Kornimate/medical-research-clean huggingface dataset:
a phase 2 pilot study to assess asp7147 in patients with diarrhea predominant irritable bowel syndrome (ibs-d)

Conditions: Diarrhea Predominant Irritable Bowel Syndrome

Summary: this trial will evaluate the effect of asp7147 on daily abdominal pain due to ibs-d during 4 weeks of treatment. it will also evaluate safety and tolerability in patients with ibs-d over the 4-week treatment period.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent * men or women aged 18-75 years * patient has ibs with diarrhea (ibs-d) * ability to communicate with the investigator exclusion criteria: * ibs with constipation (ibs-c) or mixed ibs (ibs-m) * other significant disease or condition that may interfere with trial completion * untreated lactose intolerance * history of alcohol or drug abuse in past two years * participation in other clinical trials within prior month
lubiprostone in children with functional constipation

Conditions: Constipation - Functional

Summary: study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

dose administration details: * participants with a body weight \<50 kg at baseline received lubiprostone 12 mcg bid for 12 weeks. if the dose was safe but did not show any efficacy at week 1, dosage was increased to 24 mcg bid. * participants with a body weight \>50 kg at baseline received lubiprostone 24 mcg bid for 12 weeks. if the dose was unsafe at week 1, dosage was decreased to 12 mcg bid.

Eligibility criteria:
inclusion criteria: * medically-confirmed diagnosis of functional constipation per rome iii diagnostic criteria for childhood functional constipation * at least 6 years of age but less than 18 years of age at the time of randomisation * only stable dose of selective serotonin re-uptake inhibitors (ssris), serotonin-specific reuptake inhibitor (snris), or monoamine oxidase inhibitors (mao) inhibitors are allowed if subject is taking antidepressants exclusion criteria: * any gastrointestinal (gi) condition, other than constipation and/or irritable bowel syndrome (ibs), affecting gi motility or defecation * untreated faecal impaction at the time of screening * medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication
ba253bineb compared to ba253mdi (metered dose inhaler) in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this study is to investigate the efficacy and safety of ba253bineb during the continuous 4 weeks administration to the patients with copd using ba253mdi (tersigan® aerosol) as the comparator drug.


Eligibility criteria:
inclusion criteria: the patients with copd (chronic bronchitis, emphysema) and who satisfy the following criteria 1. patients whose symptoms are stable and have at least 4 symptomatic days a week 2. patients with fev1.0/fvc of \<= 70% in the screening test 3. patients aged \>= 40 years or older 4. patients must be able to inhale the study drug via bineb and mdi 5. patients must be able to understand the patient information form exclusion criteria: those who correspond to the following shall be excluded from the subjects of study. 1. patients complicated with bronchial asthma, making the assessment of drug efficacy against copd difficult 2. patients who are constantly administered oral steroid 3. patients with glaucoma 4. patients who have prostatic hypertrophy 5. patients with hypersensitivity to anticholinergic drugs or beta2 agonists. 6. patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study 7. women who are pregnant or who may become pregnant, or nursing women 8. patients who are judged by the investigator as inappropriate as the subjects of the study
acellular dermal matrix versus tenting technique in peri-implant soft tissue augmentation and crestal bone stability

Conditions: Soft Tissue Augmentation

Summary: this study looks at two ways to make gums thicker and bones stable around dental implants for people with thin gums. it compares two methods in 40 people: one method uses a special graft, and the other uses a technique called tenting. the goal is to see which method might work better for making the gums and bones around implants healthier. the check-ups are planned when the implant is put in and again after one year. the study focuses on how these methods are done without talking about what the results are.

the study's protocol entails a randomized comparison between acellular dermal matrix grafting and the tenting technique, aimed at enhancing gum thickness and bone stability around dental implants in individuals with thin gum profiles. forty participants are systematically assigned to one of the two methods under investigation. the study is structured to evaluate the interventions' potential in improving conditions conducive to the success of dental implants, specifically targeting soft tissue thickness and crestal bone level stability. the comprehensive investigation is designed to explore effective approaches for managing patients with particular soft tissue challenges, focusing on the clinical application and procedural aspects without presenting any results or conclusions.

