Kornimate/medical-research-clean huggingface dataset:
study of ibrutinib & obinutuzumab with/without chop for richter's transformation or richter's syndrome patients

Conditions: Richter Syndrome

Summary: this research study studies the combination of ibrutinib and obinutuzumab with or without the standard chemotherapy regimen of chop to see how well these drugs work in treating patients with a diagnosis of richter's transformation or richter's syndrome. the bruton's tyrosine kinase (btk) inhibitor, ibrutinib, may stop growth of cancer cells by blocking the signal needed for cell growth. the monoclonal antibody obinutuzumab may block cancer growth by targeting cells present in richter's transformation. giving ibrutinib with obinutuzumab may be a better treatment for patients with richter's transformation. depending on fitness, the patients may receive ibrutinib and obinutuzumab in combination with a regimen known as chop (c= cyclophosphamide, h= hydroxydaunorubicin (also called doxorubicin), o= oncovin (also called vincristine, and p= prednisolone or prednisone (corticosteroids).


Eligibility criteria:
inclusion criteria: * confirmed richter's transformation in treatment naïve and previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma patients * may have had prior exposure to ibrutinib and other b-cell signaling receptor agents * adequate hematologic function * adequate liver and kidney function * willing and able to participate in all required evaluations and procedures in this study protocol * female subjects of childbearing potential must not be pregnant upon study entry * male and female subjects who agree to use highly effective methods of birth control exclusion criteria: * known allergy to any of medications * chemotherapy taken within 21 days of study treatment * targeted therapy within 10 days of study treatment * bcr inhibitors within 24 hours of study treatment * major surgery within 4 weeks of first dose of study treatment * women who are pregnant * known infection with hiv or hepatitis c * vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug

Keywords: leukemia richter
evaluation of the performance and safety of the aktiia spot-check optical blood pressure monitoring device at wrist against double auscultation

Conditions: Hypertension

Summary: this study, with n = 85 participants minimum over 3 visits spread over 23 hours, has been designed to assess the accuracy and precision of the blood pressure and pulse rate values as generated by aktiia.product-g0 for up to 23 hours after initialization in a cohort of subjects representative of the us population. for the study, subjects will be asked to stay seated while measurements are taken at different timepoints.


Eligibility criteria:
inclusion criteria: 1. participants must be able to provide an informed consent to participate. 2. participant must be willing and able to comply with all of the study procedures and return for a day 2 visit. 3. participants must be 22 to 59 years of age. 4. participant or witness must be able to read or write in english. exclusion criteria: 1. participants with compromised circulation, injury, or physical malformation of the equipment test sites or other sensor sites which would limit the ability to test sites needed for the study. (note: certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.) 2. female participants who are known to be pregnant or who are trying to get pregnant confirmed by a day 1 positive urine pregnancy test unless the study participant is known to be not of child-bearing potential. 3. participants with known clotting disorders or currently taking a prescription blood thinner. 4. other known health conditions that will prevent safe participation in the study upon disclosure in health assessment short form or verbally. 5. participants suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation. 6. participants suffering from pathologies that systematically reduce peripheral perfusion including raynaud's disease, diabetes, renal dysfunctions (egfr \< 60ml / min / 1.73 m2), hyper- / hypothyroidism, pheochromocytoma or arteriovenous fistula. 7. a wrist circumference below 14 cm or above 23 cm. 8. an upper arm circumference \ 42cm. 9. any subject that, in the opinion of the investigator, does not exhibit any phenotype relevant to the objectives of this study. 10. any condition or circumstance that, in the opinion of the investigator, may preclude study completion, interfere with accurate data collection, bias the results, by instance a subject presenting a lateral blood pressure difference at screening of more than 15 mmhg for the systolic and/or more than 10 mmhg for the diastolic.

Keywords: hypertension blood pressure
effect of sporebiotics in fd

Conditions: Dyspepsia; Dysbiosis

Summary: single-site prospective interventional study aiming to demonstrate the effect of spore-forming probiotics on dyspeptic symptoms and blood, saliva and stool parameters in fd patients with and without acid suppression, compared to placebo.

prospective randomized placebo-controlled study in 2 parallel fd cohorts (8 weeks) with open-label extension phase (8 weeks): * cohort 1fd (on-ppi): study procedures at inclusion (1) and after 8 weeks on-ppi+ sporebiotics or placebo (2) followed by 8 weeks on-ppi+ sporebiotics (open label) * cohort 2fd (off-ppi): study procedures at inclusion (1) and after 8 weeks of sporebiotics or placebo (2) followed by 8 weeks of sporebiotics (open label) clinical outcomes and blood, saliva and stool parameters will be assessed at the beginning and end of each treatment period (week 0, 8 and 16) with additional questionnaires after 1 month (week 4 and 12).

