Kornimate/medical-research-clean huggingface dataset:
celecoxib versus hyoscine butyl-bromide in reducing pain associated with iud.

Conditions: IUD Insertion Pain

Summary: many oral analgesic drugs such as the nonsteroidal anti-inflammatory drug (nsaid) are used to relieve pain from gynaecological procedures and dysmenorrhea. hyoscine-n-butyl bromide, an antispasmodic drug is commonly used for relief of smooth muscle spasms and can be used to alleviate genito-urinary spasm. some studies reported hyoscine couldn't relieve pain in minor gynaecological procedures. so the efficacy of hyoscine-n-butyl bromide use is still controversial, and no previous studies investigated its effectiveness for pain relief in iud insertion procedure.

the study objective is to compare the effectiveness and side effects of oral celecoxib 200mg versus oral hyoscine butyl bromide 10 mg in reducing pain associated with iud insertion. the study is an attempt to find the most effective drug with the least possible side effects to be used before iud insertion.

Eligibility criteria:
inclusion criteria: * non-pregnant nulliparous and parous menstruating women. * women who did not receive any analgesics or misoprostol in the 24 hours prior to insertion. * presenting for insertion of cut380a intrauterine device. * the absence of contraindication for iud insertion including positive cultures for gonorrhoea or chlamydia * the absence of sedative or long-acting narcotics use 48 h before iud insertion * no history of severe mental stress in the past two months. exclusion criteria: * • allergy to hyoscine butylbromide or celecoxib or contraindication to it as paralytic ileus, myasthenia gravis, pyloric stenosis and narrow-angle glaucoma. * women who had been pregnant within the previous four weeks. * women presenting for iud removal and reinsertion * any uterine abnormalities distorted uterine cavity as congenital anomalies, endometrial lesions, adenomyosis, and submucous myoma. * enrollment in another study. * a psychological or neurological disorder associated with altered pain sensation. * a history of dysmenorrhea * a contraindication for iud use such as a gynaecological malignancy, pelvic inflammatory disease or undiagnosed abnormal vaginal bleeding.
a study of mk0657 in parkinson's disease patients (0657-006)

Conditions: Parkinson's Disease

Summary: in this clinical trial, the safety of mk0657 when given with levodopa will be assessed in patients with parkinson's disease. this study will also measure the effectiveness of mk0657, when given in combination with levodopa, to improve motor symptoms and ameliorate dyskinesias (uncontrolled movements of a part of the body) as compared to placebo.


Eligibility criteria:
inclusion criteria: * parkinson's disease patients between the ages of 40 and 80 inclusive * patient is in general good health based on screening assessments * patient is willing to discontinue anti-parkinson's medications at least 8 hours prior to dosing * patient is levodopa responsive with levodopa-induced peak-dose dyskinesias * patient taking selective serotonin inhibitors (ssris), sleep medications and neuroleptics, have been on a stable dose for at least 30 days and has not experienced any cns-related side effects * patient is not a heavy smoker or drinker exclusion criteria: * patient has atypical parkinson's syndrome due to drugs, identified metabolic and/or neurologic disorders, encephalitis, or other degenerative syndrome * patient has known intolerance or hypersensitivity to levodopa or carbidopa * patient has been on anticholinergics or memantine within 30 days prior to dosing * patients have a history of the following: seizure disorder, stroke or head trauma, pronounced cognitive impairment, psychiatric disorder, cardiovascular disease, cancer, diabetes as defined by hba1c of greater than 8% * patient has a systolic bp or less than 80 mm hg or greater than 150 mm hg
einstein junior: oral rivaroxaban in children with venous thrombosis

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.


Eligibility criteria:
inclusion criteria: * children aged birth to \< 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of ufh (unfractionated heparin), lmwh (low molecular weight heparin) or fondaparinux and require anticoagulant therapy for at least 90 days. however, children aged birth to \< 2 years with catheter-related thrombosis require anticoagulant therapy for at least 30 days. * for children younger than 6 months: * gestational age at birth of at least 37 weeks. * oral feeding/nasogastric/gastric feeding for at least 10 days. * body weight ≥2600 g exclusion criteria: * active bleeding or bleeding risk contraindicating anticoagulant therapy * an estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m\*2 (in children younger than 1 year, serum creatinine results above 97.5th percentile excludes participation) * hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alt\> 5x upper level of normal (uln) or total bilirubin \> 2x uln with direct bilirubin \> 20% of the total * platelet count \< 50 x 109/l * sustained uncontrolled hypertension defined as \> 95th age percentile * life expectancy \< 3 months * concomitant use of strong inhibitors of both cytochrome p450 isoenzyme 3a4 (cyp3a4) and p-glycoprotein (p-gp), including but not limited to all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically * concomitant use of strong inducers of cyp3a4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine * childbearing potential without proper contraceptive measures, pregnancy or breast feeding

