Kornimate/medical-research-clean huggingface dataset:
somatropin + leuprorelin vs somatropin alone in pubertal children with idiopathic short stature

Conditions: Idiopathic Short Stature (ISS)

Summary: the present randomized trial was initially intended to study the benefits of a combined treatment with growth hormone (gh) and a gonadotropin-releasing hormone (gnrh) agonist for pubertal children with idiopathic short stature. however, treatments were stopped in january 2012 at the request of the french drug agency. therefore, a protocol amendment divided the study in two study periods. study period 1 involved combined treatment with somatropin and leuprorelin or treatment with somatropin alone. participants from france who participated in this period 1 of the study were asked to participate in a long term safety follow up defined as a period 2 of the study. participants from the netherlands were offered participation in genetics and neuroendocrinology of short stature international study (genesis, clinicaltrials.gov identifier: nct01088412) for long term safety follow up independent of this study.


Eligibility criteria:
inclusion criteria: * male or female children with iss * age greater than or equal to 8 years and less than or equal to 12 years and 3 months for girls and greater than or equal to 9 years and less than or equal to 14 years and 3 months for boys * bone age less than or equal to 12.0 years for girls and less than or equal to 14.0 years for boys based on a central reading of an x-ray of the left hand and wrist * pubertal stage b2 and b3 for girls based on the tanner method * pubertal stage g2 and g3 for boys based on the tanner method exclusion criteria: * growth hormone deficiency (ghd) * insulin-like growth factor-i levels greater than 3 sds * chromosomal abnormality diagnosed locally on a karyotype. for girls, the karyotype to eliminate a turner syndrome, is mandatory * small for gestational age (sga) * has reached menarche (had her first menstrual period) * have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to growth hormone treatment
patient-reported outcomes and quality of life in adult and pediatric patients with nodular lymphocyte-predominant hodgkin lymphoma (nlphl)

Conditions: Nodular Lymphocyte-Predominant Hodgkin Lymphoma

Summary: there is a pressing need to measure patient-reported symptoms in patients of all ages diagnosed with nodular lymphocyte-predominant hodgkin lymphoma (nlphl). this study aims to measure longitudinal symptom burden and treatment tolerability utilizing validated patient-reported outcomes (pros) instruments. primary objective: * to develop the data collection infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (pros) survey instruments in adult and pediatric patients diagnosed with nlphl. secondary objective: * to examine differences in baseline and longitudinal changes in pros based on disease characteristics, disease status, and treatment strategies among adult and pediatric patients diagnosed with nlphl.

the broad aim of this study is to develop the foundational data management infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (pros) survey instruments in adult and pediatric patients diagnosed with nodular lymphocyte-predominant hodgkin lymphoma (nlphl). the study team further aims to elucidate how pros change over time and how they may be affected by different patient, disease, and treatment characteristics.

Eligibility criteria:
inclusion criteria * age ≥ 8 years * patient or their adult proxy must have verbal and written english language proficiency. * pathologically confirmed diagnosis of nodular lymphocyte-predominant hodgkin lymphoma (nlphl); patients with evidence of transformed lymphoma at diagnosis or subsequent development of transformed lymphoma after diagnosis are eligible. * patients or their adult proxy must be able to provide consent. * patients and/or adult proxy must be able to complete electronic quality of life surveys exclusion criteria * age 7 years or less. * patient or adult proxy does not have verbal and written english language proficiency. * patients with histologic evidence of a composite lymphoma (nlphl with a concurrent diagnosis of hodgkin lymphoma, indolent non-hodgkin lymphoma, or gray zone lymphoma) at diagnosis are not eligible. * inability or unwillingness of research participant or legal guardian/representative to give consent.
arsenic trioxide in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of arsenic trioxide in treating patients who have advanced solid tumors.

objectives: i. determine the maximum tolerated dose (mtd) of arsenic trioxide in adult and pediatric patients with advanced solid tumors. ii. determine the pattern of clinical adverse experience of arsenic trioxide in this patient population. iii. evaluate evidence of clinical responsiveness to this treatment regimen. outline: this is a dose escalation, open label study. patients are stratified by age (pediatric vs adult). patients receive arsenic trioxide iv over 1-2 hours once daily for 3 consecutive days then once weekly for 5 weeks. patients with stable or responding disease receive additional courses of therapy every 8 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. patients receive escalating doses of arsenic trioxide until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity. patients are followed for at least 1 month after treatment. projected accrual: approximately 48 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed advanced solid tumor relapsed from or resistant to at least 1 course of standard anticancer therapy and/or lack of standard therapy that is known to be beneficial in the underlying disease patient characteristics: age: not specified performance status: ecog 0-3 life expectancy: not specified hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 2.5 times upper limit of normal (uln) renal: creatinine no greater than 2.5 times uln other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception during and for at least 4 months following study no active serious infections that are not controlled by antibiotics prior concurrent therapy: biologic therapy: see disease characteristics chemotherapy: see disease characteristics no other concurrent chemotherapy endocrine therapy: see disease characteristics radiotherapy: see disease characteristics no concurrent radiotherapy surgery: see disease characteristics other: no other concurrent investigational agents

