Kornimate/medical-research-clean huggingface dataset:
recommendations for the treatment of children with burkitt's lymphoma

Conditions: Burkitt Lymphoma

Summary: this is the 4th lmb study by the french african pediatric oncology group (gfaop). the study hopes to be able to evaluate children earlier with stage i and ii disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage iv disease.

this is the 4th burkitt's lymphoma (lmb) study by the gfaop group. this study hopes to include at least 14 sub saharian countries some of whom have never participated in a lmb study. the evaluation of improvement in early diagnosis should be possible in this study. the study hopes to be able to evaluate children earlier, with stage i and ii disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for children with a stage iv disease.

Eligibility criteria:
inclusion criteria: clinical diagnosis of burkitt's lymphoma: all location. diagnosis by cytology or histology. not possible to follow all the treatment. - exclusion criteria: not a b cell tumor. child has been previously treated. child has also another illness which would render the treatment incompatible. parents refusal.
assesment of retinal nerve fiber layer in first episode depressive patients using selective serotonin reuptake inhibitor

Conditions: Unipolar Depression

Summary: the aim of this study is to assess the changes in retinal nerve fiber layer due to ssri treatment in first-attack major depressive patients.

selective serotonin reuptake inhibitors (ssris) are among the most used and safe antidepressant drugs in the world. in previous studies, ssris have been found to cause an increase in brain gray matter volume in patients with major depression (md). optical coherence tomography (oct) is a non-invasive medical imaging method that displays biological tissue layers by taking high-resolution tomographic sections. changes in the thickness of the retinal nerve fiber layer (rnfl), a layer of the ganglion cell complex in the retinal layer of the eye and composed of ganglion cell axons, occur due to axonal damage in the retinal nerve tissue. since rnfl is similar to brain gray matter tissue, recently neurological and psychiatric studies have been conducted to provide data on the neurodegeneration that occurs in the brain by oct. however, in a recent cross-sectional study, contrary to what was expected, thinning of the retinal nerve fiber layer was detected in psychiatric patients using ssri drugs compared to the healthy group, and this was attributed to a probable maculopathy caused by ssris in the eye. in this study, it is aimed to assess the probable cortical volume changes of the patients by measuring the changes in retinal nerve layers due to ssri treatment in first-attack md patients.

Eligibility criteria:
inclusion criteria: * first attack depressive patients between 18 and 65 years * diagnosed with the structured clinical interview for diagnostic and statistical manual of mental disorders 5 / clinical version (scid-5 / cv) * started to be treated with selective serotonin reuptake inhibitors * having a standardized mini mental test (smmt) score of 24 or more and * healthy subjects with no psychiatric history, having a scl-90-r (gsi) score of less than 1.0 exclusion criteria: * depressive subjects with any neurological (cerebrovascular disease, head trauma, intracranial mass, dementia, epilepsy, multiple sclerosis, etc.) or general medical (such as diabetes, hypertension, myocardial infarction, etc.) diagnosis, with an ocular surgery or a history of ocular trauma, retinal pathology (detachment, etc.), other eye pathologies such as optic nerve neuropathy and refractive error, previous history of antidepressant drug use, alcohol-substance abuse or addiction, * healthy individuals with a history of psychiatric diagnosis or a scl-90-r (gsi) score of 1.0 or above

Keywords: unipolar depression optical coherence tomography retinal nerve fiber layer selective serotonin reuptake inhibitor
clinical evaluation of a novel wearable compression technology in the treatment of lymphedema, an open-label controlled study

Conditions: Breast Cancer Related Lymphedema; Lymphedema of Upper Arm; Lymphedema; Quality of Life

Summary: an open-label study to clinically assess a novel wearable advanced compression technology (dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. the dayspring™ device is a novel fda-cleared wearable solution that is portable and easy-to-use sequential compression system. the following endpoints are examined: 1. improvement in qol in subject with upper-extremity edema after 28 days as measured by the lymqol disease-specific validated assessment tool. 2. arm volume maintenance or improvement as measured prior to and after 28 days of device use. 3. safety as assessed by reported adverse events 4. patient satisfaction as measured by visual analog scale (vas) and survey at the end of the study; and 5. adherence to therapy as measured with a smart phone app.


Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age * willing to sign the informed consent and deemed capable of following the study protocol * subjects must have a diagnosis of primary or secondary unilateral or bilateral upper extremity edema exclusion criteria: * individuals with a history or presence of a systemic disorder or condition that could place the patient at increased risk from sequential compression therapy * inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent * patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) * diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer * diagnosis of acute infection (in the last two weeks) * diagnosis of acute thrombophlebitis (in last 2 months) * diagnosis of peripheral arterial disease (pad): pad is defined as an ankle brachial index (abi), of 0.7 or lower * diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months * diagnosis of pulmonary edema * diagnosis of congestive heart failure (uncontrolled) * diagnosis of chronic kidney disease * diagnosis of epilepsy * patients with poorly controlled asthma * any condition where increased venous and lymphatic return is undesirable * women who are pregnant, planning a pregnancy or nursing at study entry * participation in any clinical trial of an investigational substance or device during the past 30 days
collect and assess tissue samples from subjects with hematologic malignancy

Conditions: Acute Myelogenous Leukemia; Multiple Myeloma; Myelodysplastic Syndromes; Lymphoma; Acute Lymphoblastic Leukemia; Chronic Myelogenous Leukemia; Myeloproliferative Neoplasm

Summary: this is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the notable assay platform and clinical outcome.

this is a prospective, multicenter, observational study with collection of de-identified biospecimens with matched clinical data from up to 1000 participants from clinical networks in the united states and canada. clinical information, demographics, and medical data relevant to cancer status are collected from all participants and their medical record at baseline (at study entry and time of baseline biospecimen collection), and subsequent visits per patient consent, for up to 1 year. the primary assessment is the establishment of a tumor registry with annotated clinical outcomes. exploratory assessments include correlation of ex vivo functional testing results with clinical outcomes, as well as identification of potential biomarkers that correlate responses with genotype and/or phenotype.

Eligibility criteria:
inclusion criteria: * provide written informed consent; * age ≥ 18 years, male or female, of any race; * documented hematologic malignancy (any of the below) in need of starting an active anti-cancer therapy: * acute myelogenous leukemia (aml) * multiple myeloma (mm) * myelodysplastic syndrome (mds) * lymphoma * acute lymphocytic leukemia (all) * chronic lymphocytic leukemia (cll) * chronic myelogenous leukemia (cml) * neoplasm (mpn) * other (upon review and approval by medical monitor) note: \*supportive care agents including erythropoiesis-stimulating agents (esas) such as epo, procrit, aranesp, etc; granulocyte colony stimulating factor (g-csf); hydroxyurea (hydrea); and luspatercept (reblozyl) are not considered anti-cancer therapy for this study * intent to start anti-cancer therapy within 21 days of biospecimen collection •≥7 days from last anti-cancer therapy; * any number of prior therapies * subject cohort is currently open exclusion criteria: * unwilling or unable to give consent * subject's disease is in remission * subject cohort is not open at time of consent * subject is restarting an ongoing treatment regimen after a dose interruption
progress trial - prophylactic gabapentin for relief of symptoms and improved swallowing

Conditions: Oropharyngeal Cancer; HPV-Related Squamous Cell Carcinoma

Summary: enrollment is only available to patients enrolled on the optima ii study (nct03107182). the purpose of this trial is to compare rates of opioid use at completion of radiation for patients with common terminology criteria for adverse events (ctcae) grade ≥ 2 oral mucositis after receiving definitive nonoperative locoregional therapy with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, hpv-related oropharyngeal cancer. secondary purposes include comparison of total equivalent opioid dosage above baseline opioid use at end of treatment, quality of life metrics, swallowing function, feeding tube dependence, and protocol compliance in patients managed with best support care with or without prophylactic gabapentin. rates of gabapentin-related side effects and discontinuation will also be investigated.

enrollment is only available to patients enrolled on the optima ii study (nct03107182). primary objective: to compare rates of opioid requirement as a function of supportive care in patients experiencing ctcae grade ≥2 oral mucositis at completion of radiation or chemoradiation as part of optima ii secondary objectives: to compare total opioid equivalent dose above baseline opioid requirement at end of radiation, quality of life metrics, swallowing function, feeding-tube dependence, and protocol compliance in patients managed with best supportive care with or without prophylactic gabapentin. to investigate rates of gabapentin-related toxicity and discontinuation for patients treated on protocol.

