Kornimate/medical-research-clean huggingface dataset:
an extension study of treprostinil palmitil inhalation powder (tpip) for pulmonary hypertension associated with interstitial lung disease (ph-ild)

Conditions: Pulmonary Hypertension; Interstitial Lung Disease

Summary: the primary objective of this study is to evaluate the safety and tolerability of the long-term use of tpip in participants with ph-ild from study ins1009-211 (nct05176951) and other lead-in studies of tpip in participants with ph-ild.


Eligibility criteria:
inclusion criteria: * participants who completed the end of treatment visit in study ins1009-211 (nct05176951). participants for whom the ole study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit. * complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in study ins1009-211, or any other lead-in ph-ild tpip study. * capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * participants who experienced any hypersensitivity or adverse drug reaction or were withdrawn early/discontinued in a previous ph-ild tpip study, which in the opinion of the investigator, could indicate that continued treatment with tpip may present an unreasonable risk for the participant. * initiation of parenteral administration of prostacyclin analogues (eg, tre, epoprostenol) since the completion of study ins1009-211 or other tpip studies. initiation of inhaled prostacyclin analogues (eg, tre \[tyvaso\] or iloprost) and oral prostacyclin analogues (eg, tre \[orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration. pregnant or breastfeeding. male and female participants must use contraceptives that are consistent with local regulations regarding the methods of contraception for those participating in clinical studies. female participants of childbearing potential must have a negative urine pregnancy test result at trial entry before the first dose of study drug. - any medical or psychological condition, including relevant laboratory abnormalities at screening that, in the opinion of the investigator, suggest a new and/or insufficiently understood disease that may present an unreasonable risk to the study participant as a result of participation in the study.

Keywords: treprostinil palmitil
endotracheal tube (ett) cuff pressure study in the emergency department (ed)

Conditions: Endotracheal Tube Cuff Pressure Pediatric Emergency

Summary: our study will measure the pressure of the endotracheal tube cuff in intubated patients in the emergency department.

although manometers are available for the purpose of measuring ett intra-cuff pressures, they are not currently in use at our institution's emergency department. this prospective cohort study will endeavor to determine the incidence of unacceptably high ett cuff pressures in the ed, laying the foundation for follow up studies on patient outcomes and the potential need for more careful management of intra-cuff pressures in the ed.

Eligibility criteria:
inclusion criteria: * cuffed ett in place on arrival in the ed * cuffed ett placed while in the ed exclusion criteria: * ett cuff electively left deflated by practitioner * uncuffed ett used

Keywords: intubation cuff cuffed endotracheal tube pressure pediatric child children emergency
minocycline for bipolar depression

Conditions: Bipolar Depression

Summary: the purpose of this study is to evaluate minocycline as a potential treatment for bipolar depression when added to a mood-stabilizing medication. minocycline is an antibiotic that is approved for the treatment of infections and acne. participation in this research study is expected to last 8 weeks, and includes five outpatient visits.

bipolar depression remains the great unmet need in the treatment of bipolar disorder. only two treatments have been fda-approved for the management of acute bipolar depression (the combination of olanzapine and fluoxetine and quetiapine). early pilot data suggests the drug minocycline has potent antidepressant effects. minocycline is approved by the food and drug administration (fda) (for acne and bacterial infections), is inexpensive and readily available in generic formulation, and is generally well-tolerated. this study will examine whether administering the drug minocycline to individuals with bipolar depression over 8 weeks will improve their depressive symptoms. this study will also offer an option to participate in proton magnetic resonance spectroscopy (1h-mrs) to measure n-acetylaspartate (naa) levels in the brain, which are thought to be decreased in bipolar disorder.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for bipolar i disorder or bipolar ii disorder, depressed phase * a baseline score of at least 18 on the montgomery-asberg depression rating scale (madrs) * participants on mood stabilizer medication for at least two weeks prior to starting the study, and must remain on the treatment during the study * able to understand english exclusion criteria: * dsm-iv diagnosis of bipolar nos, cyclothymia, or schizoaffective bipolar type * pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, iud, s/p tubal ligation, partner with vasectomy) * serious suicide or homicide risk * unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease * clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before visit 1 * drug/alcohol dependence within past 30 days, or current substance use disorder that requires detoxification * current use of minocycline or history of anaphylactic reaction or intolerance to minocycline * primary clinical diagnosis of antisocial or borderline personality disorder * patients with metallic foreign bodies or claustrophobia will be excluded from the mrs component

Keywords: bipolar disorder depression minocycline mood disorders bipolar depression
usability of a breathing-cbt platform (cbt = cognitive behavioural therapy)

Conditions: Breathing, Mouth

Summary: the study will examine the usability of a breathing platform in the home environment. it will be a randomized, open-label crossover study of 10 participants who will complete the cbt and breathing components in their home, prior to sleeping. usability will be measured by scores assigned by participants. qualitative feedback and compliance information will also be collected.


