Kornimate/medical-research-clean huggingface dataset:
pomegranate extract biomarker study in osteopenic women

Conditions: Osteopenic Women

Summary: treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo.


Eligibility criteria:
inclusion criteria: * postmenopausal women (having had their last menstrual period within the past 15 years and an appropriate serum fsh value) 45-65 years of age; * the subject must have a t score of -1 to -2.5 at the lumbar spine or proximal femur; * all clinical safety laboratory values at screening and randomization must be either within the reference range or be determined by the investigator and the sponsor to be abnormal, but not clinically significant; * the patient must have provided written informed consent. exclusion criteria: * the subject has any of the following conditions: connective tissue disease, history of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrinological, urological, immunological, neurologic or psychiatric disorders, unless approved by the sponsor on a case by case basis; * the subject has a positive test result for hepatitis b surface antigen or antibody to hepatitis c virus at screening; * the subject has a known history of infection with the human immunodeficiency virus (hiv); - * the subject has used bisphosphonate or fluoride therapy within the past 12 or 24 months, respectively; * the subject has used denosumab within the past 24 months; * the subject has used tibolone, parathyroid hormone (or any of its derivatives), systemic glucocorticoids or inhaled glucocorticoids, anabolic steroids or testosterone within the past 6 months; * the subject has used estrogens, selective estrogen receptor modulators, calcitonin or calcitriol within the past 3 months; * the subject has hyperparathyroidism, hypoparathyroidsim, hyperthyroidism, hypothyroidism, hypocalcemia, rheumatoid arthritis, paget's disease of bone, osteomalacia; * the subject has had a bone fracture within the past year; * the subject has acute or chronic disease requiring frequent changes in medications or dosages of chronic therapy; * a history of alcoholism within the last 2 years or a current history of imbibing 3 or more units of alcohol per day. (1 unit is equivalent to 1 glass of wine, 1 pint of beer, or 1 shot of hard liquor); * the subject has participated in another study with an investigational drug or device during the 30 days prior to study entry; * the subject has a condition interfering with his ability to provide informed consent or comply with study instructions, or the patient has a condition, which might confound the interpretation of the study result; * the subject has a condition endangering herself if she were to participate in this trial

Keywords: pomx osteopenia postmenopausal women pomegranate
effects of maternal interpretation biases on child anxiety and related responses

Conditions: Anxiety Disorders

Summary: the purpose of this study is to expand our understanding of the intergenerational transmission of cognitive risk for childhood anxiety disorders by examining whether changes in maternal interpretations of situations result in changes in child interpretations and child anxiety.


Eligibility criteria:
inclusion criteria: * children ages 8-12 * children with primary diagnosis of anxiety disorder * mothers with clinical levels of anxiety symptoms on the depression, anxiety, and stress scales (dass; lovibond \& lovibond, 1995) exclusion criteria: * physical disability impairing ability to use a computer * intelligence quotient \<80 * reading comprehension and fluency composite \<75 * concurrent primary diagnosis of any non-anxiety disorder * currently receiving psychological or pharmacological treatment for anxiety * danger to self/others * non-english speaking child/parent * maternal current involvement in cognitive-behavioral therapy * maternal changes in pharmacological treatment in the 12 weeks prior to enrollment.
relative contribution of brain insulin action for postprandial metabolism

Conditions: Glucose Metabolism Disorders

Summary: the goal of this clinical trial is to clarify (i) the contribution of brain insulin action on regulation of systemic metabolism, (ii) sex-specific differences in the central regulation and (iii) the influence of the menstrual cycle in women. therefore, participants will undergo oral glucose tolerance tests combined with a double tracer dilution technique. this approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray.

this research project aims to investigate to what extent brain insulin action is responsible for the control of postprandial metabolism compared to direct effects of insulin in peripheral target tissues. furthermore, the study will investigate sex differences and the influence of the menstrual cycle on brain-derived coordination of postprandial signaling for metabolic control. therefore, insulin action in the brain will be introduced by application of insulin as nasal spray (on one day) versus carrier solution as placebo nasal spray (on another day) in a randomized, blinded fashion. spray administration will be performed 15 minutes before a 75 gram oral glucose tolerance test that will introduce a postprandial state. on placebo day, the known spillover of tiny amounts of nasal insulin into the systemic circulation will be mimicked by an appropriate i.v. insulin bolus. this approach will be combined with a double-tracer dilution technique. labeled glucose (\[6,6-2h\]glucose) will be infused 120 minutes before and during the ogtt (180 min) and will be used to address endogenous glucose production. the glucose drink from the ogtt will be enriched with \[u-13c6\]glucose to compute the glucose appearance rate (ra). basal endogenous glucose production will be calculated as well as post-load endogenous glucose production and rates of glucose disappearances (rd). using this approach, brain-derived regulation of postprandial metabolism including endogenous glucose production, glucose disappearance, insulin secretion, and secretion of proglucagon-cleavage products (incretins) will be examined.

