Kornimate/medical-research-clean huggingface dataset:
multifocal contact lenses fitting methods comparison

Conditions: Presbyopia

Summary: the purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

this was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. it compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.

Eligibility criteria:
inclusion criteria: * at least 40 years old; * have read and understood the participant information sheet; * have read, signed and dated the informed consent; * best corrected visual acuity of at least 20/25 in each eye; * have normal eyes with the exception of the need for visual correction; * current multifocal contact lens wearer; * spectacle refraction: distance: sphere: -6.00d to + 4.00d astigmatism: 0.00d to -0.75d near addition: established presbyopes: +1.50d \& +1.75d * be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule. exclusion criteria: * ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; * monocular participants (only one eye with functional vision) or participants fit with only one lens; * any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit; * history of herpetic keratitis, ocular surgery or irregular cornea; * known pregnancy or lactation during the study period; * enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
intratumoral bromelain + acetylcysteine in relapsed and unresectable pseudomyxoma peritonei

Conditions: Pseudomyxoma Peritonei

Summary: this trial pursues studying a compassionate treatment option for patients with inoperable pseudomyxoma peritonei through percutaneous administration of bromelain + n-acetylcysteine (nac) in order to decrease tumoral volume. secondary endpoints are the decrease of ascites, compressive symptoms and pain through the dilution of mucins, which would better intestinal blockage.


Eligibility criteria:
inclusion criteria: * pseudomyxoma peritonei diagnosis through imaging tests and/or histological studies * pseudomyxoma peritonei relapse in abdominal area in patients who comply inoperability criteria, which are: at least two hipec operations or major abdominal surgery (pss \> 3). patients with acute morbidities (asa score iv) * ecog 0-2 * age ≥ 18 * signs informed consent exclusion criteria: * candidates to other potentially healing treatments * allergy to bromelains (pineapple), n-acetylcysteine or possible cross-reactive allergy (eggs, sulphate. latex, carrots, celery, wheat...) * non-manageable coagulation alterations * no possibility of intraabdominal drainage catheter * acute respiratory pathology (asthma, copd), acute hepatic, cardiopathic or kidney pathology * allergy to any substance that might cause crossed reactivity to bromelain * unwillingness to participate in this clinical trial

Keywords: pseudomyxoma peritonei n-acetylcysteine acetylcysteine nac bromelain
validation of rdq questionnaire

Conditions: Gastroesophageal Reflux

Summary: the primary objective of this study is to determine the accuracy of the reflux disease questionnaire (rdq) as a diagnostic test for gastroesophageal reflux disease. symptom evaluation by the rdq will be compared with other established approaches to the diagnosis of gastroesophageal reflux disease (gerd) in a primary care patient population with symptoms thought to be of upper gastrointestinal (gi) tract origin.


Eligibility criteria:
inclusion criteria: * subjects who seek medical advice at their family doctor (primary care physician) for symptoms thought by the primary care physician to arise from the upper gi tract * the symptoms thought to pertain to the upper gi tract must have been present for at least 4 weeks prior to visit 1 and to have occurred at least twice a week during that period * the symptoms thought to pertain to the upper gi tract must have been of at least mild severity for a minimum of 3 days during the week prior to visit 1 exclusion criteria: * upper gi endoscopy performed within a year prior to visit 1 * previous anti-reflux surgery, surgery for peptic ulcer or any form of upper gastrointestinal resective surgery * contra-indication to the bravo™ procedure such as subjects with a history of bleeding diathesis, strictures anywhere along the gi-tract, esophageal varices, obstructions, or subjects equipped with a pacemaker, an implantable cardiac defibrillator or an implantable neurostimulator (nb: subjects with severe esophagitis (grade d) confirmed by endoscopy at visit 2 can continue the study without performing the bravo™ procedure)

Keywords: gerd
using laser spatiotemporal photoplethysmogram and computational method for management of chronic disorders.

Conditions: Blood Glucose Monitoring; Blood Pressure Measurement

Summary: this investigational study is carried out to find out if a smartwatch monitor worn on the wrist that acts like a blood pressure monitor, will be able to replace the traditional blood pressure measurements using the traditional cuff that is wrapped around your arm.

nhc inpatients (group a) patients will be required to put on the lsppg wearable sensor to take measurement once a day, starting from the day of recruitment till day of discharge. 3 ecg electrodes with cable linking to the lsppg sensor wearable will also be attached on the chest. this helps to capture ecg rhythm at the same time. study team member will assist the patient to take daily measurement. nhc outpatients scheduled for 24-hour abp monitoring (group b) patients will wear the lsppg wearable sensor whilst wearing the 24-hour ambulatory blood pressure monitor. 3 ecg electrodes with cable linking to the lsppg sensor wearable will also be attached on the chest. this helps to capture ecg rhythm at the same time. readings will be obtained on an hourly basis during the duration of wearing the ambulatory blood pressure machine (clinical grade device).

