Kornimate/medical-research-clean huggingface dataset:
a study to assess adults with cidp transitioning from ivig to efgartigimod ph20 sc

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

Summary: this study will measure how adults with cidp receiving ivig treatment adjust to efgartigimod ph20 sc. the study duration for each participant will be approximately 17 to 19 weeks.


Eligibility criteria:
inclusion criteria: * is at least 18 years of age and the local legal age of consent * is diagnosed with cidp (confirmed or possible cidp) according to the criteria of the european academy of neurology/peripheral nerve society * is being treated with ivig every 3-6 weeks, on a stable dose and dosing interval (between 0.5-2 g/kg) for at least 3 doses * if receiving oral corticosteroids, this should be at a stable dose of less than 20 mg a day or less than 40 mg every other day, for at least a month. * if receiving nonsteroidal immunosuppressive medication, this should be at a stable dose for at least 3 months exclusion criteria: * besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of cidp or puts the participant at undue risk * types of other polyneuropathy other than cidp
post-market surveillance of micorport crm cardiac implantable electronic devices

Conditions: Cardiac Rhythm Disorder; Heart Failure; Sudden Cardiac Death

Summary: the primary objective of the study is to assess the chronic safety of microport crm market-released systems.

piano post market surveillance (pms) investigation will cover microport crm systems ce- market and released since 2018. continuous monitoring of microport crm market-released systems will also enable to: * confirm the safety and performance of the device throughout the study duration * identify previously unknown side-effects and monitoring the identified side-effects and contraindications, * identify and analyse emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio * identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct

Eligibility criteria:
inclusion criteria: subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study: 1. subject implanted with one of the following microport crm market-released system: * eno, teo, oto, alizea, borea, or celea pm single chamber (sr) or dual chamber (dr) implanted after 01 january 2020 in combination with at least one xfine or vega pacing lead * ulys, edis icd single chamber (vr) or dual chamber (dr) system in combination with an invicta defibrillation lead. additional xfine or vega atrial pacing lead is optional. * gali crt-d implanted in combination with an invicta defibrillation lead. additional navigo left ventricular pacing lead is optional. * gali sonr crt-d in combination with an invicta defibrillation lead and with either a navigo left ventricular or a sonrtip atrial pacing lead. * future generation of market approved microport crm pm, icd or crt-d device associated with existing or future generation of microport crm lead 2. subject equipped with remote monitoring system (rms) (only for subject implanted with icd or crt-d system) 3. subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system 4. subject reviewed, signed and dated the informed consent form (icf) if applicable per country regulation exclusion criteria: subjects who meet any of the following criteria are not eligible to be enrolled in the study: 1. age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention 2. life expectancy less than 1 year 3. currently enrolled in an active study of microport crm
a study of the safety and tolerability in participants with pik3ca-related overgrowth spectrum or proteus syndrome who are being treated with miransertib (mk-7075) in other studies (mk-7075-006)

Conditions: PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome (PS)

Summary: this is a study of the safety and tolerability of oral miransertib (mk-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (pik3ca)-related overgrowth spectrum (pros) or proteus syndrome (ps). this is an extension of other miransertib studies (mk-7075-002 \[nct03094832\] or arqule cu/eap \[nct03317366\]), and may also enroll participants who are approved for mk-7075-002 but have not yet started miransertib therapy.


Eligibility criteria:
inclusion criteria: * has pros or ps and has been screened in study mk-7075-002 (or has been approved by the sponsor to screen for mk-7075-002) or is currently being treated with miransertib as part of study mk-7075-002 (nct03094832) or arqule's cu/eap (nct03317366) * for males, agrees to be abstinent from heterosexual intercourse or use contraception unless confirmed to be azoospermic during the study period and for ≥90 days after the last dose of study intervention * for females, is not pregnant or breastfeeding, and is either not a participant of childbearing potential (pocbp) or is a pocbp and is abstinent or uses a highly effective method of contraception exclusion criteria: * has previously discontinued miransertib due to related saes or other intolerance of miransertib * has received other investigational agents, if any, that were administered between leaving study mk-7075-02 or arqule's cu/eap and entering this trial * is receiving systemic inhibitors of the mechanistic target of rapamycin (mtor) pathway (eg, sirolimus, everolimus) * is receiving immunosuppressive therapies * is receiving continuous high dose steroids

