Kornimate/medical-research-clean huggingface dataset:
a study of ziftomenib, an oral menin inhibitor, in combination with imatinib in patients with advanced gastrointestinal stromal tumors (gist)

Conditions: Gastrointestinal Stromal Tumor (GIST); Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal Tract; Gastrointestinal Stromal Cancer; Gastrointestinal Stromal Neoplasm; Gastrointestinal Stromal Tumor, Malignant; Gastrointestinal Stromal Cell Tumors

Summary: in this clinical trial, the safety, tolerability, and preliminary antitumor activity of ziftomenib in combination with imatinib will be evaluated in adults with gastrointestinal stromal tumors (gist) who have been treated previously with imatinib.


Eligibility criteria:
key inclusion criteria: * documented diagnosis of advanced or metastatic kit mutant gist. * documented disease progression on imatinib therapy as current or prior treatment. * eastern cooperative oncology group (ecog) performance status (ps) of ≤2 at screening. * at least 1 measurable lesion per mrecist. * negative pregnancy test for female patients of childbearing potential. * adequate organ function per protocol requirements. * resolution of all clinically significant toxicities from prior therapy to ≤grade 1 (or patient baseline) within 1 week prior to the first dose of study drug. * participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure. key exclusion criteria: * diagnosis of non-kit mutation or a t670x kit mutation-driven gist. * history of prior or currently has cancer which has potential to interfere with obtaining study results. * received a prohibited medication, including investigational therapy, less than 14 days or within 5 drug half-lives prior to the first dose of study intervention. * active central nervous system metastases. * uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease. * mean corrected qt interval (qtcf) greater than 470ms. * left ventricular ejection fraction (lvef) \<50%. * major surgery within 2 weeks prior to the first dose of study intervention. * is pregnant or lactating. * gastrointestinal abnormalities that may impact taking study intervention by mouth. * actively bleeding, excluding hemorrhoidal or gum bleeding.

Keywords: gastrointestinal stromal tumor gastrointestinal stromal cancer gastrointestinal stromal neoplasm
androgen effect on klinefelter syndrome motor outcome

Conditions: Klinefelter Syndrome

Summary: the purpose of this study is to evaluate the effects of low-dose androgen on the motor and cognitive development of boys with klinefelter syndrome.

klinefelter syndrome (ks), a genetic disorder that affects males only, is characterized by having an extra x chromosome. the phenotype - or physical and learning features - includes testicular failure, tall stature, and specific cognitive and behavioral attributes such as diminished motor function, language-based learning difficulties, poor self-image, and shyness. the ks phenotype may be the result of androgen deficiency in utero, infancy, and childhood. for individuals with ks, androgen replacement is standard treatment in adolescence and adulthood but has not been used earlier in childhood or included in the standard medical care of ks children ages 4 to 12. the purpose of this study is to examine the effects of androgen on learning and development in boys with ks. researchers also want to determine if low-dose androgen replacement at an early age will improve some of the learning difficulties associated with the disorder. the overall goal of this study is to address questions regarding the relationship of early androgen deficiency to learning and motor function. participants in the study will be randomized to one of two treatment groups, receiving either oxandrolone (low-dose androgen) or placebo, for two years. all participants will be evaluated for safety at the beginning of the study and at 3, 6, 12, 18, and 24 months. also at the beginning of the study and every 3 to 6 months thereafter (for a total of 6 visits), the researchers will perform a careful history and physical examination and a bone age x-ray, and obtain a blood sample. participation in the trial will last two years and includes 6 clinic visits.

Eligibility criteria:
inclusion criteria: * karyotype diagnosis of klinefelter syndrome * chronological age of 4-12 years * no treatment with androgen in the past year exclusion criteria: * major liver, kidney or other systemic disease * variant karyotypes including 47,xyy males * evidence of spontaneous onset of puberty, defined as testicular size \> 4ml

Keywords: klinefelter syndrome androgen androgen oxandrolone
an observational study of mircera (methoxy polyethylene glycol-epoetin beta) in stage iii-iv chronic kidney disease patients not on dialysis with renal anemia

