Kornimate/medical-research-clean huggingface dataset:
a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (bms-477118) in combination with metformin ir or metformin xr in pediatric patients with type 2 diabetes who have inadequate glycemic control on metformin alone

Conditions: Diabetes Mellitus, Type 2

Summary: to evaluate the efficacy, safety, tolerability, of saxagliptin (bms-477118) in combination with metformin in pediatric patients with type 2 diabetes

a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of saxagliptin (bms-477118) in combination with metformin ir or metformin xr in pediatric patients with type 2 diabetes who have inadequate glycemic control on metformin alone or in combination with baseline insulin therapy

Eligibility criteria:
inclusion criteria: * male and female patients eligible if 10 years of age, up to 17 years and 30 weeks of age at the time of screening * previously diagnosed as having type 2 diabetes * hba1c ≥7.0% and ≤10.5% * body weight ≥ 30 kg * stable dose of metformin (≥ 1000mg - ≤ 2000mg) for a minimum of 2 months * women must have a negative serum or urine pregnancy test * women must not be breastfeeding exclusion criteria: * current use of anti-diabetic medications or use within the specified timeframe prior to screening (exception: metformin) * fasting plasma glucose (fpg) \> 255 mg/dl * diabetic ketoacidosis (dka) within 6 months of study entry * abnormal renal function * active liver disease * anemia * an abnormal thyroid stimulating hormone (tsh) * creatinine kinase (ck) ≥ 3x uln
app for adverse events to oral chemotherapy - pilot study

Conditions: Breast Neoplasms; Chemotherapeutic Toxicity

Summary: in recent years, the treatment paradigm for hormone receptor positive, her2-negative disease has shifted from "chemotherapy for visceral disease" and "hormone therapy for bone disease" to "chemotherapy only for visceral crises or endocrine resistance". in recent years, cdk4/6 inhibitors have been added to the therapeutic arsenal. a meta-analysis of clinical trials of first-line metastatic cdk4/6 inhibitors showed an improvement in progression-free survival but an increase in toxicities compared to endocrine therapy alone. other commonly used oral therapies for breast cancer are mtor inhibitors and capecitabine. other oral molecules will be added to the therapeutic arsenal in the coming years (e.g. alpelisib and tucatinib), each with specific toxicities. newer targeted therapies given in combination with endocrine therapies for breast cancer (eg with palbociclib, everolimus, and capecitabine) pose a challenge to health care providers because they are oral drugs. for "traditional" intravenous chemotherapy, patients must go to the hospital regularly, which allows close care by a team of doctors, pharmacists and nurses dedicated to breast cancer. on the other hand, for oral agents, monitoring is less systematic. monitoring and managing the toxicities of oral treatments becomes a challenge. suboptimal management of side effects can compromise patients' adherence to their treatment, have a negative impact on their side effects and increase costs for the healthcare system. systematic follow-up is therefore necessary. in the information age, public access to the internet is increasing and most households in the province of quebec now have access to the internet, either on a smart phone, tablet or computer. recent studies have shown that having a system to "self-report" side effects could even improve the survival of cancer patients and reduce costs. apps allow patients to take an active role in their healthcare. with the availability of an increasing number of oral therapies, monitoring the toxicities experienced by these patients is becoming a challenge and oncology teams need tools to help them ensure patient safety. at the same time, patients clearly want more information. the potential benefits and ease of use of web interfaces and patient portals for the management of oral therapy toxicities are appealing, but there is a lack of studies on them.


Eligibility criteria:
inclusion criteria: * \>=18 years of age * metastatic breast cancer * receiving oral chemotherapy (palbociclib, everolimus, or capecitabine) * possess an smartphone, a tablet, or a personal compiter exclusion criteria: * cognitive impairments
dose finding study of pramipexole (sifrol) in patients with idiopathic restless legs syndrome (rls)

Conditions: Restless Legs Syndrome

Summary: the purpose of this study was to evaluate the efficacy and safety of different doses of pramipexole (sifrol) on subjective and objective symptoms of idiopathic restless legs syndrome (rls) and also to determine the optimal dose of pramipexole in patients with rls by polysomnography and evaluation of clinical improvement.