Eligibility criteria:
inclusion criteria: * participants are willing to give written, informed consent * participants are healthy adults * participants are able to comprehend and speak english * participants are at least 18 years of age exclusion criteria: * participants who are/may be pregnant or lactating * participant that have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: copd, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury) * participants who are unsuitable for the inclusion at the discretion of the investigator
the acute effect of atorvastain on renal function in patients with type ii diabetes

Conditions: Healthy Subjects

Summary: we wanted to test the hypothesis that acute treatment with atorvastatin changes renal sodium excretion, glomerular filtration rate, tubular function and vasoactive hormones in patients with type ii diabetes, not in treatment with insulin.


Eligibility criteria:
inclusion criteria: 1. age: 40-70 yrs 2. estimated gfr between 30 and 90 ml/min 3. bmi\<35 4. fertile women had to use oral contraceptives or iud 5. hba1c\< 10% 6. urine-albumin\<1,5 g/l exclusion criteria: 1. treatment with insulin 2. cerobrovascular insult or other disease of the brain 3. insufficiency of the heart or lungs 4. liverdisease with alat \> 200 u/l 5. hemoglobin \< 7,0 mmol/l 6. cancer 7. alcohol abuse 8. medical treatment with psycopharmaca or/and analgetics 9. pregnancy and breast feeding, 10 blood donation one month before the study.

Keywords: atorvastatin renal function hemodynamics diabetes type ii sodium excretion
facilitation of fear extinction with yohimbine hydrochloride in phobic participants

Conditions: Phobic Disorders

Summary: procedurally virtual reality exposure therapy (vret) is quite similar to models of extinction of conditioned fears. recent advances in animal research have identified pharmacological agents that appear to both accelerate and consolidate extinction learning. one of these cognitive enhancers is yohimbine. an interesting finding in animal literature is that the administration of yohimbine during extinction trials accelerates fear reduction and may convert ineffective exposures in to successful ones. it is thought that the mechanism of enhanced emotional memory is through elevated norepinephrine in the prefrontal cortex. therefore, we propose to extend these studies by combining vret with yohimbine. in this pilot study with a between groups design 20 participants with a fear of flying will be treated with vret plus yohimbine or vret plus placebo. this between groups design was chosen to further characterize the differential within and between trial extinction. outcome will be measured by self-report, behavioral, and psychophysiological assessments at pre- and post-treatment. in addition, we will examine extinction parameters during exposures.


Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of specific phobia (fear of flying). * between the ages of 18-65 * sufficient fluency in dutch to complete treatment and research protocol exclusion criteria: * presence of medical condition, assessed by self-report questionnaires at the intake (i.e., pregnancy, seizure disorder, respiratory disorder, cardiovascular disease, pacemaker, hypertension). * resting blood pressure higher than 140 (systolic) or 105 (diastolic) * unstable psychotropic medication. * current use of tranquilizers (benzodiazepines) * psychosis * depression with suicidal ideation * dementia or other severe cognitive impairment * substance dependence * bipolar disorder * borderline personality disorder * anti-social personality disorder * current use of beta-blockers

Keywords: phobic disorders (fear of flying) virtual reality exposure therapy fear extinction yohimbine
vitamin deficiency and blood pressure in hospitalized jewish general hospital (jgh) patients

Conditions: Vitamin C Deficiency; Vitamin D Deficiency

Summary: there is suggestive evidence that vitamin c and vitamin d deficiency may increase blood pressure across the range of blood pressures from normal to elevated. information about this relationship is inadequate in part because of the rarity of individuals with subclinical vitamin c and d deficiency. the investigators have observed subnormal to deficient plasma vitamin c and 25-hydroxyvitamin d levels in a large proportion of patients under active treatment in the investigators' hospital. the clinical implications of widespread hypovitaminosis c and d are unknown. in this randomized prospective comparison trial the investigators will measure vitamin levels and blood pressure in clinically stable acutely hospitalized patients with a wide range of diagnoses, and expected to remain in the hospital for at least 7 more days. the investigators will examine for an inverse relationship between baseline vitamin level and blood pressure across the range of blood pressures. consenting patients will be randomized to receive vitamin c (500 mg twice daily) or vitamin d (1000 iu twice daily) for as long as 10 days. blood pressure will be re-measured every 2 days and vitamin levels re-measured on the last study day. treatment courses of at least 5 days will be considered sufficient for analysis. the hypothesis is that either treatment will reduce blood pressure in patients whose baseline systolic blood pressure is 110 or more; the investigators will also examine whether the reduction in blood pressure with treatment is proportional to the increase in the circulating vitamin level with treatment.


