Kornimate/medical-research-clean huggingface dataset:
assessment of optune therapy for patients with newly diagnosed glioblastoma using advanced mri

Conditions: Glioblastoma

Summary: the purpose of this prospective, nonrandomized controlled phase iv study is to compare standard and advanced mri for their ability to predict response to optune therapy.

protocol summary: optune therapy is a newly approved treatment for patients with glioblastoma. this therapy demonstrated comparable outcomes for patients with recurrent gbm, in comparison to standard therapies, but better quality of life. more recently, in an interim analysis of 315 patients with gbm, adding tumor treating fields (ttfields) to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival. it also has demonstrated promise in other cancers such as pancreas, mesothelioma, ovarian and lung. however, in order to optimize the treatment regimen, and potentially predict which patients are most likely to respond, reliable ways of evaluation are necessary. advanced perfusion and diffusion mri methods have shown utility with other treatments such as bevacizumab. preliminary data suggests the same might be true for the evaluation of optune therapy. the team therefore proposes to determine the utility of these methods to predict response to optune therapy. a successful result will have wide-ranging implications not only for the optimization of optune treatment of brain cancer but also other cancers shown to benefit from this novel therapy. objective: to compare standard and advanced mri for their ability to predict response to optune therapy. the team's approach will be to obtain both standard and advanced mri in patients with newly diagnosed glioblastoma undergoing adjuvant chemotherapy plus optune therapy. the ability of standard and advanced mri to predict response will be assessed. the hypothesis is that perfusion and/or diffusion imaging metrics can be used to predict response to and elucidate mechanisms of action for optune treatment.

Eligibility criteria:
inclusion criteria: * newly diagnosed glioblastoma (gbm), world health organization (who) grade iv. exclusion criteria: * optune compliance \< 75%; they would be excluded from the final analyses. * history of craniectomy or significant skull defect (contraindication to optune). * active implantable medical device (e.g., deep brain stimulator (dbs), spinal cord stimulator, pacemaker, defibrillator, vagus nerve stimulator, programmable shunt). * karnofsky performance status (kps) \< 60.

Keywords: optune therapy mri novocure-ttf-200a
abc school intervention among ugandan adolescents

Conditions: Anxiety; Depression Disorders

Summary: schools can be pivotal in addressing mental health challenges, especially in low-income settings like uganda. this pilot cluster-randomized trial examines the impact of a culturally sensitive act-belong-commit (act) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety and depression among ugandan adolescents attending secondary school. adolescents from four secondary schools were randomized by school to either a 12-week, weekly two-hour teacher- and peer-led act intervention or a care-as-usual control. anxiety (gad-7) and depression (phq-9-a) were measured at baseline and immediately post-intervention. childhood trauma (ctq-sf), self-reported health, wealth, and food security were assessed at baseline. linear mixed modeling was used to evaluate intervention effects.

introduction: schools can be pivotal in addressing mental health challenges, especially in low-income settings like uganda. however, randomized controlled trials tailored to cultural and contextual factors are scarce. this pilot cluster-randomized trial examines the impact of a culturally sensitive act-belong-commit (act) intervention, combined with physical activity, sleep hygiene and stress management measures on anxiety and depression among ugandan adolescents attending secondary school. methods: a total of 2,598 adolescents (1,295 intervention; 1,303 control; 1,199 boys \[46.1%\]; mean age 16.3 ± 1.0 years) from four secondary schools were randomized by school to either a 12-week, weekly two-hour teacher- and peer-led act intervention or a care-as-usual control. anxiety (gad-7) and depression (phq-9-a) were measured at baseline and immediately post-intervention. childhood trauma (ctq-sf), self-reported health, wealth, and food security were assessed at baseline. linear mixed modeling was used to evaluate intervention effects.

Eligibility criteria:
inclusion criteria: * all students aged 14 to 17 years in the four schools were screened for depression and anxiety using the patient health questionnaire - 9 (phq-9) (spitzer et al., 1999) and generalized anxiety disorder - 7 (gad-7) (spitzer et al., 2006) as part of school health screening service embedded within the study. exclusion criteria: * none

Keywords: act belong commit adolescents uganda anxiety depression physical activity sleep
prediction of muscle responsiveness to fes therapy

Conditions: Spinal Cord Injury Cervical

Summary: reduced arm and hand function has a significant impact on independence and quality of life after spinal cord injury. functional electrical stimulation therapy (fes-t) is a treatment that can produce improvements in reaching and grasping function after neurological injuries. however, not all paralyzed muscles respond equally well to the therapy. currently, therapists cannot predict which muscles will respond, limiting their ability to create a personalized therapy plan that can maximize outcomes while making the best use of the limited treatment time available. the objective of this study is to develop a diagnostic method that will allow therapists to quickly and easily screen muscles in the clinic, in order to predict how they will respond to fes-t. participants with cervical spinal cord injury will receive fes-t through the rocket family upper extremity clinic at the toronto rehabilitation institute - university health network. muscles receiving training will undergo a electrophysiological examination before the start of therapy, and will then be tracked for strength recovery over the course of 30 sessions. lastly, signal processing and machine learning techniques will be applied to the electrophysiological data to predict the recovery profile of each muscle. the significance of this work will be to provide personalized therapy planning in fes-t, leading to more effective use of healthcare resource as well as improved outcomes.


