Kornimate/medical-research-clean huggingface dataset:
obstructive sleep apnea and neurocognitive and cardiovascular function in children with down syndrome

Conditions: Down Syndrome; Obstructive Sleep Apnea Syndrome

Summary: many individuals with down syndrome (ds) have breathing problems during sleep. this is called obstructive sleep apnea syndrome (osas). osas is very common in individuals with down syndrome because of the shape of their face and tongue and because of their low muscle tone. osas can cause a lot of health problems including behavioral and learning problems as well as heart problems. the purpose of this research study is to look at the effects of treating osas in individuals with down syndrome with a machine called continuous positive airway pressure (cpap). the investigators want to see if treatment of osas improves learning, behavior and heart problems.

all individuals participating in the study will be evaluated for obstructive sleep apnea syndrome (osas) with a baseline sleep study. based on the results of the sleep study,individuals with osas will be randomly assigned into two groups. one group will receive continuous positive airway pressure (cpap) and the other intervention group will receive sham cpap(placebo) for four months. cpap is a machine with a mask that fits over the nose, is worn during sleep and helps keep the airway open. sham cpap (placebo) is a machine that looks and sounds like a cpap machine but does not give pressure so it does not treat osas. individuals with normal breathing during the sleep study will not receive a machine, and will serve as controls. individuals will also have baseline tests including blood tests, an echocardiogram (pictures of the heart), a walking test and learning tests. after 4 months, the baseline tests will be repeated in all participants. at the end of the study, all individuals with osas will get treatment.

Eligibility criteria:
inclusion criteria: 1. aged 8-20 years 2. down syndrome (based on the characteristic phenotype) 3. families provide informed consent and child provides assent exclusion criteria: 1. subjects and families who do not speak english well enough to undergo psychometric testing. 2. subjects living in institutions where there is no primary caregiver to participate in the neurocognitive/behavioral battery. 3. major chronic lung disease such as chronic aspiration. 4. previous or current cpap therapy. 5. participation in a weight loss program. 6. craniofacial or neuromuscular conditions other than those associated with ds. 7. untreated hypothyroidism. participants with normal thyroid function tests will be included in the study.

Keywords: down syndrome obstructive sleep apnea syndrome continuous positive airway pressure sham or placebo cpap
increlex treatment of children with chronic liver disease and short stature

Conditions: Growth Failure; Chronic Liver Disease

Summary: a major consequence of chronic liver disease in childhood is growth failure. this is because a chemical essential for growth called growth factor is created in the liver. lack of response to growth hormone in people with chronic liver disease is characterized by high levels of growth hormone and low levels of growth factors. this growth hormone resistance is reflected in a variety of factors including insulin resistance and low nutritional intake. unfortunately, growth hormone therapy has no effect for children with liver disease. in addition, failure of normal growth or malnutrition makes liver disease even worse in children, and growth hormone therapy is not likely to reverse this. a lack of proper nutrition is associated with hospitalizations and frequent complications. poor growth is a predictor of poor outcomes after liver transplantation. thus the management of children with liver disease remains a challenge. children who have successful orthotopic liver transplants (olt) show much improvement in some aspects of growth, including skin fold thickness, mid-arm circumference, and normalization of growth factor levels. however, some studies have recently reported that the growth of 15-20% of children remains poor even after a liver transplant. this can be explained by persistent abnormalities in growth factors after transplant. growth factor was found to be a good tool for prognosis in patients with chronic liver disease. studies showed that patients with liver cirrhosis and growth factor levels below normal values showed lower long-term survival rates compared with patients who had above normal values. this suggests that growth factor can be a good predictor of survival and early marker of poor liver function. in this case, aggressive feeding may modestly improve growth factor levels leading to improved growth but it is unlikely that effects will be optimal. the investigators propose that growth factor administration may have a positive effect that leads to better growth which is a major predictor of good outcome. to date, no reports study the use of growth factor in children with chronic liver disease. this study proposes to examine the effect of growth factor therapy in childhood chronic liver disease.


