Kornimate/medical-research-clean huggingface dataset:
a study extension period of peg-somatropin (pegylated-somatropin) in the treatment of children with idiopathic short stature

Conditions: Dwarfism

Summary: after the first stage (52 weeks) of phase ii clinical trial, pegylated recombinant human growth hormone (peg-rhgh) injection of appropriate dose in compliance with iss clinical treatment strategy is used to treat children with iss (idiopathic short stature). the long-term efficacy and safety of the investigational product are evaluated, which can provide more scientific and reliable medication guidance information for clinical diagnosis and treatment.


Eligibility criteria:
inclusion criteria: * all subjects who have completed the first stage (52 weeks) of phase ii clinical trial (including negative controls) with completed follow-up records may be enrolled in the extension period study. * before the extension period study, the investigator shall fully inform the subjects and their guardians of all the information about the extension period study, including detailed follow-up procedure, treatment plan, laboratory examination items during follow-ups and possible benefits and risks. the extension period study shall only be initiated after the subjects and their guardians are well informed, and agree to cooperate and complete the treatment, follow-ups and examinations during the study, and sign the written informed consent. exclusion criteria: * subjects who have taken the following medications within 2 months before entering the extension period study: 1. aromatase inhibitors (which include but are not limited to lelrozol and anastrozole), with continuous medication ≥1 month; 2. gonadotropin releasing hormone analogues (which include but are not limited to triptorelin, leuprorelin and goserelin),, with continuous medication ≥1 month; 3. sex steroids (which include but are not limited to any type of estrogen, progestin and androgen) , with continuous medication ≥1 month; 4. protein anabolic drugs (which include but are not limited to oxandrolone, danazol and strombafort), with continuous medication ≥1 month; 5. glucocorticoids via oral/intravenous administration for more than 1 month..
single-step placenta accreta resective technique tourniqueted vs absence, conservative uterine surgery

Conditions: Placenta Accreta

Summary: background: an optimal international standard for pas surgery is not yet available, and the establishment of a suitable surgical method is an important focus of in pas management. objective: to assess the efficacy and safety of tourniquet uses for conservative approach in the management of placenta accerta spectrum. patients and methods: 40 pregnant women who underwent conservative management of placenta accrete at kasr el-aini hospital (obstetrics and gynecology department - faculty of medicine - cairo university) were included and were divided according to the use of tourniquet into 2 equal groups: study group (tourniquet group): consists of 20 women for whom tourniquet was used in the lower part of the uterus during surgical treatment of placenta accreta spectrum.control group (no tourniquet group): consists of 20 women for whom no tourniquet was used.


Eligibility criteria:
inclusion criteria: * pregnant females with previous cs deliveries (at least 1). * patients with ultrasound criteria of placenta accerta spectrum. * patients desiring fertility (uterine conservation). * patients with gestational age that completed 34 weeks (or more) confirmed by the 1st day of the lmp or 1st trimester ultrasound scan. exclusion criteria: * maternal age above 40 years. * chronic medical disorders (e.g., cardiac, renal, dm and hepatic diseases). * patients presented with severe antepartum hemorrhage (unstable vital signs). * patients requested radical management (caesarean hysterectomy).
a single and multiple ascending dose study to assess the safety, pharmacokinetics and pharmacodynamics of cat-2003

Conditions: Dyslipidemia

Summary: this is a two-part phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. in part a, cat-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of cat-2003 or placebo after a high fat meal. in part b, cat-2003 is administered for 14 consecutive days.


Eligibility criteria:
major inclusion criteria: * provision of written informed consent prior to any study-specific procedure; * good health as determined by medical history, physical examination, vital signs, ecg, and clinical laboratory measurements; * satisfies one of the following: 1. females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal for 2 years or at least 1 year with a follicle stimulating hormone assessment (fsh) greater than or equal to 40 iu/l; or 2. males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose; major exclusion criteria: * clinically significant disease that requires a physician's care and/or would interfere with study evaluations * clinically significant electrocardiogram (ecg) abnormalities or laboratory results as assessed by the investigator, such as qtcf \>450; * use of any investigational drug or participation in any investigational study within 30 days prior to screening or 5 half-lives of the study agent, whichever is longer;
genetic susceptibility to predict weight loss after bariatric surgery

Conditions: Bariatric Surgery Candidate; Obesity, Morbid; Genetic Predisposition; Metabolic Syndrome; Weight Loss