Eligibility criteria:
inclusion criteria: * cervical spinal cord injury * paralysis or paresis in at least one upper extremity * at least 6 months post sci * able to understand and follow instructions * able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy * willing to attend treatment sessions and all assessment sessions * able to understand and provide informed consent * male and female participants ≥ 18 years of age at the time of enrollment exclusion criteria: * previous history of any other neuromuscular disorder or conditions that may affect motor response * upper extremity injury or condition prior to sci that limits the function of the hand or arm * in the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study * currently enrolled in another upper limb study and/ or has received myndmove therapy within the past 3 months * botulinum toxin injection into affected upper extremity and the muscle targeted by myndmove® therapy within 3 months prior to the study start. no botulinum toxin injections in the upper extremity during the study treatment. * females who are pregnant or planning to become pregnant in the duration of the trial * regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion

Keywords: spinal cord injury functional electrical stimulation upper limb electromyography prediction.
prevention of preterm labor in patients with a previous episode of threatened preterm labor with progesterone

Conditions: Preterm Birth; Obstetric Labor, Premature

Summary: the purpose of this study is to determine if the use of 250 mg of intramuscular progesterone biweekly can reduce the incidence of preterm labor in patients with an episode of threatened preterm labor during the current pregnancy.

preterm birth is one of the main causes of neonatal mortality and morbidity around the world, with serious repercussions on the health system and the families of the preterm baby. many drugs have been evaluated with the purpose of preventing preterm birth in the patient at risk. one of these drugs is 17 α hydroxyprogesterone caproate. the purpose of this study is to evaluate if the use of biweekly doses of 17 α hydroxyprogesterone caproate in patients hospitalized with the diagnosis of threatened preterm labor, defined as the presence of uterine contractions and a short cervix (below the 10th percentile for the gestational age), can reduce the incidence of preterm birth in this high risk group population.

Eligibility criteria:
inclusion criteria: * pregnant women between 26 and 34 weeks of gestation. * cervical length (determined by transvaginal ultrasound) below the 10th percentile for the gestational age. exclusion criteria: * multiple gestations. * maternal pathologies in which preterm termination of pregnancy is required.

Keywords: progesterone obstetric labor, premature short cervix
urea breath test (ubt) with breath hp system /breathid hp lab system pediatrics

Conditions: Helicobacter Pylori Infection

Summary: clinical study to confirm safety and accuracy in detection of h. pylori with 13c-urea breath test using the breathid® hp and breathid® hp lab systems in the pediatric population

pediatric subjects with indication for h.pylori testing, will be tested with both stool antigen as a reference standard and a urea breath test using the breathid® hp and breathid® hp lab systems. the breathid® hp system continuously measures breath via a nasal cannula and the breathid® hp lab system measures breath collection bags before and after ingestion of a solution with enriched carbon 13 urea and citric acid. the stool sample will be provided within a week of the breath tests and will be analyzed by a central laboratory. safety and overall efficacy will be assessed.

Eligibility criteria:
inclusion criteria: * be older than 3 and younger than 18 years of age * present with a clinical indication compatible with h. pylori based on the judgement of the treating physician (such as abdominal pain, nausea, diarrhea, reflux, peptic ulcer, dyspepsia, etc., or following treatment for h.pylori) * subject/legal guardian (and subject whenever relevant) is willing to sign the informed consent/assent form * naïve to h. pylori treatment in the past 6 weeks exclusion criteria: * participation in other interventional trials * ppi or h2 blockers within two (2) weeks prior to breath test/stool antigen test * pregnant or breastfeeding female * allergy to test substrates * antibiotics (not related to h. pylori eradication) and/or bismuth preparations within four (4) weeks prior to breath test * exposure to any type of anesthesia, analgesics or sedation 24 hours prior to the breath test. * exposure to any 13c-enriched substance 24 hours prior to the breath test. * children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group * subjects outside us - to be excluded after a written notification from the sponsor is received at the site that the limit of 1/3 of the sample size was achieved for this group
efficacy of nsaid peritendinous injection for acute tendinitis

Conditions: Tendinitis; Acute Tendonitis; NSAID (Non-Steroidal Anti-Inflammatory Drug)

