Kornimate/medical-research-clean huggingface dataset:
compare the compliance of patients treated with once-daily (od) or twice-daily (bid) glimepiride and metformin fixed combination therapy

Conditions: Type 2 Diabetes Mellitus

Summary: the study design of this trial is open-label, randomized, multi-center, parallel-group study.

the effectiveness of treatment of a disease depends mainly on two factors: the efficacy of the treatment and the compliance of the patient with this treatment. polymedication is one of the predisposing factors to low compliance in type 2 dm. it can be expected that a simple regimen may improve compliance. amaryl mex phase iii trial was not designed to compare the compliance of patients with different dosing regimens of oral antidiabetic drugs. however, it was found that patients' compliance in the morning was better than in the evening, suggesting that amaryl mex once daily regimen may improve compliance. pill count is the gold standard for measuring compliance, but this method provides incomplete and unreliable results. advanced electronic monitoring device obtains details of patients' behavior during the day and over long periods.

Eligibility criteria:
inclusion criteria: * patients aged between 18 \~ 75 years at screening * patients who have been diagnosed with type 2 dm for at least 3 months * patients who were treated with a stable dose with combination therapy of glimepiride 4mg or more and metformin 1000mg or more which can switch to amaryl m 2/500mg bid or amaryl mex 2/500mg 2t od regimen. * hba1c ≤ 9 % at randomization * bmi ≤ 40 kg/m2 at randomization * patients who would give the informed consent * patients who can perform smbg and record the data on the patient's diary * patients who can understand and use mems properly exclusion criteria: * patients with the medical history of acute metabolic complications such as diabetic ketoacidosis, hyperosmolar nonketotic coma within 3 months prior to the study participation * patients who are under insulin therapy at randomization * patients who received systemic corticosteroid agent within 4 weeks prior to the study participation * patients with acute, severe cardiovascular disease (e.g., heart failure, myocardial infarction, stroke, etc). * pregnant or lactating females * history of drug or alcohol abuse * patients with known hypersensitivity to the ingredient of the study drug or drugs in sulfonylurea, sulfonamide, biguanide class * night-shift workers * patients with an experience of participating in other clinical trial within 3 months prior to the study participation * clinically significant laboratory abnormality on screening labs or any medical condition that would affect the completion or outcome of the study based on investigator's decision * patients with serum creatinine level \> 1.5 mg/dl in male and \> 1.4 mg/dl in female * patients with alt or ast \> 3x uln * any conditions requiring help of others with drug administration (e.g. manual disability, serious visual defect, etc.)

Keywords: amaryl mex
relative effectiveness of schizophrenia therapy study

Conditions: Schizophrenia; Bipolar Disorder

Summary: the purpose of this study is to validate that sult4a1-1 status stratification improves responses to atypical antipsychotics in schizophrenia and to extend these findings into bipolar disorder.

the total economic burden for schizophrenia (sz) in the u.s. is estimated to be more than $60 billion annually. a large contributor to the economic burden of this and other chronic mental disorders, including bipolar disorder (bpd), is the exacerbation of symptoms and disability due to lack of drug efficacy. for these disorders, clinicians typically choose a first line antipsychotic therapy without the support of a diagnostic tool; often, patients are switched to another drug after less than six months of treatment due to what is perceived by patients and clinicians as both insufficient efficacy and unacceptable side effects. originally, the sulfotransferase family 4a, member 1 (sult4a1) gene was selected as a biomarker of interest in sz based on results showing associations between the gene and disease severity. later on, sult4a1 gene status was also associated with better efficacy of atypical antipsychotic (e.g. zyprexa® (olanzapine) and risperdal® (risperidone)), with respect to both time to discontinuation and quantitative measures of clinical improvement. in this prospectively designed, non-randomized retrospective study, we will recruit and genotype subjects with schizophrenia or bipolar disorder that were/are new to therapy for any of the four drugs under evaluation. by looking at retrospective and prospective longitudinal medical and pharmacy data stored within the integrated claims database, we will validate the association of the sult4a1 gene to the efficacy of selected atypical antipsychotic therapies.

Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years of age * subjects with either a confirmed diagnosis of schizophrenia or bipolar disorder or subjects with self reported schizophrenia or bipolar disorder * subjects who were/are new to therapy for olanzapine, risperidone, quetiapine or ziprasidone * subjects who are willing and able to provide informed consent exclusion criteria: * subjects initially prescribed less than the generally accepted minimally effective dose of the drugs under study * subjects with major depressive disorder (mdd) or another psychotic disorder other than schizophrenia or bipolar disorder * subjects with catatonic schizophrenia * subjects with moderate to severe mental retardation * subjects that refuse to participate in the study

Keywords: schizophrenia bipolar disorder atypical antipsychotic adherence cost effectiveness pharmacogenetics mental illness sult4a1
deep infiltrating endometriosis : laparoscopic nerve-sparing surgery and use of neutral argon plasma

Conditions: Endometriosis Ovary

Summary: medical treatment of endometriosis has a suspensive and sometimes incomplete effect on the symptoms, making surgical treatment necessary. the aim of surgical treatment of deep endometriosis is to restore normal anatomy and functional integrity. resection of deep endometriosis lesions is recommended to relieve pain, gynecological and digestive symptoms, but rarely urinary disorders. nerve-sparing surgery, when feasible, reduces post-operative dysuria by sparing the lower hypogastric plexus. the major limitations of these surgical procedures are the experience of the surgeon and the extent of the disease. acquiring the surgical techniques and skills necessary to carry out these types of procedures is essential to providing optimal patient care.


Eligibility criteria:
inclusion criteria: * adult woman (≥18 years old) * patient who benefited from treatment by nerve-sparing surgery and the use of neutral argon plasma in the context of symptomatic deep pelvic endometriosis at the strasbourg university hospital during 2021 * patient who did not express, after information, the reuse of her data for the purposes of this research. exclusion criteria: * patient who expressed her opposition to participating in the study * patient under legal protection, under guardianship or under curatorship

Keywords: endometriosis ovary laparoscopic surgery laparoscopic surgical procedure schwanoma
iglucose® remote patient monitoring device as an adjunct to routine glucose meter devices for glycemic management and control in gestational diabetes

Conditions: Gestational Diabetes; Type2 Diabetes; Pregnancy in Diabetic

Summary: the purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed smbg checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? this is a rct


Eligibility criteria:
inclusion criteria * all patients \>/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks. * non-anomalous singletons * ability to provide informed consent exclusion criteria * patients with type 1 diabetes * patients with fetal major congenital abnormalities * patients identified/referred after 30.6 weeks
hza113091 efficacy and safety of fluticasone furoate/vilanterol (gw642444) in adults and adolescents

Conditions: Asthma

Summary: the purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (gw642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of asthma * reversibility of at least 12% and at least 200mls within 10-40 minutes following 2-4 inhalations of albuterol * fev1 of 40-85% predicted normal * currently using inhaled corticosteroid therapy exclusion criteria: * history of life-threatening asthma within previous 5 years (requiring intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxic seizures) * respiratory infection or oral candidiasis * asthma exacerbation requiring oral corticosteroids or that resulted in overnight hospitalisation requiring additional asthma treatment * uncontrolled disease or clinical abnormality * allergies * taking another investigational medication or prohibited medication * night shift workers * current smokers or subjects with smoking history of at least 10 pack years

Keywords: salmeterol fluticasone furoate vilanterol fluticasone propionate gw642444
eeg@home (phase 3b of the project, interviews)

Conditions: Epilepsy

Summary: the goal of this project is the development of an eeg-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality eeg signals. the purpose is to use the eeg-cap to investigate clinical neurological disorders (e.g. epilepsy). the eeg-cap could also be used at home so that hospital admission in the emu can be avoided for some patients and an increasing number of patients can be examined. phase 3 of this project will be divided into phase 3a and phase 3b. in phase 3b of the project epilepsy patients and their family will be interviewed about different eeg-cap models in development. this interview is anticipated to take approximately 1 hour. minimum 4 - maximum 20 epilepsy patients and their family will be interviewed. the results of the interviews will be analysed by the design company pilipili nv.