Summary: obesity is a complex chronic disease, in which both genetic and environmental factors are involved, that shows a great heterogeneity in the response to different weight loss programs. identifying patients as responder or no responder to the different obesity treatment options is a concept of great interest, both due to the high prevalence of obesity and its high consumption of resources. more than 500,000 surgeries are performed every year around the world, of which approximately 30% will present unsatisfactory results. the general objective is to carry out a multi-omics approach for the discovery and validation of markers of weight response to bariatric surgery (bs) in a large sample of people with severe obesity (n=6,966 men and women who underwent sleeve gastrectomy or gastric bypass, including an additional external validation set). thus, the investigators want to know the integrated contribution of several genomic markers (genome wide association study, gwas), new clinical and analytical variables (human exposome concept) and gender perspective to the prediction of response to the intervention at 12 month and its long-term longitudinal maintenance (3 years). the investigators intend, therefore, to provide new evidence to advance towards precision medicine. the investigators will focus our attention also on identifying those patients who, after being classified at the weight loss nadir as responders experienced weight regain.


Eligibility criteria:
inclusion criteria: * men and women between the ages of 18 and 65 at the time of surgery * sg or rybp as bariatric procedure. * with a bmi≥35.0 kg/m2 with one or more comorbidities or a bmi\>40.0 kg/m2 at the time of surgery. * provision of an informed consent form signed and personally dated by the patient. * with available baseline data (anthropometric, analytical, surgical procedure, pharmacological therapies, and obesity-related comorbidities). exclusion criteria: * any previous gastrointestinal surgery * treatment with any approved antiobesity drug in spain (orlistat, liraglutide 3.0 mg and/or naltrexone/bupropion extended release) or systemic glucocorticoids for more than 4 consecutive weeks during the 3 years following bs * end stage kidney disease (egfr \<15 ml/min/1.73m2) or liver cirrhosis at baseline * patients who developed any major medical conditions that limits the practice of a healthy life within normal limits (advanced cardiovascular disease or heart failure, stroke with neurological sequelae, chronic pulmonary obstructive disease with dyspnea at minimal exertion, severe joint pathology, end stage renal failure, or active cancer) * known type 1 diabetes or lada diabetes * women who become pregnant during the follow-up period * current drug or alcohol abuse * uncontrolled psychiatric illness or eating disorders developed during the follow-up period.
assessment of postural stability in patients with total knee arthroplasty

Conditions: Knee Arthritis; Arthroplasty Complications; Obesity; Balance; Distorted

Summary: postural balance can be described as the integration of the information obtained from visual, vestibular and somatosensory systems. postural stability is achieved by sensory information about the static or dynamic position of the body resulting in an appropriate motor response. poor postural stability in individuals with knee osteoarthritis often results in an increased risk of falling and decrease in mobility. it has been reported that 40% of knee osteoarthritis patients fall at least once in a year. total knee arthroplasty (tka) is a surgical treatment approach applied to individuals with advanced knee osteoarthritis. it has been shown that this method provides an improvement in the postural stability levels of individuals compared to the preoperative period and a decrease in number of falls reported by the patient. even if this improvement is achieved, postural stability losses can still be observed in individuals undergoing tka which affect balance performance. obesity is defined by an excessive increase in the ratio of body fat mass relative to lean mass. individuals with a body mass index (bmi) above 30 kg/m2 are defined as obese. changes in body composition and increased adiposity rate lead to significant locomotor system problems. a decrease in postural control, increased risk of falling or fear of falling can be defined as locomotor system problems. it has been reported that there is a relationship between increased fat ratio and loss of postural stability in adult obese individuals. in a published study, it was reported that as of 2029, 46% of the population in america will be obese or morbidly obese, and 69% of individuals who have undergone total knee arthroplasty surgery will be obese or morbidly obese. obesity causes several complications such as increased mortality and increase in likelihood of revision surgery that can be seen after total knee arthroplasty. therefore, it is clinically important to determine the functional status and balance status in order to reduce the possible long-term complications that may develop in the post-operative period and the risk of falling, especially in obese individuals. the effects of increasing obesity level on postural stability in individuals undergoing total knee arthroplasty are unknown. in this context, the aim of our study is to compare the postural stability levels of normal, overweight and obese individuals who underwent total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * follow-up period is between 1-5 years, * volunteer to participate in the study, exclusion criteria: * having undergone revision surgery on the same or opposite knee after total knee arthroplasty, - presence of vertigo or another neurological disease, * patients who have undergone total hip replacement.
a study of atezolizumab in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with carboplatin + nab-paclitaxel in participants with stage iv squamous non-small cell lung cancer (nsclc) [impower131]

