Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of deferasirox (icl670) in patients with iron overload resulting from hereditary hemochromatosis

Conditions: Iron Overload; Hereditary Hemochromatosis

Summary: brief summary: this study was designed to explore a safe dose and characterize the preliminary safety and efficacy of icl670 in adult patients with previously documented history of homozygous c282y.


Eligibility criteria:
inclusion criteria: * age 18 years of age or older * male or female patients homozygous for the c282y mutation. * iron overload as documented by serum ferritin and transferrin saturation * no known allergy or contraindication to the administration of deferasirox * ability to comply with all study-related procedures, medications, and evaluations * effective use of birth control measures. exclusion criteria: * iron overload not due to hereditary hemochromatosis * males with hemoglobin \<13 mg/dl, females with hemoglobin \<12 mg/dl * desferal treatment within 1 month of the screening visit * patients currently or previously treated with deferiprone or deferasirox * significant medical condition interfering with the ability to partake in this study * presence of a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any study drug * clinical evidence of active hepatitis b or c * positive hiv serology * pregnant or breast feeding patients * patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug within 7 days prior to the screening visit other protocol-defined inclusion/exclusion criteria may apply.

Keywords: deferasirox icl670a iron chelators deferiprone transfusional hemochromatosis
magnitude: a phase 3 study of ntla-2001 in participants with transthyretin amyloidosis with cardiomyopathy (attr-cm)

Conditions: Transthyretin Amyloidosis (ATTR) With Cardiomyopathy

Summary: to evaluate the efficacy and safety of a single dose of ntla-2001 compared to placebo in participants with attr-cm.

this is a multinational, multicenter, double-blind, placebo-controlled study in approximately 765 participants, who will be randomized to receive a single infusion of either ntla-2001 or placebo.

Eligibility criteria:
inclusion criteria: * documented diagnosis of attr amyloidosis with cardiomyopathy * medical history of heart failure (hf) * symptoms of hf are optimally managed and clinically stable within 28 days prior to administration of study intervention * screening nt-probnp, a blood marker of hf severity, greater than or equal to 600 pg/ml and less than 10,000 pg/ml exclusion criteria: * new york heart association (nyha) class iv hf * polyneuropathy disability score of iv (confined to wheelchair or bed) * has hepatitis b, hepatitis c or human immunodeficiency virus (hiv) infection * history of active malignancy within 3 years prior to screening * rna silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. any prior vutrisiran use is not allowed * initiation of tafamidis or acoramidis within 56 days prior to study dosing * estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m\^2 * liver failure * uncontrolled blood pressure * unable or unwilling to take vitamin a supplementation for the duration of the study

Keywords: ttr amyloidosis cardiomyopathy ntla-2001 attr-cm transthyretin attr ttr-mediated amyloidosis amyloidosis, hereditary amyloidosis, hereditary, transthyretin-related amyloidosis transthyretin amyloid cardiomyopathy ttr cardiomyopathy wild-type ttr v122i amyloidosis, wild type
mobile attentional bias modification training in pediatric ms

Conditions: Pediatric Multiple Sclerosis

Summary: this study will examine the feasibility of using a mobile abmt application as a treatment modality in the pediatric multiple sclerosis population. participants will be asked to undergo one hour-long baseline evaluation, followed by at-home abmt application sessions. subjects will complete online redcap or mycap surveys weekly and at the end of the study.


Eligibility criteria:
inclusion criteria: * age 12-24 years * confirmed diagnosis of multiple sclerosis with onset \< 17 years and 11 months (defined by the 2013 international pediatric ms study group (ipmssg) criteria (krupp, tardieu, amato, banwell, chitnis, dale, ghezzi, hintzen, kornberg, pohl, rostasy, tenembaum, wassmer, \& sclerosis, 2013) and the 2010 mcdonald criteria (polman et al., 2011).) * followed at nyu multiple sclerosis comprehensive care center * access to a mobile device with ios (devices will be provided to subjects if this criteria is not met, see section 4.4) * active or concurrently enrolled in the ongoing us network of pediatric ms centers study consortium exclusion criteria: * previous report of an iq \< 70 * wide-range achievement test-fourth edition (wilkerson, 2006) reading subtest standard score \<85 * non-english speaking, learned english in the past three years, or learned english after the age of 12 years * not willing to comply with all study procedures * insufficient visual and motor ability to operate the intervention and assessments
medical images collection research

Conditions: Kidney Diseases; Brain Diseases

Summary: this is a not-for-profit project for the collection, archiving and reuse of magnetic resonance imaging, computed tomography and ultrasound images, and related demographic and clinical data, for research purposes only.

