Kornimate/medical-research-clean huggingface dataset:
effects of inspiratory muscle training on dyspnea in subjects with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determinate whether inspiratory muscle training (imt) associated with a conventional respiratory rehabilitation program is more effective than a conventional respiratory rehabilitation program alone,on dyspnea in chronic obstructive pulmonary disease (copd) subjects with a normal maximum inspiratory pressure (ip \> 60 cmh2o).

dyspnea is the main complaint of patients with copd. dyspnea is explained largely by the distension, objectified by measuring inspiratory capacity (ic), which places the diaphragm at a disadvantage to be effective, which raises the sensation of dyspnea. currently, inspiratory muscles training is recommended by the french-language society of pneumology, in case of an objective reduction of the strength of these muscles (corresponding to maximum inspiratory pressure \<60 cm h20).

Eligibility criteria:
inclusion criteria: * patient with copd * hospitalized in the pulmonary rehabilitation unit in the hospital of morlaix, with a 3 weeks pulmonary rehabilitation course exclusion criteria: * pneumonectomy, lobectomy less than 6 months * cardio-pulmonary anomaly * max inspiratory pressure \< 60 cm h2o

Keywords: inspiratory muscle training copd conventional respiratory rehabilitation dyspnea scale
comparing high-flow nasal cannula oxygen and noninvasive ventilation to standard oxygenation in non-selected icu patients admitted for hypoxemic arf

Conditions: Acute Respiratory Failure

Summary: the goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (niv and/or hfno) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (arf) patients.

this randomized controlled trial is a superiority study to test if one of the methods (niv and/or hfno) is superior to standard oxygen in arf patients requiring oxygen. it is an investigator-initiated, multicenter, adaptive, three arms parallel-group trial with a computer-generated allocation sequence and an electronic system-based randomization, with a stratification on medical (then stratification between immunocompromised and non-immunocompromised patients) versus surgical (then stratification between cardiothoracic and abdominal patients).

Eligibility criteria:
inclusion criteria: * adult (age ≥ 18 years) * a diagnosis of hypoxemic arf occurring defined as the presence and persistence for more than 30 minutes of hypoxemia (defined by a partial oxygen pressure \<60 mm hg when breathing room air or \<80 mmhg when breathing 15 l/min of oxygen or a peripheral oxygen saturation \[spo2\] ≤90% when breathing room air and/or a pao2(partial pressure of oxygen)/fio2 ratio \< 300 mmhg plus either \[1\] a respiratory rate higher than 30/min or \[2\] clinical signs suggestive of intense respiratory muscle work and/or labored breathing, such as use of accessory respiratory muscles, paradoxical motion of the abdomen, or intercostal retraction). exclusion criteria: * contraindications to niv and/or hfno * sleep apnea syndrome with home ventilator * immediate tracheal intubation * requirement for an emergent surgical procedure requiring intubation * hypercapnia with a formal indication for niv (formal indication for niv with paco2 ≥ 50 mmhg or clinical signs of hypercapnia) * isolated cardiogenic pulmonary edema (formal indication for niv). patients with pulmonary edema associated with another arf etiology can be included. * anatomical factors precluding the use of niv and/or hfno * patients with limitation or withdrawal of life-sustaining therapies with a do-not-intubate order * pregnancy in progress or planned during the study period or breastfeeding women * patients protected by law (art. l1121-6 and l1121-8 of the code de la santé publique): adult protected by law or patient under guardianship or curatorship * subjects not covered by public health insurance * absence of written informed consent from the patient or his or her proxy (if present) before inclusion or when possible when the patient has been included in an emergency setting

Keywords: high-flow nasal cannula oxygen non-invasive ventilation post-operative immunocompromised acute respiratory failure intensive care unit
efficacy of chinese herbal medicine to prevent and treat covid-19 close contacts

Conditions: Healthy Participants

Summary: this is a randomized, blank-controlled study in adults with household contact exposure to individuals with sars-cov-2 infection. all subjects in the study will be household contacts with close exposure to the first household member known to be newly infected with sars-cov-2. subjects in each cohort will be randomly assigned to the chinese herbal medicine treatment group or blank control group in a 4:1 ratio, followed by 1 week of the treatment period and 2 weeks of follow-up.


