Kornimate/medical-research-clean huggingface dataset:
ruxolitinib efficacy and safety in patients with hu resistant or intolerant polycythemia vera vs best available therapy.

Conditions: Polycythemia Vera

Summary: this study compared the efficacy and safety of ruxolitinib to best available therapy (bat) in patients with polycythemia vera (pv) who were hydroxyurea (hu) resistant or intolerant and did not have a palpable spleen.

this was a prospective, multi-center, open-label, randomized, phase iiib study evaluating efficacy and safety of ruxolitinib versus bat as selected by the investigator in patients with pv who are resistant to, or intolerant of hu. the study comprised of the following periods: screening period (up to 5 weeks: day -35 to day -1): screening evaluations were performed at one or more clinic visits, and reviewed to determine eligibility before the patient was randomized in the study. core treatment period (day 1 to week 80): patients were randomized in 1:1 ratio to either treatment group (ruxolitinib or bat) and were to be treated with their randomized treatment. crossover treatment period (week 28 or after) for bat patients only: patients randomized to bat who did not respond by week 28 were eligible to crossover and start treatment with ruxolitinib. patients crossing over on or after week 28 had to complete all assessments for the end of treatment (eot) visit of the core treatment period followed by the assessments in cross-over visit evaluation schedule. extended treatment period (week 80 to week 260): patients receiving ruxolitinib at week 80 (including patients who have crossed over from bat) were eligible to continue up to week 260 in the extended treatment period. patients continued the ruxolitinib dose that they received at week 80. patients who received bat at week 80 were not eligible to enter the extended treatment period and had to have the eot visit at week 80 and an end of study (eos) visit 30 days after the eot visit. follow-up period: patients were followed for safety during 30 days after the last dose of study drug and eos visit assessments were performed post 30 days after the last dose of study drug. patients who completed eot (week 80 for patients who received bat, week 260 for patients who received ruxolitinib or from the time of premature discontinuation) were to be followed-up for every 3 months for survival till the end of the study.

Eligibility criteria:
inclusion criteria: confirmed diagnosis of pv according to the 2008 world health organization criteria, non-palpable spleen, phlebotomy dependent, resistant to or intolerant of hydroxyurea, ecog performance status of 0, 1 or 2. exclusion criteria: inadequate liver or renal function, significant bacterial, fungal, parasitic, or viral infection requiring treatment, active malignancy within the past 5 years, excluding specific skin cancers, previously received treatment with a jak inhibitor, being treated with any investigational agent, women who are pregnant or nursing. other inclusion/exclusion criteria apply.

Keywords: polycythemia vera hematologic diseases myeloproliferative disorders bone marrow diseases hydroxyurea inc424 ruxolitinib
protocol of geriatric rehabilitation in patients of 60 and older who live in moscow boarding houses or nursing homes

Conditions: Frail Elderly Syndrome

Summary: after screening complex geriatric assessment (cga) the participants will undergo geriatric rehabilitation programs. after termination of 21-day program, cga will be repeated and subjects will get a program of long-term rehabilitation. a phone call in six months and a face-to-face visit in 12 months will be scheduled to follow-up and to evaluate the progress in rehabilitation.

after screening complex geriatric assessment (cga) the participants will undergo geriatric rehabilitation programs. the participation duration will not exceed 13.5 months including the screening period. the study comprises three periods: * screening (1-14 days) * a treatment course of 21 days * a follow-up period of 12 months on screening visit study procedures will include * informed consent signing * the comprehensive geriatric assessment (cga) * the recommendations on a program of geriatric rehabilitation based on cga visit 2 will be performed at the end of rehabilitation program. it will include: * the abbreviated cga * the evaluation of the results of 21-days geriatric rehabilitation program * the recommendations on a long-term geriatric rehabilitation visit 3 will be scheduled in 3 months after visit 2 as a phone call. special questionnaire will be suggested to study subjects. the questionnaire includes questions on implementation of a geriatric rehabilitation program and on quality of life visit 4- the last study visit will be performed in 12 months after visit 2. it will include cga and study completion procedures.

