Kornimate/medical-research-clean huggingface dataset:
randomized, controlled trial of regular sildenafil citrate in the prevention of altitude illness

Conditions: High Altitude Pulmonary Edema; Acute Mountain Sickness

Summary: the purpose of this study is to determine whether regular oral use of sildenafil citrate can prevent or attenuate high altitude illnesses.

high altitude pulmonary oedema (hape) is a life-threatening non-cardiogenic lung injury precipitated by exaggerated pulmonary hypertension. the incidence of this rapidly progressive illness, among the estimated 40 million visitors to high altitude each year, may be as high as 0.5-2.0%. the pathogenesis of hape is multifactorial and may include impaired clearance of alveolar fluid, increased pulmonary vascular permeability and genetic susceptibility. elevated pulmonary artery pressure (pap) caused by hypoxic pulmonary vasoconstriction (hpv) is a key prerequisite for the development of hape and thus the reduction of pap is paramount in the prophylaxis and treatment of this devastating illness. nitric oxide (no) is thought to play an important role in the exaggerated hpv that characterises hape. no, constitutively produced in the lung by the enzyme endothelial nitric oxide synthase (enos), increases intracellular cgmp in pulmonary vascular smooth muscle and activates cgmp-dependent protein kinase, ultimately leading to a reduction in intracellular calcium and smooth muscle relaxation. hape-susceptible individuals exhale less no during both normobaric and hypobaric hypoxia suggesting that a deficiency of no synthesis may predispose to hape. at high altitude, inhaled no causes a significantly greater reduction in the systolic pap of hape-susceptible individuals compared to its effect on the pap of hape-resistant subjects, but the administration of no would be impractical in the field. most recently, work has concentrated on another target in the no pathway. sildenafil citrate is an orally active, potent and selective phosphodiesterase type-5 (pde-5) inhibitor. pde-5 is the predominant enzyme responsible for degradation of cgmp in the lung. in a small sea level study, zhao et al. demonstrated that pre-treatment with sildenafil nearly completely abolished the pulmonary vasopressor response to breathing hypoxic gas in healthy humans. more recently, studies at altitude have also shown reductions in pulmonary artery systolic pressure (pasp) in subjects taking sildenafil at high altitude. one potential problem with the use of sildenafil at altitude is that pde-5 inhibitors may worsen symptoms of acute mountain sickness (ams). headache is a defining symptom in ams and is a prominent side effect of sildenafil. we conducted a double-blind placebo-controlled randomised trial to assess the effect of regular sildenafil administration on pasp and lake louise ams score at an altitude of 5200 m.

Eligibility criteria:
inclusion criteria: * participant in apex 2 high altitude expedition exclusion criteria: * previous history of high altitude pulmonary edema

Keywords: sildenafil citrate prevention high altitude pulmonary edema acute mountain sickness healthy lowland subjects pulmonary artery systolic pressure
clinical efficacy of remote monitoring in the management of heart failure

Conditions: Heart Failure

Summary: this is a clinical trial to evaluate the clinical benefit of remote monitoring in patients with heart failure having an icd-crt implanted. study purpose the purpose of this study is to test the hypothesis that the monitoring of specific clinical parameters, obtained by remote controls of icd-crt could improve clinical course of patients with heart failure. study design this is a prospective observational study, comparing clinical course of patients with heart failure having an icd-crt implanted, followed or not by remote monitoring. this study will include 870 subjects with icd and crt-d, and followed by a remote monitoring system (with or without weight and pressure external sensors) or followed by conventional ambulatory visits. primary endpoints the primary endpoint of this study is to document no superiority of unplanned hospital access for cardiac reasons (included access to the emergency units ) or death for cardiovascular causes in remote monitoring group (with or without weight and pressure external sensors) compared to conventional follow-up (usual care group).

aim of the study the purpose of this study is to evaluate the clinical benefit of a dedicated remote monitoring system (rpm) in the management of patients with heart failure and implanted with icds and crt-d. the clinical benefit will be assessed by: * increased cardiovascular events (death, myocardial infarction, hospitalization). * events arrhythmia: atrial fibrillation, sustained and nonsustained ventricular tachycardia or ventricular fibrillation. * autonomic profile, echocardiographic parameters, 6-minute walk test, quality of life questionnaire. the primary endpoint of this study is to estimate the incidence (and its accuracy) of the first event of unplanned hospitalizations for cardiac reasons or death from cardiovascular causes in the group monitored using rpm (with or without external sensors) and in the group management via conventional follow-up (usual care).

