Kornimate/medical-research-clean huggingface dataset:
financial incentives for smoking treatment

Conditions: Smoking; Smoking, Tobacco; Tobacco Use Disorder

Summary: the investigators plan to compare the impact of two approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life among a diverse population of patients at the manhattan campus of the va new york harbor healthcare system, which serves a critical safety-net role for urban veterans. during hospitalization, all smokers will receive usual care. patients will be randomized to one of two arms: financial incentives plus usual care vs. usual care alone, which includes referral to the state quitline. all patients enrolled in the study will be offered nicotine replacement therapy. the investigators will conduct follow-up assessments at 2 weeks, 2 months, 6 months and 12 months after discharge. the primary study outcome is smoking abstinence at 6-month follow-up, verified by salivary/urinary cotinine.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, 2. smoked tobacco during the prior 30 days, 3. have an active u.s. phone number and address, 4. can provide consent in english and 5. are in at least the contemplative stage of change for quitting smoking, as assessed by a single measure, readiness to quit exclusion criteria: 1. use only smokeless tobacco, 2. are pregnant or breastfeeding, 3. are discharged to an institution (e.g., nursing home, long-term care facility), 4. are unable to provide informed consent, or do not have cognitive ability to enroll or participate in the study

Keywords: inpatients
safety of indacaterol in patients (≥ 12 years) with moderate to severe persistent asthma

Conditions: Asthma

Summary: this study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma.


Eligibility criteria:
inclusion criteria: 1. male and female patients aged ≥ 12 years (or ≥ 18 years depending upon regulatory and/or institutional review board/independent ethics committee/research ethics board \[irb/iec/reb\] approval) who have signed an informed consent form. 2. patients with moderate to severe persistent asthma, diagnosed according to the global initiative for asthma (gina) guidelines (updated 2006) and who additionally meet the following criteria: * patients who have used treatment with a bronchodilator, either regularly or on-demand, and who had used a daily dose of at least 100 μg beclomethasone dipropionate (or equivalent) for at least 1 month prior to screening. * patients whose forced expiratory volume in 1 second (fev1) is ≥ 50% of the predicted normal value. * patients with documented (in the previous 6 months) or who demonstrate (prior to randomization) a ≥ 12% and at least 200 ml increase in fev1, after inhaling 200 μg salbutamol. exclusion criteria: 1. pregnant or nursing (lactating) women and women of child-bearing potential unless they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception. 2. patients who have used tobacco products within the 12 month period prior to screening, or who have a smoking history of greater than 10 pack years. 3. patients who suffer from chronic obstructive pulmonary disease (copd) as diagnosed by the global initiative for chronic obstructive lung disease (gold) guidelines (2006). 4. patients who have had emergency room treatment for an acute asthma attack in the 6 weeks prior to screening or who have been hospitalized for an acute asthma attack in the 6 months prior to screening, or at any time between screening and week 1. 5. patients with diabetes type i or those with uncontrolled diabetes type ii including patients with a history of blood glucose levels consistently outside the normal range or glycosylated hemoglobin (hba1c) \> 8.0% measured at screening. 6. patients who, in the judgment of the investigator or the responsible novartis personnel, have a clinically significant condition or a clinically relevant laboratory abnormality that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. 7. patients with a history of long qt syndrome, or whose qtc interval (bazett's formula) is prolonged to \> 450 ms (males) or \> 470 ms (females). 8. certain medications for asthma and allied conditions such as long-acting bronchodilators must not be used prior to screening and for a pre-specified minimum washout period. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: asthma qab149 indacaterol
injectable platelets rich fibrin versus hyaluronic acid for alveolar ridge preservation

Conditions: Alveolar Ridge Enlargement

Summary: thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had arp either with i-prf with xenograft, ha with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate.

the aim of this study was to compare injectable platelets rich fibrin (i-prf) versus hyaluronic acid (ha) in combination with xenografts for arp. methods: thirty-six patients (19 females and 17 males) that required implant placement in esthetic zone participated in this study and were blindly allocated 12 patients per group, all patients had arp either with i-prf with xenograft, ha with xenograft or xenograft alone, the sockets were sealed with free gingival graft harvested from the palate. the assessment was done by cone beam ct preoperative and 4 months postoperative to assess radiographic bone gain and crestal bone loss. clinical parameters were soft tissue thickness, keratinized gingiva and clinical bone width that were assessed preoperative, 4 months and 1 year postoperative. histological assessment of core bone biopsies 4 months postoperatively was performed by histomorphometric analysis of newly formed bone %, mature bone% and residual graft%

