Kornimate/medical-research-clean huggingface dataset:
trabectedin in combination with olaparib in advanced unresectable or metastatic sarcoma

Conditions: Sarcoma; Sarcoma Metastatic

Summary: this phase ii trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. giving trabectedin and olaparib may shrink or stop the tumor from growing.


Eligibility criteria:
key inclusion criteria * age ≥ 16 years * advanced unresectable or metastatic sarcoma * cohort 1: leiomyosarcoma (lms)/liposarcoma (lps) * cohort 2: other sarcoma histologies (excluding gastrointestinal stromal tumors) * received at least 1 prior standard chemotherapy. for cohort 1 patients, this must have included a prior anthracycline. * measurable disease by recist 1.1 * adequate hematologic, renal, hepatic function * adequate creatine phosphokinase * ecog performance status ≤ 1 * left ventricular ejection fraction (lvef) \>= institutional lower limit of normal (lln) * women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment key exclusion criteria * prior therapy with parp inhibitor, including olaparib * prior therapy with trabectedin * additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years * pregnant or breastfeeding women * known hypersensitivity to trabectedin or olaparib * other exclusions per protocol
cc-42344 safety study in healthy participants

Conditions: Influenza A

Summary: cc-42344 phase 1 study with single-ascending dose (sad) and multiple-ascending dose (mad) parts.

this study is testing the safety, tolerability, and pharmacokinetics (pk, the amount of study drug in the blood) of a new drug called cc-42344.up to 78 healthy men or women aged between 18-55 are planned to be enrolled in this study in two parts. part 1 will involve a single-ascending (increasing) dose (sad) where 32 participants (4 groups of 8) will be assigned randomly to receive a single oral dose of the study drug or placebo. the placebo will look the same as the study drug but will not contain any medicine. an additional 6 participants will receive a single oral dose of cc-42344 to help further understand the effect of food on the uptake of the drug. part 2: will involve a multiple-ascending dose (mad) where 40 participants (5 groups of 8) will be randomized to receive an oral dose of study drug or placebo given once a day for 14 days, once a day for 5 days, or twice a day for 5 days. the placebo will look the same as the study drug but will not contain any medicine.

Eligibility criteria:
inclusion criteria (main): * healthy males or healthy, non-pregnant, non-lactating females * body weight of at least 50 kg * body mass index between ≥18.0 and ≤32.0 kg/m2 * good state of health (mentally and physically) * negative severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test, if required and per site policy exclusion criteria (main): * have received any investigational drug in a clinical research study within the previous 30 days before screening * have received any vaccine within 7 days prior to randomization * history of any drug or alcohol abuse in the past 2 years * females of childbearing potential who are pregnant or lactating or planning to become pregnant during the study * clinically significant abnormal biochemistry, hematology, coagulation, or urinalysis as judged by the investigator
this is a study to determine the antidepressant effects of azd6765

Conditions: Treatment Resistant Major Depressive Disorder

Summary: the purpose of this study is to determine the antidepressant effects of azd6765 compared to placebo.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of major depressive disorder, currently depressed without psychotic features * females must be of non-childbearing potential. exclusion criteria: * treatment with clozapine or ect within 3 months prior to study * current or past history of psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the dsm-iv

Keywords: patients
role of topical steroid injection with refractory benign esophageal stricture endoscopic dilatation in children

Conditions: Pediatric Disorder; Esophageal Diseases; Esophageal Stricture

Summary: this clinical trial study included 21 children with refractory benign esophageal strictures. upper gi endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. the effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (pdi) and dysphagia score.

background and study aims: benign esophageal strictures are primarily treated with dilation therapy, but strictures can recur or can be unresponsive, requiring additional or repeated treatment. this study investigates the efficacy and safety of intralesional steroid injections (isis) in addition to dilation in patients with refractory benign esophageal strictures. methods: this clinical trial study included 21 children with refractory benign esophageal strictures. upper gi endoscopy performed up to the area of stricture, esophageal dilatation done, endoscopy repeated, and steroid injected intralesional under direct endoscopic vision. the effect of the procedure was followed over a period of 12 months by evaluation of number of dilatation, maximum dilator size, periodic dilatation index (pdi) and dysphagia score.