Eligibility criteria:
inclusion criteria: * subjects \>18 years * patients implanted or eligible for implant with icd-crt-d, accordingly with guidelines of the centers, for heart failure treatment and/or primary prevention of sudden death exclusion criteria: * presence of clinically overt heart failure. * myocardial infarction within 2 months before enrolment. * significant concurrent illness or condition severely limiting life expectancy. * any surgical or medical condition which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period. * history of drug or alcohol abuse within the last 2 years. * inability to communicate and comply with all study requirements including the unwillingness or inability to provide informed consent.

Keywords: heart failure remote monitoring icd follow-up
a study of hrs-7535 compared with dapagliflozin in adult participants with type 2 diabetes and inadequately controlled with metformin

Conditions: Type 2 Diabetes

Summary: the aim of this trial is to evaluate the efficacy and safety of hrs-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.


Eligibility criteria:
inclusion criteria: 1. male or female, 18-75 age years, both inclusive; 2. type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; 3. hba1c 7.5-11.0% (both inclusive) at screening; 4. treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening. exclusion criteria: 1. known or suspected allergy to the investigational drug or its components or excipients. 2. diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening. 4. proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 5. pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (wocbp) or male subject not using adequate contraceptive measures.
expanded access to glecaprevir/ pibrentasvir

Conditions: Hepatitis C Virus Infection

Summary: this is an expanded access program (eap) for eligible participants. this program is designed to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory agency. availability will depend on territory eligibility. participating sites will be added as they apply for and are approved for the eap. a medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:

Keywords: special access scheme expanded access pre-approval access compassionate use special access program named patient basis
dedicated breast ct for quantitative breast density measurements in mexican-origin women in southern arizona

Conditions: Metabolic Syndrome; Obesity Associated Disorder

Summary: the overall objective of this clinical study is to determine the feasibility of breast ct for breast density assessment and association of ct-derived density measures with metabolic syndrome in overweight/obese mexican-origin women in southern arizona. these evaluations will help support follow-up clinical research utilizing breast density acquired by breast ct as a surrogate endpoint biomarker to evaluate breast cancer preventive strategies. the long-term goal of these research efforts is to develop safe and effective preventive strategies to reduce obesity-associated breast cancer burden in our catchment area.


Eligibility criteria:
inclusion criteria: * women with bmi of 25 kg/m2 or greater * 40-65 years of age * must self-identify as mexican-origin living in southern arizona * ability to understand and the willingness to sign a written informed consent document in english or spanish exclusion criteria: * women who are pregnant or lactating * women who have undergone treatment of chemotherapy and/or radiation for any malignancies within the past 2 years, excluding non-melanoma skin cancer or cancer confined to organs with surgical removal as the only treatment * women who have breast implants * women who have used selective estrogen receptor modulators, aromatase inhibitors, and /or hormone replacement therapy within the past 12 months. * women who have undergone bilateral mastectomy * women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker * women who are unable to tolerate study constraints, frail, or unable to cooperate * women who weigh more than 440 lbs (200 kg), which is the weight limit for the patient support table of the bct system * women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus gland as an infant, irradiation for benign breast conditions, including breast inflammation after giving birth, and treatment for hodgkin's disease * women who have received large number of diagnostic x-ray examinations of the horax for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.

Keywords: breast density breast ct mexican-origin women breast cancer prevention metabolic syndrome obesity- associated breast cancer
comparison between bupivacaine-dexmedetomidine versus bupivacaine-dexamethasone in pericapsular nerve group (peng) block

Conditions: Hip Fractures; Post Operative Pain

Summary: the aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in peng block as post-operative analgesia in hip surgeries


Eligibility criteria:
inclusion criteria: 1. age 18-65 years. 2. sex: both sexes. 3. american society of anaesthesiologists (asa) physical status class i and ii. 4. scheduled for hip surgeries under spinal anaesthesia. exclusion criteria: 1. declining to give written informed consent. 2. history of allergy to the medications used in the study. 3. contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection). 4. psychiatric disorder. 5. american society of anesthesiologists (asa) physical status class iii and iv.
effect of the kv7-channel opener flupirtine on the excitability of human peripheral myelinated axons in vivo

Conditions: Axonal Change, Neuronal; Pain

Summary: slow axonal kv7 potassium channels are found along unmyelinated axons and at the nodes of ranvier of myelinated axons in peripheral nerve. as such the pharmacological activation of kv7 channels offers a potential means of reducing the excitability of peripheral axons. to determine whether this is the case for human peripheral myelinated axons, the effect of the kv7 channel agonist flupirtine on the electrical excitability of a fibres was examined in both isolated segments of human sural nerve in vitro and in motor axons of the median nerve supplying abductor pollicus brevis in vivo. axonal excitability was assessed in 21 human sural nerve fascicles in vitro and in 20 volunteers in vivo using threshold tracking in qtrac (© institute of neurology, london, uk). strength-duration time constant, rheobase current, relative refractory period (rrp), post spike superexcitability at 5 and 7 ms and threshold electrotonus over the 90 100 ms period were used as indices of electrical excitability. in addition, suppression of ectopic discharge in a model of upper limb ischaemia.


