Kornimate/medical-research-clean huggingface dataset:
is recombinant growth hormone therapy associated with increased intraoccular pressure?

Conditions: Growth Hormone Treatment; Glaucoma

Summary: recombinant growth hormone is a common therapy in the pediatric population. a number of associated side effects have been described. several years ago, a case report was published concerning a child that was treated with rgh and developed acute glaucoma. to date no study has evaluated the connection.


Eligibility criteria:
inclusion criteria: * age 6-18 years * treatment with recombinant growth hormone exclusion criteria: * underlying chronic diseases * family history of eye diseases * elevated occular pressure prior to starting treatment
biomarker feedback on health and wellbeing and exercise adherence following a 6 month weight management course

Conditions: Exercise Training; Biomarkers

Summary: participants who have signed up to the watford football club community and education trust weight management programme called shape up will be approached to see if they would like to take part in this research study. their participation in the shape up programme will not be affected if they do not choose to opt in to the research component. fifty participants will be recruited and randomised in to one of two groups. one group will be the control group and they will undertake the shape up programme as normal and will be asked to complete some questionnaires in week 1, week 12 and then at 12 weeks follow up. the intervention group will be asked to complete the same questionnaires and will also have a venous blood sample taken at week 1, 12 and then at 12 weeks follow up. this is for measures of cholesterol, sugar, vitamin d, vitamin b12 and iron. the participants will receive a report from a medical doctor in layman terms on these results a week later and will have access to their data on an online portal set up by medichecks. the weight management programme is based on a behaviour change programme where the participants attend a 90-minute session for 12 weeks, and they are then supported for another 12 weeks following the end of the supervision. the participants have weight and bmi measured at week 1, 12 and 12 weeks follow up. each session consists of an education component followed by an exercise component. initially, the education part is longer and the exercise is shorter, but as the programme progresses the education part becomes shorter and the exercise longer. the education programme includes topics such as healthy eating, increased physical activity and stress. the exercise programme includes whole body activities such as circuit training as well as other group exercise such as football. the questionnaires will include the treatment self-regulation questionnaire which will identify the motivation behind the participants' health. a general health questionnaire which is a subjective measure of health (euro qol eq-5). the mental component summary of the 12- item short form (sf12) which measures emotional quality of life. physical activity will be measured through the short active lives questionnaire. all these questionnaires have been attached as appendices. all participants will complete an exit telephone interview from the study to determine qualitative feedback on their experience of the study and to explore whether the biomarkers influenced their motivation to change their lifestyle. some example questions have been attached. this is just a feasibility study, therefore no hypothesis testing will be undertaken.


Eligibility criteria:
inclusion criteria: * bmi \>28 * no injuries exclusion criteria: * injury preventing from participating in exercise * fear of needles * does not pass a physical activity readiness questionnaire

Keywords: exercise training weight management biomarkers
safety, tolerability and pharmacokinetic profile of syl1801 eye drops

Conditions: Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers; Choroidal Neovascularization

Summary: study of the safety, tolerability and pharmacokinetic profile of different doses of syl1801 eye drops in healthy volunteers.


Eligibility criteria:
inclusion criteria: * signed informed consent * body mass index (bmi) between 19.5 and 29.0 kg/m2 * intraocular pressure (iop) \<=21 mmhg * best corrected visual acuity (bcva) \>= 70 etdrs * normal corneal and conjunctival assessment * normal funduscopy exclusion criteria: * pregnant or breastfeeding females or those with a positive pregnancy test. females of childbearing potential who will not use a medically acceptable contraceptive method * current relevant diseases according to the investigator's judgement. * previous relevant chronic processes according to the investigator's judgement * relevant visual alterations according to the investigator's judgement * administration of systemic medications * case history of hypersensitivity to medicinal products or any other allergic process * participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.

Keywords: oligonucleotide sirna (small interfering ribonucleic acid) eye drops wet amd (age-related macular degeneration)
evaluate the safety and diagnostic advantages of tilt down verses standard horizontal colonoscopy positioning

Conditions: Diverticulosis

Summary: a tortuous sigmoid colon makes colonoscopy difficult. the purpose of this study was to systematically evaluate the diagnostic utility and incidence of adverse events in women using standard horizontal compared to lateral tilt down positioning for colonoscopy.

this was a prospective, randomized study. subjects who provide informed consent and present to the offices of specialists in gastroenterology for colonoscopy will be randomized in a 1:1 distribution to either left lateral tilt down versus left lateral horizontal positioning to initiate colonoscopy. demographic data as well as routine information regarding the colonoscopy was filled out during or at the end of each procedure. in addition, the following parameters were assessed, and compared between groups: 1. occurrence of complications related or possibly related to the colonoscopy procedure 2. scope insertion time 3. pain during and after the procedure the subjects' participation was limited to the duration of the colonoscopy, which is typically less than 60 min and a follow up by telephone 24 hours later to assess the occurrence of complications.

