Kornimate/medical-research-clean huggingface dataset:
a phase 2, open-label study of amuvatinib in combination with platinum-etoposide chemotherapy in small cell lung cancer

Conditions: Small Cell Lung Carcinoma

Summary: the purpose of the study is to evaluate the safety and potential benefit of combination amuvatinib with standard of care chemotherapy treatment (platinum and etoposide) in small cell lung cancer (sclc) subjects.

amuvatinib is an oral multi-targeted tyrosine kinase inhibitor which inhibits the mutant forms of c-kit and pdgfr alpha. it also disrupts dna repair likely through suppression of homologous recombination protein rad51. in a phase 1b clinical study in combination with vp-16 and carboplatin, responses in sclc were observed. in vitro and in vivo data demonstrated amuvatinib synergy with vp-16 thereby further supporting this combination for continued evaluation in clinical trials. pharmacokinetic data from phase 1 clinical trials suggest that co-administration of amuvatinib did not alter exposures of standard of care agents vp-16 or carboplatin as measured by overall exposure.

Eligibility criteria:
inclusion criteria: 1. male or female ≥ 18 of age at the time of consent and have histologically or cytologically confirmed sclc 2. measurable sclc per recist guideline that meets one of the following: * disease progression by recist at anytime during platinum-etoposide (pe) chemotherapy; * relapse by recist within 90 days after completing pe chemotherapy; * stable disease by recist as best response after at least two (2) ≥ 21-day cycles of pe chemotherapy. the assessment of stable disease should be made at least 2 weeks after the start of the second cycle subjects who received another second-line therapy are eligible if they still fulfill any one of the above three conditions, and all other eligibility criteria 3. start treatment with the same last regimen (dose and schedule) of first-line pe chemotherapy that they progressed or relapsed on, including any dose reductions because of toxicity, prior to study entry 4. ecog performance status 0 to 2 5. adequate organ function 6. subjects with screening 12-lead ecg with measurable qtc interval of \< 450 msec. if qtc ≥ 450 msec, then confirm the reading by evaluating the mean qtc interval of triplicate ecgs. 7. sign approved informed consent form exclusion criteria: 1. prior exposure to amuvatinib 2. no longer eligible for first-line pe chemotherapy due to toxicity and the investigator believes that the risk of retreating with the same pe chemotherapy regimen would outweigh the benefit 3. ongoing toxicity from prior treatment unless the toxicity has resolved, or in the opinion of the investigator, is stable and does not compromise the safety of the subject 4. mixed sclc and non-small cell lung cancer, or large cell lung cancer 5. untreated, unstable, or symptomatic brain metastasis 6. hypersensitivity to amuvatinib, excipients of amuvatinib, or any agent given in association with this trial 7. a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or interfere with study outcomes

Keywords: small cell lung carcinoma
validation of urdu version of leicester cough questionnaire (lcq)

Conditions: COPD

Summary: leicester cough questionnaire (lcq) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. the objective of the study is to cross culturally adapt lcq in urdu language and to find the reliability and validity in patients of copd. it is a three-stage study. leicester cough questionnaire (lcq) will be adapted in urdu and will be first tested for its content validity by using content validity index (cvi). in the second stage, the urdu version of the leicester cough questionnaire (lcq) will be pilot run; tested for its validity and reliability. in the third stage, the urdu version of the leicester cough questionnaire (lcq) will be tested for its validity and reliability in patients with copd. 114 patients with copd will be selected according to inclusion criteria. intra class correlation coefficient (icc), cronbach's alpha and factor analysis will be used to analyze the data.

cough is a common symptom of asthma, copd, and bronchiectasis, little is known about how it affects health status; therefore any negative effects may go unnoticed in these situations. leicester cough questionnaire (lcq) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. to the extent of author's knowledge, this widely used leicester cough questionnaire (lcq) has not been translated and validated for urdu-speaking patients with copd. the objective of the study is to cross culturally adapt lcq in urdu language using international guidelines used for translation of instrument from its source language to target language and to find the reliability, validity, sensitivity, and specificity of the urdu version of leicester cough questionnaire (lcq) in patients of copd. it is a three-stage study. leicester cough questionnaire (lcq) will be adapted in urdu and will be first tested for its content validity by using content validity index (cvi). in the second stage, the urdu version of the leicester cough questionnaire (lcq) will be pilot run; tested for its validity and reliability. in the third stage, the urdu version of the leicester cough questionnaire (lcq) will be tested for its validity and reliability in patients with copd. 114 patients with copd will be selected according to inclusion criteria. intra class correlation coefficient (icc), cronbach's alpha and factor analysis will be used to analyze the data.

