Kornimate/medical-research-clean huggingface dataset:
xw014 in healthy subjects and patients with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase 1, randomized, double-blind, placebo-controlled, first-in-human (fih) study to evaluate the safety, tolerability, food effect (fe), pharmacokinetics (pk), and pharmacodynamics (pd) of orally administered xw014 in healthy participants and patients with t2dm. this study will consist of 4 parts: a single ascending dose (sad) part in healthy subjects (part a), and multiple ascending dose (mad) parts in healthy subjects with elevated bmi (part b and part b-ext) and patients with t2dm \[optional\] (part c).

part a - sad, including fe cohort: healthy participants with bmi in the range of ≥18.5 kg/m2 to ≤35.0 kg/m2 will be randomized to receive a single oral dose of either xw014 or placebo in each of the planned sad cohorts. part b and part b-ext - mad in healthy participants with elevated bmi: healthy subjects with bmi in the range of ≥30 kg/m2 to ≤40.0 kg/m2 will be randomized to receive oral doses of xw014 or placebo in each of the planned mad cohorts. part c - mad in patients with t2dm: patients with t2dm for at least 6 months, having hemoglobin a1c (hba1c) in the range of 6.5% to 8.5% will be randomized to receive oral doses of xw014 or placebo in each of the planned mad cohorts.

Eligibility criteria:
inclusion criteria: 1. ability and willingness to participate in the study, give written informed consent, and comply with the study restrictions and all protocol procedures 2. sex: male or female 3. weight: \>50 kg, inclusive, at screening 4. age: 1. for part a 18 to 70 years, inclusive, at screening 2. for part b, part b-ext, and c 18 to 55 years, inclusive, at screening 5. body mass index 1. for part a: ≥18.5 kg/m2 and ≤35.0 kg/m2, inclusive, at screening 2. for part b and part b-ext: ≥30.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening 3. for part c: ≥25.0 kg/m2 and ≤40.0 kg/m2, inclusive, at screening 6. patients with t2dm for at least 6 months, having hba1c of 6.5% to 8.5% (part c) key exclusion criteria: 1. history or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurologic, renal, pancreatic, immunologic, dermatologic, endocrine, genitourinary, or hematologic system 2. uncontrolled hypertension 3. history of type 1 diabetes mellitus 4. history or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis 5. personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 or subjects with suspected medullary thyroid carcinoma 6. existence of any surgical or medical condition that, in the judgment of the investigator, might interfere with the absorption, distribution, metabolism, or excretion of the investigational product
a clinical trial to assess the safety & efficacy of the treatment of patients with metastasis from malignant melanoma - treatment consists of the substances lomustine (capsules) & cytarabine (injected into an area near the spinal cord), accompanied by radiotherapy of the brain

Conditions: Leptomeningeal Metastasis From Malignant Melanoma

Summary: the purpose of this trial is to test the safety and tolerance of the combination therapy with cytarabine, lomustine and radiotherapy in patients with leptomeningeal metastasis from malignant melanoma.


Eligibility criteria:
inclusion criteria: * malignant melanoma (including melanoma of unknown primary site, recurrent and pretreated systemic melanoma and/or melanoma with parenchymal cns metastases) with leptomeningeal metastasis as demonstrated by a positive csf (cerebrospinal liquor) cytology and/or by the presence of characteristic signs and symptoms of leptomeningeal metastasis supported by an mri scan indicating the presence of meningeal tumour * csf flow abnormalities must be excluded * males or females ≥ 18 years of age * karnofsky performance status \> 50% * adequate organ function (adequate bone marrow reserve, adequate liver function, adequate renal function. adequate blood clotting) exclusion criteria: * unresected parenchymal brain metastases with a diameter \> 3 cm * prior non melanoma malignancy (unless adequately treated carcinoma in situ of the cervix or non melanoma skin cancer) * prior intrathecal chemotherapy * prior treatment with systemic cytarabine or nitrosureas * the patient ist pregnant or breast feeding * severe, active co-morbidities
a phase 2 study of jnt-517 in adolescent participants with phenylketonuria

