Kornimate/medical-research-clean huggingface dataset:
phase 1 xg005-03 topical study

Conditions: Pain

Summary: phase 1, randomized, single-blinded, placebo-control, ascending single and multiple dose of the pk, safety, and tolerability of xg005-03 topical formulation in healthy volunteers.

this is a single-blind, placebo-controlled study which will investigate the pk, safety and tolerability of xg005-03 topical formulation, in three ascending concentrations after single and multiple topical applications in healthy subjects. the trial consists of two parts: a single ascending dose (sad; part 1) and a multiple ascending dose (mad; part 2). the mad study will begin after the sad portion of the study is complete. the study will consist of 4 weeks of screening period, treatment period (1 day of dosing for sad and 6.5 days for mad), and 14 days of safety follow-up period. each subject will serve as his/her own control, as the xg005-03 and placebo will be applied on contralateral legs. application of xg005-03 or placebo to a particular leg will be randomly assigned. approximately 36 healthy subjects will be enrolled. eighteen healthy subjects (3 alternates per dose group) in part 1 (sad) and part 2 (mad), who fulfill eligibility criteria will receive the study drug: xg005-03 (1%, 5%, and 10%) and placebo.

Eligibility criteria:
inclusion criteria: 1. healthy males or females between 18 and 55 years of age 2. bmi 18.0 to 30.0 kg/m2 3. non-pregnant, non-breastfeeding female subjects exclusion criteria: 1. unstable or severe illness 2. skin infection or lesion 3. subjects with scars, moles, tattoos at application site 4. expose to excessive uv 5. hypersensitivity or allergy to nsaid
expanded access program of taletrectinib in patients with advanced or metastatic ros1-positive nsclc

Conditions: Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Bronchogenic Carcinoma; Non Small Cell Carcinoma of the Lung; ROS1-positive Non-Small Cell Lung Cancer (NSCLC)

Summary: this expanded access program will provide access of taletrectinib therapy to patients with locally advanced or metastatic ros1-positive nsclc who are not an appropriate candidate for an approved therapy, for any ongoing taletrectinib clinical trial and who, in the opinion of their oncologist, may benefit from treatment.

this expanded access program will provide access of taletrectinib therapy to patients with locally advanced or metastatic c-ros-oncogene 1 (ros1)-positive non-small cell lung cancer (nsclc). these patients are not an appropriate candidate for an approved therapy, including crizotinib, entrectinib, or repotrectinib, for participating in ongoing nuvation bio clinical trial ab-106-g208 and who, in the opinion of their oncologist, may benefit from treatment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * histologically or cytologically confirmed diagnosis of locally advanced (including inoperable stage iiia or iiib nsclc) or metastatic nsclc. * evidence of ros1 gene fusion. * adequate bone marrow and organ function * ineligible for participation in ongoing nuvation bio clinical trial ab-106-g208. exception may be granted by the sponsor/supplier if they have a restriction or hardships that prevent them from participating in a clinical trial. * failed approved therapy or are not an appropriate candidate for an approved therapy including crizotinib, entrectinib, or repotrectinib. exclusion criteria: * prior systemic anticancer therapy washout of 5 half-lives or 2 weeks, whichever is sooner. * patients who develop acute medical conditions which require immediate treatment or stabilization (e.g., new diagnosis of pulmonary embolism that requires anti-coagulation; acute and symptomatic spinal cord compression that requires immediate spinal radiotherapy). note: patients may enroll after starting treatment for these acute conditions and the patients are considered stabilized. * history or evidence of interstitial fibrosis, interstitial lung disease or drug-induced pneumonitis that did not resolve prior to screening. * active and untreated hepatitis b or c. exception is chronic stable hepatitis b and c with stable liver function at screening. * ongoing cardiac dysrhythmias of common terminology criteria for adverse events (ctcae) ≥grade 2, uncontrolled atrial fibrillation of any grade, or qt interval corrected for heart rate by fridericia's formula \>470 milliseconds, or symptomatic bradycardia \<45 beats per minute; patient has family or medical history of long qt syndrome.

