Kornimate/medical-research-clean huggingface dataset:
a study to investigate efficacy and safety of bcl2 inhibitor sonrotoclax as monotherapy and in combination with zanubrutinib in adults with waldenström macroglobulinemia

Conditions: Waldenstrom Macroglobulinemia; Waldenstrom's Macroglobulinemia Recurrent; Waldenstrom's Macroglobulinemia Refractory

Summary: this study will evaluate the safety and efficacy of the bcl2 inhibitor sonrotoclax (bgb-11417) in participants with relapsed/refractory waldenström's macroglobulinemia (r/r wm) and in combination with zanubrutinib in adult participants with previously untreated wm.

this study will test whether sonrotoclax (bgb-11417) can be used to improve outcomes in participants with waldenström's macroglobulinemia (wm) both when used alone in those who have not responded well to conventional treatments and when used in combination with zanubrutinib in those who have not yet received treatment. the main goals of the study are to determine how many participants no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience. bcl2 is a key protein involved in cell death, and abnormal levels of bcl2 are associated with many cancers. blocking the action of bcl2 proteins is a promising approach with potential therapeutic benefits in participants with different types of cancers, including wm. this study will enroll approximately 105 participants. all participants will receive sonrotoclax orally as a tablet. the study will take place at multiple centers worldwide. the overall time to participate in this study is approximately 5 years.

Eligibility criteria:
inclusion criteria: * clinical and definitive histologic diagnosis of wm. * meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd international workshop on waldenström's macroglobulinemia (iwwm). * for cohorts 1-3, refractory or relapsed disease at study entry unless participants had intolerance to the most recent therapy. refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy. * for cohort 4, patients must not have received prior therapy for wm (except for plasmapheresis). * adequate organ function. exclusion criteria: * central nervous system (cns) involvement by wm. * transformation to aggressive lymphoma, such as diffuse large b-cell lymphoma. * history of other malignancies ≤ 2 years before study entry. * uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: waldenström's macroglobulinemia waldenstrom's macroglobulinemia recurrent waldenstrom's macroglobulinemia refractory lymphoma bgb-11417 bcl-2i
non-invasive neurally adjusted ventilatory assist versus nasal intermittent positive pressure ventilation for preterm infants after extubation

Conditions: Prematurity; Respiratory Failure; Ventilator Lung; Newborn

Summary: non-invasive respiratory support has been emerging in the management of respiratory distress syndrome (rds) in preterm infants to minimise the risk of lung injury. intermittent positive pressure ventilation (nippv) provides a method of augmenting continuous positive airway pressure (cpap) by delivering ventilator breaths via nasal prongs.it may increase tidal volume, improve gas exchange and reduce work of breathing. however, nippv may associate with patient-ventilator asynchrony that can cause poor tolerance and risk of intubation. it may also in increased risk of pneumothorax and bowel perforation because of increase in intrathoracic pressure. on the other hand, neurally adjusted ventilatory assist (nava) is a newer mode of ventilation, which has the potential to overcome these challenges. it uses the electrical activity of the diaphragm (eadi) as a signal to synchronise the mechanical ventilatory breaths and deliver an inspiratory pressure based on this electrical activity. comparing ni-nava and nippv in preterm infants, has shown that ni-nava improved the synchronization between patient and ventilator and decreased diaphragm work of breathing . there is lack of data on the use of ni-nava in neonates post extubation in the literature. to date, no study has focused on short-term impacts. therefore, it is important to evaluate the need of additional ventilatory support post extubation of ni-nava and nippv and also the risk of developing adverse outcomes. aim: the aim is to compare ni-nava \& nippv in terms of extubation failure in infants\< 32 weeks gestation. hypothesis: investigators hypothesized that infants born prematurely \< 32 weeks gestation who extubated to ni-nava have a lower risk of extubation failure and need of additional ventilatory support.

study design: randomised controlled trial study setting: single center nicu level iii, kfafh tertiary care center , jeddah saudi arabia

Eligibility criteria:
inclusion criteria: 1. born less than 32 weeks gestation with respiratory distress syndrome (rds) and requiring endotracheal tube and mechanical ventilation. 2. less than two weeks old 3. first extubation attempt 4. crib score 0-5 5. written-informed parental consent for the study exclusion criteria: 1. major congenital malformations or respiratory abnormalities 2. neuromuscular disease 3. phrenic nerve palsy 4. intraventricular hemorrhage (ivh) grade iii or iv 5. absence of informed consent 6. out born infants

