Kornimate/medical-research-clean huggingface dataset:
utility of pcd diagnostics to improve clinical care

Conditions: Primary Ciliary Dyskinesia

Summary: this is a study evaluating the utility of current primary ciliary dyskinesia (pcd) diagnostic tests, including nasal nitric oxide testing.

this study is a prospective data collection of individuals referred to the investigators clinical center for considerations of pcd. participants sign informed consent to have clinical information entered into a secure electronic database. as part of this study, participants may have nasal nitric oxide (nno) testing performed. nno testing is a research procedure, but it is a test with growing utility for making a diagnosis of pcd when performed in the right clinical setting.

Eligibility criteria:
inclusion criteria: * referred to center for pcd diagnosis considerations * ability to perform study procedures * age greater than 2 years of age exclusion criteria: * age less than 2 years of age inability to perform informed consent
adult depression and integrative medical care

Conditions: Depression

Summary: the goal of this quasi-experimental study is to learn if integrative medical care works to treat depression in adults and compare it to usual medical care. the main question it aims to answer is to find out whether integrative medical care is equal or better to usual medical care in treating depressed adults over one year. participants attended five data collection visits which occurred at baseline, 3, 6, 9 and 12 months. at each visit, they completed questionnaires and had a small blood sample drawn. they were also asked to keep a diary of their symptoms and what they did between visits. they brought a calendar summary with a saliva sample at visits 2 to 5.


Eligibility criteria:
inclusion criteria: * experiencing depressive symptoms as defined by a centre for epidemiologic studies-depression (ces-d) scale score of 16 or higher as categorized by lewinsohn et al. * willing to commit to five study visits over one year. exclusion criteria: * substance abuse * pregnancy * non-depression neurological problems.

Keywords: adults depression integrative medical care quasi-experimental design
angiotensin 2 for hepatorenal syndrome

Conditions: Hepatorenal Syndrome; Cirrhosis; Kidney Failure, Acute

Summary: hepatorenal syndrome (hrs) is a disease in which patients with cirrhosis (end stage liver failure) develop secondary kidney injury and failure. the current treatment available in the united states is a combination of octreotide and midodrine, which are meant to decrease the release of those hormones and raise the blood pressure, respectively, which would increase blood flow to the kidneys. angiotensin 2 (ang2) is a new vasopressor drug that was approved by the fda in december 2017 for patients with low blood pressure and has been shown to have similar effects to octreotide and midodrine. this study will investigate whether ang2 reverses hrs among patients admitted to the intensive care unit (icu) at ronald reagan medical center. our study population will be patients with hrs who are already or will be admitted to the icu. hrs will be defined by new internationally accepted guidelines published by the international club of ascites. all patients who are consented will undergo an ang2 response trial, where low-dose ang2 will be administered for 4 hours to see how the patients respond. this will help us characterize the nature of the patients' kidney failure for later analysis. patients will then be randomized into the control group or the study group. patients in the control group will receive octreotide (a subcutaneous injection) and midodrine (an oral drug). patients in the study group will continue receiving intravenous infusion of ang2. patients in both groups will also receive albumin, a protein found commonly in human blood. treatment will continue in both groups for four days, until complete reversal of hrs, dialysis, or death. our primary outcome will be rate of reversal of hrs, defined as improvement in kidney function.


Eligibility criteria:
inclusion criteria: patients in the icu with hrs-aki defined as * acute kidney injury defined as an increase in serum creatinine (scr) \>=0.3 mg/dl or \>=50% from baseline within 7 days * presence of cirrhosis and ascites * absence of other causes such as shock, nephrotoxic drugs, or other suspected causes of kidney injury. * lack of response to diuretic withdrawal and albumin challenge of 1 g/kg of body weight exclusion criteria: * age \<18 years * current or anticipated (within 24 hours) need for renal replacement therapy (rrt) * cr \> 6 mg/dl * renal transplantation status * fractional excretion of sodium (fena) \> 2% * pregnancy * recent cerebrovascular accident (cva), myocardial infarction (mi), venous or arterial thrombosis (within last 3 months) * known hypercoagulable state other than cirrhosis * uncontrolled hypertension (sbp \> 160) * anticipated mortality within 72 hours * inability to obtain consent.
is non-cycloplegic photorefraction applicable for screening refractive risk factors of amblyopia?

Conditions: Amblyopia

Summary: purpose: : this study was performed to compare the accuracy of non-cycloplegic photorefraction with cycloplegic refraction in detection of refractive amblyopia risk factors and determine some corresponding beneficial cut points. method: in this diagnostic accuracy study, right eyes of 185 children (1 to 14 years) underwent first non-cycloplegic photorefraction (with plusoptix so4 photoscreener) and then cycloplegic refraction from october 2009 to august 2010. based on the cycloplegic refraction results, hyperopia (≥+3.5d), myopia (≥-3d), astigmatism (≥1.5d), and anisometropia (≥1.5d) were set as criteria based on aapos guidelines. the difference in detection of refractive amblyopia risk factors between the two methods was the main outcome measure.


