Kornimate/medical-research-clean huggingface dataset:
study evaluating tigecycline vs levofloxacin in hospitalized with community-acquired pneumonia

Conditions: Community Acquired Pneumonia; Bacterial Pneumonia; Cross Infection

Summary: to compare the efficacy and safety of tigecycline with those of levofloxacin in the treatment of subjects with cap requiring hospitalization. the co-primary efficacy endpoints in the study will be the clinical response in the clinically evaluable population and the clinical response in the clinical modified intent-to-treat population at the toc visit. the primary efficacy analyses will first determine whether tigecycline is noninferior to levofloxacin. if tigecycline is found to be noninferior, the analyses will determine whether tigecycline is statistically better than levofloxacin.


Eligibility criteria:
inclusion criteria: * male and female subjects ≥ 18 years of ag. * subjects hospitalized with cap for whom iv antibiotic treatment is indicated * the presence of fever (within 24 hours prior to randomization), defined as oral temperature \>38°c/100.4°f, axillary temperature \>38.1°c/100.6°f, tympanic temperature \>38.5°c/ 101.2°f, or a rectal/core temperature \>39°c/102.2°f or hypothermia (within 24 hours prior to randomization), core temperature \<35°c/95° exclusion criteria: * any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed (eg, life expectancy \<30 days) * hospitalization within 14 days prior to the onset of symptoms * residence in a long-term care facility or nursing home ≥14 days before the onset of symptoms

Keywords: bacterial pneumonia
fetal alcohol damage prevention study

Conditions: Fetal Alcohol Syndrome; Substance Abuse

Summary: the goal of this study was to determine whether a series of blood markers of alcohol use obtained from alcohol using pregnant women could help them to change their behavior.

this study involved screening pregnant women with an alcoholism screening questionnaire and obtaining blood from those women who screened positive and a subset of women who screened negative. each woman who had blood drawn were informed of their results, educated about alcohol use in pregnancy and had a brief intervention about their alcohol use, if appropriate. they were monitored throughout the pregnancy with additional blood tests obtained, depending upon their stage in pregnancy. after birth the babies were examined for any signs of alcohol exposure.

Eligibility criteria:
inclusion criteria: * pregnant women seen at one of the obstetric clinics in the study and willing to give a blood sample exclusion criteria: * over 36 week gestation

Keywords: fetal alcohol exposure blood markers of alcohol use brief intervention
18f-fdg pet/ct versus 18f-fdg pet/mri in detecting locoregional recurrence 3 months after crt in head and neck scc

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: comparing fdg pet/ct and fdg pet/mri in the diagnostic accuracy of detecting local recurrence 12 weeks after the end of crt in head and neck squamous cell carcinoma patients. forty patients aged more than 18 years who have a histologically confirmed hnscc and have received chemoradiation therapy will be recruited for the study. the patients will be scanned with both pet/ct and pet/mri 12 weeks after the end of crt.

since recurrence of hnscc occurs in up to 50 percent of cases in the first two years following treatments and the recurrent diseases are less responsive to new treatments, detecting local/regional recurrence at an earlier time is crucial in order to provide salvage treatments. the primary objective of this prospective study is to compare the diagnostic accuracy of fdg pet/ct to fdg pet/mri in the detection of local recurrence 12 weeks after the end of chemoradiation treatment in hnscc patients. the hypothesis is that pet/mri might be able to diagnose locoregional recurrence earlier and more accurately which would lead to a better outcome for the patient. if it is proven correct, it would be possible to optimize the use of pet/mri imaging on selected patients who are likely to benefit clearly from the use of that modality. forty patients aged more than 18 years who have a histologically confirmed hnscc and have received chemoradiation therapy will be recruited for the study. the patients will be scanned with both fdg-pet/ct and fdg-pet/mri 12 weeks after the end of crt. all study participants will be consented, and the estimated time for completing the pet scans of 40 patients will take 12 to 15 months. the results will be reported in international peer-reviewed high-impact journals.