Eligibility criteria:
inclusion criteria: 1. men and women aged 60 and older who wanted to participate in the study and signed a consent form. 2. one or more indications for geriatric rehabilitation: * a discharge after a hospitalization due to an acute illness (excluding stroke and myocardial infarction), trauma, surgery, including planned ones. * a condition leading to an acute impairment of functional status (stress, etc.) * newly admitted patients * abnormalities of gait and mobility (r26) exclusion criteria: 1. one or more contraindications to geriatric rehabilitation: 1. severe sensory and cognitive impairment hampering rehabilitation 2. end stage diseases requiring palliative care 3. end stage frailty (bedridden patients) 2. an acute illness or an exacerbation of a chronic disease during two weeks before the enrollment in the study 3. a contradiction to any component of a rehabilitation program 4. hearing or visual lost that can influence on study tests results 5. refuse to participate in the study -

Keywords: geriatric rehabilitation elderly frailty complex geriatric assessment
different laparoscopic techniques for management of congenital inguinal hernia in pediatrics

Conditions: Congenital Inguinal Hernia

Summary: comparison between multiple approaches of laparoscopic hernia ( percutaneous assisted laparoscopic hernia, purse string closure of hernial sac, total dissection of hernial sac).

in pediatric age, indirect inguinal hernia represents more than 95% of the hernial disease. it is a congenital type, in contrast with adulthood in which acquired forms are more frequently found. inguinal hernia repair is one of the most frequently performed surgical procedure in infants and young children. laparoscopic hernia repair in infancy and childhood is still debatable. there are many techniques available for laparoscopic hernia repair in pediatrics. laparoscopic hernial repair is increasingly adopted even for neonates and has achieved a high success rate with low recurrence rate with long-term follow-up. the main advantages of laparoscopy are no incision of the fascia, exploration of the other side in case of bilateral hernia, and visualization and safeguarding of the vas deferens and the spermatic vessels. moreover, it is advantageous over open technique in case of recurrent hernia. different modalities of techniques have been used for repair such as needlescopic disconnection of hernia sac, flip flap technique, muscular arch repair, and ring closure.

Eligibility criteria:
inclusion criteria: * patients in the age limit with congenital inguinal hernia exclusion criteria: * recurrent hernias * cases inwhich laparoscopic surgery is contraindicated * cases with collagen defect diseases
ibrutinib and rituxan for chronic gvhd

Conditions: Graft Vs Host Disease

Summary: this is a phase ii trial evaluating the safety and efficacy of the combination of ibrutinib and rituximab as primary treatment of chronic gvhd. we plan to enroll 35 patients on this study. patients will be formally monitored monthly for 12 months to evaluate for outcome and safety endpoints. all other assessments will be done at the physician's discretion or institutional standards. all patients, responders and treatment failures, will be followed for a period of one year from the time of initiation of therapy. the primary endpoint will be the proportion of patients that are alive and off all systemic ist at 12 months following initiation of treatment.


Eligibility criteria:
inclusion criteria: * first episode of systemic immunosuppression-requiring cgvhd, defined as classic or overlap cgvhd by the nih consensus criteria. * previously untreated cgvhd, defined by having received \<10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cgvhd. * kps 70% or greater exclusion criteria: * late persistent or recurrent acute gvhd * active uncontrolled infection * history of hiv infection; active hbv or hcv infection * inability to tolerate oral medications * progressive or recurrent malignancy following allogeneic transplant * exposure to btk inhibitor following transplant * received prior treatment with ecp for cgvhd

Keywords: ibrutinib rituximab cgvhd chronic gvhd
miniflare versus long protocol in poor responders

Conditions: Infertility

Summary: the study is performed to compare the outcomes of two stimulation protocols, the minidose long protocol versus the microdose flare protocol in poor responders undergoing ivf/icsi.


