Kornimate/medical-research-clean huggingface dataset:
clinical study of inhaled gb002 for treatment of who group i pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: this is a phase 1b, randomized, participant- and investigator-blinded, placebo-controlled, multi-center clinical trial to evaluate the safety, pharmacokinetics (pk), pharmacodynamics (pd), and biomarkers of inhaled gb002 in adults with world health organization (who) group 1 pulmonary arterial hypertension (pah).

the primary objective for this trial is to evaluate the safety and tolerability of gb002. the secondary objective for this trial is to evaluate the pk parameters of gb002. exploratory objectives are to evaluate the pd readouts, change in who group i functional class, and change in quality of life associated with gb002 treatment. in this phase 1b study, two dose levels of gb002 will be tested in adult participants with pah. four participants in cohort 1 will be randomized to receive up to two daily doses of either active drug or placebo, with 3 subjects receiving gb002 and 1 subject receiving placebo. an additional 4 participants (3 active and 1 placebo) may be added to cohort 1 at the discretion of the data review committee (drc). the dose and dosing interval (i.e., once daily or twice daily) for the second cohort will be determined by review of the safety, tolerability, and drug levels in the blood from cohort 1. cohort 2 participants will also be randomized such that 6 subjects receive gb002 and 2 subjects receive placebo. eligible subjects who have completed the 2 week treatment period have the option to participate in a 24 week open label extension.

Eligibility criteria:
inclusion criteria: 1. adult (males and females) aged 18 to 75 years (inclusive) with pulmonary arterial hypertension (pah) (main study) 2. a current diagnosis of symptomatic pah classified by one of the following (main and ole study): 1. idiopathic (ipah) or heritable pulmonary arterial hypertension (hpah) 2. pah associated with one of the following connective tissue diseases (ctds): systemic sclerosis, rheumatoid arthritis, mixed ctd or overlap syndrome, or systemic lupus erythematosus 3. pah associated with anorexigen or methamphetamine use 3. world health organization (who)/new york heart association (nyha) functional class ii-iv symptomatology (main study) exclusion criteria: 1. clinically significant systemic hypertension or hypotension (main and ole study) 2. history of left-sided heart disease and/or clinically significant cardiac disease (main and ole study) 3. history of decompensated right heart failure within 30 days of screening (e.g., hospitalization for pah or the need to add an additional pah medication) (main study) note: additional inclusion/exclusion criteria may apply, per protocol.
controlled phonation and vocal rest programs after acute vocal exertion in healthy adults

Conditions: Healthy

Summary: the proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. this study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. the investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.


Eligibility criteria:
inclusion criteria: * within age range exclusion criteria: * voice disorders * strong gag reflex * craniofacial disorders * cognitive impairments * head and neck cancer * hearing difficulties * dentition problems that prevent an oral scope being placed in mouth
biomarker to evaluate protein profiles of neutropenic fever/infection with acute or chronic leukemias

Conditions: Leukemia, Lymphocytic; Leukemia, Myeloid

Summary: the purpose of this study is to measure, in pilot/observational study, panels of circulating proteins in real time at the onset of neutropenic fever/infection in patients with acute or chronic leukemias undergoing chemotherapy or other biologic treatment. and to generate preliminary trend results in panels of circulating proteins longitudinally during the period of neutropenia and to correlate those values to clinical/laboratory data and patient outcomes.

to identify potential biomarkers for the prediction of nf, we performed serial measurements of nine biomarkers \[c-reactive protein (crp), protein c, interleukin (il)-6, il-8, il-10, il-1β, tumor necrosis factor-α, monocyte chemotactic protein-1, and intercellular adhesion molecule-1\] using a multiplex elisa array platform every 6-8 hours in patients undergoing myelosuppressive chemotherapy for hematologic malignancies.