Eligibility criteria:
inclusion criteria: * ability to understand and sign consent * women and men with a bmi (body mass index) \<35 kg/m2 * age 18 - 90 years * no liquids by mouth for ≥2 hours * no solid food for ≥8 hours exclusion criteria: * inability to provide informed consent * morbid obesity (bmi ≥35) * pregnancy * uncontrolled gastroesophageal reflux disease * gastroparesis * scleroderma * achalasia * crohn's disease * ulcerative colitis * history of a colon resection * parkinson's disease * brain tumor * multiple sclerosis * ischemic optic neuropathy * glaucoma * active pulmonary infection * liquid intake \<2 hours * solid food intake \<8 hours prior to the procedure * intra-procedure findings of a stricture resulting in an incomplete colonoscopy or boston bowel preparation scores of \<6

Keywords: colonoscopy technique tilt insertion safety efficacy
metabolic disturbances in polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: the scope of the study was to investigate different metabolic aspects that may lead to or are a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome (pcos). we use gold standard methods for evaluation of insulin resistance. we take muscle and fat biopsies for investigation of gene expression of different cytokines associated with insulin resistance. we investigate the incretin hormones gip and glp-1. these two hormones play a central role in glycemic control, and diabetic subjects are known to have alterations in their incretin hormones. the incretin hormones have not previously been investigated in women with pcos.


Eligibility criteria:
inclusion criteria: * premenopausal women that meet the rotterdam criteria for pcos (bmi \< 40) * age and bmi matched control women that do not have any signs or symptoms of pcos exclusion criteria: * bmi \> 40. mani fest diabetes or other known diseases

Keywords: polycystic ovary syndrome (pcos)
humanistic burden of (fsgs) focal segmental glomerulosclerosis and igan (immunoglobulin a nephropathy)

Conditions: Focal Segmental Glomerulosclerosis; Immunoglobulin A Nephropathy

Summary: the aim of this observational study is to assess humanistic burden among adults and children/adolescents with fsgs and igan as well as the burden and impact for patient care-partners in six countries (united states \[us\], united kingdom \[uk\], france, germany, italy and spain).


Eligibility criteria:
inclusion criteria: * adult patients and their adult care-partners: at least 18 years old; either have a physician-provided diagnosis of fsgs or igan (with renal biopsy confirmation of the diagnosis) or being a care-partner for someone with a physician-provided diagnosis of fsgs or igan (with renal biopsy confirmation of the diagnosis); * able to provide informed consent; * located in the united states (us), united kingdom (uk), germany, france, spain or italy. \*care-partners (paired with adult patients) (defined as the individual \[e.g., spouse, parent, sibling, relative, or friend\] providing direct disease-related support to the adult patient. \*\*all patient groups including chronic kidney disease (ckd) stage 1-5, with or without dialysis, and with or without kidney transplant will be included. * care-partners/parents of children/adolescents: at least 18 years old; * being a care-partner of children/adolescents with physician-provided diagnosis of fsgs or igan (with renal biopsy or genetic confirmation of the diagnosis); * able to provide informed consent; located in the us, uk, germany, france, spain or italy. * care-partners will be defined as family members who provide disease-related support and unpaid care to child/adolescent patients exclusion criteria: * patient has fsgs or igan secondary to another condition; * patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer; * patient has a co-existing glomerular disease (e.g., membranous nephropathy, lupus nephritis); * patient is currently participating in a kidney disease clinical trial, and potentially receiving active treatment as part of the trial.

Keywords: observational cross-sectional survey health-related quality of life (hrqol) patients care-partners humanistic burden
irinotecan plus thalidomide in second line advanced gastric cancer

Conditions: Gastric Cancer

Summary: recent clinical studies have demonstrated a reduction of irinotecan (cpt-11) gastrointestinal toxicities when the cpt-11 is administered in combination with thalidomide in patients with diagnosis of gastric cancer. the main purpose of this study is to investigate the efficacy and safety of thalidomide and cpt-11 in advanced gastric cancer. the investigators will also manage to find out the possible interactions between cpt-11 pharmacokinetics and thalidomide to explain the previously described gastrointestinal toxicity reduction.

this is a prospective, randomized, multi-center, controlled clinical trial, aimed to evaluate efficacy and tolerability of thalidomide and cpt-11 in advanced gastric cancer. a total of 900 patients are planned to be enrolled into the study. patients with diagnosis of advanced gastric cancer will be randomized into two groups, and be treated with thalidomide+ cpt-11 or cpt-11, respectively. the primary end point is time to progression (ttp), and the secondary end points include efficacy, overall survival (os) and the occurrence of delayed diarrhea.