Eligibility criteria:
inclusion criteria: * pediatric patients aged less than 14 years * with refractory benign esophageal strictures * received a dilatation therapy without triamcinolone injections exclusion criteria: * failure to pass a guide wire secondary to pharyngeal stenosis * tracheo-esophageal fistula * those who received triamcinolone injections at early dilatation

Keywords: esophageal stricture steroid injection esophageal dilatation
response of the gut microbiome and circulating metabolome to diet in children: ancillary study to kidfit (nct03405246)

Conditions: Gastrointestinal Microbiome; Metabolome; Pediatric Obesity; Dietary Approaches to Stop Hypertension

Summary: this is an ancillary study to kidfit (nct03405246). kidfit tests whether preschool-age children, born to overweight or obese mothers, respond to a healthy dash diet intervention with better cardiovascular health. this ancillary study to kidfit investigates how the children's gut microbiomes (bacteria in the intestines) and blood metabolomes (small molecules in the blood) are affected by the dash diet intervention, and how the microbiome and metabolome relate to the children's cardiovascular health over time. the investigators hypothesize that (1) the dash diet will modify the gut microbiome and blood metabolome, (2) the gut microbiome and blood metabolome will be related to each other, and (3) the microbiome and metabolome will be associated with the children's cardiovascular health profiles (things like weight, body fat, blood pressure, and cholesterol).

the majority of deaths from cardiovascular disease (cvd) in us adults ages 25-54 years are associated with suboptimal diet. while diet is an important target of cvd prevention efforts in adults, intervention on the childhood diet may be more effective. animal data suggest that early-life diet has the unique potential to modulate biological systems and durably program a child's biology for long-term health or disease. the objective of this study is to define the molecular effects of a dietary pattern intervention on the gut microbiome and circulating metabolome in young children. this objective will be attained through an ancillary study to kidfit, a clinical trial that tests the effects of a 12-month dietary approaches to stop hypertension (dash) diet intervention on adiposity and other cardiovascular health (cvh) metrics (e.g., blood pressure, lipids) in 3- to 5-year old children. using additional participant samples, deep phenotyping and advanced bioinformatics, the ancillary study will address three specific aims. first, it will test the effect of the dash diet intervention on the gut microbiome, including abundances of microbial taxa, communities, and metabolism-related genes and transcripts. second, it will define the associations of diet and the gut microbiome with the circulating metabolome. using targeted and nontargeted metabolomics approaches, blood metabolites, metabolite networks, and metabolic pathways will be evaluated. finally, in an exploratory fashion, it will probe pathways linking the diet intervention with subsequent adiposity and cvh metrics, through the gut microbiome and serum metabolome. the expected outcome is a preliminary model of how the dash diet alters the gut microbiome and circulating metabolome in young children, and how these alterations relate to short-term cvh outcomes.

Eligibility criteria:
inclusion criteria: - participating in kidfit (nct03405246) exclusion criteria: - none
the role of remazolam in reducing the incidence of postoperative delirium in elderly patients

Conditions: Postoperative Delirium

Summary: this study is a prospective, randomized, controlled trial.the selected patients were randomly divided into remazolam general anesthesia group and propofol + midazolam general anesthesia control group according to computer randomization method. there were 65 patients in each group. remazolam general anesthesia group (r group): remazolam 0.4 mg/kg for rapid induction of loss of consciousness for anesthesia induction and 1 mg/kg/h for maintenance. propofol + midazolam general anesthesia control group (group p): propofol 1.5 mg/kg + midazolam 0.05 mg/kg slow intravenous push until the patient's consciousness disappeared, then propofol 4-8 mg/kg/h anesthesia was maintained. except for different sedative drugs, the analgesic and muscle relaxant medication regimens were the same between the two groups. in the study, the application of inhaled anesthetics, other benzodiazepines and anticholinergic drugs was restricted, and the mean arterial pressure during the operation was kept above 60 mmhg to avoid perioperative hypotension, hypoxemia, and hypercapnia. warm measures were used to maintain the patient's intraoperative body temperature above 36.0 °c. pod assessment was performed on the day before surgery and on days 1-7 after surgery.


Eligibility criteria:
inclusion criteria: * elderly patients with limited abdominal tumor surgery (age ≥65 years) * asa classification i-iii. exclusion criteria: * refusing to participate in the study * patients with severe arrhythmia or cardiac dysfunction (ef\<35%) * a clear history of neurological and psychiatric disorders before surgery or long-term use of sedatives or antidepressants * history of alcoholism or drug dependence * history of brain surgery or trauma * severe vision or hearing impairment * inability to cooperate with the completion of cognitive function tests
super-resolution ultrasound of the brain in 3d

Conditions: Cerebral Stroke

Summary: the goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3d transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3d ultrasound localization microscopy. visualization of these vessels would allow us to conclude on the presence, or absence, of an ischemic stroke in the region of the middle cerebral artery. to answer the question asked, 20 participants who suffered a stroke will carry out a transtemporal ultrasound examination specifically for research in the 7 days following his stroke. the data obtained will be analyzed by the cnrs medical imaging laboratory, in order to characterize the presence of a stroke and to compare the data obtained with that of standard examinations (ct and mri).