Eligibility criteria:
inclusion criteria: * age 18 years or older * language spoken: finnish or swedish * diagnosis: histologically confirmed hnscc * chemoradiotherapy treatment with curative intent to the primary tumor and/or neck ln metastasis that has ended 12+- 4 weeks before the pet scan. * clinical stage: stage i-ii at least 20 patients, stage iii-iv at least 20 patients * mental status: patients must be able to understand the meaning of the study * informed consent: the patient has to have signed the appropriate ethical committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * uncontrolled serious infection * contraindications for mri (cardiac pacemaker, intracranial clips etc., allergic reaction to contrast agent) * severe claustrophobia

Keywords: pet-imaging local recurrence pet/mri chemoradiotherapy
rygb and the gastric adipose axis

Conditions: Obesity

Summary: the purpose of this study is to determine if interruption in gastric-adipose tissue axis signaling contributes to early improvements in oxidative stress, insulin sensitivity, and inflammation, and to determine if interruption of the stomach in rygb results in reduction of plasma acylated ghrelin (ag) and in an altered acylated ghrelin:unacylated ghrelin (ag:uag) ratio which may contribute to decreased oxidative stress and improved insulin sensitivity.


Eligibility criteria:
protocol i inclusion criteria: * age 18-65 years * bmi ≥ 35 kg/m\^2 * scheduled for bariatric surgery * considering bariatric surgery * waiting for insurance approval for bariatric surgery * currently not considering bariatric surgery, but otherwise eligible * enrollment in medical weight loss program exclusion criteria: * smoking \>7 cigarettes per day * precious malabsorptive or restrictive intestinal surgery * pregnant or breastfeeding * recent history of neoplasia (5\<years ago) * malabsorptive syndromes * inflammatory intestinal disease * established organ disfunction * allergy to acetaminophen

Keywords: obesity bariatric surgery nashville, tennessee
a long-term safety and tolerability study of usl261 in patients with seizure clusters

Conditions: Epilepsy

Summary: the purpose of this study is to examine the long-term safety and tolerability of usl261 in the treatment of seizure clusters.


Eligibility criteria:
inclusion criteria: 1. has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes 2. has an established diagnosis of partial or generalized epilepsy that includes all the following: * a documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any) * a second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition * a seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures * a seizure cluster pattern established \>3 months before visit 1 * a frequency of ≥ 3 stereotyped seizure clusters during the year before visit 1 * at least 1 stereotyped seizure cluster occuring ≤ 4 months before visit 1 3. currently on a stable regimen of aed(s) that includes a benzodiazepine 4. weight is 40 kg to 125 kg, inclusive exclusion criteria: 1. has a neurological disorder that is likely to progress in the next year 2. has a severe chronic cardio-respiratory disease 3. has a psychogenic, non-epileptic seizure(s) within the 5 years before visit 1 4. has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before visit 1 5. has a history of acute narrow-angle glaucoma 6. has had active suicidal plan/intent or active suicidal thoughts in the 6 months before visit 1 or a suicide attempt in the past 5 years

Keywords: epilepsy seizure cluster acute repetitive seizures open-label intranasal midazolam usl261 upsher-smith
prothrombotic factors and anaesthesia in prostate cancer

Conditions: Prostatic Cancer; Surgery

Summary: this study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (lrp).

the utility of anti-thrombotic prophylaxis in cancer patients undergoing laparoscopic radical prostatectomy (lrp) is still controversial. moreover, different anaesthetic techniques could modify coagulant factors. thus, in this study we will be to investigate the variations of pro- and anti-coagulant and fibrinolytic factors in two established types of anaesthesia in patients with prostate cancer undergoing elective lrp.

