Kornimate/medical-research-clean huggingface dataset:
can calcium ionophore application enhance the icsi outcomes in severe male factor infertility?

Conditions: In Vitro Fertilization; Male Factor Infertility

Summary: the purpose of this study is to determine the impact of the use of calcium ionophore on the icsi outcomes in couples with severe male factor infertility. investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.

elevation of calcium levels inside the oocyte is one of the most initial steps which takes place during normal fertilization (1). the interaction between the sperm and oocytes surface protein receptors may be the triggering event for oocyte activation during the process of fertilization (2). it is suggested that the process of intracellular calcium elevation is triggered by binding of the sperm to the oocyte oolemma and hence the fertilization starts (3). severe male factor couples might have compromised fertilization and pregnancy outcomes (4). a prospective multicenter non-randomized study indicated that calcium ionophore could improve the fertilization as well as the clinical pregnancy rates in these patients (5). on the other hand, a randomized controlled trial did not find any significance for the use of calcium ionophore in the couples with poor ovarian reserve with regards the fertilization and clinical pregnancy rates (6). the purpose of this study is to determine the impact of the use of calcium ionophore on the icsi outcomes in couples with severe male factor infertility. investigators conduct a randomized controlled trial on the sibling oocyte to justify the use of calcium ionophore in these cases.

Eligibility criteria:
inclusion criteria: * severe male factor infertility, average response to coh, exclusion criteria: * poor responders,

Keywords: calcium ionophore fertilization sperm oocyte icsi
bip in jämtland härjedalen: increased access to cbt within regular health care in northern sweden

Conditions: Anxiety Disorder; Obsessive-Compulsive Disorder

Summary: the purpose of this study is to test internet-delivered cognitive behavior therapy for children and adolescents with anxiety disorders and obsessive-compulsive disorder in a routine clinical setting in a rural part of sweden.

aim the aim of this study is to conduct a pragmatic evaluation of icbt for children and adolescents with anxiety disorders and ocd within routine health care in a rural area. research questions * is icbt an acceptable method for the patient group? * is icbt effective in a clinical setting? * is further treatment needed after icbt? * what are the long-term effects of icbt? * what predicts treatment outcome? * how does icbt work in a clincal setting? (time spent, negative effects etc)? design this is a uncontrolled intervention study where included families and children will be recruited consecutively during two years from a routine care camhs unit. all participants will be offered icbt and assessed pre- and post-treatment, and at three-month follow-up through clinician ratings and self-report measures. the primary outcome measure is clinician rated severity of principal disorder at three-month follow-up. long-term results will be assessed through study of medical records two years after completed icbt.

Eligibility criteria:
inclusion criteria: * fulfills diagnostic criteria for an anxiety disorder or ocd * access to a computer and internet connection * read and speak swedish exclusion criteria: * icbt is currently not assessed to be a suitable treatment * acute psychiatric problem (eg. severe depression or suicidality) * current psychosocial problems in the family (i.e substance abuse, abuse, neglect)
obstructive sleep apnea management in people with spinal cord injury

Conditions: Obstructive Sleep Apnea; Spinal Cord Injuries

Summary: the prevalence of obstructive sleep apnea (osa) is a significantly higher in people after spinal cord injury (sci) than in the general population. as a positive pressure therapy (cpap) is often poorly tolerated, a mandibular advancement device (mad) can be used for the treatment of osa. the purpose of this study is to determine the efficacy of mad in people with sci and to verify their adherence to the therapy.

obstructive sleep apnea (osa) is a disorder with serious health consequences. compared to the general population, a significantly higher prevalence of osa was found in individuals with spinal cord injury (sci). as treatment, positive pressure therapy in the respiratory tract during sleep (cpap) is commonly instituted. however, cpap therapy is often rejected or poorly tolerated by patients. alternatively, the american association of sleep medicine recommends the use of mandibular advancement devices (mad). the mad prevents the upper airway from collapsing by anterior displacement of the mandible. the aim of the project is to determine the efficacy of mad therapy in people with sci and to verify their adherence to the therapy. the research group will consist of 60-80 subjects. the selection of suitable participants will be based on the results of a polygram. the mad for a group of subjects with an apnea-hypopnea index (ahi) higher than five will be fabricated using their dental impressions. subsequently, the subjects will be retested while wearing the mad and outcomes will be compared. the evaluation will include a set of questionnaires. adherence to therapy will be checked after three and six months. the investigators anticipate that the results of the study will confirm the effectiveness of mad devices in the treatment of osa in the monitored group. most importantly, the investigators intend to set a standard for a long-term system of diagnosing and addressing osa in individuals with sci.

