Kornimate/medical-research-clean huggingface dataset:
study of gbt021601 in participants with renal impairment

Conditions: Renal Impairment

Summary: renal impairment study of gbt021601.

this is a phase 1, two-part, non-randomized, open-label, parallel group study to evaluate the pk, safety, and tolerability of gbt021601 following a single dose administration in adult participants with ri.

Eligibility criteria:
inclusion criteria: * males or females, ≥ 18 years of age at the time of screening. * have liver (alanine aminotransferase \[alt\], aspartate aminotransferase \[ast\], and total bilirubin \[direct and indirect\]) and renal function tests, hb, and hematocrit values within normal limits or are not clinically significant at screening and day -1 (cohort 2 only). * has a stable renal function with no clinically significant change in renal status at least 1 month prior to study drug administration. exclusion criteria: * any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests unrelated to their medical condition related to renal impairment, that might confound the results of the study or pose an additional risk in administering study drug to the participant. * evidence or history of clinically significant allergic (except for untreated, asymptomatic seasonal allergies at the time of study drug administration), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease unrelated to renal impairment.

Keywords: end stage renal disease sickle cell disease
international multi centre randomized clinical trial of anticoagulation in children following fontan procedures

Conditions: Heart Defect; Triscupid Atresia

Summary: compare heparin/warfarin to asa for thromboembolic prophylaxis in the first two years following fontan procedures.


Eligibility criteria:
inclusion criteria: 1. patient is scheduled to have a fontan or modified fontan procedure exclusion criteria: 1. requirement for long-term anticoagulation (e.g., prosthetic heart valve, active dvt) 2. risk of significant bleeding or any other known medical contraindication to heparin, warfarin, or asa. 3. inability to supervise therapy due to social or geographical reasons. 4. pregnancy or potential pregnancy during study period

Keywords: fontan procedure anticoagulation thrombosis thromboembolism prevention
health and early life microbiota

Conditions: Child Development; Growth; Allergy; Overweight; Infectious Disease; Noncommunicable Diseases

Summary: the aim of this cohort is to identify environmental, lifestyle and genetic factors that modify the human intestinal microbiota development during the first years of life, and to identify early microbiota features that associate to child health and well-being with focus on the development of allergic diseases and overweight.

1055 healthy term infants born in 2016-2018 mainly at the capital region of finland, and their parents. fecal samples collected from infants and their parents. electronic questionnaires on a weekly basis during the first 4 months of life, thereafter less frequently. focus on diet, well-being and health and social manners. at one-year and at two-years comprehensive questionnaires including development and cognition. parental stress evaluation included.

Eligibility criteria:
inclusion criteria: * general population, singleton pregnancy, at least one parent finnish speaking * willingness and ability of parents to consent for 2 year follow-up involving frequent electronic questionnaires and freezing of faecal samples at home * infant born on gestational weeks 37-42 without known congenital defects exclusion criteria * preterm birth * severe birth defect * parents fail to activate the online questionnaires

Keywords: birth cohort intestinal microbiota child health
optoacoustic images versus imagio® ultrasound

Conditions: Breast Cancer

Summary: the imagio® pivotal study is intended to evaluate if the results observed in the previous feasibility study can be confirmed for pre-specified effectiveness endpoints. using intention-to-diagnose (itd) masses from the pioneer pivotal study, 480 to 840 masses are to be used for the pivotal study, the remaining masses will be reserved for training the senogram® model.

this will be a controlled, blinded, multi-reader, multi-case (mrmc) study using a sequential design. the study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. readers that participated in the seno pioneer study (nct01943916) or the reader-01 feasibility study (nct03708393) are not eligible to participate as readers in this pivotal study. imagio® \[ultrasound (ius) + optoacoustic (oa)\] (ius)(ius+oa) training will be completed prior to any reads taking place. read 1 will be immediately followed by read 2 within the same read session.

Eligibility criteria:
inclusion criteria: * one analyzable mass per patient: bi-rads 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via pioneer study inclusion criteria and categorized as birads 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (cdu) * masses declared to be in the pioneer intention to diagnose (itd)/analysis population, including high risk cases per original pioneer protocol * patient age, indication for study entry and available medical history * evaluable mammograms and oa and ius video loops and stills for each mass exclusion criteria: * critical missing ius or oa still image and/or video loop views or incorrect ius or oa stills and video loops that would preclude a case from being evaluated by readers * reader-02 proficiency test and training cases
goal attainment evaluation of multidisciplinary telerehabilitation after traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the purpose of the study is to evaluate the outcome of a multidiscplinary telerehabilitation after traumatic brain injury assessed by the patient and the therapists with respect to the overall feasibility of the therapy protocol and the effects on psychological well-being and quality of life..