Eligibility criteria:
inclusion criteria: * competent to grant informed consent * anticipated to remain in hospital at least 7 days after enrollment exclusion criteria: * end-stage renal disease on renal replacement therapy * critical illness * judged unstable clinical status at the time of enrollment

Keywords: blood pressure vitamin c vitamin d
efficacy and safety of patidegib gel 2% for preventing basal cell carcinomas on the face of adults with gorlin syndrome

Conditions: Gorlin Syndrome

Summary: the aim of this clinical study is to find out how well patidegib gel 2% works in preventing new basal cell carcinomas (bccs) developing on the face of adults with gorlin syndrome, and how safe patidegib gel 2% is to use. people who take part will apply either patidegib gel 2% or a vehicle gel (with no active drug substance) to their face twice a day for a year (12 months). the number of new bccs on the face will be compared between those who used patidegib gel 2% or vehicle gel after 12 months.

this is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of patidegib gel 2%, applied topically twice daily to the face of adult subjects with gorlin syndrome. subjects will be randomized (1:1) to receive either patidegib gel 2% or vehicle gel for 12 months. the assignment of subjects to the 2 groups will be stratified by sex assigned at birth, age (≥60 or \ 30) at baseline. all suspicious lesions will be imaged and tracked consistently throughout the study so that new bccs that arise can be readily identified. new bccs will be confirmed by dermoscopic analysis through the study. the bcc images will be reviewed and assessed by a central photo review board (cprb).

Eligibility criteria:
key inclusion criteria: 1. the subject must be at least 18 years old at the screening visit. 2. the subject must be confirmed to have a ptch1 mutation. 3. the subject must have at least 10 bccs on the face at randomization (baseline/day 1). 4. the subject must be willing to abstain from application of any non-study topical medication (prescription or over the counter) to their facial skin for the duration of the trial, except as prescribed by the investigator. key exclusion criteria: 1. the subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study investigational product (ip). 2. the subject is known to have hypersensitivity to any of the ingredients in the ip formulation. 3. the subject has uncontrolled systemic disease. 4. the subject has been treated for invasive cancer within the past 5 years excluding chronic lymphocytic leukemia stage 0, non-melanoma skin cancer, successfully treated melanoma in situ and stage i melanoma, stage i cervical cancer, or ductal carcinoma in situ of the breast. 5. inefficacy of previous hedgehog inhibitor therapy.
study comparing arzoxifene with raloxifene in women after menopause with osteoporosis

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose of this study is to compare the effect of arzoxifene to raloxifene on the bone mineral density (bone strength).


Eligibility criteria:
inclusion criteria: * must have osteoporosis * must be between 50 and 75 years old and be able to walk * have at least two of your back bones that can be x-rayed * have not had a period in at least two years * be willing to have blood tests exclusion criteria: * have a bone disease other than osteoporosis * history of estrogen dependent cancer * history of stroke or certain heart problems * possibly have an allergy to raloxifene or arzoxifene * have certain abnormal lab values * history of seizure disorder * have unexplained vaginal bleeding or an abnormal pap smear
t-cell based immunotherapy for of melanoma

Conditions: Melanoma

Summary: the aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma. patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. patients will be evaluated for toxicity, tumor response, and immune response. after the first 6 patients the treatment with il-2 has been changed to include higher doses of il-2 (see intervention)


Eligibility criteria:
inclusion criteria: * patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. further inclusion criteria: performance status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable cbc and blood chemistry results. acceptable organ functions. exclusion criteria: * patients with a history of any other malignancies less than five years ago. brain metastases. other significant illness including severe allergy, asthma, dm, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
characteristics of patients diagnosed with nsaid sensitivity in thailand

Conditions: Aspirin Sensitivity; Aspirin-exacerbated Respiratory Disease; Aspirin-Induced Angioedema-Urticaria; Aspirin Allergy; NSAID-Induced Asthma; NSAID-Induced Angioedema-Urticaria; NSAID-Induced Anaphylactoid Reaction; Aspirin-Induced Anaphylactoid Reaction

Summary: study clinical characteristics and phenotypes of patients diagnosed with nsaid sensitivity in thailand