Eligibility criteria:
inclusion criteria: * \> 1 year old /with consent exclusion criteria: * mental retardation * impaired fixation * strabismus * ptosis and any other organic ophthalmic disorder interfering with refraction

Keywords: non-cycloplegic photorefraction cycloplegic refraction, amblyopia
olanzapine in the treatment of hair pulling (trichotillomania)

Conditions: Trichotillomania

Summary: trichotillomania (ttm) or hair-pulling has been considered as part of the obsessive compulsive disorder (ocd) spectrum, although treatment with ocd medications has largely been unsuccessful. tics/tourrettes' syndrome (ts) is a disorder, which appears to be related to ttm, but is treated with a different class of medications than used in ocd, namely antipsychotics such as olanzapine. this is a study of the safety and efficacy of olanzapine in the treatment of hair pulling.


Eligibility criteria:
inclusion criteria: * primary dsm-iv trichotillomania; cgi-severity ≥ 4 exclusion criteria: * any other axis i primary diagnosis; cgi-s \< 4; current comorbid: ocd, mdd, alcohol or substance abuse; lifetime hx of: schizophrenia, bipolar affective disorder or dementia; current pregnancy/lactation; current suicidality or homicidality; major medical problems or clinically unstable medical disease; hx of: seizures, stroke or head trauma; prior use of neuroleptics
to investigate the safety and tolerability of aztreonam-avibactam (atm-avi)

Conditions: Complicated Infection; Bacterial Infections

Summary: this is a randomised, double-blind, 3-part study designed to investigate the safety and tolerability of atm-avi. the study aims to characterise the pharmacokinetics of atm-avi, when both drugs are administered alone (atm or avi) and in combination (atm-avi), following single administration, and following multiple administrations of atm-avi in healthy male and female (females of nonchildbearing potential) volunteers both young and elderly.

a phase i, randomised, double-blind, 3-part study in healthy young and elderly subjects to assess the safety and tolerability, and investigate the pharmacokinetics of aztreonam and avibactam given alone and in combination (atm-avi)

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures * healthy young male and female volunteers aged 18 to 45 years (inclusive) and healthy elderly volunteers aged 65 or older (part c) with suitable veins for cannulation or repeated venipuncture * have a body mass index (bmi) between 19 and 30 kg/m2 * be able to understand and willing to comply with study procedures, restrictions, and requirements, as judged by the pi exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the pi, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study * history or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * known history of severe allergy to betalactam and/or l-arginine * history of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the pi or history of hypersensitivity to drugs with a similar chemical structure or class to atm or avi * any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of ip

Keywords: phase i, safety, tolerability, healthy.
ruxolitinib for the treatment of chronic myelomonocytic leukemia (cmml): a phase 2 expansion

Conditions: Chronic Myelomonocytic Leukemia; Leukemia

Summary: this study is to find out if treating chronic myelomonocytic leukemia (cmml) with a study drug (ruxolitinib) can improve outcomes of patients with cmml.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of chronic myelomonocytic leukemia (cmml)using the world health organization (who) classification. * 18 years of age or older at the time of obtaining informed consent. * must be able to adhere to the study visit schedule and other protocol requirements. * participants must be able to provide adequate bm aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure. * an eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2 is required. * women of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. * must understand and voluntarily sign an informed consent form. * must have a life expectancy of greater than 3 months at time of screening. * must have symptomatic splenomegaly and/or an myeloproliferative neoplasms symptom assessment form total symptom score \>17. exclusion criteria: * any of the following lab abnormalities: platelet count of less than 35,000/ul, absolute neutrophil count (anc) less than 250/ul, serum creatinine ≥ 2.0, serum total bilirubin \>1.5x uln * use of cytotoxic chemotherapeutic agents, or experimental agents (agents that are not commercially available) for the treatment of cmml within 28 days of the first day of study drug treatment. * prior history of metastatic malignancy in past 2 years * any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study. * concurrent use of granulocyte-macrophage colony stimulating factor (gm-csf). granulocyte colony stimulating factor (g-csf) could be used for the short-term management of neutropenic infection. stable doses of erythropoietin stimulating agents that were started \>8 weeks from first ruxolitinib dose or corticosteroids that were being administered prior to screening are allowed. * uncontrolled current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * pregnant women are excluded from this study because ruxolitinib has not been studied in pregnant participants. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib.

Keywords: cmml
safety and efficacy of aae581 in postmenopausal women with osteoporosis

Conditions: Osteoporosis

Summary: this study will test the safety and efficacy of aae581 in increasing lumbar spine bone mineral density (bmd) at 12 months, by dexa-scan (dxa) in postmenopausal women with osteoporosis.