Eligibility criteria:
inclusion criteria: * voluntarily * age \> 18 years old exclusion criteria: * current use of medication (e.g. analgetics, antiepileptics, antidepressants, etc.) * prevailing organic disease (e.g. diabetes, vascular or neurologic illness, etc.) * previous physical trauma of the forearm (e.g. burning, surgery) * primary organ failure * pregnancy and lactation

Keywords: neuropathy axonal excitability myelinated nerve human ectopic discharge flupirtine
efficacy of a family telephone intervention for stroke

Conditions: Stroke

Summary: the purpose of this trial is to determine if a family intervention administered by telephone to stroke patients and their caregivers increases adaptation and functioning after stroke.

stroke is a major health problem which affects an estimated half million persons each year. in many cases family members assume the long-term burden of care after hospital discharge. methods such as family education, peer support groups, and counseling are available to help meet the needs of caregivers, by enhancing their coping abilities. family intervention also potentially benefits patients by improving the quality of caregiving skills. few investigations have examined the benefits of family intervention methods. this trial will study the effectiveness of a family-based, telephone-administered intervention called family intervention: telephone tracking (fitt) for acute stroke patients and their caregivers. study patients will be recruited from those admitted to the rhode island hospital following an acute stroke. all patients and caregivers will receive standard medical care. in addition, these patients and their caregivers will be randomly assigned to one of two treatment conditions: fitt or no intervention. treatments will begin once the patient returns home and will continue for a six-month period. during the trial, specially trained staff will carefully monitor the progress of the stroke patient and his/her family member, checking for changing in thinking, concentration, attention, memory, mood, and family functioning that sometimes occurs in stroke. participants will be contacted by telephone every week for 6 weeks, then every 2 weeks for 2 months, and then monthly for 2 months. the telephone calls will check on how the participants are doing after discharge and will assist with questions and concerns.

Eligibility criteria:
inclusion criteria: * age \> 35 years, * mri or cat scan proof of stroke or definitive hemiplegia, and * competency to sign an informed consent form. exclusion criteria: * presence of subarachnoid hemorrhage, transient ischemic attack or subdural hematoma, * significant medical disorder severe enough to require hospitalization within the 3 months prior to stroke, * functional psychosis, * absence of a caregiver (anyone living within a 30 minute drive who is available and willing to attend to patient), * admitted from nursing home (since these patients are likely to return to the nursing home) and * inability to speak english.

Keywords: stroke telephone intervention
radiological response of pancreatic neuroendocrine tumors: comparison between the choi and the recist criteria

Conditions: Pancreatic Neuroendocrine Tumors

Summary: the response evaluation criteria in solid tumors (recist), based on differences in tumor size, has been considered as a reproducible method that facilitates not only the measurement of the mass but the evaluation of response to given treatments; while classic chemotherapy induces a reduction of the tumor, new target therapies frequently produce the stabilization of the disease or a delayed progression. these new therapeutic alternatives have shade light on the limitations of the recist criteria, since the response to these type of treatments are basically associated with changes on the radiological characteristics of the tumor, as well as other findings in functional imaging. this study is aimed to compare the response rates according both choi and recist criteria.


Eligibility criteria:
inclusion criteria: * patients with a pancreatic neuroendocrine tumor with a ki67 index \<20%, who accept to participate and sign the consent form. in case of death patients, waiver of consent has been considered. * patients who, according daily clinical practice, have been treated with sunitinib between february 2012 to end of inclusion period, with a follow up of at least 6 months. * patients with a baseline imaging study (tc with arterial phase) and, at least, a 6-months follow-up evaluation. patients with progression or exitus before the first imaging evaluation will not be included. exclusion criteria: * patients with a follow-up of \<6months because of any other cause beyond progression of disease or exitus. * patients without a baseline radiological evaluation or at 3/6 months. * patients who do not accept to participate in the study. * patients with anti-angiogenic treatment within 3 months prior to the start of sunitinib treatment. * patients treated with sunitinib plus any other anti-proliferative agent beyond ass.
impact of intravenous lidocaine on clinical outcomes of patients with ards during covid-19 pandemia

Conditions: Acute Respiratory Distress Syndrome (ARDS); COVID-19; Corona Virus Infection

Summary: the purpose of our prospective monocentric, randomized, controlled trial is to evaluate the effects of intravenous lidocaine on gas exchange and inflammation in acute respiratory distress syndrome (ards) due or not to covid-19 pneumonia. half of the patients will receive intravenous lidocaine and the other half will receive intravenous nacl 0,9 % as placebo.