Eligibility criteria:
inclusion criteria: * non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar) * socket type i according to elian et al., 2007 classification * tooth to be extracted was free from acute periapical infection or sinus tracts * thick gingival biotype * systemically free according to modified cornell medical index exclusion criteria: * smokers patients * bruxism habits * patients with poor oral hygiene or not willing to perform oral hygiene measures
efficacy, safety, and tolerability of higher doses estrogen therapy in women with premature ovarian insufficiency

Conditions: Primary Ovarian Insufficiency

Summary: the goal of this study is to assess the effects of higher doses versus standard hormone therapy on quality of life (qol), symptoms due to estrogen deficiency, and bone health in women with premature ovarian insufficiency (poi). the efficacy of the hormonal treatment will be assessed clinically and also by measuring serum concentrations of estradiol (e2), follicle-stimulating hormone (fsh), luteinizing hormone (lh), total testosterone (t), estrone (e1), e1 sulfate (e1s), and sex hormone binding globulin (shbg). bone mineral density (bmd) will be measured using dual-energy x-ray absorptiometry. safety will be assessed by measuring endometrial thickness with gynecological transvaginal ultrasound (tvs), treatment-related adverse events (aes) and treatment-emergent aes monitoring.


Eligibility criteria:
inclusion criteria: * patients with karyotypically normal spontaneous poi diagnosed before the age of 40. poi as defined by: change in menstrual function (oligomenorrhea and/or amenorrhea for at least 4 months), elevated serum follicle stimulating hormone (fsh ≥ 25 iu/l with 4 to 6 weeks interval) * between 18-45 years of age * use of standard-dose estradiol hrt (estradiol 2 mg+ dydrogesterone10 mg) for at least the last 12 months * signed informed consent before inclusion in the study exclusion criteria: * any contraindication to hrt per the current drug labels. these could include, but are not limited to: history of venous thromboembolism, estrogen-sensitive cancer history, regular cigarette smoking and history of or active liver disease, bleeding from the genital tract of unknown origin, etc. * poi due to cytotoxic chemotherapy or radiation therapy, surgery * diseases that may be associated with hot flashes (such as pheochromocytoma, hyperthyroidism, medullary carcinoma of the thyroid, acromegaly, pancreatic islet-cell tumors, renal cell carcinoma, carcinoid syndrome, systemic mast cell disease, neurological flushing, emotional flushing, spinal cord injury) * taking medications that can also cause hot flashes (such as tamoxifen, raloxifene, tricyclic antidepressants, monoamine oxidase inhibitors, calcium channel blockers, depo leuprolide, clomiphene, serotonin uptake inhibitors) * severe somatic conditions (uncontrolled hypertension, kidney disease, liver disease, etc.) * diseases with impaired thyroid and adrenal gland function * refusal to participate
lumina phase iii study assessing the efficacy and safety of intravitreal injections of 440 ug de-109 sirolimus for the treatment of active, non-infectious uveitis of the posterior segment of the eye

Conditions: Non Infectious Uveitis

Summary: this is a phase iii study to assess the efficacy and safety of de-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (niu-ps). there is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of de-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.


Eligibility criteria:
inclusion criteria: non-infectious active uveitis of the posterior segment exclusion criteria: females who are pregnant, nursing, or planning a pregnancy confirmed or suspected infectious uveitis
chromoendoscopy or narrow band imaging (nbi) for improving adenoma detection in colonoscopy

Conditions: Colorectal Neoplasms

Summary: narrow band imaging or electronic chromoendoscopy might provide similar adenoma detection capabilities while limiting time spent when compared to conventional chromoendoscopy method.


Eligibility criteria:
inclusion criteria: 1. age ≥ 40 years 2. referral for screening, surveillance or diagnostic colonoscopy exclusion criteria: 1. inflammatory bowel disease 2. history of colorectal cancer or colon resection 3. indication of positive fit or cologuard 4. any colorectal cancer syndromes (fap, hnpcc, sps) 5. patient with poor bowel preparation identified during insertion
efficacy and safety study of sorafenib plus pravastatin to treat advanced hepatocarcinoma

Conditions: Advanced Hepatocarcinoma

Summary: the purpose of this study is to evaluate the overall survival (os) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.


Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with advanced hepatocarcinoma (hcc), confirmed histologically or with non-invasive criteria, according to the clinical practice guidelines by the american association for the study of liver diseases (aasld) during a maximum period of 15 days prior to the baseline visit. * males and females, over 18 years of age. * patients who have not previously received treatment with sorafenib. * have an ecog ≤ 2. * liver function: child a and b7. * life expectancy greater than 12 weeks. * adequate kidney function: serum creatinine concentration less than or equal to 1.5 times the upper limit of normal (uln). * sign the written informed consent before starting any procedure, including randomization. exclusion criteria: * patients who routinely (more than 3 times a week) take some sort of statin. * patients with hypersensitivity to statins. * pregnant or breastfeeding women. * peripheral neuropathy: grade 2 or higher * patients who have been diagnosed, within the previous 5 years, with another type of tumor, except for non-melanoma skin cancer, or in situ carcinoma of the cervix or the urinary bladder. * patients receiving chemotherapy or radiotherapy for another type of tumor. * patients with heart failure greater than nyha grade ii, hypertension that is uncontrolled with medication, uncontrolled arrhythmias or ami within the previous six months. * a history of perforation or hemorrhage due to a gastroduodenal ulcus within the last month. * greater hemorrhagic diseases. * asthmatic patients uncontrolled with medication. * any other contraindication associated to the use of statins. * physical or psychological inability to participate in the trial. * treatment with another investigational drug or participation in another clinical trial within 6 months prior to inclusion in the study.
effects of gemigliptin versus sitagliptin or glimepiride with metformin on glucose variability(mage, glucose sd) patients with type 2 dm(stable study)

Conditions: Type 2 Diabetes Mellitus

Summary: to compare efficacy and safety of initial combination therapy of gemigliptin versus sitagliptin or glimepiride with metformin on glucose variability(mage, glucose sd) in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * adults aged ≥ 20 and aged ≤ 70 years old * patients who had not taken anti diabetes drug for 8 weeks prior to screening visit with hba1c ≥ 7.5% * all patients give written informed consent * patients applicable to any one of following 3 categories 1. patients with surgically induced infertility 2. post-menopause woman ≥45 years of age with over 2 years from the last menstruation 3. fertile pre-menopause woman or male patients who has consented for use of two or more contraceptive methods at least up to 14 days after final administration of the investigational product to avoid getting pregnant exclusion criteria: * patients with type 1 diabetes, patients with diabetic ketoacidosis or diabetic coma as well as pre-coma * patients with gestational diabetes mellitus or with secondary diabetes * patients with nyha class iii, iv congestive heart failure or with treatment-requiring arrhythmia * patients with thyroid dysfunction whose tsh is out of normal range, requiring medication therapy * patients with pituitary insufficiency or hypoadrenalism * patients whose bmi is less than 20 kg/m2 or exceeds 40 kg/m2 * patients whose total bilirubin level is 1.5 times higher than the upper limit of normal range and alt/ast are \> 2.5 times higher than the upper limit of normal range * patients currently taking strong cyp3a4 inducers * patients currently taking warfarin, dicoumar or digoxin * patients currently taking any medication from within 4 weeks before visit 1 (screening) likely to have significant effects on glycemic control or who require to take such medication * patients who had taken anti-obesity drugs within 12 weeks in prior to visit 1 (screening) * subject who had been treated with insulin or glp-1 analogue within 6 months before visit 1 (screening) * patients who had participated in other clinical study in the past 3 months before visit 1 (screening) * any other patients whom the investigator considers as inadequate for this study

Keywords: diabetes mellitus
genicular artery embolization as pain treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the aim of this study is to investigate the safety and efficacy of geniculate artery embolization (gae) as pain treatment in patients with mild to moderate knee osteoarthritis.

this is a single arm, prospective, pilot study investigating the safety and efficacy of gae as pain treatment in patients with mild to moderate knee osteoarthritis. patient related outcome measurements (proms), physical tests and several image modalities will be conducted. it may form the grounding for further research in the shape of a larger randomized clinical trial. the hypothesis is, that gae will reduce synovitis and thereby pain in the patient group. this may secondary improve physical function and reduce consumption of analgesics.

Eligibility criteria:
inclusion criteria: * body mass index \< 35 kg / m2. * x-ray verified mild to moderate koa (kellgren lawrence grade 1-3 \[24\]), obtained maximum 6 months prior to inclusion. * moderate to severe knee pain during walking (visual analog scale (vas) \> 50 mm) - resistant to minimum 3 months physiotherapy. * willing, able, and mentally competent to provide informed consent. exclusion criteria: * local infection in knee or groin areas. * moderate to severe pain in ipsilateral lower limb joints; vas \> 2. * intermittent claudication. * rheumatoid arthritis or seronegative arthropathies. * prior ipsilateral open knee surgery. * ipsilateral arthroscopy within 6 months. * ipsilateral intra-articular knee injection within 6 months. * current/recent (within 4 weeks) use of oral corticosteroids. * generalized pain syndrome (e.g. fibromyalgia) or nerve root compression syndromes. * pregnant or planned pregnancy during the study period. * lactation. * active malignancy. * known history of allergy to contrast media. * contra-indications for mri (e.g. metallic foreign bodies, etc). * manifest hyperthyroidism. * diabetes (i+ii). * liver disease. * only one kidney, former kidney surgery, reduced kidney function or failure (chronic or acute). * estimated glomerular filtration rate \ 60 years: another blood sample maximum 3 months prior to last mri scan with contrast agents). * inr \> 1.4, platelets ≤ 40 x 109 / l (all participants: blood sample maximum 30 days prior to gae). * antithrombotic treatment except acetylsalicylic acid. * diseases affecting the bone metabolism (e.g. severe osteoporosis, paget's disease, or hyperparathyroidism). * american society of anesthesiologists classification \> 3.

