Kornimate/medical-research-clean huggingface dataset:
effectiveness and tolerance of inhaled fentanyl aerosol (25µg/dose) in chinese patients with btcp

Conditions: Breakthrough Cancer Pain

Summary: breakthrough cancer pain (btcp) is a common problem in patients with cancer. this is a phase iia dose-response and safety study of inhaled fentanyl aerosol (25µg/dose) in chinese patients with breakthrough cancer pain.

consenting patients who met inclusion and exclusion criteria were allowed to enter the study. the medication for background pain during screening were maintained until the end of the study. each patient would be treated and observed for 6 episodes of targeted btcp. patients were randomly assigned to 1 of the 6 prespecified dose sequences which were established by a computer-generated schedule of active drug and placebo in a 4:2 ratio. all patients and personnel involved with the study (including investigators and investigation site personnel) were blinded to the medication codes.

Eligibility criteria:
inclusion criteria: 1. age of 18 years or above 2. subjects must be diagnosed with cancer. 3. subjects must experience persistent pain associated with cancer, and the pain score assessed by nrs should be \<4 within 1week before screening. 4. in the past 7 days, the subject must experience an average of 1 to 4 episodes of breakthrough cancer pain per day,the breakthrough cancer pain score should be ≥4 assessed by nrs 5. ecog status of 0 to 2. 6. subjects must consent to take adequate contraception during the study and 1 months after the study. women of childbearing potential must show negative in the pregnancy test before dosing. 7. the subject must be able to understand the requirements of the study and provide a written informed consent. exclusion criteria: 1. history or suspected allergies to fentanyl. 2. hgb \< 80 g/l, neut ≤1.0 × l09/l, plt ≤50 × l09/l；alt and ast higher than 3 times of uln;total bilirubin and cr higher than 1.5 times of uln;pao2 \<95%;fev1/fvc\<70% and fev1 accounted for less than 80% of the predicted value. 3. any uncontrolled disease (e.g., severe mental, neurological, infectious, cardiovascular, respiratory and other systemic diseases). 4. tumor infiltration to central nervous system. 5. subjects are not able to slef evaluate pain intensity using nrs 6. receive surgery in past 3 weeks 7. treatment with any form of radiotherapy winth 1week prior to study entry that could alter pain or response to pain medication. 8. taking monoamine oxidase inhibitors(maois), cyp3a4 inhibitors or inducers within 14 days of the screening 9. participated in other clinical trials in past 1months. 10. pregnancy and breast-feeding women, women of childbearing age ready to conceive, and pregnancy test positive. 11. other conditions that may affect the informed consent, compliance with the protocol, study results and safety of the subject.
investigating non-invasive brain stimulation to enhance fluency in people who stutter

Conditions: Stuttering, Developmental

Summary: this study aims to test whether the application of transcranial direct current stimulation (tdcs) concurrent with fluency training results in improvements in speech fluency in adults with developmental stuttering, measured up to three months after the intervention.

developmental stuttering affects 5% of children and persists to adulthood in about 1%. changing the way speech is produced in adults who stutter is a particular challenge for speech and language therapy and there is a need for novel interventions. one such intervention involves the application of transcranial direct current stimulation (tdcs) alongside therapies aimed at improving speech fluency. tdcs influences brain activity by modulating neuronal plasticity through the application of weak electrical currents across the brain. pairing tdcs with speech therapy has potential for producing larger or longer lasting effects and reducing time spent in therapy. the study will evaluate the potential of tdcs combined with speech fluency training to improve outcomes in people who stutter (pws). pws will have this training while receiving tdcs for five days (1 milliampere \[ma\] for 20 mins per day) in a double-blind randomized controlled trial. outcomes will be measured in terms of changes to stuttering severity. an additional research questions is how changes in interactions between sensory and motor brain regions relate to changes in speech fluency in pws. mri will be used to measure brain structure and function and the vocal tract during speech production. transcranial magnetic stimulation (tms) will assess motor excitability before and after the training.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * diagnosed with developmental stuttering of mild-moderate or greater severity * native speaker of english * normal or corrected-to-normal vision * normal hearing exclusion criteria: * speech, language or communication disorder other than developmental stuttering. * contraindication to brain stimulation (tdcs or tms) * contraindication to mri * history of drug abuse * history of a neurological or psychiatric illness * any previous neurosurgical procedures * taking prescription or over-the-counter medication that may affect brain function (for example, anti-depressants) * family history of epilepsy (first degree relative) * severe claustrophobia (as they may be unable to tolerate scanner)

