Kornimate/medical-research-clean huggingface dataset:
gamec-ii, risk-adapted protocol for relapsed germ cell tumours (gct)

Conditions: Testicular Neoplasms

Summary: st bartholomew's hospital completed a study using the regimen gamec (peg-filgrastim, actinomycin-d, methotrexate, etoposide, cisplatin). the results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. these results are very encouraging and compare very favourably to other treatment protocols. in reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. in addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal ldh (lactate dehydrogenase). ldh is a blood test which monitors cancer activity. selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. this will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects.

gamec-ii (gamec -s \& gamec-a) is an open-labelled, non-randomised clinical trial in patients with relapsed germ cell tumours (gct) and its objectives are: 1. to establish the response rates to gamec-s or gamec-a 2. to establish the safety and efficacy of substitution of epirubicin for etoposide (gamec-a regimen) 3. to establish the toxicity of gamec-a 4. to establish progression free survival (pfs) 5. to establish whether shortening gamec-s in patients without adverse prognostic factors reduces toxicity without compromising survival.

Eligibility criteria:
inclusion criteria: * germ cell tumour (gct), relapsed or progressing on or following platinum-based chemotherapy - as evidenced by rising tumour markers or progressive disease on ct scan * neutrophil count \>1.0 x109/l * platelets \>70 x109/l * haemoglobin \>100g/l (may be transfused) * creatinine clearance should be \>60ml/min. however, if creatinine clearance \<60 ml/min then an edta clearance is mandatory. (if edta clearance is \<60 ml/min then the patient will be excluded.) * males age \>16 ≤35 years \[decision made on physical fitness to participate\] * ecog performance status 0-3 * full written consent exclusion criteria: * other malignancy except basal cell carcinoma * evidence of clinically significant cardiac failure, unstable angina or uncontrolled hypertension * current participation in any other investigational drug study

Keywords: germ cell tumour
masitinib in combination with methotrexate, in treatment of patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: a 12-week with possible extension, phase ii study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.


Eligibility criteria:
inclusion criteria: 1. disease duration of at least 6 months meet american college of rheumatology (acr) criteria for ra. 2. acr functional class i-iii 3. have active ra 4. failed (defined as active ra with stable dose during 3 months) i. methotrexate or ii. any dmard including anti tnf alpha if patients previously failed methotrexate or iii. methotrexate in combination with any dmard including anti tnf alpha exclusion criteria: 1. patient had a major surgery within 2 weeks prior to study entry. 2. life expectancy \< 6 months.

Keywords: rheumatoid arthritis methotrexate dmard c-kit inhibitor
post-marketing study of the safety of tygacil (tigecycline)

Conditions: Complicated Skin and Skin Structure Infections; Complicated Intra-abdominal Infections

Summary: the purpose of this study is to collect post-marketing information on the safety of tygacil in filipino patients.

three-thousand or 10% of total number of patients given tigecycline will be included in the study

Eligibility criteria:
inclusion criteria: * all patients from the study center who received or will receive at least one dose of tygacil according to the approved product indication. exclusion criteria: * previously discontinued tygacil therapy due to significant safety concern.

Keywords: observational study tigecycline infection skin abdominal
retrospective analysis of performance and treatment data collected for genius sleddflux filter, ultraflux av 600 s filter & genius 90 concentrates in haemodialysis patients

Conditions: Renal Failure; End Stage Renal Disease; Acute Renal Failure

Summary: retrospective analysis of performance and treatment data collected for genius sleddflux filter, ultraflux av 600 s filter \& genius 90 concentrates in acute haemodialysis, haemodynamically instable patients and chronic haemodialysis patients * to analyse performance and treatment data from patients treated with the investigational device * to evaluate the filter characteristics for ahd (acute haemodialysis) patients * to evaluate the improvement of kidney function for ahd patients


Eligibility criteria:
inclusion criteria: * all patients with an indication for the extracorporeal blood treatment suffering from renal insufficiency who received all treatments, between january 2019 and december 2019, with the investigational devices have to be included in the study in chronological order. * for ahd patients: availability of at least 3 of the 5 primary variables (daily urea, creatinine, potassium, ultrafiltration and effluent volume) for 50 % of the documented treatments. * for chd patients: availability of the ultrafiltration values for all treatments and at least one value for urea and creatinine per week exclusion criteria: * simultaneous use of another filter/adsorber for another form of therapy

Keywords: hemodialysis genius system slow extended daily dialysis
a phase ii trial neoadjuvant paclitaxel and cisplatin in patients with locally advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * locally advanced, stage ii-iv (except m1), hand and neck cancer * \> = 1 measurable lesion * not been previously treated for head and neck cancer exclusion criteria: * history of another malignancy * organ allografts * pre-exiting neuropathy \> = ctc grade 2
an open-label study of aripiprazole lauroxil in subjects with stable schizophrenia

Conditions: Schizophrenia

Summary: this study will evaluate the safety, tolerability, and pharmacokinetics (pk) of various doses and dosing intervals of aripiprazole lauroxil.


