Kornimate/medical-research-clean huggingface dataset:
clinical investigation into inhaled treprostinil sodium in patients with severe pulmonary arterial hypertension (pah)

Conditions: Pulmonary Hypertension

Summary: this is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. the primary outcome is the change in 6-minute walk distance from baseline to week 12.

patients who have been on a stable dose of 125 mg twice daily (bid) of bosentan or any stable dose of sildenafil for at least three months prior to study start were randomized to either treprostinil inhalation solution or matching placebo. administration of study medication was performed by inhalation with the optineb™ ultrasonic nebulizer. the proposed dosing regimen was four times daily-upon awakening, at midday, evening (dinner time) and bedtime. after a patient has completed the twelve-week study period, they were given the option of enrolling into an open-label extension study.

Eligibility criteria:
inclusion criteria: * clinically stable, pulmonary arterial hypertension diagnosed as either idiopathic or familial pah, collagen vascular disease associated pah, hiv pah, or pah induced by anorexigens, new york heart association (nyha) class iii or class iv. * been on a stable dose of 125 mg twice daily (bid) of bosentan or any stable dose of sildenafil for at least three months prior to study start * an unencouraged six minute walk test (6mwt) of between 200 and 450 meters at screening * cardiac catheterization within the past 13 months consistent with pah, specifically mean pulmonary artery pressure (papm) ≥25 mmhg (at rest), pulmonary capillary wedge pressure (pcwp) (or left ventricular end diastolic pressure) ≤15 mmhg, and pulmonary vascular resistance (pvr) \>3 mmhg/l/min * within the past 12 months, patients must have had a chest radiograph consistent with the diagnosis of pah * willing and able to follow all study procedures exclusion criteria: * considering pregnancy, are pregnant and/or lactating * pah due to conditions other than noted in the above inclusion criteria. * have had any change in or discontinued any pah medication within the last three months, including but not limited to endothelin receptor antagonist (era), or calcium channel blockers (ccb) (with the exception of anticoagulants) * have received any prostanoid within the 30 days before screening or are scheduled to receive any during the course of the study * have received any investigational medication within 30 days prior to the start of this study or are scheduled to receive another investigational drug during the course of this study * have a known intolerance to any drug, especially to treprostinil sodium or prostanoids * have an increased risk of hemorrhage * have a new type of chronic therapy (e.g., a different category of vasodilator, diuretic) for pah added within the last month, except anticoagulants * have any musculoskeletal disease or any other disease that would limit ambulation.

Keywords: pulmonary arterial hypertension
2-hydroxybenzylamine (2-hoba) to reduce hdl modification and improve hdl function in familial hypercholesterolemia (fh)

Conditions: Familial Hypercholesterolemia

Summary: the investigators will test the hypothesis that 2-hoba will reduce modification of hdl and ldl and improve hdl function in humans with heterozygous fh. the investigators plan to first study subjects with familial hypercholesterolemia (fh), treating them with 750 mg of 2-hoba or placebo every 8 hours for 6 weeks.


Eligibility criteria:
inclusion criteria: * individuals with heterozygous familial hypercholesterolemia. exclusion criteria: * myocardial infarction or stroke within the last 6 months * unstable angina, symptoms of angina within the last 3 months * nyha class iii or iv heart failure or lvef \< 30% * poorly controlled hypertension: sbp \> 180 mm hg or dbp \> 110 mm hg, * pregnancy, * evidence of a previous acute coronary syndrome, * current smokers, * individuals with type 2 diabetes mellitus, obesity (bmi \> 30), * hypertriglyceridemia (fasting tg \> 250 mg/dl), * renal insufficiency (cr \> 1.8), * hepatic disease (aspartate aminotransferase(ast) or alanine aminotransferase (alt) \> 2x uln), * hypothyroidism, * nephrotic syndrome, * rheumatoid arthritis, * systemic lupus erythematosus, * aids or hiv * history of malignancy of any organ in last 5 years.