Eligibility criteria:
inclusion criteria: * 18y \<age\<75y * patients with histologically proven tumor focus will be eligible for this protocol * measurable or assessable disease * at least 4 weeks since last chemotherapy ;chemotherapy regimens without irinotecan * no hepatic, renal and hematopoietic dysfunction; no hemorrhage of digestive tract,obstructive jaundice, gastrointestinal perforation or obstruction * ecog ps:0-2 * expected os ≥ 3 months exclusion criteria: * obstruction of digestive tract, thrombosis or other intolerant side effects during treatment

Keywords: thalidomide irinotecan second line
urinary kidney injury molecule-1 (kim-1) excretion as biomarker for injury in kidney transplant recipients

Conditions: Kidney Transplant Dysfunction

Summary: the purpose of this study is to determine if measuring the level of a protein called kidney injury molecule-1 (kim-1) in the urine will help healthcare providers detect any problems with the transplanted kidney before the laboratory investigations that are used on a routine basis do. this approach may allow the doctor to intervene at an earlier point of a rejection episode and may thereby prolong survival of the transplant kidney.

specific aims: 1. to investigate the role of urinary kim-1 excretion as a marker of delayed graft function, acute kidney allograft rejection and/or virus-induced allograft nephropathy and/or calcineurin-inhibitor nephrotoxicity. 2. to determine the role of urinary kim-1 excretion in predicting long term outcome after kidney transplantation compared to standard diagnostic tests. 3. to determine the role of reduction in urinary kim-1 excretion after a rejection episode and/or viral infection as a marker of repair of renal tubules. hypothesis: monitoring of urinary kim-1 in kidney transplant recipients will facilitate the detection of delayed graft function, acute allograft rejection or infectious causes of proximal tubular injury, allowing earlier intervention with better long-term graft survival. detection of urinary kim-1 will precede increases in serum creatinine to detect acute graft injury and urinary kim-1 will decrease faster than serum creatinine and will predict responsiveness (or lack thereof) to intervention more accurately.

Eligibility criteria:
inclusion criteria: children and adults from the age of 3 years who are eligible transplant candidates listed for deceased donor kidney or who are scheduled for a living related or unrelated donor kidney transplant at mount sinai hospital will be eligible for inclusion in this project. patients will be recruited from the population awaiting kidney transplant treated at the schneider children's hospital and mount sinai hospital.

Keywords: rejection infection side effect of immunosuppressive drug (nephrotoxicity)
effects on dementia caregivers

Conditions: Dementia

Summary: the three good things (3gt) is a gratitude list intervention that is empirically supported (emmons \& mccullough, 2003; seligman et al., 2005) and is a low-cost, easily accessible tool for medical and mental providers to recommend and dementia caregivers to implement independently. thus, this study aims to investigate the feasibility of use of 3gt in the dementia caregiving population and investigate potential therapeutic mechanisms of the intervention.

the hypothesis predicts that caregivers of persons diagnosed with dementia who are randomized into the intervention group (3gt) will report reduced levels of depression, burden, burnout, show an increase in levels of gratitude, increased positive emotion, and increased positive reframing (brief cope: positive reinterpretation scale and positive aspects of caregiving measure) as compared to baseline levels, and post-follow up assessment in 15 days. the participants will be recruited from local community partners and amazon mturk. they will be randomized into 2 groups; one group will be asked to reflect on three good things that happened that day, and the other group will be asked to reflect on early memories. participants will be reminded via text message daily for 15 days and asked to document their three good things or early memories on a qualtrics link that will be provided in the text message. additionally, they will be asked to answer 10 mood-related questions daily. an anova will be used to assess the pre and post intervention differences between groups for depression, burden, burnout, gratitude, positive emotion, and positive reframing. multilevel modeling will be used to assess the relationships between gratitude and depression at the within-subjects level and then between-subjects by intervention condition. identified demographic factors will be added to covary at both levels of analysis. data will be de-identified and stored on a university of central florida local hard drive, which requires special permission and password-protected profiles.

Eligibility criteria:
inclusion criteria: * self-identified caregivers of persons with dementia at least 18 years of age * identify english as their primary language * self-report current care for an older adult with dementia identified by a medical professional exclusion criteria: * participants that are currently receiving psychotherapy, have a diagnosis of dementia, and/or severe mental illness * individuals under the age of 18 years old * adults who cannot consent in english * pregnant women and prisoners will not be included in the study. * participants who do not have access to a phone that can not receive text messages will not be able to participate, as equipment will not be provided to participants.

