Kornimate/medical-research-clean huggingface dataset:
the efficacy of zoledronic acid in modic changes-related low back pain (lbp)

Conditions: Low Back Pain

Summary: modic changes are associated with low back pain (lbp) both in clinical and general population-based samples. type i changes are regarded as more likely to be painful than type ii changes. several studies suggest that type i changes are inflammatory in nature.

so far, no treatment exists for lbp due to modic changes. bisphosphonates could be effective in this specific low back disorder through two mechanisms: 1) they could consolidate vertebral bodies thereby improving the tolerance for mechanical load and 2) they could diminish inflammation as observed recently in case of ibandronate in an experimental model.

Eligibility criteria:
inclusion criteria: * age over 18 years old * low back pain for more than 3 months * modic type i or ii change in lumbar magnetic resonance imaging * intensity of low back pain at least 6 on 10-cm vas or oswestry disability score at least 30% exclusion criteria: * premenopausal female patients with possibility of pregnancy * patients with calculated creatinine clearance of less than 40 ml/min * patients with hypocalcemia * patients with known hypersensitivity to zoledronic acid or other bisphosphonates or ingredients of the infusional product * patients with red flags symptoms * patients with nerve root impingement * patients with willingness for early retirement

Keywords: low back pain modic changes vertebral endplate signal changes efficacy zoledronic acid bisphosphonates rct
metabolomic study for localized prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer is a common disease in men treated using surgery, radiation therapy and/or hormonal therapy. clinical prognosis relates to stage and grade of disease. recent advances in omic analysis may offer additional information to the physician about prognosis and radiation response. we propose to establish a protocol to incorporate omic analysis into the evaluation and treatment of patients with prostate cancer.


Eligibility criteria:
inclusion criteria: * males who are older than 18 years old, * with clinically localized prostate cancer * are receiving radiation therapy exclusion criteria: * none
exenatide study of cardiovascular event lowering trial (exscel): a trial to evaluate cardiovascular outcomes after treatment with exenatide once weekly in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (mi), or nonfatal stroke.


Eligibility criteria:
inclusion criteria: * patient has type 2 diabetes mellitus * patient has an hba1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the following treatment regimens: a) treatment with 0-3 oral antihyperglycemic agents b) insulin therapy, either alone or in combination with up to two oral agents * female patients must not be breast feeding and agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant. exclusion criteria: * patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis. * patient has ever been treated with an approved or investigational glp-1 receptor agonist. * patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial. * patient has a planned or anticipated revascularization procedure. * pregnancy or planned pregnancy during the trial period. * patient has end-stage renal disease or an estimated glomerular filtration rate (egfr) of \<30 ml/min/1.73m2. * patient has a history of gastroparesis or pancreatitis. * personal or family history of medullary thyroid cancer or men2 (multiple endocrineneoplasia type 2) or calcitonin level of \>40 ng/l at baseline.

Keywords: exenatide once weekly cardiovascular bydureon amylin
the pio (propel in office) iii study of in-office placement of a steroid-eluting implant immediately following ethmoid sinus surgery

Conditions: Chronic Sinusitis

Summary: report on the technical feasibility and outcomes of in-office placement of propel or propel mini implants immediately following ethmoid sinus surgery

the propel mometasone furoate-releasing implant (intersect ent, menlo park, ca) is the first fda-approved device for reducing the need for post-operative interventions by maintaining patency and delivering steroid medication directly into the ethmoid cavity following surgery. five recently published clinical trials have demonstrated that the mometasone furoate-releasing implant placed in the hospital operating room or in the office setting produces statistically significant reductions in inflammation, polyp formation, and postoperative adhesions. in addition, the implant has been found to significantly reduce the need for postoperative prescription of oral steroids and to decrease the frequency of postoperative lysis of adhesions. minimal adverse effects were reported in these trials.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * confirmed diagnosis of crs (chronic rhinosinusitis) based on the 2015 clinical practice guideline for adult sinusitis \[6\] * prior ess (ethmoid sinus surgery) including bilateral total ethmoidectomy at least 90 days prior to being considered for this study * planned ess includes bilateral polypectomy * ess including bilateral polypectomy has been successfully completed without significant complication that, in the opinion of the investigator, would confound study results, and the patient's anatomy remains amenable to implant placement. * bilateral polyposis (minimum grade 2 on each side) originating from the ethmoid sinus region * complaints of at least 2 of the 5 hallmark symptoms of chronic sinusitis: nasal obstruction/congestion, post-nasal discharge, thick nasal discharge, facial pain/pressure, or decreased sense of smell. * minimum symptom threshold (nasal obstruction/congestion minimum score of 2 on scale from 0 to 3) * failed medical therapy within the preceding 12 months exclusion criteria: * not able to give consent * oral-steroid dependent condition * allergy or intolerance to corticosteroids * clinical evidence of bacterial sinusitis or invasive fungal sinusitis * pregnancy