patients from 18 to 60 years of age recovering after traumatic brain injury are recruited to participate in a multidisciplinary telerehabilitation containing total of 20 video meetings over a period of 4-5 months. the study design consists of a 3-day visit in rehabilitation ward for the pre-treatment clinical assessments and education on the telerehabilitation protocol. a self-exercise program is supervised and monitored using a health platform application on a tablet computer through weekly video meetings. a digital diary recordings enable the therapists to track on the progress of therapies. the primary goal is to achieve the individual goals set in the goal attainment scaling. the secondary goals are related to the improvement of psychological well-being (bdi) and quality of life (whoqol-bref).

Eligibility criteria:
inclusion criteria: * sequelae of traumatic brain injury * capable of doing self exercises at home and participating in video meetings exclusion criteria: * moderate or severe aphasia * poor recovery potential for return to school or working life based on clinical assessment

Keywords: telerehabilitation case series traumatic brain injury
effectiveness of an intervention program for fine motor skills

Conditions: Hand Injuries

Summary: investigators have created a protocol of intervention to treating the general disability of upper limbs.

a protocol of intervention for fine motor skills will be performed on institutionalized elderly people. this protocol consist on implementation of a manual activity that it is well known in the clinical setting. this activity will enhance several skills such as strength, coordination of upper limbs, range of motion, general auto-efficacy and the quality of life. the intervention or rehabilitation will be implemented for two month.

Eligibility criteria:
inclusion criteria: * institutionalized elderly people, on a full or part-time. * voluntary participation. exclusion criteria: * cognitive impairment (\< 23 in normal school population and \< 20 points with a low education or illiteracy, in spanish validation of mini-mental state examination (mmse)). * postural control problems. * balance disorders, while the subject is seated.

Keywords: frail elderly motor skills upper extremity
positron emission tomography (pet) study with [11c]az12713580 to determine central mglur5 receptor occupancy of azd2066

Conditions: Healthy

Summary: the study is carried out in order to determine the relationship between azd2066 exposure and mglur5 receptor occupancy in the brain and to demonstrate that azd2066 can displace \[11c\]az12713580 from mglur5 binding-sites in the central nervous system


Eligibility criteria:
inclusion criteria: * provision of informed consent * bmi (body mass index) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg * normal mri (magnetic resonance imaging) scan at visit 2 exclusion criteria: * history of previous or ongoing psychiatric disease or condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the diagnostic and statistical manual of mental disorders * history of psychotic disorder among first degree relatives (parents, siblings) * history of use of antipsychotic, antidepressant or anxiolytic (anxiety treatment) drugs, prescribed or non-prescribed use. history of antidepressants or anxiolytics for non-psychiatric conditions such as pain or post-operative insomnia is allowed

Keywords: pain pet phase 1 analgesia positron emission tomography mglu5 receptor dose finding analgesia/pain
validation and refinement of noninvasive diagnostic biomarkers for endometriosis, the endomarker protocol

Conditions: Endometriosis

Summary: this study involves the prospective collection of endometrial biopsy tissue, serum, plasma, whole blood for dna extraction, and urine from women who will be diagnosed as having (or not having) endometriosis at the time of scheduled surgery. the investigators plan to enroll approximately 500 women to validate and optimize the use of genomic classifiers alone or in combination with serum markers (such as cytokines) as a non-surgical marker of disease.


Eligibility criteria:
exclusion criteria: * • currently pregnant * current or past diagnosis of any malignancy (with the exception of non-melanoma skin cancer) * known to be hiv-positive * unable to give informed consent * unwillingness to have samples banked in repository for future use * clinical evidence of active cervical infection * lupron (or other grh agonist) therapy within the last 2 months (or depo-lupron within the last 4 months) * current use of estrogen or progestin (oral, transdermal, intrauterine or ring). o current use is defined as use in the index menstrual cycle (since the onset of the last menstrual period). * use of depo estrogen or progestin in last 3 months * current use of aromatase inhibitor inclusion criteria: * women aged 18-44 scheduled to undergo gynecologic surgery (laparoscopy/laparotomy). indication for surgery can include: infertility, endometriosis, tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition), myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
causes of complicated appendicitis at referral hospital

Conditions: Complicated Appendicitis

Summary: the study was conducted on a medical record of previously treated patients for acute appendicitis at hfsuh, harar, ethiopia. the study design was case-control with a total sample size of 402.

the case-control study conducted at hfsuh was proceeded following the university's protocol and after passing institutional ethical review permission.