Conditions: Anemia

Summary: this observational study will evaluate the use in clinical practice and efficacy of mircera (methoxy polyethylene glycol-epoetin beta) in stage iii-iv chronic kidney disease patients not on dialysis receiving mircera for the treatment of chronic renal anemia. eligible patients will be followed for 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, 18 to 65 years of age, inclusive * patients with stage iii-iv chronic kidney disease not on dialysis * erythropoiesis stimulating agent (esa) naïve with hb \< 10 g/dl, or on treatment with esas other than mircera and hb within the target range of 10-12 g/dl * adequate iron status as judged by the treating physician exclusion criteria: * hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication * clinically significant concomitant disease or disorder as defined by protocol * clinical suspicion of pure red cell aplasia (prca) * planned elective surgery during the study period , except for cataract surgery or vascular access surgery * transfusion of red blood cells in the previous 2 months * pregnant women * contraindications for mircera according to local prescribing information or as judged by the investigator
acute effects of gastrocnemius myofascial release on cervical flexion and extension range of motion in healthy adults: a randomized controlled trial

Conditions: Healthy

Summary: the purpose of this study is to verify the immediate effects of gastrocnemius myofascial release on the active cervical flexion and extension range of motion.

after completing the questionnaire, 91 healthy participants will be randomly divided into two groups: the intervention group (ig) (n=46) and the control group (cg) (n=45). in the first assessment (m0), the range of motion of cervical flexion and extension will be measured using a smartphone (galaxy s21 fe 5g, android) and the clinometer application. the myofascial release technique (foam roller) will be applied to the gastrocnemius of the dominant lower limb for 4 minutes (3 sets of 1 minute with 30 seconds of rest). participants in the control group will remain at complete rest for a period of 4 minutes, lying in the supine position, without performing any type of active or passive intervention. immediately after the intervention/control, all groups will be reassessed (m1).

Eligibility criteria:
inclusion criteria: * healthy participants of both sexes aged 18-40 years. exclusion criteria: * deformities in the lower quadrant region of the body; * complaints in this region in the last 6 months; * surgical procedures or musculoskeletal, cardiac, renal, metabolic, neurological and or oncological pathologies; * limb length discrepancy greater than 1.5 cm; * pregnant women; * ingestion of non-steroidal anti-inflammatory drugs or consumption of any type of narcotic drugs and participants who have drunk alcohol in the last 12 hours.
prospective assessment in newborns for diabetes autoimmunity

Conditions: Type 1 Diabetes; Autoimmunity

Summary: this is an observational study designed to help researchers understand the genetics and pathogenesis of type 1 diabetes, and to identify biomarkers for disease and disease complication prediction.

this study is designed to identify people who are at risk for developing type 1 diabetes, based on their genetics, family history and autoimmunity status, and to understand the role genetics plays in the development of the complications associated with type 1 diabetes in patients already affected by type 1 diabetes.

Eligibility criteria:
inclusion criteria: all are welcome - exclusion criteria: -

Keywords: genetics type 1 diabetes biomarkers autoimmunity
italian national study on the critically ill liver transplant patient with an infection

Conditions: Liver Transplantation; Infection; Sepsis; Intensive Care Unit

Summary: despite major advances, infections remain one of the major causes of morbidity and mortality in patients undergoing orthotopic liver transplantation (olt). furthermore, data on the epidemiology, severity, and type of post-olt infections nowadays available come from dated, monocentric, retrospective series. finally, there is no available data focused on the critical olt patient admitted to the intensive care unit (icu). therefore this study was conceived (1) to describe incidence, severity, epidemiology and outcomes of infections recorded in olt patients in the icu (first or re-admission ); (2) to identify possible risk factors and (3) to report the type of the involved microorganism with their antibiotic sensitivity pattern

the study will record clinical, epidemiological and microbiological data from the clinical files of olt patients admitted at italian icus

Eligibility criteria:
inclusion criteria 1. age\> 18 aa 2. sex: both 3. written consent to participate in the study 4. having been undergone to olt in the 10 years prior to enrollment 5. infection diagnosis (any type, any localization, any agent) 6. being admitted in the icu exclusion criteria 1. death within 72 hours of admission 2. withdrawal of consent -
a multi-center study to assess the performance of saturation patterns.

Conditions: Sleep-Disordered Breathing; Obstructive Sleep Apnea; Sleep Apnea; Central Sleep Apnea

Summary: a multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (psg) studies performed at multiple different sleep lab centers.

the polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or central sleep apnea. subjects who have been prescribed with needing a polysomnography (psg) will be enrolled into the study.

