Kornimate/medical-research-clean huggingface dataset:
effect of a dash-style diet on urinary risk factors for kidney stone disease

Conditions: Kidney Stone

Summary: the true capacity for a healthy diet to improve urinary stone risk factors is not well-defined. the objective of this study is to measure the effect of adopting a healthy dietary pattern on kidney stone disease (ksd) risk. the working hypothesis is that a dietary approaches to stop hypertension (dash)-style diet will improve 24-hour urine stone risk parameters. the approach to testing this hypothesis will be to randomize participants with ksd to a standardized dash-style vs. western-style diet for one week. the bionutrition unit of the center for clinical and translational science will provide all meals to participants. the rationale for this study is that by measuring the effect of a dash-style diet on urinary stone risk parameters, a benchmark for future real-world, implementation studies will be established. based on available evidence, this will be the first controlled diet study to assess the dash dietary pattern for improving urinary stone risk parameters.


Eligibility criteria:
inclusion criteria: * birmingham, al area participants of the coronary artery risk development in young adults (cardia) study or patients of the university of alabama at birmingham/kirklin clinic * self-reported, documented, and/or prior imaging-based diagnosis of kidney stone disease * age 19-89 * any sex * any race * able to provide informed consent * willing to perform 24-hour urine collections * willing to consume meals prepared by bionutrition unit * no food allergies/intolerance to any of the foods in the study menus * willing to stop for 7 days before and during study: multivitamins and/or dietary supplements (including calcium and vitamin c) exclusion criteria: * dialysis * kidney transplant recipient * estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m2 based on historical laboratory measurements * renal tubular acidosis * current use of acetazolamide, topiramate, or zonisamide * primary hyperparathyroidism or history of parathyroidectomy * hyperthyroidism * sarcoidosis * primary hyperoxaluria * cystinuria * nephrotic syndrome * malabsorptive conditions including inflammatory bowel disease or history of malabsorptive surgery (e.g., roux-en-y gastric bypass, small bowel resection) * urinary retention requiring catheterization * urinary diversion * pregnancy * breastfeeding * malignancy treated in the past 12 months other than non-melanoma skin cancer

Keywords: dash diet western diet
patient-reported outcomes in rheumatoid arthritis patients treated with tofacitinib or biological disease-modifying antirheumatic drugs (dmards) in real life conditions

Conditions: Arthritis, Rheumatoid

Summary: this study is aimed to describe the outcomes related to physical activity, activity of disease, quality of life, work productivity and safety in latin-american patients with rheumatoid arthritis (ra) treated with tofacitinib or biological dmards after failure to respond to conventional dmards in real-life conditions. this will be a non-interventional, hybrid study (prospective and retrospective data collection) comparing tofacitinib to biologic dmard treatments in patients with ra after failure of conventional dmards. the population will be composed by adult patients over 18 years of age diagnosed with ra and who have been prescribed tofacitinib or any biological dmards.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age at the time of recruitment * patient diagnosed with moderate to severe ra ≥ 6 months before enrollment * patients who have had an inadequate response to the continuous use of methotrexate or combination of conventional dmards for at least 12 weeks before the study without dose change within the last 8 weeks before enrollment in the study * patients with no biological dmards use in patient history. * patients prescribed with tofacitinib or biological dmards in the last two weeks at doses established in acr guidelines published in 2015 and following medical criteria. * acceptance for patients to participate in the study and signing of the informed consent. exclusion criteria: * patients who do not have the ability to answer the questionnaires by themselves or who have any kind of mental disorder that may affect their answers. * patients diagnosed with autoimmune rheumatic diseases other than ra and sjogren's syndrome. * patients treated with biological dmards in monotherapy. * participation in other studies involving investigational drug(s) (phases 1-4) within 4 weeks or 5 half-lives (whichever is longer) after discontinuation of the investigational compound before the current study begins and/or during study participation. * patients with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. * patients with lymphoproliferative disorders (e.g., epstein barr virus (ebv) related lymphoproliferative disorder), a history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
sentinel node biopsy alone or with axillary dissection after primary chemotherapy