Eligibility criteria:
inclusion criteria: * patients diagnosed with acute appendicitis exclusion criteria: * incidental appendectomy patients

Keywords: complicated appendicitis, acute abdomen
tofo insulin combination trial

Conditions: Type 2 Diabetes Mellitus

Summary: primary objectives: to assess the effects of tofogliflozin on glycemic control in comparison to placebo as an add-on treatment to insulin treatment in terms of glycated hemoglobin (hba1c) reduction over a period of 16 weeks in patients with type 2 diabetes mellitus. to assess the safety of tofogliflozin in combination with insulin treatment throughout 52 weeks. secondary objectives: to assess the effects of tofogliflozin in comparison to placebo on: * body weight * fasting plasma glucose (fpg) * postprandial plasma glucose (ppg) to assess the long term safety and tolerability of tofogliflozin.

the total study duration from screening for a patient can be approximately up to 1 year, including a screening period of 2 weeks, double-blinded placebo controlled treatment period of 16 weeks, an open-labeled extension period of 36 weeks, and a follow-up period of 3 days.

Eligibility criteria:
inclusion criteria: * patients aged 20-75 years old with type 2 diabetes mellitus (t2dm). * hemoglobin a1c ≥7.5% - ≤10.5% and fpg ≤220 mg/dl. * basal bolus (bb), bolus, premix, basal supported oral therapy (bot) regimens used for more than 12 weeks before screening. * stable dose (-/+20%) of insulin and no change in the dose of oral hypoglycemic agents for more than 12 weeks before screening. * only dipeptidyl peptidase-4 inhibitor is allowed for basal supported oral therapy (bot) regimen. * body mass index (bmi) ≥18.5 kg/m\^2 and \<35.0 kg/m\^2. * no change of antihypertensive, anti-hypercholesterolemia and uric acid lowering drug 4 weeks before screening. exclusion criteria: * type 1 diabetes mellitus. * pregnancy or lactation. * severely uncontrolled glycemic situation. * history of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening. * history of myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months. * a measured serum creatinine level greater than 2.0 mg/dl for men and 1.5 mg/dl for women. * aspartate aminotransferase (ast) or alanine aminotransferase (alt) ≥2.5 times the upper limit of the reference range at the central laboratory test facility. * has previously received treatment with the investigational product. * has received treatment with another investigational product or non-approved drug within 3 months before tests for provisional enrolment. * corticosteroid therapy for 14 or more days in total within 8 weeks before tests for provisional enrolment (excluding those used for localized effects, such as drugs for topical \[skin\] application, eye drops and sprays). * patients who are frequently experiencing orthostatic hypotension. * required a change in the dosing regimen for the following drugs within 4 weeks before tests for provisional enrolment: * lipid-lowering drug * antihypertensive drug * thyroid hormone preparation * uric acid lowering drug the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
thyme and carvacroll nanoparticle effect on fungi

Conditions: Aspergillosis

Summary: invasive aspergillosis (ia) has increasingly been recognized as an emerging disease of non-neutropenic patients and in patients admitted to the icu, even in the absence of an apparent predisposing immune-deficiency, with incidence ranges from 0.3% to 5.8% with an overall mortality rate exceeding 80%.


Eligibility criteria:
inclusion criteria: * intensive care patients exclusion criteria: * none
recovery effect of sugammadex measured by bispectral and neurosense indices

Conditions: Anesthesia

Summary: it has been demonstrated that antagonism of neuromuscular blockade (neostigmine 0.04 mg kg-1) affects depth of anaesthesia with an increase in bispectral index (mean maximal change of 7.1) and middle-latency auditory evoked potentials (mean maximal change of 9.7). sugammadex has a quicker and more complete effect than neostigmine. this study aims to demonstrate if sugammadex administration increases bispectral and neurosense indices of the depth of anesthesia while patients still receive propofol-remifentanil iv anesthesia.


Eligibility criteria:
inclusion criteria: * patients scheduled to receive general anesthesia with muscle relaxation exclusion criteria: * contra-indication to the administration of propofol, remifentanil, rocuronium and to the use of the bispectral index or neurosense monitor * known drug allergy or hypersensitivity to a drug used in the study * history of central brain injury * patient treated with a psychotropic agent * patient with a pacemaker * severe renal insufficiency * treatment by toremifene, flucloxacillin or fusidic acid in the preoperative or immediate postoperative period
study of talabostat + docetaxel versus docetaxel in stage iiib/iv non-small cell lung cancer (nsclc) after failure of platinum-based chemotherapy

Conditions: Carcinoma, Non-Small Cell Lung

Summary: this phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with stage iiib/iv nsclc who have failed a platinum-based chemotherapy regimen.