Keywords: stammering speech motor disorder electrical current stimulation metronome-timed speech
chorus - comprehensive hht outcomes registry of the united states (formerly our hht registry)

Conditions: Hereditary Hemorrhagic Telangiectasia; HHT; Arteriovenous Malformation of Brain

Summary: the goal of this study is to better understand hht, the symptoms and complications it causes ("outcomes") and how the disease impacts people's lives. the investigators are aiming to recruit and gather information together in the registry from 1,000 hht patients from four hht centres of excellence in north america. the investigators will collect long-term information about the people in the registry, allowing the investigators to understand how the disease changes over time, and what factors can influence those changes. ultimately, this should help improve treatments for the disease.

background and rationale hht has an estimated prevalence of 1 in 5000, affecting children and adults, in multiple organs. the disease is characterized by the presence of vascular malformations (vms), including arteriovenous malformations (avms) of the lung, liver, brain, spinal cord and smaller mucosal lesions (telangiectasia) of the nose, mouth and gi tract. these lesions lead to acute and chronic bleeding, stroke, heart failure and death. treatments are currently mostly limited to managing complications, while approximately 90% of adults have ongoing symptoms, despite best surgical and medical therapies. with recent drug development related to angiogenesis, there is hope for effective novel therapies. investigators, experts, the international hht guidelines, pharma representatives, the cdc and hht patient advocates (curehht.org) all agree that there is an urgent need for natural history data in this disease, with characterization of clinical outcomes, to allow patients to benefit from the explosion of drug development in the field. as of august 27, 2023, the our hht registry has transitioned to the chorus platform (studytrax) for ongoing data collection. only select chorus-funded sites are currently enrolling. the toronto site has completed enrollment but remains active with reb approval.

Eligibility criteria:
inclusion criteria: * participants diagnosed with hht by the curacao criteria (either 3+ clinical diagnostic criteria or genetic diagnosis). * capable of giving informed consent in person or via a substitute decision maker * \>18 years exclusion criteria: * participants unable to give informed consent either in person or with a substitute decision maker
hemodynamic effects of delayed umbilical cord clamping in full-term newborns

Conditions: Cardiac Output, High; Cardiac Output, Low

Summary: the sequence of events at the time of delivery includes delivery of the infant, clamping of the umbilical cord, and lastly delivery of the placenta. there are some benefits for delayed cord clamping. this study aims to compare the effects of two different duration of delayed cord clamping. infants will be randomized into two groups based on the duration of delayed cord clamping: 30 seconds vs 120 seconds. different hemodynamic effects will be measured in each group at different time intervals. the hypothesis of the study is that delayed cord clamping for 120 seconds is associated with better cardiac output and with other hemodynamic advantages.

the study will include full term infants delivered via cesarean section. written informed consent for participation in the study will be obtained from parents prior to delivery. newborns will be randomly assigned into two groups according to the duration of cord clamping: group 1: the cord will be clamped at 30 seconds, and group 2: the cord will be clamped at 120 seconds of life. stopwatch will be started when infants buttocks (or head if breech) are delivered from the uterus. the time elapsed will be counted aloud by the investigator in 10-second intervals. during this time, the infant will be held in linen on the mothers legs. care will be taken not to apply traction on the cord. milking of the cord will not be allowed. immediately after resuscitation, infants will be attached to the leads of the electrical cardiometry device. device output will be imported at 5, 10, and 15 minutes after birth in both groups. a follow up measurement will be imported later at 24 hours of age. in addition, a peripheral blood sample will be obtained at 24 hours of age for assessment of hemoglobin, glucose and bilirubin concentrations. . the calculated sample size is 31 newborns in each group. this number will be adequate to detect an effect size of 10% in the mean cardiac output between the two groups with 95% confidence and 80% power. the study plans to recruit 34 infants in each group (10% attrition rate).