Eligibility criteria:
inclusion criteria: * ahi \> 5 on polygraphy * sufficient set of teeth to hold a splint * written informed consent exclusion criteria: * use of medication that could affect breathing or sleep * oxygen-dependent or decompensated lung disease * decompensated congestive heart failure * evidence of other sleep disorders (narcolepsy, restless legs syndrome, insomnia) * abnormalities of the upper airway * periodontal problems and untreated caries * mental disorders

Keywords: apnea spinal cord injury mandibular advancement device
comparison of endoscopic radiofrequency ablation versus photodynamic therapy for inoperable cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: the purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * pathologically or radiologically confirmed biliary malignant * inoperability by staging exclusion criteria: * cholangiocarcinoma with widespread metastasis * coagulopathy (inr \> 2.0 or prothrombin time \> 100 sec or platelet count \< 50,000) * prior sems placement * pregnancy * eastern cooperative oncology group (ecog) performance status ≥ 3 ) * life expectancy \< 3months

Keywords: cholangiocarcinoma pathologic digestive system neoplasms neoplasms by site digestive system diseases bile duct diseases biliary tract diseases pathological conditions constriction adenocarcinoma carcinoma
a modified lateral lumbar interbody fusion vs. transforaminal lumbar interbody fusion for adult degenerative scoliosis

Conditions: Degenerative Scoliosis; Minimally Invasive; Spinal Deformity

Summary: a modified lateral lumbar interbody fusion vs. transforaminal lumbar interbody fusion for the treatment of adult degenerative scoliosis with 2 year follow-up with a multiple center, randomized case-control study

adult degenerative scoliosis (ads) is the most common spinal deformity in the elderly, and the severe patients need surgical treatment. the elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new choice for spinal surgeons to treat ads. modified lateral lumbar interbody fusion (clif) is an new modified spinal minimally invasive interbody fusion technique in the investigator's department. the results of preliminary studies showed that it has the advantages of less trauma, short operation time and fewer complications, and the clinical and imaging outcome are remarkable. therefore, the present study aims to establish a multicenter, large sample prospective randomized controlled study to explore the technical advantages and surgical indications of the new technique in the treatment of ads by comparing with the traditional posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish a long-term follow-up to further quantify the clinical and imaging outcome of the new technique. therefore, this study will further verify the safety and effectiveness of the clif in the treatment of ads on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of ads.

Eligibility criteria:
inclusion criteria: * at least 50 years of age, diagnosed with adult thoracolumbar scoliosis including any number of intervertebral levels between t8 and s1, unresponsive to conservative treatment for at least 6 months, and had a preoperative coronal cobb angle of at least 10° and preoperative odi score of at least 30%. exclusion criteria: * with prior lumbar fusion surgery or spondylolisthesis greater than grade ii
study of cytrix use in pelvic floor prolapse treatment

Conditions: Vaginal Vault Prolapse

Summary: to evaluate safety and effectiveness of using the fetal bovine dermis (cytrix) in the treatment of pelvic organ prolapse.


Eligibility criteria:
inclusion criteria: * female \>30 years of age * willing and able to comply w/ the study procedures and provide written informed consent to participate in the study. * diagnosed with pelvic organ prolapse with or without pelvis floor dysfunction * patient is willing to complete pfdi-sf20 and pisq-12 questionnaires at 6 and 12 months post-operatively * patient is willing to answer phone questionnaires at 2 weeks, 6 weeks, and 3 months * patients with a history of pelvic surgery (cystocele/anterior repair, hysterectomy, vault suspension, etc) prior to this procedure are allowed to participate in the study except if the patient had a dermal graft implanted. exclusion criteria: * patients who, in the clinical judgment of the investigator, are not suitable for this study * patients who are, in the investigators opinion, mentally or legally incapacitated preventing informed consent or unable to read or understand written material. * patients who have participated in an investigational study within 30 days of study entry that may impact analysis of this device or have previously participated in the current trial * patient whose pelvic organ prolapse is stage i * patient with diabetes mellitus type i or ii * patient with morbid obesity (weight parameters determined by physician) * patient with undiagnosed pelvic mass outside of the uterus (not expected to be functional in nature) * patient with unexplained abnormal menstrual bleeding * patient with any acute or chronic infection (kidney, bladder, lung, etc) * patient with coagulopathy * patient participating in other investigational device or drug study * patients must not be pregnant * patients with life expectancy less than 2 years * patients with known or suspected hypersensitivity to collagen or bovine products * patients with preexisting local or systemic infection * patients with a history of soft tissue pathology where the implant is to be placed * patients with any pathology that would limit the blood supply and compromise healing * patient diagnosed with autoimmune connective tissue disease
real-world health outcomes in canadian patients using semaglutide

Conditions: Type 2 Diabetes

Summary: glucagon-like peptide-1 receptor agonists (glp-1 ra) are an injectable, non-insulin therapy for patients with type 2 diabetes (t2d). semaglutide (ozempic®) is the newest glp-1 ra to become available in canada in 2018, and is administered subcutaneously once-weekly. in clinical trials, semaglutide has been superior to placebo and other antihyperglycemic agents in hba1c reduction and body weight loss. however, there is little real-world evidence available on the effectiveness of semaglutide in real-world clinical practice. to better understand the effectiveness of semaglutide on clinical outcomes in a real-world setting, this retrospective cohort study will use the canadian lmc diabetes registry to examine the effects of semaglutide on glycemic control, body weight, and other clinical outcomes in patients with t2d who initiate once-weekly semaglutide as part of usual clinical care in a diabetes specialist practice group in canada.