Keywords: familial hypercholesterolemia hdl ldl 2-hoba hdl function
a study of decitabine given subcutaneously to adults with low or intermediate-1 risk myelodysplastic syndromes (mds)

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to determine the effectiveness and safety of two different dose schedules of dacogen® (decitabine) for injection in patients with myelodysplastic syndromes (mds).

this is a randomized open-label phase 2 efficacy and safety study of two (2) subcutaneous (sq) dosing schedules of decitabine in subjects with low or intermediate 1 risk mds. this study will be conducted in up to 6 study centers in the united states. the primary efficacy outcome is the overall improvement rate. these two doses will be administered subcutaneously. the probability that one schedule is superior to the other will be estimated, and the level of toxicity for each schedule will also be evaluated.

Eligibility criteria:
inclusion criteria: each patient must meet the following criteria to be enrolled in this study: 1. male or female patients age 18 years and older. 2. patients must sign an institutional review board (irb)-approved informed consent form, and understand the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment. 3. must have eastern cooperative oncology group (ecog) performance status of 0-2. 4. adequate renal and hepatic function (creatinine \< 2 times upper limit of normal, total bilirubin of \< 2 times upper limit of normal, and ast and alt ≤ 2 times upper limit of normal) unless proven to be related to disease infiltration. 5. female patients need a negative serum or urine pregnancy test within 7 days prior to study drug administration (applies only if patient is of childbearing potential. non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized). 6. women of childbearing potential and men must use contraception. men and women must continue birth control for the duration of the study. 7. patients with low or intermediate-1 risk mds by the international prognostic scoring system (ipss) classification. exclusion criteria: patients who meet any of the following criteria will be excluded from the study: 1. women who are pregnant or nursing. 2. those who have received prior therapy with decitabine. 3. prior therapy with azacitidine (vidaza®). 4. those who received growth factor support or lenalidomide in the 30 days prior to the first dose of decitabine. 5. those who have received an investigational agent 30 days prior to the first dose of decitabine. 6. patients with active, uncontrolled, systemic infection considered opportunistic, life threatening or clinically significant; or any severe, concurrent disease, which, in the judgment of the investigator and after discussion with the sponsor and primary investigator, would make the patient inappropriate for study entry.

Keywords: myelodysplastic syndrome decitabine dacogen mgi pharma, inc.
udall project 1 aim 4

Conditions: Parkinsons Disease; Deep Brain Stimulation

Summary: by defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (bgtc) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for dbs that take advantage of this understanding.


Eligibility criteria:
inclusion criteria: * implanted with a dbs system * existing 7t imagery (either done as standard-of-care or done as part of noam harel's study, irb #1210m22183) * diagnosed with idiopathic parkinson's disease * minimum age 21 years exclusion criteria: * other significant neurological disorder, as determined by pi * diagnosis of dementia * pregnant
stress-reducing interventions in hiv+ patients: pilot

Conditions: Stress Disorders, Post-Traumatic; HIV Infections

Summary: the primary aim of this project is to examine the efficacy of prolonged exposure (pe) therapy at reducing hiv-related ptsd symptoms, increasing adherence to antiretroviral medication regimens, and increasing health-related quality of life (qol) in hiv+ patients.

hiv+ patients will be randomized to receive either pe therapy (up to 18 possible sessions) or weekly symptom monitoring (described below) and will complete measures of ptsd, adherence, and qol pre- and post-intervention and at 3- and 6-month follow-up assessments. secondary analyses will examine the impact of the intervention on disorders commonly comorbid with ptsd (i.e., anxiety, mood, and substance abuse/dependence disorders).