Eligibility criteria:
inclusion criteria: * normal full term newborns ≥37 weeks gestational age * both genders are included * singleton * delivered by elective cesarean section due to previous cesarean section, cephalo-pelvic disproportion, or mal-presentation * successfully transitioned without need for respiratory or medication support exclusion criteria: * neonates needing any active resuscitation * in-utero fetal distress * suspected perinatal asphyxia * major congenital malformations * twin or multiple gestation * intrauterine growth restriction * placenta previa * mothers with cardiac disorders
study to determine the efficacy of bendamustin in patients with recurrent small cell lung cancer (sclc)

Conditions: Recurrent Small Cell Lung Cancer

Summary: determination of response rate assessment of toxicity and determination of "time to progression"

phase ii study to determine the efficacy of bendamustin(ribomustin) in patients with recurrent small cell bronchial carcinoma after cytostatic polychemotherapy

Eligibility criteria:
inclusion criteria: * patients with histological proven, curative non treatable small lung cell carcinoma * recurrence \>8 weeks, \> 1 year after 1st line treatment with platin- and etoposide polychemotherapy, without brain metastases exclusion criteria: * brain metastases * who-ps 3 - 4

Keywords: recurrent sclc
bupivacaine or radiofrequency for shoulder pain

Conditions: Shoulder Pain; Rotator Cuff Impingement Syndrome; Impingement Syndrome; Adhesive Capsulitis; Rotator Cuff Injuries

Summary: comparative study between pulsed radiofrequency in suprascapular nerve or bupivacaine block for chronic shoulder pain

prospective, randomized, comparative study of 40 participants with chronic shoulder pain allocated into two groups. patients in group 1 underwent pulsed rf (180sec, with a fixed temperature at 42c, twice) on the suprascapular nerve, and the other group, 2, underwent nerve block with bupivacaine (5ml). after the procedure, patients were evaluated for 3 months regarding pain intensity, shoulder range of motion and dose of rescue opioids.

Eligibility criteria:
inclusion criteria: * age over 18 years old * chronic shoulder pain (more than 3 months) * clinical and imaging diagnosis: rotator cuff injury, adhesive capsulitis, supraspinatus, tendinopathy, bicipital tendinitis, impingement syndrome, subscapularis tendinopathy, , subacromial and subdeltoid arthrosis, acromioclavicular arthrosis, subdeltoid subacromial bursitis * pain intensity ≥4 on movement, on a numerical scale from zero to 10 (where zero means no pain and 10 the most intense pain imaginable). exclusion criteria: * arrhythmia * cognitive change (inability to answer questions) * psychiatric illness * infection at the site of the procedure * coagulopathy, * use of anticoagulants * hypersensitivity to medications * pregnant * use of pacemaker

Keywords: shoulder pain pulsed radiofrequency bipuvacaine nerve block
validation of bedside ultrasound to predict body composition in non- and critically ill patients

Conditions: Ultrasound; Body Composition

Summary: the prospective study will include 200 patients and 50 critically ill patients, who had an abdominal computed tomography (ct) scan including the l3 level for any clinical reason. ultrasound scans of the anterior thighs and forearms will be taken after the ct scan within 48 hours. bioelectrical impedance analysis (bia) will also be performed. in addition muscle strength, mobility, physical function and nutrition will be assessed. primary outcome is the prediction of ct-based whole body muscle and fat volume and bia-based fat and lean body mass from ultrasound-based muscle and fat thickness. other secondary outcomes include the intra- and interrater reliability of the ct evaluation and ultrasound examination of muscle and fat mass. the relationship between clinical aspects (strength, mobility, physical function, nutrition) and whole body composition is another secondary outcome.