Eligibility criteria:
inclusion criteria: * bmd t score between -2 to -3.5 * 50-75 years old exclusion criteria: * urolithiasis * bisphosphonates other protocol-defined inclusion/exclusion criteria may apply.

Keywords: osteoporosis/osteopenia, bmd, postmenopausal
bone arches: performance of pseudo-scanner sequences in segmenting the extent of the tumour and in planning surgical resection using the ct scan as a reference

Conditions: Sarcoma

Summary: the goal of this exploratory interventional study aims to evaluate the performance of "pseudo-scanner" mri sequences in delineating the tumor extent within bone sarcomas and its ability to serve as a reference for designing cutting guides and enabling "navigation" during the surgical procedure, thus exploring the possibility of replacing the scanner to minimize exposure to ionizing radiation in patients with sarcoma.

the management of bone sarcomas is complex, and imaging plays an important role in both diagnosis and treatment monitoring. mri is the method of choice to provide accurate information on the extent of the bone tumor and its relationship to adjacent soft tissues. however, an additional ct scan is routinely performed and combined with mri images (spatial realignment) using software and relying on manual control and/or correction. this is essential during surgical planning to i) ensure resection with properly defined safety margins and ii) allow for accurate bone reconstruction.ing. this exploratory interventional study aims to evaluate the performance of "pseudo-scanner" mri sequences in delineating the tumor extent within bone sarcomas and its ability to serve as a reference for designing cutting guides and enabling "navigation" during the surgical procedure, thus exploring the possibility of replacing the scanner to minimize exposure to ionizing radiation in patients with sarcoma.

Eligibility criteria:
inclusion criteria: * diagnosis of bone sarcoma with surgical indication exclusion criteria: * implanted material incompatible with mri. * severe claustrophobia. * pregnant women

Keywords: imaging sarcoma cutting guide mri
stem cell transplant to treat patients with favorable or intermediate risk minimal residual disease negative acute myeloid leukemia

Conditions: Acute Myeloid Leukemia; Minimal Residual Disease Negativity

Summary: this phase ii trial studies how well autologous stem cell transplant works in treating patients with favorable or intermediate risk, minimal residual disease (mrd)-negative, acute myeloid leukemia. giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body. after treatment, stem cells are collected from the patient's blood and stored. higher dose chemotherapy is then given to prepare the bone marrow for the stem cell transplant. the stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

primary objectives: i. assess the estimated probability of relapse at 2 years after autologous peripheral blood stem cell (pbsc) transplant. secondary objectives: i. estimate the probability of transplant-related mortality (trm) at 100 days following autologous stem cell transplant (asct). ii. estimate probabilities of overall and disease-free survival. iii. assess if biological and molecular correlative studies can predict better outcome. outline: patients receive targeted busulfan intravenously (iv) or oral (po) every 6 hours on days -7 to -4 and etoposide iv on day -3. patients then undergo autologous stem cell transplant on day 0. after completion of study treatment, patients are followed up yearly for 2 years.

Eligibility criteria:
inclusion criteria: * aml favorable or intermediate eln risk * achieved true 1st complete response (cr) (absolute neutrophil count \[anc\] and platelet count \> 1,000/ul and 100,000/ul respectively) after first cycle of induction therapy, with no minimal residual disease (mrd) * no measurable residual disease (mrd) as assessed by flow cytometry after initial induction therapy * performance score eastern cooperative oncology group (ecog) 0, 1 or 2 * creatinine \ 50 * not pregnant * received 1-2 courses of post remission "consolidation" therapy prior to mobilization pbsc * no mrd by flow, cytogenetics, fluorescence in situ hybridization (fish) and molecular testing prior to collection of autologous pbsc collection * plan is to collect at least 3 x 10\^6 cd34+ pbsc/kg cryopreserved; preference is 4-5 x 10\^6 cd34 cells/kg exclusion criteria: * life expectancy is severely limited by diseases other than aml * total bilirubin \> 2.0 mg/dl or serum glutamic-oxaloacetic transaminase (sgot)/serum glutamate pyruvate transaminase (sgpt) \> 2.5 x upper limit of normal (uln) * history of gilbert's disease * uncontrolled arrhythmias, left ventricular ejection fraction (lvef) \< 50% or corrected diffusion capacity of the lung for carbon monoxide (dlco) \< 50% * significant active infection that precludes transplant * hepatitis b or c viremia at time of asct * history of central nervous system (cns) involvement with aml
pulmonary physiologic assessment of patients on veno-arterial extracorporeal membrane oxygenation (va ecmo)