Conditions: Phenylketonuria (PKU)

Summary: the goal of this phase 2, randomized study is to assess the safety, tolerability, and pharmacokinetics (pk) of oral jnt-517 in adolescents (12 to less than 18 years of age) with pku. participants will receive either jnt-517 or placebo and will be blinded to their treatment assignment. participants will have a 4 in 5 (or 80%) chance of receiving jnt-517. the study will last for up to 63 days including a screening period, treatment period and follow-up period for safety. participants will: * take 75 mg jnt-517 or a placebo bid (2x per day) for 28 days * visit the clinic or have a mobile health nurse visit your home for checkups and tests * collect urine sample at home and bring to clinic on specified days * keep a food diary 3 days before each study visit


Eligibility criteria:
key inclusion criteria: 1. males and females 12 to less than 18 years of age, inclusive on day 1. 2. clinical diagnosis of pku. 3. ability to swallow tablets. 4. average of 2 plasma phe levels during the screening period greater than 360 μm and no plasma phe level less than 300 μm. 5. body weight equal or greater than 45 kg and body mass index less than 40 kg/m2. 6. females of childbearing potential must practice sexual abstinence or agree to use 2 highly effective contraceptive methods. 7. capable of giving signed informed consent (emancipated minors) or parent/legal guardian to provide informed consent and the participant to give assent and confirm ability to comply with study procedures. key exclusion criteria: 1. any acute or chronic medical condition that would prevent the participant from complying with the procedures or place the participant at risk if they participate in the study. 2. positive for hepatitis b or c or human immunodeficiency virus. 3. any history of malignancy in the last 5 years, excluding nonmelanoma skin cancer. 4. any history of liver disease. 5. any history of cataracts or more than minimal cataracts observed during the screening ophthalmologic examination. 6. any surgical or medical conditions that may affect study drug absorption, distribution, metabolism, or excretion. 7. creatinine clearance less than 90 ml/min by cockcroft-gault formula. 8. history of drug or alcohol abuse in the last year 9. current, recent, or suspected infection within 14 days of screening of sars cov 2/covid 19. 10. participation in another investigational drug trial within 30 days or, if known 5 half-lives of investigational drug (whichever is longer). 11. unable to tolerate oral medication. 12. allergy to jnt-517 or any component of the investigational product. 13. received greater than 50 ml of blood or plasma within 30 days of screening or greater than 500 ml of blood or plasma within 60 days of screening.

Keywords: pku
tissue procurement for gastric cancer, gastrointestinal stromal tumors (gist), esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer in patients undergoing surgery or biopsy

Conditions: Gastric Cancers

Summary: the purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, gist, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. to collect and store blood samples from patients with gastric cancer, gist, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. to create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. to create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, gist, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. to grant access to dr kindler, dr. salgia, and dr. catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as met and ron, receptor tyrosine kinase family members, stats, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of gi cancers. examples of molecular testing include evaluation of dna mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. these studies will be correlated with clinical information as stated above.


Eligibility criteria:
inclusion criteria: * any patient diagnosed with gastric (stomach) cancer, esophageal (foodpipe) cancer, pancreas cancer, liver cancer, biliary (gallbladder) cancer, gastrointestinal stromal tumor, peritoneal mesothelioma (cancer in the lining of the abdomen), neuroendocrine (of or relating to the cells that release a hormone into the blood in response to a neural stimulus) tumor, anal cancer or colorectal cancer cancer that requires you to undergo a surgical or diagnostic procedure.
the assessment of right ventricular contractility in response to sildenafil

Conditions: Hypertension

Summary: the primary objective of this study is to examine the effects of sildenafil, administered during cardiac catheterization, on right ventricular contractility in children with pulmonary arterial hypertension.