Eligibility criteria:
inclusion criteria: * male and female patients between 18-75 years old. * physical and psychological capacity to undergo implant therapy (asa i or ii). * fully healed single mandibular posterior treatment sites (premolars or molars) being edentulous for at least 3 months. * minimum of 6 mm width and 8 mm height native bone ridge. * no requirement for concomitant or a history of regenerative treatments. * minimum of 4mm keratinized mucosa at the implant site (2 mm buccal and 2mm lingual). * healthy non-inflamed keratinized soft tissues with a maximum soft tissue thickness height of 2 mm measured at crestal buccal and lingual aspects. * periodontally healthy by fulfilling all of the following criteria: full-mouth bleeding score (fmbs) \< 20%, full-mouth plaque score (fmps) \< 15%, community periodontal index of treatment needs (cpitn) \< 2. exclusion criteria: * patients with a history of periodontitis. * poor oral hygiene after oral hygiene instructions (ohi). * pregnant or lactating. * uncontrolled concomitant medical diseases, e.g., diabetes. * receiving or having received pharmacological treatment affecting wound healing within 3 months prior to the study-related intervention.

Keywords: dental implant phenotype mucosal tissues mucosal tissue augmentation vertical soft tissue height bone resorption bone remodeling
a study to evaluate safety, pharmacokinetics, and activity of gdc-7035 as a single agent and in combination in patients with advanced solid tumors

Conditions: Solid Tumor

Summary: this is a first-in-human phase i/ii, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of gdc-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the kras g12d mutation.


Eligibility criteria:
inclusion criteria: * histologically documented advanced or metastatic solid tumor with kras g12d mutation * agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm exclusion criteria: * malabsorption or other condition that would interfere with enteral absorption * active brain metastases * clinically significant cardiovascular dysfunction or liver disease
comparison of two different treatment effects on individuals with chronic lateral epicondylitis

Conditions: Tennis Elbow; Lateral Epicondylitis; Tendinopathy

Summary: the aim of this study is to compare the effects of radial extracorporeal shockwave therapy (reswt) treatment and deep friction massage (dfm) treatment on pain, functionality, grip strength (gs), edema, range of motion (rom) of the elbow and quality of life in individuals with chronic lateral epicondylitis (cle). 36 individuals diagnosed with cle will be randomly divided into two equal groups. reswt treatment will be applied to group 1 and dfm treatment to group 2. visual analogue scale will be used to assess pain severity, functionality with patient-rated elbow evaluation turkish version (prtee-t), gs with digital dynamometer, rom of the elbow joint with goniometer, edema with environmental measurement, and quality of life with short form 36 (sf-36).


Eligibility criteria:
inclusion criteria: * individuals with pain on the lateral epicondyle or proximal musculotendinous area of the forearm extensor muscles for at least 3 months, * individuals with a positive thomsen test , - individuals who have not received physical therapy for lateral epicondylitis, * individuals with a positive maudsley test will be included. exclusion criteria: * individuals who have received any physical therapy, * individuals with reflected pain due to cervical and shoulder pathologies, * individuals with elbow osteoarthritis, * individuals with previous elbow fractures or elbow joint operations, * individuals with a history of systemic inflammatory disease, * individuals with osteoporosis, * individuals with cardiovascular problems will not be included in the study.
diagnosis of primary ciliary dyskinesia

Conditions: Primary Ciliary Dyskinesia; Kartagener Syndrome

Summary: primary ciliary dyskinesia is an inherited respiratory disease caused by various functional and ultrastructural abnormalities of respiratory cilia. the genetic heterogeneity underlying pcd is extremely important and only few genes are clearly implicated in pcd. their mutations account for about 20% of patients. for all the other pcd patients, the genes responsible for their ciliary defect remain to be identify.

1/ evaluating the frequency of mutations of the two main genes implicated in pcd, in a large cohort of patients with pcd confirmed by ciliary investigations.2/ identifying and testing new candidate genes responsible not only for typical pcd and related disorders of the axoneme, but also for so far-unexplored "syndromic forms of pcd", taking advantage of data obtained through comparative genomic approaches between different species, ciliated or not.

Eligibility criteria:
inclusion criteria: * patients with suspected or confirmed primary ciliary dyskinesia after ciliary investigations who accepted to participate to the genetic studies. exclusion criteria: * patients with exclusion of primary ciliary dyskinesia after ciliary investigations.

Keywords: cilia axoneme dynein gene ultrastructure linkage analysis
an internet-based education program for care partners of people living with dementia

Conditions: Dementia; Burden, Caregiver; Self Efficacy; Knowledge

Summary: with the aging population, the prevalence of dementia is increasing dramatically. people living with dementia are highly dependent on family care partners, who may have little knowledge of the disorder. national and provincial guidelines have all highlighted the importance of online resources to improve care partner education; however, very few have been widely implemented or rigorously studied. the investigators have developed the award-winning dementia education platform to complement traditional patient and family educational approaches. it allows free access to multimedia e-learning lessons, live expert webinars, and email-based content that care partners can access any time, anywhere. in a pilot randomized controlled trial (rct), the investigators propose to study 1) the feasibility and care partner acceptance of the intervention and some of the study methods, and 2) the impact of the intervention on care partner self-efficacy, knowledge, and sense of burden. this initiative has the potential to improve the quality, cost effectiveness, and efficiency of dementia care. the intervention could be easily scaled and spread both provincially and nationally to complement other dementia education methods, at a time when the prevalence of dementia is increasing and access to high quality internet-based interventions is essential.