Keywords: arq 092 arqule akt mtor pik3ca pros proteus overgrowth congenital malformations mosaic
safety and efficacy of idp-118 lotion to ultravate® in the treatment of plaque psoriasis

Conditions: Psoriasis

Summary: safety and efficacy of idp-118 lotion to ultravate® cream, in the treatment of plaque psoriasis

a phase 2, multi-center, double-blind, randomized, vehicle-controlled study to compare the safety and efficacy of idp-118 lotion to ultravate® cream, in the treatment of plaque psoriasis

Eligibility criteria:
key inclusion criteria: * male or female, of any race, at least 18 years of age (inclusive). * freely provides both verbal and written informed consent. * has an area of plaque psoriasis appropriate for topical treatment that covers a bsa (body surface area) of at least 3%, but no more than 12%. the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation. * is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * has a clinical diagnosis of psoriasis at the baseline visit with an iga (investigators global assessment) score of 3 or 4. (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.) * if female and of childbearing potential, must have a negative urine and serum pregnancy test at the screening visit and negative urine pregnancy at baseline visit prior to randomization. * subject is willing to comply with study instructions and return to the clinic for required visits. key exclusion criteria: * has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator. * presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator. * presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. * is pregnant, nursing an infant, or planning a pregnancy during the study period. * has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
survey assessment of patient and provider impressions of telemedicine in radiation oncology

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: to understand more about the opinions of patients and health providers on the use of telemedicine in radiation oncology.

primary objective: to characterize patient and provider satisfaction with telemedicine in ro secondary objective: * to provide evidence for or against the use of telemedicine in radiation oncology (ro) * to assess the feasibility of and value added by telemedicine in ro * to describe barriers and facilitators to telemedicine in ro * to identify preferred use cases for telemedicine in ro

Eligibility criteria:
inclusion criteria: * patients will be eligible if they are aged 18 or older and have undergone at least 1 telemedicine encounter (video visit) with the radiation oncology department at md anderson or its affiliates within 2 months from the initiation of the study (and prospectively as the study enrolls). this would include weekly see visits, follow-up visits, or consultations * english speaking * access to email and internet to complete the survey * attending physicians in the radiation oncology department who have utilized telemedicine will be contacted to fill out surveys reflecting their experience exclusion criteria: • protected populations such as adults unable to consent, pregnant women, prisoners, and individuals who are not yet adults will be excluded
clinical effects of soluble dietary fiber supplementation

Conditions: Hypomotility; Constipation

Summary: the purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on colonic transit time, clinical symptoms and the gut microbiota in adults with slow-transit constipation.

patients were randomized to receive either pectin or placebo. treatment consisted of 4 weeks supplementation with pectin (fiber group) or placebo. we evaluated the colonic transit time, constipation symptoms and fecal bacterial population in two groups.

Eligibility criteria:
inclusion criteria: * all patients(age≧18y) * admitted for slow-transit constipation were considered eligible exclusion criteria: * mental disorders * cancer * inflammatory bowel disease

Keywords: constipation colon transit time gut microbiota soluble dietary fiber disturbance of gut microbiota in constipation
advancing brain outcomes in pediatric critically ill patients sedated with volatile anesthestic agents

Conditions: Intensive Care Units, Pediatric; Anesthetics, Inhalation; Mechanically Ventilated, Critically Ill Children

Summary: the goal of a pilot study is to test a study plan to see if it is appropriate for a larger study. this study plan is looking at whether the use of inhaled sedatives (medications that help people be calm and sleep) can reduce delirium (extreme confusion) in children who need a ventilator (breathing machine) compared to iv or oral sedatives. the main question\[s\] it aims to answer are: * will people join the study? (recruitment) * will participants finish the study? * will healthcare teams accept the study procedures? participants will be randomized to receive study treatment (inhaled sedation) or standard of care (iv sedation). they will be monitored daily for up to 28 days. they will complete memory, thinking and behaviour tasks after 9-12 months.


