Kornimate/medical-research-clean huggingface dataset:
effect of coadministration of sotorasib on the pharmacokinetics of rosuvastatin in healthy participants

Conditions: Healthy Participants

Summary: a study to determine the effect of sotorasib on the pharmacokinetics (pk) of rosuvastatin, and to assess the pk of rosuvastatin when administered alone, in healthy participants.


Eligibility criteria:
inclusion criteria: * healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of screening. * body mass index, between 18 and 30 kg/m2 (inclusive), at the time of screening. * females of nonchildbearing potential exclusion criteria: * inability to swallow oral medication or history of malabsorption syndrome. * history of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee) and in consultation with the sponsor. * poor peripheral venous access. * history or evidence, at screening or check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Keywords: amg 510 sotorasib rosuvastatin healthy participants
incisional hernia repair long-term outcomes

Conditions: Incisional Hernia

Summary: long-term extension of a previous trial comparing outcomes after open (ovhr) or laparoscopic incisional ventral hernia repair (lvhr), assessing recurrence, reoperation, intraperitoneal mesh-related complications and self-reported quality-of-life with 10-15 years of follow-up.

long-term studies comparing outcomes after open (ovhr) or laparoscopic incisional ventral hernia repair (lvhr) are scarce. we carried-out a long-term extension of a previous trial comparing both approaches, assessing recurrence, reoperation, intraperitoneal mesh-related complications and self-reported quality-of-life with 10-15 years of follow-up. patients will be followed to assess recurrence (main endpoint), reoperation, mesh complications and death, from the date of index surgery (between 2003 to 2006) until recurrence, death or study completion with a clinical revision (between 2017 to 2019) whichever was first. by intention to treat, incidence rates of recurrence, reintervention and death by 1000 person-year of follow-up will be estimated, and also rates of mesh complications by 1000 person-year for the lvhr group excluding conversions. quality of life, using the european hernia society quality of life score (eurahs-qol), will be assessed for survivors no reoperated patients

Eligibility criteria:
inclusion criteria: * incisional hernia between 5 and 15 cm in largest diameter * no ontraindication for laparoscopic surgery. exclusion criteria: * patients with any type of stoma, * non-residente in the valencia región

Keywords: incisional hernia laparoscopic surgery recurrence health related quality of life
comparison of rotator interval injection versus intraarticular hydrodilatation in frozen shoulder

Conditions: Adhesive Capsulitis

Summary: this study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus rotator interval approach for treating patients with adhesive capsulitis.

adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. this study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis. design: a prospective, single-blinded, randomized, clinical trial patient and methods: patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided rotator interval injection ) and group 2 (ultrasound guided steroid hydrodilatation). the patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. outcomes measures included a pain scale (visual analog scale), range of motion, constant shoulder score, and shoulder pain and disability index.

Eligibility criteria:
inclusion criteria: * diagnosis of frozen shoulder by physical examination and ultrasonography exclusion criteria: 1. other conditions involving the shoulder ( rheumatoid arthritis, hill-sachs lesions,osteoporosis, or malignancies in the shoulder region) 2. neurologic deficits affecting shoulder function in normal daily activities 3. shoulder pain caused by cervical radiculopathy 4. a history of drug allergy to xylocaine or corticosteroid 5. pregnancy or lactation; 6. received injection into the affected shoulder during the preceding 3 months 7. history of surgeries on the affected shoulders 8. secondary frozen shoulder

Keywords: adhesive capsulitis
pert to improve quality of life in patients undergoing pancreaticoduodenectomy: a pilot randomized controlled trial

Conditions: Pancreatic Insufficiency

Summary: after pancreas surgery, patients may develop pancreatic exocrine insufficiency (pei). pei can be treated with oral pancreatic enzyme replacement therapy (pert). however, the diagnosis of pei is difficult and the guidelines about when to start pert after pancreas surgery are conflicting. this pilot study aims to determine the feasibility of implementing a large-scale clinical trial to definitively evaluate if starting pert immediately after surgery can improve outcomes in patients undergoing pancreas surgery.

after pancreas surgery, patients may develop pancreatic exocrine insufficiency (pei). this occurs when there are not enough exocrine cells in the pancreas to release enzymes that help with food digestion. potential symptoms may include bloating, cramping, large and foul-smelling bowel movements (steatorrhea), and other gastrointestinal symptoms like diarrhea, weight-loss, and malnutrition. pei can be treated with oral pancreatic enzyme replacement therapy (pert), for example creon. many studies have shown that treatment of pei with pert is safe, effective, and may improve quality of life, reduce weight loss, improve abdominal symptoms, and may improve overall survival. however, the diagnosis of pei is difficult and the guidelines about when to start pert after pancreas surgery are conflicting. this pilot study aims to determine the feasibility of implementing a large-scale clinical trial to definitively evaluate if starting pert immediately after surgery can improve outcomes in patients undergoing pancreas surgery. participants will be recruited from ontario hospitals using a two-step eligibility process (pre- and post-operatively) and randomized 1:1 to receive either standard of care or pert plus standard of care. outcome measures will be collected 1 and 3 months postoperatively.

