Kornimate/medical-research-clean huggingface dataset:
radiotherapy - adjuvant versus early salvage

Conditions: Prostate Cancer

Summary: radical prostatectomy (rp) is the most common curative approach offered to men with newly diagnosed prostate cancer. unfortunately, up to half of these patients will have factors placing them at high risk of their cancer recurring. having radiotherapy after rp is known to improve cure rates, but what is not known is whether it should be given straight after the operation or only when there is a rising psa after surgery indicating active cancer. immediate rt may not benefit all men, and can cause serious side effects such as bladder and bowel problems and impotence. international lack of consensus on the optimal timing of rt has resulted in varied clinical practice. this phase 3 trial will compare the two approaches.

this is a prospective, multi-centre, international, randomised controlled trial with a 1:1 allocation ratio. patients with positive margins and/or pt3 disease will be randomised to adjuvant rt (standard arm) or active surveillance with salvage rt delivered at early relapse (experimental arm). 64 gy in 32 fractions will be delivered to the prostate bed. qol self-assessment questionnaires, hospital anxiety and depression score and toxicity will be assessed at baseline, the end of rt and annually for 5 years. patients will be seen by their doctor 6 monthly for the first 5 years, then annually for the next 5 years. a blood test measuring prostate specific antigen (psa) is done 3 monthly for the first 5 years for patients randomised to early salvage rt, then 6 monthly from years 5 to 10.

Eligibility criteria:
inclusion criteria: * prior radical prostatectomy (rp) for adenocarcinoma of the prostate. * histological confirmation of adenocarcinoma of the prostate with the gleason score reported (radical prostatectomy specimen). * patients must have at least one of the following risk factors: 1) positive margins, 2) extraprostatic extension (epe) with or without seminal vesicle involvement (pt3a or pt3b) * capable of starting rt within 4 months of rp (a requirement if randomised to adjuvant rt arm) * most recent psa ≤ 0.10 ng/ml following rp and prior to randomisation * eastern cooperative oncology group (ecog) performance status 0 - 1 * patient able to adhere to the specified follow-up schedule and complete the quality of life and anxiety/depression self-assessments * written informed consent obtained prior to randomisation * completion of all pre-treatment evaluations * 18 years and older exclusion criteria: * previous pelvic rt * androgen deprivation (ad) prior to or following rp * evidence of nodal or distant metastases * co-morbidities that would interfere with the completion of treatment and/or 5 years of follow-up * concurrent cytotoxic medication * hip prosthesis

Keywords: oncology prostate cancer radiotherapy radical prostatectomy prior radical prostatectomy (rp) histological confirmation of adenocarcinoma of the prostate positive margins and/or extraprostatic extension (epe)
latarjet versus modified eden-hybinette for anterior shoulder dislocation

Conditions: Shoulder Dislocation

Summary: randomized clinical trial, parallel 1:1, comparing latarjet to modified eden-hybinette (iliac bone crest + capsular repair) for recurrent traumatic anterior glenohumeral dislocation.

the latarjet technique has proven reliable for the treatment of dislocations, with lower recurrence rates (5%) even in the presence of bone lesions. this technique allows a stable fixation of the graft, with 2 screws, and the dynamic effect of the conjoint tendon, the sling effect. however, several complications are described, such as neurological injuries, nonunion and graft resorption. hamel et al, showed that vascularization of the coracoid graft is impaired during the course of latarjet procedure. together with the small thickness of the coracoid, it may justify its high rate of resorption. the eden-hybinette surgery does not have the potential advantages of the sling effect. however, it allows a better restoration of the area of the glenoid, without the risks related to the coracoid osteotomy. all clinical studies about the different bone grafting techniques have a low quality. furthermore, there is no comparative study of the techniques of latarjet and eden-hybinette.

Eligibility criteria:
inclusion criteria: * history of one or more previous episodes of traumatic glenohumeral dislocation; * anterior glenoid bone loss superior to 20% of its diameter, regardless of the isis score; * recurrence of glenohumeral dislocation in cases previously treated with arthroscopic bankart repair, regardless of the isis score and severity of bone lesion of the glenoid; * borderline bipolar bone lesions: * instability severity index score of (isis) greater than or equal to 4 points, with anterior glenoid bone loss (bone bankart lesion) greater than 13.5% of their diameter, measured by the method described by sugaya et al.; * hill-sachs lesion and glenoid considered "off-track". exclusion criteria: * hill-sachs lesion greater than 40% of the humeral head diameter (measured by the preoperative ct); * untreated seizures; * previously diagnosed rotator cuff complete tear; * fractures of the proximal humerus (except for hill-sachs lesions); * multidirectional instability; * advanced glenohumeral osteoarthritis (grade 3 samilson and pietro)
a notch signalling pathway inhibitor for patients with t-cell acute lymphoblastic leukemia/lymphoma (all)(0752-013)

