Kornimate/medical-research-clean huggingface dataset:
a study to assess bms-986458 alone and in combination with anti-lymphoma agents in relapsed/refractory non-hodgkin lymphomas

Conditions: Relapsed/Refractory Non-Hodgkin Lymphoma

Summary: the purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of bms-986458, a bifunctional cereblon-dependent ligand-directed degrader (ldd) of bcl6 (bcl6 ldd), as a single agent and in combination with anti-lymphoma agents in participants with relapsed/refractory non-hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * participants ≥ 18 years of age with r/r nhl (including dlbcl \[ie, dlbcl not otherwise specified (nos) and diffuse large b-cell lymphoma/high-grade b-cell lymphoma with myc and bcl2 rearrangements\], and fl): * for r/r dlbcl (de novo) and fl 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids and at least one additional treatment). * for r/r dlbcl (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation. * for r/r fl (except for fl 3b): following at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment based on investigator´s assessment. * participant must have measurable disease (defined by at least one fdg-avid lesion for fdg-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion \> 1.5 cm in the transverse diameter). * participants must accept and follow pregnancy prevention plan. exclusion criteria: * participants must not have an eastern cooperative oncology group (ecog) performance status ≥ 2. * participants with an inability to comply with listed restrictions, precautions and prohibited treatments. * participants must not have prior car-t, cereblon-modulating drug or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic sct ≤ 6 months or autologous sct ≤ 3 months prior to study intervention initiation. * participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study. * participants must not have known or suspected central nervous system involvement.
pharmacokinetics study of ianalumab in chinese participants with autoimmune diseases

Conditions: Sjogren Disease; Systemic Lupus Erythematosus

Summary: the purpose of this pharmacokinetic (pk) study is to describe the pk profile of ianalumab following s.c. administration in chinese participants with systemic lupus erythematosus (sle) and/or sjögren's disease (sjd). collection of intensive pk data from chinese population had been designed in the ianalumab phase 3 studies of sjd cvay736a2302 (nct05349214) and lupus nephritis (ln) cvay736k12301 (nct05126277) on an optional basis. this study is conducted to provide supplementary chinese pk data in addition to the intensive pk data from the two phase 3 studies .

the study consists of the following periods: * screening period: up to 4 weeks * treatment period (week 0 - week 12) : 12 weeks * extended treatment period (after the completion of week 12 - week 52 (end of treatment (eot)) : 40 weeks \~ after completion of the 12-week treatment, participants will have the option to enter the extended treatment period. if a participant does not enter the extended treatment period, the eot visit will be performed at the next planned visit following the completion of week 12, followed by the post-treatment follow-up period. * post-treatment follow-up period: at least 20 weeks and up to 2 years from the last dose of study treatment.

Eligibility criteria:
key inclusion criteria: * male and female patients 18 years to 70 years of age (inclusive) * body weight at least 35 kg and not more than 120 kg and must have a body mass index (bmi) within the range of 18 - 35 kg/m2. bmi = body weight (kg) / \[height (m)\]2 at screening * diagnosed with sjd and/or sle as determined by the investigator * have active disease (sjd and/or sle) that may benefit from b-cell depletion therapy, as determined by the investigator. * participants currently receiving protocol-allowed soc should be on stable doses of soc medications for 4 weeks prior to first dosing of study treatment key exclusion criteria: * use of prohibited therapies * active viral, bacterial or other infections requiring systemic treatment at the time of screening or baseline or history of recurrent clinically significant infection * receipt of live/attenuated vaccine within a 4-week period before first dosing * uncontrolled co-existing serious disease * pregnant or nursing (lactating) women * women of child-bearing potential (wocbp), defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pharmacokinetic (pk) systemic lupus erythematosus (sle) sjogren disease (sjd) vay736 ianalumab b cell depletion
respiratory physiotherapy in mechanical ventilation

Conditions: Respiratory Failure

Summary: this study aimed to evaluate the effect of respiratory physiotherapy that is breathing exercise during weaning on ventilated patients in icu.

respiratory physiotherapy is a treatment approach to increase ventilation and function in patients with acute and chronic problems and to reduce respiratory work and dyspnea.airway cleaning techniques, lung volume-enhancing approaches, thoracic mobilization, positioning, breathing exercises and inhalation therapy are among the strategies used. in patients with invasive mv support, respiratory physiotherapy is the position, tracheal cleaning and inhalation therapy when necessary. but breathing exercises are not indicated in the acute phase. in the process of weaning, inspiratory muscle training and breathing exercises can be used.