Keywords: non-invasive neurally adjusted ventilatory assist ni-nava nasal intermittent positive pressure ventilation nippv post extubation
valorization of dairy sidestreams to fight calcium deficits in postmenopausal women

Conditions: Osteoporosis, Postmenopausal

Summary: the primary objective of this study is to investigate the effects of 12-months supplementation with calcium-enriched permeate, taken alone or in conjunction with inulin, on changes in markers of bone formation and resorption and in bone mass density (bmd) in apparently healthy postmenopausal women compared with calcium-carbonate or maltodextrin supplementation.

the study will include an information visit, a randomization visit, a month 3 visit and a final visit at month 12. besides, two visits at month 6 and 9 for dispensing of trial products. outcome parameters will be measured using blood samples obtained at the randomization visit, the month 3 visit and at the final visit at month 12. outcome parameters will moreover be analyzed based on dxa scan obtained at the randomization visit and at the final visit at 12 months.

Eligibility criteria:
inclusion criteria: * subject is between 45 years and 65 years of age by the time of inclusion. * subject has been menopausal for at least 1 year, defined as 12 months after last bleeding and up to 10 years. * subject is caucasian. * has a bmi below 35.0. * holder of a computer. * has a sufficient vitamin d status (plasma 25ohd concentration \> 50 nmol/l). * subject is willing and able to provide written informed consent prior to participation. exclusion criteria: * subject taking supplements or medicine that affects calcium and bone metabolism e.g. diuretics or hormone replacement therapy evaluated by the investigator. * intake of antibiotics in the last 3 months before enrollment. * subject with an osteoporosis diagnosis or history of osteoporotic fractures. * presence of renal, gastrointestinal, hepatic or endocrinological diseases. * subject with any serious illness or history of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer). * known or suspected abuse of alcohol or recreational drugs. * known milk allergy. * known or suspected hypersensitivity to trial products or related products. * blood donation except from the donation in this study. * subject where it is not possible to obtain sufficient data.
insight in persons presenting schizophrenia or related troubles during hospitalization in psychiatry

Conditions: Schizophrenia

Summary: therapeutic alliance, and drug observance are major difficulties in the care of persons presenting schizophrenic symptomatology. they appear to be linked to insight, the consciousness that one has of his troubles. nurse care in psychiatry aims at improving it, but usually without using specific evaluation tool. insight is usually not evaluated during care, and its evolution is also not known, although it is highly probable that a positive evolution of insight for a person in hospital correlated to an adapted and optimal care by the medical and nursing teams. the investigators do not know examples of insight evaluation during a sequence of hospital care, or any evidence of insight variation in relation to evolution abilities of some schizophrenic patients cared in hospital. the investigators propose here to evaluate insight in people presenting schizophrenia or related troubles, at the beginning of hospitalization (i1) and 1 month later (i2), to better characterize insight variations, and identify the sociodemographic, clinical and therapeutic variables linked to it.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, * persons requiring psychiatric care in one of the participating care unit * i1 \< 6 (absent or bad consciousness of the trouble). exclusion criteria: * i1≥6 * expression capacities incompatible with q8 scale quotation (delirium, no understanding of the french language, mutism, contention or therapeutic isolation) * age under 18, absence of health care insurance

Keywords: schizophrenia, insight
study with etanercept focusing on remission and predictability of remission in real life clinical practice

Conditions: Rheumatoid Arthritis

Summary: defining which remission criterion at month 6 predicts remission at month 12 in a real life clinical practice, in a cohort of rheumatoid arthritis patients treated with etanercept

the analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at month 12 and the 5 independent variables as cdai, sdai, das28, das28 and ultrasound, and eular boolean definition for clinical practice and clinical studies. this analysis will be conducted in each arm of the study as well as after a pooling of both patient groups. in this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). in order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop out rate of 30% over 1 year period.

