Kornimate/medical-research-clean huggingface dataset:
impact of endovenous water vapor treatment on quality of life in superficial venous insufficiency of the lower limbs

Conditions: Venous Insufficiency of Leg

Summary: the prevalence of superficial chronic venous insufficiency (cvi) of the lower limbs is estimated at 18 million french people. the number of patients operated for varicose veins is around 300,000 per year. post-operative complications such as venous ulcer, venous thrombosis and varicose vein rupture require a lot of medical care. varicose veins are responsible for a decrease in quality of life and represents 1 to 2% of total health expenditure. currently, operating techniques tend towards minimally invasive procedures in order to minimize the surgical trauma, improve patient comfort and reduce the time of postoperative work stoppages. this study aims to compare two surgical techniques for the treatment of superficial chronic venous insufficiency of the lower limbs : phlebectomy, the gold-standard technique, and endovenous steam treatment. several studies have already been carried out on endovenous steam treatment for saphenous veins but none has been published concerning the tributary veins.the main objective of involve is to assess the quality of life of patients 1 month after surgery. clinical improvement and economic impact will also be evaluated.


Eligibility criteria:
inclusion criteria: * women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches) * signature of the informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study * affiliation to a french social security scheme or beneficiary of such a scheme * patient with a reflux of the tributary veins, associated or not with a reflux of the large saphenous veins * patient with a reflux of the tributary veins already treated for a reflux at the saphenous level * clinical stage between c2 and c5 (from the ceap classification). diameter of the vein between 3 and 13 mm * patient treated with one or two lower limbs * patient able to understand and complete a quality of life questionnaire exclusion criteria: * legal incapacity or limited legal capacity * subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator * subject without health insurance * pregnant woman * subject in the period of exclusion from another study or provided for by the "national file of volunteers" * patient with an absolute or relative contraindication to the treatment of his varicose veins by an endovenous technique * venous insufficiency at the expense of the small saphenous vein * patient with a history of venous thrombosis * patient with hemostasis disorders * patient with an associated severe pathology (cancer, heart failure, renal failure) * patient treated with sclerotherapy
phase 1/2 study of etx-636 in participants with advanced solid tumors

Conditions: Advanced Solid Tumors; Advanced Breast Cancer

Summary: phase 1/2, open-label study of etx-636 in participants with advanced solid tumors

brief summary: this is a phase 1/2, open-label, multicenter, 3-part study to evaluate the safety, tolerability, pk, pd, and preliminary efficacy of etx-636 in participants with advanced solid tumors harboring a pik3ca mutation. part a will evaluate escalating doses of etx-636 as monotherapy in participants with advanced solid tumors. part b will evaluate escalating doses of etx-636 as combination therapy with fixed dose fulvestrant in participants with hormone receptor positive (hr+), her2 negative (her2-) locally advanced or metastatic breast cancer. part c will be a combination therapy expansion in participants with hr+, her2- locally advanced or metastatic breast cancer. each study part will include a 28-day screening period, followed by treatment with etx-636 monotherapy or combination therapy.

Eligibility criteria:
key inclusion criteria: * metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy. * tumor harboring an activating pik3ca mutation detected in either tumor tissue or ctdna. * at least 1 measurable lesion or evaluable disease per recist v1.1. * an ecog performance status score of 0 or 1. * adequate organ function. additional key inclusion criterion for parts b and c: - confirmed metastatic or locally advanced hr+/her2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior cdk4/6 inhibitor and at least 1 prior anti-estrogen therapy. key exclusion criteria: * has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied. * has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (cns) involvement. * has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2. * has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment. * has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy. * has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.

Keywords: cancer breast cancer solid tumors pik3ca pi3kα inhibitor breast neoplasms neoplasms by site neoplasms breast diseases her2-negative breast cancer hr-positive breast cancer gynecologic cancer endometrial cancer ovarian cancer cervical cancer head and neck cancer head and neck squamous cell carcinoma fulvestrant antineoplastic agents pi3kα pi3k alpha pi3kα mutation alpelisib estrogen receptor antagonists estrogen antagonists hormone receptor antagonists hormone antagonists hormones, hormone substitutes, and hormone antagonists physiological effects of drugs pik3ca mutation
secretory azoospermia and fdg (fluoro deoxyglucose) pet-ct

Conditions: Fertility

Summary: compare fdg pet-ct parameters between azoospermia patients having an extraction of sperm cells by positive testicular extraction and those with a negative extraction.