Conditions: Squamous Non-Small Cell Lung Cancer

Summary: this randomized, open-label study will evaluate the safety and efficacy of atezolizumab (mpdl3280a) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with stage iv squamous nsclc.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status 0 or 1 * histologically or cytologically confirmed, treatment-naïve stage iv squamous nsclc * previously obtained archival tumor tissue or tissue obtained from biopsy at screening * measurable disease as defined by recist v1.1 * adequate hematologic and end organ function exclusion criteria: * active or untreated central nervous system (cns) metastasis * malignancies other than nsclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * pregnant or lactating women * history of autoimmune disease * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan, history of radiation pneumonitis in the radiation field (fibrosis) is permitted * positive test for human immunodeficiency virus (hiv) * active hepatitis b or hepatitis c * prior treatment with cluster of differentiation 137 (cd137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-pd-1), and anti-pd-l1 therapeutic antibody * severe infection within 4 weeks prior to randomization * significant history of cardiovascular disease
recovery of bupivacaine or bupivacaine-lidocaine spinal anesthesia and infiltration anesthesia in herniorrhaphy

Conditions: Anesthesia; Inguinal Hernia

Summary: the purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.

consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a prospective protocol.spinal anesthesia will be commenced in group bls with 2 ml hyperbaric bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in group bs, hyperbaric bupivacaine (10 mg) + saline in the same volume and group lia will have anesthesia with bupivacaine and lidocaine for step by step local anesthetic infiltration. sensorial block will be measured with pinprick test, motor block will be tested with bromage scale. heart rate, blood pressure and peripheral oxygen saturation will be measured every 5 minutes. time of subarachnoid injection, onset of sensorial block (block at l1 dermatome), time to block t10 dermatome, maximum block level, time to maximum block and time to two segment regression, t10 regression , li regression and s1 regression of the block will be recorded in group bls and bs.the onset and resolution of the sensorial and motor block will be assessed by anesthetists blinded to group allocation. pacu stay and discharge times and vas pain scores will be recorded in all patients. patients also will be investigated for adverse events (hypotension, bradycardia, nausea,pdph, tns, urinary retention)and satisfaction regarding the anesthetic method.

Eligibility criteria:
inclusion criteria: * patients having inguinal hernia * not hypersensitive to study drugs * asa classification i-iii exclusion criteria: * asa classification iv-v * contraindications for spinal anesthesia

Keywords: spinal anesthesia bupivacaine lidocaine local infiltration anesthesia recovery duration of anesthesia outpatient herniorrhaphy
general vs spinal in total joint arthroplasty (tja)

Conditions: Knee Osteoarthritis; Hip Osteoarthritis

Summary: the purpose of this research is to compare post-operative outcomes from patients undergoing tja. the study team wants to learn about outcomes like length of hospital stay, post-operative pain scores, post-operative nausea, deep and superficial surgical site infection, periprosthetic fracture (a broken bone that occurs around an orthopaedic implant), implant dislocation, readmission rates, and revision rates.


Eligibility criteria:
inclusion criteria: * patients undergoing a primary total hip or knee arthroplasty * subjects must be capable of providing informed consent * english or spanish speaking exclusion criteria: patients with contraindications for spinal anesthesia such as: * prior lumbar surgery with hardware insertion * elevated intracranial pressure * infection at the site of the procedure * thrombocytopenia or coagulopathy * severe mitral and aortic stenosis and left ventricular outflow obstruction * severe spine pathology (spinal stenosis, spondylolisthesis, spondylosis) with radiculopathy and/or neurogenic claudication * preexisting neurological disease patients with contraindications for general anesthesia such as: * congestive heart failure * severe aortic stenosis * patient is unable/unwilling to consent * current pregnancy or women planning on becoming pregnant in the next year, and women who think they might be pregnant, or women who become pregnant during the study period will be removed from the study. * prisoners

Keywords: total joint arthroplasty general anesthesia spinal anesthesia
evaluation of add on enstilar in patients using otezla for psoriasis

Conditions: Psoriasis

Summary: add-on enstilar to otezla therapy.

50 adult patients with moderate to severe plaque psoriasis will be given otezla® for 16 weeks with add-on enstilar.