Keywords: pediatric
acute effect of functional crackers on postprandial metabolism

Conditions: Healthy

Summary: the aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants.

a pilot cross-over, controlled, randomized and single-blinded, intervention-clinical trial was carried out, in twelve healthy men and women, aged nineteen to sixty-five years, after random allocation into the control, the grape and the barley interventional groups, received a high-fat and high-carbohydrate meal, containing wheat flour or wheat and 10% grape seed flour or wheat and 40% barley flour, enriched with β-glucan, crackers. participants consumed the same meals, allocating in cross-over order, with 1 washout week after each trial period. differences on the metabolism of postprandial serum total, high density lipoprotein (hdl-), low density lipoprotein (ldl-) cholesterol, glucose, triglycerides and uric acid levels, as well as of plasma total antioxidant capacity according to ferric reducing antioxidant power method, were determined between groups in fasting, thirty minutes, one and a half hour, and three hours after meal intake.

Eligibility criteria:
inclusion criteria: * age 19-65 years exclusion criteria: * age over 65 years old * history of chronic illness including type i and ii diabetes (hemoglobin a1c-hba1c \> 5%) * abnormal body mass index (bmi) (\>25 kg/m2) * alcohol overconsumption (\>40 g alcohol/day) * abnormal hematological and biochemical profiles (cholesterol \> 6.8 mm, triglycerides \> 2.8 mm, glucose \> 6.11 mm)

Keywords: enriched with 10% grape seed flour crackers 40% barley flour crackers enriched with β-glucan postprandial effect
cycling of topical steroids for treatment of eoe (eosinopilic esophagitis)

Conditions: Eosinophilic Esophagitis

Summary: the purpose of our research study is to assess whether patients with eoe who have achieved control of their disease on topical fluticasone or budesonide are able to cycle or take breaks from their treatment with continued remission of their eoe. there will be 30 participants enrolled in this study. there will be 15 patients who will stay on steroid therapy every day and 15 patients who will cycle their steroid therapy on and off to help us compare the two groups. the cycling group will cycle their steroid therapy in a three-months on three-months off fashion.


Eligibility criteria:
inclusion criteria: * pediatric patients between 4-18 years of age with eoe followed by the division of pediatric gastroenterology, hepatology and nutrition at rainbow babies and children's hospital * patients who are currently on treatment with topical corticosteroids and scheduled for an upcoming endoscopy as part of their routine clinical care (to be used as egd1) within 3 months of enrollment date * patients who have achieved documented clinical and endoscopic remission using topical steroids as evidenced by egd exclusion criteria: * patients who are not responsive to topical corticosteroid treatment for their eoe as evidenced by failure to obtain clinical or endoscopic remission on any pervious screening egd * patients less than 4 years of age and older than 18 years of age at the time of recruitment * patients with history of or current diagnosis of esophageal strictures

Keywords: fluticasone budesonide adolescent cycling
outcome after revisions of infected knee arthroplasties

Conditions: Periprosthetic Knee Infection

Summary: a prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection.

a prospective multicenter cohort study on all types of revision knee arthroplasty procedures performed due to infection. most previous studies investigating outcomes after revisions of infected knee artrplasties are single-center studies and retrospective. the study group has previously investigated outcome of the surgical treatment of infected knee arthroplasties in denmark based on nationwide data from danish registries. these studies revealed that the risk of treatment failure causing re-revision or mortality was 30-40% in denmark. based on these findings, an ongoing randomized controlled trial "one-stage versus two-stage revisions of the infected knee arthroplasty" (clinicaltrials.gov id: nct03435679) has been initiated by the study group in febuary 2018. it has been possible to include 20% of the patients with surgically demanding periprosthetic knee infections from the including centres in this randomized trial due to in- and exclusions criteria. hence, the investigators wish to include the remaining patients with periprosthetic knee joint infection in a prospective cohort study in order to obtain high quality prospective data on function, quality of life and complications after all types of surgical procedures performed due to periprosthetic knee joint infection. based on these data it will be possible to evaluate the surgical treatment overall and it will be possible to evaluate whether the patients included in the randomized trial are representative. study aim: to present patient reported outcome and postoperative complications after all types of surgical procedures performed due to periprosthetic knee infection. furthermore, to analyze the role of potential risk factors (patient comorbidity, microbiological diagnosis, surgical intervention, antibiotic treatment, duration of symptoms) on outcome of the patients.