Eligibility criteria:
inclusion criteria: 1. adults aged \>18 years 2. willing and able to provide informed consent and/or have a substitute decision maker (sdm) provide informed consent on behalf of the participant 3. planned pd for any indication and, at randomization 4. pd performed 5. discharge planned within 21 days of surgery exclusion criteria: 1. contraindication to pert including: 1. hypersensitivity to porcine protein, pancreatic enzymes or any excipients 2. history of fibrosing colonopathy 3. unable to tolerate oral medication 2. current use of pert or, at randomization 3. use of pert at the time of randomization

Keywords: pancreaticoduodenectomy pancreatic enzyme replacement therapy
puri-pro - symptoms impact and ehealth intervention for menopausal women with urinary incontinence

Conditions: Urinary Incontinence

Summary: urinary incontinence (ui) is a public health problem that disrupts the quality of life, productivity, social isolation and sexual function; its prevalence in peri- and postmenopausal women is around 30-40%. ui remains underreported and undertreated. previous ehealth interventions have been efficacious with women. thus, puri-pro (portuguese urinary incontinence project) (fct grant 2020.05710.bd) entailed a low-cost 8-week ehealth cognitive-behavioural multidisciplinary intervention aimed at reducing ui symptoms' severity through pelvic floor muscle training, development of healthy bladder habits, and promotion of adherence to exercises, realistic ui-beliefs, and functional coping strategies. urinary incontinence symptom severity, frequency and its impact on quality of life, beliefs and strategies regarding urinary incontinence, self-esteem, social isolation, and adherence to pelvic floor muscle excercises were evaluated.

puri-pro's intervention followed an experimental design (randomised controlled trial) involving ui intervention (experimental group-eg) vs. health literacy single-leaflet (control group-cg), both delivered through the internet (ehealth). the study was comparative, since the sample was distributed in two groups (eg vs cg) through randomised distribution, and longitudinal, since all the outcome measures were evaluated at four different times.

Eligibility criteria:
inclusion criteria: * age (40-65 years); * sex (women); * the presence of ui (positive response to a question about experiencing involuntary urine loss during intra-abdominal pressure increment and/or when feeling an incontrollable urge to urinate, occasionally or frequently); * internet access. exclusion criteria: * pregnancy or delivery in the past 6 months; * previous ui-related surgery; * history of pelvic prolapse: * known malignancy in the lower abdomen; * neurological disease that could affect bladder control; * substance use disorder.

Keywords: urinary incontinence menopause quality of life sexual function beliefs and coping strategies social isolation self esteem pelvic floor muscle training
evaluation of biological biomarkers diagnostic of toxoplasmosis uveitis

Conditions: Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection

Summary: toxoplasmosis affects one to two newborn each 10000 births. among them, 1 to 2 % develop learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an amblyopia responsible for visual impairment. toxoplasmosis uveitis affects too adults immunocompetent and immunodepressed who have had an acquired toxoplasmosis. clinical diagnosis of ocular toxoplasmosis is more complicated in presence of posterior neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. in this situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful. highly kept molecules (during evolution) like stress proteins (hsp) are are found in the host and the pathogen and there can trigger a crossed immune response. stress proteins haven't been explored yet, in the context of toxoplasmosis uveitis on humans. the hypothesis is that hsp70 and antibodies anti-hsp70 are diagnostic and prognostic markers of ocular toxoplasmosis. the goal is to evaluate diagnosis value of biological markers (hsp70 and antibodies igg anti-hsp70) in toxoplasmosis uveitis.