Eligibility criteria:
inclusion criteria:- age \>= 18 * pre-admission (atu, ita) or inpatient status * absolute neutrophil count (anc) \<= 1500/mm\^3 * patients with acute myeloid or lymphoid leukemia who: * are admitted with newly diagnosed disease and have not yet received induction chemotherapy * are admitted with neutropenic fever after receiving post-remission chemotherapy or are admitted for post-remission chemotherapy * patients with chronic myeloid leukemia or a chronic lymphoid leukemia/disorder who have received chemotherapy or other disease-specific treatment in the last 30 days where the anc of \<=1500/mm3 is considered by the treating physician to be at least possibly treatment-related * an intravenous line or catheter (hickman, port, portacath, or peripherally inserted central venous catheter \[picc\] line) must be in place at the time of protocol participation/study start, but will not be inserted solely for the purposes of the study. * whenever possible, patients will be consented and blood monitoring will be initiated before the first dose of antibiotic, but if not possible, at no time will standard of care measures will be delayed or interrupted for the purposes of study enrollment. * patients must be able to understand the nature of the study and give written informed consent. there are no exclusion criteria. anyone who does not meet inclusion criteria will be excluded.
a study to confirm efficacy and safety of hs-10374 for moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: this study has been designed to confirm the clinical efficacy and safety of hs-10374 in the treatment of moderate to severe plaque psoriasis.

this is a 52-week, multi-center, randomized, double-blind, placebo-controlled, phase 3 study. the study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. all eligible subjects will be randomly assigned in a 2:1 ratio to receive hs-10374 or placebo qd. at week 16, subjects receiving placebo will be switched to hs-10374 qd.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 years and older * diagnosis of plaque psoriasis for at least 6 months * eligible for phototherapy or systemic therapy * plaque covering ≥ 10% of bsa * pasi ≥ 12, spga ≥3 exclusion criteria: * diagnosis of non-plaque psoriasis or drug-induced psoriasis * recent history of infection, history or risk of serious infection * any major illness or evidence of unstable condition of major organ systems including psychiatric disease * any condition possibly affecting the pk process of the study drug * evidence of other skin conditions that would interfere with the evaluation of psoriasis * history of hypersensitivity to the ingredients of study drugs, history of anaphylaxis * prior exposure to tyk2 inhibitors * have received the prohibited treatment during the protocol required washout period * any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period
dopamine in acute decompensated heart failure ii

Conditions: Acute Decompensated Heart Failure

Summary: the aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.

the aim of this study is to compare the effects of: 1. high-dose furosemide (hdf, 40 mg furosemide bolus iv, followed by continuous iv infusion of 20 mg/h for a total of 8 hours), 2. low-dose furosemide (ldf, 40 mg furosemide bolus iv, followed by continuous iv infusion of 5 mg/h furosemide for a total of 8 hours), and 3. low-dose furosemide combined with low-dose dopamine (ldfd, 40 mg furosemide bolus iv, followed by continuous iv infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, perceived dyspnea, renal function, electrolyte balance, total length of stay, and 60-day post-discharge outcomes in patients hospitalized with adhf.

Eligibility criteria:
inclusion criteria: * patients with new york heart association (nyha) functional class iv heart failure according to the american heart association (aha) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea, * signs of congestion (third heart sound or pulmonary rales on physical examination), * pulmonary congestion on chest x-ray, * serum b-type natriuretic peptide levels \> 400 pg/ml or nt-probnp \> 1500 pg/ml, * echocardiographic documentation of systolic or diastolic dysfunction, * age \>18 years old, * on medical therapy with an ace-inhibitor and/or a β-blocker, * experiencing an acute decompensation of known chronic hf, * baseline oxygen saturation \<90% on admission arterial blood gas exclusion criteria: * acute de novo hf; * severe renal failure (serum creatinine \>200 μmol/l or gfr \<30 ml/min/1.73m2) * admission systolic blood pressure \<90 mm hg; * severe valvular disease; * known adverse reactions to furosemide or dopamine; * hf secondary to congenital heart disease; * a scheduled procedure with a need for iv contrast dye; * a scheduled cardiac surgery within 6 months

Keywords: heart failure dopamine furosemide worsening renal function hypokalemia outcomes prognosis
carpal tunnel release under local anaesthesia with or without distal median nerve block