Eligibility criteria:
inclusion criteria: 1. male or female adult ≥ 18 years of age; 2. diagnosis of chronic plaque-type psoriasis 3. moderate to severe plaque type psoriasis as defined at baseline by: * pga score of 3 or greater * bsa affected by plaque-type psoriasis of 10% or greater * pasi ≥ 12 4. able and willing to give written informed consent prior to performance of any study-related procedures 5. must be in general good health (except for disease under study) as judged by the investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (note: the definition of good health means a subject does not have uncontrolled significant co-morbid conditions). exclusion criteria: 1. other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled. 2. forms of psoriasis other than chronic plaque-type (e.g., pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis 3. subjects who previously used any biologic agent for psoriasis. 4. use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine). 5. patient used topical therapies to treat psoriasis on the hands and/or feet within 2 weeks of the baseline visit (includes, but not limited to, topical corticosteroids, vitamin d analogs, or retinoids). 6. patient received uvb phototherapy within 2 weeks of baseline.
effect of blood pressure on rso2 in carotid endarterectomy (cea)

Conditions: Intra-operative Hypotension; Carotid Stenosis

Summary: carotid endarterectomy (cea) is the recommended treatment for symptomatic high degree stenosis of the internal carotid artery (ica). ica obstruction is often associated with an impaired cerebral autoregulation, implicating that cerebral perfusion pressure becomes dependent on systemic blood pressure. therefore, to maintain cerebral perfusion pressure in this type of patients intraoperative hypotension needs to be avoided. different short-acting agents such as phenylephrine, (a drug with vasoconstrictive properties), or ephedrine (a drug with vasoconstrictive properties combined with an increase in heart rate) can be used to correct intra-operative hypotension. in healthy subjects these agents affect the cerebral perfusion differently despite an identical effect on the systemic blood pressure. cerebral perfusion decreases after phenylephrine administration while it is preserved after the use of ephedrine. the optimal agent for correcting hypotension in cea patients, and thus in a situation of an impaired cerebral autoregulation, is unknown. therefore, the investigators propose to perform a prospective study observing the effect of phenylephrine and ephedrine on cerebral perfusion to make a recommendation regarding the use of either phenylephrine or ephedrine during cea.


Eligibility criteria:
inclusion criteria: 1. all patients undergoing cea in the university medical centre utrecht and having an appropriate temporal bone window for reliable perioperative tcd monitoring could be included. 2. all patients must have given written informed consent. exclusion criteria: 1. not having a temporal bone window appropriate for tcd measurement 2. not willing to give informed consent. 3. if the effect on bp of the given agents is insufficient (if relative hypotension persists five minutes after administration).

Keywords: cerebral autoregulation
a cross-sectional study to investigate the effect of topiramate on bone and mineral metabolism in female participants with epilepsy

Conditions: Seizures; Convulsions; Epilepsy; Osteopenia; Osteoporosis

Summary: the purpose of this study is to investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers, and bone density (the amount of mineral per square centimeter of bone ) in female participants with epilepsy (seizure disorder), before menopause (time in life when a woman stops having a menstrual period), as compared with healthy participants and comparative group received either carbamazepine or valproic acid monotherapy for at least last one year.

this is a cross-sectional (observations or measurements made at a single point in time, usually at participant enrollment), multi-center (conducted in more than one center), and comparative study of topiramate monotherapy in female participants with epilepsy. female participants must have received either topiramate, carbamazepine, or valproic acid monotherapy for more than one year for the treatment of epilepsy. blood samples will be obtained from fasting participants to investigate the effect of study drug on the bone and mineral metabolism markers, and bone density compared to healthy participants and comparative group (carbamazepine and valproic acid monotherapy). bone mineral density will be measured from the participants' lumbar spine or femur. a survey of food intake and physical activity for the participants will be performed using a standardized validated detailed questionnaire. the post-study visit (or follow up phone contact) will be performed for the occurrence of serious adverse events (sae) for safety evaluation. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants who agree to participate in this study * female epileptic participants * participants who are receiving topiramate, carbamazepine or valproic acid monotherapy for more than one year * participants who are using proper contraceptive method (s) or have a negative pregnancy test result exclusion criteria: * participants with a motor function disorder * participants with a disease which affects their skeleton including primary hyperparathyroidism, paget's disease, multiple myeloma, liver and kidney disorder, thyroid disease, malabsorption disorder, diabetes, and malignancies * participants who have taken within last one year, or are currently taking a drug which affects the bone and mineral metabolism such as vitamin d, calcium, anabolic steroids, bisphosphonates, calcitonin, glucocorticoids, and diuretics * voluntary or surgical postmenopausal participants * participants with amenorrhea for more than 6 months

Keywords: topiramate carbamazepine valproic acid epilepsy bone mineral density monotherapy