Keywords: embolization geniculate artery embolization knee osteoarthritis trans-arterial embolization
laser acupuncture in egyptian systemic lupus females with insulin resistance

Conditions: Systemic Lupus Erythematosus; PreDiabetes

Summary: glucose hemosatasis, oxidative stress, abnormalities of blood pressures, and high inflammatory status is high presented in lupus patients.

64 lupus prediabetic women will equally distributed to group a (n =32 that will receive laser acupuncture (active) for one month (3 days week) on acupoint number 14 of gv meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont) or group b (n =32 this group will receive the same protocol of group a but the points will be sham points)

Eligibility criteria:
inclusion criteria: * prediabetic lupus females (n =64) exclusion criteria: * obesity diabetes heart or respiratory problems
the influence of gip (glucose-dependent insulinotropic polypeptide) infusion on human adipose tissue: an in vivo study

Conditions: Adipose Tissue

Summary: study part-1 gip (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones secreted by specialized cells of the gastrointestinal tract in response to ingestion of nutrients. data emerging from studies in animal models and cultured human fat cells support a physiological role for gip in the adipose tissue metabolism which may contribute to the pathogenesis of obesity. the proposed study will shed more light on the interactions between gut hormones and adipose tissue. for this pilot study, male subjects fulfilling the inclusion criteria will be given gip or placebo infusions in a randomized manner. fat tissue biopsies will be obtained from all subjects during both visits, once in the basal state (before the start of the peptide/placebo infusion) and then repeated at the end of the period of infusion. study part-2 surgery represents the most effective therapeutic modality for morbid obesity. resolution of type 2 diabetes mellitus (t2dm) has been consistently observed as an additional benefit of surgical treatment of obesity. the mechanisms underlying the dramatic effects of surgery on insulin sensitivity and β-cell function are poorly understood. bariatric surgery (gastric bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from the physiological intestinal routes with subsequent profound modification of gut hormone secretion we hypothesize that restoration of gip action after bariatric procedures plays a cardinal role in the improvement and/or restoration of diabetes, we propose to study patients (both sex)with morbid obesity and t2dm within 3 months after their surgery. their responses will be compared to those of bmi matched control subjects with normal glucose tolerance


Eligibility criteria:
inclusion criteria: * lean (bmi 20-25 kg/m2) subjects with normal glucose tolerance * obese (bmi \>30 kg/m2) subjects also with normal glucose tolerance. * obese with impaired glucose tolerance * obese with diet controlled diabetes mellitus * morbid obesity, type diabetes and post bariatric surgery (study part 2) exclusion criteria: * history of severe cardiac, hepatic or renal disease * thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction) * current malignant disease * known alcohol misuse * major psychiatric disease (including current use of antidepressants) * history of major eating disorder (anorexia or bulimia nervosa)

Keywords: gip obesity hsl lpl adipocytokines bariatric surgery
safety study of ragweed allergy immunotherapy tablet in subjects 50 years of age and older (study p06081)

Conditions: Rhinoconjunctivitis; Rhinitis; Conjunctivitis; Allergy

Summary: the purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (ait) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.


Eligibility criteria:
inclusion criteria: * subject must be 50 years of age or older, of either sex, and of any race/ethnicity. * subject must have a clinical history of ragweed-induced allergic rhinoconjunctivitis with or without asthma. * subject must have a positive skin prick test response to ambrosia artemisiifolia at the screening visit * subject must have a forced expiratory volume in 1 second (fev1) of at least 70% of predicted value at the screening visit and at randomization. * a subject's clinical laboratory tests, electrocardiogram (ecg) and vital signs conducted at the screening visit must be within normal limits or clinically acceptable to the investigator. exclusion criteria: * subject with asthma who requires inhaled corticosteroids for the treatment of their asthma during the study period. * subject requiring anti-allergy medications during the time period from randomization to study completion. * subject who has received an immunosuppressive treatment within 3 months prior to the screening visit (except steroids for allergic and asthma symptoms). * subject with a history of anaphylaxis with cardiorespiratory symptoms. * subject with a history of chronic urticaria or angioedema. * subject with current severe atopic dermatitis. * female subject who is breastfeeding, pregnant, or intending to become pregnant. * subject with a history of allergy, hypersensitivity or intolerance to the ingredients of the investigational medicinal products (imps) (except for ambrosia artemisiifolia), or self-injectable epinephrine. * subject with a history of self-injectable epinephrine use.

Keywords: immunotherapy