Eligibility criteria:
inclusion criteria: * patient aged 18 and over * hospitalized patient with ischemic stroke in the deep territory of the middle cerebral artery * patient with lesion observable on mri * patient included between 24 hours and 7 days after the ischemic stroke * patient with a temporal window which allows soundproofing of the polygon of willis and the middle cerebral artery * patient having signed free, informed and written consent * patient affiliated to a social security system (excluding ame) exclusion criteria: * contralateral middle cerebral artery territory stroke or contralateral middle cerebral artery occlusion * patient with contraindication to doppler ultrasound with contrast (right-left shunt, severe pulmonary arterial hypertension) * patient with hypersensitivity to the active princip of sonovue (sulfur hexafluoride) or these excipients * patient with uncontrolled systemic hypertension * patient with respiratory distress syndrome * patient under guardianship or curatorship * pregnant or breastfeeding patient (positive blood pregnancy test during hospitalization) * patient with damaged skin at the temporal level * patient having presented in the 7 days preceding inclusion an acute coronary syndrome or suffering from unstable ischemic heart disease
tolerability/safety of intranasal azd8848 in healthy male volunteers and seasonal allergic rhinitis male patients out of season

Conditions: Healthy; Allergic Rhinitis

Summary: investigate safety/tolerability after a single dose intranasal administration of azd8848 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season


Eligibility criteria:
inclusion criteria: * history of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years * body mass index (bmi) between 19 and 30 kg/ m2 and a weight between 50 and 100 kg * no clinically relevant abnormal findings exclusion criteria: * acute illness which requires medical intervention * definite or suspected personal history of adverse drug reactions or drug hypersensitivity * clinical relevant disease or disorder (past or present) * a history of asthma

Keywords: healthy male allergic rhinitis tolerability safety intranasally healthy subjects
world bleeding disorders registry

Conditions: Hemophilia A; Hemophilia B; Von Willebrand Diseases

Summary: the wbdr is an international observational disease registry of patients with hemophilia. it will provide a platform for a network of hemophilia treatment centres (htcs) around the world to collect uniform and standardized patient data and guide clinical practice. with informed consent from the patient, the wbdr stores anonymous data about the person's disease, such as hemophilia type and severity, symptoms, and treatment.

the wbdr is a prospective, global registry of patients diagnosed with hemophilia a and b. following the success of a pilot study, implementation of the full scale wbdr is underway. the goals are to enroll at least 200 htcs from more than 50 countries, and at least 10,000 people with hemophilia, during the first five years, aiming for representation of patients from around the world and from all levels of access to care. minimal criteria for participation of htcs include access to reliable internet, human resources for data entry and commitment to long-term enrolment and follow-up of patients. the wbdr database is being developed through a collaboration between the wfh, karolinska institute and health solutions. by combining data from countries around the world, the wbdr will provide a large amount of real world data, on which researchers can address important scientific and clinical issues. the world bleeding disorders registry (wbdr) is intended to fill existing gaps in knowledge by collecting real world data on the patient clinical experience around the globe.

Eligibility criteria:
inclusion criteria: * patients of participating hemophilia treatment centres with hemophilia a or b, or von willebrand disease exclusion criteria: * none
gross motor function and living skills in cp

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is non-progressive disorder, which undergoes mishap to the developing brain and it affects a person's ability to move and maintain balance and posture. old name of cp is "little's disease".through social and community participation, children and youth with cerebral palsy (cp) form friendships, gain knowledge, learn skills, express creativity, and determine meaning and purpose in life. the purpose of this study is (1) to determine whether social and community participation of children and youth with cp differ based on age, sex, and gross motor function, and (2) to identify the types of activities in which social and community participation are highest

those participants will be excluded having any unstable medical condition that precluded safe community physical activity, any orthopedic or neurological surgery in the previous 6 months, moderate to profound intellectual disability, moderate to severe communication disability, severe visual impairment, any sensory impairment or psychological disorder. the tools that will be used are whodas 2.0(who disability assessment schedule), washington group short set of disability questions, child and adolescent scale of participation activities of daily living, functional mobility and participation. data will be analyzed on spss version 25, normality of the data will be checked and data will be presented in the form of descriptive statistics, mean, sd range correlation.