Eligibility criteria:
inclusion criteria: 1. they are a family and/or friend care partner of a person living with dementia, 2. they reside in canada, 3. they are 18 years of age and over, 4. they have a good command of the english language, 5. they have access to email and internet, 6. they are comfortable using email and internet, 7. they have the ability to grant online informed consent, and 8. they complete online baseline assessments. exclusion criteria: 1. they are a not family and/or friend care partner of a person living with dementia, 2. they do not reside in canada, 3. they are not 18 years of age and over, 4. they do not have a good command of the english language, 5. they do not have access to email and internet, 6. they are not comfortable using email and internet, 7. they do not have the ability to grant online informed consent, and 8. they do not complete online baseline assessments.

Keywords: web-based intervention internet e-health dementia caregiver alzheimer disease education and training clinical trial knowledge translation
the impact of an animated video on preoperative anxiety in children undergoing elective otoplasty

Conditions: Pre-operative Anxiety; Otoplasty; Paediatric Surgery

Summary: the study is a prospective, randomized, single-blind controlled superiority trial to evaluate the effect of viewing an informative animated video a day prior to surgery on preoperative anxiety in pediatric patients scheduled for elective otoplasty. the primary outcome will be modified yale preoperative anxiety scale (mypas) score at the time of general anesthesia induction compared between families that were assigned to view the animated video the day before and those that were not. the participants for this study will be children undergoing elective otoplasty at the iwk health centre. those participants randomized to the intervention group will receive a link to a short survey gauging parent anxiety levels. the survey will be followed by a link to an informative animated video which the participants and their families will watch. the control group will be participants assigned not to receive the email link to the informative animated video.


Eligibility criteria:
inclusion criteria: * they are undergoing an otoplasty alone with no other procedures on the same day * the patient must not have previously undergone an otoplasty; the patient must be between the ages of 4 and 12; * the patient must understand spoken english; * the participating parent must be able to read english at a grade six level; and the patient should not have received premedication. exclusion criteria: * under the age of 4 or over the age of 12 * have not undergone a previous otoplasty

Keywords: otoplasty pre-operative anxiety animated video
effect of the laparoscopic approach in reducing postoperative severe complications following hepatectomy for colorectal liver metastases

Conditions: Liver Metastasis Colon Cancer; Postoperative Complications

Summary: the objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the comprehensive complication index (cci) within 90 days of the procedure or regardless of the date during the hospital stay.

while laparotomy is still the standard approach of resectable colorectal liver mestastases, its associated morbidity remains non-negligible with reported mortality and complications rates ranging from 2 to 8% and 30 to 70%, respectively (1). besides the underlying liver disease together with the comorbidities of the patients, this high morbidity is also related to the type of surgical approach. since less than 15% of liver resections are currently performed using the laparoscopic approach in france, a trial showing the superiority of the laparoscopic approach in comparison to the open approach for patients with colorectal liver metastases qualifying for both approaches would allow improving management of patients, reducing the length of stay, maybe decreasing the global cost and changing current practices on a national scale. in order to demonstrate the superiority of the laparoscopic approach over the laparotomy approach, patients with colorectal hepatic metastasis will be randomly assigned to either the laparoscopy or laparotomy groups. post-operative complications (including mortality) will be measured using the comprehensive complication index (cci) within 90 days postoperatively or at any time during hospitalization. the participation time for each patient in the study is 3 years, the patient will be followed at 1, 3, 6, 9, 9, 12, 15, 18, 21, 24, 30 and 36 months.

Eligibility criteria:
inclusion criteria: * presenting with colorectal liver metastases requiring liver resection ± concomitant radiofrequency ablation. * qualifying for both a laparoscopic approach and an open approach. * informed written consent. * affiliated to health insurance regimen. exclusion criteria: * hybrid liver resection (including both laparoscopic and open resection). * liver resection requiring an associated vascular or biliary reconstruction. * contraindication to surgery. * contraindication to laparoscopy (pneumoperitoneum). * asa (american society of anesthesiologists) score iv or v or life expectancy \< 3 months. * poor comprehension of french language or cognitive impairment * pregnancy or breastfeeding. * patient under guardianship or unable to give consent * people particularly protected by french law.

