Kornimate/medical-research-clean huggingface dataset:
nasal versus buccal oxygen administration for endobronchial ultrasound-guided transbronchial needle aspiration

Conditions: Lung Diseases

Summary: the purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration .

anesthesia for endobronchial ultrasound (ebus) may be range from routine bronchoscopy sedation to general anesthesia. during sedation to ebus increased duration of anesthesia and sedative dosing put patients at increased risk for hypoxic events. to avoid this, oxygen supplementation is mandatory. there are different techniques for oxygen supplementation during the procedure. at this study we will compare to nasal and buccal oxygen supplementations during ebus.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age * body mass index (bmi) between 20 and 30 * american society of anesthesiologists physical status i-iii exclusion criteria: * congestive heart failure * ischemic heart disease * increased intracranial pressure * known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam) * an anatomical feature precluding adequate positioning of the buccal device.
predictive role of microbiome in patients with urothelial carcinoma

Conditions: Urinary Bladder Cancer

Summary: this study aims to establish the microbiota composition as a predictive tool for the response to the intravesical immunotherapy with bacillus calmette-guérin (bcg) and 2 different chemotherapies schemes. in this prospective cohort study patients with low/intermediate/high risk non muscle invasive bladder carcinoma (nmibc) that undergo bcg/chemo treatment will be enrolled to collect urine stool and blood at different endpoints. microbiota, short-chain fatty acids and immunophenotype will be quantified to develop a predictive screening platform, which might also integrate traditional urinary cytology and fish data.

the purpose of this research is to understand the possible use of microbial profile from catheterized urine and feces of patients with nmibc to categorize patients in two groups: those likely to respond positively and those unlikely to respond to the therapy. goal of this study is to identify the predictive role of the microbiome to therapy response, thus allowing clinicians to deliver the most appropriate treatment based on the microbiome (microbiome-personalized therapy).

Eligibility criteria:
inclusion criteria: * adults aged ≥ 18 years, all able to signed informed consent form; * diagnosis of nmibc provided by an experience pathology, by using tissue specimens that were staged according to the tnm classification and morphoarchitectural criteria according to the who classification. exclusion criteria: * participants with ongoing urinary tract infection; * antibiotic treatment within the last month; * immuno-/chemo- therapy within the past 3 months; * chronic immunosuppressive therapy; * additional major diagnosis known to affect the gut or bladder microbiota; * use of probiotics; * uncontrolled diabetes; * participants with other malignancy or previous history of oncological or autoimmune diseases.
treatment of posttraumatic stress disorder by trained lay counsellors in an african refugee settlement

Conditions: Posttraumatic Stress Disorder

Summary: the study is a pragmatic trial to study the efficacy of two active methods of psychotherapy for the treatment of posttraumatic stress disorder in a refugee camp in africa. treatment was administered by lay counsellors.

traumatic stress due to conflict and war causes major mental health problems in many resource-poor countries, especially those coping with displaced populations. there is a lack of intervention research in these populations. te purpose of this study was to examine whether trained lay counsellors can carry out effective treatment of ptsd in a refugee settlement.

Eligibility criteria:
inclusion criteria: * diagnosis of posttraumatic stress disorder exclusion criteria: * drug abuse * psychosis * mental retardation

Keywords: ptsd, posttraumatic stress disorder, refugees, war
evaluation of the safety and tolerability of ocular lubricants

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate the safety and tolerability of three new artificial tear formulations in subjects with moderate dry eye disease.

this study will be conducted in 2 stages. in stage 1, subjects will attend a total of 10 scheduled visits: one screening visit, four investigational product visits, four 12-hour follow up visits (one for each investigational product visit), and an exit visit. at each investigational product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. the first investigational product visit will occur 1 to 7 days after the screening visit. a washout period of 2 to 7 days will separate each investigational product visit. total individual duration of participation in stage 1 will be 8 to 34 days. the planned enrollment for stage 1 is 72 subjects. at the conclusion of stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for stage 2. this study will be conducted in australia.