Keywords: unspecified childhood solid tumor, protocol specific unspecified adult solid tumor, protocol specific
a study to determine the safety and effectiveness of a connective tissue allograft (activematrix) verses standard of care in adhesive capsulitis of the shoulder

Conditions: Adhesive Capsulitis

Summary: the purpose of this study is to compare activematrix® to standard of care corticosteroid injection in the treatment of adhesive capsulitis of the shoulder (frozen shoulder).


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * have a clinical diagnosis of adhesive capsulitis, defined as: i. pain along the c5 dermatome; and ii. limitations of passive range of motion of more than 20 degrees in the abduction internal rotation, neutral external rotation, forward elevation and abduction planes when compared to the contralateral shoulder * have no contraindications or allergies to the treatment administered * have experienced shoulder pain for more than 6 weeks and less than 1 year (to ensure the patient is in the "freezing" stage of adhesive capsulitis). * have current imaging studies (plain radiographs and mri exams) of the shoulder to rule out other etiologic diagnoses. exclusion criteria: * any prior treatment for this episode of shoulder pain, such as prior intra-articular injection or prior physiotherapy * evidence, based on mri or plain radiographs, of any pathology within the shoulder other than adhesive capsulitis (e.g., glenohumeral osteoarthritis, full thickness tears of the labrum or rotator cuff, tendinosis, calcific tendonitis) * a history of significant trauma to the shoulder * poorly controlled diabetes mellitus, as defined by hba1c \> 7.5 mmol/l and glucose \> 200 mg/dl. for diabetic participants hba1c and glucose levels will be measured prior to intervention and documented for later analysis. for non-diabetic participants, previous labs will be utilized. all other medical diseases will be documented for later analysis. * history of cardiovascular accident (cva) such as stroke or transient ischemic attack (tia) * blood dyscrasias * use of any nsaids besides tylenol. a letter will be sent to each participant's primary care physician(s) requesting that no additional pain medications be given for the duration of the study * prior shoulder surgery

Keywords: frozen shoulder musculoskeletal injuries
biomarkers in tumor samples from younger patients with neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies biomarkers in tumor samples from younger patients with neuroblastoma.

objectives: * to determine the expression of ube4b, hrs, and members of the ubiquitination protein complex in previously banked primary neuroblastoma tumor samples from the children's oncology group. * to determine the correlation of expression levels and cellular localization of the ube4b and hrs proteins with growth factor-receptor tumor cell-surface expression. * to determine the 1p36 deletion status by fluorescence in situ hybridization (fish) analysis and their association with expression levels of ube4b and hrs in previously banked primary neuroblastoma tumor samples from the children's oncology group. outline: banked tumor tissue samples are analyzed for expression of ube4b, hrs, members of the ubiquitination protein complex, growth factor receptors, and 1p36 deletion status by immunohistochemistry (ihc), fluorescent microscopy, and fluorescence in situ hybridization (fish).

Eligibility criteria:
disease characteristics: * tumor tissue microarrays from the children's oncology group neuroblastoma tumor bank patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: neuroblastoma
bravo: background regimen of raltegravir on virologic outcome

Conditions: HIV Infections

Summary: this is a retrospective chart review of participants in raltegravir expanded access program and will compare virologic response in regimens not containing a protease inhibitor in the antiretroviral background regimen to regimens containing a protease inhibitor in the background regimen.

eap charts from patients at the study sites who meet the inclusion criteria will be reviewed and data abstracted. a comparison of the response to treatment by viral load measurement with raltegravir will be compared in patients whose regimens contained a protease inhibitor (pi) with those that did not contain a pi. other endpoints will also be assessed including percent of patients with viral loads less than 400 copies/ml, less than 50 copies/ ml, cd4 cell changes, consequences of failure of raltegravir and use of predictive parameters such as gss and pss.

Eligibility criteria:
inclusion criteria: * patients previously enrolled in the mk 0518 eap are eligible * patients not enrolled in the mk 0518 eap (or other raltegravir protocols) but who meet the specific eap protocol entry criteria are eligible: * age \>= 16 years * limited or no treatment options due to resistance or intolerance to multiple antiretroviral regimens, documented resistance to at least one drug in each of the 3 classes of oral arts (nrti, nnrti, pi) by genotype or phenotype testing, intolerance defined as having had a clinically significant adverse event which in the opinion of the clinician provides a contraindication to the use of any drug in that class iii. patient did not achieve virologic suppression on art regimen prior to receipt of raltegravir iv. patient was clinically stable at time of initiation of raltegravir, eg. clinical status and all chronic medications (except arts) unchanged for \>= 2 weeks prior to raltegravir receipt. * patient received raltegravir for at least 8 weeks * baseline and week 8 or later hiv viral load done and available for review * resistance test (either genotypic or phenotypic test) available prior to receipt of raltegravir exclusion criteria: * patient did not receive approved raltegravir dose of 400 mg bid for at least 8 weeks. * patient chart not available for review.

