Kornimate/medical-research-clean huggingface dataset:
intensive referral to reduce smoking in probationers

Conditions: Smoking Cessation; Substance Use Disorder

Summary: the purpose of this study is to determine if intensive referral intervention increases motivation to quit cigarette smoking and quitting-related behaviors in probationers and also to determine if intensive referral intervention improves short-term substance use outcomes in probationers with substance use disorder.

this is a longitudinal study of adults on probation who have a substance use disorder (sud) and smoke cigarettes. one-half of probation officers will be trained in the intensive referral intervention (iri) while one-half will deliver standard practice which is to encourage support group attendance. research staff will assess fidelity to the iri in trained probation officers. the investigators propose to enroll 150 probationers over a four month period and complete 3 and 6-month follow-up interviews to assess smoking and substance use measures.

Eligibility criteria:
inclusion criteria: * cbr-mh probationers in douglas county, ne * sud * daily cigarette smoker exclusion criteria: * under guardianship * unwilling to provide personal contact information * unable to pass mini-cog
artificial intelligence prediction tool in non-muscle invasive bladder cancer (nmibc)

Conditions: Non-muscle-invasive Bladder Cancer

Summary: this is a multi-center study and the aim is to develop and validate an artificial intelligence (ai) -based histologic analysis tool to predict responsiveness to intravesical bacillus calmette-guérin (bcg) and intravesical chemotherapy in intermediate and high-risk non-muscle invasive bladder cancer patients.

analysis will be performed on the most recent transurethral resection of bladder tumor (turbt) histologic specimen obtained prior to bcg induction and on histologic specimens at time of recurrence after bcg induction. this stratification is of potential utility to clinicians for patient counseling purposes, for the identification of patients likely to benefit from induction or re-induction with bcg, and for consideration of alternative treatment strategies including clinical trials, chemotherapy, or cystectomy. additionally, there is currently no reliable tool for identifying which nmibc patients are most likely to benefit from adjuvant bcg versus intravesical chemotherapy. this is of current relevance in the management of intermediate-risk (ir) nmibc since both bcg and chemotherapy are first-line treatment options and will likely become of increasing relevance in high-risk (hr) nmibc as efficacious first-line alternatives to intravesical bcg are introduced into clinical practice. in the proposed prospective study, the study team also aims to develop and then validate an ai-based histologic analysis tool for clinicians that is intended to predict recurrence following intravesical chemotherapy in ir and hr nmibc patients.

Eligibility criteria:
inclusion criteria: * diagnosis of intermediate or high-risk non-muscle invasive bladder cancer as defined by aua/suo criteria (intermediate-risk: recurrence within 1 year low grade ta, solitary low grade ta \>3 cm, multifocal low grade ta, high grade ta ≤3 cm, low grade t1; high risk: high grade t1, recurrent high grade ta, high grade ta \>3 cm, multifocal high grade ta, any cis, any bcg failure in high grade disease, any variant histology, any lymphovascular invasion) following pathologic evaluation of tissue specimens from turbt. * intravesical therapy within 6 months from enrollment including patients treated with bcg, mitomycin c, or gemcitabine/docetaxel. * english or spanish speakers * ≥ 18 years of age * ability to understand and the willingness to provide an informed consent exclusion criteria: * inadequate tissue from turbt * ≥ t2 bladder cancer * systemic therapy * inability to read or write english or spanish * unwilling to sign written informed consent

Keywords: nmibc bladder cancer
hysteroscopic metroplasty in unexplained infertile women with dysmorphic uterus

Conditions: Hysteroscopy; Pregnancy Rate; Abortion; Ectopic Pregnancy; Intrauterine Insemination

Summary: the correlation between dysmorphic uterus and infertility still remains enigmatic. we aim to evaluate the reproductive outcomes of metroplasty via office hysteroscopy in unexplained infertile women with dysmorphic uterus with comparing a group of unexplained infertile women performing 6 months spontaneous cycles plus 3 cycles controlled ovarian hyperstimulation and intrauterine insemination by randomized trial.

a dysmorphic uterus is a second-class (class u1) uterine anomaly in the the european society of human reproduction and embryology (eshre) and the european society for gynaecological endoscopy (esge) (eshre/esge) consensus on the classification of congenital genital tract anomalies, which was formerly known as "t-shaped uterus" in the american fertility society (afs) classification of anomalies of the müllerian duct that leads to poor reproductive and obstetric outcomes. the reproductive performance of dysmorphic uterus is not well-known issue. we designed a randomized trial in unexplained infertile couples women with dysmorphic uterus. after allocation of properly selected women, hysteroscopy group will be undertaken metroplasty procedure and 9 months follow-up period with natural conception. second group will be undertaken to six months spontaneous coitus and three cycles clomiphene citrate and intrauterine insemination cycles. after nine months of follow-up of both groups, the pregnancy and reproductive outcomes will be evaluated.