Eligibility criteria:
inclusion criteria: * above 21 years of age * sufficient language skills in english, chinese, malay or tamil * provided informed consent exclusion criteria: * skin sensitivity to adhesives
sch 727965 in patients with mantle cell lymphoma or b-cell chronic lymphocytic leukemia (study p04715)

Conditions: Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Summary: participants will be randomized to sch 727965 or a comparator drug (bortezomib for mantle cell lymphoma \[mcl\] or alemtuzumab for b cell chronic lymphocytic leukemia \[b cll\]). part 1 of the study will determine the activity of sch 727965 treatment in participants with mcl and participants with b-cll. part 2 of the study will determine the activity of sch 727965 treatment in participants who experienced disease progression after standard treatment with the comparator drug during part 1.


Eligibility criteria:
inclusion criteria: * age \>=18 years, either sex, any race. * eastern cooperative oncology group performance status of 0 or 1. * adequate hematologic, renal, and hepatic organ function and laboratory parameters. * for subjects with mcl: * diagnosis of mcl according to the world health organization (who) criteria. * received at least one prior chemotherapeutic regimen, but no more than two regimens including stem cell transplantation.. * measurable or assessable disease by the revised response criteria for malignant lymphoma. * for subjects with b-cll * documented b-cll according to the national cancer institute working group (nci-wg) criteria. * received at least one prior alkylating agent-based regimen and one fludarabine- or pentostatin-containing regimen, but must not have received more than two prior regimens. * measurable or assessable disease by nci-wg criteria. exclusion criteria: * known central nervous system involvement of mcl or b-cll. * previous treatment with sch 727965 or other cyclin-dependent kinase inhibitors. * for mcl, previous treatment with bortezomib. * for b-cll, previous treatment with alemtuzumab. * known hiv infection. * known active hepatitis b or c.
multiple ascending dose (mad) combination in subjects with multiple myeloma

Conditions: Advanced Cancer, Various, NOS

Summary: to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of bms-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of multiple myeloma * men and women at least 18 years old * ecog status 0-2 * last therapeutic or diagnostic treatment at least 21 days prior * bone marrow transplants must have been completed at least 3 months prior * any toxicity from prior therapies must have resolved to grade ≤1 exclusion criteria: * women pregnant or breastfeeding * wocbp unwilling/unable to use acceptable method to avoid pregnancy * uncontrolled medical disorder or active infection * current or recent (w/in 3 months) gastrointestinal disorder * inability to swallow oral medication * inability to be venipunctured * uncontrolled or significant cardiovascular disease * uncontrolled hyperlipidemia * intolerance of lenalidomide or bortezomib if participating in arms b and c * concurrent therapy with any other investigational product * subjects involuntary incarcerated * subjects detained for treatment of psychiatric or physical illness
a trial comparing sgc and conventional empiric treatment for glucose control in critically ill patients with mechanical ventilation in icu

Conditions: Hyperglycemia; Respiratory Failure; Critical Illness

Summary: poor glycemic control in critically ill patients can increase their mortality, while safe and efficient glucose control is laborious and time-consuming. the space glucosecontrol which is installed with empc(enhanced model predictive control) can get the blood glucose target range safely and effectively through regulating insulin dose rate. this study is a random controlled trial involving the patients with mechanical ventilation in intensive care unit in order to evaluate the difference of safety and efficacy of blood glucose control between sgc directed and conventional treatment. at last, the trial results can determine whether the space glucosecontrol can control blood glucose safely and effectively in the patients with mechanical ventilation in intensive care units.

