Kornimate/medical-research-clean huggingface dataset:
effects of iloprost on hypoxic pulmonary vasoconstriction at altitude

Conditions: Hypoxic Pulmonary Vasoconstriction

Summary: the objective of this study is to determine if single dose administration of inhaled iloprost will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve arterial oxygenation at rest and during exercise at high altitude.

three major pathways in addition to oxygen modulate pulmonary vascular tone: 1) nitric oxide, 2) endothelin, and 3) prostacyclin. considerable animal data support the role of the prostacyclin pathway in modulating hypoxic pulmonary vasoconstriction. in humans, prostacyclin and its analogs are important therapeutic agents in the treatment of pulmonary arterial hypertension (pah). despite the animal data and human data in pah there is very little information about the use of to relieve hypoxic pulmonary vasoconstriction in healthy humans. inhaled iloprost is an ideal agent to study the prostacyclin pathway due to its short duration of action (30-90 min) and elimination half-life of only 20-30 min. individuals already participating in the nepal medex 2008 trip will be invited to participate in this research. participants will be healthy active females or males, between 18-80 years of age, without known pregnancy or liver disease, who have a readily measurable tricuspid regurgitant velocity by doppler echocardiography. if possible, we will attempt to identify a cohort of hape susceptible patients. participants will undergo evaluation both at sea level (baseline) and at high altitude. baseline (low altitude) testing will be performed in bangor, north wales, uk, and will include evaluation of pulmonary artery systolic pressures, cardiac output, and oxygen saturation at rest and during submaximal exercise before and after inhalation of iloprost. this strategy will then be repeated at an altitude of approximately 5000 meters in the dhaulagiri region of nepal.

Eligibility criteria:
inclusion criteria: 1. age: 18 - 80 years 2. healthy physically active males or females 3. have readily measurable tricuspid regurgitation (tr) peak systolic velocity by continuous wave doppler ultrasound exclusion criteria: 1. known liver disease 2. pregnancy 3. medications that in the opinion of the investigators could place subjects at increased risk of complications any other medical condition that in the opinion of the investigators would place the subject at high risk

Keywords: iloprost hypoxic pulmonary vasoconstriction altitude
efficacy and safety of corticosteroids in covid-19

Conditions: COVID-19; Novel Coronavirus Pneumonia

Summary: there is still controversy about the effective of glucocorticoids for the treatment of novel coronavirus pneumonia. this is a prospective randomized controlled trails. the aim is to explore the effectiveness and safety of glucocorticoids in the treatment of novel coronavirus pneumonia.


Eligibility criteria:
inclusion criteria: * age more than 18 years old * accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of novel coronavirus pneumonia (covid-19). * admitted in the general wards * be able to sign informed consent exclusion criteria: * severe immunosuppression (hiv infection, long-term use of immunosuppressive agents * pregnant or lactation period women * glucocorticoids are needed for other diseases * unwilling or unable to participate or complete the study * participate in other study
validation of a clinical assessment scale specific to alternating hemiplegia

Conditions: Alternating Hemiplegia

Summary: alternating hemiplegia of childhood (ahc) is a very rare neurological disorder of genetic origin, combining paroxysmal episodes and neurodevelopmental impairment. the disease is generally sporadic, and its incidence has been estimated at 1 in 100,000 births, with around 500 cases published worldwide. the true prevalence of ahc may be underestimated due to a lack of understanding of the disease and a high degree of phenotypic heterogeneity. it should be noted that, to date, it is difficult to assess the clinical characteristics of ahc patients in a homogeneous way. the lack of disease-specific clinical outcome measures therefore constitutes a critical node for advancing ahc research. in addition, recognition of the pattern of movement disorders and the ability to classify their severity are very important and useful for the clinician. homogeneous disease assessment will help plan rehabilitative and pharmacological interventions, facilitate monitoring of treatment outcomes, and predict prognosis. this is why an ahc assessment scale have been developed in collaboration with clinical teams from the iahcrc consortium. the scale has already been tested and validated on italian and spanish patients. the aim of this study is therefore to validate the use of this same scale on our french population of ahc patients. the hypothesis of the study is that the practical use of this scale specific to alternating hemiplegia is reproducible. to this end, all the items on the scale will be scored independently for each patient by 4 neuropediatricians with expertise in the disease, in order to observe the reproducibility of the results obtained with this scale. the scale will be used for twenty ahc patients of all ages.