Eligibility criteria:
inclusion criteria: unexplained infertile couples with; 1. dysmorpic uterus in hysterosalpingography 2. normal spermiogram 2. bilateral patent tubes in hysterosalpingography 3. normal ovarian reserve (amh \>1.5 ng/dl and/or total bilateral antral follicle count \>8) exclusion criteria: 1. women with history of pelvic surgery including endometriosis and/or tubal surgery 2. women with endometrioma which was visualised/suspected on transvaginal ultrasonography 3. women with anovulation 4. women with diminished ovarian reserve (amh \< 1.5 ng/dl and/or total bilateral antral follicle count \<8) 5. couples with abnormal spermiogram parameters (oligospermia, oligoasthenospermia, oligoasthenoteratozoospermia, azospermia) 6. women with alive children 7. obese women (bmi\>30 kg/m2)

Keywords: dysmorphic uterus, metroplasty, hysteroscopy
an open-label trial of dexlansoprazole 60mg for the relief of heartburn during the fasting month of ramadan

Conditions: GERD; Proton Pump Inhibitor

Summary: dexlansoprazole modified release (mr), the r-enantiomer of lansoprazole, is an fda approved drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1. dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet needs that may accompany traditional proton pump inhibitors, with two separate ph-depended release phases, the first in the proximal duodenum and the second in the more distal small intestine. this dual release system extends the plasma concentration and pharmacodynamics effects beyond those of single-release ppis, allowing for dosing at any time of the day without regard to meals 1. a study conducted by fass et al. has shown that the use of dexlansoprazole mr 30 mg in patients with symptomatic gerd is significantly more effective than placebo in improving nocturnal heartburn, reducing gerd-related sleep disturbances, and consequently improving work productivity, sleep quality and quality of life 2. because of its pharmacokinetic properties, dexlansoprazole modified release (mr) may prove beneficial in optimizing the management of gerd and the associated burdens that often surface after the heavy evening and suhur meals, such as increased nocturnal symptoms and poor sleep quality.

to investigate the efficacy and quality of life improvement of dexlansoprazole 60mg taken once daily at iftar time in patients with known symptomatic heartburn exacerbated in ramadan and who are not on daily treatment.

Eligibility criteria:
inclusion criteria: * individuals 18-75 years old * fasting in ramadan * no daily ppi use * individuals willing to sign consent form * patients owning a smartphone and able to use a smartphone application exclusion criteria: * known erosive gerd on ppi * pregnant females * prior gastric surgery * long standing diabetes mellitus (≥10 years of disease) * frequent nsaid use (\>3x/week) * morbid obesity (bmi\>35) * history of recent (\<6 months) upper gi bleeding * patients who do not own a smartphone or who cannot use a smartphone application * known allergy to ppis * known history of poor compliance or adherence and active psychological problems which might impact adherence
tissue sparing surgery in total hip arthroplasty

Conditions: Total Hip Arthroplasty; Hip Arthrosis

Summary: rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior posterolateral approach (sperimental approach) to the hip articulation which entirely spares i.e. avoids the sacrifice of the fascia lata might elicit a better outcome in terms of gait, balance, strengths recovery, clinical performance, patient reported outcome measurement (short form-12(sf-12); hip disability and osteoarthritis outcome score (hoos)) and overall recovery time in patients undergoing totalhiparthroplasty with the aid of dedicated, modified instrumentation in order to properly access this modified route. the investigators expect an improvement on selected gait analysis parameters in sperimental approach in order of 2% of range of motion (rom) recorded 1 month after surgery. based on this assumption sample size calculation will be conducted.

rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior approach (experimental approach) to the hip articulation which entirely spares i.e. avoids the sacrifice of the fascia lata (posterolateral approach) might elicit a better outcome in terms of gait, balance,strenghts recovery, clinical performance, patient reported outcome measurements and overall recovery time in patients undergoing totalhiparthroplasty with the aid of dedicated, modified instrumentation in order to properly access this modified route.two patients groups will randomly be allocated in one of the two group with a computer generated 1:1 randomization table.total number of subjects participating in the study:50.