Conditions: Cardiac Arrest; Pulmonary Injury

Summary: there is limited data on the respiratory system mechanics and ideal mode of ventilation for patients on veno-arterial extra-corporeal membrane oxygenation (va ecmo) post cardiac arrest. in this observational study, the investigators will review and/or obtain laboratory, hemodynamic, respiratory system mechanical, and clinical data from patients on va ecmo. the specific aims of this study are as follows: aim 1: to characterize the lung ventilation strategy employed in patients on va ecmo and its success. aim 2: to characterize respiratory system mechanics while on ecmo using esophageal manometry and electrical impedance tomography (eit). aim 3: to characterize right heart function and pulmonary vascular hemodynamics on the employed ventilation strategy. the overarching hypothesis is that fine-tuned individualized ventilation might be superior to an algorithm that does not account for cardiac and pulmonary functions. therefore, the aims of this study are to identify areas in which the ventilation strategy may theoretically be suboptimal, which will guide future interventional studies investigating alternatives methods of ventilation which may reduce time on the ventilator after cardiac arrest, time in the intensive care unit, and need for veno-venous ecmo.


Eligibility criteria:
inclusion criteria: * on va ecmo after cardiac arrest * between 18 and 85 years of age * has an orogastric or nasogastric tube with esophageal balloon capabilities in place exclusion criteria: * known pre-existing significant pulmonary pathology * pacemaker or implanted cardiac defibrillator
evaluation of the ulthera® system for treatment of the face and neck

Conditions: Wrinkles; Rhytids; Skin Laxity

Summary: up to 15 subjects will be enrolled. enrolled subjects will receive one ulthera® treatment on the face and neck. follow-up visits will occur at 45, 90 and 180 days post-treatment. study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

this is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the ulthera® system to improve jawline definition and submental skin laxity. changes from baseline in the fitzpatrick facial wrinkle scale and facial pigmentation will be assessed at study follow-up visits. global aesthetic improvement scale scores, patient satisfaction questionnaires, and quality of life questionnaires will be obtained.

Eligibility criteria:
inclusion criteria: * male or female, aged 30 to 65 years. * subject in good health. * score of 1 to 6 on the fitzpatrick's classification of wrinkling scale. * mild to moderate rhytids in the periorbital or perioral region. * mild to moderate laxity in the areas to be treated, which includes length and depth of lines. * mild to moderate vertical perioral lines * mild to moderate marionette lines. * subjects who desire lift and tightening of periorbital, perioral, and cheek tissue, improvement in jawline definition and/or submental skin laxity * understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. * willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. exclusion criteria: * presence of an active systemic or local skin disease that may affect wound healing. * severe solar elastosis. * excessive subcutaneous fat on the cheek. * excessive skin laxity on the lower face and neck. * deep wrinkles, numerous lines, with or without redundant skin in the areas to be treated. * excessive hooding with or without redundant skin in the areas to be treated.

Keywords: ultherapy™ treatment ulthera® system ulthera, inc. ultrasound treatment for skin tightening
inhaled no for the treatment of covid-19 caused by sars-cov-2 (canada trial)

Conditions: COVID-19; SARS-CoV 2; Respiratory Disease; Pneumonia, Viral; Corona Virus Infection

Summary: the purpose of this open label, 2-phase, study is to obtain information on the safety of 80 ppm and the safety and efficacy of 150 ppm nitric oxide given in addition to the standard of care of patients with covid-19 caused by sars-cov-2.


Eligibility criteria:
inclusion criteria: 1. patients (male and female) admitted to the hospital for covid-19 2. patients with oxygen saturation less than 93 % on room air 3. shortness of breath, with symptom onset within the previous 8 days. 4. ability to understand and comply with study requirements . 5. signed informed consent by subject exclusion criteria: 1. patients who are treated with or require high flow nasal cannula, cpap, intubation, mechanical ventilation, or tracheostomy 2. diagnosis of acute respiratory distress syndrome 3. breastfeeding or pregnancy as evidenced by a positive pregnancy test. 4. subjects diagnosed with immunodeficiency, with history of congestive or unstable heart disease, left ventricular dysfunction (lvef \<40%) or myocardial damage, severe pulmonary hypertension and/or unstable hypertension 5. history of frequent epistaxis (\>1 episode/month). 6. significant hemoptysis during the last 30 days prior to enrollment 7. methemoglobin level \>3% at screening 8. patients on systemic steroids (any formulation) within 30 days prior to enrollment. 9. history of daily, continuous oxygen supplementation 10. patients with bmi greater than or equal to 36 11. patient receiving drugs that have a contraindication with no, 12. patients with clinically significant anemia, e.g., hb \<100 g/l and thrombocytopenia, e.g., platelets \<75 thousand cells/mcl. 13. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data, e.g., known or suspected thalassemia, sickle cell disease or other diseases associated with poor oxygen carrying capacity. 14. the subject is identified by the investigator as being unable or unwilling to perform study procedures.