Eligibility criteria:
inclusion criteria: * patient with confirmed diagnosis of ahc, unrestricted age range 0-99 years * at least one parent and/or legal guardian who understands and speaks the national language adult patients : * gathering of the non-opposition of the patient and/or his legal representative minor patients : * collection of non-opposition from parents/guardians exclusion criteria: * patient's refusal to participate in the study * patient under court protection, unable to give consent

Keywords: alternating hemiplegia of childhood rating scale
pain relief after primarytka

Conditions: Pain, Postoperative

Summary: while a majority of people who undergo tka have significant long-term improvement in functional ability, many patients may experience significant pain in the early postoperative period, which may adversely impact postoperative rehabilitation and recovery. traditionally, opioid medications have been used to control postoperative pain. however, there are many risks with using opioid medications, including addiction and overdose, which kills over 48,000 people yearly. in an effort to overcome this, opioid-sparing multimodal analgesia (mma) regimens have been developed, commonly using nonsteroid anti-inflammatory drugs (nsaids), acetaminophen, regional nerve blocks, and local anesthesia.


Eligibility criteria:
inclusion criteria: * patients 18 years or older * patients undergoing primary unilateral tka * patients receiving spinal anesthesia during primary tka * patients with adequate cognitive function to participate and complete questionnaires for the study exclusion criteria: * patients undergoing bilateral simultaneous tka * patients undergoing conversion tka * patients undergoing unicompartmental knee arthroplasty * patients undergoing patellofemoral arthroplasty * patients with an allergy to nsaids or bupivacaine * patients who have a contraindication to the use of nsaids * patients who are using chronic anticoagulation, precluding them from using nsaids * patients with a history or diagnosis of chronic pain syndrome or complex regional pain syndrome * patients who are determined to be in severe pain from other concomitant conditions * patients with chronic opioid use disorder, defined as patients who are taking more than 20 mg/day morphine milligram equivalents for 30 days consecutively in the 3 months prior to surgery.
tend study:telemedicine nurse dbs for parkinson's disease

Conditions: Parkinson Disease

Summary: the central hypothesis is that home health nurses can improve access and provide high quality care when guided by a sophisticated platform that integrates bioinformatics, patient-specific computational modeling, and continuous symptom measurement.


Eligibility criteria:
inclusion criteria: * pre-operative inclusion criteria: a good response to levodopa is required in order to exclude patients with parkinson's plus syndromes, and will be defined as a 30% improvement in parkinsonian motor signs based upon the unified pd rating scale (updrs) motor examination subscore, following the administration of 1.5 times the typical dopaminergic dose during the screening neurological examination. patients must also have pd for a minimum of 5 years duration. * additional inclusion criteria consist of: 1) hoehn \& yahr stage ii or worse when off; 2) intractable, disabling motor fluctuations and/or tremor; 3) age between 30-75 years; 4) unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of antiparkinsonian drugs). 5) a stable/optimal medical regimen of antiparkinsonian drug therapy for at least one month prior to surgery; 6) access to high-speed internet in the home. exclusion criteria: * clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g. significant cardiac or pulmonary disease, uncontrolled hypertension). * evidence of secondary or atypical parkinsonism. * mri scan with significant evidence of brain atrophy or other abnormalities. * dementia as evidenced by impairment in two neuropsychological domains and impaired or borderline neuropsychological function in one additional domain. * a major untreated psychiatric disorder.

Keywords: home health
an observational, cross sectional study to assess the prevalence of chronic kidney disease (ckd) in type 2 diabetes patients

Conditions: Diabetes

Summary: this non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of chronic kidney disease in indian patients with type 2 diabetes (t2dm). 3000 patients will be enrolled from 30 investigative sites all over the country. each investigative site will be expected to enrol 100 subjects. all the procedures will be completed in a single day.

this is an observational, multicenter, cross-sectional study to be conducted at 30 sites in india. endocrinologist/ diabetologist from multiple private clinics will evaluate the type 2 diabetes patients. the study will be conducted over 9-10 months and will be started after obtaining written approval of independent ethics committee (iec) and written informed consent of the patient. . each investigative site will be expected to enrol 100 subjects. all the procedures will be completed in a single day.

Eligibility criteria:
inclusion criteria: 1. known cases of t2dm. 2. male and female patients aged 18 years and above. 3. must provide written informed consent. exclusion criteria: 1. patients with known type-1 diabetes. 2. patients with any form of acute kidney injury based on investigator's discretion. 3. patients on maintenance dialysis or known renal transplant patients. 4. patients who have participated in any interventional study within past 3 months prior to entry in this study. 5. pregnant women. 6. patients with symptomatic urinary tract infection (uti) or with history of hematuria.