Eligibility criteria:
inclusion criteria: * newly diagnosed cancer of the prostate * histological gleason score evaluation. exclusion criteria: * asa \>2 * metabolic equivalent task \< 4 * bmi\>30 * no pre-operative pharmacological thromboprophylaxis and/or anti-coagulant therapy * history of abnormal bleeding, or abnormal coagulant factors * sepsis within the last 2 weeks * previous new adjuvant treatments (chemo, hormone, and radiotherapy) * non-steroid , anti-inflammatory and statins drugs for at least 2 wks before surgery * venous or arterial thromboembolism within the last 3 months, peripheral venous disease * neurological disease with extremity paresis * chronic liver disease * pre-operative haemoglobin concentration \< 9 mg dl-1 * prolonged duration of surgery (\>3 hrs) * peri-operative blood transfusion * not adequate material for laboratory testing

Keywords: prostatectomy coagulation factor balanced anesthesia intravenous anesthesia,
prgf-endoret® infiltrations in the treatment of low back pain.

Conditions: Diseases [C] - Musculoskeletal Diseases [C05

Summary: the goal of this clinical trial is to evaluate the efficacy of prgf in reducing pain and improving patients' quality of life. researchers will compare an experimental drug (plasma rich in growth factors) to a control corticosteroid solution in saline solution.


Eligibility criteria:
inclusion criteria: * patients of legal age (≥18 years). * patients diagnosed by magnetic resonance imaging (mri) with lumbar intervertebral disc degeneration(s) (pfirrmann scale \> 1).patients with positive signs in mri at l4-l5 and/or l5-s1 levels, including rupture of the annulus fibrosus, annular fissure, with or without disc herniation in its protrusion form will be included. * patients with low back pain with symptoms of low back pain for at least 3 months of evolution that has not responded to drug treatment. * numerical pain scale (comi pain score): between 6 and 10, average of the last month. * availability of an mri performed in the last six months to allow the diagnosis. * availability of a complete blood test (hemogram, basic biochemistry and coagulation tests) performed in the last two months. * signed informed consent to participate in the clinical trial and authorization for data processing by the different centers involved for subsequent scientific publication. exclusion criteria: * patients with lumbar fracture, extruded herniated discs and herniated discs with signs of calcification are excluded. * patients with severe discopathies at levels adjacent to l4-l5 and/or l5-s1. * patients who have previously undergone spinal surgery. * patients who have undergone invasive procedures on the spine in the last 6 months, such as infiltrations, blocks, lavage or lumbar rhizolysis. * patients with neurogenic motor claudication. * patients with severe cardiovascular diseases, central nervous system diseases, epilepsy, coagulopathies, immunological diseases, infectious diseases (e.g. hepatitis b and c, hiv, syphilis), cancer or neurodegenerative pathologies. * patients with a history of drug use (e.g. alcoholism or others) and mental illness or marked psychological conditions related to pain. * morbidly obese patients (bmi \> 40 kg/m2). * women who are pregnant or breastfeeding or women of childbearing age who are not taking effective contraceptive measures as outlined in the clinical trials facilitation and coordination group (ctfg) "recommendations regarding contraception and pregnancy testing in clinical trials" v 1.1. * patients with pathologies that produce marked alterations in the efficacy of prgf or coagulation, such as, for example: poorly controlled diabetes mellitus (glycosylated hemoglobin above 9%), hematological alterations (thrombopathy, thrombopenia, anemia with hb \< 9), being subjected to immunosuppressive and/or dicoumarinic treatments, or any treatment with systemic corticosteroids during the 6 months prior to inclusion in the study * patients who present allergy to any component of the sedation or to the corticoid. * patients who have received previous back treatment with prgf in the last 6 months.
an islamic psychospiritual-acceptance and commitment-based prevention program for at-risk young adults in the covid-19 pandemic

Conditions: Psychological Distress

Summary: the covid-19 pandemic has increased mental health concerns worldwide, and young adults are at higher risk of experiencing increased psychological distress due to the pandemic. university students face compounding stressors during the pandemic, such as online and remote learning, economic insecurity, and uncertain career prospects. this study aims to evaluate the effectiveness of an online modular prevention program featuring integrated elements of acceptance and commitment therapy (act) and islamic spirituality in reducing the psychological distress and increasing the psychological flexibility, self-compassion, and resilience of muslim university students in malaysia.