Keywords: steroid-eluting implant mometasone furoate
intensive communication for chronically critically ill

Conditions: Critical Care

Summary: this study was a trial of a formal system of family meetings to support family decision makers of chronically critically ill patients in the intensive care unit.

formal family meetings have been recommended as a useful approach to assist in goal setting, facilitate decision making, and reduce use of ineffective resources in the icu. we implemented an "intensive communication system" to test the effect of regular, structured formal family meetings on patient outcomes among long-stay icu patients the design was a pre-post, tandem assignment of patients (n=217) receiving usual care and communication, followed by enrollment of intervention patients (n=354), from 5 icus. the "intensive communication system" included: (1) family meeting within 5 days of icu admission and weekly thereafter; (2) each meeting addressed medical update, values and preferences, goals of care; treatment plan, and milestones for judging effectiveness of treatment. we measured differences between control and intervention patients in indicators of aggressiveness of care or timing of treatment limitation decisions (icu mortality, los, duration of ventilation, treatment limitation orders, or use of tracheostomy or percutaneous gastrostomy). difference in outcomes among patients who died or who had treatment limitation orders, comparing control and intervention groups, was also examined.

Eligibility criteria:
inclusion criteria: * cognitively impaired mechanical ventilation \>3 days not expected to be discharged before 5 days having a family decision maker exclusion criteria: * no family member hospice referral

Keywords: mechanical ventilation critical care
deltoid ligament arthroscopic repair in ankle fractures: case series

Conditions: Ankle Injuries; Ankle Fractures; Deltoid Ligament; Sprain (Strain) (Ankle); Ligament Rupture

Summary: to demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair.

introduction: the diagnosis and treatment of ankle medial ligament lesions in malleolar fractures have always been surrounded by controversies. even in the certainty of deltoid involvement and its consequent instability, the direct repair of this structure is not a consensus. in recent years, the arthroscopic technique to approach this ligament has been described with the objective of potentiating clinical results and minimizing possible complications. objective: to demonstrate the functional results of patients with ankle fractures operated with arthroscopic deltoid repair. methods: this is a retrospective study in patients diagnosed with ankle fractures associated with acute deltoid injuries and submitted to a malleolar fixation and deltoid arthroscopic repair between january 2018 and january 2020. all patients will fill an epidemiological questionnaire and will be evaluated for pain and function according to the visual analogue scale (vas) and the american orthopaedic foot and ankle society score (aofas) at 12 months (6-24 months) average of follow-up. discussion: the inclusion of the deltoid complex and the low invasiveness of this technique can improve the clinical outcomes of these patients. additional studies, with a prospective and comparative methodology are required to sustain this proposal.

Eligibility criteria:
inclusion criteria: - acute (less than two weeks) ankle fracture containing a medial ligament injury suspicion will be included. syndesmotic lesion with a deltoid association will also be addressed exclusion criteria: * previous surgery * autoimmune diseases * neuropathy * inflammatory diseases * radiographic preoperative findings of ankle arthritis * open medial wound * coagulopathies * any other condition that would contraindicate surgery
a 26-week study to evaluate the efficacy and safety of tenapanor in ibs-c

Conditions: Constipation Predominant Irritable Bowel Syndrome

Summary: this phase 3, 26-week, randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of one dose of tenapanor in subjects with constipation-predominant irritable bowel syndrome (ibs-c) as defined by the rome iii criteria and who have active disease as determined after a two-week screening period. subjects who qualify and are randomized into the study will either receive 50mg bid of tenapanor (1:1) for a 26 week treatment period.

during the 26-week double-blind treatment period, subjects will record daily assessments including: frequency and timing of bowel movements; sensation of complete bowel emptying; consistency of bowel movements; degree of straining, worst abdominal pain, abdominal discomfort, abdominal bloating, abdominal fullness and abdominal cramping; and use and timing of rescue medication. subjects will also record weekly assessments including: adequate relief of ibs symptoms, degree of relief of ibs symptoms, ibs severity, and constipation severity.