Keywords: hiv aids raltegravir bravo protease inhibitor treatment experienced
signal:identifying behavioral anomalies using smartphones to improve cancer care

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Uterine Cancer; Cervical Cancer; Gynecologic Cancer

Summary: this research study is testing the use of a smartphone app to identify clinically meaningful changes in the behaviors of patients' with gynecological cancers by using passively collected smartphone data.

this is a pilot study of patients with advanced gynecologic cancers and oncology providers from the dana-farber cancer institute's gynecologic oncology program to explore the feasibility and acceptability of a smartphone-based real-time behavioral anomaly detection system (signal). the research study procedures include screening for eligibility and study interventions including smartphone data collection, surveys, and a brief interview once you have completed the study to learn more about your experiences on the study. participants will download the adapted beiwe app for a 6-month period and the investigators will collect passive smartphone sensor data and active pro data bi-weekly.

Eligibility criteria:
inclusion criteria: * women \>18 years of age with newly diagnosed ovarian cancer (i.e. prior to completion of cytoreductive surgery-whether primary or interval cytoreductive surgery). * own a smartphone (android or ios). * capable of downloading and running the study apps. * can read and provide informed consent in english. * do not have cognitive or visual impairments that would preclude use of the app. exclusion criteria * patients will be ineligible if they are participating in an investigational drug treatment trial that requires structured symptom or toxicity reporting at the time of enrollment. * patients with severe cognitive impairments or who appear too weak, emotionally distraught, agitated or ill to participate, as judged by either the research study staff or an oncology provider, will be excluded. * patients who are unable to provide informed consent in english will be excluded because the smartphone app is only available in english at this time. * children and young adults up to age 17 will be excluded because the diagnosis of metastatic gynecologic cancers in this age group is rare and the proposed instruments are not designed for people of those ages.

Keywords: ovarian cancer fallopian tube cancer primary peritoneal carcinoma uterine cancer cervical cancer gynecologic cancer
circulating cytokines as predictors of radiation induced pulmonary toxicity

Conditions: Lung Neoplasms

Summary: this study is being conducted by the university of rochester cancer center to determine the levels of cytokines in the blood, and to determine if blood levels of these cytokines are related to the side effects of radiation therapy combined with other treatments.


Eligibility criteria:
inclusion criteria: patients receiving radiation therapy for lung cancer combined with surgery either pre or post rt to the chest for lung cancer not associated with atelectasis, pleural effusion. patients receiving hdr brachytherapy for lung cancer. patients receiving concomitant radiation and interferon therapy for lung cancer. patients receiving concomitant chemotherapy and radiation for lung cancer. prior drug therapy does not make patients ineligible. karnofsky ≥ 70 %. there are no age restrictions. acceptable bone marrow function - wbc 2 3000/mm3, platelet count \> 100,000, hematocrit ≥ 33%, hemoglobin ≥ 11 gms/dl. life expectancy \> 6 months. patients must sign informed consent meeting all federal and institutional guidelines. exclusion criteria: patients not meeting eligibility criteria stated above
cervical erector spinae plane block vs cervical plexus block in controlling acute postoperative pain after thyroidectomy

Conditions: Cervical; Erector Spinae Plane Block; Cervical Plexus Block; Postoperative Pain; Thyroidectomy

Summary: this study aims to compare the efficacy and safety of cervical erector spinae plane block vs. cervical plexus block in controlling acute postoperative pain after thyroidectomy.

thyroidectomy is one of the most commonly performed surgeries in females worldwide, as thyroid disease predominantly affects females with a ratio of 4:1. thyroid operations can cause mild to moderate incisional pain. it has also been reported that the morphine consumption on the first postoperative day is 90%. cervical plexus block, either superficial or deep or combinations given bilaterally, could easily lead to an adequate block appropriate for thyroid surgery without any significant side effects. erector spinae plane block (espb) is the new favorite among various fascial plane blocks. local anesthetic drug is injected in the fascial plane superficial to the transverse process and deeper to the erector spinae muscle (esm).

