Kornimate/medical-research-clean huggingface dataset:
elb245 for 12 weeks versus 4mg tolterodine in patients with incontinent overactive bladder (oab)

Conditions: Overactive Bladder; Urinary Incontinence

Summary: this study is designed to determine the efficacy of escalating doses of elb245 versus placebo , when administered to patients with oab and to compare the efficacy of escalating doses of elb245 versus the standard treatment tolterodine, when administered to patients with oab.


Eligibility criteria:
inclusion criteria: * male or female outpatients at least 18 years of age * symptoms of oab for a minimum of 3 consecutive months prior to study entry; severity of oab (as defined by patient reported symptoms) for a minimum of one month prior to study entry * ability to use a toilet independently and without difficulty * no treatment with any medication against oab during the 4 weeks prior to study entry * written informed consent exclusion criteria: * breastfeeding women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control * any local pathology, that might cause the bladder symptoms * significant stress urinary incontinence or mixed stress/urgency incontinence * any neurological disease affecting bladder function or muscle strength * patient history of any lower urinary tract surgery or previous pelvic irradiation * local administration of botulinum toxin within the last 9 months in the lower urinary tract * start or change of a behavioral bladder training program * post voiding residual volumes larger than 250ml or symptoms of clinically relevant bladder outlet obstruction * nocturial polyuria * history of liver disease and/or impaired liver function * cholestasis * chronic alcohol or drug abuse * evidence of significantly impaired renal function ( * diabetes mellitus (type i or ii) with significant peripheral neuropathy and/or polyuria * inflammatory bowel disease such as crohn's disease, or ulcerative colitis * uncontrolled narrow angle glaucoma * chronic use of carbamazepine or paracetamol * participation in any drug study in the preceding 3 months * concomitant treatment with strong cyp3a4 inhibitors * history or evidence of relevant cardiovascular or cerebrovascular disorders

Keywords: oab, proof of concept overactive bladder (oab) with incontinence
the role of nutrition in muscle function of bariatric surgery patients

Conditions: Obesity, Diabetes, Nutrition, Physical Health; Body Composition Changes; Muscle Function, Handgrip Strength Test; Protein Metabolism; Bariatric Surgery Patients

Summary: current recommendations for protein intake after bariatric surgery are not based on strong scientific evidence. it remains unclear how much protein should be eaten to minimize muscle loss and preserve the metabolism and function of individuals post-bariatric surgery. the objective of this study is to analyze the relationships between changes in body composition, nutrition and protein intake, and muscle function after bariatric surgery to further our understanding of the nutritional needs of patients after bariatric surgery. we intend to recruit around 75 participants, men and women, aged between 18 and 65 years. participants will be recruited from the bariatric surgery clinic, mcgill university health center.


Eligibility criteria:
inclusion criteria: * male and female * aged 18 to 65 years old * undergoing first bariatric surgery (any type) * diabetics and non-diabetics * non-smokers and non-cannabis consumers exclusion criteria: * pregnant and breastfeeding women * individuals undergoing second bariatric surgery * regular smokers and cannabis consumers * current use of ozempic (or ozempic-like medication) and anti-psychotic meds * limited physical mobility (using walking aids such as canes, walkers, or wheelchairs) and issues with hand resistance * kidney disease, non-controlled / unstable hypertension and hypothyroidism, and any metabolic disease other than diabetes

Keywords: obesity bariatric sugery protein function muscle function 6-minute walk test handgrip strength test nutritional needs nutritional guides nutrition
use of plasma rich in growth factors (prgf) in pilonidal sinus excision

Conditions: Pilonidal Sinus

Summary: the use of plasma rich in growth factors in wound excision pilonidal sinus could improve the healing process of the wound, when compared with the usual technique of daily local healing. the investigators propose the objective of evaluating the efficacy of intra- and postoperative application of plasma rich in growth factors, to reduce healing time and complications, arising from its removal, compared to the standard surgical treatment.

prospective randomized control trial, comparing prgf application vs daily local care(betadine +saline) in sinus pilonidal wound excision. prgf is extracted from de patient blood and infiltrated in the pilonidal wound every week. this treatment is compared with betadine and saline wound care in terms of wound healing time, pospoperative pain and other complications. this study try to keeps the advantages of using open technique for pilonidal desease( low recurrence rate and surgical site infections) and improving the disadvantages (high wound healing time and postperative pain with wore quality of life) when it´s compared with direct closure or flap techniques.

