Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphomas and treated with myelosuppressive chemotherapy

Conditions: Solid Tumors; Lymphoma

Summary: the purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.

this is a phase 2, open label, multicenter study of eflapegrastim in pediatric participants (≥1 month to \<17 years) with solid tumors or lymphoma. approximately 40 participants will be enrolled and assigned to one of 4 age-based cohorts. participants enrolled in cohort 1 will be followed for dose-limiting toxicities (dlts) prior to initiating parallel enrollment into cohorts 2 through 4. all participants will receive chemotherapy as standard of care after which a subcutaneous (sc) dose of eflapegrastim will be administered up to 4 treatment cycles.

Eligibility criteria:
inclusion criteria: 1. participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement. 2. participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the national comprehensive cancer network (nccn) guidelines. 3. participant has adequate hematological, renal, and hepatic function. 4. participant must have an echocardiogram (echo) or multigated acquisition (muga) within 14 days of screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of \>50%. 5. participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (cns) involvement within 14 days of study entry. 6. participant has a karnofsky performance level ≥50% for patients ≥16 years of age or a lansky performance level ≥50 for children \<16 years of age. exclusion criteria: 1. participant has an uncontrollable infection, has an underlying medical condition, and/or another serious illness that would impair the ability of the participant to receive protocol-specified treatment. 2. participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (g-csf) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim) 3. participant requires concurrent radiation therapy specifically in cycle 1. 4. participant has had prior bone marrow or hematopoietic stem cell transplant and/or has concurrent bone marrow involvement in their malignancy, including leukemia. 5. participant has had spinal radiation therapy within 30 days prior to study enrollment. 6. participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study. 7. participant has a known sensitivity or previous reactions to any of the g-csf products. 8. participant with active cns disease. 9. participant has not recovered from previous treatment adverse events to ≤grade 1.

Keywords: lymphomas solid tumors chemotherapy
narrative exposure therapy in women with borderline personality disorder and posttraumatic stress disorder

Conditions: Borderline Personality Disorder; Stress Disorders, Post-Traumatic

Summary: narrative exposure therapy (net) is an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity. patients with borderline personality disorder (bpd) often suffer from a comorbid posttraumatic stress disorder (ptsd) caused by multiple traumatic events. therapeutic aims are the reduction of ptsd-symptoms in these patients via activation of associative neural networks related to traumatic experiences and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography. this practice enables the processing of and coping with painful memories and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. the investigators assume that using net the reduction of ptsd symptom severity is greater compared to treatment by dialectical-behavioral therapy (dbt).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * dsm-iv-tr diagnoses of bpd and ptsd * legal competence * none or stable medication * illegal drug abstinence for at least the last 6 months * capacity to consent and contract exclusion criteria: * other severe mental disorders (e.g., bipolar disorder, acute psychosis) * simultaneous consumption of drugs * simultaneous participation in other treatment-studies * pregnancy or breastfeeding * lack of capability to negotiate a no-suicide agreement * suicide attempt or attempts during the 8 weeks prior to start of treatment * perpetrator-contact * body mass index (bmi) \< 16

Keywords: borderline personality disorder comorbid posttraumatic stress disorder narrative exposure therapy dialectical-behavioral therapy
the bioavailability of red clover isoflavones

Conditions: Healthy

Summary: previous literature has shown that the molecular form of isoflavones (as aglycones or glycosides) and food matrices can influence the bioavailability of these compounds in humans and hence their efficacy. to determine the effects of processing and food matrices on the bioavailability of active compounds derived from red clover the investigators will execute a 5 phase, cross-over design, open label, rct using 20 healthy women aged between 18 to 40 years. participants will receive 5 different formulations of red clover and bioavailability will be monitored in blood plasma using lc-ms.

the aim of this study is to elucidate the effects food matrices and processing on the bioavailability of active compounds on the bioavailability of red clover derived isoflavones. 20 healthy participants will receive red clover derived isoflavones in five different formulations. the five formulations are split up into five phases: phase 1) fermented extract in liquid form phase 2) fermented extract (freeze-dried) in capsule form phase 3) fermented extract (freeze-dried) in tablet form phase 4) fermented extract (concentrated) mixed in yogurt phase 5) un-fermented red clover in capsule or tablet form the trial will last 5-6 weeks for each participant. plasma sample collection will take place both pre-and post- ingestion of a formulation, participants will receive blood tests at intervals -15 min, 0 min, 2hr, 4hr, 6hr, 8hr and 12hr (on the day of ingestion) and on the subsequent two mornings (24hr and 48hr) following the initiation of a phase. there will be a minimum. 5 day intervals between all phases (washout periods). isoflavones biochanin a, formononetin, genistein and daidzein present in plasma will be detected using hplc-ms for each phase, thus creating a bioavailability curve that can be compared to each of the other phases. the primary endpoint is to determine whether fermented extract is more bioavailable than unfermented extract.