Eligibility criteria:
inclusion criteria: * patients \>18 years with fd diagnosis (rome iv criteria) * male or female (not pregnant or lactating and using contraception or postmenopausal) * normal bowel habits (defecation once every 3 days up to 3 times a day) * witnessed written informed consent * access to home freezer (-18 to -20°c) * capable to understand and comply with the study requirements exclusion criteria: * any active somatic or psychiatric condition that may explain dyspeptic symptoms (stable dose of single antidepressant allowed for psychiatric indication, no limitation for other indications) * predominant symptoms of gastro-esophageal reflux disease (gerd) or irritable bowel syndrome (ibs) * use of immunosuppressants or antibiotics \<3 months * history of major abdominal surgery (except for appendectomy, cholecystectomy or splenectomy) * personal history of diabetes mellitus type 1, celiac disease or inflammatory bowel disease * diabetes mellitus type 2 (including therapy) * active malignancy (including therapy) * known hiv, hbv or hcv infection (including therapy) * significant alcohol use (\>10 units/weeks)

Keywords: spore-forming probiotic sporebiotic proton pump inhibitor dyspepsia
association of hydroxychloroquine, braf and mek inhibitors in metastatic melanoma : a retrospective case-control study.

Conditions: Dermatology and Oncology

Summary: patients with a braf mutated melanoma are usually treated in france by a first line of immunotherapy followed by a second line that combines a braf inhibitor (dabrafenib, vemurafenib, encorafenib) and a mek inhibitor (trametinib, cobimetinib, binimetinib). the combination dabrafenib/trametinib is initially very efficient but it is unfortunately limited because acquired resistances usually occur after a year of treatment. patients who become resistant to dabrafenib/trametinib and immunotherapy, unfortunately do not have an approved effective treatment at their disposal. they usually receive a palliative chemotherapy by dacarbazine or fotemustine, and they have a mean overall survival that is less than three months. activation of autophagy in presence of braf and mek inhibitors is a known mechanism of resistance to braf/mek inhibitors. hydroxychloroquine is an autophagy inhibitor and it has been suggested in vitro that it could decrease resistance to braf/mek inhibitors. following the positive results in 2018 of a phase i/ii study in the usa that showed the efficacy and the absence of toxicity of the association of dabrafenib, trametinib and hydroxychloroquine when used as a first line treatement, we proposed to our patients who had become resistant to the dabrafenib/trametinib combination, to pursue their treatment beyond progression and to receive in addition hydroxychloroquine. this prescription was initiated in patients for whom no further therapeutic options were available, after validation by a multidisciplinary tumor board. all patients were informed that the combination dabrafenib/trametinib/hydroxychloroquine was not approved by a regulatory agency.


Eligibility criteria:
inclusion criteria: * patients with metastatic melanoma with an activating braf mutation * who received at least one line of immunotherapy * whose disease is resistant to a braf inhibitor used as a single agent or in combination with a mek inhibitor * who received either cytotoxic chemotherapy or the combination dabrafenib + trametinib + hydroxychloroquine after disease progression to dabrafenib/trametinib from january 2008 to june 2020 in the dermatology ward of the lyon sud hospital exclusion criteria: * patients who did not received an immunotherapy prior to dabrafenib/trametinib treatment * absence of tumor board validation

Keywords: metastatic melanoma braf inhibitor mek inhibitor hydroxychloroquine autophagy
laryngeal mask airway in pediatric adenotonsillectomy

Conditions: Sleep Apnea, Obstructive; Tonsillitis

Summary: the study will compare how often the tubing kinks when a lma (laryngeal mask airway) with modified retractor is used compared to use of an endotracheal tube (ett) and non modified retractor is used.

the laryngeal mask airway (lma)is a device used to secure the airway of patients during general anesthesia. this device is routinely used for anesthesia in elective head and neck surgeries, including adenotonsillectomy. in this study, the efficacy of the lma will be studied as it pertains to operative times and cost. the child will be randomized into either the lma group or the ett group.