one third of infertilities is of exclusive male origin and one third of mixed origin (presence of a male factor). ten percent of infertile male have azoospermia with a secretory origin in most of cases. surgical extraction of spermatozoa from testicle is the unique possibility to increase the chance for these men to have children using in vitro fecundation. however, surgical extraction of spermatozoa is successful in 50% of these patients. to date, none of the methods for exploration of male fertility (spermogram, hormonal investigation - with dosage of fsh (follicle stimulating hormone) and inhibin b - and scrotal ultrasound) can predict the success of surgical sperm cells extraction. we also miss the prognostic markers of the testicular function recovery after sterilizing treatments (chemotherapy, radiotherapy). the presence of glut3 (glucose) transporters, which are responsible for the fluoro deoxyglucose uptake, has been reported in seminiferous tubules. we have previously shown in a pilot study on a population of men without testis cancer that fdg pet-ct parameters - including the standardized uptake value mean, the standardized uptake value max, and the functional testicular volume - were correlated with the parameters of spermogram (sperm count, motility, vitality). these findings open the way to investigations on the role of the fdg pet-ct in evaluation of secretory azoospermia.

Eligibility criteria:
inclusion criteria: absence of sperm cells on 2 spermograms in 3 months interval testicular size has to be determined in order to categorized in a group to accept surgery- exclusion criteria: allergy to fluoro deoxyglucose clinical varicocele
using virtual reality (vr) models for preoperative planning

Conditions: Kidney Cancer; Renal Cell Carcinoma

Summary: a prospective, randomized, controlled study designed to assess whether digital virtual reality (vr) models, created from existing ct scans and mris, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic partial nephrectomy) and improved patient care.


Eligibility criteria:
inclusion criteria: * subject is undergoing robotic partial nephrectomy being performed by participating surgeon * subject is willing to be randomized between intervention and control arms exclusion criteria: * cases involving subjects who are minors, pregnant or require an authorized representative for informed consent * cases in which the subject has a solitary or horseshoe kidney * cases in which the subject has more than two masses in the applicable kidney * cases involving a bilateral operation
mastermind - understanding individual variation in treatment response in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: response to treatment in type 2 diabetes is highly variable; the same medicine may have little effect in one person but a large effect in another. understanding mechanisms of altered response to treatment could aid treatment selection and assist the design of new medications with lower nonresponse rates. this study will examine the physiological mechanisms and potential clinical/biomarker predictors of altered response to sulphonylurea and dppiv inhibitor glucose lowering medication and answer fundamental methodological questions for the future study of variation in treatment response in type 2 diabetes. participants will withdraw sulphonylurea therapy for up to 2 weeks with assessment of baseline characteristics and glycaemic response. participants will then enter an optional extension where they receive sulphonylurea or dppiv inhibitor therapy in crossover fashion.

participants will withdraw sulphonylurea therapy for up to 2 weeks (part 1) followed by an optional cross-over extension (part 2)where they are randomized to 4 weeks of treatment with gliclazide (dpp-iv thera) or sitagliptin (sulphonylurea), followed by 4 weeks of the second treatment with a 2 week wash-out period in between. part 1 will allow assessment of response rates to long standing sulphonylurea treatment in clinical practice and potential predictors of this, as well as whether a very brief period (1 week) of treatment withdrawal is a valid assessment of an individual's response to therapy. part 2 will allow comparison of the approach in part one with response to the same treatment in a trial setting and will allow assessment on whether response is consistent across therapies with different mechanisms of action.

Eligibility criteria:
inclusion criteria: * age \>18 and \<80 * clinical diagnosis of type 2 diabetes * currently treated with sulphonylurea tablets * no change in diabetes treatment (new treatments or dose change) within last 3 months * last hba1c (taken within last 12 months) of ≥42 mmol/mol and ≤75 mmol/mol (6-9%) * able and willing to monitor home blood glucose * able and willing to give informed consent exclusion criteria: * current treatment includes: insulin, glp-1 agonists, dpp-iv inhibitors, glinides * renal impairment (egfr \<30 ml/min/1.73m2) * active infection (any infection requiring antibiotics at present) * recent (within 3 months) surgery or planned surgery * cardiovascular disease (angina, myocardial infarction, stroke, transient ischemic episode) occurring within the previous 3 months * previous history of pancreatitis * pregnant, breastfeeding or planning a pregnancy over the study period * unable/unwilling to monitor home blood glucose
patiromer with or without food for the treatment of hyperkalemia