Eligibility criteria:
inclusion criteria: * enrollment to optima ii trial (nct03107182) exclusion criteria: * ineligible for enrollment to optima ii trial (nct03107182) * prior gabapentin therapy * creatinine clearance of \< 45 ml/minute * documented intolerance, allergy, or hypersensitivity to gabapentin * hemodialysis or peritoneal dialysis

Keywords: hpv-related oropharyngeal cancer oropharyngeal cancer hpv-related squamous cell carcinoma prophylactic gabapentin optima ii study
ga-dotatate pet for phosphaturic mesenchymal tumors in patients with tumor induced osteomalacia

Conditions: Osteomalacia

Summary: the researchers are trying to evaluate a newer imaging technique (ga-dotatate pet/ct) to see if it is more sensitive to localize the source of the hormone, which has caused the low phosphate levels.

subjects will be contacted (phone script attached) to inform them of the study and the imaging modality. the first 10 patients that agree to participate in the study will be asked to present to the mayo clinic where they can provide a written consent and perform the imaging study. enrolled subjects will be evaluated in the clinical practice prior to having 68ga-dotatate pet/ct imaging performed. the treating endocrinologist will be informed of the imaging results and will review the results with the subject using a follow-up visit or phone call; when a tumor is localized, the endocrinologist will discuss appropriate management options. subjects will be follow for one year post 68ga-dotatate pet/ct.

Eligibility criteria:
inclusion criteria: * adults (18 years of age or older) seen at mayo clinic, rochester for fgf23 mediated osteomalacia between 1/1/2000 and 1/30/2018 who provide informed consent to participate in the study. exclusion criteria: * pregnant * prisoners * subjects diagnosed with heritable hypophosphatemic rickets/osteomalacia * subjects who do not consent for the study or withdraw consent during the duration of the study. * subjects in whom tumor localization and successful resection has already occurred.

Keywords: fgf 23 oncogenic tumor induced
intraocular pressure (iop) lowering efficacy of transdermal latanoprost therapy

Conditions: Glaucoma

Summary: the purpose of this study is to evaluate the safety and effectiveness in lowering intraocular pressure (iop) utilizing an experimental lotion containing 0.005% latanoprost that is applied to the outside of one eyelid.

glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma the most common form of glaucoma. vision loss is caused by damage to the optic nerve. the modern goals of glaucoma management are to avoid glaucomatous damage, nerve damage, preserve visual field and total quality of life for patients with minimal side effects. although intraocular pressure is only one of the major risk factors for glaucoma, lowering it via various pharmaceuticals and/or surgical techniques is currently the mainstay of glaucoma treatment. intraocular pressure can be lowered with medication, usually eye drops. there are several different classes of medications to treat glaucoma with several different medications in each class. in order to prevent blindness from glaucoma, it is critical that patients take their glaucoma eye drops accurately and faithfully for the rest of their lives. poor compliance with medications and follow-up visits is a major reason for vision loss in glaucoma patients. in addition, coordination involved in placing an eye drop in the eye is considerably more difficult and unpleasant to patients than many other therapies. thus, localized transdermal eyelid lotion would create a leap in safety of drug delivery while at the same time rendering ocular drugs easy and non traumatic to use.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of stable chronic open angle glaucoma and stable vital signs who are controlled on a stable dose of a single iop lowering agent and who have demonstrated stable target intraocular pressure for a minimum of 3 months. * male or female patients aged at least 18 years of age. * females of childbearing potential must use a reliable form of contraception throughout the study period such as celibacy, birth control pills, or condoms. * a negative urine pregnancy test result at screening and baseline (day 1) for women of childbearing potential. * best-corrected visual acuity of 20/800 or better in both eyes * written informed consent. * ability to follow instructions and likely to complete all study visits based upon patient factors such as cognition, reliability, motivation, and ability to obtain reliable transportation to study site. exclusion criteria: * uncontrolled glaucoma * glaucoma requiring more than a single agent for iop control * patients with a corneal thickness greater then 620 micrometers * female patients who are pregnant, nursing, or planning a pregnancy during the study * patient who has any situation or condition, which in the investigator's opinion, may put the patient at a significant risk, may confound the study result or may interfere significantly with the participation in the study * active intraocular inflammation * cystoid macular edema

Keywords: glaucoma xalatan transdermal
trial of an injectable biologic and u0279 as combination therapy for severe plaque-type psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of the study is to assess the safety and efficacy of an injectable biologic and u0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis.

