Kornimate/medical-research-clean huggingface dataset:
improving pancreas radiotherapy plans using respiration-driven anatomic deformation: a pilot study

Conditions: Pancreatic Cancer

Summary: the overall aim of this study is to investigate a novel "dual instance" planning method to make use of the respiratory motion to improve pancreatic radiation therapy (rt) treatment planning. specific aim 1: acquire patient abdominal mri and ct at both deep inspiration (insp) and expiration (exp) positions and characterize the changes in geometric relationships between the insp and exp instances for tumor and normal tissues including stomach, duodenum and bowel. we hypothesize that insp and exp mri and ct characterization will allow identification of patients who may benefit from the dual instance planning method. specific aim 2: develop, investigate and evaluate plans based on free breathing, single instance breath hold, and the novel dual instance anatomical information. we hypothesize that use of the dual instance method will lead to improved plans, demonstrated by the ability to increase dose to the target, while maintaining the clinically-accepted normal tissue dose constraints.


Eligibility criteria:
inclusion criteria: * any patient with a biopsy proven diagnosis of malignancy involving the pancreas to be treated with radiation therapy * age \>18 years * ability to understand and the willingness to sign a written informed consent document * creatinine or creatinine clearance of \ 45 ml/min/1.73m2 for patients with creatinine levels above normal. modification of diet in renal disease (mdrd) formula was used to calculate the creatinine level exclusion criteria: * patients who are currently receiving any investigational agents * unable to undergo mris * patients with late stage kidney disease or who have had a liver transplant * individuals who are allergic to animal dander or have asthma that may be enflamed by proximity to animals will be excluded as the scans will take place in a facility where animal research is also performed.

Keywords: pancreatic malignancy radiation therapy
prevalence and clinical spectrum of the 22q11 deletion

Conditions: Congenital Disorders

Summary: the purpose of this project is to conduct population based surveillance for prenatally diagnosed congenital defects amount residents of the five counties to: improve the comprehensiveness of the metropolitan atlanta congenital defects program (macdp) to (1) better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and elective termination on the birth prevalence of congenital defects in atlanta (3) develop a registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in evaluation prevention programs and in monitoring prenatal diagnostic technology.

since 1967, the centers for disease control and prevention (cdc) has conducted surveillance of birth defects in metropolitan atlanta through review of hospital delivery and newborn medical records and records from various other medical sources in the five central counties of the metropolitan area (clayton, cobb, dekalk, fulton and gwinnett, and has been expanded to include prenatal records. the project was begun n the aftermath of thalidomide and rubella epidemics as a kind of early-warning system for new or resurgent teratogens. the voluntary participation of atlanta hospitals was sought and obtained at the inception of the system (the original system was a joint effort of the cdc, the georgia institute of mental health and emory university). a case must be diagnosed by the child's sixth birthday or within six years of the date of elective termination. children's healthcare is one retrospective source of medical records reviewed for discharge summaries and disease indices.

Eligibility criteria:
inclusion criteria: * birth defect diagnosed by the child's sixth birthday * birth defect diagnosed within 6 years of the elective date of termination exclusion criteria: * those who do not meet inclusion criteria

Keywords: infant prenatal birth defects 22q11 deletion
metabolic effects of endogenous bile acids after gastric bypass surgery

Conditions: Bariatric Surgery Candidate; Bile Acid, Elevated Serum; Glucose Metabolism Disorders

Summary: non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (fgf-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (rygb).

the study design consists of 4 study visits, two performed before (v1 at day -7 and v2 at day 0 relative to initiation colesevelam treatment) and two after approximately 8 weeks of colesevelam treatment (v3 at day 49 and v4 at day 56). biometrics, fasting blood samples and a standard mixed meal test are performed at v2 and v4. 75se-hcat scintigraphy is carried out between v1 to v2 and v3 to v4, respectively. between v2 and v3 the subjects will have two telephone calls and one visit at the endocrine research unit for fasting blood samples to make sure they do not experience any adverse events and are compliant. the control groups will only participate in v1 and v2. the aim with the control groups is to have baseline values for unoperated subjects with and without diabetes to compare with the values in the intervention group after 8 weeks of depletion of endogenous bile acids.