Eligibility criteria:
inclusion criteria: 1. male and female 18-80 years 2. confident diagnosis of rls according to international rls study group criteria 3. rls rating scale for severity score \>15 4. plm (during time in bed ) index at least 5 per hour 5. weekly presence of rls symptoms within last three months 6. written informed consent exclusion criteria: 1. women of childbearing potential, who do not use adequate protection such as barrier protection, intrauterine device, or hormonal (oral or subcutaneous) contraception 2. postmenopausal women less than 6 months after last menses, surgically sterilised, oophorectomised or hysterectomised less than 3 months after operation and not using adequate protection 3. women neither using adequate protection nor being postmenopausal and their partner is not sterilised at least 6 months post operation or does not use condom 4. any women not having negative serum pregnancy test at screening
the effectiveness of intermittent pneumatic compression on neuropathic pain in patients with diabetic polyneuropathy

Conditions: Diabetic Neuropathic Pain

Summary: in this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated

the investigators conducted our research from 50 patients with type 2 diabetes of 5-20 years, who received pregabalin treatment with diabetic neuropathy with consent form between 40-75 years.the investigators divided the patients into two equal groups , some of the patients were given an intermittent pneumatic compression program at a pressure of 35 mmhg for 30 min to the lower extremity for 10 days of extreme alternation in our clinic and pregabalin treatment was continued,only pregabalin treatment of the other group was continued. vas, pqas, lanss, sf-36 were evaluated.the evaluation was done before the treatment, at the end of the intermittent pneumatic compression treatment(approximately 2 weeks after the start of the treatment) and 3 months later.

Eligibility criteria:
inclusion criteria: * 5-20 years history of type 2 diabetes * between the ages of 40-75 * body mass 25-40 * blood pressure 100/60-140/90 * patient diagnosed with diabetic polyneuropathy * use of pregabalin exclusion criteria: * connective tissue disease * peripheral nerve vasculitis * postherpetic neuralgia * alcoholic neuropathy * autonomic neuropathy * chronic renal failure * charcot-marie tooth disease

Keywords: intermittent pneumatic compression diabetic neuropathy pain measurements quality of life
clinical and radiographic outcomes of the corin tri-fit total hip replacement

Conditions: Osteoarthritis of Hip; Congenital Hip Dysplasia; Avascular Necrosis

Summary: the study will evaluate the radiographs (x-rays) of 100 patients with a trifit total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. the study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals.

the present study will prospectively recruit 100 patients scheduled for elective total hip replacement with corin's trifit hip system at the ottawa hospital - general campus. as part of their clinical care, patients routinely undergo a clinical examination and have had radiographs taken at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery. using specialized software, radiographs from each interval will be examined to assess femoral stem migration and joint wear patterns. femoral stem migration will be assessed using computer-assisted software. the study will also assess the rate of implant failure during the first two post-operative years. clinical assessments and questionnaires will also be completed during each of the follow-up intervals.

Eligibility criteria:
inclusion criteria: * patients scheduled for primary, unilateral total hip replacement (thr) with no previous history of hip replacement and/or fracture surgery. * patients with arthritis secondary noninflammatory degenerative joint diseases (nidjd), including osteo/degenerative arthritis, congenital hip dysplasia, and avascular necrosis. * patients who do not meet any of the exclusion criteria. exclusion criteria: * patients with previous fusions, acute femoral neck fractures, above knee amputations, or previous total knee replacement. * patients who had previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device. * patients with neuropathic joints. * patients who required structural bone grafts. * patients with an ipsilateral girdlestone. * patients who otherwise met the study criteria, but for which appropriate clinical follow-up data is not available (i.e. patients deceased prior to 2-year follow-up, patients refused to return for follow-up).

Keywords: arthroplasty, replacement, hip/methods hip joint/physiopathology hip joint/radiography hip joint/surgery hip prosthesis outcome assessment (health care) female male adult
clinical management of hereditary hemochromatosis: phlebotomy vs. erythrocytoapheresis

Conditions: Hereditary Hemochromatosis

Summary: the purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of hh

patients affected by hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. so, 25 caucasian patients, 16 males and 6 females of age \>18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis

Eligibility criteria:
inclusion criteria: * patiens newly diagnosed having hereditary hemochromatosis exclusion criteria: * age \< 18 yrs. * not obese (bmi \<30) * not consuming alchol beverages, * not affected by systemic diseases and known hepatic viruses

Keywords: clinical management phlebotomy eritrocytoapheresis
a study to evaluate the long term safety and effectiveness of novantrone therapy followed by copaxone treatment for multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: it is thought that treating multiple sclerosis with novantrone for a short period of time prior to treatment with copaxone may enhance the onset effect of copaxone.