Eligibility criteria:
inclusion criteria: 1. household contact exposure to individuals with sars-cov-2 infection 2. aged ≥18 3. general healthy or have a chronic, stable medical condition 4. voluntarily signing a written informed consent form 5. able to follow written and oral instructions in chinese exclusion criteria: 1. moderate to severe symptomatic sars-cov-2 infection 2. an allergic history to chinese herbal drugs or a known allergy to the ingredients of the study drug 3. pregnancy, breastfeeding or plan to become pregnant within the study timeframe 4. vulnerable adults (i.e., mentally or physically disabled to take care of himself/herself) 5. any physical examination findings, and/or history of any illness, or concomitant medications that, in the opinion of the study investigator, might not be suitable to participate in the study
oral contraceptive hormone-free interval pituitary/ ovarian activity

Conditions: Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy

Summary: the degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian axis during the hormone-free interval in combined oral contraceptive (coc) hormone users varies depending on the dose of ethinyl estradiol in the formulation. this variation in activation may be associated with different side effects during the hormone free interval. progesterone (p) remained suppressed during all 6 coc regimens (\<1.8 ng/ml), which indicates continuous contraceptive efficacy during the 7-day hormone free interval of all formulations studied.


Eligibility criteria:
inclusion criteria: * healthy, reproductive age women * 18 to 35 years old, * seeking contraception from the general gynecology clinics of the lac and usc medical center w * taking one of 6 possible monophasic coc formulations for at least 3 cycles prior to enrollment * regular menstrual cycles prior to cocs exclusion criteria: * irregular bleeding * bilateral oophorectomy * amenorrhea * hormone-sensitive cancer * concurrent medications known to interfere with steroid metabolism (i.e., barbiturates, phenytoin, carbamazepine, ethosuximide, primidone, rifampin, tetracycline)
ultrasonography swe for hepatic fibrosis evaluation

Conditions: Cirrhosis

Summary: the purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.

hepatic fibrosis causes liver dysfunction and hcc. since hepatic fibrosis is reversible dynamic condition, its monitoring is important to predict long term outcome and to determine treatment plan. the reference of standard to diagnose hepatic fibrosis is biopsy, but recently non-invasive method such as stiffness imaging has been drawing a lot of attention. in this study, ultrasound shear wave elastography will be performed and its diagnostic performance to detect advanced hepatic fibrosis (= \> f2) will be measured using histologic grade as a reference.

Eligibility criteria:
inclusion criteria: * volunteers who agree to undergo us shear elastography or * patients with chronic liver disease who are scheduled to undergo liver resection or liver parenchymal biopsy. and * = or \> 18 years * sign informed consent exclusion criteria: * none

Keywords: elastography ultrasonography
prospective prevalence and validation study of pediatric intensive care delirium.

Conditions: Pediatric Delirium

Summary: pediatric delirium (pd) is a poorly investigated clinical problem that needs to be further explored in a danish context. children are at risk of discomfort and suffering if they experience delirium. the condition is associated with prolonged mechanical ventilation, longer hospital stay, increased mortality, and risk of long-term cognitive impairment. therefore, it is important to assess critically ill children with a validated tool to enable early detection and management of the condition. in this study, the investigators will determine the prevalence of pediatric intensive care delirium. to this end, the investigators will validate the sophia observation withdrawal symptoms - pediatric delirium scale (sos-pd) for patient assessment.

prospective prevalence and validation study of pediatric intensive care delirium. aim: to validate the sos-pd assessment tool and determine the prevalence of delirium in children aged 3 months to 18 years in a danish context. data analysis and power calculation: with 140 patients, the accuracy estimate in this study will have a 95% confidence interval of +/- 5%. accuracy defined as (true positive + true negative) / all x 100 is expected to be 90%. the validity of the sos-pd assessment tool is calculated from standard definitions of sensitivity, specificity, positive predictive value and negative predictive value. the prevalence is calculated in percent. all data will be entered and encoded in redcap and exported to spss for statistical analysis of data.

Eligibility criteria:
inclusion criteria: * pediatric intensive care patients * length of stay of 48 hours or more exclusion criteria: * non danish speaking * use of neuromuscular blocking agents * sedation level at comfort behavior score \> 11 or richmond agitation sedation scale \> -3
benefit study (betaferon® / betaseron® in newly emerging multiple sclerosis for initial treatment) and benefit follow-up study

Conditions: Multiple Sclerosis

Summary: this study will primarily compare the long-term effects of an early and continued treatment with betaferon/betaseron (patients who were treated with active medication during the double-blind benefit study) to treatment initiated either after clinically definite multiple sclerosis (cdms) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind benefit study). analyses are based on the integrated data of the initial benefit study and this follow-up study.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer healthcare pharmaceuticals inc.. bayer healthcare pharmaceuticals inc. is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * patients who have reached scheduled end of study in benefit, either by developing cdms or by completing 24 months exclusion criteria: * no participation in the initial benefit study
pacemaker therapy in adults with congenital heart defects