Eligibility criteria:
inclusion criteria: * undergraduate or postgraduate student enrolled in a malaysian university * aged 18-29 years old * obtained moderate and above levels in either one of the stress, anxiety, and depression subscales of the dass-21 pre-intervention assessment * muslim * owns a gadget with internet access * can read and understand english exclusion criteria: * those with previous experience with a modular act-based treatment with islamic elements * those with past or present diagnosis of mental/neurological disorder * those reporting active suicidality * those involved in any other form of psychological treatment (ie. psychotherapy, pharmacotherapy)

Keywords: acceptance and commitment therapy (act) islamic psychospiritual intervention online intervention covid-19 prevention program
safety and efficacy of ibi306 in chinese subjects with non-familial hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: ibi306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (pcsk-9), preventing its interaction with the low-density lipoprotein cholesterol receptor (ldl-r) and thereby restoring ldl-r recycling and low-density lipoprotein cholesterol(ldl-c) uptake. this study is being done to investigate the effects of ibi306 in chinese people with non-familial hypercholesterolemia with very high or high cardiovascular risk. this study will see if ibi306 will reduce low density lipoprotein cholesterol (ldl-c) in chinese people who are taking a certain type of lipid-lowering medication (statins with or without ezetimibe) and whether it causes any side effects

this is a phase 3, multicenter, double-blind, randomized, placebo-controlled study of ibi306 in chinese non-familial hypercholesterolemia subjects with very high or high cardiovascular risk. a total of around 600 subjects who meet admission criteria will be randomized and receive one of the two dose levels of ibi306 or matching placebo: 450mg q4w, or 600mg q6w. the double blind period for both groups will be 48 weeks. the study will last 52 weeks

Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 to ≤ 75 years of age 2. diagnosis of hypercholesterolemia 3. ldl cholesterol ≥ 70 mg/dl (1.8mmol/l) 4. very high or high cardiovascular risk 5. tg≤500 mg/dl(5.64 mmol/l) exclusion criteria: 1. diagnosis of hofh or hefh 2. uncontrolled hypertension 3. uncontrolled hyperthyroidism or hypothyroidism 4. severe renal dysfunction 5. known sensitivity to any of the products to be administered during dosing
high intensity functional training for individuals with neurologic diagnoses and their care partners

Conditions: Neurologic Disorder; Parkinson Disease; Spinal Cord Injuries; Spina Bifida; Stroke; Poliomyelitis; Multiple Sclerosis; Brain Injuries

Summary: individuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. this is an issue for both them and their care partners as their health is often linked. this study aims to examine the long-term physical and psychosocial effects of structured, group-based, high intensity functional training (hift) exercise for people with neurologic diagnoses and their care partners.

over the course of two years, this study will provide no-cost, twice weekly, group-based, hift exercise for people with neurologic diagnoses and their care partners. all participants will be required to have physician or advanced practice provider clearance to exercise. all participants will be evaluated by a physical therapist at no-cost prior to beginning the intervention to assess eligibility for the study. all eligible participants will complete a demographics questionnaire, questionnaires regarding physical and psychosocial health, and a battery of physical tests assessing mobility, strength, endurance, and balance. participants' physical activity levels will also be monitored throughout the study through accelerometers. participants will participate in a maximum of twice weekly hift exercise for up to 2 years. all exercise programming will be led by licensed physical therapists with assistance from doctor of physical therapy students. all exercise staff will be cardiopulmonary resuscitation/basic life support certified and an automated external defibrillator will be available onsite. exercise classes will utilize hift, which includes various exercises that are functional and to be performed at a high intensity. exercises will include aerobic, resistance, and/or balance training and align with the 2018 physical activity guidelines for americans.