Eligibility criteria:
inclusion criteria: * age over 18 years * subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection * persons affiliated to national social security exclusion criteria: * pregnant, parturient or breastfeeding women * persons deprived of liberty by judicial or administrative decision, person under legal protection * refusal by a patient to do the pca (anterior chamber puncture) * patients whose following will be difficult or nonexistent

Keywords: toxoplasmosis uveitis chorioretinitis infection
treatment of depression in parkinson's disease trial

Conditions: Parkinson Disease; Depression

Summary: the goal of this study is to evaluate the effectiveness and safety of two antidepressants--nortriptyline and paroxetine, compared to placebo in patients with parkinson's disease and depression.

depression is the most common neuropsychiatric disorder found in patients with parkinson's disease (pd). it causes immense personal suffering and is associated with increased disability and caregiver burden. despite the adverse consequences of depression in patients with pd, there are virtually no empirical data to guide clinical treatment. this study will begin to answer some questions on the treatment of depression by testing a ssri (selective serotonin reuptake inhibitor) antidepressant, paroxetine, a tricyclic antidepressant, nortriptyline, and placebo in a placebo-controlled trial. a total of 75 patients with pd will be randomized to each of the three arms in a balanced design.

Eligibility criteria:
inclusion criteria: * parkinson's disease without dementia. * depression. * males or females. exclusion criteria: * psychosis * heart block

Keywords: parkinson's disease parkinson disease depression antidepressants nortriptyline paroxetine
descriptive study of multiligamentary reconstruction of the knee

Conditions: Injury, Knee

Summary: evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. comparison of two types of transplant: allograft versus autograft. there is currently little data in the clinical outcome literature after allograft reconstruction. there is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). no study compares postoperative laxity after allograft versus autograft reconstruction.


Eligibility criteria:
inclusion criteria: * patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury * \>18 years old exclusion criteria: * neurological or vascular injury during trauma. * fracture of the femur or both bones of the leg. * ligamentous lesion on the contralateral knee. * history of surgery on the affected knee.
clomiphene citrate plus ufsh versus aromatase inhibitor plus ufsh in clomiphene resistant infertile pcos women

Conditions: Polycystic Ovary Syndrome; Infertility

Summary: polycystic ovarian syndrome (pcos) is a condition characterized by infertility, infrequent periods and amenorrhea or irregular bleeding plus anovulatory infertility. clomid is the standard first drug of treatment for ovulation induction. ovulation and conception will occur in approximately 75 and 30 percent of cases respectively. cases not ovulating in response to doses of clomid up to 150 mg/day are known as clomid resistant pcos.

to test whether cc co- treatment with chronic low dose hp ufsh versus lirizole plus chronic low dose hp ufsh in cc resistant pcos will yield comparable results in terms of, ovulation rate, lower follicle number, lower hp ufsh dose, better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates, lower cycle cancellation.

Eligibility criteria:
inclusion criteria: * cc resistant pcos * infertile * females * age 18-38 exclusion criteria: * hyperprolactinaemia * cushing syndrome * adult onset adrenal hyperplasia * age \> 38 * other infertility factors in the couple than pcos: male factor,tubal factor,edometriosis

Keywords: pcos clomiphene citrate resistant pcos aromatase inhibitors
effect of early pulmonary rehabilitation after lung transplantation

Conditions: Lung Transplantation

Summary: the purpose of this observation study is to evaluate the effects of an early, 3 week lasting rehabilitation program, that starts roundabout 4 weeks after lung or combined lung transplantation, on physical activity, functional and physical condition (6-min-walk, fev1, adl-score) and quality of life (sf36) in lung transplant recipients with a different length of stay on the waiting list and a different duration of hospitalization in the transplantation centre after transplantation.

to which extend a prolonged duration from listing for lung transplantation until a successful transplantation or a long length of hospitalization may influence the success of a pulmonary rehabilitation, that starts after discharge from the transplantation centre, is still unknown. long waiting periods before transplantation and surgical, infectious or immunological complications after transplantation influence the physical condition and the quality of life of the organ recipient. a poor physical condition before transplantation results in an unfavourable outcome in the first 12 months after transplantation. at present it is unclear, whether a structured pulmonary rehabilitation may overwhelm differences between patients with a prolonged course roundabout the transplantation compared or not. at present it is not clear whether it is necessary for lung transplant recipients to participate in a rehabilitation program including structured exercise training. the aim of this observational study is to assess the effect of a short-term pulmonary rehabilitation, that starts immediately after discharge from the transplantation centre on patients with a prolonged waiting period or an extended postoperative hospitalization. * hypothesis: a structured pulmonary rehabilitation early after transplantation may overwhelm poor physical and functional conditions after a prolonged period on the transplant waiting listor a prolonged hospitalization after transplantation resulting in a significant improvement in all transplanted patients * antithesis: a prolonged period on the waiting list before transplantation or a prolonged hospitalization after transplantation can not be influenced significantly by an early transplant rehabilitation resulting in a persistent lack of functional status and quality of life compared with a short waiting period or a normal duration of hospitalization after transplantation. * outcomes: functional status (6-min. walk, exercise capacity, fev1, adl), and quality of life (sf36) will be assessed at the beginning and on discharge from the rehabilitation centre.

