis syndrome. * participants who had been took anti-spasmosic drugs prior to colonoscopy within 24 hours (anticholibergic/antimuscarinic : hyoscine(buscopan®), dicyclomine(berclomine®) or smooth muscle relaxant : mebeverine(duspatin®,colofac®), pinaverium bromide(dicetel®), alverine(meteospasmyl®), peppermint oil(colpermin®)) * participants with prothrombin time \> 3 second uln, inr \> 1.5 or platelet \< 50,000. * pregnancy or breast feeding * participants who cannot consent. * participants who had history of peppermint oil allergy.

Keywords: peppermint oil, adenoma detection rate, colonic peristalsis
prophylactic acetaminophen for prevention intraventricular hemorrhage in premature infants

Conditions: Intraventricular Haemorrhage Neonatal

Summary: the purpose of this study is to determine whether acetaminophen is effective in prevention or reducing the severity of ivh in premature infants.

it will be a double-blind randomized control trial, single center. the study will include neonates with a gestational age of less than or equal 32 weeks and a birth weight of less than or equal 1500 g, and will randomly assigned to two treatment groups (see below). infants will be randomized to equal-sized groups using block randomization with blocks of four. stratified randomization for gender and gestational age will be included in the randomized blocks. gestational age will be divided into two categories: 23 weeks +0 day to 27 weeks +6 days, and from 28 weeks +0 day to 32 weeks +6 days. gender (2) × gestational age (2) will give 6 strata, requiring 6 separate random number lists to achieve randomization.

Eligibility criteria:
inclusion criteria: * premature baby less than or equal 32 week and birth weight less than or equal 1500 g exclusion criteria: * out-born babies, infants with major congenital anomalies, babies have ivh iii, iv, high expectancy of early death
psychological factors that influence severity of allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: objective biomarker of allergic rhinitis severity is necessary for monitoring disease severity and response to treatment in clinical setting and for research. we believe that psychological factors are the missing link between patient-perceived severity of allergic rhinitis and objective biomarkers. in our pilot study, several psychological factors were studied in relation to patient reported outcomes for severity of allergic rhinitis.

monitoring allergic rhinitis (ar) severity with objective biomarkers is important for the clinical management of patients as well as for research purposes. the most commonly used tool for the assessment of ar severity is the total nasal symptom score (tnss). objective biomarkers like skin prick test size or specific ige levels don't correlate with tnss. we studied skin prick test size and specific ige and several patient reported outcomes including symptom score, medication scores, combined score and juniper mini rhinitis quality of life questionnaire (rqlq). psychometric evaluation was performed using 5 different psychological questionnaires that measure 13 different psychological factors.

Eligibility criteria:
inclusion criteria: * positive grass pollen skin prick test (spt) with a wheal diameter \>3mm and a history of allergic rhinitis during the grass pollen seasons exclusion criteria: * positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families

Keywords: skin prick test specific ige patient reported outcome psychological factor