Kornimate/medical-research-clean huggingface dataset:
study of bms-354825 (dasatinib) in patients with chronic myeloid leukemia who are either resistant or intolerant to imatinib

Conditions: Chronic Myeloid Leukemia; Philadelphia-Positive Myeloid Leukemia

Summary: the purpose of this study is assess the effects of the investigational drug dasatinib on participants who are in chronic phase philadelphia chromosome chronic myeloid leukemia and who are either resistant to or intolerant of imatinib. other purposes of the study are to identify any side effects the drug may produce and to study the level of dasatanib in the blood and assess the efficacy of dasatanib in the treatment of leukemia.


Eligibility criteria:
inclusion criteria: * age of 18 years and older. * chronic myeloid leukemia (cml) * previous treatment with imatinib at a dose of \>600 mg/day and the development of progressive disease while receiving imatinib at that dose, or * cml with resistance to imatinib at a dose less than or equal to 600 mg/day with genetic mutation in the bcr-abl gene that is associated with a high level of resistance to imatinib, or * intolerance to imatinib at any dose * adequate organ function * women who are able to bear children must have a negative serum or urine pregnancy test. adequate methods of contraception must be used throughout the study to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication. exclusion criteria: * woman who are pregnant or breastfeeding * men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above * previous diagnosis of accelerated phase or blast crisis cml. * participants who are eligible and willing to undergo transplantation during the screening period * uncontrolled or significant cardiovascular disease * use of imatinib within 7 days. * use of interferon or cytarabine within 14 days * use of a targeted small-molecule anticancer agent within 14 days * use of certain medication that carry a known side effect risk of torsade de pointes - certain medications that irreversibly inhibit platelet function or anticoagulants * prior therapy with dasatinib.

Keywords: chronic phase philadelphia chromosome chronic myeloid leukemia (ph+cml)
an enhanced vaginal dilator to reduce radiation-induced vaginal stenosis

Conditions: Endometrial Cancer; Cervical Cancer; Vaginal Stricture; Radiation Toxicity

Summary: this is a randomized control trial aimed to decreased radiation-induced vaginal stenosis in patients with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. the intervention is an enhanced vaginal dilator model, including a silicone band placed at the desired depth of dilator insertion. the new model will be compared against the traditional vaginal dilator model used as our institutional standard of care. we hypothesize the enhanced model will improve adherence, correct use and efficacy of vaginal dilator use.

pelvic radiotherapy and vaginal brachytherapy play an integral role in managing gynecological malignancies, including endometrial and cervical cancer. radiation-induced vaginal stenosis is a well recognized complication of radiation therapy and can result in painful, inadequate pelvic exams and sexual dysfunction. current recommendations to prevent and manage vaginal stenosis include regular use of vaginal dilators, with our institutional recommendation being three times weekly for 10 minutes. compliance varies among studies but is generally perceived to be low. limited literature exists regarding ways to improve adherence and correct use of vaginal dilators. the goal of this study is to enhance the standard vaginal dilator model to improve patient outcomes. eligibility includes women with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. patients will be randomized to either the standard vaginal dilator or an enhanced model. the enhanced dilator model includes the addition of a silicone band placed at the desired depth of vaginal dilator insertion, aimed to aide in correct insertion length. the primary aim of the study is patient adherence to vaginal dilator use. secondary aims include vaginal length, ctcae v5.0 grading scale for vaginal stricture, sexual function, self-reported comfort with use, and discomfort during office pelvic exams. outcomes will be obtained based on physician reporting and patient surveys. all analyses will be completed by a biostatistician in the clinical research office using sas version 9.4.

Eligibility criteria:
inclusion criteria: * diagnosis of endometrial or cervical cancer * undergoing external beam radiation therapy with or without brachytherapy * english-speaking exclusion criteria: * history or current presence of fistula

Keywords: vaginal dilator vaginal stenosis
analgesia in total hip arthroplasty by quadratus lumborum block

Conditions: Total Hip Replacement Surgery

Summary: patients are painful after total hip arthroplasty. these patients have significant co-morbidities. analgesics cause significant side effects in this population. locoregional analgesia is therefore an effective means of reducing the consumption of opioids in this surgery. the "gold standard" of locoregional analgesia after total hip arthroplasty is the femoral block. however, a new technique has recently been described: the quadratus lumborum block. the comparison of these two techniques is lacking in the literature. the comparison of the quadratus lumborum block to the femoral block in total hip arthroplasty is important in the analgesic strategy of patients undergoing this surgery.

the aim of this study is to compare the clinical efficacy of two regional locoregional analgesia strategies in total hip replacement surgery: the ultrasound-guided quadratus lumborum block and the ultrasound-guided femoral block. this is a double-blind, randomized study in prospective inclusion with a superiority test. two groups of patients will be compared: a group of patients with a quadratus lumborum block and a group of patients with a femoral block. management (quadratus lumborum block or femoral block) will be randomized. the randomization will be stratified on the type of anesthesia (spinal anesthesia and general anesthesia). randomization will be done on the day of surgery to determine the patient's treatment group. the surgical procedure will not be modified by the participation of the patent in the study. patients who would benefit from total hip replacement surgery in the reims university hospital and who agreed to participate in the study were included.