Eligibility criteria:
inclusion criteria: pre liver transplant patients with: * chronic liver disease * short stature (\< 5%) * low igf-1 (\<-1sds for age) * chronologic age 4-18 and bone age \< 14 for boys and \< 12 for girls (pre-pubertal) exclusion criteria: * status post transplant * evidence of malignancy * diabetes mellitus * participation in other clinical trials involving investigational products * treatment with growth hormone within 3 months * pregnancy * significant abnormality in clinical results * hypoglycemic at baseline * allergic to benzyl alcohol

Keywords: pre-pubertal children pre-transplant not treated with growth hormone for at least 3 months
non-invasive ventilation after extubation in hypercapnic patients

Conditions: Respiratory Failure

Summary: the purpose of this study is to assess the efficacy of noninvasive ventilation in the prevention of extubation failure and mortality in patients with chronic respiratory disorders and hypercapnic respiratory failure during spontaneous breathing.

background and aims: patients with chronic respiratory disorders, intubated and mechanically-ventilated in intensive care units (icu), often exhibit hypercapnia during the spontaneous breathing trial prior to extubation; this is associated to increased incidence of extubation failure and mortality. we will assess the efficacy of noninvasive ventilation (niv) in the prevention of extubation failure and mortality in these patients. design: prospective, randomized, controlled clinical trial with two groups: support with noninvasive ventilation, and conventional clinical management (control group). subjects: patients with chronic respiratory disorders, intubated and ventilated ³48 hours, with hypercapnia (paco2 \>45 mmhg) during the spontaneous breathing trial, ready to be extubated. interventions: random allocation into two groups: niv immediately after extubation during 24 hours, on conventional clinical management. clinical follow-up (incidence of extubation failure, reintubation, icu and hospital mortality, 90-day survival, complications associated to mechanical ventilation, icu and hospital length of stay). analyses of data: comparison between two groups (niv and control) in non-paired data design: quantitative variables (t-test, mann-whitney test, roc curves), qualitative or categorical variables (chi square, fisher's exact test), and kaplan-meier estimate of survival curves).

Eligibility criteria:
inclusion criteria: * chronic respiratory disorders with invasive mechanical ventilation * hypercapnic respiratory failure during successful spontaneous breathing trial exclusion criteria: * face or cranial trauma or surgery * recent gastric or esophageal surgery * tracheostomy or other upper airway disorders * upper gastrointestinal bleeding * excess respiratory secretions * lack of collaboration

Keywords: non-invasive ventilation hypercapnic respiratory failure mechanical ventilation respiratory failure after extubation
safety and tolerability after four weeks of treatment with azd1656 in patients with type 2 diabetes

Conditions: Type II Diabetes

Summary: the purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of azd1656 in patients with type 2 diabetes mellitus treated with insulin


Eligibility criteria:
inclusion criteria: * type ii diabetes patients, female with non child-bearing potential * subjects with t2dm diagnosis for at least one year, treated with insulin alone or insulin in combination with other anti-diabetic drugs. subjects must have been treated with insulin the last 3 months prior to enrolment (screening) * hba1c \<11% at enrolment (screening) (hba1c value according to international diabetes control and complications trial \[dcct\] standard). * fpg in the range of 7.0 to 13.0 mmol/l (126 to 234 mg/dl) exclusion criteria: * history of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease * use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening) and use of potent cyp450 inhibitors, eg, ketoconazole and macrolide antibiotics within 14 days before randomisation. * any clinically significant abnormality identified on physical examination, laboratory tests or ecg, which in the judgment of the investigator would compromise the patients' safety or successful participation in the clinical study.