Eligibility criteria:
inclusion criteria: * must be hiv+ * must meet ptsd diagnostic criteria * must be taking hiv medications * must be able to read and write in english exclusion criteria: * current or previous diagnosis of schizophrenia, any current diagnosis with psychotic features, or current suicidal ideation * being in a current abusive relationship or ongoing intimate relationship with one's assailant * mental retardation

Keywords: prolonged exposure therapy adherence to hiv medications complementary therapies
dalbavancin real-life utilization in diabetic patients suffering from infections (dalbadia)

Conditions: Diabetes; Infection

Summary: the study aims to describe the current use of dalbavancin among diabetic patients with infections in a real-world clinical setting in italy and spain.

the study aims to describe the current use of dalbavancin in diabetic patients suffering from infections proven or suspected to be caused by gram-positive or mixed gram-positive and gram-negative bacteria (with dalbavancin chosen for treating the gram-positive component) in italy and spain. as overall strategies to reduce the risk of developing severe infections and poor treatment outcomes among diabetic patients are under-researched and should be explored. this study could increase the knowledge of infection management among diabetic patients treated with dalbavancin in order to support appropriate clinical decision-making.

Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of dalbavancin treatment initiation * male and female patients * patients who received dalbavancin as targeted or empirical therapy to treat gram-positive bacterial infection or as anti-gram-positive component of a treatment regimen for mixed infection (e.g., with concurrent antibacterial or antifungals drugs for covering gram-negative strains or fungi) * patients who received the last dose of dalbavancin according to the current standard clinical practice at least 30 (+7) days before enrolment in the study * patients with known type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm) at the time of infectious disease of interest diagnosis * patients with available retrospective data in medical charts, including information about dalbavancin treatment and diabetes history * patients who gave informed consent and personal data processing consent to take part into the study following local regulation. exclusion criteria: * patients enrolled in a clinical trial in which treatment with dalbavancin was managed through a study protocol * patients diagnosed with any hyperglycemic state other than t1dm or t2dm at the time of dalbavancin treatment initiation * patients with long-term infection (over than 12 months of duration) at the time of dalbavancin treatment initiation * previous participation in this study. participation is defined as having given informed consent in this study * pregnant or breast-feeding patients from start time of dalbavancin treatment initiation till enrolment visit.

Keywords: diabetes absssi infection gram-positive bacteria dalbavancin
non-invasive hemoglobin study

Conditions: Anemia

Summary: the investigators clinical trials will be for a medical device that is non-invasive in nature. the investigators will be studying whether their non-invasive medical device gets data that is as good as, or better than, an fda previously approved, blood analysis device. there is no study hypothesis for this study.


Eligibility criteria:
inclusion criteria for this study are: 1. subject is capable of giving informed consent. 2. subject has an anatomically intact digit capable of having a capillary sample taken and of being placed in the poct device. exclusion criteria for this study are: 1. age less than 18 years at time of research 2. subject lacks the digits to place in the poct device 3. subject displays symptoms or has a history of raynaud's disease 4. subject has a neurological disorder resulting in an inability to hold the index finger steady for 20 sec. 5. subject has a history of long term continuous decreased perfusion to either hand (\>30 days). 6. subject has had surgery within the last 2 weeks on finger or hand that he wishes to use in the study 7. subject's same day participation in this study 8. capillary sample volume is not adequate to complete testing on the comparative device. 9. cold agglutinin disease
effects of intramuscular oxytocin on sensory function in healthy volunteers with ultraviolet burn injury to the skin

Conditions: Chronic Pain

Summary: this study proposes to evaluate the effects that a dose of oxytocin given by intramuscular (im) injection (into the muscle) will have on an area of skin that has been exposed to ultraviolet (uv) light. the area of skin exposed to uv light will have a mild sun burn feeling. sensory testing will be performed on the area of uv burn. the area will be evaluated for sensitivity in 3 methods: touch, vibratory

this protocol aims to provide an estimate of effect size of intramuscular oxytocin on a test of aβ and of aδ fiber sensitivity in injured skin following ultraviolet b (uvb) burned skin. for the primary goal - to examine the effects of oxytocin peripheral nerves after tissue injury - the investigators chose the controlled ultraviolet sunburn model. the investigators propose a randomized, blinded, cross over design with treatment with oxytocin one day and placebo on another. following baseline measures on each of the two study days, participants will receive an intramuscular injection of oxytocin (pitocin®) in its indicated dose of 10 iu (17 μg) or an equivalent volume of saline. in order to determine the highest frequency that aβ nerve fibers can respond to, the investigators will use a device that produces an oscillatory / vibratory stimulus which can be used on the hand. pain threshold to punctate stimulation within the area of irradiation will be determined using calibrated von frey filaments and an up-down sequential method which efficiently estimates median thresholds. thermal heat testing will also be performed by the surface of the skin of the forearm or leg is heated to 45°c using a computer controlled thermode for a period of 5 minutes.