Eligibility criteria:
inclusion criteria: * poor responder women who fulfilled the criteria defined by the eshre consensus in 2011\[4\]; poor responder females are those who possess two out of these three criteria: i) female age ≥40 years; ii) females who have at least one previous cancelled ivf cycle; iii) por according to afc ≤5 or low amh value. exclusion criteria: * females with fsh more than 20 iu/l * females with previous ovarian surgery * females suffering from causes of infertility other than poor ovarian response, cases with polycystic ovaries syndrome * females refusing to be enrolled in the study, females with any endocrine disorder such as: diabetes, thyroid * patients with male factor of infertility.
search for a link between response to treatment and circulating leucocytes in high grade glioma patients

Conditions: Glioblastoma; Glioma

Summary: bevacizumab, a monoclonal antibody against vascular endothelial growth factor (vegf), is an antiangiogenic treatment currently proposed to recurrent high grade glioma patients. unfortunately some patients fail to respond to this treatment and finding biological factors allowing the discrimination between potential responders and non responders would be very helpful. as the immune system plays a key role in angiogenesis induction and maintenance in cancer, it could serve as a surrogate marker of angiogenesis in cancer patients. the purpose of this study is to determine the influence of bevacizumab treatment on circulating immune cells in high grade glioma patients and to search for a link between the variation of these cells and the response to treatment.

the following leucocyte subsets will be analyzed in whole blood before treatment and before cycles 3, 5 and 7: * classical, intermediate, nonclassical and tie2 expressing monocytes. * regulatory t cells (treg). * myeloid derived suppressor cells (mdscs) the variation of the absolute numbers (or relative percentages) of the cells in the blood of patients will be correlated to the response to treatment assessed according to the rano criteria.

Eligibility criteria:
inclusion criteria: * patients with histologically proved recurrent glioblastoma or anaplasic glioma, * tumor recurrence documented by mri at least 3 months after the end of radiotherapy or chemotherapy. * patients for whom a treatment by bevacizumab is proposed by a multidisciplinary team staff. * age ≥ 18. * signed informed consent. * affiliation to a social security coverage exclusion criteria: * known hepatitis b or c or hiv. * inclusion in another clinical trial. * patient having received an anti-angiogenic therapy. * pregnant or breast-feeding woman. * person deprived of liberty or under guardianship or trusteeship or judicial protection * inability to give informed consent * person unable or unwilling to comply with the requirements of the protocol for geographical, social or psychological reasons.

Keywords: high grade glioma bevacizumab chemotherapy myeloid cells treg
pericapsular nerve group (peng) block versus periarticular injection for pain management after total hip arthroplasty

Conditions: Total Hip Arthroplasty; Postoperative Pain

Summary: adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. the pericapsular nerve group (peng) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. peng block provides sufficient analgesia but it is still the potential for quadriceps weakness that might delay ambulation. periarticular injection has attached attention as an effective analgesic modality with a low prevalence of adverse effects. the investigators will compare ultrasound-guided peng block with periarticular injection in patients undergoing total hip arthroplasty.


Eligibility criteria:
inclusion criteria: 1. aged 19 years old or older 2. american society of anesthesiologists physical status 1-3 3. scheduled for elective unilateral total hip arthroplasty exclusion criteria: 1. allergy or intolerance to any of the drugs used in the study 2. hepatic or renal insufficiency 3. opioid dependency 4. coagulopathy 5. pre-existing neurologic or anatomic deficits in the lower extremities 6. severe psychiatric illness
pragmatic use of next-generation sequencing for management of drug-resistant tuberculosis

Conditions: Drug-resistant Tuberculosis; HIV Coinfection; Cost-Benefit Analysis

Summary: ts eliot is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.