Eligibility criteria:
inclusion criteria: * age ≥18 years * hospitalized in icu * presence of all of the following conditions, within one week of a clinical insult or new or worsening respiratory symptoms: * pao2/fio2 \<300 mmhg with positive end-expiratory pressure (peep) ≥5 cmh2o * bilateral opacities not fully explained by cardiac failure or fluid overload * intubated and sedated for mechanical protective ventilation * affiliation to the french sociale security * beta hcg negative for women for covid-19 subgroup: - covid-19 infection (rt-pcr \< 7 days and/or another approved diagnostic technique and/or typical ct appearance of covid-19 pneumonia exclusion criteria: * allergy to amide local anesthetics * acute porphyria * disorders of atrioventricular conduction requiring a non-done permanent electrosystolic pacing * uncontrolled epilepsy * fluvoxamine treatment * class iii antiarrythmic agent treatments (amiodarone, dronedarone) * class i antiarythmic agent (quinidine, disopyramide, hydroquinidine, flecainid, propafenone) * hepatocellular insufficiency defined by pt\<15% in the absence of anti-vitamin k * patient under a tutelage measure or placed under judicial protection * known pregnancy * breastfeeding
evaluation of the safety and efficacy of titanium-nitric oxide-coated stent (optimax®) in patients with lesions with a low risk of restenosis (diameter ≥ 3.0 mm and length ≤ 20 mm)

Conditions: Coronary Artery Disease

Summary: this prospective registry is intended to evaluate the safety and efficacy of the optimax® stent.

this prospective registry is intended to evaluate the safety and efficacy of the optimax® stent in de novo coronary lesions with reference diameter ≥ 3.0 mm and length ≤ 20 mm.

Eligibility criteria:
inclusion criteria: * patients with age ≥ 18 years old. * patients with de novo coronary lesion treated with optimax® stent, reference diameter = 3.0 mm and length ≤ 20 mm. * informed consent signed. exclusion criteria: * refusal of the patient to participate at the study. * treatment of other injuries that do not meet the conditions (3x20).

Keywords: cobalt-chromium
reducing ketamine-induced agitation, by midazolam or haloperidol premedication after adult procedural sedation

Conditions: Ketamine Induced Agitation

Summary: ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. as a solution, some propose using midazolam or haloperidol before ketamine injection. in this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. in first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). the patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure.

ketamine is the cornerstone of procedural sedation in emergency department but ketamine induced agitation has limited its usage by many physicians. as a solution, some propose using midazolam or haloperidol before ketamine injection. in this randomized double blind clinical trial, patients who are eligible for sedation by ketamine are allocated in 3 groups. in first group, the patients will receive 0.05 mg/kg midazolam, in second group 5 mg of haloperidol and in 3rd group a placebo five minutes before receiving the sedative dose of ketamine (1 mg/kg). the patients are assessed for agitation during and after the procedure the clinician's satisfaction with sedation instrument is evaluated after the procedure. the investigator will fill standard questionnaires for agitation assessment (richmond agitation-sedation scale and pittsburgh agitation scale).

Eligibility criteria:
inclusion criteria: * adult patient older than 18, who need to sedate in emergency department exclusion criteria: * age younger than 18 years, * patients with significant cardiovascular disease,congestive heart failure (chf) * central nervous system lesions or injuries, increased intracranial pressure (icp) * ocular pathology, increased intraocular pressure (iop) * thyroid disease, * acute pulmonary infections, * conditions requiring stimulation of the posterior pharynx, * had ingested solid food in the previous 4 hours or clear liquids in the previous 2 hours. * acute intermittent porphyria * alcoholism * hepatic impairment * myasthenia gravis * respiratory depression * allergy to haloperidol as established by direct questioning of family members and available medical history, * moderate to severe dementia as documented by medical history, * parkinson's disease, * corrected qtc interval (qtc) greater than 500 ms, * usage of drugs prolonging qt-interval, * history of torsades de pointes, * history of neuroleptic malignant syndrome, * family history of dystonic reactions to drugs, * epilepsy or history of seizures * chronic psychiatric disease, * intoxication * bone marrow suppression * pregnancy