Keywords: type 2 diabetes
evaluation of the jarvik 2000 left ventricular assist system with post-auricular connector--destination therapy study

Conditions: Heart Failure

Summary: this investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. the multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the jarvik 2000 lvas with post-auricular connector to an active control group treated with the pma approved thoratec heartmate® ii lvas for destination therapy.

study success for primary endpoint a will be established if the proportion of subjects in the treatment group meeting the subject success criteria a, is determined to be non-inferior to that of the control group (at two years) according to the pre-specified statistical analysis. subject composite success requires the subject to achieve the effectiveness endpoint: 1. two year actuarial survival 2. freedom from procedures to repair, or replace the implanted device 3. freedom from stroke resulting in a modified rankin score of \>3 at the two-year follow-up study success for primary endpoint b will be established if the proportion of subjects in the treatment group meeting the subject success criteria b is determined to be superior to that of the control group (at three years) according to the pre-specified statistical analysis. subject composite success requires the subject to achieve the effectiveness endpoint: 1. three year survival 2. freedom from the serious adverse event of drive cable or pump pocket infection

Eligibility criteria:
inclusion criteria: 1. cardiac transplantation ineligible. 2. late stage heart failure in nyha class iiib or iv for at least 45 of past 60 days. 3. cardiac index \< 2.2 l / min / m2 4. lvef = 25% or less 5. patients on optimal medical management (omm) as defined in section 9.2 or dependent on intra-aortic balloon counter-pulsation for 7 days or other temporary (indicated for 30 days use, or less) mechanical circulatory support for 7 days, or supported with iv inotropes for 7 days and failing to respond. 6. bsa \> 1.2 m2 and \< 2.5 m2. exclusion criteria: 1. history of cardiac transplantation or left ventricular reduction procedure. 2. clinical conditions, other than heart failure, which could limit survival to less than three years. 3. cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis. 4. intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy. 5. known sensitivity to products of bovine origin. the jarvik 2000 incorporates a hemashield vascular graft. patients with a known sensitivity to products of bovine origin should not be implanted. 6. chronic immunosuppression.

Keywords: heart failure
performance and safety of lubri-cream for pain minimization during urethral catheterization and cystoscopy

Conditions: Urethral Catheter; Complications

Summary: the primary aim of this study is to collect clinical data on the performance of lubri-cream applied in routine clinical practice. safety and efficacy parameters of lubri-cream in lubrication on bladder catheterization and cystoscopy will be assessed.

the study is designed as a prospective, multicenter, single-group, observational study to evaluate lubri-cream for urethral catheterization and cystoscopies lubrication. at least 2 different centers located in spain will participate. it is primarily aimed to collect data on the performance of the product under investigation in a large patient population when used in routine clinical practice. safety and performance of lubri-cream will be assessed to study the pain minimization when patients undergo urethral catheterization and cystoscopy procedures.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * any patient who needs urethral catheterization or cystoscopy (rigid or flexible). * signed informed consent exclusion criteria: * contraindications as stated in the instructions for use * any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures * inclusion in another investigational study in the field of urethral catheterization or cystoscopy which could interfere with the clinical practice regarding the application and care of the investigational product.
local treatment with rp for newly-diagnosed mpca

Conditions: Prostatic Neoplasms; Neoplasm Metastasis

Summary: the objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.

patients recently diagnosed with metastatic prostate cancer (mpca), and meeting the eligibility criteria, will be given the opportunity to enroll in this study. study groups: after inclusion, patients requesting local treatment can undergo radical prostatectomy (rp) with pelvic lymph-node dissection (plnd) after multi-disciplinary evaluation. this resulting in a local treatment group and a no local treatment group. for ethical reasons, no randomization will be done. follow-up: patients not undergoing local treatment will undergo the current standard of care in our institution. and besides the intervention of local treatment, the other patients will receive this same current standard of care. routine follow-up visits, with physical examination, laboratory tests and questionnaires, will be scheduled every 3 months. a ct-scan (abdomen-pelvis) and bone scan will be performed if a clinical progression is diagnosed or suspected and when castration refractory pca (crpc) is established. androgen deprivation therapy (adt) will be initiated in case of one of the following: * symptoms related to metastatic lesion(s) * prostate specific antigen (psa) \> 50ng/ml and doubling time (psa-dt) \< 6 months (starting 3 months after inclusion at earliest) the estimated number of patients to be included in the local treatment arm is 40.

Eligibility criteria:
inclusion criteria: * diagnosis of prostate adenocarcinoma, confirmed by histology * newly diagnosis of metastatic disease (stage tanynanym+) * life expectancy ≥2y based on comorbid conditions, who performance status 0-2 * written informed consent, male ≥18yo * willing and expected to comply with study protocol and follow-up schedule * multidisciplinary oncologic consultation (moc) approval exclusion criteria: * previous local or systemic treatment for prostate cancer * metastatic brain disease, leptomeningeal disease or imminent spinal cord compression * symptoms clearly related to metastatic lesions * any other previous or current (malignant) disease which, in the judgment of the responsible physician, is likely to interfere with lomp treatment or assessment

Keywords: metastatic prostate cancer prostatectomy
short duration 6fed sponge for eoe patients