Eligibility criteria:
inclusion criteria: * age from 18 to 65 years. * both genders. * american society of anesthesiologists (asa) physical status i-ii. * scheduled for either hemi- or total thyroidectomy. exclusion criteria: * known allergy to local anesthetics. * allergy to all opioid medications. * pregnant patient. * previous neck surgery. * recent use of non-steroidal anti-inflammatory drugs (nsaids), opioids or steroid injection within 2 weeks. * those who cannot utilize the numeric rating scale (nrs) . * chronic opioid use. * coagulopathy.
effectiveness of the snackability smartphone application to improve quality of the snack intake, general diet quality, and weight among college students

Conditions: Obesity; Diet, Healthy

Summary: the snackability was a two-arm, 12-week randomized control trial among 272 overweight college students. participants were equally randomized to the intervention group (access to the app) or control group (no access to the app). diet and weight were assessed at baseline, at 4 weeks, at 8 weeks, and at 12 weeks.


Eligibility criteria:
inclusion criteria: * overweight or obese college students- * aged 18-24 years * owner of a smartphone with android or ios platforms with access to an internet connection to use the app * willingness to participate in a clinical trial of 3 months and complete assessments at baseline and every 4 weeks at home exclusion criteria: * nutrition students * enrolled in a weight loss and/or nutrition program * taking medications known to influence weight * pregnant or breastfeeding
tea components, mental stress and blood pressure

Conditions: Healthy

Summary: assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure during acute mental stress.

caffeine and (mental) stress can increase blood pressure. in a typical everyday and/or work environment they commonly coincide. tea has the reputation of being a relaxing drink. l-theanine is an amino acid found almost exclusively in tea. in a previous study it was shown that caffeine increased blood pressure, while theanine antagonised these effects. in the current study the effect of theanine to a placebo on blood pressure are directly compared.

Eligibility criteria:
inclusion criteria: * apparently healthy males and females * women taking the contraceptive pill * 18-45 years of age * bmi 20-30 kg/m2 * normal or corrected vision * low caffeine consumers (\<100mg/day) * non smokers and having been a non-smoker for \> 6 months * fluent english * normotensive (\>90/60 \<140/90 mmhg) exclusion criteria: * significant current or medical history of cardiovascular disease * low or high stai trait score in the opinion of the pi * known sensitivity to caffeine or theanine * colour blindness * alcohol consumption above 14/21 units female/male resp. per week * weight loss diet \> 10% of bodyweight in the previous year * anyone with a dependency on pi or staff of department of epidemiology and public health or being an employee of unilever * reported participation in another biomedical study \< 3 months before screening
a study of the safety and efficacy of topiramate in the treatment of obese, type 2 diabetes patients on a controlled diet

Conditions: Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset

Summary: the purpose of this study is to determine the efficacy and safety of topiramate compared with placebo in obese, type 2 diabetic patients on a controlled diet.

topiramate is not approved for the treatment of obesity. this is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate in obese, diet-controlled, type 2 diabetic patients. patients are randomized to receive either topiramate or placebo. after a 5 week pre-enrollment phase followed by a 6 week run-in phase, patients in the topiramate group start an 8-week titration phase to reach the assigned dose of topiramate, either 96 or 192 mg daily. treatment continues for 1 year. assessments of effectiveness include percent change in body weight, hemoglobin type a1c \[hba1c\] levels, body mass index \[bmi\], the numbers and proportion of 5% and 10% weight loss responders, glucose tolerance, waist and hip circumferences, changes in the mass of left ventricle of the heart, blood pressures, and fasting lipid profiles. safety evaluations, including incidence of adverse events, vital signs, clinical laboratory values, and electrocardiograms \[ecgs\], are monitored throughout the study. the study hypothesis is that topiramate, combined with controlled diet, will be effective in weight reduction and controlling blood sugar level and is well tolerated. during the initial 8 weeks, the oral doses of either a matching placebo or topiramate will be gradually increased to the target doses (96 milligrams\[mg\] or 192mg daily); the dose will be maintained for 1 year.

Eligibility criteria:
inclusion criteria: * body mass index \>= 27 and \< 50 * diagnosis of type 2 diabetes according to either swedish guideline or the american diabetes association (ada) criteria * hba1c \<10.5% at enrollment * no previous oral antidiabetic medication or insulin therapy * stable body weight * female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test) exclusion criteria: * known contraindication or hypersensitivity to topiramate * fasting plasma glucose (fpg) \>= 13.1 millimolesl/liter (240 milligrams/deciliter) at baseline, visit 4 (week 0) * hba1c of \>10.5% at enrollment * history of severe recurrent hypoglycemic episodes prior to study entry * use of any systemic corticosteroids within 30 days of enrollment * diagnosed type 1 diabetes * history of significant cardiovascular disease, uncontrolled thyroid disease, or kidney stones

Keywords: type 2 diabetes mellitus obesity diabetic diet hypertension hyperlipidemia adult-onset diabetes mellitus(aodm)