Eligibility criteria:
inclusion criteria: * participation \& completion of the nc-100 clinical trial. * able and willing to sign an informed consent. exclusion criteria: none
attention bias modification training for social phobia (abmsp)

Conditions: Social Anxiety Disorder

Summary: attentional bias has primarily been investigated as a primary cognitive etiology of social anxiety symptoms. previous research has found that individuals with high social anxiety showed facilitated attentional engagement to threat stimuli or delayed disengagement of attention from threat. attentional bias modification training (abmt) was developed through applying the attentional mechanism in social anxiety. during abmt, participants are deliberately induced to shift their attention away from threat stimuli and toward neutral stimuli. despite its proven effectiveness, a recent meta-study found that the effect size of abmt is significant but too small. as a result, the current study focuses on improving the existing abmt by incorporating integrative factors into attention training. the current study aims to integrate bottom-up and top-down cognitive processes in abmt. participants will be randomly assigned to one of two conditions (active or placebo training) and will complete the abmt for three weeks. the abmt's efficacy will be assessed by comparing pre- and post-training measures.

individuals with at least mild level of social anxiety symptoms will be invited to the current study. participants will be randomly assigned to one of the two attention training conditions: a integrated attentional bias modification (i-abm) training or placebo training (plt). before and after the training, participants will complete computerized tasks (e.g., attention network task, dot-probe task) and self-report questionnaires. the basic design of i-abm training will follow the dot-probe task, which will ask participants to swipe or tap on the probe in the correct direction. the i-abm training aims to shift attention away from threatening stimuli or improve the inhibitory control ability. the plt training will have the same basic design, but this will not include therapeutic components. participants will complete the training three times per week for three weeks (a total of 9 training sessions), and there will be post-training and a 2-week follow-up assessment.

Eligibility criteria:
inclusion criteria: * diagnosis of social anxiety disorder (based on the diamond interview - social anxiety module) * moderate or severe symptoms of social anxiety as revealed by the liebowitz social anxiety scale (lsas score of ≥ 40) or mini-spin (score of ≥ 6) * ages 18-60 * english as a primary language * possession of a mobile device for access to the app (inquisit 6) exclusion criteria: * self-reported visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen * self-reported history of a bipolar disorder or psychotic disorder

Keywords: attentional bias cognitive process mobile training
phase 3 study to evaluate the safety and efficacy of hydrocortisone acetate suppositories

Conditions: Ulcerative Proctitis

Summary: a randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the sephure applicator for the treatment of ulcerative colitis of the rectum.

hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a sephure suppository applicator. two arms of the study will receive different dosage regimens of hydrocortisone acetate, and the third arm will receive placebo. all subjects will administer the study drug twice a day; once in the morning and once in the evening for 28 days. the study population will consist of male and non pregnant, non lactating females aged 18 years and older with a confirmed diagnosis of active uc of the rectum.

Eligibility criteria:
inclusion criteria: * male or non pregnant, non lactating females aged 18 years and older. * subjects with a confirmed diagnosis of active uc of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at visit 2. note: subjects may have a history of more extensive uc (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment. * modified mayo sub score for stool frequency of 1 3. * modified mayo sub score for rectal bleeding of 0 2. * modified mayo endoscopic sub score of 2 3. * total modified mayo score (without physician global assessment) of 4-8. exclusion criteria: * history or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, crohn's disease, collagenous colitis and indeterminate colitis. * prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia. * concomitant active lower gastrointestinal disease (except irritable bowel syndrome) or distortion of intestinal anatomy. * bleeding hemorrhoids at the time of enrollment. * acute diverticulitis at the time of enrollment. * acute or chronic pancreatitis at the time of enrollment. * unmanaged celiac disease at the time of enrollment. * positive stool test for enteric pathogens, clostridium difficile, or presence of ova and parasites. * taking a prohibited medication.
activation of young men - population-based randomised controlled trial