Eligibility criteria:
inclusion criteria: * healthy women * age: 18-40 years exclusion criteria: * habitual intake of soy products, chickpeas or other supplements with a high content of isoflavones * hormone therapy * pregnant or breastfeeding * taking drugs affecting uptake * participation in other clinical trials within the last 3 months * severe cardiovascular, psychiatric, neurological and / or kidney disease * alcohol or substance abuse * acute illness

Keywords: bioavailability isoflavones plasma human processing cross-over
effects of respiratory muscle training on postoperative pulmonary complications of cardiac surgery

Conditions: Heart Diseases; Coronary Disease; Cardiovascular Diseases; Coronary Artery Occlusion

Summary: this study will evaluate the profilatic effects of inspiratory muscle training (imt) on functional capacity, respiratory muscle strength, postoperative pulmonary complications and days of hospitalization (ppc) in patients submitted to coronary artery bypass graft surgery (cabg).

patients undergoing coronary artery bypass graft surgery are at risk of postoperative pulmonary complications, which lead to increased postoperative morbidity and mortality. a few studies have demonstrated that preoperative physical therapy has advantages over postoperative care in patients undergoing cardiac . in this way, this study aim to investigate the effects of preoperativeinspiratory muscle training in patients at high risk of postoperative pulmonary complications who were scheduled for coronary artery bypass graft surgery.

Eligibility criteria:
inclusion criteria: * high-risk patients underwent primary elective cabg (coronary artery bypass graft), high-risk will be defined as 2 or more the following: age\>70 years; cough and expectoration; diabetes; smoker; copd (chronic obstructive pulmonary disease) exclusion criteria: * uncontrolled arrhythmia, * decompensated heart failure, * unstable angina upon selection or during the inspiratory muscle training (imt), * need for reoperation and association of another procedure during surgery (e.g. valve correction associated with cabg) * severe orthopedic or neurological conditions.
study of tisagenlecleucel in chinese adult patients with relapsed or refractory diffuse large b-cell non-hodgkin lymphoma (dlbcl)

Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)

Summary: this is a multi-center, phase ii study to evaluate the efficacy and safety of ctl019 in chinese adult patients with relapsed or refractory dlbcl.

disease assessments will be performed at screening, after bridging, 1, 3, 6, 9 and 12 months after tisagenlecleucel infusion, and every 6 months in the second year, and annually up to 60 months after infusion. efficacy will be assessed until progression; safety will be assessed throughout the study. a long term follow-up up to 15 years after ctl019 infusion will continue under a separate protocol (cctl019a2205b)(nct02445222).

Eligibility criteria:
inclusion criteria: 1. signed informed consent must be obtained prior to participation in the study 2. patients must be ≥18 years of age at the time of icf signature 3. histologically confirmed dlbcl at last relapse (including dlbcl transformed from follicular lymphoma and double-triple hit lymphoma) 4. relapsed or refractory disease after at least 2 lines of systemic therapy, including anti-cd20 antibody and an anthracycline, or having failed or being ineligible for autologous hsct 5. ecog performance status that is either 0 or 1 at screening 6. measurable disease at time of enrollment: * nodal lesions greater than 15 mm in the long axis, regardless of the length of the short axis or * extra nodal lesion (outside lymph node or nodal mass, but including liver and spleen) at least 10 mm in long and short axis 7. adequate organ function 8. must have a leukapheresis material of non-mobilized cells available for manufacturing exclusion criteria: 1. prior treatment with anti-cd19 therapy, adoptive t cell therapy, or any prior gene therapy product 2. primary mediastinal large b-cell lymphoma, ebv+ dlbcl, richter's transformation, burkitt lymphoma, primary dlbcl of cns, t cell / histiocyte rich large b-cell lymphoma, primary cutaneous dlbcl. 3. eligible for and consenting to autologous hsct 4. prior allogeneic sct 5. active cns involvement by disease under study, except if the cns involvement has been effectively treated (i.e. patient is asymptomatic) and local treatment was greater than 4 weeks before enrollment 6. active neurological autoimmune or inflammatory disorders (e.g. guillain-barre syndrome) 7. investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to screening