Eligibility criteria:
inclusion criteria: intervention group * rygb-operated ≥ 18 months prior to inclusion * history of diabetes prior to rygb (hba1c ≥48 mmol/mol or use of antidiabetic medication) * hba1c \<58 mmol/mol on no antidiabetic medication or metformin alone * weight change \ 3 months at time of inclusion control group a * no history of diabetes * hba1c \<48 mmol/mol at time of inclusion * fasting plasma glucose \< 7.0 mmol/l at time of inclusion * weight change \ 3 months at time of inclusion control group b * type 2 diabetes (hba1c ≥48 mmol/mol or use of antidiabetic medication at time of inclusion) * weight change \ 3 months at time of inclusion exclusion criteria: * pregnancy or breastfeeding * haemoglobin \< 6.5 mmol/l at time of inclusion * fasting plasma glucose \> 10.0 mmol/l at time of inclusion * prior cholecystectomy * chronic or tendency to diarrhoea
duke activity score index in obese individuals

Conditions: Obesity, Morbid

Summary: today, obesity is a global health problem and can lead to serious health complications. bariatric surgery is recognized as an effective treatment option to achieve long-term weight loss and health improvement in overweight or obese individuals. however, appropriate tools are needed to assess the physical activity levels of patients before and after bariatric surgery and to guide rehabilitation processes after surgery. the duke activity index (dai) is a scale used to assess activities of daily living and was developed at duke university medical center. the dai has been widely used to determine patients' physical functioning and monitor their activity levels in various health conditions and post-surgical recovery processes. the aim of this study was to evaluate the psychometric properties of the dai and to examine whether it is an effective tool for determining physical activity levels in patients who are candidates for bariatric surgery.


Eligibility criteria:
inclusion criteria: * body mass index higher than 30 * no disease that may affect functional performance * able to adapt to the tests to be applied exclusion criteria: * recently hospitalized due to a condition that may make it difficult to perform the test * inability to perform exercise tests due to neurological or musculoskeletal disorders * uncontrollable medical conditions (such as lung or cardiovascular disease) * dysfunction of the vestibular system or eyes
right ventricular hypertrophy after atrial switch and cardiovascular magnetic resonance (cmr) findings

Conditions: Right Ventricular Hypertrophy; d-TGA

Summary: systemic rv hypertrophy and impaired systolic function occur after atrial switch (as) in d-transposition of the great arteries (d-tga). echocardiography has limitation in the assessment of the right ventricle (rv). in this study the investigators sought to evaluate systemic rv myocardial mass and function after as for d-tga and to analyze the role of excessive hypertrophy for ventricular function under special consideration of the interventricular septal (ivs) movement.


Eligibility criteria:
inclusion criteria: * eligibility criteria were an as operation in childhood for correction of d-tga and the absence of associated hemodynamically significant heart defects. exclusion criteria: * exclusion criteria were usual cmr contraindications such as ferromagnetic metallic implants.

Keywords: d-tga dextro transposition of the great arteries systemic right ventricle right ventricular failure atrial switch procedure
platelet reactivity after cabg

Conditions: Acute Coronary Syndrome

Summary: patients who have a heart attack are regularly treated with either clopidogrel or ticagrelor. in a large clinical trial, treatment with ticagrelor before coronary bypass surgery (cabg) was associated with a lower risk of death than treatment with clopidogrel. the reason for this difference cannot be explained on the basis of the study. one possible explanation is that the reversible binding of ticagrelor is advantageous because when new platelets are released, they are inhibited by the drug. because clopidogrel binds irreversibly it cannot redistribute. the investigators will recruit patients who are scheduled for surgery after an acute coronary syndrome who have been treated with either ticagrelor or clopidogrel. after the patient provides informed consent, the investigators will review their medical record,record information and on the day after surgery the investigators will take one sample of blood. that blood will be analyzed for evidence of platelet activation (platelet microparticles, and platelet-leukocyte aggregates), the reactivity of young platelets, and the concentration of inflammatory cytokines. the investigators hypothesize that the evidence of platelet activation (platelet microparticles and platelet-leukocyte aggregates) and the reactivity of young platelets will be less in patients who have been treated previously with ticagrelor.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome, cabg, within 48 hours of last dose of clopidogrel or ticagrelor, treatment with aspirin exclusion criteria: * treatment with an antiplatelet agent other than aspirin, clopidogrel, or ticagrelor, acute or chronic hematologic disorder including a preoperative hgb less than 10 g/dl or platelet count less than 100,000/mm3, moderate or severe renal insufficiency (glomerular filtration rate less than 60 ml/min), active infection, active malignancy, unable/unwilling to provide informed consent