Eligibility criteria:
inclusion criteria: * weaning period of patients in invasive mechanical ventilation * patients in stable hemodynamic parameters exclusion criteria: * under 18 years old * pregnant * non-cooperative

Keywords: respiratory physiotherapy
biotherapies and therapeutic education in chronic inflammatory rheumatism

Conditions: Rheumatoid Arthritis; Spondyloarthritis

Summary: the hypothesis is that group interaction associated with individual interviews intensify the acquisition of safety skills compared to individual interviews alone in patients with cir treated by subcutaneous biotherapies.

selection and inclusion of patients will be done by principal investigator of rheumatology department. after verification of inclusion and non-inclusion criteria by principal investigator and signature of consent, patients will be randomized by 1: 1 randomization (centralized randomization by statistician into 2 groups at m0) : 1. experimental group (individual and group therapeutic education ) * m0 (individual) educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management". * m3 (group with 3 to 10 patients) intensification biotherapy education: workshops : "subcutaneous injection education" and "biotherapy management". * m6 (individual presential or by phone) assessment of security skills and questionnaires. * m12 (individual presential or by phone) assessment of security skills and questionnaires. 2. control group (individual therapeutic education alone ) : * m0 (individual) educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management". * m3 (individual) intensification biotherapy education: "subcutaneous injection education" and "biotherapy management". * m6 (individual présential or by phone) assessment of security skills and questionnaires. * m12 (individual présential or by phone) assessment of security skills and questionnaires. group session proposed.

Eligibility criteria:
inclusion criteria: * patient age \> 18 years old with ra (acr/eular criteria) or sa (asas criteria) initiating a first subcutaneous biotherapy. * patient able to complete a questionnaire * patient giving informed consent. * patient covered by social security exclusion criteria: * - patient with disorder of higher mental function or psychiatric disorders. * patient previously treated by intravenous biotherapy. * protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.

Keywords: chronic inflammatory rheumatism biotherapies therapeutic education safety skills
efficacy and safety study of empagliflozin as add-on to insulin in japanese patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this is a multi-center, randomised, double-blind, placebo-controlled, parallel-group, efficacy and safety study of empagliflozin as add-on to insulin in japanese patients with type 2 diabetes mellitus with insufficient glycaemic control


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus * patients on diet and exercise regimen who are pre-treated with any insulin therapy alone or in combination with 1 oral antidiabetic drug for at least 12 weeks prior to screening * fasting c-peptide must be \> 0.5 ng/ml * hba1c at screening in patients who are treated with insulin alone must be \>=7.5% and \<=10.0% * hba1c in patients who are treated with insulin with 1 oral antidiabetic drug (oad) must be \>=7.0% and \ =7.5% and \<=10.0% at placebo run-in period * age at informed consent must be \>=20 and \<75 years * bmi at screening must be \>22 and \<=40 kg/m2 * further inclusion criteria apply exclusion criteria: * patients who experience uncontrolled hyperglycaemia before randomization * patients who are treated with sulfonylurea whose dose is more than a half of daily maximum approval dose, glucagon-like peptide-1 (glp-1) analogue, thiazolidinedione and sodium-glucose co-transporter 2 (sglt-2) inhibitor * patients with recent cardiovascular and/or stroke events * patients with hepatic and/or renal dysfunction * patients who received anti-obesity drugs or other treatment leading to unstable body weight * patients who have known allergy or hypersensitivity to insulin and/or empagliflozin * pre-menopausal women who are nursing or pregnant * further exclusion criteria apply
salicylic acid peels combined with 4% hydroquinone in the treatment of moderate to severe melasma in hispanic women

Conditions: Melasma

Summary: this study will enroll 20 adult hispanic women. participants will apply 4% hydroquinone cream twice daily to affected areas on the face for 14 weeks and half the face will be peeled with 20-30% salicylic acid every two weeks for a total of 4 peels. the first two peels will be 20% salicylic acid and the second two peels will be with 30% salicylic acid. the purpose of the study will be to evaluate the safety and efficacy of salicylic acid combined with 4% hydroquinone versus 4% hydroquinone alone.