Eligibility criteria:
inclusion criteria: * males or females aged 18 to 75 years, inclusive * females must be of non-childbearing potential; if of child-bearing potential, must have negative pregnancy test and confirm the use of one of the appropriate means of contraception * males must agree to use appropriate methods of barrier contraception or have documented surgical sterilization * subject meets definition of ibs-c using rome iii criteria for the diagnosis of ibs * a colonoscopy based on aga guidelines; every 10 years at ≥50 years old exclusion criteria: * functional diarrhea as defined by rome iii criteria * ibs with diarrhea (ibs-d), mixed ibs (ibs-m), or unsubtyped ibs as defined by rome iii criteria * diagnosis or treatment of any clinically symptomatic biochemical or structural abnormality of the gi tract within 6 months prior to screening, or active disease within 6 months prior to screening; including but not limited to cancer, inflammatory bowel disease, diverticulitis, duodenal ulcer, erosive esophagitis, gastric ulcer, pancreatitis (within 12 months of screening), cholelithiasis, amyloidosis, ileus, non-controlled gerd, gastrointestinal obstruction or carcinoid syndrome. * potential cns cause of constipation (e.g., parkinson's disease, spinal cord injury, or multiple sclerosis) * subject has a history or current evidence of laxative abuse (in the clinical judgment of physician) * hepatic dysfunction (alt \[sgpt\] or ast \[sgot\] \>2.5 times the upper limit of normal) or renal impairment (serum creatinine \>2 mg/dl) * any evidence of or treatment of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous year * any surgery on the stomach, small intestine or colon, excluding appendectomy and cholecystectomy (unless within 60 days of screening visit)
evaluation of combination cholesterol treatments in patients with high cholesterol.

Conditions: Hyperlipidemia; Dyslipidemia

Summary: the purpose of this study is to see if combination therapy with a "statin" medication and two additional agents that work differently than "statin" medications can further lower the so-called "bad cholesterol." one therapy is a prescription drug approved by the food and drug administration to treat high cholesterol (welchol). the other therapy is minute maid heart wise orange juice. this study juice is available in supermarkets and contains plant sterols that have been shown to lower cholesterol.

coronary heart disease (chd) is the primary cause of morbidity and mortality in the united states. lowering ldl cholesterol in both patients with and without chd reduces coronary events and death. statin medications are the primary mechanism of lowering ldl cholesterol, but some patients do not reach their goal ldl with maximum tolerated statin doses and must utilize combination therapy to further lower cholesterol. additionally, some patients prefer to utilize "natural" mechanisms to lower cholesterol. this prospective, double-blinded, randomized study will compare plant sterol (natural cholesterol treatment) with placebo in patients treated with combination statin and colesevelam therapy.

Eligibility criteria:
inclusion criteria: * diagnosis of high cholesterol being treated with a statin * ldl cholesterol greater than 100 * ability to swallow large tablets exclusion criteria: * diabetes * use of other medications to treat high cholesterol * history of liver disease

Keywords: antilipemic agents hyperlipidemia
laparoscopic staging in patients with ovarian, fallopian tube, or other primary abdominal cancers

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: laparoscopic staging may help doctors plan more effective treatment for ovarian, primary fallopian tube, and primary abdominal cancers. purpose: phase ii trial to study the effectiveness of laparoscopic staging in patients with ovarian, primary fallopian tube, or primary abdominal cancers who have not undergone complete staging.

objectives: i. determine the feasibility of laparoscopic staging of patients with incompletely staged ovarian, primary fallopian tube, and primary peritoneal cancers. ii. assess the adverse effects associated with this technique. outline: surgery. laparoscopy with cytologic examination and lymph node sampling followed, if feasible, by surgical resection. projected accrual: up to 50 patients will be accrued over approximately 2 years. if more than 4 evaluable patients cannot complete surgery, the study will be closed.