Eligibility criteria:
inclusion criteria: * patients eligible for total hip replacement surgery in reims university hospital * patients agreeing to participate in the research and having signed informed consent * between 18 yo and 95 yo * patients affiliated to a social security system exclusion criteria: * patients with allergy to local anesthetics * patients with neuropathy * patients with an asa score of 4 * patients undergoing revision surgery for total hip arthroplasty * patients receiving anterior hip total hip replacement surgery * patients with a contraindication to the realization of the quadratus lumborum block, femoral block or spinal anesthesia (clinical coagulopathy, infection at the point of puncture ...) * patients refusing the proposed techniques

Keywords: total hip replacement surgery post operative pain quadratus lumborum block femoral block
evaluating the effects of nitroglycerin on heart function and urinary output in patients with acute heart failure

Conditions: Acute Heart Failure (AHF)

Summary: this study aims to understand how nitroglycerin affects patients with acute heart failure, a condition where the heart struggles to pump blood effectively, leading to fluid buildup and breathing difficulties. nitroglycerin relaxes blood vessels to ease the heart's workload and may help reduce fluid buildup. the investigators hypothesize that nitroglycerin can increase blood flow from the heart and promote urine production, which may reduce congestion in ahf patients. by studying heart function, blood volume, and fluid levels during treatment, the goal is to identify which patients may benefit most from nitroglycerin therapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * clinical diagnosis of ahf requiring hospitalization * systolic blood pressure ≥85 mmhg * echocardiographic signs of cardiac dysfunction, by at least one of * left ventricular ejection fraction ≤45% * abnormal left ventricular filling with dilatation of the left atrium * elevated filling pressures (systolic pulmonary artery pressure\>30, dilated vena cava inferior or e/é\>10) * significant left-sided heart valve disease exclusion criteria: * ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with heart rate \> 180 or \< 40 bpm. * retinopathy or intraocular lens implantation (contraindication to valsalva maneuver) * recent myocardial infarction or thromboembolic events. * intake of sildenafil or vardenafil withing 24 h and tadalafil within 48 h. * absolute contraindication for vasodilation using nitroglycerin as assessed by treating physician * intravenous administration of furosemide within 2 hours of baseline measurements

Keywords: acute heart failure vasodilation nitroglycerin hemodynamics stroke volume cardiac function
genetic testing in primary congenital glaucoma patients

Conditions: Congenital Glaucoma

Summary: primary congenital glaucoma patients and their immediate relatives will undergo complete ophthalmic examination and an interview with a geneticist. a blood sample will be drown from all participants for dna analysis. the cyp1b1 gene coding sequences will be screened for all individuals. if no mutation or only one heterozygous mutation will be found in the cyp1b1 gene, screening for myoc gene mutations will be performed.

primary congenital glaucoma (pcg) is usually present in the neonatal or infantile period and is accompanied by corneal opacity and edema, buphthalmos, increased intraocular pressure, optic nerve cupping, and at times, ensuing severe visual impairment. the incidence of the disease varies significantly in different geographic regions and is more frequently found in certain ethnic groups, especially where consanguinity is prevalent. the incidence in western countries has been reported to range from 1:5000 and 1:10000 births, and in populations where consanguinity is prevalent, such as among slovakian gypsies and saudi arabians, the incidence ranges from 1:1250 and 1:2500 births, respectively. pcg is believed to be an autosomal-recessive transmitted disease with incomplete penetrance. three different loci have been mapped for it, i.e., glc3a on chromosome 2p21, glc3b on 1p36.2 and glc3c on 14q24.3. the major gene that currently has been identified to be associated with pcg is the cyp1b1 gene at locus glc3a, which encodes a member of the cytochrome p450. the frequency of mutations in the cyp1b1 gene in pcg patients varies in different geographic locations and ethnic groups. for example, mutations in the cyp1b1 gene are found in 33% of patients in japan and indonesia, while among saudi arabian and slovakian gypsy patients, the incidence rises to 94% and 100%, respectively. mutations in myocilin (myoc) have also been associated with pcg. determining the presence of cyp1b1 mutations in pcg patients will improve our ability to counsel parents regarding cause, inheritance and the risk of it in future offspring. the aim of the present study is to characterize the phenotype and determine the role of cyp1b1 and myoc mutations in pcg in israeli populations