Eligibility criteria:
inclusion criteria: * recipients of single or double lung transplants * recipients of combined (heart and lung or heart an liver) transplants

Keywords: lung transplantation pulmonary rehabilitation exercise tolerance quality of life
safety and efficacy of perioperative remodulin® in orthotopic liver transplant recipients

Conditions: Liver Transplant

Summary: patients undergoing orthotopic liver transplant will experience some degree of clinical and/or biochemical hepatic dysfunction. this early injury is known as primary graft dysfunction and varies from minor abnormalities to primary nonfunction. prostaglandin-class drugs, including prostacyclin and its analogs, could represent an important advance toward the goal of reducing transplant related morbidity, mortality and associated costs by providing these benefits.

in vitro and in vivo research has consistently demonstrated an array of potential beneficial effects of prostanoids under both immune and non-immune circumstances relevant to liver allografts. (1-3) recent reviews summarize the pharmacologic rationale and nonclinical and clinical experience supporting for the use of prostanoids, including prostacyclin and its analogs, in reducing early morbidity and mortality associated with liver transplantation. prostaglandin-class drugs, including prostacyclin and its analogs, could represent an important advance toward the goal of reducing transplant related morbidity, mortality and associated costs by providing these benefits. additionally, the reduction in serum creatinine and reduced need for post-operative dialysis observed in some studies has implications in protecting the kidneys from the nephrotoxic affects of the immunosuppressant agents, especially during the early post-operative period. as a chemically stable analog of prostacyclin (pgi2), peri-operative intravenous administration of remodulin is hypothesized to ameliorate or prevent reperfusion damage and thereby decrease hospitalization time and improve the clinical outcome of liver transplantation, compared to placebo control. remodulin, as a prostanoid, is expected to facilitate restoration of the blood supply to the revascularized graft, and to provide the well-characterized protective effects of this class of compounds in liver transplant patients.

Eligibility criteria:
inclusion criteria: * accepted as a liver transplant candidate at the university of pittsburgh medical center * be receiving a cadaver donor liver transplant * treated in accordance with the standard of care protocol(s) in effect for liver transplant recipients at the university of pittsburgh medical center. exclusion criteria: * receiving a living done liver transplant * receiving a donor liver with a cold ischemia time less that 6 hours * receiving a donor liver with macrosteatosis greater than 30% * receiving any investigation drug with the except of alemtuzamab (camphath) * failed liver transplant in previous 180 days * prior organ transplant or cell infusion * undergoing multi-organ transplant * pregnant or nursing female

Keywords: liver transplant prostacyclin treprostinil sodium remodulin reperfusion injury primary nonfunction
diet quality and coronary artery calcification in adults with heterozygous familial hypercholesterolemia

Conditions: Hypercholesterolemia, Familial; Calcification; Heart; Diet Habit

Summary: the overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (hefh). we will recruit adults with hefh. they will have to complete questionnaires on diet, medication and lifestyle. coronary artery calcification will be measured in each patient using a ct scan. physiological and biochemical data will be collected.

the proposed research will deploy as cross-sectional study including treated adults with genetically-defined hefh. once recruited, participants will be asked to complete web-based questionnaires on diet, medication and lifestyle. they will thereafter complete a clinical assessment at the clinical investigation unit of the nutriss-inaf research centre. study staff will measure participants' height, weight, and waist circumference. participants' blood pressure will be measured using an automatic blood pressure monitor (bp thru, omron) after sitting quietly for 10 minutes. three sequential readings will be taken with three minutes between readings. fasting blood samples (10 ml) will be collected from an antecubital vein. body composition will be assessed with dual-energy x-ray absorptiometry (dexa). finally, participants will be asked to provide the full list of medication they are using, including type, dose and duration of use. later on the same day, participants will undergo the non-contrast ct scan at the quebec heart and lung institute. multidetector ct scans without contrast will be performed using a 256 slices helical scanner (brilliance ict, philips).

Eligibility criteria:
inclusion criteria: - genetically-defined heterozygous familial hypercholesterolemia exclusion criteria: * homozygous fh * personal history of cardiovascular disease * personal history of cancer