Conditions: Leukemia, Lymphoblastic, Acute, T-cell; Myelogenous Leukemia; Chronic Lymphocytic Leukemia; Myelodysplastic Syndromes

Summary: a notch signalling pathway inhibitor study in pediatric and adult patients with relapsed (worsening) or refractory (not responding to treatment) t-cell acute lymphoblastic leukemia/lymphoma (t-all).


Eligibility criteria:
inclusion criteria: * patients must have pathologically documented precursor t-cell acute lymphoblastic leukemia/lymphoma (t-all), relapsed or refractory to standard therapy, or not be a candidate for standard myelosuppressive chemotherapy due to age or comorbid disease. * patient must have performance status \ 16 years old; lansky performance level \>50 for patients 12 months to less than or equal to 16 years old. * patient must have adequate renal and liver function as indicated by the laboratory values performed within 14 days of receiving the first dose of study drug. * patient must have fully recovered from any chemotherapy and be greater than 2 weeks from radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea, intrathecal therapy, or immunosuppressant therapy for chronic graft-versus-host disease prophylaxis following allogeneic bone marrow transplant. * patient must be greater than 2 months following bone marrow or peripheral blood stem cell transplantation and off all immunosuppressant therapy (with the exception of patients taking immunosuppressant therapy for chronic graft-versus-host disease prophylaxis following allogeneic bone marrow transplant). * men and women of reproductive potential must use an effective contraceptive method while enrolled in the study. * patient or the patient's legal representative must be able to understand the study and give written informed consent. exclusion criteria: * patient has had treatment with any investigational therapy during the preceding 30 days. * patient has uncontrolled congestive heart failure, angina, or had a myocardial infarction in the preceding 3 months. * patient has known hypersensitivity to the components of study drug, its analogs, or to allopurinol. * patient has active or uncontrolled infection. * patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * patient is pregnant or lactating. * patient has any other severe concurrent disease which would make the patient inappropriate for entry into this study. * patient is known to be hiv positive or who has an aids-related illness. * patients with a "currently active" second malignancy, other than non-melanoma skin cancer should not be enrolled. * patient has isolated cns disease.

Keywords: relapsed or refractory t-cell all acute lymphoblastic/leukemia relapsed/refractory t-cell acute lymphoblastic/leukemia acute/chronic myelogenous leukemia poor-risk myelodysplasia
bariatric outcomes longitudinal database (bold)

Conditions: Obesity; Overweight; Diabetes

Summary: the primary purpose of the bariatric outcomes longitudinal database (bold) study is to assess the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship between these outcomes and 1) patient demographics and comorbidities, 2) clinical and surgical characteristics, and 3) pre-operative, peri-operative and post-operative care and treatment.

participants in the bold study include all patients who 1) have their bariatric surgery performed by either a participant in the american society for metabolic and bariatric surgery designated bariatric surgery center of excellence or by a fellow of the american society for metabolic and bariatric surgery 2) have been provided with a copy of the bold patient information sheet. patients under 18 years of age are included if a copy of the patient information sheet is provided to an authorized legal representative. the patient information sheet containing information pertaining to the bold study is provided to the patient at the first pre-operative visit. the patient is not required to sign a consent form to participate in the study but must let the bariatric surgeon staff know if he/she does not wish to participate. the following information will be collected for every bariatric surgery patient: * personal information: gender, race, employment status, insurance status, medical record number, year of birth, height, weight and prior surgeries. the surgeon has the option of entering patient name for internal tracking purposes. * information about surgery: date of admission, date of surgery and date of discharge. * information about medical condition before, during and after surgery. patient information is entered into bold through a secure website and permanently stored in a database that is managed by surgical review corporation (src). this database is secure and meets the requirements for the protection of patient confidentiality as required by the health insurance portability and accountability act (hipaa). data that is used for research does not include the patient name or medical record number. information about the patient's surgery will be combined with data from all other study participants in a separate research database and src research staff will analyze this combined information. the results of the study will be reported or published for the total population - no individual patient information will be published. surgeons participating in the study will attempt to obtain follow-up data on all patients who had surgery once a year for a minimum of at least five years following the date of surgery. follow-up data can be obtained by the operating surgeon or designee, or by the patient's primary care physician and reported to the surgeon.