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome is the most commonly appearing entrapment neuropathy of the upper extremity. treatment options include both non-operative and surgical methods. surgical treatment, carpal tunnel release (ctr), involves division of the transverse carpal ligament. surgery can be done under an axillary- or intravenous block, or local or general anaesthesia. there are no randomised controlled trials comparing local infiltration anaesthesia with or without a distal median nerve block in carpal tunnel release. the aim of the study is to investigate whether a distal median nerve block, in addition to local anaesthesia in carpal tunnel release, reduces pain during and after the procedure. the null hypothesis is that the use of distal median nerve block with local anaesthesia does not reduce pain after ctr compared to pure local anaesthesia. this trial is a randomised controlled trial involving patients with carpal tunnel syndrome. patients will be randomized into two study groups: local anaesthesia and local with a distal median nerve block. fifty-nine patients will be needed for each group to have adequate power. the primary outcome is the pain level after the procedure for 72 hours using visual analogue scale. the secondary outcomes include expected pain; pain during the injection of the anaesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anaesthesia; number of experienced needle stings; boston carpal tunnel syndrome questionnaire; pain killer consumption, patient satisfaction, and safety . there are no prior randomised controlled trials (rct) comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with a distal median nerve block in ctr. distal median block in ctr is believed to reduce pain intra- and postoperatively. however, the superiority of distal median block with local anaesthesia compared to pure local anaesthesia alone has not been proven.


Eligibility criteria:
inclusion criteria: * over 17 years of age * cts verified by nerve conduction studies * symptoms suitable for cts exclusion criteria: * recurrent cts * peripheral neuropathies * known allergy to the trial drugs * profound cognitive impairment * pregnancy

Keywords: carpal tunnel syndrome carpal tunnel release local anaesthesia surgery wide-awake local anaesthesia with no tourniquet nerve block
validation of an artificial intelligence system for postoperative management of cataract patients

Conditions: Cataract; Postoperative Complications; Artificial Intelligence

Summary: cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. the management strategy can also change according to postoperative time.


Eligibility criteria:
inclusion criteria: * patients who had surgery of cataract extraction combined with introcular lens implantation. * patients should be aware of the contents and signed for the informed consent.

Keywords: conjunctival hyperemia pterygium intraocular lens dislocation posterior capsule opacification pupil malformation suppurative endophthalmitis
phase 1b/2a study of gsbr-1290 in adult overweight or obese healthy subjects and subjects with type 2 diabetes mellitus

Conditions: Overweight or Obesity; Type2 Diabetes Mellitus

Summary: this study will evaluate safety, tolerability, pharmacokinetic (pk) profile, and pharmacodynamic (pd) effects on gsbr-1290 in healthy overweight/obese volunteers (hov) and type 2 diabetes mellitus on metformin (t2dm) this study includes 5 planned cohorts. participants will receive multiple-ascending doses of gsbr-1290 or placebo from day 1 to day 84


Eligibility criteria:
inclusion criteria cohorts 1-4: 1. provided evidence of a signed consent 2. age ≥ 18 and ≤ 75 years 3. healthy overweight/obese adult men and women with body mass index ≥ 27 and ≤ 40 kg/m2 4. no nicotine use 5. have a suitable venous access for blood sampling inclusion criteria cohort 5: 1. men and women with t2dm of ≥6 months duration 2. age ≥ 18 and ≤ 75 years 3. bmi ≥ 27 and ≤ 40 kg/m2 4. treated with stable doses of ≥500 mg of metformin with a duration ≥6 months and at stable doses for ≥2 months with a screening hba1c ≥7.0% and ≤10.5%. exclusion criteria: 1. history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the major 3 months 2. a sitting bp after resting for 5 minutes \> 160mm hg systolic or \> 100 mm hg diastolic or an apical pulse rate \ 100 beats per minute. 3. evidence of abnormality on the screening visit ecg, or a history of known arrhythmia or prolonged qtcf pr prolonged qrs interval 4. liver function test results elevated \> 2.0-fold above the uln for gamma glutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. bilirubin above the uln 5. estimated glomerular filtration rate \< 60ml/min/1.73 m2 body surface area 6. known hypersensitivity to any of the study drug ingredients 7. any other condition or prior therapy that would make the participant unsuitable for this study
treatment of iron deficiency anemia in malaria endemic ghana

Conditions: Anemia

Summary: iron deficiency and iron deficiency anemia (ida) are the most prevalent micronutrient deficiencies on a worldwide basis, especially in developing countries. the impact of severe ida can have mortal consequences, since without adequate hemoglobin, the brain and body become deprived of oxygen and, if allowed to continue, death may ensue. it has been shown that iron supplementation in infants and young children can enhance child development, however, it may also result in increased rates of malaria in high burden areas. the primary objective of this study is to determine the impact of providing encapsulated iron (as a powder added to complementary foods) on the susceptibility to clinical malaria among anemic and non-anemic infants and young children (6-24 months of age) living in a high malaria burden area. the value of performing this research in ghana is primarily that malaria and anemia remain the most important causes of death and morbidity.