Eligibility criteria:
inclusion criteria: washington group on disability statistics (wg) score greater than or equal to 12. * children with age group of 6 to 12 years. * with diagnosis of cp. * whodas cognition - score 2.5. * mobility - score 2.5. * self-care - score 2.5 attending to one's hygiene, dressing, eating and staying alone. * getting along -score 2.5 interacting with other people. * life activities -score 2.5 domestic responsibilities, leisure, work and school. * participation - score 2.5 joining in community activities, participating in society exclusion criteria: any unstable medical condition that precluded safe community physical activity. * having any orthopedic or neurological surgery in the previous 6 months. * moderate to profound intellectual disability. * moderate to severe communication disability. * severe visual impairmen

Keywords: cerebral palsy childhood disablity gross and motor function participation quality of life
open-label study to assess the effect of omeprazole on the pharmacokinetics of velcade in patients with either advanced solid tumors or non-hodgkin's lymphoma.

Conditions: Tumors; Non-Hodgkins's Lymphoma

Summary: this is an open-label, randomized, multiple-dose, multicenter pharmacokinetics drug-drug interaction study in patients with advanced solid tumors, including non-hodgkin's lymphoma, who are in need of anti-tumor therapy. in addition, the impact of omeprazole on the pharmacodynamics of velcade will also be evaluated.


Eligibility criteria:
inclusion criteria:1) male or female at least 18 y/o 2)weigh \>/= 50 kg (110lbs) and a bmi of \ /= 3 mos; 4)karnofsky performance status \>/=70%; 5)women must be menopausal. 3)men must agree to use an acceptable method of contraception for the duration of the study.4)must sign an informed consent document indicating understanding of the purpose and procedures required for the study;5)informed consent for genetic testing 6)subjects have advanced solid tumor (including non-hodgkin's lymphoma).7)resolution of reversible toxicities considered related to any prior antineoplastic therapies before entry; 8)must be able to swallow capsules whole; - exclusion criteria:1)prior exposure to velcade.2)has known hypersensitivity or intolerance to omeprazole, boron, mannitol or heparin. 3)medical history of of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gi, endocrine, neurologic, rheumatologic, pyschiatric or metabolic disturbances. 4)uncontrolled diabetes. 5)history of hypotension or decreased blood pressure;6)uncontrolled or severe cardiovascular disease incl. myocardial infarction within 6 mos of enrollment; 7)history of alcohol/drug abuse. 8)presence of hiv antibodies, hepatitis c antibodies or hepatitis b. 9)active systemic infection requiring treatment; 10)pregnant or breastfeeding' 11)neuropathy \>/= gr.1; 12)transfusion dependence; 12)pre-planned surgeries or procedures that would interfere with conduct of study -

Keywords: patients with advanced solid tumors or non-hodgkins's lymphoma
ketamine patient-controlled analgesia for acute pain

Conditions: Acute Pain; Multiple Trauma; Fractures

Summary: this study will compare ketamine and hydromorphone as alternative patient-controlled interventions for trauma-related pain. patients receiving ketamine pca are expected to require less total and breakthrough opioid and to have similar or improved objective pain scores. patients receiving ketamine are also expected to have shorter duration of supplemental oxygen requirement, fewer episodes of oxygen desaturation, improved pulmonary toilet, lower use of antiemetics, and shorter times to first bowel movement. ketamine is further expected to be associated with decreased intensive care unit and hospital lengths of stay, faster time to maximum allowable ambulation, decreased opioid dosage at discharge, and lower report of chronic pain syndromes.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * total injury severity score greater than 9 * functioning intravenous catheter present per standard of care * patient planned to receive pca for acute pain per standard of care * patient ability to effectively use a pca device as assessed by the primary attending trauma service * negative pregnancy test for women of childbearing age exclusion criteria: * body mass index greater than 35 * history of active psychiatric disease * acute or chronic liver or renal failure * history of heart failure or coronary artery disease * patients with documented chronic pain syndrome who use opioids as maintenance medication in outpatient therapy * patients who abuse alcohol and are at high risk for alcohol withdrawal * intubated patients * glasgow coma scale score less than 13, or motor subscore less than 6 * documented allergy to ketamine, hydromorphone, or lorazepam * pregnancy * incarceration

Keywords: pain trauma
knowledge of students about vitamin a and assessment of eye manifestations in quranic schools (khalwai) khartoum state, sudan 2022

Conditions: Vitamin A Deficiency; Night Blindness

Summary: this is an observational study that aims to study vitamin a deficiency status, knowledge, and nutritional assessment among khalwa (quran boarding school) individuals. we want to assess the magnitude of the problem and put appropriate recommendations for it.


Eligibility criteria:
inclusion criteria: * all khalwa (quranic-boarding-school) dormitory residents of in east-nile province, khartoum state exclusion criteria: * anyone who refuses to participate in the study. * those who live with their families

Keywords: vitamin a deficiency night blindness quranic boarding school knowledge nutrition