Keywords: non-small cell lung cancer (nsclc) ros1-positive non-small cell lung cancer
safety and efficacy of e/c/f/tdf versus rtv-boosted atv plus ftc/tdf in hiv-1 infected, antiretroviral treatment-naive women

Conditions: Acquired Immunodeficiency Syndrome; HIV Infections

Summary: the primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (e/c/f/tdf) versus ritonavir (rtv)-boosted atazanavir (atv/r) plus emtricitabine/tenofovir disoproxil fumarate (ftc/tdf) in hiv-1 infected, antiretroviral treatment-naive adult women.


Eligibility criteria:
key inclusion criteria: * female (at birth), age ≥ 18 years * ability to understand and sign a written informed consent form * plasma hiv-1 rna levels ≥ 500 copies/ml * no prior use of any approved or investigational antiretroviral drug for any length of time * screening genotype report must show sensitivity to emtricitabine (ftc), tenofovir disoproxil fumarate (tdf) and atazanavir (atv) boosted with ritonavir (rtv) * normal ecg * adequate renal function: estimated glomerular filtration rate ≥ 70 ml/min according to the cockcroft gault formula * hepatic transaminases ≤ 5 x upper limit of normal (uln) * total bilirubin ≤ 1.5 mg/dl * adequate hematologic function * serum amylase ≤ 5 x uln * women of childbearing potential must agree to utilize protocol recommended contraception methods or be non-heterosexually active, or practice sexual abstinence from screening throughout the duration of the study period and for 30 days following the last dose of study drug * women who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing. key exclusion criteria: * a new aids defining condition diagnosed within the 30 days * females receiving drug treatment for hepatitis c, or females who are anticipated to receive treatment for hepatitis c during the course of the study * females experiencing decompensated cirrhosis * females who are breastfeeding * positive serum pregnancy test (female of childbearing potential) * have an implanted defibrillator or pacemaker * have an ecg pulse rate interval ≥ 220 msec * current alcohol or substance use which may potentially interfere with the female's study compliance * history of malignancy within the past 5 years or ongoing malignancy other than cutaneous kaposi's sarcoma (ks), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma * active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline * participation in any other clinical trial without prior approval * any other clinical condition or prior therapy that would make the female unsuitable for the study or unable to comply with the dosing requirements * females receiving ongoing therapy with any disallowed medications, including drugs not to be used with elvitegravir, cobicistat, ftc, tdf, atv, rtv; or females with any known allergies to the excipients of stribild® tablets, truvada® tablets, atazanavir capsules or ritonavir tablets note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hiv-1 hiv treatment-naive women waves
trigger point therapy in cervicogenic headache

Conditions: Cervicogenic Headache

Summary: it is a pilot randomized controlled trial comparing real and simulated manual treatment of trigger points (trps) in patients with cervicogenic headache (ceh). the purpose of the current randomized clinical pilot trial was to determine the preliminary effects of trp manual therapy in individuals with ceh with sternocleidomastoid muscle active trps as compared to manual contact over the muscle tissues.

ceh pain has been mostly related to joint, disk and ligament pain from the upper cervical spine; however, clinicians should consider that the upper cervical spine also receives afferent inputs from muscles. in fact, the role of referred pain to the head elicited by muscle trps has received particular interest in recent years. no study has investigated the effectiveness of trp manual therapy in patients with ceh exhibiting active trps. investigators hypothesized that patients receiving a real trp treatment will exhibit a greater reduction in pain, sensitivity, cervical range of motion and neck endurance than those receiving a manual control non-therapeutic intervention.