Conditions: Breast Neoplasm Female

Summary: many doctors believe that breast cancer patients scheduled for pre-operative chemotherapy whose cancer has spread to the axilla (determined by palpation plus ultrasound) should not receive sentinel node biopsy after chemotherapy, but proceed directly to removal of all the axillary lymph nodes. in this study, breast cancer patients with operable medium-size cancer (t2) scheduled for pre-operative chemotherapy, and a disease-free or a metastatic axilla, are prospectively assigned to receive sentinel node biopsy as part of their post-chemotherapy surgical treatment (whose main aim is to remove the cancer in the breast). irrespective of whether the axilla is disease-free or metastatic before chemotherapy, if the removed sentinel nodes are disease-free on histological examination (pn0) after chemotherapy, then no further axillary treatment is given. if however the sentinel nodes contain cancer, then the other axillary lymph nodes will be removed surgically. the study hypothesis is that, irrespective of whether the axilla is disease-free or metastatic before chemotherapy, patients with negative axillary sentinel nodes on histological examination (pn0) after chemotherapy, and who are no given further axillary treatment, will do as well as pn1 patients whose axillary lymph nodes are completely removed (a more aggressive treatment).


Eligibility criteria:
inclusion criteria: * ct2 cn0/1 breast cancer * scheduled for neoadjuvant chemotherapy, * informed consent, exclusion criteria: * previous malignancy at another site * synchronous breast cancer at diagnosis * distant metastasis at diagnosis * clinically involved axilla (cn1) after neoadjuvant chemotherapy

Keywords: breast cancer sentinel node biopsy neoadjuvant chemotherapy axillary dissection
effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block

Conditions: Trauma Injury

Summary: effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block.


Eligibility criteria:
inclusion criteria: * patients between 20_60 years old * patients with asa clinical status i/ii * patients scheduled for peripheral nerve block for upper extremity surgery exclusion criteria: * 1) they refused to participate 2) had preexisting neuropathy of the surgical limb 3) hypersensitivity to amide anesthetic 4) significant pulmonary disease 5) coagulopathy 6) sepsis 7) infection at the block site 8) hypersensitivity to dexmedetomidine \& dexamethasone
using cta measures to define cardiac risk in nfl alumni

Conditions: Coronary Artery Disease (CAD); Heart Disease; Coronary Atherosclerosis

Summary: the gamefilm registry is a post-market, multi-center, data collection study assessing the presence of cad in nfl alumni.

the gamefilm registry is a post-market, multi-center, data collection study assessing the prevalence and severity of cad in nfl alumni. a retired nfl player is defined as any former player who made either a practice squad or an active nfl roster. approximately 300 participants will be included from approximately 20 sites in the us.

Eligibility criteria:
inclusion criteria: * retired nfl player exclusion criteria: * ccta not successfully processed for ffrct and ai-plaque

Keywords: nfl heart disease
non-invasive glioma characterization through molecular imaging

Conditions: Glioma; Brain Tumor; Primary Brain Tumor; Malignant Glioma; Malignant Primary Brain Tumor

Summary: mri-based sequences can provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2hg) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

this is a pilot study aiming at developing and optimizing mri-based sequences to provide non-invasive quantification of intratumoral 2-hydroxyglutarate (2hg) distribution and tumor cellularity in human gliomas and help guide the development of novel glioma therapies.

Eligibility criteria:
inclusion criteria: * adults (≥18 year old) * subjects with suspected or confirmed gliomas and who will have a medically indicated biopsy or resection of his/her brain lesion. exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women * patients unable to have mri done

Keywords: non-invasive glioma characterization molecular imaging isocitrate dehydrogenase (idh) mutations mri-based sequencing
extraperitoneal plasty vs intraperitoneal onlay mesh in ventral hernia repair

Conditions: Ventral Hernia; Abdominal Wall Defect

Summary: this study investigates on the effect of two different operative techniques to treat abdominal wall hernias. the goal of this clinical trial is to learn if the etep (extended totally extraperitoneal repair) technique leads to a better outcome than the ipom (intraperitoneal onlay mesh) technique. the main questions it aims to answer are: * pain after the operation * rate of complications * rate of recurrence and reoperations * quality of life. participants will: either be operated using the etep or the ipom technique. be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.