Eligibility criteria:
inclusion criteria: 1. patients with active ra who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the smpc. 1. first cohort: etanercept is the first biological product prescribed. 2. second cohort: etanercept is the second biological product prescribed. 2. capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed. 3. eighteen (18) years of age or older at time of consent. exclusion criteria: 1. history of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.
improving function, participation and function after acute hospitalization in older adults

Conditions: Frail Older Adults

Summary: hospitalization increases the risk for new disability in older adults. in the current health care system, home health physical therapy is understudied and often does not return older adults to prior levels of function. the proposed evidence-based multicomponent intervention that combines high intensity strength training and motor control based systems of gait and balance training will advance clinical practice by providing an intervention strategy for practitioners. if successful, improving patient function and decreasing re-hospitalization rates and falls will have large cost saving implications.

background: hospitalized older adults are 59.8 times more likely to develop disability than those who are not hospitalized. no studies have examined the effectiveness of home health (hh) physical therapy on improving function in older adults with multiple co-morbidities after hospitalization. our goal is to enable older adults with multiple chronic conditions to recover function by providing adequate content and dose of intervention after hospitalization. this intervention is designed to work within the existing medicare system and has potential for immediate clinical impact. purpose: the primary aim of our study is to determine if a progressive multi-component (pmc) intervention, initiated upon discharge from an acute care hospital, improves gait speed at the end of one 60-day episode of care, more than documented usual care (uc) physical therapy. we hypothesize that there will be a greater improvement in gait speed measured for the pmc group compared to the uc group following one episode of care. benefits of pmc will be apparent at the end of usual care and will increase further at the end of the 60 day episode of care (primary endpoint). design: we propose to conduct a single blind randomized two arm clinical trial (rct) in older adults discharged from acute care and referred to hh physical therapy. both interventions (pmc \& uc) will be medicare-reimbursed. all assessments and interventions will occur in the patients' homes. methods: twenty individuals who are 65 years of age or older with multiple co-morbid conditions will be enrolled.

Eligibility criteria:
inclusion criteria: * 65 years or older * referred to home care physical therapy * have at least 3 comorbid conditions * ambulatory without human assistance prior to hospitalization exclusion criteria: * acute lower extremity fractures with weight-bearing restriction * elective joint replacement surgery * active cancer diagnosis * acute cardiac surgery * lower extremity amputation * referred to hospice home health physical therapy * dialysis * hospice care
evaluation of the efficacy of acitretin therapy for nail psoriasis

Conditions: Psoriasis

Summary: objective: efficacy of systemic retinoid therapy of nail psoriasis has never been assessed objectively. evaluate therapeutic efficacy of acitretin in patients with isolated nail psoriasis. design: open-study on thirty-six patients with moderate to severe nail psoriasis treated with acitretin. participants: patients included 27 men and 9 women (mean age 41) with nail psoriasis. intervention: therapy consisted of acitretin 0.2 to 0.3 mg/kg/day for 6 months. main outcome measure(s): clinical evaluation, napsi and modified napsi scores before therapy, every 2 months during therapy and 6 months after treatment.

the nail psoriasis severity index (napsi) has been designed and successfully implemented to grade severity of psoriatic nail disease. moreover, the utilization of the napsi score and a modified version of this severity index score as an instrument to monitor response to therapy has been recently documented in the medical literature .this open study involves thirty-six patients with moderate to severe nail psoriasis treated with low-dose acitretin from january 2005 to january 2007.acitretin was given at the dosage of 0.2 to 0.3 mg/kg/day for 6 months. laboratory investigations and clinical evaluation, which included photographic record and scoring of napsi and modified napsi, were performed every 2 months. investigator evaluation was performed using a 0 (no improvement) to 3 (cleared or almost cleared) score treatment satisfaction by patients and tolerability were assessed at each visit. all patients were followed for at least 6 months after the end of treatment.

Eligibility criteria:
inclusion criteria: * patients with moderate to severe nail psoriasis exclusion criteria: * premenopausal women * patients with hepatic, renal or metabolic diseases * patients with skin or symptomatic arthropathic psoriasis * previous systemic treatment for nail psoriasis

Keywords: nail, psoriasis, napsi,acitretin
evaluating preventive therapy with oint threolone, synthomycine or aqua cream, for egfr'i induced acneiform rash

Conditions: Acneiform Rash

Summary: the investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by egfr'is.

the investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by egfr'is.

Eligibility criteria:
inclusion criteria: * patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab. exclusion criteria: * patients who received any facial topical treatment / systemic antibiotics or any anti-inflammatory drug during the 2 weeks prior to study initiation. * known hypersensitivity to ointment synthomycine or to threolone. * patients presented with cutaneous rash during the 2 weeks prior to study initiation

Keywords: acneiform eruption papulopustular egfr cetuximab erlotinib gefitinib panitumumab eruption secondary to treatment with either cetuximab
a study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: this is a study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe hidradenitis suppurativa who were previously enrolled in a parental study.