the effectiveness of sildenafil as a pulmonary vasodilator in children with heart disease was first reported in detail during cardiac catheterization and postoperatively in 2003. it is now used frequently for long-term treatment of children with pulmonary arterial hypertension at the hospital for sick children and it is now a routine part of the hospital's testing protocol for all patients being evaluated for pulmonary hypertension in the cardiac catheterization laboratory. the beneficial effects of sildenafil in pulmonary hypertension are thought to result predominantly from relative vasodilatory and antiproliferative effects on the pulmonary vasculature. on the basis of early data showing lack of significant pde5 expression in the normal heart, pde5 was thought to be expressed in the coronary vessels but not in the human myocardium. very recently, it was reported for the first time that pde5 is markedly upregulated in hypertrophied right ventricular myocardium in humans and that in the rat pde5 inhibition with sildenafil increases contractility in hypertrophied right ventricular myocardium but not in normal right ventricle, which lacks pde5 expression. the assessment of right ventricular contractility in humans is a challenge, but we have developed several techniques that are recognized as 'state of the art' assessment of right ventricular function. the purpose of this study is to examine the effects of sildenafil, which is routinely administered during cardiac catheterization to assess pulmonary vascular resistance, on right ventricular contractility in children with pulmonary arterial hypertension.

Eligibility criteria:
inclusion criteria: * significant pulmonary arterial hypertension (mean pulmonary artery pressure \> 25 mm hg) * patients aged 4-18 years * routine cardiac catheterization clinically indicated for deciding therapeutic treatment * informed assent/consent from patient/parent exclusion criteria: * suprasystemic pulmonary artery pressures * evidence of right heart failure * history of ventricular arrhythmia * known vascular access arrhythmia * contraindication to sildenafil * concurrent inotropic / pde administration * other medical, psychological or social circumstances which complicate a regular participation in the study, and/or increase the risk for the patients themselves * no consent/assent * pregnancy or unwillingness to comply with contraceptive advice

Keywords: pulmonary arterial hypertension pediatrics sildenafil catheterization right ventricular contractility
examining the effects of a telehealth self-management intervention in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the objective of this study is to conduct a randomized controlled trial to examine the effectiveness of a telehealth intervention that supports individuals in managing fatigue and increasing physical activity (pa) behavior in individuals with multiple sclerosis (ms). the hypothesis is that a fatigue management plus physical activity intervention will significantly improve fatigue, quality of life, physical function, and community integration.

the long-term objective of this study is to use a telehealth intervention approach to reduce the devastating effects of the reciprocal relationship between fatigue and inactivity on quality of life and participation in life roles in people with multiple sclerosis (ms). chronic fatigue and inactivity are common problems in persons with ms, and the reciprocal relationship between fatigue and inactivity may have negative synergistic effects on quality of life and participation in life roles. the proposed study is novel in that it represents a multi-disciplinary effort to merge two promising lines of ms research: fatigue management and pa promotion. the proposed fatigue management plus pa intervention (fm+) will consist of incorporating a modified teleconference version of packer et al.'s empirically-tested fatigue management program with innovative, yet simple approaches to promote lifestyle pa by encouraging goal-setting and self-monitoring with a pedometer. ambulatory individuals with ms will be recruited and randomized into one of three telehealth interventions: social support intervention, pa-only intervention, and fm+.

Eligibility criteria:
inclusion criteria: * a physician-confirmed diagnosis of ms exclusion criteria: * exercise more than 90 minutes per week * pregnant * metabolic or cardiopulmonary disease that puts patient at high risk for engaging in a home exercise program (patients with controlled diabetes and high blood pressure will still be considered eligible) * four or more falls in the past 6 months * be able to walk 25 feet with or without a cane or walker * severe cognitive deficits * a condition besides ms that had lead to hospitalization in the past year

Keywords: exercise self care fatigue
evaluation of bone union following anterior cervical fusion using a novomax™

Conditions: Intervertebral Disk Degeneration; Intervertebral Disk Displacement

Summary: the purpose of this study is to evaluate the efficacy and safety of novomax™ in anterior cervical interbody fusion - comparison of novomax™ versus chronos®.