Eligibility criteria:
key inclusion criteria: * willing and able to understand and sign an ethics committee-approved informed consent form. * willing and able to attend all study visits as required by the protocol. * exhibits symptoms of dry eye at the screening visit. * currently uses habitual artificial tears to alleviate dry eye symptoms. * willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on investigational product visit days. * other protocol-specified inclusion criteria may apply. key exclusion criteria: * has any known active ocular disease and/or infection. * has any known infection or inflammation that requires treatment or has a systemic condition that in the opinion of the investigator, may affect a study outcome variable. * has had an ocular injury to either eye in the past 12 weeks prior to screening. * currently wears contact lenses or has a history of contact lens wear within the previous 1 month. * has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study. * is pregnant, intends to become pregnant, or is breastfeeding. * other protocol-specified exclusion criteria may apply.

Keywords: scratchy eyes dry eyes
effects of static apnea at low lung volume on hypoalgesia, cardiovascular function and respiratory function

Conditions: Pain; Hypoxia; Hypercapnia; Apnea

Summary: the aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent static apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention


Eligibility criteria:
inclusion criteria: - asymptomatic subjects aged between 18 and 64 years. exclusion criteria: * cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies. * history of epilepsy. * pregnant * pharmacological treatment. * participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
single-dose and multiple-dose safety and tolerability study of pf-04856883 in type 2 diabetic adult females

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Summary: the primary objective of this study is to evaluate the safety and tolerability of pf-04856883 (cvx-096) in adult female subjects with type 2 diabetes mellitus on high dose of metformin.


Eligibility criteria:
inclusion criteria: * history of type 2 diabetes and currently being treated with high dose metformin * bmi between 22.0 and 40.0 kg/m2 * hba1c between 7.0-10.0% * fasting c-peptide \>1.21 ng/ml exclusion criteria: * history of clinically significant chronic conditions other than type 2 diabetes not well controlled by either diet or medications * treatment with anti-diabetic therapies other than metformin * history of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody * males or women of childbearing potential

Keywords: phase 1 type 2 diabetes cvx-096
magnetic correction of eye lid paralysis

Conditions: Blepharoptosis; Lagophthalmos; Facial Paralysis

Summary: objective 1: determine the safety and feasibility of externally mounted magnets for extended management of chronic eyelid movement disorders by measuring visual acuity and corneal and skin integrity and comfort over 8 weeks of wear. objective 2: collect preliminary data on the relative efficacy of external magnetic devices by comparing them to externally mounted lid weights and ptosis crutches using rating scales and video analysis of blink biomechanics.

two major types of eye lid movement disorders include lagophthalmos (incomplete closure of the eyelids) and blepharoptosis (incomplete opening of the eyelids). both of these conditions occur because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. generally paralysis of the eyelid or facial muscles is responsible for the abnormality (the eyelids can close but not open, or open but not close). an external device, if able to generate an appropriately balanced force, could restore eyelid movement by performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and the functioning eyelid closure muscle could overcome the device's force. in prior work the investigators established proof-of-concept data demonstrating safety and efficacy for temporary management of ptosis up to 2 hour per day for 2 weeks. preliminary data suggest similar safety for lagophthalmos. this study will expand on this preliminary work to examine longer wear times, home use, and feasibility for a wider range of eye lid disorders.

Eligibility criteria:
inclusion criteria: * presence of an eyelid movement disorder for at least one eye, moderate cognitive function or better defined as greater than or equal to 18 out of 30 on a pre-screening of the mini-mental state exam, age 5 or older. exclusion criteria: * absence of an eyelid movement disorder or presence of a corneal ulcer. those with a corneal ulcer are at risk for permanent loss of vision and should be managed with proven methods. age less than 5, severe cognitive impairment defined as mini-mental score \<18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy. these individuals must be excluded since participation requires competent self-care, reliable responses and cooperation during fitting of the devices.
the safety and effectiveness of isis 2922 in patients with aids who have cytomegalovirus (cmv) of the eyes

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: to evaluate the efficacy and safety of isis 2922 in aids patients with cytomegalovirus ( cmv ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are otherwise ineligible for isis pharmaceuticals' controlled trials or who have failed isis 2922 therapy on another controlled clinical trial. per 2/8/96 amendment: patients must rollover from another isis 2922 controlled trial.

patients receive intravitreal injections of isis 2922 at doses of either 150 or 300 mcg, depending on cmv retinitis location and extent of retinal involvement. there is a 3-week induction period followed by at least 18 weeks of maintenance. induction is given on days 1, 8, and 15, and maintenance doses are given every 14 days, beginning on day 29.