Eligibility criteria:
inclusion criteria: 1. pediatric patients age from 1 month to less than 18 years who need sedation to tolerate mechanical ventilation and will remain ventilated for ≥ 24 hours. 2. receiving iv sedation by infusion or bolus for ≤72h to aid mechanical ventilation (but will be recruited as early as possible). exclusion criteria: 1. current use of inhaled prostacyclin (high viscosity of prostacyclin impairs vaporizer device) 2. family history or personal history of malignant hyperthermia (mh) 3. allergy to isoflurane, sevoflurane or other volatile inhaled anesthetic gas 4. metabolic, mitochondrial or myopathy disease e.g., duchenne muscular dystrophy (volatiles may trigger malignant hyperthermia like reaction) 5. moribund with expected survival \< 24h 6. known pregnancy or lactation 7. suspected or evidence of high intracranial pressure (icp)
fatigue and inspiratory muscles training in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to assess the effect of a training of the inspiratory muscles against resistance at home during 10 weeks in multiple sclerosis patients with a severe disability.

patients will be informed about the study procedures during a follow-up consultation or an hospitalization in a physical and rehabilitation medicine unit. if they give their informed consent to participate in the study, an investigator will randomize them into one of the 2 arms of the study. this study consists of 3 visits. the first visit (inclusion) is planned at day 0, the second visit 10 weeks later and the third 3 months after day 0. a patient who is randomized in the experimental arm will have to follow 10 weeks of rehabilitation of the inspiratory muscles at home between first and second visit. during this period, investigators will call these patients once a week to assess the compliance with the rehabilitation. the patients who have been randomized in the control group will not follow this rehabilitation program.

Eligibility criteria:
inclusion criteria: * patient with remitting or progressive multiple sclerosis defined by mcdonald criteria revised in 2005, with an edss between 6 and 7,5 * aged between 18 and 65 years * patients able to maintain the powerbreathe * not to have had a flare-up since at least 6 weeks * patients at least 4 weeks since a corticoid bolus * patients at least 6 weeks since a botulinum toxin injection * patients at least 4 weeks since a pulmonary infection * questionnaire emif-sep \>= 55 * patients given their informed consent * patients who benefit or are affiliated to a social security regimen exclusion criteria: * patients with neurologic antecedents other that multiple sclerosis * patients with respiratory disorders other than those induced by multiple sclerosis * patients with orthopedic, cardiac, and rheumatologic invalidating antecedents * patients with comprehension or cognitive disorders impeding the realization of rehabilitation * pregnant women * patients under legal guardianship, or safeguard of justice * patients participating or planning participate within the 3 months of the study to another clinical research project

Keywords: inspiratory muscles multiple sclerosis rehabilitation
diet and exercise frailty intervention in cardiac device patients

Conditions: Frailty; Cardiovascular Diseases

Summary: definit-p is a prospective pilot study of frailty in cardiac device recipients, comprised of a registry and randomized control trial. the rct is a supervised exercise program and nutritional supplement intervention for pre-frail and frail cardiac device participants. the registry will be used to describe all cardiac device recipients, regardless of frailty status.

definit-p is a single center randomized controlled trial and registry. this pilot study will determine the feasibility of a larger, multi-center randomized clinical trial which aims to evaluate the efficacy of a supervised exercise program and nutritional supplement program in reversing or preventing progression of frailty in cardiac device recipients. the future trial would also examine the physiologic effects of exercise and nutritional supplementation to understand their effects on blood biomarker profiles, which will provide insight into potentially targetable mechanisms underlying frailty.

Eligibility criteria:
inclusion criteria 1. permanent pacemaker recipients or 2. implantable cardioverter defibrillator recipients exclusion criteria 1. age \<55 years, or 2. unwilling to consent patients will be eligible for the registry but not eligible for the randomized control trial if they fulfill any of: 1. are non-frail 2. already undertaking \>1 hour per week of dedicated exercise 3. existing or prior referral for cardiac rehabilitation 4. moderate or severe heart failure (new york heart association class iii or iv) 5. unstable angina 6. any other medical condition that will prevent exercise participation 7. dementia, as identified by a mini-mental state examination score \<25

Keywords: exercise nutritional supplement physical function quality of life cardiac device physical activity defibrillators pacemakers biomarkers
does hepatitis c management protect egyptian population against severe corona virus disease-2019?