Eligibility criteria:
inclusion criteria: * hispanic women ages 18-65 years of age with moderate to severe melasma * english and spanish-speaking women exclusion criteria: * pregnant or breast-feeding women * subjects who have used 4% hydroquinone within 3 months of study start * subjects who have used chemical peels, microdermabrasion or facial laser treatments within 9 months of study start

Keywords: melasma dark spots on the face
early clinical, laboratory and microbiological predictors of treatment outcomes in infective endocaridtis

Conditions: Infective Endocarditis

Summary: the investigators conduct a prospective observational study on consecutive patients being admitted to a tertiary care-centre with infective endocarditis. the investigators' primary aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital events, mortality and 6-month mortality.

mortality and major complications among infective endocarditis remain high. in addition developing nations are crippled with a high incidence of culture-negative endocarditis and lack of wide availability of transesophageal echocardiography. we intended to identify predictors among admission clinical features, laboratory paramters and culture reports that can help risk stratify patients early in the course of treatment.

Eligibility criteria:
inclusion criteria: * fulfillment of modified duke criteria exclusion criteria: * no consent * inadequate baseline data

Keywords: microbiology c reactive protein urgent cardiac surgery
bowen's technique in patients with adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: this study will help the physiotherapists in overcoming the challenges and barriers in the treatment. it will also help researchers in acquiring sufficient knowledge for further research on the bowen technique and its various applications as this technique is not widely applied in the field of physical therapy treatment.

the application of the bowen technique, producing significant results, will be opted in treatment for the better, improved, and innovative noninvasive management of adhesive capsulitis. this study will help the physiotherapists in overcoming the challenges and barriers in the treatment. it will also help researchers in acquiring sufficient knowledge for further research on the bowen technique and its various applications as this technique is not widely applied in the field of physical therapy treatment.

Eligibility criteria:
inclusion criteria: * both genders * age 25 to 60 years * history of worsening shoulder pain * painful movement from at least 3 month * grade 2 \& 3 adhesive capsulitis * both diabetic and non-diabetic * limited ranges in capsular pattern exclusion criteria: * fracture * trauma * dislocation * ongoing physical therapy treatment * cortisone injection prior 3 months

Keywords: adhesive capsulitis shoulder pain bowen technique
automated real-time feedback on cpr study

Conditions: Heart Arrest

Summary: the purpose of this study is to evaluate whether or not real-time feedback on cpr process variables will increase rates of restoration of spontaneous circulation during prehospital resuscitation and upon arrival at the receiving emergency room as well as increase rates of survival to hospital discharge.

a subset of emergency medical services (ems) agencies that are participating in the resuscitation outcomes consortium (roc) are adopting new monitor/defibrillators that are capable of monitoring cpr process during attempted resuscitation of patients in cardiac arrest, as well as providing automated real-time feedback about this process to ems providers so as to improve compliance with recommended guidelines for cpr. monitoring of cpr process during attempted resuscitation is an important step towards reducing the potential for poorly-performed cpr to modify the effect of the study interventions upon outcome. clusters formed of rigs, an individual agency or groups of agencies were randomized to turn feedback on or off. after a fixed period of time, each cluster crossed over to the other arm. an unequal number of subjects were enrolled during each period.

Eligibility criteria:
inclusion criteria: * all individuals who experience cardiac arrest outside the hospital, * are evaluated by organized ems personnel and: a) receive attempts at external defibrillation (by lay responders or emergency personnel) or receive chest compressions by organized ems personnel. exclusion criteria: * use of a mechanical cpr device
neurotrophin expression in infants as a predictor of respiratory and neurodevelopmental outcomes

Conditions: Bronchopulmonary Dysplasia; Chronic Lung Disease

Summary: important developmental processes continue until the completion of 40 weeks gestation. even during fetal life, intrinsic and environmental factors determine the balance between health and the onset and development of diseases. thus, it is crucial to understand the mechanisms that regulate normal development and the pathways that contribute to disease pathogenesis. neurotrophins are a family of four proteins that support the growth and survival of neurons. their secretion increases during brain development, when new neurons are being formed and existing ones are branching to assemble complex neuronal circuits. in addition to their role in promoting neuron growth and development, neurotrophins are also a product of neuronal activity. neurotrophins are also responsible for the maintenance of peripheral sensory neurons, including those in the lungs. airway innervation is responsible for many aspects of lung function including the regulation of airway smooth muscle tone, mucus secretion, and reactivity; therefore, a physiological expression of neurotrophins in the lungs is required for normal lung function.

currently, there is no reliable method to identify infants who will have poor neurodevelopmental and respiratory outcomes. the ability to make such predictions would be beneficial for both making care decisions in the neonatal intensive care unit and for identifying infants who require earlier and more intense intervention. we intend to determine if neurotrophins can be utilized to predict an infant's long-term outcomes. neurotrophins are a family of four proteins that support the growth and survival of neurons. their levels have been shown to increase with brain development and decrease with brain injury. neurotrophins have also been associated with development of airway injury in the neonate and later respiratory disease such as asthma. we plan to correlate serum neurotrophin levels with respiratory outcomes and neurological outcomes.