Eligibility criteria:
disease characteristics: one of the following incompletely staged malignancies: ovarian cancer of any cell type primary fallopian tube carcinoma primary peritoneal carcinoma no clinical evidence of metastases to abdominal organs, the adnexa, or retroperitoneal lymph nodes on ct with contrast or at prior abdominal surgery no metastases on chest x-ray no contraindications to laparoscopy, i.e.: no bowel obstruction no ileus no peritonitis no excessive obesity as indicated by a quetelet index over 35 (weight in kg/height in sqm) no diaphragmatic hernia on chest x-ray no grade 2 heart toxicity patient characteristics: age: adult performance status: gog 0 or 1 hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no more than 1.5 mg/dl ast no more than 3 times normal renal: creatinine no more than 2.0 mg/dl other: no second malignancy except nonmelanomatous skin cancer not pregnant prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior or concomitant chemotherapy endocrine therapy: not specified radiotherapy: no prior or concomitant abdominal or pelvic radiotherapy surgery: no prior retroperitoneal surgery no more than 10 weeks since initial abdominal surgery

Keywords: stage i ovarian epithelial cancer stage ii ovarian epithelial cancer stage iii ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma fallopian tube cancer primary peritoneal cavity cancer
apatinib versus placebo as a third line treatment in patients with advanced or metastatic gastric cancer

Conditions: Gastric Carcinoma

Summary: apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (vegfr), and it's anti-angiogenesis effect has been viewed in preclinical tests. the investigators' phase i study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. the purpose of this study is to determine whether apatinib can improve progression free survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

up to now, although fu based, cisplatin based and taxane based regimen, and ecf regimen have been suggested as the first line therapy for a/mgc by fda, the efficacy of these treatment is still unsatisfied for their toxicity and limitation in prolonging survival. based on the promising results of apatinib in the phase i study, this clinical trial has been designed to evaluate whether apatinib can improve progression free survival in patients with metastatic gastric carcinoma who failed two lines of chemotherapy compared with placebo. patients will be randomized to 3 groups, one group patients will receive the treatment of apatinib 850mg qd, one group patients will receive apatinib 425mg bid, and the other group will receive placebo.

Eligibility criteria:
inclusion criteria: * ≥ 18 and ≤ 70 years of age * histologically confirmed advanced or metastatic adenocarcinoma of the stomach * have failed for 2 lines of chemotherapy * life expectancy of more than 3 months * ecog performance scale ≤ 2 * at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan) * duration from the last therapy is more than 6 weeks for nitroso or mitomycin * more than 4 weeks for operation or radiotherapy * more than 4 weeks for cytotoxic agents or growth inhibitors * adequate hepatic, renal, heart, and hematologic functions (platelets \> 80 × 109/l, neutrophil \> 2.0 × 109/l, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(uln), and serum transaminase≤2.5×the uln). exclusion criteria: * pregnant or lactating women * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * any factors that influence the usage of oral administration; evidence of cns metastasis * history of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure * receiving the therapy of thrombolysis or anticoagulation * abuse of alcohol or drugs * allergy to the ingredient of the agent or more than two kinds of food and drug * less than 4 weeks from the last clinical trial * disability of serious uncontrolled intercurrence infection.

Keywords: progress free survival toxicity response rate overall survival quality of live
high dose intravenous fish oil reduces inflammation

Conditions: Lipid Metabolism Disorders

Summary: retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one pn including amino acids, glucose and lipids supplemented with pure fish oil le was performed.

all patients depended on parenteral nutrition (pn) are prone to inflammation. this condition may aggravate already existing proinflammatory status and can become a critical factor for developing liver dysfunction (ld). intravenous fish oil may attenuate the inflammatory status, , however, data on its use in adults is scarce. the aim of the study was to investigate the impact of the addition of pure fish oil intravenous lipid emulsion (ile) as part of short- and long term pn in patients either at risk or with already existing inflammation. retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one pn including amino acids, glucose and lipids supplemented with pure fish oil le was performed. pure fish oil emulsion (omegaven®, fresenius kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d. diagnoses were chronic intestinal failure (cif, n=20), crohn's disease (cd, n=22), and ulcerative colitis (uc, n=19). the observation period was 12 months for cif and 21days for uc and cd.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age, * metabolic stability (the absence of pathological laboratory resulting in the change of pn regime for at least one month) * ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of pn. exclusion criteria: * patients with a history of cancer and anti-cancer treatment within the last 5 years, severe hyperlipidemia, severe coagulopathy, severe renal insufficiency, acute thromboembolic events, positive test for hiv, hepatitis b or c (from medical history), known or suspected drug or alcohol abuse, participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial, for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.