Keywords: dementia caregivers
relation between the volume of subglottic secretion and risk of extubation failure in icu patients (segex)

Conditions: Airway Extubation; Pneumonia, Bacterial; Aspiration of Subglottic Secretions

Summary: this study evaluates the relation between the volume of subglottic secretion before airway extubation and the risk of extubation failure in the icu patient.

between 10 and 20% of patients develop extubation failure (10.7% in our icu at 2018), which is related to an increased in-hospital death rate, infections, higher costs and longer hospital stays. tracheal secretions, lvef\ 7d, weak of cough are identified as risk factors of extubation failures but are not completely performants. avoiding reintubation remains an important clinical goal. the subglottic secretion drainage above the cuff of an endotracheal tube is recognized as an effective method to prevent ventilator-associated pneumonia (vap) in critically ill patients. the subglottic secretion drainage is used in a regular way in our icu. volume of subglottic secretion is not analysed in the scientific literature. study : the investigators hypothesize that high volume of subglottic secretion before extubation is associated with high risk of extubation failure and à high risk of pneumonia post extubation. all planned extubations in the intensive care unit after 2 days minimal of mechanic ventilation are recorded on a designated form and standard variables charted. all data will be collected retrospectively after the extubation event. all included patients will be assigned a unique identification number (uid) by the investigator, who will secure the patient identifiers in an encrypted electronic file. the cause of extubation failure will be recorded (as identified by the attending physician on service, who is not involved in the study). for statistical analysis, group that fail extubation, will be compared, with the group that was an extubation success. standard demographics (age, sex), patient disease related factors (diagnosis, duration of intubation, secretions), care factors (cuff leak test, p/f ratio prior to extubation,lvef\<30% ), and post extubation care (post extubation respiratory support, stridor, blood gas, pneumonia) along with any complication during extubation and reintubation and reasons for reintubation will be collected and compared. as two groups are being compared, bivariate analyses utilizing chi-square tests or univariate logistic regression for categorical variables and student t -tests for interval variables, will be done. investigators will perform an interim analysis at the end of 12 months and a final analysis

Eligibility criteria:
inclusion criteria: * intubated with an orotracheal tube with a subglottic aspiration for more than 24 hours * mechanical ventilation for more than 48 hours * planned extubations in the intensive care exclusion criteria: * age \< 18 years * terminal extubation * self extubation * pregnancy

Keywords: sub glottic secretions failure extubation endotracheal tube
russian study of the effect of continuous positive airway pressure (cpap) in hypertension

Conditions: Obstructive Sleep Apnea Syndrome; Hypertension

Summary: the purpose of this study is to determine whether cpap is effective in the treatment of systemic hypertension.

it is now well known that cardiovascular risks are increased in patients with obstructive sleep apnea syndrome (osas). also a link has already been demonstrated between osas and hypertension. nowadays, the most efficient treatment of the osas is the continuous positive airway pressure (cpap). several studies have also shown that cpap could reduce arterial blood pressure in osas patients. but level of blood pressure (bp), drug treatment were not equal between groups and it's difficult to single out independent role of cpap. our study has the objective to compare the effects of cpap on hypertension in osas patients. after 3-9 weeks of antihypertensive treatment (valsartan and amlodipine) those one who reached target level of bp will be randomized either in the group "treatment by cpap" or in the group "treatment by cham-cpap" for 3 weeks and then we'll perform cross-over.

Eligibility criteria:
inclusion criteria: * male/female over than 18 years old * patient with an obstructive sleep apnea (apnea-hypopnea index \> or equal to 15) * patient with weak or moderate hypertension (140 \<= sbp \< 180 mmhg and 90 \<= dbp \< 110 mmhg) * negative pregnancy test * ambulatory patient * patient who have signed the informed consent form exclusion criteria: * pregnant or nursing woman * woman who refuses to use contraceptive method * acute hepatic failure, biliary cirrhosis, cholestasis * clearance of cockcroft \< 30 ml/min/1.73m2 * kaliemia \>= 5.5 mmol/l * acute hypertension (sbp\>= 180 mmhg and/or dbp \>= 110 mmhg) * acute daytime sleepiness (epworth rating scale \> 15) * patient with a profession that is inconsistent with the continuous positive airway pressure (cpap) treatment * known cardiovascular pathologies * contraindication to cpap * allergy to valsartan and/or amlodipine * patient treated with lithium * patient on tutelle or curatelle * patient kept in detention, major protected by the law, hospitalized person patient currently participating in another clinical trial

Keywords: obstructive sleep apnea obstructive sleep apnea syndrome hypertension systemic hypertension ambulatory blood pressure monitoring