Eligibility criteria:
inclusion criteria: * first prescription for semaglutide between feb 1 2018 and feb 1 2019 * age ≥ 18 years at medication index date * clinical diagnosis of type 2 diabetes for greater than six months * ≥ one hba1c measurement at baseline and at follow-up * ≥ one follow-up visit post index date * informed consent for medical data to be used for research purposes exclusion criteria: * clinical diagnosis of type 1 diabetes * recent egfr \<40 ml/min/1.73m2 * documented history of bariatric surgery

Keywords: semaglutide retrospective study hemoglobin a1c body weight
focus on fibre study

Conditions: Appetitive Behavior

Summary: the investigators present a diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to allow ad libitum feeding to assess impact of diet change on appetite response. the diets will vary in fibre content and type. this study will allow assessment of the physiological impact of dietary fibre on markers of appetite control for body weight, measured from plasma gut hormones. the investigators propose to recruit participants with a poor diet quality (low habitual fibre intake) to additionally examine the time-course of adaptation of the gut microbiome (measured in faecal samples), whilst assessing the impact of added fibre on body weight and subjective appetite scores. this approach is to address the impact of dietary fibre in people living with obesity and food inequalities. the investigators will assess physiological bio-markers of appetite control and their contribution to the development of a gut ecosystem that promotes health. a subsequent period of return to a low fibre feeding will allow assessment of durability of response.


Eligibility criteria:
inclusion criteria: * healthy but overweight/obese (bmi 28-40kg/m2) males and females (post-menopausal, using the oral contraceptive pill or some form of hormonal contraceptive) * low habitual fibre intake (\<10g/day) exclusion criteria: medication exclusion criteria: * antibiotic use (within the past 3 months due to impact on gut microbiota) * statins (current) * aspirin or other nsaids or anti-coagulants (current) * anti-depressants (current) * smoking or vaping medical exclusion criteria: * females who are planning to be pregnant, are pregnant or are breastfeeding * anyone with food allergies, self-reported food sensitivity or intolerance * anyone with coeliac disease or gluten intolerance * anyone taking medication which may affect their appetite * anyone with an eating disorder * anyone with diabetes * anyone with a gastrointestinal disorder, kidney disease, liver disease or gout * anyone suffering from a psychiatric disorder or any type of substance abuse * anyone suffering from unregulated thyroid disease other exclusion criteria: * anyone following a vegetarian or vegan diet * anyone following a weight loss programme (that may be affecting lifestyle, physical activity \& diet) * anyone with unsuitable veins for blood sampling * anyone who is unable to fluently speak, read and understand english * anyone who is unable to comply to an alcohol-free diet for 6 weeks

Keywords: fibre appetite control gut microbiome glycaemic control
study to determine efficacy and safety of inhaled aerolef in the treatment of acute post-op pain in adult patients undergoing elective orthopedic surgery

Conditions: Pain

Summary: the purpose of this study is to determine the effect of pain relief with aerolef in adult patients, following orthopedic surgery.


Eligibility criteria:
inclusion criteria: * male and female 18 to 70 years * patient alert and capable of self-administering an opioid anaglesic * patient is scheduled for orthopedic surgery under general anesthesia * patient has normal laboratory values * physical examination with no clincially relevant findings * patient in general good health based on medical history and clincially acceptable * patient is able to understand the requirements of the study * patient is able to communicate effectively with study personnel _patient voluntarily gives written approval. exclusion criteria: * during part 2 (randomized period) which involves the use of placebo, patients who are undergoing a major orthopedic procedure that normally requires multimodal analgesia to achieve adequate postoperative pain control (e.g. major spine surgery, total knee arthoplasty) will be excluded. * patient is taking opioid or non-opioid analgesics on a chronic basis at doses which in the opinion of the investigator would interfere with evaluations of post-operative fentanyl efficacy. * history of pulmonary, cardiovascular, neurologic, endocrine, hepatic, gastrointestinal (gi), or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study. * patient has documented or self-reported medical history of sleep apnea. * patient has a documented hypersensitivity to fentanyl or other opioid analgesics. * patient has a documented hypersensitivity/allergy to the components of the liposomes used in the aerolef formulation, including hypersensitivity to soya lecithin or related food products such as soya bean and peanut. * patient is currently receiving treatment, or has received treatment in the previous two weeks, with monoamine oxidase inhibitors. * patient has a history of malignancy within the past 5 years, with the exception of successfully treated non?metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix. * patient was dosed with another investigational drug within 30 days prior to the screening visit. * patient has current therapy with cns-depressant medications (other than stable doses of analgesics and drugs used with surgical anesthesia). * patient has current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit). * patient has a history of abuse of licit or illicit drug substances. * patient, who in the opinion of the investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.