Eligibility criteria:
inclusion criteria patients must have: * aids. * cmv retinitis in one or both eyes that was previously treated but is presently uncontrolled. * intolerance or resistance to other therapies. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * eligibility to participate in a controlled clinical trial of isis 2922. * external ocular infection in eye to be treated. * other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated. * ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated. * retinal detachment in eye to be treated. * known or suspected allergy to phosphorothioate oligonucleotides. * silicone oil in eye to be treated. * syphilis. * clinical evidence of retinal pigment epithelial stippling. * pseudoretinitis pigmentosa. concurrent medication: excluded: * foscarnet. * mellaril, stelazine, thorazine, and clofazimine. * ethambutol / fluconazole combination. * other investigational drugs for cmv retinitis. patients with the following prior conditions are excluded: * history of surgery to correct retinal detachment in eye to be treated. * history of ganciclovir implant for treatment of cmv retinitis. * history of intolerance to isis 2922. * history of syphilis. required: * prior cmv retinitis therapy with ganciclovir, foscarnet, or isis 2922.

Keywords: acquired immunodeficiency syndrome antiviral agents cytomegalovirus retinitis
a single center study on comparing the different function of endoangel in improving the quality of colonscopy

Conditions: Adenoma

Summary: an artificial intelligence-based system, named endoangel,has been constructed previously,which has polyp detection and quality monitoring functions. this study aims to evaluate the two different functions of endoangle in improving adenoma detection rate.

the detection and removal of precancerous polyps via colonoscopy can reduce the the risk of colon cancer. however, the detection rate of adenomatous polyps can vary significantly among endoscopists. endoangel is an artificial intelligence-based system,consisting of polyp detection and quality monitoring functions. the polyp detection function can remind endoscopists of the location of the polyp. the quality monitoring function can monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.this study aims to evaluate the two different functions of endoangle by 2 × 2 factorial design in improving adenoma detection rate and the quality of colonscopy .

Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years or above; 2. colonoscopy is needed to further characterize gastrointestinal diseases; 3. ability to read, understand and sign informed consent forms; 4. the researchers believe that the subjects can understand the process of the clinical study and are willing and able to complete all the study procedures and follow-up visits to cooperate with the study procedures. exclusion criteria: 1. participated in other clinical trials, signed informed consent forms and followed up in other clinical trials； 2. participate in a drug clinical trial and during the elution period of the trial or control drug； 3. drug or alcohol abuse or mental disorder in the last 5 years; 4. pregnant or lactating women; 5. patients with multiple polyp syndrome; 6. patients with a history of inflammatory bowel disease, colorectal cancer, or colorectal surgery; 7. patients with known perforation or colonic obstruction; 8. patients with a contraindication for biopsy; 9. the researchers did not consider the subjects suitable for colonoscopy; 10. the researchers determined that the subjects had high-risk diseases or other special conditions that were not appropriate for clinical trials.

Keywords: polyp detection quality monitoring artificial intelligence
dapagliflozin in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Summary: the purpose of this study is to investigate the effects of dapagliflozin on exercise capacity and hemodynamics in patients with pulmonary arterial hypertension

the objective of this study is to evaluate the effects of oral dapagliflozin (forxiga®) treatment versus placebo in clinically stable patients with pulmonary arterial hypertension or cteph on background vasodilator combination therapy on cardio-pulmonary exercise capacity, pulmonary vascular hemodynamics, rv function and metabolomic profile of the pulmonary vascular endothelium.

Eligibility criteria:
inclusion criteria: * a diagnosis of pah group 4 or group 1 in any of the following subtypes: * idiopathic pah (ipah) * heritable pah (hpah) * connective tissue disease associated pah (apah) * associated with congenital heart disease (apah) * in case of ph in group 4, no further invasive treatment including pulmonary endarterectomy or pulmonary balloon angioplasty must be planned at time of inclusion. * symptomatic pah in who functional class ii-iii as assessed by the screening clinician. * clinically stable patients on pulmonary vasodilator treatment with pde5i, era, pa/ipa alone or in combination without considerations from the treating physician team towards treatment escalation and a treatment duration of at least four weeks. clinical stability defined as stable symptoms without progression as assessed by treating clinician and without the need for unplanned hospital admissions due to worsening pah within three months of screening. * fertile women (\< 50 years of age) must use safe contraceptives (intra uterine device or hormonal contraception) for the duration of the study and have a negative pregnancy test * able to understand the written patient information in danish and give informed consent. * age ≥ 18 years * ability to perform cardio pulmonary exercise test exclusion criteria: * known allergy to the study medication * treatment with an sglt2i within 6 months prior to baseline * type 1 or type 2 diabetes * impaired renal function with an egfr \< 30 ml/min/m2 within four weeks of screening * severe liver dysfunction (child-pugh class c) * listed for lung transplantation at the time of screening * planned initiation of iv prostacyclin therapy/ ipa or current dose escalation planned * planned pulmonary endarterectomy or pulmonary balloon angioplasty. * lvef \< 50% * diagnosis of pah group 2, 3 or 5
efficacy of keppra for neonatal seizures