Eligibility criteria:
inclusion criteria:- patients affected by: * non-inflammatory degenerative joint disease, including osteoarthritis * patients in the age from 60 to 85 included * consenting to actively participate in the study and in the rehabilitation follow up program as foreseen by the study * 18 ≤ body mass index (bmi) ≥ 30 kg/m2 * patient without contralateral tha exclusion criteria:-revision procedures where other treatments or devices have failed * active infection or suspected latent infection in or about the hip joint * bone stock that is inadequate for support or fixation of the prosthesis * skeletal immaturity * any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complication in post-operative care * obesity (bmi ≥30kg/m2)

Keywords: tissue sparing surgery
value of abciximab in patients with ami undergoing primary pci after clopidogrel pretreatment (brave 3)

Conditions: Myocardial Infarction

Summary: the purpose of this study is to assess whether abciximab is associated with additional benefit in patients with ami treated with pci after high dose clopidogrel loading.

the goal of all reperfusion therapies in acute myocardial infarction (ami) is an effective restoration of coronary blood flow and the reduction of infarct size. recently, the researchers were able to achieve excellent results with primary stenting plus abciximab in terms of reduction of infarct size and improvement of clinical outcome in the stopami trial. this strategy provided a clear benefit compared to fibrinolysis. on the basis of the data published in the last 2 years, hospitals without angioplasty facilities have now better possibilities to improve the results of primary treatment of patients with ami by immediately referring these patients to highly experienced centers in coronary interventions. there is an increasing interest to assess the additional advantages of pharmacologic reperfusion approaches which are readily applicable in the time window between presentation and arrival at the catheterization room. two studies have shown that the results of the pci in patients with ami pretreated with fibrinolysis may even be more unfavorable than those achieved with angioplasty alone. glycoprotein (gp) iib/iiia blocker abciximab has been shown to improve the results of the primary pci in ami. however, no rapidly effective antiplatelets therapy was available at the time when the studies on the benefit of abciximab were performed. recent studies have shown that a high, 600 mg loading dose of clopidogrel is significantly more rapidly acting and that maximal inhibition of platelet aggregation is achieved within 2 hours after administration. in the isar-react trial, a high loading dose of clopidogrel was well tolerated, associated with such a low frequency of procedural complications that the use of abciximab offered no clinically measurable benefit at 30 days. comparison: abciximab (bolus+infusion for 12h) versus placebo (bolus+infusion for 12h) after pre-treatment with 600 mg clopidogrel.

Eligibility criteria:
inclusion criteria: * patients presenting with st-elevation acute myocardial infarction within 24 hours from the onset of symptoms exclusion criteria: * age \>80 years * malignancies * cardiogenic shock * prolonged cardio-pulmonary resuscitation * increased risk of bleeding * relevant hematologic deviations (hemoglobin \ 600 x 10\^9 /l) * known allergy to the study medication * pregnancy (present or suspected)
intravitreal injection versus sub-tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema during cataract surgery

Conditions: Diabetic Macular Edema

Summary: triamcinolone has already been used by different routes of administration to treat diabetic macular edema. in the present study, intravitreal injection (ivi) and posterior sub-tenon's infusion (sti) of triamcinolone acetonide (ta) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.


Eligibility criteria:
inclusion criteria: * refractory diffuse dme unresponsive to focal laser photocoagulation * best corrected visual acuity between 20/800 and 20/40; central subfield macular thickness greater than 300 µm exclusion criteria: * previous ocular surgery * glycosylated hemoglobin (hb a1c) rate above 10% * history of glaucoma or ocular hypertension * loss of vision as a result of other causes * systemic corticoid therapy * severe systemic disease * any condition affecting follow-up or documentation

Keywords: diabetes macular edema triamcinolone cataract refractory diabetic macular edema
compatibility and immunogenicity of a short specific immunotherapy (sit) in contrast to classic specific immunotherapy

Conditions: Immunotherapy

Summary: we wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy. therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.

see above

Eligibility criteria:
inclusion criteria: * informed consent of patient and/or parents * age \>6 and \<18 years * bronchial asthma i° or ii° * allergy on house dust-mite exclusion criteria: * age \ 18 years * vital capacity \<80% or fev1 \<70% * pregnancy * inhalative or systemic steroid use * bronchial asthma iii° or iv° * heavy exacerbation during the last 3 months

Keywords: immunotherapy mite asthma bronchial provocation sit specific immunotherapy
breathing exercises in patients with gastroesophageal reflux

Conditions: Reflux Disease, Gastro-Esophageal

Summary: the aim of this study was to examine the effects of diaphragmatic breathing exercises combined with relaxation exercises on patient-reported reflux symptoms, quality of life, anxiety, and depression levels in patients diagnosed with gastroesophageal reflux.