Conditions: Eosinophilic Esophagitis

Summary: this research is being done to see if the investigators can use the cytosponge or esophacap (depending on availability) to determine if shorter duration sfed (two weeks versus six weeks) would have equal results.

dietary therapy has been shown to be successful in the treatment of adult and pediatric patients with eosinophilic esophagitis (eoe). dietary studies were initially reported in children, but the results appear to be similar in adult patients. elemental diets are successful in 70-95% of patients but are poorly tolerated. the six food elimination diet (sfed) involves the elimination of the six most common food allergens (i.e. milk, wheat, soy, eggs, nuts, and fish) for six weeks and has become the mainstay of dietary therapy in eoe. a six week sfed has demonstrated excellent efficacy and durability in both pediatric and adult eoe. however, compliance with the sfed for a total of six weeks can be challenging for patients. previous studies have found the esophageal sponge to be an accurate technique of accessing esophageal eosinophilia in eoe . the sponge is swallowed as a 12 mm capsule on a string. the capsule rapidly dissolves upon entering the stomach and the sponge then expands and can be pulled out the mouth five minutes after ingestion. in previous studies, the procedure was very well tolerated and all patients preferred the sponge to endoscopy. therefore the sponge is a well tolerated, inexpensive, very low risk procedure that would be an ideal option to replace egd esophageal sampling in the evaluation of dietary treatment of eoe. although initially described as a six week trial, it is possible that a shorter duration food elimination diet of 2 or 4 weeks would have equal efficacy. this would have important implications for patients as it would make the diet more tolerable.

Eligibility criteria:
inclusion criteria: * adults ages 18-70 years of age * diagnosis of eoe, i.e. symptoms of esophageal dysfunction with histologic finding of 15 or more eosinophils per high power field on esophageal biopsy despite 8 weeks of high dose proton pump inhibitor therapy. * scheduled to initiate a clinical sfed for treatment of eoe exclusion criteria: * clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, cmv, herpes) * other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm) * esophageal minimal diameter \< 13 mm on structured barium esophagram * inability to read due to: blindness, cognitive dysfunction, or english language illiteracy * pregnant women

Keywords: eoe
safety and effectiveness study of rwj-445380 cathepsin-s inhibitor in patients with active rheumatoid arthritis despite methotrexate therapy

Conditions: Rheumatoid Arthritis

Summary: the primary objective of the study is to evaluate the safety and tolerability of 100, 200, and 300 mg/day doses of rwj-445380 for up to 12 weeks in patients with active rheumatoid arthritis despite methotrexate therapy.

trials with a new, first -in-class drug will be done to ascertain safety, tolerability, and to explore efficacy in the treatment of rheumatoid arthritis, including its effects on biomarkers. approximately 240 adult patients with rheumatoid arthritis despite the use of methotrexate therapy will be recruited for the study. they will be randomly assigned to one of 4 treatment arms; each patient has an equal chance of receiving the placebo, or 100 mg, 200 mg, 300 mg dose of rwj-445380. patients will take the medication daily for up to 12 weeks. patients will receive study medication in a blinded fashion, i.e. the patient, the doctor and the study sponsor will not know what group the patient is in until all patients complete the study. the investigator and the sponsor will monitor the study for the occurrence of possible side effects. in addition to a screening visit, patients will have visits every week for the first 2 weeks then every 2 weeks until 12 weeks of treatment. after 12 weeks, there will be a followup visit 4 weeks after the last dose of study drug is taken. medical history, physical examination, blood pressure, heart rate, temperature, and ecgs are checked periodically. joints will be assessed to explore whether the drug might affect tender and swollen joints. blood samples will be taken for standard safety laboratory tests as well as special tests of the drug blood level, biomarkers to see whether the drug might be affecting the biological pathway of antigen presentation, and other markers for rheumatoid arthritis. samples will also be taken to see whether certain types of immune cells are affected by taking the drug. immunization with tetanus vaccine will be done to see if taking the drug might affect immune responses to this agent patients will receive rwj-445380, 100, 200, 300 mg, or placebo. patients will receive oral capsules daily for up to 12 weeks.

Eligibility criteria:
inclusion criteria: * patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints * methotrexate treatment for 6 months * at least 10mg/wk and stable dose for at least 8 weeks * negative tb screening exclusion criteria: * use of other disease-modifying anti-rheumatic drugs (dmards) (other than methotrexate mtx) * previous use of more than 1 anti-tnf (tumor necrosis factor) agent * previous use of cytotoxics, p38 mapkinase inhibitor, anti-cd4 antibody * receipt of live vaccine within 1 month of study drug * serious infection in previous 2 months or history of chronic or recurrent infectious disease or history of opportunistic infection * other clinically significant disease of other organ system

Keywords: arthritis joints auto immune