Conditions: Neonatal Seizures

Summary: the purpose of this research study is to learn how well the medication levetiracetam (keppra) works to treat seizures in full term and premature babies. levetiracetam is commonly used in babies with seizures at cincinnati children's hospital, especially if the seizures have not been stopped by other medicines. the food and drug administration (fda) has approved the use of levetiracetam for older children (over the age of 4) but not for infants. even though it is not fda approved for this age group, doctors at cincinnati children's use the medicine as a second drug in babies whose seizures are not stopped by phenobarbital. some doctors are concerned that phenobarbital is not the best medicine to treat seizures in babies, so researchers are trying to study other medicines. in this study, the investigators are looking at how well levetiracetam stops or slows down seizures in babies. the investigators are also studying the blood levels of levetiracetam to learn more about how the medicine is processed by the body and what level of medicine in the body works to stop seizures. the investigators are checking labs before and after giving the dose to make sure the medication does not cause any changes in blood counts, kidney function, or liver function. the investigators are following all of the babies in the study after hospital discharge to see if the parents notice any side effects of the medication. babies in the study will come back to the high risk follow up clinic at cincinnati children's at 6 months of age for a visit with a neurologist and a neonatologist and developmental testing.


Eligibility criteria:
inclusion criteria: * gestational age ≥ 35 weeks * postnatal age ≤ 30 days * birth weight ≥ 2000 grams * clinical or electrographic seizures of any etiology requiring treatment with an antiepileptic medication (as per the judgment of the clinician caring for the patient) * parental consent obtained exclusion criteria: * infants with renal insufficiency indicated by serum creatinine \> 2.0 (as part of pre-screening, labs obtained as part of routine care will be reviewed. infants who have not had a creatinine drawn will have one drawn as part of the study after consent is obtained. if the baby requires levetiracetam emergently before the results of the creatinine are back, the dose will still be given and levels will still be drawn as per the protocol. * infants who have previously received levetiracetam * parents refuse consent
study of count coughs in subjects with acute upper respiratory tract infections

Conditions: Infection

Summary: the objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. the hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.


Eligibility criteria:
inclusion criteria: * male or female subjects at least 18 years of age and in generally good health who are experiencing an acute upper respiratory infection of 10 days or less in duration; * subjects currently have acute cough self-rated as at least moderate due to an acute upper respiratory infection (urti) (i.e., cold or flu) as established by a study physician, nurse practitioner, or physician's assistant; * subjects who have \> 5 cough bouts during the 30 minute baseline assessment period exclusion criteria: * subjects who have acute, subchronic, or chronic cough due to any condition other than a urti as established by the investigator, nurse practitioner, or physician's assistant, in accordance with the american college of chest physicians (accp) guidelines for diagnosis and management of cough. special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, chronic obstructive pulmonary disease (copd), and gastroesophageal reflux disease (gerd) (n.b. subjects with exercise-induced asthma may be eligible for the study as long as they have not experienced an episode of asthma within 24 hours of enrollment) * in the opinion of a study physician, nurse practitioner, or physician's assistant, subjects with sinusitis or who have a history of (within the past 2 years) frequent clinically significant sinusitis; * subjects with a history (within the last 3 years) of alcohol abuse (i.e., consuming greater than or equal to 3 alcoholic drinks/day on a regular basis) or substance abuse (i.e., ingesting/smoking marijuana more than once a week at any time during the past 6 months or using any other recreational drug more than once during the past 6 months). (note: one "drink" of alcohol=1 oz. liquor, 6 oz wine, 12 oz. beer.);

Keywords: cough assessment in upper respiratory infection guaifenesin honey