the collection of medical images and related data will be proposed to each participant to concluded or ongoing clinical trials promoted or partnered by the mario negri institute for pharmacological research (irfmn) requiring the collection of images or subject who perform a clinical practice examination at the hospitals that adopted the image acquisition protocols of irfmn. each subject will be provided with an informed sheet and will be asked to provide consent to donate his/her medical images and related data for future research. for participants in new clinical trials, the consent sheet of the study will be accompanied by this trial's consent sheet. in addition to the information reported in the specific trial information sheet, each subject shall have access to the list of studies included in the clinical trials register of irfmn/bioengineering department that are reusing their medical image data. any new study protocol promoted by irfmn and which provides for the use of medical images stored in this trial will be submitted to the local ethics committee for approval.

Eligibility criteria:
inclusion criteria: * healthy subjects: adults ≥ 18 years; subjects with no previous history of kidney or cerebral disease * patients: adults ≥ 18 years; subjects with renal or cerebral disease exclusion criteria: * n/a

Keywords: medical images repository kidney diseases cerebral diseases database
elosan efficacy study (ees)

Conditions: Chronic Pain

Summary: the "elosan cabin" is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage in patients with chronic pain, especially those with rheumatic diseases. patients assigned to the elosan group (group a) will have 8 sessions in the elosan cabin, with an interval of 3 to 4 days between sessions. patients assigned to the control group (group b) will have no treatment except for the continuation of their prescribed pain medication and pain therapy.

included in the study can be all persons suffering from chronic pain, as it is often the case with rheumatic disease or traumata. the elosan therapy to be investigated aims to treat chronic pain by applying an electrical charge to the body surface and by disruption of positive bio-feedback to restore physiological reflex relations between the periphery and the central regulation. the electric charge is created by a generator which can produce an electrostatic field. the electrical voltage is delivered to the hands via a metal handle in a closed cabin and is spread over the entire body surface. a total number of 42 patients will be included into this trial in order to show a statistically significant reduction of pain compared to reduction of pain in the control group.

Eligibility criteria:
inclusion criteria: * informed consent * adults, age ≥ 18 years, male or female patients * history of pain ≥ 6 months * suffering from chronic pain, either reumatic pain or pain caused by traumata * intensity of pain rated ≥ 50 mm on vas pain exclusion criteria: * untreated thyroid disease * history of seizure disorder (epilepsy) * history of or current psychosis * women who are pregnant, breast feeding or intending to become pregnant * patients who are currently participating in other studies or have participated in other studies within the last 30 days * patients who have expressed their intention, or are suspected of intending, to discontinue therapy or stop therapy before the end of trial * patients with an electric or electronic implant.
safety and immune response of covid-19 vaccination in patients with hiv infection

Conditions: HIV Infections; Covid19

Summary: on 11 february 2020, the international committee for the classification of viruses named the disease caused by saｒs-cov-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, covid-19). people infected with human immunodeficiency virus (hiv) are affected by their underlying diseases and are listed by the world health organization (who) as a high-risk population of sars-cov-2 infection.to evaluate the safety and effectiveness of covid-19 vaccine in those patients with human immunodeficiency virus infection , and to guide the covid-19 vaccination more scientifically, reasonably and effectively, this study was carried out.

people infected with human immunodeficiency virus (hiv), affected by their underlying diseases, are listed by the world health organization (who) as a high-risk population for sars-cov-2 infection.. more attention should be paid to personal protection and disease prevention. vaccination of covid-19 can effectively prevent covid-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality. the safety and effectiveness of covid-19 vaccine in this population were evaluated in order to play a scientific and theoretical supporting role in guiding covid-19 vaccination more scientifically, reasonably and effectively. the samples of this study were collected and tested in the second affiliated hospital of chongqing medical university. patients with contraindications for vaccination will be excluded. the detected indexes included blood routine test, cd4, hiv virus load, covid-19 antibody titer, antibody duration and other indexes of healthy people (control group) and hiv infenction people after vaccination ( 1, 3, 6 months after vaccination). the adverse reactions related to the vaccine were recorded.