Eligibility criteria:
inclusion criteria: * patient age \>18 years * informed consent obtained * primary or incisional ventral hernia * epigastric, umbilical or infraumbilical ventral hernias with transversal diameter \>1cm and \</= 4cm, +/- rectus diastasis which doesn't demand specific treatment * if multiple hernias: cumulative transversal diameter \</= 4cm * considered eligible for minimally-invasive approach exclusion criteria: * subxyphoidal or suprapubic hernias * precedent hernia treatment with mesh placement in the retromuscular space * liver disease defined by the presence of ascites * end-stage renal disease requiring dialysis * need of an emergency surgery * pregnancy * need of rectus diastasis treatment intraoperatively criteria for participating surgeons - each participating surgeon has performed 20 or more laparoscopic ipom procedures and 20 or more etep procedures.
stable angina observational registry

Conditions: Stable Angina

Summary: the purpose of this study is to describe the clinical profile and current status of the diagnosis and management of stable angina in india by non-interventional consulting physicians (cp) through a large multicenter observational registry.

an observational registry on diagnosis and management of stable angina in india purpose to describe the clinical profile and current status of the diagnosis and management of stable angina in india by non-interventional consulting physicians (cp) through a large multicenter observational registry. design a prospective, multi-center, observational registry. subject population adult, male or female subjects with symptomatic stable angina visiting non-interventional consulting physicians for treatment and who meet the study inclusion/exclusion criteria. enrollment: the study is expected to enroll 1000 to 1500 subjects by 150 - 250 non-interventional consulting physicians. the enrollment period will be around 4 months. inclusion criteria subject must meet all of the following criteria to be eligible for inclusion in the trial: 1. subject has been provisionally diagnosed with stable angina by the cp (consulting physician) during the current visit or within 3 months preceding the current visit 2. subject agrees to sign a data release form exclusion criteria subjects will be excluded from the trial if any of the following criteria are met: 1. subject has a history of acute coronary syndrome 2. subject has a history of prior revascularization 3. subject has a history of previous mi 4. subject has new onset angina with symptoms less than one month objectives: 1. describe the demographic and medical profile of subjects diagnosed with stable angina by non-interventional consulting physicians in india 2. describe the diagnostic pathway prescribed by non-interventional consulting physicians and adopted by stable angina subjects in india 3. describe the management of stable angina by non-interventional consulting physicians and undertaken by subjects in india

Eligibility criteria:
inclusion criteria subject must meet all of the following criteria to be eligible for inclusion in the trial: 1. subject has been provisionally diagnosed with stable angina by the cp (consulting physician) during the current visit or within 3 months preceding the current visit 2. subject agrees to sign a data release form exclusion criteria subjects will be excluded from the trial if any of the following criteria are met: 1. subject has a history of acute coronary syndrome 2. subject has a history of prior revascularization 3. subject has a history of previous mi 4. subject has new onset angina with symptoms less than one month

Keywords: symptomatic stable angina subjects with symptomatic stable angina visiting non-interventional consulting physicians for treatment and meets the inclusion/exclusion criteria
investigation of the superiority effect of orally disintegrating desmopressin tablets to placebo in terms of night voids reduction in nocturia adult male patients

Conditions: Nocturia

Summary: the purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.


Eligibility criteria:
inclusion criteria: * written informed consent prior to performance of any trial-related activity * male sex 18 years of age or older * at least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary. exclusion criteria: * evidence of severe daytime voiding dysfunction defined as: urge urinary incontinence (more than 1 episode/day in the 3-day diary period), urgency (more than 1 episode/day in the 3-day diary period), frequency (more than 8 daytime voids/day in the 3-day diary period) * interstitial cystitis * chronic prostatitis/chronic pelvic pain syndrome * suspicion of bladder outlet obstruction (boo) or a urine flow of less than 5 ml/s as confirmed by uroflowmetry performed after suspicion of boo * surgical treatment, including transurethral resection, for boo or benign prostatic hyperplasia within the past 6 months * urinary retention or a post void residual volume in excess of 250 ml as confirmed by bladder ultrasound performed after suspicion of urinary retention * habitual or psychogenic fluid intake resulting in a urine production exceeding 40 ml/kg/24 hours * central or nephrogenic diabetes insipidus. * syndrome of inappropriate anti-diuretic hormone. * current or a history of urologic malignancies e.g. urothelium, prostate, or kidney cancer * genitourinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms * neurogenic detrusor activity (detrusor overactivity) * suspicion or evidence of cardiac failure * uncontrolled hypertension * uncontrolled diabetes mellitus * hyponatraemia: serum sodium level must be within normal limits * renal insufficiency: serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 ml/min * hepatic and/or biliary diseases: aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) levels must not be more than twice the upper limit of normal range. total bilirubin level must not be more than 1.5 mg/dl * history of obstructive sleep apnea * previous desmopressin treatment for nocturia * treatment with another investigational product within 3 months prior to screening * concomitant treatment with any prohibited medication, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug * known alcohol or substance abuse * work or lifestyle that may interfere with regular nighttime sleep e.g. shift workers * any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial
safety and efficacy of repeated administrations of nurown® in als patients