Eligibility criteria:
inclusion criteria: * subjects with gold ii, iii and iv chronic obstructive pulmonary diseases * having age18 years or more * subjects having chronic cough (\> 8 weeks) * subjects understanding urdu exclusion criteria: * a previous history of other lung disorders * pregnant females, subjects having infections * any systemic disorder which is unstable * subjects who are not willing to participate * subject with cognitive \& speech disorders

Keywords: cough patient reported outcome measures pulmonary diseases validation study translations
evaluation of safety and efficacy of intravenous sulbactam-etx2514 in the treatment of hospitalized adults with complicated urinary tract infections

Conditions: Complicated Urinary Tract Infection; Acute Pyelonephritis

Summary: this study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iv etx2514sul in patients with complicated urinary tract infections (cutis) who are otherwise relatively healthy.

this study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of iv etx2514sul in patients with cutis who are otherwise relatively healthy. patients with acute pyelonephritis may also be enrolled. approximately 80 patients will be randomized to receive either 1 g etx2514/1 g sulbactam iv or matching placebo every 6 hours (q6h). all patients will receive background therapy with 500 mg iv imipenem/cilastatin q6h.

Eligibility criteria:
inclusion criteria: * a signed informed consent form (icf). if a study patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient as permitted by local law and institutional standard operating procedures. * male or female, 18 to 90 years of age, inclusive. * expectation, in the judgment of the investigator, that the patient's cuti would require initial hospitalization and treatment with iv antibiotics. * documented or suspected cuti or acute pyelonephritis (ap). exclusion criteria: * gross hematuria requiring intervention other than administration of study drug or removal or exchange of a urinary catheter. * known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization that would interfere with evaluation of response to the study antibiotics. * patient requires continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study. * receipt of a single dose of a long-acting, potentially-effective systemic antibiotic with activity against gram-negative uropathogens for more than 24 hours within the 72-hour window prior to randomization. * requirement at time of randomization for any reason for additional systemic antimicrobial therapy (including antibacterial, antimycobacterial, or antifungal therapy) other than study drug, with the exception of a single oral dose of any antifungal treatment for vaginal candidiasis. * likely to require the use of an antibiotic for cuti or ap prophylaxis during the patient's participation in the study \[from randomization through the late follow-up (lfu) visit\]. * any patients previously randomized in this study.
non-nutritive sucking vs non-nutritive sucking combined with breast milk on the neonatal comfort

Conditions: Infant, Premature

Summary: the aim of the study is to determine the effect of the use of non-nutritive sucking vs non-nutritive sucking combined with breast milk on neonatal comfort during diaper change in preterm infants.

newborns are faced with many painful interventions including tactile stimulation such as diaper change, axillary temperature measurement, intraoral and endotracheal aspiration during the postnatal period in the neonatal intensive care units (nicu) at the beginning of their lives. painful interventions negatively affect the physiological parameters, comfort, sleep, growth and hospital stay of newborns. as a result of these interventions, the stress level increases in preterm infants. increased stress level can cause long-term sequelae, risk of intraventricular hemorrhage, increased oxygen consumption and hypertension. in addition, the increased stress experience may make the infant sensitive to pain and stress in other periods of his life. this randomized controlled prospective study was planned to be conducted in the nicu of a private hospital with branches in istanbul until the whole sample group would be reached. in the nicu, where the study will be conducted, preterm infants will be divided into two groups as control and experimental groups. non-nutritive sucking (nns) combined with breast milk will be used during diaper change for newborns in the experimental group, and only nns will be used in the control group. nns will be given to both groups 5 minutes before diaper change. the comfort level of the newborns will be measured with the premature infant comfort scale before the nns, 5 minutes after the nns, during the procedure, immediately after the procedure and 5 minutes after the procedure.

Eligibility criteria:
inclusion criteria: * the preterm infants whose parents agree to participate in the research and sign the informed consent form; * who have no congenital anomaly; * who have no chronic disease; * who have undergone no surgical procedure; * who have no neurological symptoms; * who have no nec (necrotizing enterocolitis) diagnosis; * who are not sedated; * who are not hypoglycemic; * who have been administered no pharmacological analgesic method 4 hours before; * who are born between ≥28 and ≤36+6 gestation weeks, or are in between ≥28 and ≤36+6 gestation weeks during the procedure. exclusion criteria: * the infants whose parents do not agree to participate in the research and do not sign the informed consent form; * who have a congenital anomaly; * who have a chronic disease; * who had undergone a surgical procedure; * who have neurological symptoms; * who have nec (necrotizing enterocolitis) diagnosis; * who are sedated; * who are hypoglycemic; * who have been administered no pharmacological analgesic method 4 hours prior; * who were between \ 36+6 gestation weeks.