Eligibility criteria:
inclusion criteria: * patients among 13 and 65 years old * possibility of observation during the follow-up period * patients who have read and signed informed consent exclusion criteria: * abscessed pilonidal sinus * recurrent pilonidal sinus * patients treated with immunosuppressive drugs or anticoagulants
quantifying patellar tendon microstructure using dti

Conditions: Patellar Tendinopathy; Anterior Cruciate Ligament Reconstruction

Summary: the goal of this observational study is to understand how diffusion tensor imaging (dti) relates to other traditional measures and knee function. the main question it aims to answer is: will regions of known patellar tendon pathology present with smaller dti scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon. participants will: * undergo mri and ultrasound imaging * perform knee function test * complete questionnaires

patellar tendon injuries are commonly accompanied by macrostructural alterations captured on common imaging modalities, and the extent of these alterations correlate to knee joint function. evidence for using tendon macrostructure for diagnosis and prognosis of tendon injuries is not as clear, suggesting that these imaging modalities are not providing a complete picture of the alterations. diffusion tensor imaging (dti) tractography can quantify tendon microstructures that underlie the alterations in pathological tendons and shows promising results in healthy tendons. this study is the first step in evaluating whether tendon microstructure captured using dti technology can be applied as a biomarker to optimize treatment for patellar tendon injuries.

Eligibility criteria:
inclusion criteria: * age 18 or older * have patellar tendon injury as confirmed through subjective report, clinical examination, and ultrasound by an experienced physical therapist * patellar tendinopathy group must present with current symptoms of patellar tendinopathy * control group must have no history of patellar tendon injury exclusion criteria: * participants with a history of invasive procedures other than bone-patellar tendon-bone (bptb) autograft harvest to the patellar tendon or extensor mechanism * participants with history of contralateral bptb autograft harvest, or aclr using any other graft type * participants with contraindications to mri * participants with contraindications to nmes
comparison between hcg and gnrh agonist for ovulation induction in patients with high response to ivf drugs

Conditions: Infertility

Summary: hcg and gnrh agonist can be used to induce final oocyte maturation and ovulation in ivf cycles. these two approaches will be compared in this study in terms of pregnancy rates and embryological data using patients with hyper-response to ivf drugs.

hcg is commonly used for the substitution of the endogenous lh surge to induce oocyte maturation and ovulation induction in ovarian hyperstimulation protocols for in vitro fertilization (ivf). however, hcg is related to the occurrence of the ovarian hyperstimulation syndrome (ohss), a potentially life-threatening complication and hyper-responding patients are particularly in high risk. an alternative to exogenous hcg is the administration of a gnrh agonist inducing an endogenous rise in both lh and fsh levels due to the initial flare effect. comparisons: pregnancy rates and embryological data will be compared from hyper-responding patients receiving either gnrh agonist (arvekap) or hcg (pregnyl) for ovulatrion induction following a gnrh antagonist treatment cycle.

Eligibility criteria:
inclusion criteria: * hyper-responder patients (\>20 oocytes retrieved) exclusion criteria: * normal responders * poor responders * pcos

Keywords: ovulation induction hcg gnrh agonist hyper-responders
health effects of soccer training in men with prostate cancer receiving androgen deprivation therapy

Conditions: Prostatic Neoplasms; Exercise; Soccer Training; Androgen Deprivation Therapy

Summary: androgen deprivation therapy (adt) is standard treatment for locally advanced or advanced prostate cancer (pc). the musculoskeletal toxicity associated with adt is well established, leading to a decrease in muscle mass, increased fat percentage, weight gain, sexual dysfunction and increased risk of depression, fatigue, diabetes, cardiovascular disease and reduced quality of life. numerous studies have shown an association between physical activity, physical capacity and quality of life in cancer patients and recent epidemiological research suggest that regular, moderate-intensity physical activity may have a positive effect on survival in men with prostate cancer. within exercise physiology there is new evidence pointing to recreational soccer as a unique form of intermittent exercise that effectively stimulates aerobic and anaerobic energy delivery systems, leading to beneficial musculoskeletal, metabolic and cardiovascular adaptations of importance for health. it is our overall hypothesis that 12 weeks of recreational soccer training 2-3 times per week will improve the health profile of pc patients receiving adt treatment.