Eligibility criteria:
inclusion criteria: * unilateral pain starting in the neck and radiating to the frontal-temporal region * pain aggravated by neck movement * restricted cervical range of motion * joint tenderness in at least one of the joints of the upper cervical spine (c1-c3) * headache frequency of at least one per week over a period greater than 3 months * active trps in the sternocleidomastoid muscle exclusion criteria: * other primary headaches (i.e., migraine, tension type-headache) * bilateral headaches * had received treatment for neck or head pain in the previous year * presented any contraindications to manual therapy * had pending legal action regarding their neck and head pain.

Keywords: cervicogenic headache trigger point sternocleidomastoid manual therapy
inorganic nitrate (nano3) prevention of contrast-associated acute kidney injury

Conditions: Kidney Injury, Acute

Summary: this pilot study is designed to test the logistics and recruitment of a trial testing the benefit of sodium nitrate in the prevention of contrast-associated kidney injury in a group of patients at high-risk.


Eligibility criteria:
inclusion criteria: * planned coronary angiogram or contrast-enhanced ct scan. * high-risk for contrast-associated acute kidney injury (aki) with creatine/glomerular filtration rate (gfr) within 90 days as defined as: 1. undergoing coronary angiogram with gfr \<45 ml/min/1.73m2 or 2. undergoing coronary angiogram with gfr \<60 ml/min/1.73m2 and concurrent risk of aki as defined by hamilton et al. bmc2 risk prediction model ≥ 7%. or 3. undergoing contrast-enhanced ct scan with gfr\<45 ml/min/1.73m2 * if subject is a woman of child-bearing potential, subject agrees to the use of highly effective contraception starting at screening and during study participation. * ability to take oral medication and be willing to adhere to the study intervention regimen. * ability to understand and willingness to agree to an informed consent exclusion criteria: * already fulfilling definition of acute kidney injury prior to contrast exposure by kidney disease improving global outcomes (kdigo) criteria (absolute increase in creatinine from baseline of 0.3mg/dl or more or relative increase in creatine of 50% or more from baseline). * primary indication for percutaneous coronary intervention (pci) including acute st-segment elevation myocardial infarction * end-stage renal disease actively on dialysis. * received any intravenous or intraarterial contrast within five days from planned contrast administration. * cardiac arrest within 14 days of planned contrast administration. * systolic blood pressure \< 100mmhg or diastolic blood pressure \<60mmhg or currently receiving inotropes or vasopressors for hemodynamic support. * history of hypersensitivity or known allergy to any of the components of the investigational product or placebo including sodium nitrate, inorganic nitrate, beet root juice, or lactose. this does not include lactose intolerance. * pregnancy or nursing female * participation in other investigational trials within the past 30 days prior to enrollment. * use of tadalafil within 48 hours, sildenafil or vardenafil within 24 hours, and avanafil within 12 hours of initiation of trial medication. if participant is on continuous dosing of tadalafil, sildenafil, vardenafil, or avanafil, they will be excluded from the trial. if participant is on intermittent dosing of tadalafil, sildenafil, vardenafil, or avanafil, patient agrees to withhold use of medication for duration of medication treatment extending 48 hours after the final dose.

Keywords: sodium nitrate
systematic follow up of drug treatment by pharmacists in secondary prevention after transient ischemic attack

Conditions: Ischemic Attack, Transient; Stroke

Summary: use of drugs is an important factor in secondary prophylaxis after transient ischemic attack (tia), but studies show that adherence to the prescribed drugs is often poor. this randomised controlled trial aims to investigate whether a systematic follow up of drug treatment using medication reconciliation, medication reviews and patient counselling by clinical pharmacists, improves adherence and/or decreases cardiovascular events the first three months and the first year after tia. patient satisfaction will also be compared between the two groups.