Eligibility criteria:
inclusion criteria: * participants who have completed a parental study (m1095-hs-301 or m1095-hs-302 \[adult studies\] or m1095-hs-304 \[adolescent study\]) and are eligible to continue to receive sonelokimab at the time of completing the parental study. * female participants are eligible to participate if they are not pregnant or breastfeeding * male participants must be willing to use a condom when sexually active with a partner of childbearing potential . male participants must also agree to refrain from donating sperm during the study and for at least 8 weeks after the last dose of study treatment. exclusion criteria: * participants who meet any of the discontinuation criteria of the parental study at the time of enrollment in this ole study. * participants who have ongoing or planned to use one or more of the prohibited hs or non-hs treatments specified in the protocol. * participants who plan to participate in another interventional study for a drug or device during this study.

Keywords: hidradenitis suppurativa hidradenitis sweat gland diseases skin diseases skin diseases, bacterial suppuration anti-inflammatory agents sonelokimab nanobody apocrine gland disease
real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with factor xa non-vitamin-k oral anticoagulants (noacs) vs. phenprocoumon

Conditions: Atrial Fibrillation

Summary: existing real-world studies have provided evidence that novel oral anticoagulants (noacs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (nvaf) patients with renal impairment. nevertheless, it is known that clinicians often hesitate to prescribe noacs to patients with even moderate renal impairment. therefore, it is important to investigate effectiveness and safety of rivaroxaban and other noacs compared to vitamin-k antagonists in nvaf patients with renal dysfunction in real life setting. the primary objectives of this study are to describe the risk of ischemic stroke (is)/ systemic embolism (se) and intracranial hemorrhage (ich) in patients with non-valvular atrial fibrillation (nvaf) and renal impairment initiating treatment with individual noacs (rivaroxaban, apixaban, edoxaban) compared to phenprocoumon.


Eligibility criteria:
inclusion criteria: * first noac (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription (index drug) in the enrollment period between 1st january 2013 to 30th june 2017 (index date). * age of at least 18 years at index date. * continuous enrollment in the 12 months before the first noac (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period). * a verified ambulatory or primary/ secondary hospital discharge diagnosis of nvaf in the 12 months before the first noac (rivaroxaban, apixaban, edoxaban) or phenprocoumon prescription in the enrollment period (baseline period). exclusion criteria: * a verified ambulatory or primary/ secondary hospital discharge diagnosis of valvular atrial fibrillation, indicating pregnancy, transient cause of atrial fibrillation or venous thromboembolism (vte). * a claim for hip or knee replacement surgery in the 60 days prior to or on the index date. * a prescription of more than one oral anticoagulant (rivaroxaban, apixaban, edoxaban or phenprocoumon) on the index date. * a prescription of warfarin or dabigatran in the baseline period or on the index date. * a verified ambulatory or primary/ secondary hospital discharge diagnosis of end-stage kidney disease or a claim for dialysis in the baseline period. * patients receiving an initial dose of rivaroxaban 10 mg/ 2.5 mg or edoxaban 15 mg (these dosages are not indicated for the treatment of nvaf).
safety of two strategies of icd management at implantation

Conditions: Ventricular Fibrillation; Ventricular Flutter; Sudden Cardiac Death

Summary: the aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(dt) during first implant of implantable cardioverter defibrillator

the standardized requirements for implantable cardioverter defibrillator (icd) include defibrillation testing (dt), consisting in induction and termination of ventricular fibrillation (vf). an effective dt has historically been considered part of standard procedures at implant. nevertheless, implant techniques and technology have evolved during years and nowadays deviations are frequent in clinical practice mainly due to the fact that physicians are seriously concerned about the risk of severe complications related to dt. however, the practice of not performing dt is arbitrary and its safety is yet unproven. this observational study will assess the safety of the two strategies adopted at icd implant: induction (including patients who undergo dt at implant) and non-induction (including patients who do not undergo dt at implant. no deviation from the centres' current practice in choosing to perform or not perform dt is introduced by this study protocol. the study considers consecutive patients undergoing first implant of icd

Eligibility criteria:
inclusion criteria: * first implantation of icd or crt-d * patients undergoing upgrade to icd or crt-d from pacemaker * patients undergoing upgrade to crt-d from crt * age 18 or above, or legal age to give written informed consent exclusion criteria: * patients who do not give consent to treat their data.