Kornimate/medical-research-clean huggingface dataset:
a study of the effectiveness and safety of topiramate in the treatment of patients with bipolar disorder

Conditions: Bipolar Disorders; Mood Disorders; Affective Disorders, Psychotic

Summary: the primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with bipolar i disorder.

this is a randomized, double-blind, placebo-controlled study to evaluate the effectiveness of two dose levels of topiramate (400 and 600 milligrams/day) compared with placebo in the treatment of acute manic or mixed episodes in patients with bipolar i disorder. the trial consists of 3 phases: a screening period; double-blind treatment for 12 weeks; and an optional open-label period of at least 6 months. assessment of effectiveness include change from baseline to day 21 for the young mania rating scale (ymrs) total score. also included during the 12 week study are the global assessment scale (gas), montgomery-åsberg depression rating scale (madrs), brief psychiatric rating scale (bprs), clinical global impressions (cgi), and health-related quality of life measures at specified time intervals. safety assessments include evaluation of adverse events, rate of withdrawal from the study due to adverse events, and vital signs (blood pressure and pulse) throughout the study, as well as changes in clinical laboratory tests (hematology, biochemistry, urinalysis), electrocardiograms (ecgs), and physical examinations at specified times. the study hypothesis is that the change from baseline in young mania rating scale (ymsr) total score at day 21 will be significantly better for the topiramate groups than for the placebo group. topiramate tablets (50 or 100 milligrams) or placebo, beginning at 50mg daily and increasing over the first week to a maximum of 400mg/day or 600mg/day, depending on study group. maximum dosage continues up to 12 weeks. dosage can be decreased or increased at investigator's discretion.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar i disorder by criteria of diagnostic and statistical manual of mental diseases, 4th edition (dsm-iv), and currently experiencing a manic or mixed episode by dsm-iv and structured clinical interview criteria * experienced at least one previous manic or mixed episode * young mania rating scale (ymsr) score \>=20 * physically healthy * females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test. exclusion criteria: * diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence) by dsm-iv criteria * dsm-iv axis i diagnosis of schizoaffective disorder or impulse control disorder * experienced a manic episode while taking an antidepressant or psychostimulant drug * no significant and untreated or unstable medical illness of the liver, kidney, heart, lungs, or endocrine system * no hypersensitivity to topiramate or have previously participated in a topiramate study.

Keywords: topiramate bipolar disorders mood disorders manic state depression manic-depressive psychoses
radiogenomic and prognosis analysis in glioma

Conditions: Glioma

Summary: this study aims to evaluate whether mri can be used to predict genomics and prognosis in glioma. given the profound prognostic significance of genetic mutations seen in glioma, there have been increasing attempts to correlate imaging characteristics with genetic, mutational and expression patterns. to be able to predict genomics and prognosis based on imaging alone will prove useful in patients with involvement of glioma in delicate areas of the brain and better reflect tumor and molecular heterogeneity.

previous studies have proposed certain imaging characteristics correlating with genetic, molecular and expression patterns. advanced imaging provides additional clues but no studies have examined its added value particularly in a prospective setting. the investigator's aim to evaluate preoperative mri for patients suspected of glioma to predict idh mutation, 1p19q codeletion, mgmt methylation and egfr mutation status using imaging characteristics such as margin, patterns of contrast enhancement and edema as well as diffusion and perfusion characteristics. this will be confirmed pathologically and further correlated with patients' long term outcome.

Eligibility criteria:
inclusion criteria: * patients suspected of glioma undergoing mri examination prior to surgery * mri including advanced imaging such as cerebral blood volume, apparent diffusion coefficient and amide proton transfer imaging * signed informed consent exclusion criteria: * pathologic confirmation as tumors other than glioma * patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction * patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
effect of propofol on remifentanil-induced postoperative hyperalgesia in patients undergoing thyroid surgery

Conditions: Hyperalgesia

Summary: the investigators hypothesize that propofol infusion during surgery can affect the remifentanil hyperalgesia compared to sevoflurane inhalation.the outcome will be measured by a verbal numerical rating score (vnrs) and mechanical punctuating pain by electronic von frey filament.