Eligibility criteria:
inclusion criteria: * probable or possible transient ischemic attack * residing in central norway * examined within 2 weeks after the onset of symptoms * modified rankin scale 3 or less and living at home * enrolled in the midnor-tia study nct02038725 * informed consent

Keywords: secondary prevention pharmacists directive counseling medication adherence patient compliance
acute concussion and melatonin

Conditions: Concussion, Mild; Concussion, Brain; Pediatric ALL

Summary: in this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. the investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.

to compare the risk of persistent post-concussive symptoms (ppcs) between melatonin and placebo after an acute pediatric concussion. to determine if melatonin compared to placebo reduces the risk of ppcs for pediatric patients. this is a prospective single-blinded randomized control trial of pediatric patients in the emergency department (ed) diagnosed with an acute concussion. patients 12-18 years old with an acute concussion diagnosis will be eligible. all participants will receive actigraphy watches to wear on their wrists and measure sleep and activity patterns. participants in the melatonin group will be instructed to take 3 mg of liquid melatonin 1 hour prior to their habitual fall asleep time daily for 30 days. participants in the placebo group will be instructed to take their placebo liquid 1/2 hour prior to their habitual fall asleep time daily for 30 days. all participants will be given standardized weekly assessments to track their concussion, sleep and depressive symptoms for one month. research assistants will also arrange follow up in the telemedicine neurology headache clinic within 4 weeks post injury. at the follow-up visit, subjects will complete the post concussion symptom inventory (pcsi), pediatric sleep disturbance (psd), and revised childhood anxiety and depression scales (rcads).

Eligibility criteria:
inclusion criteria: * patient diagnosed with an acute concussion within 72 hours * patient greater than 8 and less than 19 years old exclusion criteria: * currently taking psychiatric medication * cognitive delay * glasgow coma score \< 14 * positive findings on head computed tomography * any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc) * use of melatonin within the last week
the neurobehavioral effects of anesthetics on infants with hearing impairment（retrospective research）

Conditions: Long Term Neurobehavioral Effects

Summary: the long-term effect of general anesthesia on developing brain is the focus of clinicians when infants exposed to general anesthesia for a long time during operation. a retrospective study showed that children exposed to long-term or repeated operations, the anesthetics had a higher incidence of cognitive impairment in adolescence than those did no. when infants with hearing impairment undergo bilateral cochlear implant surgery, they are at high risk of long-term neurobehavioral abnormalities caused by anesthesia. in this study, investigators intend to observe the long-term behavioral abnormalities of hearing-impaired infants after intravenous or inhalation anesthesia by a ambispective cohort study.

gesell development scale contains five subscales including adaptability, fine motor, gross motor, language, and social skill evaluation. developmental quotient (dq) = (development age/actual age)×100. total dq is the average of five dq of subscales. dq≥86 is normal, 76≤dq≤85 is suspicious, 55≤dq≤75 is mild neurological damage, 40≤dq ≤54 is moderate neurological damage, 25 b dq b 39 is severe neurological damage, and dq\< 25 is very severe neurological damage.

Eligibility criteria:
inclusion criteria: * children undergoing cochlear implantation under general anesthesia * 6 to 36-month-old child * normal body weight * children with normal structures of the inner ear and auditory nerve * children without contraindications to anesthesia and surgery * patients who have not participated in other clinical trials * without any acute infectious diseases or systematic diseases exclusion criteria: * the participants with a gesell score (fine motor and gross motor) lower than 86 after preoperative evaluation. * with other illness which could affects curative effect of recovery, such as inner ear malformations (except for large vestibular aqueduct syndrome), auditory vestibular nerve dysplasia, dysgnosia and mental disease; * inability to cooperate with the hearing evaluation and the language training * cute and chronic otitis media and mastoiditis, unhealed tympanic membrane perforation * abnormal structure of brain, including white matter dysplasia, demyelinating diseases

Keywords: infant anesthesia neurobehavioral development
gene-environment-interaction: influence of the comt genotype on the effects of different cannabinoids - a pet study

Conditions: Healthy Volunteers; Modeling Psychosis

Summary: the study evaluates the gene-environment interaction of the comt-genotype on the effects of the phytocannabinoids delta-9-tetrahydrocannabinol, cannabidiol or a combination of both on induction of psychotic symptoms, endocannabinoid levels in human body fluids, neuronal processing, and neural oscillations. in addition the effects of the phytocannabinoids on lipid levels in serum and cerebrospinal fluid, cognition, neuronal processing assessed by fmri as well as d2-receptor availability assessed by \[18f\] desmethoxyfallypride.