Conditions: Corona Virus Infection; Hepatitis

Summary: modulation of the renin angiotensin system by the chronic hepatitis c virus treatment either by (daclatasvir and sofosbuvir), (daclatasvir and sofosbuvir plus ribavirin), or (ribavirin and interferon) protocols could give an explanation for the low incidence of covid-19 among egyptian population. adding it may play a role in covid 19 prophylaxis.

the interaction of severe acute respiratory syndrome corona virus-2 (sars-cov-2) and the renin angiotensin system (ras) via angiotensin converting enzyme-2 (ace-2), the receptor used by the sars-cov-2 to gain access to cells could provide an explanation for the several unusual clinical findings observed in covid-19 although chronic hepatitis is one of the risk factors listed by who for severe covid-19, low incidence of covid-19 was observed among hcv patients admitted to egyptian hospitals. modulation of the ras by the chronic hepatitis c virus treatment either by (acei or arbs), (daclatasvir and sofosbuvir), (daclatasvir and sofosbuvir plus ribavirin), or (ribavirin and interferon) protocols could give an explanation for the low incidence of covid-19 among egyptian population. adding it may play a role in covid 19 prophylaxis.

Eligibility criteria:
inclusion criteria: * all consecutive patients who were diagnosed to have covid-19 and admitted to zagazig university hospitals during the period from may 2020 to january 2021 exclusion criteria: -
g-csf in preventing neutropenia in patients with solid tumors who are receiving chemotherapy

Conditions: Chemotherapeutic Agent Toxicity; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: colony-stimulating factors, such as g-csf, may increase the number of white blood cells found in bone marrow or peripheral blood and may prevent persistent neutropenia in patients receiving chemotherapy. it is not yet known which regimen of g-csf may be more effective in preventing neutropenia. purpose: this randomized phase iii trial is comparing two different regimens of g-csf to see how well it works in preventing persistent neutropenia in patients with solid tumors who are receiving chemotherapy.

objectives: primary * determine the efficacy of filgrastim (g-csf) in preventing persistent moderate neutropenia in patients with solid tumors while maintaining chemotherapy courses. secondary * compare the tolerability of 2 regimens of g-csf in these patients. * determine the number of courses of g-csf needed in each regimen. * evaluate the frequency of infections. * determine dose intensity. outline: this is a multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive filgrastim (g-csf) subcutaneously (sc) once daily for 6 days beginning 1 week after the start of chemotherapy (days 7-12). if chemotherapy begins on day 8, patients receive g-csf sc on days 9-14. * arm ii: patients receive g-csf sc every 2 days on days 10-20 for up to 6 injections.

Eligibility criteria:
disease characteristics: * diagnosis of solid tumor * receiving chemotherapy in any line of treatment (adjuvant or metastatic) * chemotherapy courses repeating every 21 days or beginning on day 8 allowed * received at least 2 prior courses of chemotherapy * moderate neutropenia (grade 1-3) leading to a delay of the first course by ≥ 7 days or a delay of the second course of treatment patient characteristics: * not pregnant or nursing * fertile patients must use effective contraception * no known hypersensitivity to filgrastim (g-csf) or any of its components * no severe immunodepression * no malignant hematological disease * no history of psychiatric illness * no patients deprived of liberty or under guardianship * no psychological, familial, social, or geographical reasons preventing follow-up prior concurrent therapy: * see disease characteristics

Keywords: chemotherapeutic agent toxicity neutropenia unspecified adult solid tumor, protocol specific
use of a novel catheter lock solution for treatment of hemodialysis catheter infections

Conditions: Infection; Dialysis Catheter

Summary: aim: to conduct a randomized, double-blinded, controlled phase ii trial to investigate the use of a catheter lock solution consisting of n-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy. the investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. all patients will receive systemic antibiotics for treatment of their infection. additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of n-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. the control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). the main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.


Eligibility criteria:
inclusion criteria: * any adult (≥ 18 years of age) who has esrd and a prevalent or incident tunneled hemodialysis catheter and expected to continue hemodialysis for 3 months will be eligible for enrollment. exclusion criteria: * the following patients will be excluded from study entry: 1. patient is unable (and no guardian or legal representative is available) or unwilling to provide informed consent and 2. patient is allergic to nac, tigecycline, minocycline, or heparin. the following patients will be excluded from randomization: 1. patient has evidence of a complicated bacteremia such as endocarditis, septic thrombophlebitis, septic emboli, osteomyelitis, deep seated abscess, or hypotension requiring use of vasopressors, 2. patient has evidence of an exit site infection around the catheter such as a pus pocket, purulent drainage, or erythema, 3. patient is pregnant or will become pregnant, 4. the infection is due to an organism that is resistant to tigecycline such as candida or pseudomonas species.

Keywords: salvage infected hemodialysis catheters novel catheter lock solution