Eligibility criteria:
inclusion criteria: * cross-sectional abdominal ct scan including the level of l3 vertebra for any clinical reason * study-related ultrasound examination must take place within 48 hours of ct exclusion criteria: * patients younger than 18 years

Keywords: reliability bioelectrical impedance analysis computed tomography strength mobility
a study of tirzepatide (ly3298176) in chinese participants with type 2 diabetes (surpass-cn-mono)

Conditions: Type 2 Diabetes

Summary: the main purpose of this study is to investigate the efficacy and safety of tirzepatide monotherapy in chinese participants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes * have hba1c ≥7.0% (≥53 mmol/mol) to ≤9.5% (≤80 mmol/mol) despite diet and exercise treatment * are of stable weight 5%) during the 90 days preceding screening and agree not to initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment * have body mass index (bmi) ≥23.0 kilogram per square meter (kg/m²) exclusion criteria: * have type 1 diabetes * have a history of chronic or acute pancreatitis any time prior to study entry * are currently receiving treatment for diabetic retinopathy and/or macular edema * have a history of ketoacidosis or hyperosmolar state/coma * have a history of new york heart association functional classification iv congestive heart failure (chf) * have acute or chronic hepatitis including a history of autoimmune hepatitis * use of insulin 1-year preceding screening and between screening and baseline; use of any antihyperglycemic medication 90 days preceding screening and between screening and baseline.
vitamin d deficiency in patients with hypertension

Conditions: Vitamin D Deficiency; Hypertension

Summary: this study will evaluate the effects of vitamin d replacement and the effects of an approved medication for hypertension, aliskiren (tekturna), in patients with high blood pressure who have low levels of vitamin d in their blood. the study will compare the effects of vitamin d or aliskiren alone and in combination on 24-hour blood pressure and biochemical parameters.

this study will assess whether aliskiren will lower clinic blood pressure and 24-hour blood pressure in patients with hypertension and vitamin d deficiency. additionally, this study will further explore the potential additional effects of adding vitamin d to aliskiren in this patient population.

Eligibility criteria:
inclusion criteria: * men or women over 21 years of age with a history of stage 1 or 2 hypertension (defined as a seated diastolic bp ≥ 90 mmhg and \< 110 mmhg in the untreated state). * patients under treatment for hypertension must be willing and able to discontinue any previous antihypertensive medications for the duration of the study. * 25-hydroxyvitamin d levels \ 12 ng/ml. * women of childbearing potential must be using a medically acceptable form of birth control for the duration of the trial, must have a negative serum pregnancy test at screening, and must have a negative urine pregnancy test within 7 days before initiating aliskiren therapy. exclusion criteria: * vitamin d levels \< 12 ng/ml * known hypersensitivity or allergy to aliskiren * clinic blood pressure \> 180/110 mmhg * known forms of secondary hypertension * chronic atrial fibrillation * uncontrolled or unstable cardiovascular diseases * shift or night workers * mid-arm circumference \> 42 cm in diameter * current or recent (\<1 year) alcohol or drug abuse * pregnant or lactating women

Keywords: vitamin d hypertension
platelet transfusion and repeat teg-pm in patients with severe tbi on antiplatelet therapy (repeat teg-pm)

Conditions: Traumatic Intracranial Hemorrhage

Summary: the aim of this study is to see if administering platelets (cells in our blood that stop or prevent bleeding) results in improved platelet function and slows/stops the progression of a head bleed for patients who have a traumatic head bleed and are on antiplatelet therapy (medications that stop blood cells from forming a blood clot) prior to admission.

this study aims to determine if platelet function has improved following platelet transfusion by prospectively performing repeat thromboelastographic with platelet mapping (teg-pm) assays on all patients consented and enrolled in the study. this study will also examine the rate of progression or stability of ich on repeat head ct following platelet administration and will aid in the determination of a potential association between repeat ct head findings and the repeat teg-pm results.