Keywords: liver resection laparoscopy
treatment of unstable both-bone midshaft forearm fractures in children

Conditions: Fracture

Summary: the investigators created a randomized clinical trial between 1 or 2 elastic stable intramedullary nails to find out what kind of treatment is optimal for unstable both-bone midshaft forearm fractures.

children who arrive at the emergency unit with an unstable both-bone midshaft forearm fracture will be asked to join the trial. if the fracture will be unstable during reposition in the operating room, a randomization between 1 or 2 esin will be done. the aftertreatment will be the same for both groups: above elbow plaster for 3 weeks. outpatient clinic visits till a follow-up of 9 months. during these visits we will investigate: consolidation and dislocation on x-ray, function of both arms, complaints in daily living and complications.

Eligibility criteria:
inclusion criteria: * stable both-bone forearm fracture * age \< 16 years old * dislocation * unstable exclusion criteria: * fracture older than 1 week * no informed consent * refracture * open fracture (gustillo 2 and 3)

Keywords: fracture forearm midshaft child treatment
promoting physical activity in patients with type 2 diabetes (diafit)

Conditions: Diabetes

Summary: the aim of this study is to evaluate the effects of a physical activity intervention in patients with type 2 diabetes in a community setting.

the aim of this study is 1. to evaluate the effects (before and after) of a physical activity program (diafit program) which contains 36 sessions of structured pa and also encourages unstructured pa in an unselected population of patients with type 2 diabetes independent of the selected variant of the program 2. to compare the effects of a standard diafit program (3 times per week for 12 weeks) with and alternative program which suggests a more progressive pa activity intensity (starting with one pa session per week during 4 weeks and then twice a week over a period of 16 more weeks (20 weeks total). in total the program also consist of 36 sessions)

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes exclusion criteria: * orthopedic complications * diabetic foot ulceration * "active " cardiac (ischemia during the exercise test) or stade iii peripheral vascular disease * untreated proliferative retinopathy * autonomic neuropathy * active psychiatric, neurological, orthopedic, muscular or rheumatic disease interfering with a participation in a physical activity program * pregnancy

Keywords: diabetes physical activity body composition aerobic fitness metabolic control
the impact of puncture angle on total fluoroscopy time reduction during percutaneous biliary drainage

Conditions: Interventional Radiology

Summary: the purpose of this study is to retrospectively assess the importance of initial bile duct puncture angle on total fluoroscopy time and overall efficacy during ultrasound and fluoroscopy guided percutaneous transhepatic biliary drainage (ptbd) performed for patients with malignant biliary hilar obstruction.

data used for this study will be collected from medical records of patients who underwent ptbd at the interventional radiology department. only patients who received percutaneous biliary drainage performed with right sided intercostal approach will be included in study. the initial puncture was ultrasound-guided in all patients. any subsequent step of the procedure was performed under fluoroscopy. the cumulative fluoroscopy time (the total time of the exposure to x rays during intervention) after the us guided puncture was recorded. it will be used as an indirect measure of the complexity of the intervention and as an important parameter of radiation exposure. the patients will be divided into two groups based on the puncture angle: ≤30° group and \>30° group. the two groups will be retrospectively analysed for technical success, fluoroscopy time and complications.

Eligibility criteria:
inclusion criteria: * pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1. exclusion criteria: * terminally ill patiens, performance status ˃2, hepatic decompensation (including ascites), severe underlying cardiac or renal diseases and coagulation disorders

Keywords: biliary drainage, fluoroscopy time, puncture angle
evaluation of monthly darbepoetin alfa dosing for correction of anemia in non-dialysis chronic kidney disease

Conditions: Anemia; Chronic Kidney Disease

Summary: the purpose of this study is to determine whether once monthly (qm) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (q2w) dosing of darbepoetin alfa for the correction of anemia in patients with chronic kidney disease who are not receiving dialysis.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * diagnosis of chronic kidney disease with egfr of 15-59 ml/min/1.73 m2 (mdrd equation) * two consecutive screening hb values taken at least 7 days apart must each be \<10.0 g/dl * tsat ≥ 15% exclusion criteria: * upper or lower gi bleeding within 6 months before enrolment * esa use within 12 weeks before enrolment * uncontrolled hypertension * systemic haematologic disorders * prior history within 12 weeks before enrollment of events including: acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism. * grand mal seizure within 6 months prior to enrolment * evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment. * red blood cell transfusion within 12 weeks prior to enrolment * androgen therapy within 8 weeks prior to enrolment * pregnancy or breast feeding, or inadequate contraception * currently receiving immunosuppressive therapy

Keywords: ckd anemia correction darbepoetin alfa