Eligibility criteria:
inclusion criteria: * participants must be at least 18 years of age * participants must be able to communicate and read in english * participants must have physician and/or advanced practice provider clearance to exercise * participants must have a neurologic diagnosis (e.g., spinal cord injury, parkinson's, brain injury, stroke, poliomyelitis, multiple sclerosis, spina bifida, etc.) or participants must be care partner of a person with neurologic diagnosis. * participants must possess at least 4/5 elbow flexion strength bilaterally * participants must be able to locomote independently (i.e., ambulate or propel a manual or power wheelchair independently). * participants must provide their own transportation to/from the research study exclusion criteria: * participants will be excluded if they fail to meet any of the inclusion requirements

Keywords: hift exercise
a study to evaluate kin-2787 in participants with braf and/or nras mutation positive solid tumors

Conditions: Solid Tumor, Adult; Non-small Cell Lung Cancer; Melanoma

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of kin-2787 in adults with braf/nras-mutated advanced or metastatic solid tumors.

this is a two-part, open-label, multi-center, dose escalation and dose expansion study in participants with braf mutation-positive and/or nras mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (pk) of kin-2787, a raf small molecule kinase inhibitor, to determine a recommended phase 2 dose (rp2d) of kin-2787, and to assess the objective response to kin-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (mek) inhibitor. the dose expansion phase (part b) will assess the safety and efficacy of kin-2787 at the recommended dose and schedule in patients with cancers that contain braf class i, ii or iii mutations, including lung cancer, melanoma, and other selected solid tumors.

Eligibility criteria:
inclusion criteria: * provide written informed consent prior to initiation of any study-specific procedures. * metastatic or advanced stage solid tumor * known braf class i, class ii, or class iii alteration or melanoma with an nras mutation as confirmed by previous genomic analysis of tumor tissue or ctdna. * measurable (part a and b) or evaluable (part a only) disease by recist v1.1. * ecog performance status 0-1 * adequate organ function, as measured by laboratory values (criteria listed in protocol). * able to swallow, retain, and absorb oral medications. exclusion criteria: * known participants who have received local therapy with either surgery and/or radiation therapy (participants with asymptomatic untreated brain metastasis may be eligible if met with certain criteria) * in part b dose expansion, previous treatment with any approved or in-development small molecule braf-, mek-, or mapk-directed inhibitor therapy. * gi tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory gi disease. * active, uncontrolled bacterial, fungal, or viral infection. * participant with a positive test result for sars-cov2 infection, is known to have asymptomatic infection or is suspected of having sars-cov2, is excluded * women who are lactating or breastfeeding, or pregnant. * participants with any other active treated malignancy within 3 years prior to enrollment complete inclusion and exclusion criteria are listed in the clinical study protocol.

Keywords: braf inhibitor braf pan-raf pan-raf inhibitor raf1 araf braf alteration braf class ii braf class iii v600 tumor growth inhibitor (tgi) melanoma nsclc solid tumor targeted therapy braf class i nras metastatic unresectable crc atc colon thyroid advanced exarafenib binimetinib
renal effects of ripc in patients after total arch replacement

Conditions: Acute Kidney Injury; Dialysis

Summary: the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

acute kidney injury (aki) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. total arch replacement is reported with a relatively high incidence of post-operative aki. in addition, few effective preventive or therapeutic interventions for aki have been identified. a number of studies have now addressed renal protection as a primary outcome following ripc. because the mechanism of i/r injury are similar to those proposed for aki after cpb, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.

Eligibility criteria:
inclusion criteria: * patients scheduled for total arch replacement * written informed consent exclusion criteria: * pre-existing aki * peripheral vascular disease affecting the upper limbs * hybrid total arch replacement * the history of kidney transplantation