Eligibility criteria:
inclusion criteria: 1. active rr-tb diagnosed at a study facility during the study period 2. positive mtb culture, smear, or specimen derivative (e.g., genolyse remnant, xpert cartridge extract) exclusion criteria: 1. patient expects to relocate/move residence outside of the study region 2. patient does not agree to participate in the study in addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic dst, lpa, or sequencing) will be considered late exclusions.
pilot study evaluating the efficacy of allomem after loop ileostomy

Conditions: Colon Cancer; Rectal Cancer

Summary: the objective of this study is to investigate whether the use of human peritoneal membrane (hpm) in a temporary loop ileostomy is beneficial to patients. benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.

a loop ileostomy is a common procedure used to divert fecal matter from anastomotic sites after abdominal surgeries. major complications from creation and subsequent closure of a temporary loop ileostomy include: stoma retraction, stoma prolapsed, stenosis, herniation, intra-abdominal abscess, anastomotic leak, wound dehiscence. small-bowel obstruction (sbo) was the most common complication. sbo is caused by adhesions in the surgical site, with narrowing or angulation of the intestine causing obstruction. prevention of these adhesions may reduce the frequency with which sbo is seen after this surgery. furthermore, surgery to close the ileostomy is complicated by the presence of adhesions which make dissection of the ileostomy difficult, and increase the risk of injury of the small intestine during dissection, prolonging the operation time in an effort to minimize risk to the patient. allomem™ is human peritoneal membrane designated by the food and drug administration (fda) for use as a homologous tissue where native peritoneum is absent or traumatized. the allomem™ is not regulated as a device and no 510k submission has been made by the fda. allomem™ is allogeneic freeze-dried, irradiated human peritoneal membrane used as a soft tissue wound covering solely regulated under 361 hct/p because by fda definition it is: minimally manipulated; intended for homologous use only; does not involve the combination of cell or other tissues, and does not rely on the metabolic function of cells for its primary function. two animal studies have shown that allomem™ can help prevent intra-abdominal adhesions and provides the biological framework for peritoneal remodeling. by decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. the combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy.

Eligibility criteria:
inclusion criteria: * between 18 - 85 years old at the time of ileostomy formation * scheduled to undergo planned diverting loop ileostomy exclusion criteria: * patients undergoing emergency surgery * patients with abdominal or pelvic abscess present at time of initial surgery * patients with a history of pulmonary embolism or deep vein thrombosis (dvt) within 1 year of surgery

Keywords: ileostomy stenosis surgical wound dehiscence peritoneal colorectal surgery
a study of ibi351 in combination with cetuximab in subjects with kras g12c mutated metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: phase 1b consists of combined dose escalation phase and dose expansion phase. phase 3 study will compare efficacy and safety of ibi351 combined with cetuximab versus chemotherapy in treatment of kras g12c-mutated metastatic colorectal cancer

a phase 1b study of the safety, tolerability and preliminary efficacy of ibi351 combined with cetuximab in the treatment of kras g12c mutant metastatic colorectal cancer will be conducted based on recommended dose of ibi351, which consists of combined dose escalation phase and dose expansion phase. after confirming the efficacy and safety of ibi351 combined with cetuximab in phase ib, an open-label phase 3 study of the efficacy and safety of ibi351 combined with cetuximab versus oxaliplatin-based mfolfox6 regimen or irinotecan-based folfiri with or without bevacizumab in treatment of kras g12c-mutated metastatic colorectal cancer will be conducted.