Eligibility criteria:
inclusion criteria: * bariatric surgery patients * males and females * all races exclusion criteria: * negative psychological evaluation * surgeon's evaluation that patient is not a candidate for surgery

Keywords: obesity bariatric bold weightloss database data registry
incidence of tenderness opposite to adductor canal in patients suffering from osteoarthritis knee pain. a cohort study.

Conditions: Knee Arthritis

Summary: knee osteoarthritis (koa) is a common knee disorder. the pathological changes affecting the knee are typically examined by using x-ray imaging to assess the narrowing of the joint space and the presence of osteophytes. however, some previous clinical trials have revealed a discrepancy between the severity of joint pain and the image finding even with the use of knee mri. some studies have revealed that there are age-related changes in the type of fibers with the formation of a network of transverse fiber bands, and this may cause some compression or traction on the neurovascular content of the adductor canal. other studies noted the presence of excessive yellow-colored adipose tissue that stretches or entangles some nerve fibers. the primary outcome of this study will be the incidence rate of tenderness over the midthigh corresponding to the ac in patients with koa who are complaining of severe pain that is discordant with the radiological finding.


Eligibility criteria:
inclusion criteria: * adult patients with confirmed koa by symptomatic (rated knee pain \> four on a 10-point numeric rating pain scale (nrp scale)) and radiologically (kellgren-lawrence grades i, ii ) findings exclusion criteria: * post-traumatic knee osteoarthritis, oncological diseases, endocrine diseases (gout, diabetes), autoimmune diseases (rheumatoid arthritis), infectious diseases and patients with a history of previous knee surgeries or endoscopies
study for newly diagnosed follicular lymphoma patients with a large tumor burden

Conditions: Lymphoma

Summary: the purpose of this study is to assess in a prospective multicentric study (phase iii) the introduction of a monoclonal antibody directed against b-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma.

follicular lymphoma patients with a large tumor burden will be randomized for 18 months of treatment with either: * arm a: chvp + alpha2a-interferon. patients will receive 12 courses of chvp (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days), one course every month for 6 months then one course every other month for 12 additional months associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months. * arm b: chvp + alpha2a-interferon + rituximab. patients will receive 6 monthly courses of chvp (cyclophosphamide 600 mg/m², adriamycin 25 mg/m², etoposide 100 mg/m² on day 1 and prednisolone 40 mg/m² for 5 days) associated with 6 infusions of rituximab (375 mg/m2) associated with alpha2a-interferon 4.5 millions units sub-cutaneously three times a week for 18 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed follicular lymphoma with a biopsy performed in the last 3 months * patients previously untreated. * patients with at least one of the following symptoms requiring initiation of treatment: * bulky disease at study entry according to the groupe d'etudes lymphomes folliculare (gelf) criteria: nodal or extranodal mass \> 7cm in its greater diameter * b symptoms * eastern cooperative oncology group (ecog) performance status (ps) \> 1 * elevated serum lactate dehydrogenase (ldh) or beta2-microglobulin * involvement of at least 3 nodal sites (each with a diameter greater than 3 cm) * symptomatic splenic enlargement * compressive syndrome * pleural/peritoneal effusion * age must be \> 18 years and less than 76 years * having previously signed a written informed consent form. exclusion criteria: * transformation to high-grade lymphoma (secondary to "low-grade" follicular lymphoma). * patients without a large tumor burden. * patients with prior or concomitant malignancies except non-melanoma skin cancer or adequately treated in situ cervical cancer. * poor renal function: serum creatinine \> 150 μmol/l, * known hiv infection or active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. * patients with contra-indication to interferon, adriamycin, or rituximab. * serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). judgment is up to the investigator. * known sensitivity or allergy to murine products * adult patient under tutelage.