Eligibility criteria:
inclusion criteria: * primary congenital glaucoma pediatric patients * glaucoma that was diagnosed within the first 12 months of their life * primary congenital glaucoma pediatric patients's parents exclusion criteria: * any other ocular or systemic diseases

Keywords: primary congenital glaucoma neonatal genotype correlation phenotype correlation
to evaluate the efficacy and safety of abaloparatide injection (qlg2128) in the treatment of postmenopausal women with osteoporosis and at high risk of fracture

Conditions: Postmenopausal Women With Osteoporosis

Summary: the purpose of this study is to evaluate the efficacy and safety of qlg2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.


Eligibility criteria:
inclusion criteria: * postmenopausal women who can walk freely (≥50 and ≤85 years); * the patient has a body mass index(bmi) of 17.0 kg/m2 to 30 kg/m2； * the patient has a bone mineral density t-score≤-2.5 and \> -5.0 at the lumbar spine (l1-l4) or femoral neck or total hip by dual energy x-ray absorptiometry (dxa)； * the patient has at least one of the following high risk factors of fracture: 1) history of previous fragility fractures; 2) family history of hip fragility fracture; 3) age≥70 years; 4) bmi≤19.0 kg/m2；5) currently smoking. * the patient with at least 2 consecutive vertebrae(l1 to l4) and at least 1 hip can be evaluated for bmd. exclusion criteria: * in addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism； * history of osteosarcoma； * history of orthostatic hypotension； * currently suffering from active urinary calculus； * received anti-osteoporosis treatment that does not meet protocol requirements； * received medication that affects bone metabolism within 4 weeks prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period.
irinotecan and carboplatin in treating patients with metastatic or recurrent small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) may kill more tumor cells. purpose: this phase ii trial is studying how well giving irinotecan together with carboplatin works in treating patients with metastatic or recurrent small cell lung cancer.

objectives: * determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin. * determine the median survival of patients treated with this regimen. * determine the toxicity of this regimen in these patients. outline: this is a multicenter study. patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed). patients receive irinotecan hydrochloride iv over 90 minutes and carboplatin iv over 15-30 minutes on day 1. treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed small cell lung cancer, meeting 1 of the following criteria: * previously untreated metastatic or extensive disease * malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease * prior radiotherapy allowed * recurrent disease * limited, metastatic, or extensive disease * relapsed after prior chemotherapy, excluding irinotecan hydrochloride * at least 90 days since prior chemotherapy * measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by physical examination or radiographic techniques * known brain metastases allowed patient characteristics: * ecog performance status 0-2 * life expectancy ≥ 3 months * white blood cells \> 3,000/mm³ * absolute neutrophil count ≥ 1,500/mm³ * platelet count ≥ 100,000/mm³ * hemoglobin ≥ 9.0 g/dl * bilirubin ≤ 1.5 mg/dl * sgot ≤ 2.5 times upper limit of normal (uln) (5 times uln if liver metastases present) * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 months after completion of study treatment * no medical disease that, in the opinion of the investigator, would preclude study treatment prior concurrent therapy: * see disease characteristics * at least 10 days since prior radiotherapy (including brain) * no prior irinotecan hydrochloride * at least 2 weeks since prior and no concurrent anticonvulsants * no concurrent radiotherapy

Keywords: extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer
study to compare the bioavailability of omeprazole 20 mg before and after undergoing surgery for morbid obesity

Conditions: Bariatric Surgery Candidate

Summary: the principal aim was to evaluate whether gastric bypass surgery modifies the bioavailability of omeprazole 20 mg at one month and six months after surgery. other objectives were: * to compare bioavailability of omeprazole 20 mg between patients undergo gastric bypass surgery and patients who avoid it. * to asses other pharmacokinetic parameters, demographic parameters and drug safety. study design it was planned a mixed design which intended to compare the bioavailability in patients with gastric bypass (before and after surgery) and control subjects matched by sex and body mass index (bmi) post-surgery. this was a single-dose, open-label, crossover bioavailability study of omeprazole in surgical group and controls.