Conditions: Congenital Disorder

Summary: review the feasibility, safety and outcomes in adults with congenital heart disease who undergo pacemaker implantation for bradycardia, tachycardia or heart failure indications

survival to adulthood is now common for children born with congenital heart defects (chd). this improved survival is in large part due to advances in cardiac surgery over the past 4 decades. however, few cardiac surgical repairs are curative. many 'repaired' children with congenital heart defects later develop problems as adults. arrhythmias, need for additional surgery, and heart failure are the more common late sequelae of congenital heart disease (1). in addition, many adults with chd will need a pacemaker for sick sinus syndrome (inability of the inherent pacemaker of the heart to function properly resulting in bradycardia sometimes alternating with tachycardia), tachyarrhythmias or heart block (2, 3). certain group of patients, such as those with congenital corrected transposition of the great arteries (cctga), d-transposition s/p atrial switch procedures and those with single ventricle physiology are at particular risk of developing heart failure (4). attached figures show the anatomy of these congenital heart defect. cardiac resynchronization therapy improves exercise tolerance, symptoms and reduces mortality in adults with heart failure due to acquired left ventricular dysfunction.(5-8). in addition, automatic internal cardioverter - defibrillators (icd) have now been shown to decrease mortality in patients with low ejection fraction due to ischemic or non-ischemic etiologies (9, 10). patients with chd pose a challenge to traditional transvenous pacemaker lead placement due to either complex venous anatomy that precludes conventional percutaneous approaches for pacemaker implantation or occlusions of central venous form multiple prior procedures (11, 12). as evident in the study by janousek et.al, 7 out of 8 patients enrolled in this study required a thoracotomy for lead placement (4). while thoracoscopic epicardial lead placement has been described for placement of pacemaker leads in adults without congenital heart defects (13, 14), it has not been described for adult patients with congenital heart disease.

Eligibility criteria:
inclusion criteria: * congenital heart disease diagnosis * pacemaker implantation completed during the period of jan. 1, 1996 to dec. 1, 2005 * age 18 to 80, inclusive exclusion criteria: * those who do not meet inclusion criteria

Keywords: adult pacemaker bradycardia tachycardia heart failure
a phase i study of zn-d5 in chinese subjects with non-hodgkin lymphoma

Conditions: Non-Hodgkin Lymphoma

Summary: a phase i dose-escalation, open-label, multicenter study to assess the safety, tolerability, clinical activity, and pharmacokinetics (pk) of zn-d5 in chinese subjects with non-hodgkin lymphoma (nhl).

for the phase i dose escalation study of zn-d5, it is planned that after the starting dose, subsequent dose assignments will be made by means of a model-assisted design, until the mtd or rp2d is determined in the chinese population.

Eligibility criteria:
inclusion criteria: 1. nhl, relapsed from or refractory to at least 2 prior lines of systemic therapy (excluding radiotherapy and surgery); subjects must have failed or not be candidates for available standard therapy expected to provide clinical benefit. 2. female subjects of childbearing potential must have a negative serum pregnancy test and agree to use contraception while on study. 3. eastern cooperative oncology group performance status ≤ 1. 4. adequate blood and other organ function, defined by the following criteria: 1. neutrophil count (anc) ≥ 1.0 × 109/l. 2. platelet count ≥ 75 × 109/l at least 3 days after platelet transfusion (≥ 50 × 109/l permitted if the bone marrow is \> 50% lymphoma cells). 3. hemoglobin ≥ 8.0 g/dl. 4. coagulation parameters ≤ 1.5 × upper limit of normal (uln). 5. liver enzymes ≤ 3 × uln and total bilirubin ≤ 1.5 × uln. 6. creatinine clearance ≥ 60 ml/min. exclusion criteria: 1. received any of the following prior to start of zn-d5 treatment: 1. systemic administration of antineoplastic agents (including investigational agents) within the shorter of 28 days or 5 half-lives. 2. major surgery within 28 days. 3. radiotherapy within 14 days. 4. autologous or allogeneic stem cell transplantation within 60 days, or receiving immunosuppression for active graft-versus-host disease. 5. use of strong cyp3a4 inhibitors, p-gp inhibitors or qt prolonging agents within 5 half-lives, or potent or moderate cyp3a4 inducers within 14 days. 2. ongoing and clinically significant non-hematologic toxicity related to prior antineoplastic therapy. 3. presence of major cardiovascular system diseases (including qtcf \> 480 msec). 4. positive serology for human immunodeficiency virus, hepatitis b, or hepatitis c unless no detectable hepatitis b or c viral load. 5. unable to take oral drugs or presence of severe gastrointestinal abnormalities. 6. active and uncontrolled clinically significant infection. 7. other active systemic malignancy or other severe, unstable, or poorly controlled acute or chronic medical conditions. 8. prior treatment with venetoclax or other bcl-2 inhibitors. 9. primary or secondary cns lymphoma. 10. presence of post-transplant lymphoproliferative disease, burkitt's lymphoma, burkitt-like lymphoma, t lymphoblastic lymphoma and t lymphoblastic acute leukemia.
bg00012 phase 2 combination study in participants with multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis

Summary: the primary objective of the study is to evaluate the safety and tolerability of bg00012 (dimethyl fumarate) administered in combination with interferon b (ifnß) or glatiramer acetate (ga) in participants with relapsing-remitting multiple sclerosis (rrms).