Keywords: lymphoma follicular b-cell rituximab interferon
clinical characteristics and practice patterns of type 2 diabetes mellitus patients treated with oads in japan: analysis of medical and health care database of the mdv

Conditions: Diabetes Mellitus, Type 2

Summary: appropriate use of oral antidiabetic drugs (oads) including dose-reduction is important for patient's safety in t2dm patients with renal impairment (ri). however, there are insufficient data on dose adjustment in accordance with the prescription pattern and the risk of ri of oads, in particular dipeptidyl-peptidase-4 inhibitors, in clinical practice in japan. therefore, we will investigate oads usage conditions and dose selection in t2dm patients with ri in clinical practice in japan


Eligibility criteria:
inclusion criteria: * patients with t2dm (icd code: e11 or e14). * patients must have their first prescription (defined as index date\*) for any study drugs between 01/01/2014 and 30/09/2016. * patients must have at least 6 months enrolment verified by the presence of any record except for the study drug prescriptions within the database (look back period) prior to the index date for each drug. exclusion criteria: * patients who were under 40 years at the time of diagnosis of diabetes. * patients with record of type 1 diabetes mellitus. * patients who prescribed the study drugs during 6 month prior to index date for each drug. * patients whose mean visit interval are more than 92 days
a prospective randomized comparison of three methods for fixation of hammertoes

Conditions: Acquired Deformities of Toe

Summary: the purpose of this research project is to compare three different methods for fixation of hammertoe deformities: (1) kirschner wire; (2) integra ipp-on pip fusion system; and (3) stryker smart-toe implant.

this is a prospective, randomized study and will assist us in ascertaining which of the three tested interventions has the most beneficial outcome.

Eligibility criteria:
inclusion criteria: * adult subjects (greater than or equal to 18 years of age) diagnosed with hammertoe deformity, acquired (icd9 734.5) requiring surgical fixation * subject has given voluntary, written informed consent to participate in this clinical investigation. * subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits * subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language. exclusion criteria: * subjects less than 18 years of age * subjects with peripheral or central neurologic disease causing neurologic symptoms, including pain, dysthesia, or numbness of the operative leg * subjects diagnosed with complicated diabetes mellitus with noted neuropathy, diagnosed by the 10-g monofilament test * inability to provide informed consent

Keywords: hammertoe
insulin resistance and metformin use on volume of benign thyroid nodules

Conditions: Thyroid Nodule; Insulin Resistance

Summary: it has been shown that insulin might be involved in the pathogenesis of thyroid growth. objective to evaluate the impact of ir and metformin use on the volume of benign thyroid nodules (tns). methods a randomized clinical trial to placebo (p) or mtf use. previous fine needle aspiration confirming the diagnosis is necessary to inclusion. patients will receive similar tablets of mtf and placebo and instruct to take 3 tablets/day of mtf (500mg/tablet). thyroid volume, as tn volume, will be assess by ultrasound, both in the beginning, six months and one year after randomization, by the same researcher blinded regarding location group. blood samples to measure: tsh, ft4, tpo-ab, lipid profile, glucose and insulin were done after 8h fasting.

it has been shown that insulin might be involved in the pathogenesis of thyroid growth. previous studies suggest that metformin (mtf) therapy decreased thyroid volume and nodule size in subjects with insulin resistance (ir). objectives to evaluate the impact of ir and metformin use on the volume of benign thyroid nodules (tns). methods a randomized clinical trial to placebo (p) or mtf use. previous fine needle aspiration confirming the diagnosis is necessary to inclusion. exclusion criteria were: nodules with a predominantly cystic pattern, pregnancy, diabetes, acromegaly, previous use of mtf, levothyroxine, corticoid or any weight loss medication in the past six months, hepatic or cardiac insufficiency, creatinine levels \> 1.4 mg/dl and mtf intolerance doses \>1.0 gram/day. patients will receive similar tablets of mtf and placebo and will be instructed to take 3 tablets/day of mtf (500mg/tablet). thyroid volume, as tn volume, will be accessed by ultrasound, both in the beginning, six months and one year after randomization, by the same researcher blinded regarding location group. blood samples to measure: tsh, ft4, tpo-ab, lipid profile, glucose and insulin were done after 8h fasting.

Eligibility criteria:
inclusion criteria: * patients with benign nodules diagnosed by fine needle aspiration biopsy (fnab) exclusion criteria: * nodules with a predominantly cystic pattern * eggshell calcification * coalescent thyroid nodules (not suitable for size analysis) * pregnancy * diabetes * acromegaly * previous use of mtf, levothyroxine, corticoid or any weight loss medication in the past six months * hepatic or cardiac insufficiency * creatinine levels \> 1.4 mg/dl * mtf intolerance doses \< 1.0 gram/day

Keywords: thyroid insulin thyroid nodule insulin resistance thyroid volume metformin