study design: the proposed study is a community-based blinded randomized controlled trial with 2 study arms that will be conducted in two phases: * phase i will take place during the dry season (december to april), when malaria transmission rates are lower. eligible subjects (one per household) will be individually randomized to receive a daily dose of either a powdered vitamin/mineral fortificant containing 12.5 mg of iron (plus ascorbic acid, vitamin a and zinc), or a placebo (containing all micronutrients excluding iron), added to complementary foods, for 5 months. * phase ii will take place during the wet season (june to october), when malaria transmission rates are higher. eligible subjects, who did not participate in phase i, will be individually randomized to one of the two study arms as described above and followed for 5 months. a dual phase design, with two unique cohorts, was chosen so that preliminary results (at the end of phase 1) could be assessed by an independent data safety and monitoring committee. it is possible that during the dry season no impact of iron will be detected, while during the wet season, an impact will be observed. with this possible outcome, it is potentially feasible to translate this knowledge into a ministry of health program to only provide iron supplementation (fortification) during the dry months of the year (december to april).

Eligibility criteria:
inclusion criteria: * age 6-24 months * ingesting weaning food in addition to breastmilk * free from malaria or other major illnesses * afebrile * living in brong ahafo region of ghana for duration of intervention and follow-up exclusion criteria: * severe anemia (hemoglobin \<70g/l) * weight-for-height \<-3 z-score(severe wasting) * kwashiorkor (defined as evidence of edema) * congenital abnormality * treatment with iron supplements within the past 6 months * presence of any chronic illness

Keywords: iron deficiency anemia sprinkles® micronutrients malaria incidence iron supplement
italian multicentric study on the treatment of visceral aneurysms with the flow diversion stent derivo peripher and derivo 2

Conditions: Aneurysm Abdominal; Arterial Aneurysm

Summary: this is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent derivo peripher and derivo 2 (ded, acandis gmbh) follow-up will include clinical and radiological (ct) evaluation at least 12 months after the intervention. the enrollment period will be of 65 months (01/jan/2020-30/jun/2025). sample size will be of 100 patients.


Eligibility criteria:
inclusion criteria: * \>18 years old * visceral artery aneurysms, evaluated with computed tomography angiography-cta- withindication for treatment according to 2020 svs and 2024 sicve/sirm and 2024 cirse guidelines. specifically: * renal artery: \>2 cm if fusiform morphology or all dimensions if sacculary or bifurcation morphology, if in fertile women or in hypertensive patients with renal stenosis * splenic artery: if \>2 cm, or all dimensions in fertile women. * celiac tripod: if \>2 cm. * hepatic artery: if \>2 cm or growth greater than 0.5 cm/year. * superior mesenteric artery, gastric or gastroepiploic artery, pancreaticoduodenal or gastroduodenal arteries, colic arteries, jejunal arteries, and ileal arteries: any size * anatomical characteristics compatible with the stent ded instruction for use (ifu). specifically: * the stent diameter should match the largest diameter of either the proximal or distal vessel of the aneurysm with an oversizing of 1-2 mm according to ifu. * the stent length must allow for adequate proximal and distal landing, covering the neck of the aneurysm to 2.5 times the vessel's internal diameter and no less than 15 mm. * proper adherence to the anticoagulant and antiplatelet pharmacological protocol for the peri-procedural and post-procedural periods. specifically: * all patients should begin dual antiplatelet therapy (dapt) before surgery (for at least 3 days before the procedure or with a loading dose pre-procedurally). * all patients receive systemic anticoagulation during the procedure (heparin 70 iu/kg to achieve an activated clot time (act) \> 250 s). * after the procedure, the patient should continue dapt (e.g., asa 100 mg daily and clopidogrel 75 mg daily) for at least 1 month, then continue with single antiplatelet therapy (e.g., asa 100 mg) indefinitely. exclusion criteria: * patients who are hemodynamically unstable or show ct signs of rupture or contained rupture of visceral aneurysm * pregnant or breastfeeding women * life expectancy less than 2 years

Keywords: flow diverter visceral aneurysm stenting