Keywords: ticagrelor coronary artery bypass surgery platelet function receptor binding platelet reactivity reversible binding
evaluation of artesunate-mefloquine as a novel alternative treatment for schistosomiasis in african children

Conditions: Schistosoma Haematobium; Schistosoma Mansoni

Summary: the schistosam study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern senegal. the study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (am) is respectively similar to or higher than that of a standard praziquantel (pzq) treatment. secondly, the study will assess if novel dna- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response.

the schistosam study is an open label, two-arm, individually-randomized controlled trial with a non-inferiority design, conducted in northern senegal. the study aims at determining if the efficacy of one and of repeated courses of artesunate-mefloquine (am) is respectively similar to or higher than that of a standard praziquantel (pzq) treatment. secondly, the study will assess if novel dna- and antigen-based diagnostics are more accurate than microscopy in assessing antischistosomal treatment response. for this purpose, 726 school children, aged 6-14 years old and infected with schistosoma (as demonstrated by presence of eggs in stool and/or urine) will be randomized in one of the following arms: 1. am, available in fixed dose tablets of 25/50 mg and 100/200 mg will be administered once daily for three days in a dose closest to 4 mg/kg artesunate and 8 mg/kg mefloquine. this treatment course will be repeated 2 times at 6-week intervals. 2. pzq, available in tablets of 600 mg, will be administered as a single dose of 40 mg/kg. trial participants will be regularly followed-up: 1. at each dose administration 2. at day 7 after each dose for follow-up of safety 3. at week 4, 10 and 16 for parasitological assessment and follow-up of safety 4. at week 6 and 12 for clinical assessment before the second and third drug administration (only in the am arm) 5. at week 24 and 48 for assessment of schistosoma spp. and malaria infection and associated morbidity (compared to baseline)

Eligibility criteria:
inclusion criteria: 1. children ≥6 and ≤14 years of age 2. enrolled in one of the selected primary schools in the region 3. infected with schistosomiasis (i.e. schistosoma spp. eggs in urine and/or stool) 4. informed consent from parents/guardians signed exclusion criteria: 1. history of, or ongoing, epilepsy or psychiatric illness (i.e. recent history of depression, generalized anxiety disorder; history of psychosis, schizophrenia or other major psychiatric disorders) or known hypersensitivity to one of the three study drugs 2. chronic medication for any reason 3. any severe underlying illness, including severe malnutrition or severe chronic schistosomiasis, based on clinical judgement 4. any febrile illness 5. exposure to pzq or act within the three previous months.

Keywords: schistosoma schistosomiasis senegal praziquantel artesunate mefloquine
trial of novoseven® in haemophilia - joint bleeds

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this trial is conducted in the united states of america (usa). this study compares the effectiveness and safety of novoseven® to feiba (feiba vh) in haemophilia patients with inhibitors being treated for joint bleeds.


Eligibility criteria:
inclusion criteria: * diagnosis of hemophilia a or b with inhibitors to factor viii or ix, respectively
new treatment perspectives in eating disorders: the efficacy of non-invasive brain-directed treatment

Conditions: Eating Disorders; Binge Eating Disorder; Anorexia Nervosa

Summary: the present study grounds on the possible role of hemispheric lateralization in eating disorders (ed): specifically, hyperactivity of the right frontal regions in anorexia nervosa (an), and hypoactivity of the right frontal regions in binge eating disorder (bed) and food craving behaviors. therefore, the investigators hypothesized that active excitatory tdcs over left prefrontal cortex (pfc) (anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in an patients, re-establish control over eating behaviors. on the contrary, active excitatory tdcs over right pfc (anode right/cathode left) may aid in altering/resetting inter-hemispheric balance in bed patients and people with frequent food cravings, decreasing cravings/appetite binge eating behaviors.

the study design is randomized stratified, double blind, add-on, placebo-controlled. a group of children and adolescents with an will be selected and randomly assigned to two different conditions: treatment "as usual" plus experimental treatment (active tdcs); treatment "as usual" plus placebo treatment (sham tdcs). similarly, a group of children and adolescents with over-weight/obesity (ow/ob) and bed will be selected and assigned with randomized stratified sampling to the following conditions: treatment "as usual" plus experimental treatment (active tdcs); treatment "as usual" plus placebo treatment (sham tdcs). in this project, the investigators will work to understand whether a brain-based treatment, with the use of tdcs, can improve the outcome of patients with eating disorders. the investigators will test whether tdcs treatment produces improvements in under-eating and over-eating diseases, such us an and ow/ob with bed and food craving. our overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ed.