Eligibility criteria:
inclusion criteria: - patients with locally advanced or advanced prostate cancer being treated with androgen deprivation therapy (s-testosterone \< 1.7) for at least 6 months at the time of inclusion exclusion criteria: * who performance level above 1,symptomatic cardiovascular disorders, osteoporosis (t-score below -2.5)

Keywords: prostatic neoplasms prostate cancer exercise soccer androgen deprivation therapy body composition cardiovascular fitness bone health health related quality of life
imagery rescripting in the treatment of post traumatic stress disorder (ptsd) following early chronic interpersonal trauma

Conditions: Posttraumatic Stress Disorder (PTSD)

Summary: imagery rescripting (ir)is a promising treatment for ptsd in adult survivors of early, chronic, interpersonal trauma (e.g. smucker \& dancu, 1999). so far, this protocol has not been investigated within a controlled setting with patients with ptsd following early, chronic, interpersonal trauma. the aim of the proposed study is to 1. investigate the efficacy of imagery rescripting and 2. check whether the efficacy of imagery rescripting can be improved by adding a stabilization phase (skills training in affective and interpersonal regulation, stair) prior to this treatment. in a randomized controlled trial three conditions will be compared: 1. imagery rescripting 2. stair + imagery rescripting 3. wait-list control


Eligibility criteria:
inclusion criteria: * a full diagnosis of post-traumatic stress disorder (ptsd) according to dsm-iv * having experienced repeated or chronic interpersonal trauma by care-takers or authority figures before the age of 15 * between the age of 18 and 65 years * sufficient fluency of dutch to complete treatment and research-protocol * participants using prescribed anti-depressant medication are required to be on a stable dose for at least 6 weeks before the beginning of treatment and remain on this dose throughout the treatment exclusion criteria: * psychosis * bipolar disorder * significant cognitive impairment * substance dependence * current use of benzodiazepines * severe suicidal ideation or life-threatening automutilation * current trauma or threat * unstable living circumstances * antisocial personality disorder * primary diagnosis of borderline personality disorder

Keywords: imagery rescripting imagery rescripting and reprocessing therapy skills training in affective and interpersonal regulation post-traumatic stress disorder childhood abuse childhood sexual abuse
effectiveness of endoluminal treatment of autologous arteriovenous endovascular fistula failure

Conditions: Hemodialysis Access Failure

Summary: this study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.this is a prospective, multi-center cohort study.

the study will recruit 180 patients with venous segment stenosis of autologous arteriovenous fistulas at multiple centers from june 2024 to december 2025. patients will be divided into two cohorts based on the treatment method: the cutting balloon group and the drug-coated balloon group. the primary outcomes observed will be the primary patency rates of the target lesion at 1, 3, 6, and 12 months post-operation, re-intervention rates of the target vessel, and the technical success rates and procedural success rates of the two devices, along with major adverse events during the perioperative period.

Eligibility criteria:
inclusion criteria: 1. subjects aged between 18 and 75 years. 2. subjects possess a mature upper limb autologous arteriovenous fistula (avf) and have undergone at least one hemodialysis session. 3. target lesion must be located in the venous segment of the upper limb avf. 4. doppler ultrasound confirms that the target lesion stenosis is ≥50%, accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal fistula signs, significant reduction in blood flow (\<200ml/min). 5. guidewire and balloon successfully pass through the lesion and complete dilation. 6.subjects or their legal representatives must understand the purpose of the trial, voluntarily participate in the clinical trial, and sign an informed consent form, while also being willing to adhere to the specific follow-up schedules set by this trial. exclusion criteria: 1. target lesion located in the arterial segment or anastomosis of the avf. 2. target lesion located in the lower limb avf. 3. subjects with previous stent implantation in the avf. 4. patients diagnosed with symptomatic central venous occlusive disease: avf flow reduction accompanied by swelling of the ipsilateral limb, chest, or facial area, with dsa confirmation of central venous occlusive disease. 5. subjects with two or more target lesions in the avf (when two stenoses are less than 3 cm apart, they are considered as one target lesion). 6. subjects with acute thrombosis in the avf or who have undergone avf thrombolysis or thrombectomy within the past 30 days. 7. subjects who have undergone or plan to undergo surgical intervention on the avf within 30 days. 8. subjects with avf infection or concurrent systemic active infection. 9. subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months. 10. subjects with diseases causing coagulopathy, such as thrombocytopenic purpura. 11. subjects undergoing immunotherapy or suspected/diagnosed with vasculitis. 12. subjects with allergies or contraindications to heparin or contrast agents. 13. subjects who are pregnant or breastfeeding. 14. subjects with a life expectancy of less than 12 months.
use of novoseven® in active variceal bleeding

Conditions: Acquired Bleeding Disorder; Cirrhosis

Summary: this trial is conducted in asia and europe. the trial is planned to investigate the effectiveness and safety of novoseven® in patients with advanced cirrhosis and active variceal bleeding.