Eligibility criteria:
inclusion criteria: * informed consent given by the subject * healthy young man (age between 18 and 45) insightful to the study (wst\> 95) * right handedness * at least one time consumption of cannabis but less than 10 times/ per lifetime, no consumption of other psychotropic agents (despite coffee or nicotine), no alcohol abuse * negative drug-screening at the time of screening * body mass index between 18 and 30 exclusion criteria: * lack of accountability * participation in other interventional trials * severe medical or neurological illness, especially cardiovascular, renal, advanced respiratory, hematological or endocrinological failures or infectious diseases (acute hepatitis a, b or c or hiv) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, at the discretion of the investigator * any known psychiatric illness in the participant's history * known family history concerning psychiatric disorders * cannabis consumption within the last six months * consumption of any illegal drugs (except cannabis in history, see above) * intake of interfering medication, at the discretion of the investigator * high intracranial pressure * any disorders in stereoscopic vision (measured by the tno-test, lamerics, utrecht) or hearing deficits * contraindications due to the investigators brochure contraindication for magnetic resonance imaging (e.g. cardiac pacemaker, claustrophobia, attached brace, in body metal, tattoos) or lumbar puncture (e.g. local or systemic infection, disturbance of blood coagulation, medication with anticoagulants like phenprocoumon) or contradiction for the pet-ct method and the radiopharmaceutical

Keywords: delta-9-tetrahydrocannabinol cannabidiol comt
zileuton to treat adults with chronic obstructive pulmonary disease (the leuko study)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: chronic obstructive pulmonary disease (copd) is a long-term lung disease that is caused by cigarette smoking or by breathing in other lung irritants, including pollution, dust, or chemicals. the purpose of this study is to evaluate the effectiveness of zileuton, a medication that is used to control asthma symptoms, at reducing the length of a hospital stay for adults who are hospitalized for a copd exacerbation, or worsening of copd symptoms.

copd is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. copd is the fourth leading cause of death in the united states. symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. treatment usually includes inhaled bronchodilator or steroid medications that work by relaxing the muscles around the lung airways and reducing inflammation. zileuton, a medication that is used to prevent asthma symptoms, may be beneficial in treating people who experience copd exacerbations. zileuton works by blocking the formation of substances that cause inflammation, fluid retention, and constriction in the lungs. the purpose of this study is to evaluate the effectiveness of zileuton at reducing the length of a hospital stay for adults who are hospitalized for a copd exacerbation. this study will enroll adults who are admitted to the hospital due to severe copd symptoms. participants will be randomly assigned to receive either zileuton or placebo four times a day for up to 14 days. while in the hospital, lung function testing and urine collection will occur. study visits will occur at days 14 and 30, and will include lung function testing, a medical history review, and a study drug adverse effects review.

Eligibility criteria:
inclusion criteria: * admitted to the hospital for a copd exacerbation * fev1 less than 60% of predicted level * at least 10 pack years of smoking exclusion criteria: * any uncontrolled systemic disease * known hypersensitivity to zileuton * asthma * lobar pneumonia or pulmonary edema * interstitial lung disease * medical condition that is likely to limit survival to less than 30 days at the time of study entry * history of liver disease * current use of theophylline * participation in another clinical trial in the copd clinical research network * incarceration * institutionalization * pregnant * history of a suicide attempt * prior inpatient admission for a psychiatric disorder * bipolar disorder '

Keywords: chronic obstructive pulmonary disease copd exacerbation anti-leukotriene length of stay los