Eligibility criteria:
inclusion criteria: * male or female \> 18 and \< 60 years of age, * body mass index (bmi) \<40 * generally in good health as determined by the principal investigator based on prior medical history * normal blood pressure and resting heart rate without medication exclusion criteria: * hypersensitivity, allergy, or significant reaction to any ingredient of pitocin® * any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the principal investigator, would place the subject at increased risk * women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years. * neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
study of efficacy of welt-ip in insomnia (wctp-i-b-01)

Conditions: Insomnia

Summary: the purpose of the study was to determine safety and efficacy of welt-ip in adult insomnia patients. welt-ip is a cognitive behavioral therapy for insomnia (cbt-i) based digital therapeutics.

this was a randomized, double-blinded, sham-controlled trial. overall, 52 subjects were randomized into the following groups: * welt-ip group: welt-ip (insomnia digital therapeutics) use * control group: sham app use subjects in both groups continued to receive their clinician-directed standard-of-care treatment for insomnia, if applicable, including pharmacotherapy. subjects were randomized and in welt-ip group used welt-ip and subjects in control group used a sham for a period of 6 weeks.

Eligibility criteria:
inclusion criteria: * dsm-5 insomnia patient * isi of 8 or above * for 7 days before baseline visit (visit 2), completing sleep diary for more than 4 days in the guidelines * capable of using mobile device and application exclusion criteria: * currently on non-pharmacological treatment for insomnia (ex. cbt-i, light therapy, oriental therapy for insomnia) * sleep disorders diagnosis other than insomnia (ex. obstructive sleep apnea, sleep behavior problem, restless leg syndrome) * progressive and active medical conditions * received continuous psychotherapy such as cbt, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months * major psychiatric illness as assessed through mini * suicide risk as assessed through c-ssrs * having occupational risk due to sleep restriction * shift workers

Keywords: digital therapeutics
safety and efficacy of magnesium sulphate as an adjuvant to levobupivacaine in ultra-sound guided transversus abdominis plan block in pediatric abdominal cancer surgery

Conditions: Postoperative Pain

Summary: to study the efficacy of magnesium sulphate as adjuvant to levobupivacaine in transversus abdominis plane (tap) block in patient undergoing abdominal cancer surgery.

in this randomized study, patients with (asa) ӏ and ӏӏ, aged from 1 to 7 years old and their weight less than 30 kg of both sex will undergo surgery will be enrolled. a written informed consent from all parents are obtained

Eligibility criteria:
inclusion criteria: * patients with (asa) ӏ and ӏӏ physical status, aged from 1 to 7 years old and their weight less than 30 kg of both sex will undergo surgery will be enrolled. exclusion criteria: * children with infection, hemorrhagic disorders, hypersensitivity to the studied drugs, muscular disorders, central and peripheral neuropathy, organ dysfunction, cardiac problems and unconscious or mentally retarded patients will be excluded

Keywords: tap, magnisum sulphate
guided self-help for common mental disorders

Conditions: Bibliotherapy

Summary: common mental disorders (cmds) like depression and anxiety account for a large proportion of disability worldwide. access to effective treatments like cognitive-behavioral therapy (cbt) is limited and has not reduced the public health burden of psychopathology. for patients with mild-moderate cmds, lower-intensity treatments like guided self-help cbt (gsh-cbt) are effective and more scalable (e.g., via the internet). the advent of social media has opened avenues for dissemination of gsh-cbts and allows for passive sensing of mood, thinking, behavior, and social networks. we propose to leverage a social media platform used by over a fifth of the united states (twitter) as a recruitment tool to virtually screen over 150 individuals, recruit n=60 to a 5-week course of gsh-cbt, and extract social media data from individuals engaged in gsh-cbt. sociodemographic and social media data will be used to predict engagement, outcomes, and processes in gsh-cbt.