Eligibility criteria:
inclusion criteria: 1. male or female subjects, ≥ 18 years and ≤ 75 years 2. have documentation of kras g12c mutation 3. at least one measurable lesion per recistv1.1 4. eastern cooperative oncology group (ecog) performance status of 0-1. 5. life expectancy of \>12 weeks, in the opinion of the investigator exclusion criteria: 1. history of deep venous thrombosis or any other serious thromboembolism within 3 months prior to enrollment.. 2. history of radiation-induced pneumonitis, idiopathic pneumonia, active pneumonia, pulmonary fibrosis, diffuse pulmonary interstitial disease, or organizing pneumonia. 3. surgical procedures (excluding needle biopsy) performed within 28 days prior to enrollment that may affect the dosing or study assessments in this study. 4. received therapeutic or palliative radiation therapy within 14 days prior to enrollment 5. pregnant or lactating women
impact of non invasive ventilation on quality of sleep

Conditions: Restrictive Pulmonary Disorders; Non Invasive Ventilation

Summary: quality of sleep is profoundly affected in patients with hypercapnic respiratory failure and restrictive disorders, with a decrease in rapid eye movement (rem) and slow wave sleep, and an increase in sleep fragmentation. assisted ventilation aims at improving blood gases, but may also have a favorable impact on sleep structure. the investigators reviewed polysomnographic and blood gas data obtained between 1987 and 2008 in 95 patients with restrictive pulmonary disorders, before and after implementing non-invasive ventilatory support.

chart review of all patients with predominantly restrictive pulmonary disorders treated for respiratory failure by niv at our institution between 1987 and 2008. data systematically recorded included pulmonary function tests, diurnal arterial blood gases, and polysomnography before and after implementation of nocturnal niv.

Eligibility criteria:
inclusion criteria: * patients with restrictive pulmonary disorders (neuro-muscular diseases, chest wall disorders, sequellae of tuberculosis) leading to hypercapnic respiratory failure requiring non invasive ventilation (niv), investigated according to clinical standards in our institution by polysomnography before and after implementation of niv exclusion criteria: * patients fulfilling inclusion criteria for whom diagnostic polysomnography and/or polysomnography under niv were not performed
the pk/pd study of a single subcutaneous injection of shr-1209 in healthy subjects

Conditions: Hypercholesteremia

Summary: this is a single center, randomized, double-blind, dose escalation, placebo parallel controlled phaseⅰclinical study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics with a single subcutaneous injection of shr-1209 in healthy subjects. the primary objective of this study is to investigate the safety and tolerability of a range of subcutaneous shr-1209 in healthy subjects. secondary objectives are to determine the pharmacokinetics (pk) and pharmacodynamics(pd) profile of shr-1209 in healthy subjects including assessment of immunogenicity.

32 adult healthy subjects with 4 dose groups will be enrolled in the study, including two subjects in the lowest dose group, all of whom received the shr-1209 without placebo control. the other three groups have 10 subjects in each group, 8 administered shr-1209 and 2 administered placebo. the primary endpoint is the safety and tolerability : adverse events, vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, injection site reactions, etc.

Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤45 years old; 2. the body mass index (bmi) should be 19 or greater and \< 28kg/m2, the male weigh ≥50.0kg and \<90.0kg, and the female weigh ≥45.0kg and \<90.0kg; 3. serum ldl-c concentration≥2.0mmol/l and \< 4.1mmol/l; 4. fasting triglycerides \< 2.3 mmol/l; 5. the comprehensive physical examination is eligible or slightly abnormal but the researchers determine no clinical implication. 6. signed informed consent. exclusion criteria: 1. subjects determined by the researchers have diseases that affect drug absorption, distribution, metabolism and excretion or low compliance; 2. a clinical history of drug allergy or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or a known allergy to experimental or similar experimental drugs; 3. serum creatinine exceeded the upper limit of normal value (uln) during screening; 4. alanine aminotransferase (alt) or aspartate aminotransferase (ast) or gamma pancreatic acyl transferase (ggt), more than 2 x uln, or total bilirubin more than 1.5 x uln during screening; 5. human immunodeficiency virus antibody (hiv-ab), syphilis serological examination, hepatitis b virus surface antigen (hbsag), hepatitis c virus antibody (hcv-ab) were positive; 6. subjects with previous malignant tumor diseases; 7. 3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening. etc

Keywords: shr-1209 phase 1