design: the study was conducted as a single-centre, open randomized controlled, parallel trial. study population: adult medical icu patients who were mechanically ventilated and assumed to require at least 3 days of intensive care were recruited. patients fulfilling the inclusion criterion of glucose≥9.0 mm were randomly assigned using serially numbered to either the intervention group (bg control by sgc) or the control group (conventional empiric bg management). the both group aim to establish the bg levels 5.8-8.9mm. study protocol: bg measurements were performed using glucometer to test the fingertip capillary blood sample for the bg levels. as for patients with shock or required vasopressor, arterial bg was sampled to measure through the glucometer. insulin \[40 iu of actrapid hm (wanbang biopharmaceuticals, jiangsu province, china)/40ml of 0.9% sodium chloride\] was infused intravenously applying the standard perfusor of the icu (perfusor®space, b. braun melsungen ag, melsungen, germany). all trial-related activities were carried out until the end of the patient's icu stay, or for a period of 72 hours. meanwhile, enteral and parenteral nutrition was administrated to patients according to their condition. statistical analysis was performed on an intention-to-treat basis. the percentage of values in the target range (5.8-8.9mm) was defined as primary end point for the assessment of glucose control. data are reported as mean±sd values if not otherwise indicated. data analysis was performed using spss19.0.

Eligibility criteria:
inclusion criteria: 1. admitted to the icu 2. at least one bg measurement 9.0mmol/l or higher 3. expected to stay in icu ≥3 days; 4. mechanical ventilation exclusion criteria: 1. aged \< 18 years; 2. admitted because of diabetic ketoacidosis or nonketotic hyperosmolar state 3. pregnant 4. in a state in which death was perceived as imminent 5. without written informed consent
high fidelity simulation vs standard teaching training of cardiac resuscitation

Conditions: Cardiac Arrest

Summary: high fidelity simulation has spread from anesthesiology to other disciplines such as internal medicine, pediatrics, and emergency medicine . over the past decade, the use of simulation in medical education has increased exponentially. the term ''simulation'' spans a wide variety of formats, from the low-tech actor portraying a standardized patient to high-fidelity mannequin-based human patient simulation (hps). hps is able of both simulating realistic patient encounters and giving real-time, physiologically accurate feedback. studies thus far show that use of simulation in training medical students and residents is helpful in strengthening students' knowledge and in evaluating their performance. students appreciate simulation-based education as ''an opportunity to learn new skills in a safe environment .

this was a randomized, controlled trial of a simulation- based educational intervention designed to increase medicine student's clinical skills in cardiac arrest procedures .the investigators included 181 fifth-year medical students rotating in the emergency department of fattouma bourguiba university hospital of monastir (tunisia) during the period from january 2013 to january 2014.students were randomized into two groups using a random number generator to an intervention group (simulatortrained, n = 99) or a control group (traditionally teaching, n =82). the investigators conducted a prospective, randomized, non-blinded study to determine whether simulation based training is superior to traditional teaching in the assessment and management of simulated patients presenting with myocardial infarction (mi) complicated by ventricular fibrillation.

Eligibility criteria:
inclusion criteria: * medecine students exclusion criteria: * non medecine students

Keywords: medical education simulation acls
prochymal® expanded access for adults who have failed steroid treatment for acute graft versus host disease (gvhd)

Conditions: Graft-Versus-Host Disease

Summary: this protocol allows for the treatment of patients, male and female, between the ages of 18 years and 70 years. patients must have failed to respond to steroid treatment for grade c-d acute gvhd.

this is a treatment protocol to provide patients who have failed steroid treatment for acute gvhd expanded access of prochymal. it is anticipated that a maximum of 10 patients per month for a total of 120 patients per year will be treated according to this protocol. patients will be treated with prochymal twice per week at a dose of 2 x 106 human mesenchymal stem cell (hmsc)/kg (actual body weight) for each of 4 consecutive weeks. infusions will be administered at least 3 days apart.

Eligibility criteria:
inclusion criteria: * patients must be 18 years to 70 years of age, inclusive. * biopsy confirmation of gvhd is strongly recommended, to exclude patients presenting with diarrhea or abnormal liver function tests caused by infection. * patients must have failed to respond to steroid treatment (methylprednisolone \[≥1mg/kg/day\] or equivalent) for grades c-d acute gvhd. * prochymal must be administered not longer than 14 days after the initiation of systemic steroid therapy for acute gvhd. * prochymal must be administered either before or at the same time any additional gvhd therapy is administered * patients must have an adequate renal function as defined by cockcroft-gault equation:calculated creatinine clearance (crcl) \> 30 ml/min * patients who are women of childbearing potential, must be non-pregnant, not breast-feeding, and use adequate contraception. male patients must use adequate contraception. exclusion criteria: * patient has stage 3 or 4 liver gvhd, bilirubin \>6 mg/dl. * patient has stage 4 gi-gvhd. * patient has any underlying or current medical condition that would interfere with the evaluation of the patient including uncontrolled infection, sepsis, organ failure, etc or any medical condition that has a high probability of causing death in less than 30 days. * patient may not receive any other investigational agent (not approved by the fda for any indication) concurrently for the duration of the protocol. * patient has evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must not be likely to require more than 2 liters of oxygen via face mask or an estimated fractional inspired oxygen concentration (fio2) of 28% via other delivery methods in order to sustain an o2 saturation of 92% during the next 3 days. * patient has a known allergy to bovine or porcine products * patient has a medical history of a solid tumor disease.