Keywords: diffuse large b-cell lymphoma double/triple hit lymphoma relapsed/refractory tisagenlecleucel ctl019 chinese
assessment of pulmonary function in relation to the anesthetic used in patients undergoing bariatric surgery

Conditions: Obesity and Obesity-related Medical Conditions

Summary: it is known that more or less pronounced impairment of pulmonary function occurs after anesthesia. it has been demonstrated in the postoperative period in both patients undergoing general and regional anesthesia, in patients after intra-abdominal and superficial procedures, in overweight and normal-weight patients. it has also been shown that when general anesthesia is performed with the inhalation anesthetic sevoflurane, there is a slightly smaller reduction in lung function parameters than when only intravenous anesthetics are used. the purpose of this study is to evaluate lung function before induction and after awakening from general anesthesia depending on the inhalational anesthetic used in obese patients undergoing bariatric surgery


Eligibility criteria:
inclusion criteria: * obese patients qualified for bariatric surgery. exclusion criteria: * patients who have absolute contraindications to spirometry testing, i.e: * with aneurysms of the aorta or cerebral arteries threatening to rupture, after recent vascular surgery * with increased intracranial pressure, after recent intracranial bleeding or head surgery within the cranial cavity * after acute conditions within 6 months prior to surgery such as stroke, myocardial infarction, unstable angina, pneumothorax * with uncontrolled hypertension * after recent eye surgery or a history of retinal detachment * with hemoptysis of unknown etiology. and patients unable to perform spirometry testing
perioperative ischemic evaluation-3 trial

Conditions: Perioperative Bleeding; Venous Thrombosis; Arterial Thrombosis

Summary: this study is a multicentre, international, randomized controlled trial of tranexamic acid (txa) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

the poise-3 study is a 10,000 patient, multicentre, international, non-inferiority randomized controlled trial of tranexamic acid (txa) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy. the primary objective of the study is to determine; if txa is superior to placebo for the occurrence of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic event; and to determine the impact of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of vascular death and major vascular events in patients who are followed for 30 days after noncardiac surgery.

Eligibility criteria:
inclusion criteria: 1. undergoing noncardiac surgery; 2. ≥ 45 years of age; 3. expected to require at least an overnight hospital admission after surgery; 4. provide written informed consent to participate in the poise-3 trial, and 5. fulfill ≥1 of the following 6 criteria (a-f): a. nt-probnp ≥200 ng/l b. history of coronary artery disease c. history of peripheral arterial disease d. history of stroke e. undergoing major vascular surgery; or f. any 3 of 9 risk criteria i. undergoing major surgery; ii. history of congestive heart failure; iii. history of a transient ischemic attack; iv. diabetes and currently taking an oral hypoglycemic agent or insulin; v. age \>70 years; vi. history of hypertension; vii. serum creatinine \> 175 µmol/l (\> 2.0 mg/dl); viii. history of smoking within 2 years of surgery; ix. undergoing emergent/urgent surgery. exclusion criteria: 1. patients undergoing cardiac surgery 2. patients undergoing cranial neurosurgery 3. planned use of systemic txa during surgery 4. low-risk surgical procedure (based on individual physician's judgment) 5. hypersensitivity or known allergy to txa 6. creatinine clearance \<30 ml/min (cockcroft-gault equation) or on chronic dialysis 7. history of seizure disorder 8. patients with recent stroke, myocardial infarction, acute arterial thrombosis or venous thromboembolism (\<3 month) 9. patients with fibrinolytic conditions following consumption coagulopathy 10. patients with subarachnoid hemorrhage within the past 30 days 11. women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding 12. previously enrolled in poise-3 trial

Keywords: noncardiac surgery myocardial injury perioperative myocardial infarction tranexamic acid hypotension hypertension
study comparing two sirolimus regimens vs. tacrolimus and mycophenolate mofetil regimen in kidney transplant recipients

Conditions: Graft Rejection; Kidney Failure; Kidney Transplant

Summary: to demonstrate the superiority of srl + tac elimination + corticosteroids (group i) and srl + mmf + corticosteroids (group ii) to tac + mmf + corticosteroids (group iii) with respect to renal allograft function at month 12 post-transplantation.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * end-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. unreported hla values will be considered a match. * women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment. other inclusions apply. exclusion criteria: * evidence of active systemic or localized major infection. * known hypersensitivity to srl or its derivatives, macrolide antibiotics, corticosteroids, tac or mmf. * multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant). other exclusions apply.