Keywords: non nutritive sucking preterm infant comfort
effects of sit combined with remote ischemic preconditioning on vascular function in young women with masked obesity

Conditions: Vascular Function

Summary: comparison of the effects of combined sprint interval training (sit) with remote ischemic preconditioning (ripc) and sit on vascular function in young women with masked obesity.

this is a randomized clinical trial of single-blind with 3 arms (control group, sit group and sit with ripc group), in which a pre-treatment-posttest design has been used.

Eligibility criteria:
inclusion criteria: * females aged between 18 and 30 years; * bmi within the normal range (18.5～24.9 kg/m²), bf% \> 30%; * participants with no clinically diagnosed contraindications for exercise, in good health, and not engaged in regular exercise, as determined by the health and physical activity questionnaire (based on the american college of sports medicine's guidelines for exercise testing and prescription). exclusion criteria: * history of cardiovascular diseases, including coronary heart disease, stroke, or peripheral arterial disease diagnosed through vascular imaging techniques; * currently participating in other intervention studies, including dietary, nutritional, or psychological education programs; * those with regular professional training; * musculoskeletal disorders that make long-term exercise interventions unsuitable.

Keywords: sprint interval training masked obesity young women ischemic preconditioning vascular function
stereotactic body radiation therapy (sbrt) for lung tumors

Conditions: Lung Cancer

Summary: the purpose of this research study is to determine if stereotactic body radiation therapy(sbrt) is a good way to treat tumors near the thorax. stereotactic body radiation therapy (sbrt) is a general term for a group of techniques that are designed to deliver radiation therapy in a way that damages normal tissues less than conventional radiotherapy. the two features that distinguish sbrt from conventional therapy are procedures that decrease errors in patient positioning and technology that results in a radiation dose distribution that conforms more tightly to the tumor target. patients will receive either 48 gy or 60 gy fractions depending on the type of tumor. the majority of patients will be treated in 1 week, monday through friday, with wednesday off.

stereotactic body radiotherapy (sbrt) for tumors in the thorax is a relatively new therapy in the united states, but has been used extensively in japan for more than 10 years. this protocol seeks to enroll patients in three broad categories based on histology and clinical scenario: primary therapy for non-small-cell lung cancer (nsclc), primary therapy to thoracic metastases, and retreatment of previously irradiated tumors or lung. primary lung tumors several studies have been published describing the utility of stereotactic body radiotherapy (sbrt) for primary untreated lung tumors. in the united states, the most influential has been the experience of robert timmerman at the university of indiana (7). they enrolled 37 patients in a dose escalation trial of sbrt for t1 n0 and t2 n0 patients with non-small-cell lung cancer (nsclc). the trial began with 24 gy given in 3 fractions and escalated to 60 gy given in 3 fractions. dose limited toxicity (dlt) was defined as any grade 3 pulmonary, esophageal, cardiac, or pericardial toxicity, or any grade 4 toxicity that was ascribed to the protocol treatment using the common toxicity criteria from the national cancer institute. the maximum tolerated dose (mtd) was defined at dose where less and 2 of 5 enrolled patients experienced dlt. the mtd was not determined by this trial as this criteria was not met in the enrolled patients. of the 37 patients, 2 experienced grade 3 toxicity. one patient experienced pneumonitis and other patient experienced hypoxemia. both patients responded to therapy and made full recoveries. there were no long term complications reported from the treatment at a mean follow-up of 15 months.

Eligibility criteria:
inclusion criteria: * informed consent to participate in this protocol * patients of all ages are eligible * all tumor types are eligible * patients with prior thoracic radiotherapy and/or surgery are eligible * tumor size ≤ 5 cm exclusion criteria: * the subject is eligible for surgical resection or prefers treatment on this protocol to surgical resection. * less than 1 year since original radiation to thorax for retreatment patients. * more than 2 tumors requiring sbrt * the patient cannot be positioned reproducibly due to pain or other factors
nirst and icg-based perfusion imaging in acute compartment syndrome

Conditions: Compartment Syndromes; Compartment Syndrome of Lower Leg; Compartment Syndrome of Forearm

Summary: this is a prospective observational study of patients with suspected acute compartment syndrome. the primary objective of this work is to determine whether intensity changes associated with the nirst signal, reflecting oxy- and deoxy-hemaglobin and water concentrations or icg fluorescence signal, reflecting tissue perfusion, can be associated with development of acute compartment syndrome and identification of at-risk soft tissue and muscle.