the study is being conducted in order to obtain safety and efficacy data for an injectable biologic and u0279 as combination therapy compared to that of an injectable biologic alone for severe plaque-type psoriasis. the subjects will be randomized to either u0279 or placebo after having been on an injectable biologic for 12 weeks previously. the subject will be on study medication for 12 weeks. the subjects must have moderate to severe psoriasis

Eligibility criteria:
inclusion criteria: * male or female subjects 18 years of age or older. * surgically sterile females. females who have had a hysterectomy or completed menopause are allowed. * affected body surface area with psoriasis of ≥10%. * psoriasis global assessment rating of "moderate to severe" or "severe". * achieved mild to moderate improvement after receiving an injectable biologic therapy for at least 12 weeks. * a pasi score of ≥ 50 and ≤75 * capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed exclusion criteria: * understand that the sponsor can not pay for the an injectable biologic therapy during the course of the study; be willing to pay out of pocket or secure payment through their private health insurance for an injectable biologic. * history of systemic infection, or other conditions that may interfere with study evaluations or may increase risk for participation. such as, tuberculosis, human immunodeficiency virus (hiv), hepatitis; congestive heart failure or demyelinating disorder. * used of prohibited medications or therapies

Keywords: psoriasis moderate to severe plaque psoriasis
prevention of coronary heart disease in morbidly obese patients

Conditions: Morbid Obesity; Hypertension; Type 2 DM; Obstructive Sleep Apnea; Osteoarthrosis

Summary: the changes in risks of developing coronary heart disease in patients with morbid obesity after different weight loss interventions have not been extensively studied. the primary objective of this study is to investigate whether an intensive lifestyle intervention program in a tertiary care clinic (spesialsykehuset for rehabilitering) is comparable with a 7-week low-energy-diet followed by bariatric surgery in decreasing the risk of cardiovascular disease in these patients.

patients matching the eligibility criteria were divided into two groups (not randomized). one group underwent a 7 weeks low-energy-diet before bariatric surgery, the other group participated in an intensive lifestyle intervention program for 3 months. data on arterial stiffness, body weight, body composition, blood pressure, blood samples, vital parameters are registered in the both groups at baseline, 7 weeks and after 1 year.

Eligibility criteria:
inclusion criteria: * morbidly obese patients with bmi \> 40, or bmi \> 35 with comorbidity such as hypertension, obstructive sleep apnea, weight related osteoarthrosis, type 2 dm. exclusion criteria: * participation in other weight loss program the last 12 months. serious psychiatric conditions

Keywords: arterial stiffness pulsewave velocity body composition bioimpedance morbid obesity apo a apo b framingham risk score prevention of coronary heart disease lifestyle intervention bariatric surgery low energy diet
effects of free weight and machine training with and without aerobic training among body builders

Conditions: Sports Physical Therapy

Summary: effects of free weight and machine training with and without aerobic training among body builders.

effects of free weight and machine training with and without aerobic training on strength, endurance and muscle mass of lower limb among body builders.

Eligibility criteria:
inclusion criteria: * age: - 17-35 years(16) * body builders(16) * physically fit athletes (17) * male athletes * benchmarks for body builders 1. minimum 60 kg leg press 2. minimum 15 kg hams curl 3. minimum 10 kg weighted squats exclusion criteria: * participants who will be unable to complete the training * no musculoskeletal disorder * no cardiorespiratory disorder * jumper's knee * any respiratory issue * foot and ankle injuries * patellar tendinopathy * pulmonary disorder * ligamentous and meniscal injury * bone deformity * fractures of lower limb

Keywords: resistance training free weights machine training body builders
non-interventional study to examine rituximab treatment in follicular lymphoma participants

Conditions: Follicular Lymphoma

Summary: it is a non-interventional study with a duration of approximately 24 months per participant to investigate the therapeutic efficiency, safety and treatment regimens of rituximab maintenance therapy in daily routine in participants with previously untreated, relapsed or refractory cluster of differentiation 20 (cd20)-positive follicular lymphoma (fl) in clinical practice.


Eligibility criteria:
inclusion criteria: * age over 18 years * previously untreated, relapsed or refractory cd 20-positive fl * responding to rituximab containing induction therapy (complete response \[cr\] or partial response \[pr\]) * to receive rituximab maintenance therapy (decision taken by doctor prior to and independent of this non-interventional study) * no ineligibility for rituximab exclusion criteria: not applicable (na)