Eligibility criteria:
inclusion criteria: * patients undergoing thyroidectomy * age 20-65 * american society of anesthesiologists physical status classification i or ii exclusion criteria: * history of chronic pain, regular use of analgesic, antiepileptic or antidepressive drugs * history of drug \& alcohol abuse * psychiatric disorder * use of opioids within 24hrs * renal disease with decreased glomerular filtrate ratio * neuromuscular disease, severe cardiac disease

Keywords: remifentanil hyperalgesia
community based treatment for (combat) glaucoma

Conditions: Glaucoma

Summary: the purpose of this research is to evaluate if intervention and education can change the behavior of someone's willingness to see an eye care provider to prevent blindness and glaucoma. the researchers are investigating if adding additional resources improves participant access to care.

outcome measures related to acceptability and feasibility are exploratory. they will not be registered or results reported.

Eligibility criteria:
inclusion criteria: * black or african american * participated in the screening examination portion of the study exclusion criteria: * current eye pain (\> 8 out of 10) * sudden decrease in vision (within 1 week) * double vision that doesn't stop when you blink and stops no matter what eye you cover (not blurred, but seeing 2 objects) * pregnant women * prisoners * cognitive impairment- unable to give an ocular and social history * moving outside of michigan or driving distance to the church within 6 months

Keywords: eye care care utilization community-based faith-based glaucoma
study to evaluate the safety, phage kinetics, and efficacy of inhaled ap-pa02 in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary pseudomonas aeruginosa infection

Conditions: Non-cystic Fibrosis Bronchiectasis; Pseudomonas Aeruginosa; Lung Infection

Summary: a phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled ap-pa02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary pseudomonas aeruginosa infection.

this study will be conducted in two cohorts running in parallel: cohort a will evaluate the safety, tolerability, and efficacy of inhaled ap-pa02 in subjects who have not received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. cohort b will evaluate the safety, tolerability, and efficacy of inhaled ap-pa02 in subjects who have received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. subjects in both cohorts a and b will be followed for approximately 4 weeks after last dose of study drug and evaluated for safety, tolerability, and efficacy.

Eligibility criteria:
key inclusion criteria: * ≥ 18 years old * body mass index (bmi) of ≥ 18 kg/m2 * evidence of bronchiectasis per ct * evidence of chronic pulmonary pseudomonas aeruginosa infection * willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate) * fev1 ≥ 35% of predicted normal \[per global lung function initiative (gli) standards\] at screening * for cohort a: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to visit 1 * for cohort b: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to visit 1 key exclusion criteria: * abnormal vital signs at screening * history of lung transplantation * history of cystic fibrosis * history of α1-antitrypsin deficiency * history of primary or acquired immunodeficiency syndromes * history of copd * history of pulmonary malignancy or any other malignancy requiring treatment * history of prolonged qt syndrome * history of hemoptysis * recent significant weight loss * recent use of supplemental oxygen during the day while at rest * recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vaping * recent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids * currently receiving treatment for active infection at any site * female pregnant of breastfeeding

Keywords: bacteriophage phage ncfb be pseudomonas pseudomonas aeruginosa
genotype-drive study of irinotecan-cisplatin combination for advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and irinotecan in advanced gastric cancer, and try to find out the optimal dosage of combination chemotherapy.

open label single arm phase ii study of cisplatin and irinotecan in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 40 patients will be enrolled in this local trial. the primary objective of this study is to determine the response rate of the treatment.schedule for this study is as follows: 8 cycles/14 days of irinotecan 125 mg/m2 on day 1 and cisplatin 50 mg/m2 on day2. this study will also include genotype investigations of ugt1a1 and ercc1 expression in order to assess determinants of efficacy and toxicity of the treatment with cisplatin and irinotecan in the study population.

Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of adenocarcinoma of the stomach (including adenocarcinoma of the gastroesophageal junction) * stage iii or stage iv disease, according to american joint committee on cancer criteria * patients with ugt1a1\*28 genotype 6/6 or 6/7 * performance status of 0-2 on the eastern cooperative oncology group (ecog) performance status scale * previous adjuvant or pre-operative chemotherapy without containing irinotecan or platinum at least 6 months before enrollment * adequate organ function including the following: bone marrow: absolute neutrophil count (anc) \>or equal to 1.5 \* 109/l, platelets \>or equal to 100 \*109/l, hemoglobin \> or equal to 10 g/dl. hepatic: bilirubin \ or equal to3g/dl. renal: calculated creatinine clearance major or equal to 60 ml/min (using the standard cockcroft-gault formula). exclusion criteria: * no prior palliative chemotherapy for advanced disease * previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). prior radiotherapy must be completed at least 30 days before study enrollment * known or suspected brain metastasis * second primary malignancy

Keywords: advanced gastric cancer irinotecan cisplatin
piloting a virtual navigation (vn) system for bronchoscopic lung nodule sampling

Conditions: Lung Cancer

Summary: the overall goal is to evaluate the role of a virtual navigation (vn) system (the virtual navigator) in the bronchoscopic evaluation and tissue sampling of lung cancer and other chest lesions at the penn state hershey medical center (hmc). the virtual navigator is a software package that runs on a mobile windows-based computer. the computer takes in up to four clinical image/video sources, ordered by the clinician for clinical purposes: 1) 3d ct (computed tomography) imaging scan; 2) 3d pet (positron emission tomography) imaging scan (optional); 3) bronchoscopic video of the airway tree interior; 4) ultrasound video of scanned anatomy outside the airways, as provided by an endobronchial ultrasound (ebus) probe (optional). during a live guided procedure, the virtual navigator presents images that assist with navigating the bronchoscope to predesignated chest lesions. lung cancer patients that present a suspicious peripheral tumor on their chest ct scan are often prescribed to undergo a diagnosis-and-staging bronchoscopy, whereby the bronchoscopist examines both the suspect tumor and any identified central-chest lymph nodes. for the clinical study, we consider bronchoscopy performance for two cohorts: 1) a cohort of consented patients who undergo image-guided bronchoscopy via the virtual navigator; and 2) a historical controls cohort consisting of patients who underwent bronchoscopy recently at our medical center (state-of-the-art bronchoscopy practice). the study's general hypothesis is that an image-guided bronchoscopy system (the virtual navigator) that integrates 3d imaging, bronchoscopy, and ebus images enables more complete evaluation and sampling of chest lesions than current state-of-the-art clinical techniques. more specifically, for peripheral-tumor diagnosis, the sub-hypothesis is that the vn system increases diagnostic biopsy yield as compared to state-of-the-art bronchoscopy practice; for central-chest nodal staging, the sub-hypothesis is that the vn system enables the sampling of more lymph nodes than state-of-the-art bronchoscopy practice.


Eligibility criteria:
inclusion criteria: * patients from age 18 and over * a planned clinical bronchoscopy to evaluate abnormal lung parenchyma and/or central chest lymph nodes * a clinical ct scan performed at hershey medical center that meets technical specifications and is available on the radiology research server * (optional, use if available) ct/pet images that meet technical specifications and are available on the hershey medical center clinical image storage system exclusion criteria: * inability to give consent * the ct scan does not meet technical specifications

Keywords: bronchoscopy computer-assisted surgery image-guided surgery surgical navigation image-guided biopsy multimodal imaging
tumor perfusion and hypoxia assessed by dce-mri and 18f-fmiso pet as biomarkers of treatment response in cervical cancer

Conditions: Cervical Cancer

Summary: this study is to assess how patients respond to their treatment for cervical cancer. this research does not involve a specific treatment for the cancer that will be recommended by the doctor and may include radiation therapy and/or chemotherapy. this is a separate research imaging study designed to assess how patients respond to their treatment for cervical cancer.


Eligibility criteria:
inclusion criteria: * biopsy-documented, newly-diagnosed primary cervical cancer of all histopathology types. * clinically visible gross lesion (international federation of gynecology and obstetrics (figo) stage ib1 and above). * treatment (chemoradiation), dce-mri and 18f-fmiso pet studies will be at mskcc. * patients must be an adult female 18 years of age or older. exclusion criteria: * patients who because of general medical or psychiatric condition, or physiologic status cannot give an informed consent. * patients who received prior radiation treatment to pelvis. * patients with contraindications to dce-mri (non-compatible cardiac pacemakers or intracranial vascular clips, allergy to gadolinium, end-stage renal disease) and/or 18f-fmiso pet. * patients who do not fulfill the screening criteria for safe dce-mri or 18f-fmiso pet as per the department of radiology guidelines. * pregnant patients; and or patients who are breast-feeding their babies.