Eligibility criteria:
inclusion criteria: 1. hiv infection group: a. the hiv positive diagnosis is clear; b. 18-80 years old; c. has been vaccinated against the covid-19 ; d. volunteer to participate in the project; 2. healthy control group: a. hiv negative; b. age 18-80 years old; c. the covid-19 vaccination has been completed; d. volunteer to participate in the project exclusion criteria: 1. previous confirmed case of covid-19 2. confirmed contact history of covid-19 3. vaccination contraindications.
cerebral tissue oxygenation in highlanders/lowlanders

Conditions: High Altitude Pulmonary Hypertension

Summary: the purpose of the current study is to evaluate the cerebral tissue oxygenation of kyrgyz highlanders with high altitude pulmonary hypertension (haph) by performing a longitudinal cohort study. to this end, the investigators will invite the same highlanders who participated in the study in 2012 to undergo follow-up examinations in 2017, in order to allow comparisons of current results with baseline data from 2012.


Eligibility criteria:
inclusion criteria: * high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure \>30 mmhg measured by echocardiography at altitude of residence. * healthy subjects (high altitude controls) * both genders * age \>16 y * kyrgyz ethnicity * born, raised and currently living at \>2500 m * healthy subjects currently living at \<1000 m (low altitude controls) exclusion criteria: * pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography * excessive erythrocytosis * other coexistent disorders that may interfere with the cardio-respiratory system and sleep * regular use of medication that affects control of breathing * heavy smoking

Keywords: pulmonary hypertension cerebral tissue oxygenation disease progression hypoxia
local infiltration with levobupivacaine during laparoscopic cholecystectomy

Conditions: Laparoscopic Cholecystectomy; Postoperative Pain; Local Infiltration; Levobupivacaine

Summary: randomized controlled trial on laparoscopic cholecystectomy. interventional group: preincisional infiltration with levobupivacaine. control group: no local infiltration. postoperative pain with numeric rating scale is registered, besides other parameters like heart rate, blood pressure, rescue analgesia requirements, nausea and vomiting, etc.


Eligibility criteria:
inclusion criteria: * elective laparoscopic cholecystectomy exclusion criteria: * patient refusal * open surgery * reintervention surgery * drain tube placement * cognitive impairment * allergic reactions to local anesthetics

Keywords: laparoscopic cholecystectomy postoperative pain local infiltration levobupivacaine randomized controlled trial
effect of 1,25-dihydroxyvitamin d3, treatment on insulin secretion and muscle strength in pre-diabetic persons

Conditions: Pre-Diabetic

Summary: the purpose of this research is to study the effects of 1,25(oh)2 d3 (a prescription form of active vitamin d) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of \>24kg/m2 * fasting serum glucose \<126 mg/dl exclusion criteria: * bmi\</=24 kg/m2 * fasting serum glucose \>/=126 mg/dl * patient is taking calcium or vitamin d supplements and is unwilling to stop for 8 weeks * serum calcium \>10.2 mg/dl * serum inorganic phosphorous \>4.5mg/dl * pregnancy or breastfeeding * diagnosis of diabetes mellitus * diagnosis of rheumatoid arthritis * diagnosis of chronic obstructive pulmonary disease (copd) * renal in sufficiency/failure ( serum creatinine \>1.5 mg/dl men, \> 1.3 mg/dl women) * chronic active liver disease (bilirubin \>1.2 mg/dl, ast\>144iu/l, or alt \>165 iu/l) * history of chronic hepatitis * active coronary artery disease ( unstable angina, myocardial infarction, stroke and revascularization of coronary, peripheral or carotid artery within the last 3 months) * oral warfarin group medications or history of blood clotting disorders * platelet count \<100,000 per ul within the last 7 days * alcohol consumption greater than 2 glasses/day or other substance abuse * untreated or uncontrolled thyroid disorders (outside a tsh range of 0.5 to 10miu/l) * debilitating chronic disease (at the discretion of the investigators) * the presence of infections, highly communicable diseases ( aids, active tuberculosis, venereal disease, hepatitis) * any malignancy

Keywords: pre-menopausal women
interactions of hepatitis c viral (hcv) dynamics and immune activation in hiv coinfected patients during hcv treatment

Conditions: Human Immunodeficiency Virus; Chronic Hepatitis C

Summary: the purpose of this study is to investigate t-cell mediated immune responses to hiv-1 and hcv and determine how these responses are affected by hcv treatment and correlates to response. furthermore, to study interferon-inducible protein-10 (ip-10) dynamics during hcv treatment, and correlate this to treatment outcome.