Keywords: type ii diabetes
the impact of minimally invasive restorative techniques on dental pain in pregnant women

Conditions: Dental Pain; Patient Satisfaction

Summary: the aim of the present study was to compare the effectiveness of chemo-mechanical caries removal using papacarie-duo and atraumatic restorative treatment (art) in reducing dental pain in pregnant women.

a randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting family health centers in alexandria, egypt with dental pain due to caries not extending to pulp who were randomly assigned into papacarie-duo group (n=82) and art group (n=80) after stratification by number of treated surfaces

Eligibility criteria:
inclusion criteria: * pregnant females in the first or second trimester * having at least mild dental pain as identified by a score of at least 5mm on a visual analogue scale (vas) 100-mm-long * having at least one carious lesion involving dentine clinically classified as a shallow or medium cavity. this cavity should be accessible to hand instruments (international caries detection and assessment system (icdas) score= 5 or 6. exclusion criteria: * pregnant women with acute pulpitis, swelling or fistula. * uncooperative patients. * patients with severe gingivitis (gingival index (gi) score=3). * patients who are unable to read and/or write and those who refused to participate.

Keywords: minimally invasive dentistry
the role of endothelin in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the purpose of the study is is to determine the effect, on the lung circulation, of bq-123, an investigational compound which is not approved by the fda.

endothelin levels are increased in patients with pulmonary hypertension. we wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.

Eligibility criteria:
inclusion criteria: * healthy volunteers or known diagnosis of pulmonary hypertension exclusion criteria: * hypertension due to other reasons (not pulmonary)

Keywords: primary pulmonary hypertension secondary pulmonary hypertension due to left heart failure secondary pulmonary hypertension due to other causes patients without pulmonary disease or pulmonary hypertension
proportional dose of sublingual fentanyl tablet based on daily opioid requirement

Conditions: Cancer Pain; Breakthrough Pain

Summary: proportional dose of sublingual fentanyl tablet (narco®) based on daily opioid requirement versus intravenous pca for breakthrough cancer pain: a prospective, randomized, open-label, noninferiority trial.

based on the previous around-the-clock analgesic demand compared to iv pca in cancer pain patients to prepare the basis for the administration of fentanyl sublingual tablets with an initial dose.

Eligibility criteria:
inclusion criteria: * age 19-80 * cancer pain * admission for the control of cancer pain or consultation for the treatment of cancer pain * stable vital sign * ecog status ≤ 3 for more than 1 or 2 months * opioid-tolerant state * no history of using sublingual fentanyl exclusion criteria: * noncancer pain * opioid naive * baseline nrs pain score\> 4 * current using sublingual fentanyl * difficult to assess cancer pain * no evidence of disease(cancer) * planned surgical resection of cancer * allergy to fentanyl * severe renal and/or liver function * severe respiratory depression or uncontrolled copd
3tc (lamivudine; gr109714x) open-label program

Conditions: HIV Infections

Summary: to make lamivudine (3tc) available to patients with progressive, symptomatic hiv disease who cannot participate in a controlled clinical trial and who are refractory or unable to tolerate other therapies. to collect data pertaining to the safety of 3tc at two dose levels. to evaluate the effect of 3tc on markers of hepatitis b in co-infected patients at five to ten selected sites.

patients 12 years and older are randomized to receive one of two doses of 3tc for a duration determined by the patient's physician or until termination of the program. patients \< 12 years receive a lower dose of 3tc. patients are followed monthly. for selected sites only, serum samples are collected every 3 months from patients identified as hbsag positive. per 02/28/95 amendment: patients enrolled prior to 3/1/95 may remain on their assigned monotherapy dose or change to combination therapy with 3tc and zidovudine.

Eligibility criteria:
patients must: * have progressive, symptomatic hiv disease. * have a mean cd4 count \<= 99 cells/mm3 for adults and \<= 300 cells/mm3 for children (original design was cd4 count \<= 300 cells/mm3 for both adults and children). * be unable to participate in a controlled trial. * be refractory to or unable to tolerate other therapies. * be able to attend clinic on a monthly schedule. * have consent of parent or guardian if under the age of consent. note: * if a pregnant or breast-feeding woman requests enrollment, her physician should contact glaxo staff directly to discuss the case. practice of unsafe sex.