Eligibility criteria:
inclusion criteria: * requiring adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis between the ages of 2-16 exclusion criteria: * children with bmi \>35 * unwillingness to comply with study procedures * children with craniofacial anomalies/abnormalities which will interfere with mask placement * children under 2 or over 16

Keywords: adenotonsillectomy
treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo

Conditions: Benign Paroxysmal Positional Vertigo

Summary: to determine the short term therapeutic efficacies of gufoni maneuver and mastoid oscillation in apogeotropic type of benign paroxysmal positional vertigo (bppv) involving the horizontal semicircular canal (hc-bppv), a randomized, prospective, sham-controlled study was conducted.

the apogeotropic type of benign paroxysmal positional vertigo involving the horizontal canal (hc-bppv) is likely due to otolithic debris in the anterior arm of the canal (canalithiasis) or the debris attached to the cupula (cupulolithiasis). it is important to seek the method to convert treatment-resistant apogeotropic form to the more treatment-responsive geotropic form in hc-bppv. recent randomized trials demonstrated that head shaking maneuver was more effective than the modified semont maneuver and the gufoni and head shaking maneuvers showed similar efficacy in treating apogeotropic hc-bppv. moreover, new repositioning maneuver using mastoid vibration showed good efficacies in patients with apogeotropic hc-bppv in recent study. so we tried to compare the short term therapeutic efficacies of gufoni maneuver and mastoid oscillation in apogeotropic hc-bppv with a randomized, prospective, sham-controlled study.

Eligibility criteria:
inclusion criteria: 1. history of vertigo associated with changes in head position 2. direction-changing horizontal nystagmus beating toward the uppermost ear (apogeotropic nystagmus) in both turning positions detected with frenzel glasses or videoculography in the head turning test 3. vertigo associated with the elicited nystagmus 4. symptom within 2 weeks 5. put one's signature on consent exclusion criteria: 1. patients with identifiable central nervous system disorders that could explain the positional vertigo and nystagmus 2. the patients with apogeotropic form which was transited from geotropic after previous therapeutic maneuvers 3. the patients who transited from apogeotropic from vertical canal bppv during study 4. patients who had possible cause of secondary bppv such as meniere's disease, migraine or recent trauma history 5. patients whose affected ear cannot be identified 6. patients with multiple canal atypical positional nystagmus or who were treated previously with repositioning maneuvers were excluded. 7. patients with cervical or lumbar spine problem
effect of high intensity exercises in treatment of patients with shoulder impingement syndrome

Conditions: Shoulder Impingement Syndrome

Summary: purposes of the study to investigate the effect of adding high-intensity exercises to conventional physical therapy in patients with shoulder impingement syndrome

patients will be randomized into either high-intensity shoulder exercise group or conventional physical therapy group. patients will receive the intervention for six weeks. outcomes will be assessed at baseline and post-intervention.

Eligibility criteria:
inclusion criteria: 1. athletic patients 2. age of the patients between 18 - 35 years 3. unilateral shoulder pain more than 3 months. 4. positive hawkins test. 5. positive empty or full cane test. 6. pain at night or incapable of lying on the shoulder. 7. pain with active shoulder elevation in the scapular plane. 8. history of pain in the c5-c6 dermatome. 9. pain with palpation of the rotator cuff tendons. 10. the patient had pain with resisted isometric abduction exclusion criteria: 1. history of shoulder instability (positive sulcus sign, positive apprehension test, and history of shoulder dislocation). 2. clinical sign of cervical radiculopathy. 3. history of acromio -clavicular pain. 4. rheumatoid arthritis. 5. adhesive capsulitis. 6. tumors 7. labrum lesions 8. capsular or ligamentous tears or avulsions 9. cartilage lesions
study of cm512 in patients with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: a phase 2 study designed to evaluate the efficacy and safety of cm512 in adult patients with moderate-to-severe atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of moderate-to-severe ad for at least 1 year according to the american academy of dermatology's consensus criteria prior to the screening visit meeting all of the following criteria: * easi≥16 at screening and baseline visits; * investigator's global assessment (iga) score of≥3 at screening and baseline visits; * 10% body surface area (bsa) of ad involvement at screening and baseline visits; * mean of weekly pruritus numeric rating scale (nrs) severity score≥4 at baseline; exclusion criteria: * not enough washing-out period for previous therapy. * concurrent disease/status which may potentially affect the efficacy/safety judgement. * organ dysfunction. * pregnancy. * other.
epididymal u.s findings in asthenozoospermic &correlation with l.carnitine level