Eligibility criteria:
inclusion criteria: * epilepsy patient exclusion criteria: * no experience with eeg
fascia iliaca block in the emergency department for analgesia after femoral neck fracture

Conditions: Femoral Neck Fracture

Summary: femoral neck fracture is very common in the elderly and can produce severe to moderate pain. as this pathology is not life-threatening, waiting time in the emergency department may be prolonged due to the high number of unforeseen cases with patients remaining in pain. fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca, resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves, with effective analgesia.

the objective of this trial is to compare the fascia iliaca block with a sham injection on patients arriving in the emergency department with a femoral neck fracture. the fascia iliaca block will be performed with an anatomical landmark technique and a volume of 30 mls of bupivacaine 0.5% with epinephrine 5 mcg/ml will be injected.

Eligibility criteria:
inclusion criteria: - patients with femoral neck fracture in the emergency department exclusion criteria: * presence of demencia * body weight less than 40kg * presence of a cancer or patients receiving chemotherapy * allergy to local anaesthetics

Keywords: analgesia emergency medicine anesthesia, regional
must cannulation technique of vascular access in patients undergoing haemodialysis: contributions for a safe nursing intervention

Conditions: Chronic Kidney Diseases; Hemodialysis; Vascular Access Complication; Hemodialysis Access Failure; Arteriovenous Fistula

Summary: the aims of this study are to: * determine the avf (arteriovenous fistula) survival of patients submitted to must compared to those submitted to rl (rope-ladder). * determine the avf (arteriovenous fistula) complication rate of patients submitted to must compared to those submitted to rl (rope-ladder). * analyze the intensity of pain perceived by the patient with each cannulation technique under study.

the must is based on the association between the rl technique in that it uses the entire length of the available vessel through progressive rotation, and the buttonhole (bh) cannulation technique since there are three specific cannulation sites for each cannulation day during the week, meaning that each site is only cannulated once a week (allowing the puncture site to heal in between cannulations).

Eligibility criteria:
inclusion criteria: * voluntarily agree to participate in the study and sign an informed consent; * are on a regular haemodialysis (hd) program with three weekly sessions; * avf has been in use for at least 4 weeks without incident; * avf with blood flow (qa) ≥500 ml/min evaluated by thermodilution; * avf paths allow cannulations along the entire length of the vein with at least 6 cm of distance between bevels, or two distinct areas of 3 cm in length; * adult patients exclusion criteria: * those who decline to take part; * those who have undergone angiography or surgical intervention in the last 4 months in the avf in use; * those who have undergone three or more interventions in the avf in use; * those with use of anesthetic creams at cannulation sites.

Keywords: chronic kidney disease hemodialysis vascular access vascular access complication rope-ladder cannulation
myofascial release technique in women with primary dysmenorrhea

Conditions: Dysmenorrhea Primary; Central Sensitisation; Myofascial Trigger Point Pain; Menstrual Discomfort; Myofascial Release

Summary: it has been found that women with dysmenorrhea have active trigger points, particularly in the rectus abdominis, oblique abdominal muscles, quadratus lumborum, and paraspinal muscles. the myofascial release technique is a widely used manual therapy method characterized by the application of low-load, long-duration mechanical forces to manipulate the myofascial complex. this technique aims to restore optimal length, alleviate pain, and improve function. this study aims to examine the effect of the myofascial release technique on central sensitization, myofascial trigger points, and menstrual symptoms in women with primary dysmenorrhea.