Eligibility criteria:
inclusion criteria: * the patient who is expected to receive anterior cervical discectomy and fusion operation. * volunteer for this study with written consent. exclusion criteria: * patient with cervical spine fracture, infection and malignant tumor * below -3.5 t-score by dexa bone densitometry * patient who is not suitable for this study judged by principal investigator

Keywords: anterior cervical discectomy and fusion novomax bioactive glass-ceramic intervertebral spacer
serial changes of soluble triggering receptor expressed on myeloid cells-1 (strem-1) levels in patients with acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: the purpose of this study is to determine the impact of the serum soluble triggering receptor expressed on myeloid cells-1 (strem-1) on etiology and prognosis of acute respiratory distress syndrome (ards)

the triggering receptor expressed on myeloid cells-1 (trem-1), a member of the immunoglobulin superfamily, is upregulated on phagocytic cells in the presence of bacteria or fungi infection and weakly expressed in samples from patients with noninfectious inflammatory disorders. in addition, trem-1 is shed from the membrane of activated phagocytes and can be found in a soluble form (strem-1) in body fluids. the level and serial change of a serum strem-1 from cirtical ill patients has been shown to be a good diagnostic and prognostic indicator of ventilation associated pneumonia (vap) and severe sepsis.

Eligibility criteria:
inclusion criteria: * fulfill clinical diagnosis of ards * require mechanical ventilation support exclusion criteria: * pregnant * immunocompromised

Keywords: acute respiratory distress syndrome soluble triggering receptor expressed on myeloid cells-1 prognosis
bioequivalence study of torrent pharmaceutical ltd.'s montelukast sodium chewable 5mg tablet under fed conditions

Conditions: Healthy

Summary: objective: primary objective of the present study was to compare the single dose bioavailability of torrent's montelukast sodium chewable 5mg tablet and innovator's(merck)singulair chewable 5mg tablet. dosing periods were separated by a washout period during fed study. study design: open-label, randomised, two period, two treatment, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: the volunteers were included in the study based on the following criteria: * sex: male. * age: 18 - 45 years. * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. * oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
vision-based assessment of joint extensibility in ehlers danlos syndrome

Conditions: Ehlers-Danlos Syndrome

Summary: ehlers danlos syndrome (eds) is a heterogenous group of genetic disorders with 13 identified subtypes. hypermobile eds (heds), although the most common subtype of eds, does not yet have an identified genetic mutation for diagnostic confirmation. generalized joint hypermobility (gjh) is one of the hallmark features of heds. the scoring system used in measurement of gjh was described by beighton. the beighton score is calculated using a dichotomous scoring system to assess the extensibility of nine joints. each joint is scored as either hypermobile (score = 1) or not hypermobile (score = 0). the total score (beighton score) can vary between a minimum of 0 and a maximum of 9, with higher scores indicating greater joint laxity. while there is moderate validity and inter-rater variability in using the beighton score, there continue to be several challenges with its widespread and consistent application by clinicians. some of the barriers reported in the literature include: i) in open, non-standardized systems there can be significant variation in the method to perform these joint extensibility tests including assessing baseline measurements, ii) determining consistent and standard measurement tools/methodology e.g. goniometer use can vary widely iii) assessing the reliability of the cut off values and, iv) performing full assessment prior to informing patients of possible classification of gjh positivity (low specificity and low positive predictive). inappropriate implementation of tests to assess gjh results in inaccurate identification of gjh and potentially unintended negative consequences of making the wrong diagnosis of eds. the objective of this study is to create a more robust and valid method of joint mobility measurement and reduce error in the screening of eds through use of a smartphone-based machine learning application systems for measurement of joint extensibility. the project will: i) create a smart-phone enabled visual imaging app to assess the measurement of joint extensibility, ii) assess the feasibility of using the smart-phone app in a clinical setting to screen potential eds patients, iii) determine the validity of the application in comparison to in person clinical assessment in a tertiary care academic eds program. if successful, the smart-phone application could help standardize the care of potential eds patients in an efficient and cost-effective manner.


Eligibility criteria:
inclusion criteria: * all patients seen in the goodhope eds clinic at toronto general are eligible for inclusion, regardless of their presenting diagnosis or the results of their assessments exclusion criteria: * patients who do not consent to participate will not be included (participants may withdraw consent at any time)

Keywords: ehlers-danlos syndrome computer-vision video smartphone beighton score joint range of motion