Keywords: drug therapy, combination acquired immunodeficiency syndrome aids-related complex antiviral agents zidovudine
comparison of gut microbiota, inflammation and symptoms following allogeneic hsct

Conditions: Graft vs Host Disease; Graft Versus Host Disease; Hematopoietic Stem Cell Transplantation; Peripheral Blood Stem Cell Transplantation

Summary: the purpose of this study is to examine the gut bacteria, levels of peripheral blood inflammation markers, and symptoms in patients with and without chronic graft-versus-host disease (cgvhd) following allogeneic hematopoietic stem cell transplant (allo-hsct). the hypothesis is that individuals with cgvhd will have lower levels of microbial diversity, higher levels of inflammatory metabolites in stool and peripheral measures, and higher levels of symptoms than individuals without cgvhd.

this study will recruit 40 (20 with cgvhd and 20 without cgvhd) adults from the bone marrow transplant program at university of florida health shands cancer hospital. after signing informed consent, participants will fill out questionnaires and have a blood sample collected from a vein in the arm. participants will be given a stool collection kit with instruction and will return the sample via the mail. data will be collected and securely stored in a system used by the cancer center for research. descriptive statistics will be used to report individual, clinical factors, and symptoms. knowledge gained from this study will provide preliminary data for future longitudinal studies to examine biological pathways for the development, severity and/or duration of cgvhd and symptom outcomes in individuals following allo-hsct impacting quality of life.

Eligibility criteria:
inclusion criteria: * group 1: adults (\> 18 years of age) within 3 months to 3 years of receiving allogeneic hematopoietic stem cell transplant (allo-hsct) diagnosed with cgvhd; * group 2: adults (\> 18 years of age) within 3 months to 3 years of receiving allo-hsct without a diagnosis of cgvhd; and * all participants must be able and willing to complete paper and pencil questionnaires, provide a blood and stool sample, and be able to give informed consent. exclusion criteria: * diagnosed with a significant secondary inflammatory disease such as multiple sclerosis, crohn's disease, rheumatoid arthritis or secondary cancer; * history of a major psychological disorder requiring psychotropic medications or initiation of antidepressants within 30 days of enrollment; * incarcerated or pregnant; or * any other condition that in the opinion of the principal investigator (pi) may compromise study participation will not be eligible for participation in this study.

Keywords: hematopoietic stem cell transplantation graft versus host disease
vegfrs predict bevacizumab benefit in advanced non small cell lung cancer

Conditions: Non Small Cell Lung Cancer; Brain Metastasis

Summary: a. vegfrs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer

1. non small cell lung cancer (non squamous carcinoma) 2. ecog 0-1 3. from 18-75 years old

Eligibility criteria:
inclusion criteria: * non squamous cell non small cell lung cancer * with measurable disease * ecog 0-1 exclusion criteria: - patients received surgery in recent 4 weeks
huc mesenchymal stem cells (19#isclife®-csd) therapy for patients with healing poor after uterus injury

Conditions: Uterus; Injury

Summary: the purpose of this study is verify the efficacy and safety of human umbilical cord mesenchymal stem cells (uc-msc) therapy for patients with healing poor after uterus injury, and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in healing poor after uterus injury disease

this is a random, open label, and self-control experiment. 10 patients are selected and sign consent forms, then divided into one group. doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, and so on.), evaluate the symptom of healing poor after uterus injury (menstrual conditions, visual analogue scale, pregnancies). all patients receive laboratory and image examination as baseline. then, cell treatment will be given based on the clinical protocol. doctors have follow-up visit on 3 and 6 month after treatment, and do efficacy evaluation.

Eligibility criteria:
inclusion criteria: * female, with bmi 18-24 kg/m\^2 * meet the clinical standard of healing poor after uterus injury * non smoker * do not accept stem cells treatment in 6 months * participants or their family members sign the consent form of this study exclusion criteria: * pregnant or breast feeding women * age \ 40 * refuse to sign the consent form * patients with underlying risk of medical disease history: history of diabetes, serious cardiovascular disease, severe infection, alimentary tract hemorrhage, etc. * serum with hiv, syphilis antibody positive * severe mental disease, cognitive disorder patients * other severe system or organ organic disease * participate other clinical experiments in 3 months * ovarian and pituitary dysfunction diseases * with some other conditions that doctor propose not to participate