Summary: this study evaluates whether nsaid peritendinous or ligament injections at acute sprain sites can relieve pain and restore function. forty patients will be randomly assigned to either the injection or oral nsaid group. pain will be assessed subjectively using the numeric pain rating scale and objectively through pressure pain threshold measurements. functional outcomes (dash for the upper limb, fadi for the lower limb) will be evaluated before treatment and at 3 days, 1 week, and 4 weeks post-treatment.

acute tendon inflammation is a common sports injury, typically treated with oral or topical non-steroidal anti-inflammatory drugs (nsaids) or local corticosteroid injections at the affected site. direct corticosteroid injections provide the fastest relief; however, the world anti-doping agency (wada) has restricted the use of corticosteroids by any route in its latest banned substance list. as a result, corticosteroid injections into tendons or joints, which were previously allowed during competitions, can no longer be used. currently, the only methods available for acute inflammation relief during competitions are oral nsaids and ice therapy. for athletes without structural damage who need to quickly reduce inflammation and return to play, these methods may be insufficient. previous clinical studies on nsaid injections into tendons and joints have shown that local nsaid injections are equally effective as corticosteroid injections for treating shoulder impingement syndrome and knee osteoarthritis. however, these studies mainly focused on patients with chronic arthritis and tendinitis. the difference in efficacy between oral nsaids and tendon injections during the acute phase of inflammation remains unknown. this study aims to compare different routes of nsaid administration to identify the most appropriate treatment for managing acute tendinitis in high-level athletes. we hypothesize that peritendinous nsaid injections will provide greater pain relief and functional improvement.

Eligibility criteria:
inclusion criteria: * ultrasonography diagnosed acute tendinitis with inflammation * 20-70 years old exclusion criteria: * cognitive impairment. * post operation at painful site. * neuropathic pain or vascularity disease * unable to receive injection therapy, including a history of syncope during injection. * allergy history to nsaid * within 14 days after coronary artery bypass graft, cabg
prospective randomized comparison of cold snare polypectomy and conventional polypectomy

Conditions: Colorectal Cancer

Summary: the aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps. cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.


Eligibility criteria:
inclusion criteria: * men or women between 20 and 100 years of age exclusion criteria: * exclusion criteria include age less than 20 years old * pregnant, american society of anesthesiologists class iii and iv * overweight (body weight \> 100 kg) * allergic to the drugs used or its components (soybeans or eggs) * poor bowel preparation or post-colorectal surgery.

Keywords: polypectomy colonic polyp colorectal polyp colorectal cancer prevention
the role of bacteria and genetic variations in cystic fibrosis

Conditions: Psuedomas Infection; Cystic Fibrosis

Summary: this study will examine 1) the role of hereditary factors in cystic fibrosis; i.e., the relationship of the disease to specific gene variations, and 2) the role of bacterial products involved in lung infections substances produced by bacteria may worsen the disease. patients with cystic fibrosis who are being followed by the medical college of wisconsin or the university of wisconsin-madison are eligible for this study. participants will have blood tests, pulmonary function tests, a sputum culture, and buccal swabbing (cotton swabbing of the inside of the cheek to collect cells for dna study). in addition, their medical records will be reviewed for a history of lung infections and the results of various tests, including pulmonary function studies, chest x-rays and bacterial cultures. blood samples collected previously at the medical college of wisconsin or the university of wisconsin-madison will also be analyzed for antibodies to bacteria. although this is a one-time study, participants may be asked to return for repeated tests. ...

individuals with cystic fibrosis (cf) are susceptible to chronic bacterial colonization by pseudomonas aeruginosa, which results in deterioration of lung function and, eventually, death. in this study, we hope to improve our understanding of the innate immune response to infection by strains of p. aeruginosa that express type iii cytotoxins and to delineate better the role of modifier genes in disease progression. we will examine relationships between the patient's clinical course, the presence of antibodies to p. aeruginosa, and single nucleotide polymorphisms in suspected cf modifier genes.

Eligibility criteria:
* inclusion criteria: patients with cystic fibrosis who have a defined mutation in cftr (e.g., any of the known variants of the cftr gene, such as the delta f508 allele) born in the state of wisconsin since 1985 or otherwise followed by the cystic fibrosis centers at the medical college of wisconsin or university of wisconsin-madison. patients will have been tested or will be tested for the cftr gene under another protocol (96-h-0100). patients may be colonized with p. aeruginosa or other organisms (e.g., burkholderia cepacia). the age range of nih participants in this study is from 9 to 80 years old. exclusion criteria: there are no exclusion criteria.