Keywords: gvhd prochymal graft vs host disease
relationship of ywhah polymorphisms to rheumatoid arthritis disease severity

Conditions: Rheumatoid Arthritis

Summary: it is hypothesized that one or several of these 6 single nucleotide polymorphisms (snps) (rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226) in the ywhah gene could be related to ra disease severity.

rheumatoid arthritis (ra) is a chronic inflammatory arthritis of substantial morbidity. serum biomarkers such as rheumatoid factor and anti-cyclic citrullinated peptide assist with disease diagnosis and prognostic assessment of future disease activity. 14-3-3 eta is a relatively new ra serum biomarker. the 14-3-3 family of proteins were named based on chromatographic elution properites and are ubiquitously expressed intracellular chaperon proteins. the isoform relevant in ra is 14-3-3 eta. 14-3-3 eta provides additional information about ra to the clinician-it assists in making diagnosis, provides prognostic assessment of disease severity, and provides insight regarding response to therapy. thus, 14-3-3 eta serves as an important mechanistic biomarker informing the clinician about patient's ra. 14-3-3 eta is the product of the ywhah gene, located on chromosome 22q12.3. it is about 13 kilobase long, consisting of two exons separated by a single intron. this gene has been implicated in linkage studies to bipolar disorder and schizophrenia. six ywhah single nucleotide polymorphisms (snps) were identified in a prior study: rs2246704, rs2853884, rs3747158, rs4820059, rs7291050, and rs933226. rs2246704 was associated with bipolar disorder (odds ratio (or) 1.31, p=0.03) and psychotic bp (or 1.66, p=0.002). all six snps are intronic. it was hypothesized that one or several of these 6 single nucleotide polymorphisms (snps) could be related to ra disease severity.

Eligibility criteria:
inclusion criteria: * have ra per 1987 or 2010 american college of rheumatology classification criteria exclusion criteria: * none
a study of hydroxychloroquine and zinc in the prevention of covid-19 infection in military healthcare workers

Conditions: Sars-CoV2; COVID19

Summary: a multicenter randomized clinical trial aiming to assess the efficacy of hydroxychloroquine associated to zinc compared to hydroxychloroquine, in the prevention of military health professionals exposed to sars cov2 in tunisia

detailed description: the study is a multicenter randomized controlled double blind clinical trial, including up to 660 military health professionals working in tunisia and exposed to sars cov2 at different levels (2 levels of exposure). the trial will assess the efficacy of hydroxychloroquine associated to zinc compared to hydrxyochloroquine. randomization will be performed by iwrs (interactive web response system) by random double blocs of 9 and 6. collected data are managed by the electronic data capture system (dacima clinical suite),according to the fda 21 cfr part 11 requirements (food and drug administration 21 code of federal regulations part 11), the eu gdpr (european general data protection regulation), the hipaa specifications (health insurance portability and accountability act), and the ich standards (international conference on harmonisation)

Eligibility criteria:
inclusion criteria: * no self-medication with chloroquine, hydroxychloroquine or antivirals * covid-19 negative diagnosis confirmed by "rapid test" and "pcr test" (polymerase chain reaction test) * no clinical symptoms suggestive of covid-19 * having given written consent for their participation in the study exclusion criteria: * participation in other clinical trials for the treatment or prevention of sars-cov-2 infection within 30 days before inclusion * hypersensitivity to any of the drugs or to any of its excipients. * ecg showing rhythm disturbances, qt interval\> 500 ms, conduction disturbances. * severe hepatic impairment. * concomitant treatments : colchicin, ergot of rye, pimozide, mizolastin, simvastatin, lomitapide, alfuzosin, dapoxetin, avanafil, ivabradin, eplerenone, dronedaron, quetiapine, ticagrelor, cisapride, astemizole, astemizol. * retinal pathology. * epilepsy. * myasthenia. * psoriasis. * methemoglobinemia. * porphyria. * pregnant or lactating women * contraindication to the study products

Keywords: prophylaxis zinc hydroxychloroquine health professionals military