Eligibility criteria:
inclusion criteria: * age 18 years or older * clinical suspicion of acute compartment syndrome based on orthopaedic provider assessment. clinical suspicion would be based upon the presence of one or more of these findings: * pain out of proportion to visible findings * escalating doses of pain medication * pain with passive stretch of toes and/or fingers * pallor, paresthesias, pulselessness * tense soft tissues * high energy tibia or forearm fracture * provision of informed consent exclusion criteria: * history of allergy to icg and/or iodine * pregnant women or nursing mothers * any patient with an open wound for whom nirst device cannot be applied \>4cm from the open wound will be excluded from nirst imaging.
intracardiac echocardiography-guided catheter ablation for premature ventricular contractions originating from the papillary muscles

Conditions: Premature Ventricular Contractions

Summary: this randomized, prospective, parallel, single-blind, multicenter clinical trial investigates the efficacy and safety of intracardiac echocardiography (ice)-guided catheter ablation versus pressure-sensing catheter ablation alone in reducing pvc recurrence among patients with confirmed papillary muscle-originating premature ventricular contractions (pvcs). participants were randomly allocated to either the ice-guided intervention group or the conventional ablation control group following definitive diagnosis.


Eligibility criteria:
inclusion criteria: * patients aged ≥18 years. * diagnosed with premature ventricular contractions (pvcs) originating from the papillary muscles. * symptoms refractory to antiarrhythmic drug therapy. * patients must be capable and willing to provide written informed consent for study participation. exclusion criteria: * history of cardiac surgery or any prior cardiac interventional procedures. * ischemic heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy. * severe hepatic or renal dysfunction: ast/alt \>3× upper limit of normal (uln); serum creatinine (scr) \>3.5 mg/dl or creatinine clearance (ccr) \<30 ml/min. * prior ablation for papillary muscle pvcs. * life expectancy \<1 year. * pregnancy or lactation.

Keywords: intracardiac echocardiography papillary muscle-originating premature ventricular contractions premature ventricular contractions
feasibility of a multi site rct to establish the effectiveness of a health behaviour change intervention for patients with peripheral arterial disease (pad).

Conditions: Health Behavior

Summary: the purpose of this study was to evaluate the feasibility of conducting a randomised controlled trial (rct) comparing brief psychological intervention to help patients with peripheral arterial disease (pad), reduce cardiovascular risk factors compared to control/treatment as usual in a vascular outpatient clinic. trial feasibility was defined as the successful recruitment and retention of participants, adherence to the intervention, identification of barriers to the intervention and collection of clinical and quality of life outcome data. qualitative data was collected to evaluate participant experience and the clinical impact of a supported self-management intervention delivered in a routine clinical setting.

the aim of this study was to assess the feasibility of conducting a definitive multi-centre trial of a specially designed health behaviour change intervention delivered in a secondary care outpatient clinic to improve the primary clinical outcome of functional walking ability this feasibility study, based on the mrc framework for assessing feasibility and piloting methods, will assess the relative strengths and weaknesses of the intervention and study design, as well as pave the way for a larger and more definitive trial.

Eligibility criteria:
inclusion criteria: * adults over the age of 18 years * newly diagnosed with pad resulting in claudication in one or both legs * reduced ankle brachial index (abi \< 0.80). exclusion criteria: * patients with an abpi of less than 0.35, with rest pain or tissue loss were excluded and classified as cases of critical limb ischaemia requiring revascularisation. * severe mental health problems such as severe depression with suicidal ideation, psychosis, personality disorder * terminal illness * patients for whom it would be medically unadvisable to increase their daily walking (including heart failure, cancer, exercise induced asthma, unstable angina. inability to walk unaided, history of orthopaedic surgery or significant bony disease impacting upon their mobility).
gabapentin to reduce postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: the intrathecal administration of morphine is gaining popularity. it is easy to do and can reduce the pain after surgery up to 24 hours. however, it causes postoperative nausea and vomiting more than other methods providing postoperative analgesia. patients suffering from these side effects have to spend a longer period of time recovering in the hospital with high cost of medical treatment.

objective: to study the efficacy of oral administrating of gabapentin 600 mg before surgery to reduce the postoperative nausea and vomiting in patients receiving intrathecal morphine. methods: eighty patients undergoing orthopedic surgery and receiving intrathecal morphine will be randomized into 2 groups. the first group will receive oral gabapentin 600 mg and the second group will receive a placebo tablet. both groups will receive a standard prophylactic medication for postoperative nausea and vomiting. the degrees of nausea and vomiting in both groups will be assessed over 24 hours postoperatively.

Eligibility criteria:
inclusion criteria: * patients undergoing general or regional anesthesia receiving spinal morphine * asa physical status i-iii exclusion criteria: * patients with allergy to morphine or gabapentin * chronic use of narcotics * psychotic * bleeding disorder * cardiovascular disorder * liver or renal failure * pregnancy or breast feeding * neurologic disorder