during the evaluation period, the participants' musculoskeletal pain threshold and tolerance will be measured using an algometer, about trigger points on the identified muscles (rectus abdominis, quadratus lumborum, erector spinae, and tibialis anterior). a total of 40 women, aged 18-40, diagnosed with primary dysmenorrhea by a gynecologist, will be included in the study. the initial assessment of the participants will be conducted on their most painful days. participants will be randomized into two groups: the myofascial release technique group (study group) and the placebo myofascial release technique group (control group). the interventions will be conducted over 10 sessions during one menstrual cycle, and all evaluations will be repeated after the treatment period. the study will be conducted as a double-blind trial, ensuring that both the evaluators and the patients are blind to the group assignments.

Eligibility criteria:
inclusion criteria: * diagnosed with primary dysmenorrhea according to the primary dysmenorrhea consensus guide, * having regular menstruation in the last 6 months (28±7 days) * those who had menstrual pain between 40 mm and 100 mm according to the visual analogue scale (vas) in the last 6 months exclusion criteria: * diagnosed with secondary dysmenorrhea, * having given birth, * those with serious gastrointestinal, urogynecological, or autoimmune diseases or other chronic pain syndromes, * undergoing urogynecological surgery, * those who are pregnant or suspected of pregnancy, * those who use analgesics or non-pharmacological agents other than nsaids for menstrual pain, * those using intrauterine or oral contraceptives, * those taking extra supplements such as magnesium, which may affect treatment

Keywords: myofascial release trigger point central sensitization dysmenorrhea sham
comparison of 2 techniques of surgically assisted rapid maxillary expansion

Conditions: Malocclusion; Maxillar Hypoplasia; Transverse Maxillary Deficiency

Summary: this study evaluates 2 techniques of surgically assisted rapid maxillary expansion (sarme) in the treatment of maxillary transverse deficiency. half of participants will undergo an osteotomy between the maxillary central incisors, while the other half will undergo an osteotomy between the maxillary lateral incisors and canines (bilateral osteotomies).

surgically assisted rapid maxillary expansion (sarme) can be performed by a osteotomy between the maxillary central incisors and by osteotomies between the maxillary lateral incisors and canines (bilateral). both techniques treat transverse maxillary hypoplasia, but they do so with different effects on esthetics, periodontium, teeth and bone expansion.

Eligibility criteria:
inclusion criteria: patients with bilateral cross-bite and bilateral transverse maxillary deficiencies equal to or greater than 6 mm - exclusion criteria: patients with previous histories of maxillary surgery, congenital craniofacial malformations, unilateral transverse maxillary deficiencies and absence of teeth in the maxilla. -

Keywords: surgically assisted rapid maxillary expansion surgically assisted rapid palatal expansion malocclusion
isp-tace versus tace for hcc with pvtt

Conditions: HCC; Portal Vein Tumor Thrombosis

Summary: for patients with advanced hepatocellular carcinoma (hcc) and portal vein tumor thrombosis (pvtt), the survival benefit of transarterial chemoembolization (tace) remains modest. this study aimed to investigate whether tace in combination with irradiation stent placement (isp) could prolong the survival in patients with hcc and pvtt.


Eligibility criteria:
inclusion criteria: * (1) newly diagnosed hcc with type ii or iii pvtt, (2) child-pugh classification grade a or b, (3) eastern cooperative oncology group (ecog) performance status score 0-2. exclusion criteria: * (1) type i or iv pvtt, (2) received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, (3) suffered from malignancy other than hcc, (4) with an incomplete data.