Keywords: kidney failure kidney transplant
a study to learn about the safety, effects and pharmacokinetics of study medication (pf-07054894) for the treatment of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a study to learn if the experimental medicine (called pf-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of moderate to severe (part a) or mild to moderate (part b) uc for ≥3 months prior to baseline. * active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy). part a (moderate to severe): must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2. part b (mild to moderate): participants with mms of 4 to 6, es of ≥2 and rb score of ≥1 * must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for uc. * total body weight \>40 kg (88.2 lb). exclusion criteria: * presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer. * history of bowel surgery within 6 months prior to baseline. * history of significant trauma or major surgery within 4 weeks of screening or considered in imminent need of surgery or with elective surgery scheduled to occur during the study. * presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia. * clinically significant infections within 6 months of baseline

Keywords: inflammatory bowel disease
soft part management for surgical fractures of the lower limb

Conditions: Leg Injuries; Fracture; Edema

Summary: the assessment consists in comparing corticoids injection versus placebo in surgery of lower limb fractures the aim of study is to assess (state cutaneous, efficacy, safety) corticoids injection on a prospective, randomized analysis

one of the major problems of below-knee fractures is edema (delaying surgery time and post-operative complications for healing). the effect corticosteroids (anti-edema and anti-inflammatory) is used in neurosurgery and maxillofacial surgery. so, it seemed judicious to evaluate the effectiveness of corticosteroids in bolus preoperatively in order to limit the importance of the edema before intervention to prevent adverse effect of the edema on the cicatrization. this study will aim to confirm this indication or not on the contrary to change current practices.

Eligibility criteria:
inclusion criteria: * patient over the age of 18, hospitalized in the orthopedics department for a leg fracture (ankle, tibia: proximal, diaphysis, distal) requiring surgery within 72 hours of the trauma * patient covered by the social security system * patient giving informed consent exclusion criteria: * open fracture with infectious risks cauchoix 2 and 3 * multiple trauma, * pathological fracture on primary or secondary lesions, * pre-existing bone disease (excluding osteoporosis) of the operated limb, * diabetes, * pre-existing trophic disorders on one of the 2 lower limbs, * long-term corticotherapy, * pathology of the pituitary-adrenal axis, * any other contraindication to glucocorticoids: any infectious condition, some developing viral diseases (including hepatitis, herpes, chicken pox, shingles), hypersensitivity to one of the constituents * hypernatremia and hypochloremia * pre-existing severe cardiac injury * contraindication to tegadermtm * patient placed under guardianship, tutorship or safeguard of justice, * pregnant or lactating women,

Keywords: preoperative procedure leg fractures osteosynthesis corticosteroids
a study in japanese children hospitalized with respiratory syncytial virus related lower respiratory tract infections

Conditions: Respiratory Syncytial Virus

Summary: the purpose of the study is to assess viral kinetics and clinical symptoms kinetics of respiratory syncytial virus (rsv) in pediatric patients hospitalized with rsv confirmed lower respiratory tract infection (lrti).

this is an exploratory prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study). the study will consist of two phases: a screening phase (day 1) and an assessment phase (day 2 to day 7). during screening phase, pediatric patients consecutively hospitalized with rsv-related infection will be enrolled in the study within 24 hours of admission if symptomatic for maximum 5 days before the hospital admission and if the informed consent form (icf) was obtained. the diagnosis of rsv infection will follow using a standard of care (soc) rapid point point of care (poc) detection method available in the hospital unit on nasal specimens .during the assessment phase the collection of nasal specimens will be done daily for a maximum of 6 days (day 2 to day 7 of hospitalization) or until patients will be discharged from hospital. approximately 50 patients will be enrolled in this study. the total duration of the study for each patient will be approximately 7 days. the study duration will extend until the targeted number of 50 rsv hospitalized children have completed the study.

Eligibility criteria:
inclusion criteria: * legal representative has provided ethics committee approved written informed onsent prior to any study-related procedure(s) being performed and is willing to allow the participation of child to the study for 7 consecutive days or until hospital discharge (whatever comes first) * patient hospitalized with lower respiratory tract infection (lrti) during respiratory syncytial virus (rsv) epidemics, within 24h of hospitalization. the diagnosis of lrti will follow the standard medical procedure in the hospital unit * onset of acute respiratory symptoms was less than or equal to 5 days ago * patient is rsv positive based on a rapid point of care (poc) detection method. the diagnosis of rsv infection will follow the standard medical procedure in the hospital unit exclusion criteria: - patient does not fulfill the inclusion criteria

Keywords: respiratory syncytial virus rsv lower respiratory tract infection lrti acute respiratory infection japanese children