Eligibility criteria:
inclusion criteria: * bmi \< 24 kg/m2 * no known primary diseases * no hormonal contraception exclusion criteria: * alcohol or drug abuse * smoking * at screening: hb \< 12 g/dl for women and hb \< 14 g/dl for men * any (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.

Keywords: postprandial glucose metabolism brain insulin action insulin sensitivity insulin secretion endogenous glucose production menstrual cycle sex differences proglucagon cleavage products
a trial of belzutifan (pt2977, mk-6482) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccrcc) (mk-6482-003)

Conditions: Renal Cell Carcinoma (RCC); Clear Cell Renal Cell Carcinoma (ccRCC); Kidney Cancer; Renal Cancer; Renal Cell Carcinoma; Renal Cell Cancer Metastatic; Renal Cell Carcinoma Recurrent; Renal Cell Cancer, Recurrent; Kidney

Summary: this is an open-label phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccrcc. belzutifan and cabozantinib will be administered orally once daily.


Eligibility criteria:
inclusion criteria: * has locally advanced or metastatic rcc with predominantly clear cell subtype * has at least one measurable lesion as defined by recist version 1.1 * eastern cooperative oncology group (ecog) performance status of 0-1 * has adequate organ function defined as follows: * absolute neutrophil count ≥ 1,000/µl, hemoglobin level ≥ 10 g/dl and platelet count ≥ 100,000/µl without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening; * serum creatinine level ≤ 2.0 × upper limit of normal (uln) * transaminase levels (ast/alt) ≤ 3.0 × upper limit of normal (uln); total bilirubin (tbili) ≤ 1.5 mg/dl in the absence of gilbert's disease \*cohort 1: participants must not have received prior systemic therapy for advanced or metastatic ccrcc * cohort 2: participants must have received prior immunotherapy and no more than two prior treatments for advanced or metastatic ccrcc exclusion criteria: * has received prior treatment with belzutifan or other hif2α inhibitors * has received prior treatment with cabozantinib * has had radiation therapy for bone metastases within two weeks of starting study drug * has a history of untreated brain metastases or history of leptomeningeal disease or spinal cord compression * has failed to recover from the reversible effects of prior anticancer therapy * has uncontrolled or poorly controlled hypertension * is receiving anticoagulant therapy * has had any major cardiovascular event within 6 months prior to study drug administration * has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results * has had major surgery within 3 months before first study drug administration * has an active infection requiring systemic treatment * is participating in another therapeutic clinical trial

Keywords: hypoxia-inducible factor (hif) hypoxia-inducible factor 2 alpha (hif-2α, hif-2 alpha)
survey tool for screening of anemia in women before pregnancy

Conditions: Anemia Complicating Pregnancy; Anemia Complicating Childbirth; Anemia Complicating the Puerperium

Summary: the goal of this observational and cross-sectional study is to develop and validate a survey that can be used to identify anemia, and its severity, among pre-pregnant women allowing for the timely implementation of focused public health and personalized interventions. participants will be asked 26 survey questions about menstrual history and provide a 5 ml venous blood sample to measure hemoglobin, ferritin, and transferrin saturation levels.

despite a variety of governmental campaigns and funded programs, anemia rates among reproductive age women in low- and middle-income countries (lmics) have not decreased over the past few decades. iron deficiency is associated with increases in morbidity and mortality in both non-pregnant and pregnant women, as well as their offspring. up to 500 currently married women between 18 and 25 years old who are not pregnant, have never been pregnant, and are not using any type of contraception other than barrier methods will be recruited for this study from primary health centres (phcs) in belagavi , karnataka, india. accredited social health activists (ashas) will identify potentially eligible participants and bring them to participating primary healthcare centers (phcs) for screening, consent, and enrollment. once enrolled, trained female interviewers will administer the prepsa survey to the participant and a laboratory technician will draw a blood sample (upon completion of the survey or within four weeks) to analyze hemoglobin, ferritin, and transferrin saturation values. the survey responses that most closely align with low iron indices will be identified and become the basis of a scored, validated instrument which may be weighted based upon the strength of the associations found. results will inform future health outcome trials.