Eligibility criteria:
inclusion criteria: * men or women age 18 years or older * histologically or cytologically confirmed nsclc * recurrent, locally advanced or metastatic, inoperable nsclc (stage iiib/iv) * patients with stage iiib nsclc must have a cytologically documented pleural effusion * failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced nsclc * measurable disease on computerized tomography (ct) scan * ecog performance status of 0 or 1 * expected survival ≥12 weeks * provide written informed consent exclusion criteria: * more than 2 prior chemotherapy regimens * clinically significant laboratory abnormalities, specifically: * total bilirubin ≥ institutional upper limit of normal (uln) * serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥1.5 x uln concomitant with alkaline phosphatase \>2.5 x uln * serum creatinine ≥2.0mg/dl * absolute neutrophil count \<1500/μl or platelets \<100,000/μl * untreated or symptomatic brain metastases * any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix * a history of severe hypersensitivity to drugs formulated with polysorbate 80 * any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol * patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for nsclc. * pregnancy or lactation. women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.

Keywords: stage iiib/iv non-small cell lung cancer nsclc lung cancer
kangroo mother care

Conditions: Preterm Birth Complication

Summary: infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.

infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs and comparing the pain intensity with preterm infants who receive conventional care.

Eligibility criteria:
inclusion criteria: * preterm infants whose corrected gestational age from (32 - \<37) weeks of pregnancy * preterm infants who do not experience any painful procedure for last 24 hours * preterm infants do not receive any sedation for last 24 hours exclusion criteria: * full-term infants whose corrected gestational age is \>37 weeks * extremely preterm (\< 28 weeks) * very preterm (28-\<32 weeks) * proven or suspected sepsis * major congenital malformations * all heart defect except neonatal patent ductus arteriosus (pda) * necrotizing enterocolitis * neurodevelopmental disability * who receive respiratory support {mechanical ventilation, continuous positive airway pressure, or high-flow support * indicated for surgery * contraindication to oral sucrose * twins * infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs
cancer, obesity/overweight and insomnia study

Conditions: Breast Cancer; Overweight and Obesity; Insomnia

Summary: this is a randomized pilot study to better understand the relationships among insomnia, weight loss, and breast cancer. this study will assess the effectiveness of a sleep intervention prior to a web- and phone-based weight loss program.

participants are women with a diagnosis of early stage breast cancer (esbc), a bmi ≥25, and insomnia. a total of 30 participants will be randomized to either cognitive behavioral therapy for insomnia and behavioral weight loss (cbt-i+bwl) or a sleep education program and behavioral weight loss (edu+bwl). measures will be collected at baseline, 8 weeks (after the cbt-i or edu program) and at 3 and 6 months after starting bwl. the primary outcome will be % total weight loss. additionally, eating behaviors, physical activity, and sleep parameters will be carefully assessed. the sleep intervention phase of the study includes 6 sessions over 8 weeks (2 in-person, followed by 4 phone or videoconferencing sessions), and the bwl intervention includes 15 sessions over 6 months (1 in-person, 14 by phone or videoconference). participants will be given physical activity trackers and will use a dietary app to record their food intake. there are 4 in-person assessment visits (baseline/randomization, 8-week follow up, 3-month follow up, 6-month follow up). these assessment visits are coordinated with in-person sleep and weight loss intervention visits. some of the measures that will be recorded throughout the study include: height, weight, anthropometric measures (waist/hip measurements), sleep diaries, and self-report measures.

Eligibility criteria:
inclusion criteria: * female * 18 years of age or older * histologically-confirmed ductal carcinoma in-situ (dcis) or stage i-iii invasive carcinoma of the breast * current bmi ≥ 25 kg/m2 and weight ≤ 400 lbs * willing to lose 10% of body weight * diagnosed with current breast cancer \>3 and \<60 months from planned baseline visit date * completed local therapy (i.e. surgery and radiation therapy) and any planned preoperative or adjuvant chemotherapy within \>3 prior to enrollment * diagnosed with insomnia or reports sleep problems * has daily access to the internet and/or smartphone exclusion criteria: * serious/uncontrolled condition likely to hinder accurate measurement of weight or sleep, such as bipolar i, seizure disorders, autoimmune disease, etc., or a medical condition that makes physical activity unsafe * current use of weight loss medications or sleeping aids * current enrollment in a sleep or weight loss program * sleep disorder other than insomnia * plan to become pregnant within next 12 months, or lactating