Eligibility criteria:
inclusion criteria: * clinical signs of periprosthetic knee joint infection and indication for revision surgery * speak and understand danish and have given informed consent exclusion criteria: * participation in "one-stage versus two-stage revisions of the infected knee arthroplasty"

Keywords: infection knee arthroplasty surgical treatment patient reported outcome
muscle strength, functional capacity, respiratory function and quality of life in cystic fibrosis patients

Conditions: Cystic Fibrosis; Muscle Strength; Pulmonary Function; Functional Capacity; Exercise Tolerance; Muscular Endurance

Summary: this study was designed to investigate the relationship between upper extremity muscle strength and endurance, functional capacity, and quality of life child and adolescent with cystic fibrosis

child and adolescent with cystic fibrosis patients were assessed for upper extremity muscle strength and (shoulder abductors muscle strength, elbow flexion muscle strength, handgrip strength) muscular endurance(arm pull-up test), lung function test, and functional capacity (six-minute walk test distance), and quality of life (cystic fibrosis questionnaire-revised)

Eligibility criteria:
inclusion criteria: * individuals diagnosed with cf with clinical findings and gene mutations consistent with cf, having over 60meq / l in two measurements in sweat chlorine examinations exclusion criteria: * patients who did not exacerbate the disease in the last four weeks, who had good cooperation and did not have any orthopedic problems in the hand-shoulder-arm complex were included.

Keywords: muscle strength pulmonary function cystic fibrosis functional capacity
glycemic control, type ii diabetes, parathyroidectomy

Conditions: Primary Hyperparathyroidism; Type 2 Diabetes

Summary: the purpose of this study is to assess glycemic control after parathyroidectomy in patients with primary hyperparathyroidism and concomitant type 2 diabetes mellitus.

primary hyperparathyroidism (phpt) is known to affect the kidney and skeletal system, however, recent data have suggested that patients can also exhibit an increased cardiovascular risk and metabolic abnormalities primary hyperparathyroidism (phpt) is the most common cause of hypercalcemia, with an estimated prevalence of 0.8% in the general population. type 2 diabetes mellitus (dm) is the most prevalent chronic disease with an estimated prevalence of 10%. based on the estimated prevalence of this two conditions, we would expect a comorbid prevalence of both diseases in the same individual of approximately 0.08%. however, the prevalence of dm in patients with phpt is much higher ranging from anywhere 7.8% to 22%, suggesting that this is not mere coincidence. while the exact mechanism is not clear, in vivo study demonstrated that parathyroid hormone (pth) reduces the insulin-stimulated uptake as well as decrease glucose transporter and the insulin receptor. hypercalcemia can also be associated with impaired insulin sensitivity and insufficient suppression of gluconeogenesis. in some patient series, some improvement in glycemic profiles have been shown in patients after parathyroidectomy (ptx). in addition, both dm and phpt are known risk factors for the development of bone abnormality patients with dm have increased risk of hip fractures while cortical bone (i.e. the forearm) are more commonly affected in patients with phpt. there are currently very few studies evaluating the interaction of both conditions in terms of patient skeletal profiles and bone health. participants with phpt and dm will be recruited and followed over the course of a year. there are two groups: the group of patients that decided to pursue a parathyroidectomy, and a group of patients that will be managed non-surgically. clinical data will be collected along with blood tests.

Eligibility criteria:
inclusion criteria: 1. study group: consecutive patients older than 18 years old with concomitant phpt and dm who will undergo ptx. the indications and need for surgery will be independent from the research team. 2. control group: consecutive patients older than 18 years old with concomitant phpt and dm who will not undergo ptx. the indications to forgo surgery will be independent from the research team. exclusion criteria: 1. patients with recurrent or persistent phpt will not be included. 2. patients who are included but have evidence of recurrent or persistent phpt based on six-month laboratory workup will be excluded from the final analysis (\<5% expected)9. 3. patients with type 1 diabetes mellitus 4. patients with secondary and/or tertiary hyperparathyroidism

Keywords: hyperparathyroidism, glycemic control
reinforcement of surgical staple lines using peri-strips dry (psd) with veritas collagen matrix

Conditions: Obesity

Summary: the purpose of this study is to verify the performance of psd veritas to provide staple line protection during surgical procedures for obesity.

the purpose of the study is to verify the performance of psd veritas in providing staple line protection for surgical procedures that buttress the stomach and other staple lines during roux-en-y surgery. the study is designed as two separate patient groups. one will enroll patients into a group where linear staple lines are buttressed at the stomach. the second portion of the trial will enroll patients into a group where the circular staple line at the gj and linear staple lines at the stomach are buttressed with psd veritas.