Eligibility criteria:
key inclusion criteria: * must have a confirmed diagnosis of relapsing-remitting multiple sclerosis (rrms) according to mcdonald criteria #1-4 (polman et al, 2005 \[appendix i\]), and have a prior brain magnetic resonance imaging (mri) demonstrating lesion (s) consistent with multiple sclerosis (ms) from any point in time. * must have an expanded disability status scale (edss) between 0.0 and 5.0, inclusive. * must be taking the same dose of a prescribed ifnβ (either avonex, betaseron, rebif) or ga for at least 12 months consecutively at the time of enrollment and remain on this treatment for the duration of the study. participants receiving rebif must be prescribed 44 μg by subcutaneous injection three times per week. key exclusion criteria: * primary progressive, secondary progressive, or progressive relapsing ms (as defined by polman et al. 2005). * other chronic disease of the immune system, malignancies, acute urologic, or pulmonary disease. * pregnant or nursing women. * participation within 6 months prior to study enrollment in any other drug, biologic, or device study. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: bg00012 ms rrms
combining mhealth and nurse-delivered care to improve the outcomes of people with serious mental illness in west africa

Conditions: Psychosis; Mania; Depression

Summary: in west africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. the stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in ghana.

the study involves deployment of an intervention in ghanian prayer camps where traditional and faith healers provide care for people with mental illness. the intervention has two components: a visiting nurse that provides medications to patients staying at the prayer camps combined with a smartphone app called m-healer that is used by the staff working at the camps. the app is designed to provide them with training on how to deliver some psychosocial interventions, monitor the health and well-being of their patients, and protect human rights at the camps. the stepped-wedge cluster randomized study design involves all participant groups beginning the trial receiving enhanced usual care with random sequential crossover of groups to the experimental condition until all groups have been exposed to the full intervention. throughout the study, participant data will be collected at baseline, mid-treatment, and post-treatment. following study completion, the intervention will be evaluated by comparing changes in psychiatric symptoms of participants from baseline to post-treatment.

Eligibility criteria:
inclusion criteria: * aged 18 years or older * speaks twi or english * current inpatient staying at a study prayer camp * a diagnosis of psychosis, mania, or depression exclusion criteria: * serious physical illness or in need of urgent medical attention

Keywords: mhealth psychosis mania depression
dose escalation study of jnj-63709178, a humanized cd123 x cd3 duobody in participants with relapsed or refractory acute myeloid leukemia (aml)

Conditions: Leukemia, Myeloid, Acute

Summary: the purpose of this study is to characterize the safety and tolerability of jnj-63709178 and identify the recommended phase 2 dose(s) (rp2d) and schedule for jnj-63709178 in part 1 and to characterize the safety and tolerability of jnj-63709178 at the rp2d(s) in part 2.

this is first-in-human (fih) phase 1, open-label (identity of assigned study drug will be known), multicenter, dose escalation study with dose expansion to identify the rp2d and to evaluate the safety, tolerability, and preliminary antitumor activity of jnj-63709178 in adult participants with relapsed or refractory acute myeloid leukemia (aml) who are ineligible for or have exhausted standard therapeutic options. the study will be conducted in 2 parts: dose escalation and dose expansion. the study is divided into 3 periods: a screening phase (within 28 days before the first dose of study drug), a treatment phase (first dose of study drug until the last dose of study drug) and a post-treatment follow-up phase (up to the end of study participation or end of study). participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * a diagnosis of acute myeloid leukemia (aml) according to the world health organization 2008 criteria with relapsed or refractory disease and ineligible for or have exhausted standard therapeutic options * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * hematology laboratory parameters within the protocol specified range * chemistry laboratory parameters within the protocol specified range * a woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin \[b-hcg\]) or urine test prior to the first dose of study drug exclusion criteria: * acute promyelocytic leukemia * active central nervous system involvement * prior solid organ transplantation * prior hematopoietic stem cell transplant within 6 months of enrollment. if the participant had an allogenic transplant there must be no apparent signs of graft versus host disease and participants must have discontinued all immunosuppressive therapies for at least 4 weeks * prior treatment with a cd123xcd3 bispecific agent, t cells expressing cd123 specific chimeric antigen receptor, or toxin-conjugated to cd123 antibodies; prior treatment with naked anti-cd123 monoclonal antibody is permitted

Keywords: leukemia, myeloid, acute jnj-63709178