Conditions: Hyperkalemia

Summary: the purpose of this study is to evaluate the efficacy and safety of patiromer administered once daily (qd) when given with food compared to without food (experimental treatment group) for the treatment of hyperkalemia (high potassium in the blood).

approximately 110 eligible participants with hyperkalemia will be randomly assigned to receive a patiromer starting dose of 8.4- g/day, either with or without food. all participants will undergo a screening period (1 day) to determine eligibility for study entry. eligible participants will be treated for 4 weeks and followed for 2 weeks after completing the patiromer treatment. there are six planned clinic visits during the treatment period and two planned visits after the last dose of patiromer during the follow-up period. the dose of patiromer may be increased or decreased (titrated) based on participants' individual potassium response.

Eligibility criteria:
key inclusion criteria: * potassium concentration \> 5.0 meq/l from two blood draws at screening * stable raasi medication, if taking * medications taken on a chronic basis are given once daily or twice daily * informed consent given key exclusion criteria: * expected need for dialysis * major organ transplant * history of conditions associated with pseudohyperkalemia * history of swallowing disorder, gastroparesis, bariatric surgery, bowel obstruction or severe gastrointestinal disorders or major gastrointestinal surgery * cancer or unstable medical condition

Keywords: treatment of hyperkalemia hyperkalemia potassium chronic kidney disease
mortality reduction after oral azithromycin contingency: mortality study

Conditions: Childhood Mortality

Summary: mordor was a cluster-randomized placebo controlled trial that assessed the efficacy of mass azithromycin distributions for the prevention of childhood mortality. all communities were subsequently treated with mass azithromycin for one year. the present trial re-randomized communities to azithromycin or placebo for the fourth and fifth year of the study.

pre-trial treatments: in the original mordor trial, communities were randomized to 4 rounds of biannual mass distributions of either azithromycin or placebo (i.e, the first two years of the trial). all communities were subsequently treated with 2 rounds of biannual mass azithromycin (i.e., the fifth and sixth rounds, during the third year of the trial). present trial design: the present trial enrolls all communities previously enrolled in the niger site of mordor, and re-randomizes communities to biannual mass distributions of either azithromycin or placebo (i.e., the seventh, eighth, ninth and tenth rounds of mass drug administration since randomization for the original mordor trial, occurring in the fourth and fifth year since randomization). this results in four patterns of community-based treatment: four years of azithromycin (aaaaa), three years of azithromycin followed by one year of placebo (aaapp), two years of placebo followed by two years of azithromycin (ppaaa), and two years of placebo followed by one year of azithromycin and then one year of placebo (ppapp). the primary outcome will be all-cause mortality in children aged 1-59 months,as determined by biannual census. the mortality rate following re-randomization (i.e., the seventh, eighth, ninth and tenth rounds of mass drug administration) will be compared between the two re-randomized groups.

Eligibility criteria:
inclusion criteria: * communities- all communities eligible for mordor (nct02047981) * individuals-all children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census exclusion criteria: * refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Keywords: childhood mortality mass treatment azithromycin infection
peng vs. qlb vs. lumbar espb in total hip surgery

Conditions: Total Hip Surgery; Pericapsular Nerve; Quadratus Lumborum; ESPB

Summary: the aim of this study is to compare between pericapsular nerve group block, erector spinae plane block and quadratus lumborum block for managing acute postoperative pain in patients undergoing total hip surgeries under spinal anesthesia.

total hip surgeries are one of the most common major orthopedic procedures to improve patient's functional status and quality of life. however, despite these advantages, the immediate postoperative period can be associated with severe pain that delays mobilization and increases hospital stay and the risk of thromboembolic events. various methods are used for postoperative pain management. intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. thus, alternative techniques are preferred.

Eligibility criteria:
inclusion criteria: * age 18-65 years * both genders * body mass index \< 40 kg/m\^2 * american society of anesthesiologists (asa) physical status i-iii * posted for total hip surgeries under spinal anesthesia exclusion criteria: * the presence of contraindications or allergy to local anesthetic agents * chronic use of opioids or corticosteroids * infection at the puncture site * coagulopathy * psychiatric disorders (dementia or cognitive impairment.
regulation of emotions and coping behaviour in patients with chronic recurrent low back pain

Conditions: Chronic Low Back Pain

Summary: this study investigates effects of a multidisciplinary rehabilitation program or physical therapy in patients with chronic low back pain on emotion regulation and coping behaviour. hypothesis: significant differences of negative emotions pre and post treatment and between groups after intervention. standardised questionnaires are used for investigation

emotionsregulations-inventar eri emotion regulation questionnaire erq positive and negative affect schedule panas brief symptom inventory bsi-18