Eligibility criteria:
inclusion criteria: * variceal bleeding

Keywords: active variceal bleeding in patients with advanced cirrhosis
examining racial and socioeconomic disparities (erased) in chronic low back pain study

Conditions: Back Pain Lower Back Chronic

Summary: it remains unclear whether certain disadvantaged subgroups of society may be at heightened risk for poor chronic low back pain (clbp) outcomes. the overall aim of this study is to incorporate a socioeconomic framework to characterize racial differences in clbp severity and disability. further, guided by the theory of fundamental causes, we aim to examine racial and socioeconomic status differences in biopsychosocial predictors of clbp outcomes, particularly endogenous pain modulation.

experimental session 1 resting blood pressure and body mass index will be assessed. participants will complete the rapid estimation of adult literacy measure-short form (realm-sf) to determine health literacy. participants will complete multiple questionnaires to measure socioeconomic status, clinical pain assessment and depression scale. all participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour. between experimental session 1 and experimental session 2 sleep assessment: sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1. experimental session 2 experimental session 2 will take place in the ccts clinical research unit (cru) all blood will be collected as part of a single draw by research nurses. participants will complete multiple questionnaires to measure clinical pain assessment and coping strategies. participants will then complete a battery of ecologically valid movement tasks that include: 1) getting in and out of a bed; 2) sitting in a chair, transitioning to a standing position, and then sitting again, and 3) lifting, performance battery (sppb) and the timed up and go test (tug). blood will be processed and stored and then used to measure vitamin d, crp assays and oxytocin. finally follow up data will be collected by phone once per week for four weeks following the completion of study session 2.

Eligibility criteria:
inclusion criteria: * chronic low back pain that has been going on consistently for the last 6 months. exclusion criteria: * surgery (fusion, laminectomy) in the last year, accident or trauma in the last year, uncontrolled high blood pressure, heart disease, cancer, diabetes hba1c \> 7%, ankylosing spondylitis, infection, parkinson's disease, multiple sclerosis, epilepsy, stroke, seizure (non-epileptic), systemic lupus erythematosus, fibromyalgia, raynaud's disease, major depression/bipolar disorder, hiv

Keywords: low back pain chronic pain health disparities in chronic low back pain
low versus high corticosteroid use in ventilator associated pneumonia

Conditions: Ventilator Associated Pneumonia

Summary: patients who had \>3 on murray score and \>6 on cpis allocated randomly in two groups 120 patients in each. group a received 30 mg/kg methyl-prednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 48 hours while group b received 1 mg/kg/day methyl-prednisolone divided to three doses given every 8 hours for two weeks. duration of the study last 16 days, morbidity considered if no improvement in any or all clinical parameters of both murray and cpis scores and failure of weaning of patients from the ventilator at the studied period.

adult patients aged \>18\ 90%. sedation and pain control done by both midazolam and fentanyl infusion to achieve richmond agitation- sedation scale (rass) -2. protective lung strategy applied and include, head elevation more than 45-degree, daily assessment for both analgesic and sedative dose, early naso-gastric feeding to prevent bacterial translocation and flooding of the blood with gram negative septicemia, usage of the minimal peep to maintain spo2 \>90%. qualitative sputum culture was taken after 3 days from ventilation. after 3 days from the conventional ventilation only 240 patients enrolled in our study. those who had a murray score (for diagnosis of ards) of \>3 and cpis (clinical pulmonary infection score) (for diagnosis of vap) \> 6. all patients were randomly allocated in 2 groups 120 patients in each. all patients received intravenous antibiotics meropenem 1 gm slowly intravenous every 8 hours for the first 8 days then antibiotics was given according to sputum culture and antibiotics sensitivity. group a received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days while group b included received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks. this study conducted for 16 days. vap diagnosed in our study by cpis 6 or more while severity of lung contusion assessed by murray score 3 or more

Eligibility criteria:
inclusion criteria: * ventilator associated pneumonia patients exclusion criteria: * post cardiac arrest
safety and mode of action of a single dose and multiple doses of long acting activated recombinant human factor vii in patients with haemophilia a and b

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Summary: this trial is conducted in europe. the aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor vii (la-rfviia) in patients with haemophilia.


Eligibility criteria:
inclusion criteria: * haemophilia a or b * bodyweight max 100 kg * body mass index (bmi) max 30 kg/m2 * adequate venous access exclusion criteria: * known or suspected allergy to trial product(s) or related products (including novoseven®) * the receipt of any investigational product within 30 days prior to enrolment in this trial * receipt of immune tolerance induction (iti) within the last 1 month prior to participation in this trial * the receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product * receipt of fviii or fix replacement therapy within 48 hours prior to trial product administration * known pseudo tumours * congenital or acquired coagulation disorders other than haemophilia a or b * any major and/or orthopaedic surgery within one month prior to trial start * advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.) * clinical signs of renal dysfunction * use of platelet inhibitors, including nsaids, one week prior to administration of trial drug * use of non-prescribed opiate substances