Eligibility criteria:
inclusion criteria: * under-weight (bmi less than 5th percentile)1 with clinical diagnosis of an as described in the 5th edition of the diagnostic and statistical manual of mental disorders (dsm-5) * over-weight/obesity (ow/ob) (bmi above the 85th percentile)1 with diagnosis of bed, or with food craving behaviors * ability to give informed consent under parents' surveillance and guidance exclusion criteria: * having a comorbidity with an important medical condition; * having neurological diseases * having epilepsy o family history of epilepsy * pregnant or planning to become pregnant; * suicide risk; * receiving counseling or psychological therapies during the study; * receiving a treatment for an eating disorder in the previous three months before the baseline screening visit.
photodynamic therapy using hpph in treating patients with recurrent dysplasia, carcinoma in situ, or stage i oral cavity cancer

Conditions: Head and Neck Cancer

Summary: rationale: photodynamic therapy uses a drug, such as hpph, that is absorbed by tumor cells. the drug becomes active when it is exposed to light. when the drug is active, tumor cells are killed. purpose: this phase i trial is studying the side effects and best dose of photodynamic therapy using hpph in treating patients with recurrent dysplasia, carcinoma in situ, or stage i oral cavity cancer.

objectives: primary * to determine the maximum tolerated dose in the oral cavity of photodynamic therapy (pdt) using hpph and 665 nm light in patients with recurrent dysplasia, carcinoma in situ, or stage i squamous cell carcinoma of the oral cavity. secondary * to determine response of dysplasia, carcinoma in situ, and selected patients with t1 squamous cell carcinoma of the oral cavity using pdt with hpph and 665 nm light. outline: this is a dose-escalation study of laser light dose therapy. patients receive hpph iv over 1 hour on day 1. approximately 24 hours after receiving hpph, patients undergo laser light treatment to the tumor bed on day 2. patients with multicentric or large area confluent disease receive a second course of treatment at least 8 weeks later for lesions untreated at the first treatment session. after completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and periodically thereafter.

Eligibility criteria:
disease characteristics: * biopsy-confirmed diagnosis of 1 of the following: * mild to severe dysplasia * carcinoma in situ (cis) of the oral cavity * carcinoma must be less than 3mm thick * stage i (t1) squamous cell carcinoma of the oral cavity * recurrent or primary disease * no t2 or greater squamous cell carcinoma, exophytic cis, or dysplasia lesions patient characteristics: * ecog performance status 0-2 * total bilirubin ≤ 2.0 mg/dl * creatinine ≤ 2.0 mg/dl * alkaline phosphatase ≤ 3 times the upper limit of normal (uln) * sgot ≤ 3 times uln * not pregnant * fertile patients must use effective contraception * no porphyria or hypersensitivity to porphyrin or porphyrin-like compounds prior concurrent therapy: * prior therapy of any type allowed * more than 4 weeks since prior and no concurrent chemotherapy or radiotherapy

Keywords: stage i squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage 0 lip and oral cavity cancer
analgesic efficacy and safety of tanezumab added on to diclofenac sr in patients with osteoarthritis of the knee or hip

Conditions: Osteoarthritis

Summary: the purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac sr in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.

this study was terminated on 16 nov 2010 following a us fda clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 june 2010 for potential safety issues.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee or hip according to acr criteria with kellgren-lawrence x-ray grade equal to, or greater than, 2. * patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen. * pain and function levels as required by the protocol at screening and baseline. * willing to discontinue all non-study pain medications throughout the study except as permitted per protocol. * willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures. exclusion criteria: * pregnant women. * bmi greater than 39. * history of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (ra), joint infections, neuropathic disorders, avascular necrosis, paget's disease or tumors. * fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with oa. * signs and symptoms of clinically significant cardiac disease within 6 months prior to screening. * diagnosis or tia within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities. * history, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder. * at screening: uncontrolled hypertension, hemoglobin a1c greater than or equal to 10%, alt or ast greater than or equal to 3x upper limit of normal, creatinine exceeding 150 micro-mol/l in men or 133 micro-mol/l in women. * patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening. * known hypersensitivity to nsaids (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).

Keywords: arthritis monoclonal antibody nerve growth factor (ngf) anti-ngf tanezumab pf-04383119 rn-624 oa