Keywords: healing poor after uterus injury, mesenchymal stem cell
radvax™: a stratified phase i/ii dose escalation trial of hypofractionated radiotherapy followed by ipilimumab in metastatic melanoma

Conditions: Metastatic Melanoma

Summary: the primary objective is to determine the maximum tolerated hypofractionated radiotherapy dose (mtd) to a solitary metastatic focus ('index lesion') when followed by ipilimumab, in metastatic melanoma patients without brain involvement the secondary objectives are to determine late toxicity, immune-related clinical responses and immune pharmacodynamic changes after hypofractionated radiotherapy followed by ipilimumab


Eligibility criteria:
inclusion criteria * patient \> 18 years old * histologically confirmed diagnosis of melanoma * previously treated or previously untreated metastatic melanoma by ajcc staging criteria * presence of an index lesion \> 1 cm amenable to hypofractionated radiotherapy and at least one other additional lesion that can be followed for response using recist criteria * ecog performance status 0 or 1 * signed informed consent document * ability to tolerate stereotactic body radiation therapy (e.g. lie flat and hold position for treatment) exclusion criteria * prior systemic therapy within 14 days of study enrollment. patients must be adequately recovered from prior systemic therapy side effects as deemed by the pi. * clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc) * presence or history of central nervous system metastasis (including brain) * long-term use of systemic corticosteroids * prior rt that precludes the delivery of hypofractionated radiotherapy

Keywords: previously untreated previously treated bone, lung, liver or subcutaneous involvement nodal involvement without evidence of brain involvement
a trial to compare two methods of obtaining tissue for diagnosis of sarcoidosis namely the conventional method or the ultrasound guided method

Conditions: Sarcoidosis

Summary: this trial compares the yield of ctbna (conventional transbronchial needle aspiration) versus the ebus-tbna (endobronchial ultrasound guided tbna) for obtaining cytology when they are combined with endobronchial biopsy and transbronchial lung biopsy and rapid onsite examination (rose) of the obtained smears in the diagnosis of suspected sarcoidosis patients visiting our hospital for evaluation of mediastinal lymphadenopathy.

this study is investigator initiated, prospective, unblinded randomized study comparing conventional tbna with ebus-tbna for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis when combined with transbronchial lung biopsy and endobronchial biopsy. it will be conducted on 80 consecutive patients with suspected sarcoidosis presenting to department of pulmonary medicine and sleep disorders in aiims (all india institute of medical sciences), new delhi. this study will help to know whether ebus (endobronchial ultrasound guided) or conventional tbna is better for obtaining tissue samples from mediastinal lymph nodes for the diagnosis of sarcoidosis. it will also help to know the value of adding rapid onsite evaluation of the cytology smears to both the procedures. it will also help to determine the overall yield of different procedures when they are combined for obtaining tissue samples for a diagnosis of sarcoidosis.

Eligibility criteria:
inclusion criteria: * age \> 18 years and suspected stage 1 (mediastinal or hilar lymphadenopathy (lap)) or stage 2 ( lap and parenchymal abnormalities) sarcoidosis * significant mediastinal lap (short axis diameter more than 10mm) * lymph node (ln) enlargement in station 4, 7, 10 or 11 and ct chest findings consistent with sarcoidosis. * with or without supportive evidence of sarcoidosis - hypercalcemia, calciuria, raised ace levels or restriction/obstruction on pulmonary function tests (pft). exclusion criteria: * obvious other organ involvement with possibility to confirm granuloma with minimally invasive diagnostic procedure (skin biopsy, superficial lymph nodes, lofgren's syndrome) * sarcoidosis stage 3 and 4 * mediastinal nodes less than 10 mm in short axis diameter * absence of right paratracheal and subcarinal lymph node enlargement more than 1 cm in short axis diameter * those who received empiric steroid for \>2 weeks in preceding 3 months * contraindication to bronchoscopy and tbna (coagulopathy, hypoxemia) * unwilling to give consent