Eligibility criteria:
inclusion criteria: * 18 - 25 year old women * not currently pregnant and have never been pregnant * currently married * if last menstrual period \>6 weeks ago, exclude pregnancy via pregnancy test exclusion criteria: * currently using any form of contraception other than barrier methods

Keywords: anemia
the effects of tramadol combined with local anesthesia on pain after the surgical extraction of third molars

Conditions: Pain After the Surgical Extraction of Third Molars

Summary: the purpose of this study was to assess the efficacy of local anesthetic and tramadol combinations in the prevention of pain after the surgical extraction of third molars.

the surgical removal of impacted third molar teeth is a procedure that is frequently encountered in oral and maxillofacial surgery practices. pain following these operations is one of the most important factors affecting patient satisfaction. several pain-management strategies are available. an alternative approach to pain control is to maximize drug levels at the tissue injury site by administering drugs locally. tramadol is a centrally acting opioid that provides good analgesia. it reduces the transmission of pain impulses by inhibiting serotonin and norepinephrine re-uptake. in addition to the systemic analgesic effects, the local anesthetic effects of tramadol on the peripheral nerves have been presented in multiple clinical and laboratory studies. the aim of this study is to test the clinical efficacy of local anesthetic and tramadol combinations during and after the surgical extraction of the lower third molars.

Eligibility criteria:
inclusion criteria: * score of asa i-ii (american society of anesthesiologists physical status i or ii) * patient weights were less than 60 kg exclusion criteria: * subjects who had taken a sedative, tranquillizer, or analgesic medication within the last 24 h, * sensitive to tramadol, * patients who needed an extra dose of anesthetic solution during the surgery

Keywords: tramadol third molar extraction analgesia
clinical trial to evaluate the efficacy of the smart insulin pen compared to a closed loop system in patients with type 1 diabetes (ebiace-1)

Conditions: Type1diabetes

Summary: analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.


Eligibility criteria:
inclusion criteria: * diagnostic criteria for dm1 according to ada * candidates for both systems (closed loop or smart insulin pen) for their usual healthcare team. * acceptance of participation in the study and signing of the informed consent exclusion criteria: * gestation * institutionalization, serious or terminal illness or renal replacement therapy. * inability to undertake the training and / or acquire the degree of knowledge to use both systems * refusal to participate in the study or to sign the informed consent
the effect of metformin on obesity and metabolic disturbance in patients taking clozapine

Conditions: Schizophrenia

Summary: the purpose of this study is the evaluation of effect of metformin on obesity and metabolic disturbance in patients taking clozapine.

in this study, the investigators are going to examine the effect of metformin on obesity and metabolic disturbance in patients with schizophrenia who have taken clozapine.the metformin 500mg will be administrated per oral twice a day for 24 weeks and for control group, placebo will be given same route and process.

Eligibility criteria:
inclusion criteria: * age: 18 \~ 65 * patient with schizophrenia according to dsm-iv criteria * patient have signed on the informed consent, and well understood the objective and procedure of this study. * patient taking clozapine 3months or more * patient increased in weight more than 10 % of that of before antipsychotics use exclusion criteria: * patient taking other antipsychotics with clozapine * patient in treatment of diabetes * patient in treatment of dyslipidemia * allergy or hypersensitivity to metformin * pregnant or breast-feeding female patient. * patient with severe medical condition

Keywords: schizophrenia obesity clozapine metformin
to evaluate the impact of consumption of a bioactive compound on fasting blood glucose levels in asian indians with pre-diabetes

Conditions: PreDiabetes

Summary: this is randomized placebo controlled, double-blinded, parallel arm study on free living asian indians. eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime. at the end of the run-in period, subjects fulfilling the inclusion/exclusion criteria at this stage will be randomized either to the intervention arm or control arm using computerized random number tables. the measured parameters will include, 24-h diet recall, food frequency questionnaire, anthropometry including circumferences, height and weight, and blood parameters including blood glucose (fasting), serum insulin (fasting), hba1c and lipid profile.