Eligibility criteria:
inclusion criteria: * has stable schizophrenia or schizoaffective disorder * has demonstrated ability to tolerate aripiprazole * has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening * has a body mass index (bmi) of 18.0 to 35.0 kg/m2, inclusive * additional criteria may apply exclusion criteria: * is pregnant, breastfeeding, or is planning to become pregnant during the study period * has received aripiprazole lauroxil or im depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months * is a danger to himself/herself at screening or upon admission * has a history of or positive test result for human immunodeficiency virus (hiv), hepatitis b, or hepatitis c * has a positive urine drug screen at screening or day 1 * additional criteria may apply

Keywords: alkermes schizophrenia aripiprazole aripiprazole lauroxil alks 9072
an open-label study of ozanimod in moderate to severe ulcerative colitis in clinical practice

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to explore the safety, efficacy, effects on quality of life (qol), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (uc) in clinical practice.


Eligibility criteria:
inclusion criteria: * a diagnosis of ulcerative colitis (uc), with signs and symptoms consistent with uc for at least 3 months prior to the first study intervention administration * moderate to severely active uc disease activity, defined as a modified mayo score of 4 through 9, inclusive, with the following minimum subscores: i) an sf subscore ≥ 1, and ii) an rb subscore ≥ 1, and iii) an es ≥ 2 (endoscopy performed within 60 days of the first study intervention administration). * report of a previous colonoscopy that documents extent of disease exclusion criteria: * current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation * extensive colonic resection or current stoma * colonic dysplasia that has not been removed other protocol-defined inclusion/exclusion criteria apply

Keywords: ulcerative colitis ozanimod rpc-1063 zeposia® inflammatory bowel disease
correlation intraocular pressure with intracranial pressure

Conditions: Intraocular Pressure; Intracranial Pressure Increase; Trauma, Brain; Children, Only

Summary: severe trauma brain injury (tbis) is a public health problem and monitoring of intracranial pressure (icp) is a determinant key of it prognosis. within the noninvasive methods to estimate the icp, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend). objective. correlate intraocular pressure with icp in children with tbis and obtain their utility values.

severe trauma brain injury (tbis) is a public health problem and monitoring of intracranial pressure (icp) is a determinant key of it prognosis. within the noninvasive methods to estimate the icp, the measurement of intraocular pressure has been proposed because of its biological plausibility (proximity of the eye to the encephalic contend). objective. correlate intraocular pressure with icp in children with tbis and obtain their utility values. material and methods. correlation and diagnostic test design study. inclusion criteria: children with tbis admitted to the emergency room and indication of catheter for icp measurement. exclusion criteria: injury or ophthalmic disease, glaucoma, encephalic death. intraocular pressure was measured with electronic tonometer in both eyes prior to placement of the catheter for icp measurement. correlation was estimated with spearman's rho. the utility values of the diagnostic test were obtained from an receiver operating characteristic curve.

Eligibility criteria:
inclusion criteria: 1. children with severe trauma brain injury (coma glasgow scale smaller than 9 points), 2. who have been admitted to the pediatric emergency room 3. and in whom the treating neurosurgeon has decided to place a catheter for intracranial pressure measurement. exclusion criteria: 1. ocular trauma, 2. brain death, 3. know eye disease, 4. refusal of parents or guardians to participate in the study.
haploidentical stem cell transplantation for children with acquired severe aplastic anemia

Conditions: Acquired Aplastic Anemia

Summary: rationale: fludarabine, cyclophosphamide, anti-thymocyte globulin and low-dose total body irradiation (ld-tbi) may induce the engraftment cross the immunologic barrier in the setting of hla-haploidentical allogeneic hematopoietic cell transplantation. in addition, depletion of cd3 cells may contribute to prevent developing severe acute graft versus host disease (gvhd) in haploidentical transplantation. purpose: phase ii trials to evaluate the efficacy of haploidentical stem cell transplantation with fixed dose of t cells after in vitro t cell depletion using cd3 monoclonal antibody for children with acquired severe aplastic anemia