Keywords: dce-mri 18f-fmiso pet 11-174
powered vascular stapler in video-assisted thoracoscopic (vat) lobectomies

Conditions: Non Small Cell Lung Cancer

Summary: this prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current standard of care stapler (for pulmonary artery/pulmonary vein transection) and powered vascular stapler.


Eligibility criteria:
inclusion criteria: * subjects with a confirmed or suspected diagnosis of stage ia to stage iiia non-small cell lung cancer scheduled for a lobectomy (lung cancer staging per american joint committee on cancer,7th edition)5; * subjects scheduled for vats lobectomy in accordance with their institution's standard of care; * performance status 0-1 (eastern cooperative oncology group classification); * american society of anesthesiologists (asa) score \</= 3; * no prior history of vat or open lung surgery (on the lung in which the procedure will be performed); * willing to give consent and comply with study-related evaluation and treatment schedule; and * at least 18 years of age. exclusion criteria * prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment); * pregnancy; * physical or psychological condition which would impair study participation; or * the subject is judged unsuitable for study participation by the investigator for any other reason.
aquatic therapy for asd

Conditions: Autism Spectrum Disorder

Summary: this is an aquatic occupational therapy group for children between the ages of 3-12 that have an autism diagnosis. intervention will focus on increasing the child's safety swim skills.

information will be collected from participants' guardians during an intake visit regarding a child's sensory processing deficits, movement abilities and exposure to swim skill instruction prior to the group. the group will provide swim instruction using the halliwick approach to learning swim skills as well as other occupational therapy techniques such as shaping, therapeutic relationship and behavior management. groups will have a minimum ratio of 1 staff to every 2 children, with the possibility of 1:1 ratio most days. there will be a certified lifeguard present at all times. qualitative interviews and a follow up survey will be conducted with parents (ages 18+) to determine impact on families and individual participants. swim skills will be tracked at each session via goal attainment scaling and daily documentation. descriptive and correlational statistics will be completed as well as coding of interview and survey data. participants can participate for one, 10 week session, or will have the option to participate in additional 10 week sessions until child participants top out on the wota or plateau in progress of swim skills.

Eligibility criteria:
inclusion criteria: * pre-existing diagnosis of autism spectrum disorder from a medical professional * family interest in swimming exclusion criteria: * ventilation system for breathing such as trachea not capped
retrospective study evaluating the contribution of rheopheresis in the treatment of uremic calciphylaxis (rheo-cua)

Conditions: Rheopheresis; Calcifying Uremic Arteriolopathy; Uremic Calciphylaxis

Summary: calcifying uremic arteriolopathy (or uremic calciphylaxis) is a rare disease (prevalence \<1% of dialysis patients), but the prognosis is often catastrophic. the main non-modifiable risk factors are age, female gender, diabetes, obesity and length of time on dialysis. today, there is no specific treatment for this pathology, and the therapeutic management is poorly codified. however, it is commonly accepted that the treatment is based on the control of risk factors, local care, and the possible addition of treatment with sodium thiosulfate. hyperbaric oxygen therapy has also been proposed by some authors, but remains not very accessible in practice. recently, it has been proposed to use rheopheresis as an adjuvant treatment for severe forms of uraemic calciphylaxis. it is a technique of apheresis in double filtration, allowing the extraction of molecules of high molecular weight, and thus the improvement of the rheological conditions of microcirculation. the expected effect is the improvement of tissue oxygenation and the acceleration of the healing of skin lesions, with the consequent reduction of infectious complications. the aim of this study is to propose a large national retrospective study, studying the evolution of patients with uremic calciphylaxis and treated by rheopheresis, compared to a control group. this will allow to have a more precise idea of the contribution of rheopheresis in this indication.


Eligibility criteria:
inclusion criteria: * adult patient * chronic hemodialysis * uraemic calciphylaxis (clinical or histological diagnosis) diagnosed between january 2010 and december 2022, * rheopheresis treatment initiated within one month of calciphylaxis diagnosis (for the exposed group) * patient informed and not opposed to the use of their health data. exclusion criteria: * minor patient, * advanced cognitive disorders.