Eligibility criteria:
inclusion criteria for interventional portion of study: * patients ≥ 18 years of age who present with tich meeting brain injury guidelines (big) 2 or 3 head bleed criteria * currently on antiplatelet medication on admission * must have taken this antiplatelet medication within the past 48 hours prior to presentation * patients who have aa and/or adp inhibition of 70% or greater and maximum amplitude (ma) \<50 will then receive a platelet transfusion and a repeat teg-pm 1hr after transfusion exclusion criteria for interventional portion of study: * under 18 years of age * have a known bleeding diatheses * current therapeutic anticoagulation use * do not know the time of their last antiplatelet medication dose * patients or their proxy who are unable to provide consent * patients with concomitant long bone fractures or solid organ injuries inclusion criteria for retrospective portion of study: • patients with a tich who are 18 years of age or older exclusion criteria for retrospective portion of study: * abbreviated injury scale (ais) \>1 in body regions other than head because of concomitant long bone fracture or solid organ injury * under 18 years of age
child adult relationship enhancement in pediatric primary care parenting group to reduce child behavior problems

Conditions: Child Behavior Disorders

Summary: the purpose of this study is to evaluate the effectiveness of pricare in decreasing child behavior problems and improving parenting capacity and skills at 4 primary care clinics in philadelphia.

child behavioral concerns are common among families served by the children's hospital of philadelphia (chop) urban primary care centers. to address this, we developed child adult relationship enhancement model in primary care parenting program (pricare), a scaled down version of parent child interaction therapy designed for urban primary care clinics. the objectives of this study are to 1) evaluate the efficacy of the modified pricare to decrease child behavior problems and improve parenting capacity and skills and 2) understand parents' perceptions of the efficacy of pricare and strategies for improving its implementation and dissemination. we will perform a randomized controlled trial (rct) of the effectiveness of the modified pricare on decreasing child behavior problems and improving positive parenting among 2- to 6-year-old children with behavior problems and their parents at chop's urban primary care centers. we intend to randomize 120 child-parent pairs (240 subjects) to receive pricare immediately plus usual treatment (intervention group) and 60 child-parent pairs (120 subjects) to receive pricare at a later time plus usual treatment (control group) for a total of 180 child-parent pairs (360 subjects). all child-parent pairs randomized to the control group will be placed on a waitlist and offered pricare after completion of data collection. child behavior and parenting style will be measured at baseline (time 1), at 6-19 weeks (time 2), and at 14-27 weeks (time 3).

Eligibility criteria:
inclusion criteria: 1. parent is 18 years or older 2. parent is english speaking 3. child is 2-6 years old 4. parent reports that child has a behavior problem 5. child attends chop urban primary care center 6) parental/guardian permission is provided (informed consent) exclusion criteria: 1. child has a cognitive age less than 2 years old as determined by the referring clinician 2. child is already receiving behavioral health therapy or medication (other than medication for adhd)

Keywords: child behavior disorders parent child relationship primary care
early access program of lazertinib in republic of korea

Conditions: Lung Cancer

Summary: this early access program will be conducted to provide access to lazertinib for adult patients with locally advanced or metastatic non-small cell lung cancer (nsclc) with t790m mutation-positive after 1st/2nd generation egfr tkis therapy.

lazertinib is an oral, highly potent, mutant-selective and irreversible egfr tyrosine-kinase inhibitors (tkis) targets both the t790m mutation and activating egfr mutations while sparing wild type-egfr. this is a multi-center, prospective, early access program of lazertinib in locally advanced or metastatic non-small cell lung cancer (nsclc) patients with t790m mutation-positive after 1st/2nd generation egfr tkis therapy to assess the safety and efficacy of real world evidence as second-line treatment.

Eligibility criteria:
inclusion criteria: * patients aged at least 19 years * patients who have written consent for use of personal and medical information for the study purpose * patients who are prescribed and administered with approved indication for lazerinib in korea and not been treated with lazertinib previously. exclusion criteria: * patients with hypersensitivity to lazertinib or its any ingredients * patients who belong to contraindication listed on lazertinib label in korea * patients who are treated for an indication not approved for the use of lazertinib * women who are pregnant or may possibly become pregnant