Eligibility criteria:
inclusion criteria: * diagnosis of life-threatening marrow failure (severe aplastic anemia) of nonmalignant etiology meeting 2 of the following criteria: * granulocyte count \< 500/mm3, * corrected reticulocyte count \< 1%, * platelet count \< 20,000/mm3 * no hla-identical family member or closely matched (8 of 8 hla-locus match) unrelated marrow donor available * hla-haploidentical related donor available exclusion criteria: * paroxysmal nocturnal hemoglobinuria or fanconi anemia * clonal cytogenetic abnormalities or myelodysplastic syndromes * active fungal infections * hiv positive * severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure * pregnant or nursing

Keywords: aplastic anemia t cell dose cd3 depletion haploidentical hematopoietic stem cell transplantation
hiv and alcohol research center focused on polypharmacy (harp) pilot 1

Conditions: HIV; Alcohol Use

Summary: this pilot intervention will consist of a brief intervention for patients with hiv who take 5 or more medications and currently (within the past month) consume alcohol. the focus of this pilot will be on bothersome symptoms and the impact of alcohol use and medications on these symptoms. the rationale is that any alcohol use may interact with medications in serious ways leading to adverse outcomes, including bothersome symptoms.


Eligibility criteria:
inclusion criteria: * participants in both veterans aging cohort study (vacs) and medications, alcohol, and substance use in hiv (mash) studies * prescribed 5 or more medications and who either have a positive peth value (8+) or a self-reported audit-c value consistent with current alcohol use (score \>0) exclusion criteria: * alcohol use disorder (aud) diagnosis in the past 12 months or who test positive for aud on the alcohol symptom checklist for moderate or severe aud (score of 4 or more)
evaluation of the antibiofilmogramme test during orthopaedic device-related infection

Conditions: Prosthetic Joint Infection; Staphylococcus Aureus; Biofilm

Summary: this is an observational study that does not change routine care. the primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.

the secondary objectives are: a. investigate the role of antibiogram-antibiofilmogramme concordance (in terms of s. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management. b. investigate the capacity of s. aureus isolates to form biofilm in presence/absence of antibiotics. c. create an s. aureus strain collection for future ancillary studies

Eligibility criteria:
inclusion criteria: * the patient must have been informed and received a non-opposition consent form * patient with a monomicrobial s. aureus bone and joint infections * patient with prosthetic or orthopaedic device exclusion criteria: * bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer * polymicrobial prosthetic joint infection * the patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study * patient is under judicial protection, under tutorship or curatorship * the patient expresses his opposition to participate to the study * it is impossible to correctly inform the patient * the patient is pregnant, parturient or breastfeeding * emergency situation precluding correct study implementation

Keywords: antibiogramme antibiofilmogramme
comparative efficacy of 3l and 2l integrated techniques for gynecologic cancer-related lower extremity lymphedema: a retrospective study

Conditions: Gynecologic Cancer-related Lower Extremity Lymphedema; Lymphedema

Summary: the goal of this retrospective study is to evaluate the long-term efficacy of 3l versus 2l integrated techniques in patients with gynecologic cancer-related lower extremity lymphedema (gcr-lel). the main research question is: do 3l integrated techniques provide superior long-term outcomes in reducing lower extremity lymphedema compared to 2l techniques in patients with gcr-lel? medical records of patients who have received either 3l or 2l integrated interventions as part of their routine clinical management for gcr-lel were reviewed and analyzed to assess treatment outcomes over an extended follow-up period.


Eligibility criteria:
inclusion criteria: 1. the patients diagnosed with gynecological cancer-related lymphedema by clinical examination are classified by the international lymphedema society (isl) guidelines as stage ii to iii. 2. .aged 18-90 years. exclusion criteria: 1. lactation, for patients with pregnancy; 2. serious heart, lung, liver, kidney disease, as well as the history of tumor patients; 3. disease history is less than 3 months; 4. in patients with mental illness; 5. immunodeficiency patients.
impacts of an advanced practice physiotherapy model of care for adults with a peripheral musculoskeletal disorders referred to an orthropaedic outpatient clinic

Conditions: Musculoskeletal Disorders

Summary: the goal of this prospective observational study is to evaluate advanced practice physiotherapy and orthopedic surgeon care and clinical outcomes for new patients with a peripheral musculoskeletal disorders consulting at the orthopedic outpatient clinic of the hôpital jean-talon. the main questions it aims to answer are: 1. to describe the models of care at the hôpital jean-talon orthopedic outpatient clinic; 2. to assess change in pain, disability, quality of life and pain catastrophizing at 6, 12 and 26 weeks after the initial evaluation; 3. to assess interprofessional collaboration between the advanced practice physiotherapists and orthopedic surgeons; 4. to assess patient satisfaction with care; 5. to assess waiting time before an initial consultation. researchers will compare patients cared in the advanced practice physiotherapy and orthopedic surgeon group and the orthopedic surgeon only group.