Eligibility criteria:
inclusion criteria: * subjects will be referred to the sleep lab center for evaluation of possible sleep-disordered breathing. * polysomnography (psg) is obtained as part of normal, standard clinical practice. * subject is able to and willingly signs the informed consent form. exclusion criteria: * subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol. * subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.
functional status, morbidity and mortality in cemented versus press-fit hemiarthroplasty

Conditions: Femoral Neck Fracture

Summary: hemiarthroplasty (half of a hip replacement) is the most common treatment for displaced fractures of the femoral neck in the elderly and is associated with a better functional outcome and fewer reoperations than internal fixation. currently, the operative management of displaced femoral neck fractures favors the use of cemented implants. this technique is believed to be more stable in the immediate post-operative period, but there is limited evidence of a decreased morbidity and mortality with cemented versus press-fit stems (uncemented). in 2006, a meta-analysis concluded that the evidence was too limited to recommend a cemented or press-fit hemiarthroplasty. in this investigation, the morbidity, mortality and functional outcome associated with cemented and press-fit hemiarthroplasty will be compared prospectively. we propose that the use of press-fit hemiarthroplasty in the treatment of displaced subcapital fractures of the femoral neck would be associated with a decreased risk of adverse peri-operative outcomes, and that the functional results of cemented and press-fit hemiarthroplasty will be equivalent at one year.


Eligibility criteria:
inclusion criteria: * older than 55 years * non-pathologic, displaced subcapital femoral neck fracture * designated for surgical reconstruction with a hemiarthroplasty by the attending surgeon * able to ambulate ten feet prior to presentation exclusion criteria: * unable to walk ten feet prior to hip fracture * multiple extremity trauma * pathologic fracture of the hip (including malignancy) * clinically recognized acute myocardial infarction within thirty days prior to enrollment * previously participated in the trial * symptoms associated with anemia * pre-existing metabolic bone disease

Keywords: hemiarthroplasty cemented press fit mortality morbidity functional status displaced femoral neck fracture
positive airway pressure on pleural effusion after drainage

Conditions: Pleural Effusion

Summary: the purpose of this study is to determine if the addition of intermittent positive airway pressure breathing (specific lung expansion technique) to conventional chest physiotherapy chest drainage is effective to accelerate the reabsorption of pleural effusion and consequently decrease the duration of chest tube drainage and respiratory system impairment. these effects would decrease hospital stay lengths and the incidence of pulmonary complications.


Eligibility criteria:
inclusion criteria: * age over 18 years * presence of pleural effusion * have undergone chest drain for fewer than 24 hours exclusion criteria: * contraindication to the use of non-invasive equipment that generates positive airway pressure (such as: intolerance, phobia, drowsiness, restlessness, confusion, hemodynamic instability requiring vasopressor therapy, systolic blood pressure \< 90 mmhg, facial trauma, ineffective cough or inability to swallow, nausea or vomiting, upper gastrointestinal bleeding, acute myocardial infarction within the last 48 hours, pneumothorax or bullous emphysema)

Keywords: pleural effusion chest tube respiratory therapy intermittent positive-pressure breathing lung function pulmonary complications
effect of myofascial release on post-exercise recovery in water polo athletes

Conditions: Fatigue

Summary: objective: to assess the acute effect of a myofascial release protocol applied to the adductor muscles of the thigh on functional, biomechanical, and physiological variables. methods: this study is a randomized, double-blind, two-arm crossover clinical trial that will analyze male water polo athletes aged 16 to 25 years recruited from a sports training center in the city of bauru. data related to the following parameters will be collected for the physical evaluation: functional performance, through the jump test; biomechanical, through maximum isometric torque of hip adductors, electromyography of the hip and gluteus medius muscles; and physiological, through the analysis of serum markers of muscle damage and inflammation, and heart rate variability. after the initial evaluation, the participants will be randomly divided into two groups: intervention group and sham group. then, all participants will perform a game simulation. after the game, the participants will receive the intervention designated for each group. for the intervention group, a manual therapy protocol will be applied, based on myofascial release in the thigh region that presents trigger points. for the sham group, a manual technique, called classic massage, will be applied, with superficial pressure, used to reach only subcutaneous tissues, without acting on muscles and fascia. this protocol will be repeated at four different times, always after the games. after a washout week, the participants will change groups and the data collection protocol will be applied again.


Eligibility criteria:
inclusion criteria: 1. male athletes; 2. age 16 to 25 years old; 3. have at least one year of experience in the sport; 4. perform a training load of at least 10 hours per week in the sport; 5. participate in at least regional level competitions exclusion criteria: 1. have no reports of muscle injury in the thigh in the three months prior to the study, 2. joint injuries in the hip, such as femoroacetabular impingement or tendinopathies of the tendons of the hip muscles or trochanteric, iliopectineal or ischial bursitis diagnosed by a clinician; 3. do not present a drop in -performance for more than four weeks that could characterize the occurrence of non-functional overreaching or signs of overtraining syndrome

Keywords: fatigue physical exertion post-exercise recovery
establishment of acute lymphocytic leukemia data base in the department of oncology