Eligibility criteria:
inclusion criteria: * patients who wish to participate in the study (men and women) after receiving adequate information about the study design, objectives and risks by signing and date of the written informed consent. * age between 18 and 60 years old. * patients who come to the endocrinology and nutrition service and on treatment with omeprazole. * patients who are to undergo bariatric surgery (roux en y gastric bypass) according to the recommendations of endocrinology and nutrition service and the department of general surgery and digestive diseases hospital clinico san carlos. * no significant abnormalities on clinical examination and laboratory analysis before inclusion in the study. exclusion criteria: * any postoperative complication that interferes with the regular intake of medication such as stenosis of anastomotic, fistula, persistent vomiting, diarrhea (\> 4 stools per day), evidence of protein malnutrition (albumin \<3.5 g / l). * high consumption of stimulating beverages (equivalent to 400 mg of caffeine per day, a cup of coffee contains approximately 100 mg of caffeine). * consumption of any medication that may interfere with the objectives of the study: \* use of enzyme inhibitors or inducers within 2 weeks prior to study inclusion (barbiturates, carbamazepine, erythromycin, phenytoin, oral contraceptives, etc.) \* any concomitant medication will be assessed by the investigator based on data recorded in the log-book for the medication (potential interactions) and registered in the crf. * history of clinically significant disease in the opinion of the investigator does not allow safe participation of the patient. * inability to relate to and / or cooperate with investigators.
comparison of two empirical antimicrobial therapies of prosthetic joint infection

Conditions: Bone and Joint Infection

Summary: the empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (pji). however, the tolerability of such high-dose intravenous regimens is poorly known. t

the empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (pji). however, the tolerability of such high-dose intravenous regimens is poorly known. the empirical antimicrobial therapy of pji is associated with an important rate of adverse, linked with the use of the vancomycin and the piperacillin-tazobactam combination. some studies suggest to use vancomycin-cefepime, which remains to be evaluated in pji.

Eligibility criteria:
inclusion criteria: * patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime exclusion criteria: * none

Keywords: prosthetic joint infection empirical antibiotherapy acute kidney injury vancomycin cefepim piperacillin/tazobactam
low intensity blood flow restriction training study

Conditions: Muscle Mass

Summary: the particpant will complete baseline testing by measuring subjects' quadriceps muscle thickness (cm) via ultrasound technology, as well as have them complete a one repetition maximum (1rm) test on the leg press machine and an isometric knee extension using a dynamometer - strength measures will be calculated for both right and left legs. after baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of leg press exercises at 30% of their 1rm. subjects will be randomized to either wear a cuff that partially restricts blood flow to the limb (study group), or to wear a cuff that does not restrict blood flow (control group). exercises will be completed 2x/week and will take approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. after 6 weeks, muscle thickness, leg press 1rm, and quadriceps extension strength will be re-tested and compared to the initial measurements.

session 1 - baseline testing * 5-minute warm-up; 1rm calculation for both right and left legs using a supine leg press machine; isometric quadriceps strength measurement using a dynamometer; muscle thickness measurements of both right and left quadriceps muscle using ultrasound technology. * after day 1 testing; randomly allocate subjects to either control group or experimental group sessions 2-13 - 6 weeks of exercise protocol, 2x/per week both the experimental and control groups will complete the same protocol for the entirety of the study: * 5- minute warm up * using a single-leg press exercise machine: subjects complete the testing protocol with either partial blood flow restriction (cuff inflated to 100-250 mmhg depending on size of person) or no blood flow restriction (placebo inflation) on right limb. * protocol: 30 repetitions - 15 repetitions - 15 repetitions - 15 repetitions with each set separated by \~30-90 seconds. * right and left legs will be alternating, but only one leg will have the occlusion cuff session 14 - re-test - re-check 1rm, isometric quad strength, as well as muscle thickness of quadriceps with ultrasound

Eligibility criteria:
inclusion criteria: * age 18-49 exclusion criteria: * pregnant * hypertensive * recent back or lower extremity injury * history of blood clotting * varicose veins * adults lacking the capacity to consent for themselves
feasibility of integrated care of depression in primary care pathways

Conditions: Depressive Disorder

Summary: this protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years.


Eligibility criteria:
inclusion criteria: * age 18-65 years * good understanding of french language * major depressive disorder based on dsm-v criteria * madrs \> 19 * failure of two antidepressants during 6wks at standard minimal dose exclusion criteria: * pregnancy or lactating * people under tutelage * bipolar disorder * no health insurance * neurological disorders * contra-indication to physical activity * high suicidal risk * first degree history of bipolar disorder, schizophrenia, autism spectrum disorder