Eligibility criteria:
inclusion criteria: * patient 18 years or older * patient willing to comply with follow-up evaluations * patient understands nature of procedure and provides informed consent * female patient has stated that she is not pregnant and will not become pregnant during trial. exclusion criteria: * patient currently enrolled in another device/drug trial that competes for same patient population * patient with short life expectancy (12 months) wherever the cause is not linked to obesity * bmi is equal or less than 40 and equal to or less than 65 * patient does not meet national institute of health (nih) criteria for gastric by-pass surgery * patient has had previous buttress or other material used in the staple lines that will affect the outcome of this trial. * patient has known sensitivity to bovine material

Keywords: staple line reinforcement, buttress
improving management of emergency department patients with undifferentiated syncope: prospective validation of the canadian syncope risk score

Conditions: Syncope

Summary: among kaiser permanente northern california (kpnc) health plan members, age ≥16 years, with recent syncope and presyncope undergoing emergency department (ed) management with a point-of-care clinical decision support (cds) tool, how well does the canadian syncope risk score predict 30-day serious outcomes that were not evident during index ed evaluation?


Eligibility criteria:
inclusion criteria: * age ≥16y * member of kaiser permanente northern california (kpnc) health plan * presentation to the ed with an ed diagnosis of recent syncope or presyncope (\<24h) without a serious etiology identified during the initial ed diagnostic assessment, that is, patients with unexplained syncope. * subjects who meet criteria will be identified electronically within the cds tool in the electronic health record. exclusion criteria: * age \<16 years old * non-members of kpnc * patients with obvious witnessed seizure, prolonged loss of consciousness (\>5 minutes), post-traumatic loss of consciousness, and new mental status changes * patients requiring hospitalization for traumatic injuries (e.g., syncope leading to motorized vehicle collision), because their outcomes may be related to trauma rather than syncope * patients with impaired communication capacity, e.g., intoxication, language barriers, and dementia.
cytokine profiles in breast cancer patients undergoing chemotherapy

Conditions: Mammary Neoplasm, Human; Periodontal Diseases; Chemotherapy Effect

Summary: aim: this study evaluated the effects of non-surgical periodontal therapy (nspt) on the cytokine profile and the correlation to clinical parameters of patients undergoing chemotherapy for breast cancer. materials and methods: 40 patients were allocated: periodontitis patients (p) (n=20) and breast cancer with periodontitis patients (can/p) (n=20). the clinical parameters: probing depth (pd), clinical attachment level (cal), plaque index (pi), bleeding on probing (bop) and levels of ifn-γ, il-4, il-10, tgf-β, il-17, il-2, il-6, il-1β and tnf-α in gingival crevicular fluid (gcf) were evaluated at baseline, 45 and 180 days after therapy.

the nspt, which consisted of subgingival debridement - scaling and root planning (srp) under local anesthesia. on average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). the srp was performed by one experienced periodontist (krvv) using gracey curettes (hu-friedy mfg. co. inc., chicago, il, usa), ultra-sonic devices (bob-cat, dentsply/cavitron, long island city, ny, usa) and, if necessary, with multilaminated drills.

Eligibility criteria:
inclusion criteria: * all patients were diagnosed with periodontitis (p) the inclusion criteria were:loss of clinical insertion (cal) ≥ 5mm and pd probing depth ≥ 6mm in ≥ 30% of sites; ≥20 teeth; radiographic bone loss that extends to the middle level of the root; presence of supragingival and subgingival calculus according to the severity of periodontal damage. grade b was assessed indirectly, considering radiographic bone loss in the tooth most affected by dentition as a function of age (0.25 to 1.0). exclusion criteria: * 1) scaling and root planning or antibiotic treatment in the previous 6 months; 2) systemic diseases that could affect the progression of periodontitis (e.g., diabetes, hypertension, cardiovascular diseases); 3) extensive prosthetic involvement; 4) long-term administration of anti-inﬂammatory medication; 6) smokers and former smokers; 7) pregnancy or lactation; 8) orthodontic therapy; 9) use of mouth rinses containing antimicrobials in the preceding 2 months; 10) patients had previously received chemotherapy or radiotherapy; 11) patients with metastasis and/or patients with neoadjuvant chemotherapy.
randomized trial on adjuvant chemotherapy in colon carcinoma dukes b

Conditions: Colon Cancer Stage II

Summary: this clinical investigation examined the influence of cytostatic chemotherapy with 5-fluorouracil, modulated by biologically active leucovorin, on patients' survival time following surgery for colon carcinoma stage ii.


Eligibility criteria:
inclusion criteria: * patients with histologically verified, operable colon carcinoma stage ii (ro, t3-4, n0, m0) * age: less than 80 years * who performance \> 2 * adequate bone marrow reserve, renal and hepatic functions * informed consent exclusion criteria: * rectal cancer * r1or r2 resection; carcinosis peritonei * start of treatment \> 42 days postop; other adjuvant radiotherapy, chemotherapy or immunotherapy * serious concomitant disease, in particular chronically inflammatory large intestine, cardiopathic or metabolic disease, malignant second carcinoma

Keywords: fluorouracil leucovorin colon cancer