gastroesophageal reflux disease is a pathological condition in which various symptoms and/or complications occur as a result of the escape of stomach contents into the esophagus, oral cavity, or lungs. gastroesophageal reflux disease is largely associated with various respiratory diseases such as chronic cough, idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, and asthma. accordingly, respiratory function deterioration may be observed in spirometric measurements. increased symptom burden in gastroesophageal reflux patients has been associated with poor quality of life, sleep disturbances, and decreased physical function and productivity. however, increased anxiety and depression levels in patients are also closely related to reflux symptoms.at the esophagogastric junction, the lower esophageal sphincter and the surrounding crura of the diaphragm constitute an important part of the protective mechanism against reflux. the crural diaphragm, which contracts during inspiration, acts as an additional external sphincter. since the crural diaphragm is a striated muscle structure, it is possible to improve its function with exercise. eherer et al. (2012) examined the effects of diaphragmatic breathing exercises performed for 30 minutes per day for 4 weeks on ph levels, quality of life, and medication use in patients with non-erosive reflux. as a result of the study, they found that quality of life increased and acid exposure decreased.the recurrence rate and maintenance treatment requirement after treatment are high in reflux patients. proton pump inhibitor drugs commonly used in treatment may have various side effects in the long term. although the diaphragm muscle is an important part of the protective mechanism against reflux, there are few studies investigating the effects of applications targeting this muscle on reflux.

Eligibility criteria:
inclusion criteria: * individuals who do not have cardiopulmonary, mental, connective tissue, metabolic, or other diseases that may prevent exercise * individuals who do not have body mass index \>35 or \<18 * individuals who are not addicted to alcohol or cigarettes * individuals who are between the ages of 18 and 65 * individuals who are diagnosed with non-erosive reflux will be included in the study. exclusion criteria: * individuals with a history of gastrointestinal surgery * individuals who are pregnant or breastfeeding * individuals who have hiatal hernia

Keywords: breathing exercises relaxation quality of life anxiety
smartset hv and palacos r rsa bone cements in primary total hip arthroplasty

Conditions: Arthritis

Summary: a randomised radiostereometric study comparing smartset hv and palacos r acrylic bone cements.

the fixation of components in total hip arthroplasty has a significant effect on the long-term survival of the prostheses. bone cement in total joint replacement acts as an anchoring medium for the prosthesis and provides a barrier to the ingress of wear debris into bone surfaces. however, there are significant differences in cement behaviour among differing types of cement. a clinical study based on the norwegian arthroplasty register demonstrated that there is an increased rate of revision due to aseptic loosening of femoral components implanted with low-viscosity cement compared with that of high-viscosity. studies have shown that high early migration for certain designs of femoral prosthesis can be a predictor for clinical loosening. rsa is a technique enabling calculation of the three-dimensional translational and rotational movements of the implant relative to the bone, and therefore provides an ideal technique to detect early micromotion of implants.

Eligibility criteria:
inclusion criteria: * patients in need for total hip arthroplasty exclusion criteria: * patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips), * patients on corticosteroid treatment, * patients who had already participated in a clinical study with an investigational product in the last 6 months.

Keywords: total hip arthroplasty charnley stem rsa non-inflammatory arthritis
bicalutamide plus aromatase inhibitors in er(+)/ar(+)/her2(-) metastatic breast cancer

Conditions: Breast Cancer

Summary: this study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in er(+)/ar(+)/her2(-) metastatic breast cancer patients who have disease progression after treatment of an aromatase inhibitor.

androgen receptor(ar) is closely related to molecular type, treatment and prognosis in breast cancer. over 70% of breast cancer expressed androgen receptor. and in some estrogen receptor positive breast cancer cells which are resistant to aromatase inhibitors can change androgen receptor dependent. so ar may be a new target in the treatment of breast cancer. bicalutamide is a selective androgen receptor inhibitor with a clinical benefit rate of 19% and median progression free survival of 12 weeks in the er-/ar+ metastatic breast cancer. this study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in er+/ar+/her- metastatic breast cancer patients who have disease progression after treatment of an ai.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed estrogen receptor positive, androgen positive and her2 negative breast cancer * metastatic or unresectable locally advanced disease * age over 18 years * postmenopausal status （continuous using luteinizing hormone releasing hormone(lhrh) analogue is available） * patient must have disease progression after treatment of an aromatase inhibitor. * eastern cooperative oncology group (ecog) performance status (ps)0-2 * life expectancy over 3 months. * measurable disease according to recist version 1.1 or only bone metastasis * adequate hematological, hepatic function. * voluntarily signed and dated written informed consent prior to any study specific procedure. exclusion criteria: * patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis * concomitant diseases/conditions that is not controllable, and any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study. * history of other primary malignancy * resistant to steroidal or nonsteroidal aromatase inhibitor

Keywords: androgen receptor bicalutamide aromatase inhibitors advanced breast cancer letrozole anastrozole exemestane