Keywords: type iii secretion pathways exotoxin a polymorphisms cystic fibrosis and pseudomonas aeruginosa adenosine deaminase deficiency severe combined immune deficiency scid ada-scid immune deficiency
intravenous iron in adults with cystic fibrosis

Conditions: Cystic Fibrosis; Iron-deficiency

Summary: this pilot interventional cohort study will examine the effects of intravenous iron in adults with cystic fibrosis and iron deficiency.

iron deficiency is common in adults with cystic fibrosis, and is associated with adverse outcomes. oral iron supplementation is poorly tolerated and may be ineffective. in some centres, intravenous iron is used to correct iron deficiency, but concerns have been raised about the safety of this treatment in the setting of chronic airways infection. the investigators are therefore planning a pilot interventional cohort study examining the effects of intravenous iron in a group of adults with cystic fibrosis. patients will be recruited in oxford and studied prospectively over 16 weeks, with iron given at week 4. the primary focus of this single-centre pilot/feasibility study is safety, specifically in relation to infection.

Eligibility criteria:
inclusion criteria: * age ≥18 years with established diagnosis of cystic fibrosis * iron deficiency (transferrin saturation ≤16 % or ferritin \<15 μg/l, within last 4 months) exclusion criteria: * urgent (\<6 weeks) need for iron supplementation * active infection (currently requiring iv antibiotics) * previous intravenous iron supplementation (within last 4 months) * current oral iron supplementation * hypersensitivity to ferric carboxymaltose * active non-tuberculous mycobacterial pulmonary disease (as defined by ats-idsa criteria) * liver failure * ferritin \>300 μg/l or transferrin saturation \>45% * pregnancy or breast feeding * previous transplantation * judged by member of trial team to be unlikely to comply with safety aspects of trial
evaluation of ventilation defects downstream of mucus plugs in patients with severe asthma

Conditions: Severe Asthma

Summary: in this study, xenon mri will be used to evaluate regional functional consequences of mucus plugs in the lungs of patients with severe asthma. mucus plugs will be identified using ct imaging, and xenon mri will be used to evaluate ventilation and gas exchange impairments in regions of the lungs corresponding to the airways downstream of mucus plugs.


Eligibility criteria:
inclusion criteria: * adequate completion of informed consent process with written documentation * patients 18 - 65 years old * physician diagnosis of asthma for \> 1 year * able to perform reproducible spirometry according to ats criteria based on clinical pfts. * blood eosinophil count \> 300 cells/μl and feno \>25ppb * smoking history \<10 pack years * no smoking history (including vapes, cigar, or marijuana use) in the last 3 months * approved for asthma therapy with either dupilumab, tezepelumab, or benralizumab as part of their standard of care exclusion criteria: * respiratory tract infection within the 4 weeks prior to visit 1 * body mass index (bmi) \> 30 at visit 1 * one-time doses such as intra-articular injections require a 4-week washout prior to visit 1 * asthma-related er visit within the previous 4 weeks of visit 1 * significant concomitant medical illness, including (but not limited to) heart disease, cancer, uncontrolled diabetes, other chronic lung diseases (determined by the investigator.) * resting o2 saturation \<90% with maximum supplemental o2 delivered by nasal canula * positive urine pregnancy test at visit 1 or at any time while on the study * participation in an intervention study (including bronchoscopy) or use of investigative drugs within the past 30 days or plans to enroll in such a trial during the study * unable or unlikely to complete study assessments in the opinion of the investigator * study intervention poses undue risk to patient in the opinion of the investigator * conditions that will prohibit mri scanning determined by the mri safety screening.

Keywords: xenon mri mucus plug severe asthma
combination chemotherapy for the treatment of indian kala-azar

Conditions: Visceral Leishmaniasis

Summary: the investigators are using a sequential design to combine miltefosine and ambisome in different doses.

in this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin b on first day followed by miltefosine. both the drugs will be used in different doses. reference arm will consist only a single dose of ambisome at 5 mg/kg. after the end of treatment, the post treatment assessment will be done on day 16 (initial cure) and six months (final cure). safety parameters will be evaluated on day 0, 8 and 16. an arm with an efficacy of less than 75% will be closed. there will be periodical assessment of study results after completion of 5 patients in each arm.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of active vl with consistent signs and symptoms (e.g., fever, splenomegaly). * confirmed diagnosis by bone-marrow or splenic aspirate smear showing characteristic amastigotes. * male or female. * ages 12 to 65 years. * both newly diagnosed cases and patients who have received previous treatment (in the latter case a 2-week wash-out will be required before starting the study treatment). * wbc \> 1,000/mm3. * hemoglobin ≥ 4 g/dl exclusion criteria: * pregnancy or breast-feeding. * hiv positive serology. * asat, alat, ap ≥ 3 times upper limit of normal range. * bilirubin ≥ 2 times upper limit of normal range. * prothrombin time ≥ 5 seconds above control. * serum creatinine or bun ≥ 1.5 times upper limit of normal range. * any medical condition or situation that compromises compliance with study procedures. * hiv

Keywords: visceral leishmaniasis miltefosine ambisome combination