Eligibility criteria:
inclusion criteria: * thai patients with a history of an immediate reaction to aspirin/paracetamol, or nsaids visiting king chulalongkorn memorial hospital exclusion criteria: * none
registry for acute decompensated heart failure patients admitted to the er

Conditions: Heart Failure, Congestive; Heart Decompensation

Summary: the purpose of this study is to collect data on the medical management of patients presenting to the emergency department who are treated for acute decompensated heart failure (adhf) in a hospital setting that has incorporated a disease management program for heart failure.

this is an observational (individuals are observed or certain outcomes are measured. no attempt is made to affect the outcome), multi-center registry study of patients presenting to the emergency department (ed) for treatment of known or suspected acute decompensated heart failure (adhf). data will be collected on the medical management of patients presenting to the ed who are treated for adhf in a hospital setting incorporating a disease management program for heart failure. the study will evaluate change in clinical management and outcomes of adhf patients treated in the ed after ed implementation of three or more components of a disease management program for heart failure. the results are intended to assist hospitals in evaluating and improving quality of care for patients with adhf by tracking quality indicators and providing site-specific benchmark reports and national benchmark reports. this registry considers patients treated with any therapy for adhf

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years at the time of ed treatment * received or is eligible to receive a principal ed and/or hospital discharge diagnosis of adhf * adhf is present as determined clinically by the patient care team and as documented in the drg (diagnosis-related group) or apc (ambulatory payment classifications) codes, and adhf is the focus of treatment * if required by site irb/iec patient (or legally acceptable representative) must be able to give informed consent for participation exclusion criteria: * adhf is present as a co-morbid condition, but is not a principal focus of diagnosis or treatment during this ed or hospital episode * patient was not treated in ed during this episode of care * participation in any clinical trial that precludes use of a disease management program (specific component of the disease are managed in an integrated manner by a team of physicians, pharmacists, nurses and communication experts)

Keywords: heart failure, congestive heart decompensation
effect of adjuvant hyperbaric oxygen therapy on bells palsy outcome

Conditions: Bell Palsy

Summary: this is a randomized, single blinded, non-placebo controlled that will compare one group of bells palsy patients receiving the current standard of care including oral corticosteroids and oral antivirals against an experimental group receiving the current standard of care in addition to hyperbaric oxygen therapy. outcome assessment will be based on both objective analyses of facial movements as well as subjective quality of life scales.


Eligibility criteria:
inclusion criteria: * 18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less. exclusion criteria: * no patients from vulnerable populations as listed above will be included. * subjects must be able to travel to nyulmc continually during the first 12 months following enrollment. * during the initial visit candidates must have no associated clinical signs or symptoms consistent with other causes of facial palsy. this includes but is not limited to: auricular papules, skin rashes, parotid masses, craniofacial trauma, and the presence of other cranial or distal neuropathies excluding facial numbness, change in taste, and/or hyperacusis. * patients with atypical presentations will be referred for cross-sectional imaging and excluded. * patients with histories consistent with possible recent tick exposure, rashes, headaches, or excessive fatigue will be serologically tested for lyme disease and excluded if it returns positive. * pneumothorax within the last two years is the only absolute medical exclusion criteria (ff). * patients who are epileptics, or are claustrophobic, will be carefully counseled on the risks of hbot before being allowed to enroll. * patients with severe comorbidities will undergo evaluation by their primary care doctor and require physician approval prior to enrollment.

Keywords: oxygen therapy bells palsy
failure rate of glyburide and metformin among gestational diabetics

Conditions: Gestational Diabetes Mellitus, Class A2

Summary: a pragmatic, comparative effectiveness trial of glyburide versus metformin.

patients with gestational diabetes requiring pharmaceutical treatment will be randomized to receive glyburide or metformin. dose increases will be determined by the patient's physician. patients will be determined to have failed either medication if glucose control can not be achieved with the maximum dose of the medication, if insulin is stared to achieve glucose control or if another oral agent is started along for glucose control.

Eligibility criteria:
inclusion criteria: we will include women between 20 and 34 weeks gestational age, with a diagnosis of gdm as per the following criteria: * 1 hour glucose tolerance test of \>130 mg/dl, followed by two abnormal values on 3 hour glucose tolerance test, or: * a single 1 hour glucose tolerance test value of \> 200 mg/dl, and: * failure to achieve glycemic control with diet and exercise or deemed to require pharmacological therapy as per physician's criteria exclusion criteria: * - known renal impairment. * known hepatic disease. * pre-gestational diabetes. * known allergy to glyburide, metformin or sulfa drugs.

Keywords: gestational diabetes glyburide metformin failure rate