Eligibility criteria:
inclusion criteria: * adults with peripheral musculoskeletal disorders * new consultation at the hôpital jean-talon orthopedic outpatient clinic * legally able to consent * understand and speak french or english * beneficiaries of the provincial universal health insurance coverage (ramq) exclusion criteria: * patients directly referred from the emergency department (not considered as patients referred to the outpatient clinic).

Keywords: advanced practice physiotherapy musculoskeletal disorders orthopedic observation
the caffeine therapy in the fetal to neonatal transition

Conditions: Mechanical Ventilation Complication; Caffeine; Ventilator Lung; Newborn

Summary: introduction: the caffeine is used in the treatment for apnea of prematurity and it has several positive effects in the neurodevelopment of preterm babies. there are innumerable observational studies suggesting that initiating caffeine in the first hours of life may offer more benefits in the reduction of the necessity of intubation and in ventilation time. it is necessary to expand further research on the best time to start caffeine, which may improve the quality of care for premature infants. objective: to evaluate the benefits of caffeine administration in the first two hours of life compared to administration at 24 hours of life in premature patients on noninvasive mechanical ventilation with birth weights less than 1250 grams. methodology: preterm newborn patients with birth weight \< 1250 grams born at hospital de clínicas de porto alegre who are not intubated in the delivery room will be included. patients will be randomized into two groups. one arm of the study will receive caffeine at 2 hours of age and the other arm will receive caffeine at 24 hours of age (control). patients in the control group will receive 0.9% sf at 2 hours of life in order to keep the study blinded. the following outcomes will be evaluated: need for intubation, time on invasive and non-invasive mechanical ventilation, bpd, necrotizing enterocolitis, need for rop treatment, pda with hemodynamic repercussions, peri-intraventricular hemorrhage, leukomalacia and death. the sample size calculation is 50 patients, 25 in each arm. expected results: it is expected to find a 43% reduction in the need for intubation in preterm infants who receive caffeine in the first two hours of life compared to administration at 24 hours of life. it is also expected to find a reduction in mechanical ventilation time, in addition to a possible reduction in negative outcomes associated with prematurity.


Eligibility criteria:
inclusion criteria: * premature newborns with birth weight less than 1250 grams * who are not intubated in the delivery room exclusion criteria: * premature newborns from other hospitals * presence of a major congenital malformation or genetic syndrome
bioequivalence study of cephalexin suspension 125

Conditions: Infections, Respiratory Tract

Summary: the objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent. test product was ceporex® (125 mg cephalexin / 5 ml; glaxosmithkline) and reference product keflex® (125 mg cephalexin / 5 ml; eli lilly). the single dosage was 20 ml of suspension. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 28 healthy volunteers, both genders, adults between 18-50 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: free will participation according to mexican regulation, helsinki declaration, and good clinical practice. healthy, between 18 and 50 years. body mass index between 18 and 27.5 in good health by complete medical history and laboratory tests. blood pressure 130-90/ 90-60 mm hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, hepatitis b and c antigens, hiv, urinalysis, anti-doping, pregnancy, electrocardiogram) - exclusion criteria: alteration of vital signs not complying with inclusion criteria history of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. those suffering from muscular trauma 21 days before the beginning of the study. requirement of any kind of medication during the course of the study, except study medication. history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. administration of any medication in the 7 half-lives previous to the beginning of the study. hospitalization for any cause in the two months before the beginning of the study. administration of investigational drugs in the 60 days before the study. allergy to any medication, food or substance. alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study. blood donation or loss =\> 450 ml in the 60 days before the beginning of the study. history of drug or alcohol abuse. special diet requirement, for instance vegetarian diet. inability to understand nature, aims, and possible consequences of the study. evidence of non-cooperative attitude during the study. positive antidoping or pregnancy test breast-feeding. females on hormonal treatment. -

Keywords: cephalexin respiratory infections mexico bioequivalence