Eligibility criteria:
inclusion criteria: * at least mild distress: k6 score ≥ 6 * having reasonably regular access to the internet or a telephone exclusion criteria: - suicidality: patient health questionnaire-9 (phq9) item 9 ("thoughts that you would be better off dead, or of hurting yourself ") ≥ 2 ("more than half the days")
interest of the f18-choline as a second line of the tracer for detection of parathyroid adenomas

Conditions: Hyperparathyroidism

Summary: the rationale for the proposed pilot study is to investigate the ability of pet-ct with f18-choline to detect and locate the parathyroid adenoma in patients with primary hyperparathyroidism and negative or non-contributory mibi (tc-99m sestamibi) and cervical ultrasound, in order to avoid unnecessary bilateral cervical exploration.


Eligibility criteria:
inclusion criteria: * patient aged 18 years or more; * patient with a primary hyperparathyroidism and witj a negative or non-contriburatory mibi parathyroid scintigraphy and neck ultrasonography, for which surgical resection is planned; * confirmation of the diagnosis of primary hyperparathyroidism on laboratory tests * affiliate to a social security system; * patient written informed consent. exclusion criteria: * patient deprived of liberty, under guardianship; * any medical or psychological condition witch could compromise the capacity of the patient to participate in the study; * pregnant or breastfeeding

Keywords: f18-choline
safety & tolerability study of ctp-499 in patients with moderate chronic kidney disease

Conditions: Stage 3 Chronic Kidney Disease

Summary: this study is being conducted to evaluate the safety and tolerability of treatment with ctp-499 in non-dialysis patients associated with moderate chronic kidney disease.

this study will evaluate the safety and tolerability of treatment with ctp-499 starting with 600 milligrams (mg) once a day (qd) for 2 weeks followed by 600 mg twice a day (bid) for 2 weeks in non-dialysis patients associated with moderate chronic kidney disease defined as an estimated glomerular filtration rate or egfr that is 30-59 ml/min/1.73m2

Eligibility criteria:
inclusion criteria: * patient has a diagnosis of chronic kidney disease * if taking antihypertensive and antidiabetes medications, regimen must be stable for a minimum of 4 weeks * patient has systolic blood pressure less than or equal to 160 mm hg and diastolic blood pressure less than or equal to 95 mm hg exclusion criteria: * patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or clinically unstable autoimmune, endocrine, neurological, psychiatric, retinal, cardiovascular, bronchopulmonary, hepatic, gastrointestinal or musculoskeletal disorder * patient has acute, active and/or current unstable renal impairment disease * patient has been hospitalized for acute renal failure in the past year * patient has active malignancy or a history of neoplastic disease * patient has qtc interval \> 450 milliseconds * patient is currently on cytotoxic or other immunosuppressive therapy
prospective study on the clinical prognosis of bilateral central lymph node dissection in the patients with unilateral thyroid papillary carcinoma

Conditions: Thyroid Papillary Carcinoma

Summary: this study recruit the patients with unilateral papillary thyroid cancer before operation,the patients agree to enter the test,and divided into experimental and control group.experimental group patients receive the surgery including unilateral thyroid lobectomy and bilateral central lymph node dissection.and control group receive the surgery including unilateral thyroid lobectomy and unilateral central lymph node dissection.last the investigators compare numbers of patient with tumor recurrence and metastasis rate of 5 years,numbers of metastatic lymph node,and numbers of participants with adverse events related to treatment between two groups in order to evaluate the significance of bilateral lymph node dissection.


Eligibility criteria:
according by thyroid carcinoma tnm(tumor,lymph node, metastasis) staging of nccn (national comprehensive cancer network) inclusion criteria: * 1.unilateral thyroid papillary carcinoma 2.tnm staging: t1\~2n0m0 exclusion criteria: * 1.bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.tnm staging: t3ort4 4.clinic n1orm1

Keywords: thyroid carcinoma center lymph node dissection