Eligibility criteria:
inclusion criteria: * chronic low back pain \> 3 months * vas \>= 2 * understanding of german language exclusion criteria: * retired * psychiatric disorders * dementia * sick headache * chronic pain disease other than chronic low back pain * patients with general contraindications of the therapy
tens in post-operative total knee arthroplasty recovery and intra-venous analgesics requirement

Conditions: Total Knee Arthoplasty; Knee Pain

Summary: total knee arthroplasty (tka) is among the major advancements for the treatment of knee pain and improvement of physical function when conservative management fails to comply with. the success of this arthoplasty results in more functional mobility and better quality of life. however, management of pain after tka in post-operative period is a big challenge to deal.

transcutaneous electrical nerve stimulation is a cost effective, non-invasive electrotherapeutic modality used in alleviating pain in both acute and chronic conditions affecting neuromusculoskeletal system of the body.

Eligibility criteria:
inclusion criteria: 1. both male and female 2. aged between 31-70 years 3. total knee arthoplasty, who had been diagnosed with knee osteoarthritis, inflammatory arthritis, trauma, fracture result in total knee arthoplasty. exclusion criteria: 1. any allergic condition of skin 2. chronic consumption of opioids 3. history of dysplasia or malignancy to knee joint 4. any major bone operation of lower limb 5. bmi higher than 35 kg m-2 6. history of mental disorder 7. neurological illness e.g. alzheimer which might interfere with assessment process.

Keywords: total knee arthoplasty knee pain post-operative transcutaneous electrical nerve stimulation intra-venous analgesics requirement recovery
exercise-snacks at work: impact on cardiometabolic parameters

Conditions: Sedentary Time; Overweight and Obesity; Work-Related Condition

Summary: the main objective is to measure the effects of intense brief exercise program in the workplace of administrative staff on the cardio-metabolic health

backgrounds: very short (\< 1 minute) and intense exercises, entitled "exercise-snacks", have been reported to be effective 1) in improving physical fitness over 6 weeks and 2) in improving vascular function and lowering blood glucose levels over one day. these studies were all carried out in the laboratory. the question therefore arises as to whether these acute vascular and metabolic benefits, as well as those on physical fitness, are sustainable over time following a chronic "exercise-snacks" program applicable in the professional environment to sedentary, overweight people. aims of this project is therefore to measure the effects of an "exercise-snacks" type physical activity program in the workplace of administrative staff on the cardio-metabolic health and sedentary behaviour of staff.

Eligibility criteria:
inclusion criteria: * administrative staff, * age between 30 and 60, * body mass index ≥25kg/m², * sedentary time ≥7h/day, * minimum 3 working days on site, * no known cardiovascular or metabolic pathology, social security affiliation or benefit, * ability and willingness to give free, written and informed consent. exclusion criteria: * pregnant or breast-feeding women, * anti-hypertensive treatment, beta-blockers and anti-diabetics, * known contraindications to physical activity (articular, cardiac or other), * exercise-induced asthma, * lack of motivation of subjects posing problems of compliance and adherence to the exercise program, * participation in a study in the preceding 3 months, ongoing participation in a clinical trial.

Keywords: brief intense exercise vascular function cardiorespiratory fitness
human anti-tumor necrosis factor (tnf) monoclonal antibody adalimumab in subjects with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (as) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (nsaid) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (dmard).


Eligibility criteria:
inclusion criteria: * subjects must be \>= 18 years of age * meet modified ny criteria definition of ankylosing spondylitis (as) * have diagnosis of active as based on protocol specified criteria * inadequate response or intolerance to \>= 1 nonsteroidal antiinflammatory drug (nsaid) * be able and willing to learn to self-administer subcutaneous (sc) injections exclusion criteria: * active tuberculosis, listeriosis,or hepatitis b, or any history of hepatitis c * history of demyelinating disease, multiple sclerosis, cancer, or lymphoproliferative disease * previous anti-tumor necrosis factor therapy * treatment with disease-modifying antirheumatic drugs (dmards - other than methotrexate, hydroxychloroquine, and sulfasalazine) * treatment with intra-articular corticosteroid joint injections within 4 weeks of study dosing * biologic or investigational therapy within 6 weeks of study dosing * treatment with intravenous (iv) antibiotics within 30 days of study dosing * treatment with oral antibiotics within 14 days of study dosing