Eligibility criteria:
inclusion criteria: intubated infants in the neonatal intensive care unit (nicu) exclusion criteria: unwilling or unable to give or obtain informed consent

Keywords: biomarkers neurotrophins
early periprosthetic joint infection and outcome debridement, antibiotics and implant retention

Conditions: Femoral Neck Fracture; Infection

Summary: introduction periprosthetic joint infection (pji) is a severe complication to hip arthroplasty for femoral neck fractures (fnf). debridement, antibiotics and implant retention (dair) is recommended in early pji in association with stable implants. few studies have evaluated the outcome of dair in this fragile population.the purpose of this study was to analyze risk factors for pji and the short-term outcome of dair in fnf patients treated with a hip arthroplasty. methods a consecutive series of patients had been treated with either a total hip arthroplasty or a hemi hip arthroplasty for a displaced fnf at our institution. data were retrospective analysed.


Eligibility criteria:
inclusion criteria: * displaced femoral neck fracture * treated with a primary hip arthroplasty

Keywords: hip arthroplasty periprosthetic joint infection outcome
clinical trial to evaluate the influence of genotype and ddis of aspirin on the pk/pd of clopidogrel and pk of digoxin

Conditions: DRUG REACTIONS

Summary: clinical trial to evaluate the influence of multiple aspirin administration on pk and pd of co-administered drugs

clinical trial to evaluate the influence of genotype of drug metabolizing enzyme or transporter and drug-drug interactions of aspirin co-administration on the pharmacokinetics / pharmacodynamics of clopidogrel and pharmacokinetics of digoxin in healthy volunteers

Eligibility criteria:
inclusion criteria: * healthy male subjects aged 20 - 45 years. * a body weight in the range of 50 kg (inclusive) - 90 kg (exclusive) and a body mass index (bmi) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (inclusive). * sufficient ability to understand the nature of the study and any hazards of participating in it. provide written informed consent after being fully. informed about the study procedures. exclusion criteria: * presence or history of hypersensitivity or allergic reactions to drugs including investigational product (clopidogrel, digoxin or aspirin) * clinically relevant abnormal medical history that could interfere with the objectives of the study. * a subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug. * a subject whose lab test results are as follows; platelet count or pt, aptt \ 1.1 x upper limit of reference range. * a subject whose sbp is over 160 mmhg or below 90 mmhg and dbp is over 100 mmhg or below 50 mmhg. * clinically significant abnormal findings of ecg during screening test. * presence or history of drug abuse or positive result in urine drug screening test. * participation in other clinical trial within 2 months before first dose. * use of cyp inducer (ex. rifampin) within 4 weeks before first dose. * use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before first dose. * use of grapefruit juice within 1 week before first dose. * blood donation during 2 months or apheresis during 1 month before the study. * use of alcohol over 21 units/weeks * smoking of more than 10 cigarettes/days within 3 months before first dose. * subject judged not eligible for study participation by investigator.
aromatase plus gnrh analogue versus gnrh analog alone in adenomyosis

Conditions: Uterine Adenomyosis; Recurrent Implantation Failure; Menstrual Pain

Summary: with this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing ivf and with previous implantation failure, between aromatase inhibitor plus gnrh analog versus gnrh alone, in term pregnancy rate and uterine volume reduction.

recently it has been shown that adenomyosis negatively affects the pregnancy rate in ivf cycles. the investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and uterine myomas a combined therapy with aromatase inhibitor plus gnrh analog. with this study the investigators want evaluate which is the best way to treat adenomyosis in order to obtain a higher pregnancy rate in women with symptomatic adenomyosis undergoing ivf who failed a previous ivf attempt. for these reasons the investigators set this controlled trial between gnrh analog plus aromatase inhibitor (3.75 mg monthly of leuprolide plus 1.0mg day of anastrazole for 3 months) versus an active comparator as gnrh analog alone (3.75 mg monthly of leuprolide for 3 months) after the treatment patients will undergo embryo transfer of a cryopreserved blastocyst in a previous ivf cycle, and will be followed up for uterine dimension reduction and pain symptom reduction.

Eligibility criteria:
inclusion criteria: * women with healty conditions * adenomyosis * increased uterine dimensions * recurrent implantation failure exclusion criteria: * presence of systemic diseases

Keywords: implantation failure adenomyosis increased uterine size ivf egg donation cycle