Eligibility criteria:
inclusion criteria: 1. fasting blood glucose between 100-125 mg/dl; 2. and bmi range 25-30 kg/m2; 3. and waist circumference ≥80cm for women and ≥90cm for men; exclusion criteria: 1. weight loss or gain ≥4.5 kg within 90 days of visit 1. 2. use of weight loss medications within 90 days of visit 1. 3. history of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes. 4. use of dietary supplements or related products that, in the judgment of the investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1. 5. history of extreme dietary habits (e.g., atkins diet, etc.), as judged by the investigator. 6. history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional. 7. current medical diagnosis of type 1 or type 2 diabetes mellitus. 8. hba1c ≥48 mmol/mol (6.5%) as measured at visit 1. 9. history of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable). 10. signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. the visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the clinical investigator) at least 5 days prior to visit 1. 11. is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. the method of contraception must be recorded in the source document. 12. any condition the investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk. 13. excessive alcohol consumption (\> 2 drinks, 60 ml of whisky per day).
randomized controlled trial to compare two anti-scorpion serums

Conditions: Scorpion Sting

Summary: the purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by birmex versus other commercial serum

we consider relevant conduct this study because the poisoning scorpion bite represents a public health problem. this is a randomized clinical trial, which included 120 subjects of both sexes aged 15 and 60 years old and residents of the state of guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of birmex and 60 patients receive other commercial serum.

Eligibility criteria:
inclusion criteria: * sting scorpion * informed consent * age 15-60 * either sex * resident in study area exclusion criteria: * previous treatment with gammaglobulin * blood transfusion at any stage of life * sensitivity or intolerance to serums antiscorpion or horse products * pregnancy * some immunodeficiency
executive function performance in children who stutter

Conditions: Stuttering, Childhood; Executive Dysfunction

Summary: the study aims to asses the executive function in children who stutter for better management of those children

it is a case control study which will be done on 30 child who stutter and 15 normal child as a control group. executive function testing will be done using computerized program called pepl . also, total intelligence quation(iq) , verbal iq, non verbal iq will be assessed in both groups. stuttering severity will be assessed in case group.

Eligibility criteria:
inclusion criteria: 1. patient and volunteers age between 7 years and 15 years. 2. iq ≥ 85. exclusion criteria: * history of secondary stuttering. * language impairment and other speech problem. * concurrent or history of psychiatric, cognitive, neurological disorders or hearing impairment.
clinical and biological characterization of patients and collection of samples

Conditions: Tricho Hepato Enteric Syndrome

Summary: objectives: collect clinical and biological data about patients with sd/the, collect samples of patients; create a secure on line database to collect worldwide data about sd/the partners : aphm, hcl, aphp currently10 patients (8 with ttc37 mutations and 2 with skiv2l mutations) present a sd/the and are managed in france in 5 different centers (marseille, paris trousseau, paris necker, paris robert debrés, and lyon). most of them are followed in hepato-gastro-enterology units for their intractable diarrhea. three aspects of the disease: intractable diarrhea, immune defect and liver disease are responsible for the main part of the burden of the disease .for each aspect, the investigators will propose a close follow-up with collection of clinical, biochemical, functional and microbial data. collect of clinical date: during a programmed consultation clinical data about symptom will be collected twice a year. a detailed form will be used for better delineation of the symptoms. these data included growth, symptom (diarrhea, pain ...), and clinical signs. most of these children have recurrent sample for follow up. during them some blood will be take for study the immune side but also the platelet function.


Eligibility criteria:
inclusion criteria: * patient \< 18 year-old * patients with sd/the control group : * patients with tufting enteropathy and short bowel syndrome. exclusion criteria: * child among whom the parents or the legal representatives refused that their child participates in this study
safety and efficacy study of sun-131 transdermal system (tds) as compared to placebo tds in patients with a chalazion

Conditions: Chalazion

Summary: this protocol for sun-131 1.5% tds is developed for the treatment of chalazion. sun-131 1.5% tds is designed for local delivery of a corticosteroid, to the upper or lower eyelid. the purpose of this study is to evaluate the efficacy and safety of sun-131 1.5% tds as compared with placebo tds in the treatment of a chalazion.


Eligibility criteria:
inclusion criteria: 1. subjects aged ≥ 6 years of either sex and of any race 2. subjects with a diagnosis of a single chalazion 3. subjects with chalazion erythema score of ≥ 1 4. normal eyelid function without active signs of eye and eyelid infection in either eye. 5. must be willing and able to correctly apply and wear a transdermal patch to the eyelid 6. avoid wearing contact lenses in the study eye exclusion criteria: 1. chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues). 2. history of chalazion incision and curettage in study eyelid. 3. multiple chalazia in any one eyelid. 4. active ocular or eyelid infection presence of hordeolum in any one eyelid. 5. an abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied. 6. diagnosed with glaucoma in either eye. 7. history of steroid-induced elevation of iop. 8. female subjects who are pregnant or lactating.