Conditions: Obesity; Well-being; Quality of Life; Depression

Summary: the aim of the study is to investigate different novel ic technologies for promoting physical activity and health and preventing obesity in young men. the purpose is to provide new evidence-based knowledge on the effectiveness of an ict-based physical activation and to identify factors predicting a positive response. specific objectives * to identify the factors associated with physical activity and physical activity relationship in young men * to develop an interactive method, based on peer networks, aimed at activating young men with use of their own skills, participation and modern ict * to assess the effectiveness of the chosen activation on the physical activity, weight, fitness, health, and relationship towards physical activity among young men the study population consists of all conscription aged men in the oulu area in 2011-2013 (n=4000). conscription-aged men provide a large, population based representative sample of young men. in finland military service is mandatory and annually all 18-year old men are called for military service. in the call-ups fitness for service is determined based on medical examination. all those who are determined fit for service or who are granted postponement due to obesity will be invited for the activation intervention study. those with severe obesity are exempted from service, but will also participate in the trial. after the call-up, the men will be randomised to an intervention group and a control group. the primary outcome variable is change in physical activity. the study will be conducted during 2011-2015. the study includes technology development (ict platform), collection of cross-sectional data at the call-ups, and a 6-month physical activity intervention (a randomized controlled trial) implemented between the call-up and start of military service. game mechanics are integrated into the ict platform to increase user engagement and participation. physical activity, fitness (aerobic and muscular), body composition,lifestyle and psychological and physical health will be followed. in addition, the subjects' entry into military service and its course will be followed.


Eligibility criteria:
inclusion criteria: * all men born 1995 liable for military service and attending call-ups in oulu area at 2013 exclusion criteria: * severe physical or mental illness
correction of fixed knee flexion deformity in children distraction by cast wedge and rod lengthening

Conditions: Flexion Deformity of Knee

Summary: the aim of our study is to produce gradual correction of fkfd in younger children.

management of pediatric fixed knee flexion deformities (fkfd) has always been a challenge for orthopedic surgeons. they occur due to a variety of causes, including cerebral palsy, arthrogryposis, spina bifida, trauma, and many others. the deleterious effects of fkfd include instability of gait and balance, exhaustion of extensor mechanism, and anterior knee pain, which together produce marked limitation of the activities of daily living in affected children . many options have been proposed for the correction of fkfd, with each having its pros and cons. hamstring release and posterior capsulotomy are frequently used. however, extensive soft tissue release may be needed to treat severe deformities with the risk of neurovascular compromise and genu recurvatum. supracondylar extension osteotomy with patellar tendon advancement requires postoperative non-weight bearing for at least three weeks and is associated with risk of neurovascular damage and coronal plane deformities and it is mostly used in older children and adolescent . gradual distraction by ring fixators may be complicated by pin tract problems, fractures, and recurrence . our study entails the application of a simple method for correction of fkfd in younger children using a simple cast distraction technique. this conservative method aims at avoiding the complications of surgery in children while achieving a reasonable amount of correction.

Eligibility criteria:
inclusion criteria: 1. children with fkfd. 2. age \< 4 years. 3. fkfd due to congenital, traumatic, neuromuscular, infections, metabolic disorders and skeletal dysplasias. exclusion criteria: * 1. older children less than 4 years 2. recent post-burn contractures and cases with unsuitable skin conditions.
a 21 day pharmacokinetics study in papulopustular rosacea

Conditions: Papulopustular Rosacea

Summary: the purpose of this study is to characterize the pharmacokinetics of once daily topical gel and confirm that steady state conditions are reached under maximal use conditions following 3 weeks of daily applications.


Eligibility criteria:
inclusion criteria: * a diagnosis of papulopustular rosacea * grade 3 or 4 on the 5-point investigator global assessment scale * presence of telangiectasia exclusion criteria: * steroid rosacea or subtype 3 (phymatous rosacea) * clinically significant abnormal findings that would interfere with study objective or risk to safety for the subject. * nodular rosacea (lesions greater than 5mm with more than 2 modules)

Keywords: rosacea