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: this study will evaluate the safety and efficacy of repeated administration of nurown® (msc-ntf cells) therapy, which is based on transplantation of autologous bone marrow derived mesenchymal stromal cells (msc), which are enriched from the patient's own bone marrow, propagated ex vivo and induced to secrete neurotrophic factors (ntfs). the autologous nurown® (msc-ntf cells) are back-transplanted into the patient intrathecally by standard lumbar puncture where neurons and glial cells are expected to take up the neurotrophic factors secreted by the transplanted cells

neurotrophic factors (ntfs) are potent survival factors for embryonic, neonatal, and adult neurons and are considered potential therapeutic candidates for als. delivery of multiple ntfs to the immediate environment of afflicted neurons in als patients is expected to improve their survival and thus slow down disease progression and alleviate symptoms. ntf-secreting mesenchymal stromal cells (msc-ntf cells) are a novel cell-therapeutic approach aimed at effectively delivering ntfs directly to the site of damage in als patients. participants meeting the inclusion and exclusion criteria will be randomized and will undergo bone-marrow aspiration. msc of the participants randomized to the treatment group will be induced into msc-ntf cells. participants will undergo a total of three intrathecal (it) transplantations with nurown® (msc-ntf cells) or matching placebo at three bi-monthly intervals

Eligibility criteria:
inclusion criteria: * als diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised el escorial criteria. * having onset of als disease symptoms, including limb weakness within 24 months at the screening visit. * alsfrs-r ≥ 25 at the screening visit. * upright slow vital capacity (svc) measure ≥ 65% of predicted for gender, height, and age at the screening visit. * rapid progressors * participants taking a stable dose of riluzole are permitted in the study * citizen or permanent resident of the united states or canadian citizen able to travel to a us site for all follow-up study visits exclusion criteria: * prior stem cell therapy of any kind * history of autoimmune or other serious disease (including malignancy and immune deficiency) that may confound study results * current use of immunosuppressant medication or anticoagulants (per investigator discretion) * exposure to any other experimental agent or participation in an als clinical trial within 30 days prior to screening visit * use of radicava (edaravone injection) within 30 days of screening or intent to use edaravone at any time during the course of the study including the follow up period * use of non-invasive ventilation (bipap), diaphragm pacing system or invasive ventilation (tracheostomy) * feeding tube * pregnant women or women currently breastfeeding

Keywords: msc autologous neurotrophic factors
fc factors and real-world hemophilia patient-reported outcomes

Conditions: Hemophilia A; Hemophilia B

Summary: the primary objective of the study is to evaluate the effectiveness of prophylactic treatment with recombinant factor viii fc fusion protein (rfviiifc) and recombinant factor ix fc fusion protein (rfixfc) therapy as assessed by patient treatment burden and health economic outcomes while maintaining disease control in males with hemophilia a or b.


Eligibility criteria:
key inclusion criteria: * have a medically documented diagnosis of hemophilia a or b that is being treated prophylactically with a factor replacement product not designed to have a prolonged half-life and satisfy a therapeutic indication for rfviiifc/rfixfc per the approved local label * have at least 50 prior exposure days (eds) to any combination of factor replacement products * have documented pre-study data available that confirm fulfillment of the eligibility criteria * have no measurable inhibitor activity in a sample obtained within 4 weeks prior to the baseline visit, and absence of clinical signs or symptoms of decreased response to the current factor replacement product key exclusion criteria: * have a diagnosis of any bleeding disorder other than hemophilia a or hemophilia b or an additional coagulation disorder(s) in addition to hemophilia a or hemophilia b * have a prior history of anaphylaxis associated with any factor viii (fviii)/ factor ix (fix) or intravenous immunoglobin administration * had an inhibitor within 5 years before the baseline visit. note: a family history of inhibitors will not exclude the patient. * past or current treatment with any factor replacement product with a prolonged half-life, including an fc product, for the treatment of hemophilia note: other protocol defined inclusion/ exclusion criteria may apply.