Conditions: Asthenozoospermia

Summary: to evaluate the epididymal findings by u.s and study its correlation with seminal parameters including l.carnitine level in infertile males

infertility is a relatively common problem affecting about15-20% of reproductive aged couples. historically, the cause of infertility was falsified attributed to the female partner, while the male factor, which is either primary or a co factor in 40-60% of cases, has largely been ignored thus, it is important to evaluate men at the same time with women.(2) the epididymis is an elongated structure, posterolateral to the testis within the scrotal sac. its primary function is the collection, maturation and transport of sperm from rete testis to the ductus deferens.(1)(3) testicular spermatozoa are nonfunctional and lack the ability to naturally fertilize an oocyte .after, spermatozoa reach the epididymis they undergo a complicated maturation process leading to biochemical, physiological and functional changes resulting in a functional spermatozo on that is able to successfully fertilize an oocyte (3)(4)(8) sperm dysfunctions are recognised as the most significant cause of male infertility and many may think that sperm dysfunction is only as a result of defective spermatogenesis. however, it can also be the result of an inadequate epididymal maturation process due to improper epididymal function (6)(7)(8) scrotal sonography is commonly used for evaluation of the infertile male. while abnormalities of the epididymis like( cysts and calcifications ) are frequently observed during sonographic assessment and their presence has uncertain importance (1)(10)(12)(13) measurement of acetyl carnitine content of human seminal plasma could be used as a marker of epididymal maturation. carnitine is present in the epididymis at higher concentrations than in other body tissues in the rat

Eligibility criteria:
inclusion criteria: * 80 married male( 50 asthenzoospermic infertile male and 30 with normal semen male) age from 18 to 55 years. exclusion criteria: * extreme age * single * recent l carnitine intake * undesended testis * genetic cause of inferitility * patients with clinical varicocele * azoospermic patients
a study of jnj-64281802 in participants with confirmed dengue fever

Conditions: Dengue

Summary: the purpose of this study is to investigate the antiviral activity of jnj-64281802 versus placebo in terms of reduction of dengue virus (denv) ribonucleic acid (rna) in primary denv infection.


Eligibility criteria:
inclusion criteria: * participant with a referral note/documentation from a health care facility or practitioner indicating non-structural 1 protein (ns1) positive for dengue virus (denv), positive ns1 rapid test at pre-screening during an ambulatory visit, or participant who tests ns1 positive at the site * participant reported a fever with an onset within the last 48 hours * a woman of childbearing potential must have a negative serum pregnancy test at screening * a woman must be: a. not of childbearing potential, b. of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of less than \[\<\] 1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until at least 90 days after last dose- the end of relevant systemic exposure * a male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention exclusion criteria: * participant with any clinical signs and symptoms for severe dengue according to the world health organization (who) criteria (such as severe plasma leakage leading to dengue shock syndrome \[dss\], fluid accumulation with respiratory distress, severe bleeding, sever organ involvement) * use of any cytochrome 3a4 (cyp3a4) inducers (example, phenytoin, rifampin), udp glucuronosyltransferase family 1 member a9 (ugt1a9) inducers (example, rifampin), or substrates for cyp3a4 with a narrow therapeutic range (example, alfentanil, cyclosporin), or sensitive breast cancer resistance protein (bcrp) substrates (example, pravastatin and folic acid) from 14 days before first dose of study drug until 28 days after last dose of study drug. systemic use of strong cyp3a4 inhibitors (example, clarithromycin, itraconazole) or ugt1a9 inhibitors (example, probenecid, mefenamic acid) from 7 days before first dose of study drug until 28 days after last dose of study drug * history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) * had major surgery, (example, requiring general anesthesia) within 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
long term administration of inhaled dry powder mannitol in cystic fibrosis - a safety and efficacy study

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. this current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. in particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. we also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. the initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.


Eligibility criteria:
main inclusion criteria: * written informed consent * confirmed diagnosis of cystic fibrosis * aged \> 6 years * fev1 \>30 % and \< 90% predicted * able to perform all the techniques necessary to measure lung function main exclusion criteria: * "terminally ill" or listed for lung transplantation * had a lung transplant * using nebulised hypertonic saline * significant episode of haemoptysis (\>60 ml) in the three months prior to enrolment * recent myocardial infarction or cerebral vascular accident * breast feeding or pregnant, or plan to become pregnant while in the study participating in another investigative drug study, parallel to, or within 4 weeks of study entry * allergy or intolerance to mannitol * using beta blockers * have a condition or be in a situation which in the investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study

Keywords: mannitol cystic fibrosis mucolytic exacerbation fev1 quality of life