Eligibility criteria:
inclusion criteria: * hiv-1 hepatitis c coinfected adult patients * hepatitis c treatment naive * stable hiv-1 infection with or without cart * \> 300 cd4+ cell count exclusion criteria: * decompensated liver disease * ongoing depression * ongoing drug abuse * other contraindications for interferon or ribavirin treatment

Keywords: hiv-1 chronic hepatitis c immune activation hcv kinetics ip-10
attitudes and technical maneuvers regarding enterostomy management and stoma creation among surgeons

Conditions: Colorectal Neoplasms; Colorectal Surgery

Summary: this study was aiming to investigate chinese surgeons' attitudes toward and technical preferences for stoma creation.

the survey comprised five parts: personnel qualification and training, attitude toward stoma-related complications, preoperative siting, process of acquiring ostomy-related surgical skills, and awareness and adoption of relevant techniques (37 items in total). the questionnaire was distributed to chinese hospitals by sojump, a professional online platform. finally, about 401 surgeons had responded including 188 hospitals of different grades across 26 provinces or municipalities directly under the central government.

Eligibility criteria:
inclusion criteria: general or gastrointestinal surgeons involved in general surgery, gastrointestinal surgery, surgical oncology, emergency, and others involved in managing enterostomies who had completed their degree and were licensed, or at least resident surgeons were included. - exclusion criteria: surgeons who did not provide consent to participate in this study were excluded. -

Keywords: surgeon attitude surgical procedure stoma enterostomy colorectal cancer cross-sectional study
cholate clearance in fontans

Conditions: Fontan Procedure

Summary: hepquant is an assay to measure liver function in other forms of liver disease such as hepatitis c. it measures the ability of the liver to process an naturally occurring substance called cholate and has been shown to predict clinical outcomes in some patient populations. the fontan survivor is a patient who has undergone surgery or a series of surgeries that result in a functional single ventricle. the liver is particularly vulnerable to disease including congestion, fibrosis, and even cirrhosis. currently liver function in the fontan is not well-characterized and the hepquant assay could help answer this question.

a novel test called hepquant® is an assay that has been used to measure liver function in other types of liver disease. in these populations, it is hoped that the assay may show more subtle or sub-clinical liver abnormalities that blood tests alone cannot detect. hepquant® is a test that examines the ability of the liver to process a substance called cholate, which is a naturally occurring substance in the body. cholate gets to the liver 2 ways: through the gut (by mouth) or through the blood (iv or intravenous). the test involves administering oral and iv cholate which is labeled. this label is not radioactive, but can act as an indicator/marker for evaluation purposes. the purpose of this study is to develop a reliable means of measuring liver function in the fontan survivor by examining cholate clearance. the investigators aim to 1) explore any association between level of cholate clearance and measurement of heart and liver function and 2) determine whether cholate clearance can predict clinical outcomes such as heart failure, ascites (development of fluid in the abdomen which can result from heart failure or liver failure), and need for heart transplant.

Eligibility criteria:
inclusion criteria: * s/p fontan operation * cardiac catheterization or cardiac mri within 1 year of enrollment exclusion criteria: * pregnant or breastfeeding * unable to comprehend and/or give informed consent * sensitivity to human serum albumin, or its preparations

Keywords: liver disease
platelet count, platelet, mean platelet volume and platelet distribution width in covid-19

Conditions: Covid-19; Mean Platelet Volume; Platelet Destruction

Summary: the study will aim to investigate the relation of platelet count (plt), mean platelet volume (mpv) and platelet distribution width (pdw) with other acute phase reactant c-reactive protein(crp) in coronavirus(covid-19). as a methodology, patients will be selected in records in one month from the online hospital system. two groups will be divided before as need for mechanical ventilation or not. the latter comparison will be about three groups as an ambulatory follow-up, hospital follow-up, and intensive care unit follow-up. parameters will be analyzed according to the groups.

in this study, as a methodology, patients diagnosed with pcr test through the online system created for covid-19 patients will be included in the study. these patients will be divided into 3 groups as outpatient follow-up, hospital follow-up and follow-up with a mechanical ventilator in intensive care. in addition, patients who have completed the 14-day treatment period, which is considered as the turning point time of the world health organization by looking at the patients 3 times, every 5-7 days, which is the accepted incubation period, will be included in the study. in these patients, hemoglobin, leukocyte, platelet, mpv, pdw and crp values will be examined for 3 weekly measurements. changes in covid-19 disease follow-up and treatment of mpv and pdw values, which have not been studied so far, will be investigated.

Eligibility criteria:
inclusion criteria: * patients diagnosed with covid-19, both pcr tests and computed tomography, as well as control hemogram and crp tests at one week intervals will be included. exclusion criteria: * those with suspicion of covid-19, those who do not perform hemogram and c-reactive protein tests 3 times with one week intervals, those who do not have standard drug treatment will be excluded from the study.