Conditions: Acute Lymphocytic Leukemia

Summary: establishment of acute lymphocytic leukemia data base in the department of oncology

establishment of acute lymphocytic leukemia data base in the department of oncology

Eligibility criteria:
inclusion criteria: * patients with diagnosed acute lymphocytic leukemia exclusion criteria: * patients with diagnosis other than acute lymphocytic leukemia

Keywords: acute lymphocytic leukemia
testosterone therapy in naturally menopausal women with low sexual desire receiving transdermal estrogen

Conditions: Hypoactive Sexual Desire Disorder

Summary: the purpose of this study is to examine whether the transdermal testosterone system (tts) is effective and safe in the treatment of hypoactive sexual desire disorder (hsdd) in postmenopausal women who are on transdermal estrogen.

this is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the uk, 6 sites in australia, 5 sites in germany, and 2 sites in canada. women will be randomised 1:1 to receive 300 mcg/day tts or placebo for a 24 week period. consistent with previous phase iii studies, efficacy will be assessed over 24 weeks using the sexual activity log (sal), and at 12 and 24 weeks using the profile of female sexual function (pfsf) and personal distress scale (pds). safety will be assessed over the entire 24 weeks. hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at weeks -4 and 24. the total duration of treatment for each patient is 24 weeks.

Eligibility criteria:
inclusion criteria: * women will be screened for study participation according to the following inclusion criteria at week -4. eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal hrt and in a stable monogamous sexual relationship with low sexual desire causing distress. exclusion criteria: * women will be screened for study participation according to the following exclusion criteria at week -4 or as specified. eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.
pain relief - tramadol versus ibuprofen

Conditions: Choroidal Melanoma; Melanoma; Eye Neoplasms

Summary: the purpose of this study is to assess post operative pain following the insertion of radioactive plaque for choroidal melanoma in patients after receiving either ibuprofen or tramadol.

patients with choroidal melanomas who are offered ruthenium plaque radiotherapy have their plaque sutured to the sclera under general anaesthesia. the plaque is removed in a few days after delivering the required radioactive dosage to the tumour. while the plaque is in situ, patients require analgesia. the management of post-operative pain is generally not considered a high priority, more importance being given to the regression of the melanoma. this is indicated by the lack of any study addressing this aspect of care. the failure of patients in general, to complain, may perhaps be due to them having accepted that some degree of pain following 'major surgery for a malignant ocular condition' is the norm. as per current protocol, ibuprofen is being prescribed, unless contraindicated. although many are comfortable, others request additional analgesics. most opioid analgesics provide better pain relief but are associated with nausea, vomiting, constipation and respiratory depression. tramadol is an opioid analgesic that is reported to have less of the above mentioned side affects. comparisons: to compare the analgesic effect of oral tramadol versus ibuprofen in such patients.

Eligibility criteria:
inclusion criteria: * all patients that are admitted for undergoing plaque radiotherapy for choroidal melanoma would be approached to participate in this study. * they should be adults who are of a sound frame of mind to give an informed consent to participate. exclusion criteria: * patients less than 18 years of age * patients of unsound mind not capable of giving informed consent * active peptic ulcer disease, asthma, renal dysfunction, warfarin therapy, hypothyroidism history of epilepsy, pregnancy, breastfeeding and hypersensitivity to either products.

Keywords: pain relief choroidal melanoma plaque radiotherapy
penicillin allergy testing in std clinics

Conditions: Penicillin Allergy

Summary: demonstration project to implement penicillin allergy testing in std outpatients using a questionnaire and pen allergy testing

all subjects receive risk questionnaire for subjects without high risk responses, randomized to direct oral challenge or pcn skin testing followed by oral challenge

Eligibility criteria:
inclusion criteria: * prior history of pcn allergy exclusion criteria: * no immunodeficiency or contraindication to skin testing
improving coping to reduce suicide risk following ed discharge

Conditions: Suicidal; Suicide, Attempted; Suicidal Ideation

Summary: the researchers hope to learn whether an electronic safety plan (esp) and a supportive text messaging program are feasible and acceptable to adult patients with recent suicidal thoughts or behavior after emergency department (ed) discharge. from this study, the researchers also hope to learn how to best carry out the esp and text messaging program to improve outcomes for patients after ed discharge.


Eligibility criteria:
inclusion criteria: individuals presenting to an ed with either: 1. actual, interrupted, or aborted attempt in the last 4 weeks 2. suicidal ideation within the last week exclusion criteria: * severe cognitive impairment or altered mental status (psychosis, manic state) * severe aggression/agitation, * being admitted or transferred into inpatient care, * patient not owning a cell phone with text messaging capability

Keywords: emergency department