Keywords: pain fentanyl analgesics opioid inhalation
dark study "dysbetalipoproteinemia and atheroma risk"

Conditions: Dysbetalipoproteinemia

Summary: dysbetalipoproteinemia (type iii, fredrickson's classification) is a rare metabolic disorder. it results from a defect in the clearance of vldl and chylomicron remnants due to homozygous apoe2 variants or heterozygous apoe mutations, and there is an elevated plasma cholesterol and triglycerides. as a consequence of the derangements in lipoprotein metabolism, dysbetalipoproteinemia predispose to the premature development of atherosclerosis. however among this population there is heterogeneity in development of cardiovascular complications and the determinants remain unclear actually. the aim of the investigators study is to evaluate the intensity of clinical atherosclerosis, and identify its determinants.


Eligibility criteria:
inclusion criteria: - apo e gene sequencing in cbe (centre de biologie est / hospices civils de lyon / france) laboratory in lyon until december 2012 exclusion criteria: * age \< 40 years * refused participation

Keywords: dysbetalipoproteinemia artery calcium score carotid intima media ankle brachial index dysbetalipoproteinemic patients
clinical study of lung protective ventilation strategies and tumor microenvironment

Conditions: Tumor Microenvironment

Summary: this study will be conducted in the affiliated hospital of nantong university. sixty colorectal cancer(crc) patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. the control group adopted conventional ventilation strategy; the experimental group used lung protective ventilation strategy. 4ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes in patients undergoing colorectal cancer surgery. follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (qor-15 score scale).

this study will be conducted in the affiliated hospital of nantong university. sixty crc patients are randomized into traditional ventilation strategy group (control group) and lung protective ventilation strategy group (experimental group), there were 30 cases in each group. the control group adopted conventional ventilation strategies: tidal volume (vt)=10-12 ml/kg, respiratory rate ( f)=12 breaths / minute, positive end expiratory pressure（peep）=0 cmh₂o, fraction of inspired oxygen =0.5; the experimental group used lung protective ventilation strategies: tidal volume ( vt)=6-8 ml/kg, f=12 breaths / minute, positive end expiratory pressure (peep)=6-8 cmh₂o, fraction of inspired oxygen =0.5, mechanical ventilation every 30 minutes (continuous positive airway pressure 30 cmh₂o about 30 seconds). 4 ml of central venous blood was extracted at 3 time points within 24h, and relevant experimental indexes were determined. observe the effect of lung protective ventilation strategy on the microenvironment of tumor inflammation and related hematological indexes nlda, pdm, sii and pni in patients undergoing colorectal cancer surgery. follow-up frailty score and quality of recovery score at 1,3,6, and 12 months after surgery (qor-15 score scale).

Eligibility criteria:
inclusion criteria: 1. pathologic diagnosis of colorectal cancer 2. american society of aneshesiologists（asa）physical status classification system grade ⅱ-ⅲ; 3. from 51-70 years old with no gender restrictions 4. normal cardiopulmonary function before operation 5. body mass index:18-30 exclusion criteria: 1. preoperative anemia (hemoglobin\<10g/dl) 2. patients with preoperative mechanical ventilation; 3. a history of pulmonary infection and pulmonary tuberculosis within 1 month before surgery; 4. preoperative blood oxygen saturation (spo₂) was less than 90% (spo₂\ 45 mmhg); 5. patients who take immunosuppressants, neoadjuvant chemotherapy and radiotherapy before surgery; 6. preoperative abnormal coagulation function.

Keywords: lung protective ventilation strategies tumor microenvironment colorectal cancer
6-month extension trial of asenapine with olanzapine in negative symptoms patients who completed the first 6- month trial (a7501014)(completed)(p05772)

Conditions: Schizophrenia

Summary: this is an extension study of a7501013 (p05771/nct00145496) to further test the efficacy and safety of asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.


Eligibility criteria:
inclusion criteria: * continue to meet all demographic and procedural inclusion criteria of the a7501013 trial to enter into this extension trial. * have demonstrated an acceptable degree of compliance and completed the a7501013 trial, and would benefit from continued treatment according to the investigator. exclusion criteria: * have an uncontrolled, unstable clinically significant medical condition. * have been judged to be medically noncompliant in the management of their disease.