Keywords: transarterial chemoembolization stent irradiation survival decompensation tumor response
roflumilast on markers of bone metabolism and endothelial function in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: our primary hypothesis is that roflumilast (500 μcg, once daily) will significantly decrease surrogate markers of bone metabolism and early cardiovascular disease in individuals with moderate to severe airflow obstruction and a chronic bronchitis phenotype.

study participants will be given roflumilast 500 micrograms daily for 30 days. at baseline, prior to drug administration, blood samples will be collected for analysis of markers of bone metabolism (c-terminal telopeptide of type i collagen (ctx), amino-terminal propeptide of type-1 procollagen (p1np) and participants will undergo measurement of endothelial function with measurement of brachial flow mediated dilation. after completion of one month of roflumilast therapy, participants will have a repeat blood collection for measurement of ctx and p1np and repeat measurement of brachial flow mediated dilation testing.

Eligibility criteria:
inclusion criteria: * subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco exposure, airflow obstruction (fev1/fvc \< 0.70) with an fev1 \< 70% * baseline sputum production at least some of the time as reported on the saint george's respiratory questionnaire, and at least one exacerbation within the past year exclusion criteria: * subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates, calcitonin, parathyroid hormone) * subjects with a body mass index less than 18 or greater than 34

Keywords: roflumilast copd
efficacy of lower limb exercises on overactive bladder symptoms in patients with multiple sclerosis

Conditions: Overactive Bladder Syndrome; Multiple Sclerosis; Muscle Strain

Summary: the aim of the study (overact_v1) is to verify if the isometric contraction of ankle plantarflexor and hamstring muscles, induces a significant reduction of overactive bladder symptoms in patients with multiple sclerosis.

the aim of the study (overact_v1) is to verify if the isometric contraction of ankle plantarflexor and hamstring muscles, induces a significant reduction of overactive bladder symptoms in patients with multiple sclerosis. it's known that the electric stimulation of the posterior tibial nerve induces an improvement of overactive bladder symptoms through a modulation of spinal circuitry, which occurs with unknown mechanisms. the investigators' hypothesis is that the voluntary muscular activation may induce a modulation of the sacral root as long as the electric stimulation. 30 patients will be recruited within 2 years, since october 2017 through october 2019. this is a monocentric, randomized controlled , in single blind, not pharmacological study.

Eligibility criteria:
inclusion criteria: * multiple sclerosis patients * urge score \>=2 * urinary daytime frequency \>=8 * stable overactive bladder symptoms for 6 months * mrc ( medical research council) scale of ankle plantarflexors and hamstrings \>=2 * signed informed consensus exclusion criteria: * fim ( functional independence measure) memory items \<=4 * impairment in registering bladder diary * inclusion in other experimental study * specific straightening during the suty period * pvr \>= 200 ml ina single evaluation or pvr (post void residual) \>=150 in 4 evaluation (twice a day for 2 consecutive days) * urinary infections * concomitant urological disease * intrathecal baclofen pump * sans (stoller afferent nerve stimulation) * modification of therapy for overactive bladder symptoms within three months before entering the study
quality of life outcomes following minimally invasive and open esophagectomy for esophageal cancer

Conditions: Esophageal Cancer

Summary: the goal of this study is to evaluate how surgery for esophageal cancer affects the patient's quality of life over time. the investigators hope this study will provide important information that can be used to improve the quality of life of patients with esophageal cancer. this study will also look at how standard tests and information collected from the patients difficulty swallowing can predict the extent of their esophageal cancer before surgery.


Eligibility criteria:
inclusion criteria: * age 18 or older * diagnosis of esophageal cancer, stages i-iiic, with no prior esophageal resection. neoadjuvant therapy given prior to presentation at mskcc will be accepted. * anticipated to undergo surgical resection (ivor lewis, trans hiatal, thoracoabdominal, or mckeown procedure) of esophageal cancer either by open or minimally invasive methods * chest and abdomen ct scan * ability to speak read and write english. exclusion criteria: * inability to give informed consent * patients requiring a laryngectomy or colon interposition as part of their surgical resection. * patients with scleroderma.

Keywords: minimally invasive esophagectomy open esophagectomy quality of life 12-003