Kornimate/medical-research-clean huggingface dataset:
role of myo-inositol and d-chiro-inositol on oocyte quality

Conditions: Infertility

Summary: controlled ovarian hyperstimulation with gonadotropins is an integral part of the various stimulation protocols for patients undergoing in-vitro fertilization (ivf) and other assisted reproductive technologies (art) such as intracytoplasmic sperm injection (icsi). the hormonal control of multiple follicular growth and maturation is a critical part of art procedures since it maximizes the yield of embryos to be transferred, thus increasing the cumulative pregnancy rate. recent studies have shown the efficacy of myo-inositol (mi) supplementation as a simple and highly effective treatment in order to improve oocyte quality in patients undergoing ivf. indeed, it was previously shown that mi follicular fluid (ff) concentration is a reliable predictor of oocyte quality. high mi concentration in the ff directly correlates with high oocyte and embryo quality. another stereoisomer of inositol was successfully used into clinical practice d-chiro-inositol (dci). in particular, dci supplementation was used to restore ovulation in hyperglycemic pcos patients. in the present study we aim to compare mi versus dci supplementation on oocyte quality of women undergoing ivf-et


Eligibility criteria:
inclusion criteria: * women undergoing ivf treatments * body mass index \<28 * fsh \<10iu/l * normal uterine cavity, anatomy and functions exclusion criteria: * pcos * stage iii or iv endometriosis * premature ovarian failure * poor responder

Keywords: poor oocyte quality ivf failure
implementing precision medicine in community hospitals

Conditions: Metastatic Cancer

Summary: this is a prospective biomarker study that aims at demonstrating the impact of liquid biopsy to deliver better treatment for cancer patients with metastatic disease managed in the community setting

patients will be selected to present a metastatic cancer (de novo or relapse after primary tumor treatment) eligible for a first line treatment (chemotherapy, immunotherapy, endocrine therapy or targeted therapy). all tumor subtype could be enrolled in the study; metastatic prostate cancer must be resistant to castration. triple negative breast cancer and hormone receptor positive, her2-negative metastatic breast cancer resistant to endocrine therapy are eligible to the study. a plasma sample will be collected at baseline and after the first radiologic assessment after treatment start. plasma samples obtained at baseline will be tested for a large panel of gene and msi status using next generation sequencing (ngs) (cf table). plasma samples obtained during treatment will be tested for the concentration of circulating dna. results will be discussed within a molecular tumor board (mtb) with all declared centers.

Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if they meet all of the following criteria: 1. age ≥ 18 years 2. histology: solid malignant tumor 3. locally advanced/unresectable and/or metastatic (for prostate cancer: castration resistant prostate cancer, for rh+/her2- breast cancer: prior treatment with endocrine therapy plus anti-cdk4/6 inhibitor) 4. eastern cooperative oncology group (ecog) performance status \< 2 5. measurable disease as per recist criteria 6. patient with a social security in compliance with the french law relating to biomedical research (article l.1121-11 of french public health code) 7. voluntary signed and dated written informed consent prior to any study specific procedure. exclusion criteria: participants will be excluded from the study if they meet any of the following criteria: 1. radiological evidence of symptomatic or progressive brain metastases 2. previous or current malignancies of others histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer 3. any condition which in the investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol 4. patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent 5. minors (age \< 18 years) 6. pregnant or breast-feeding women 7. previous enrollment in the present study.
gut microbiota, pgx and instis response

Conditions: HIV Infections

Summary: this is an interventional phase iv trial enrolling hiv-infected patients treated by dolutegravir or bictegravir-based combined antiretroviral therapy, and patients with a planned shift to a dolutegravir or bictegravir-based combined antiretroviral therapy, that aims at understanding the individual response to dolutegravir and bictegravir, in terms of efficacy and toxicity.

the main objective of our research project is to better define the inter-individual variability in terms of clinical and biological response towards integrase strand transfer inhibitors, an important arv drug class used in the treatment of hiv infection. we aim at identifying predictors of drug efficacy and toxicity, which are eagerly awaited by clinicians as instis are now prescribed worldwide and concerns about previously unidentified side effects are emerging. the specific objectives of the project are: * to study the impact of genetic polymorphisms in selected pharmacogenes (including genes coding for biotransformation enzymes and transport proteins) on instis pk parameters and biomarkers relevant for tdm, such as trough (c0) and intracellular (ic) concentrations. * to determine whether genetic polymorphisms in selected pharmacogenes might affect instis efficacy, as assessed by the measurement of the viral load. * to address the important question of the pathophysiological mechanisms lying behind the two main side effects of instis, namely neuropsychiatric adverse events and abnormal weight gain. * to describe how instis affect the gut microbiome of treated patients, and to determine in turn how and by which pathways the gut microbiome might influence the clinical response (i.e. efficacy and toxicity) to instis.

Eligibility criteria:
inclusion will be proposed to: * hiv infected adult patient regularly followed at centre de reference hiv of cusl and currently treated by 50mg od of dtg (n=80) or 50mg od of bic (n=30). * virally controlled immunologically functional hiv infected adult patient regularly followed at centre de reference hiv of cusl and shifting from another arv class to a treatment containing 50mg od of dtg (n=20) or 50mg od of bic (n=20). * hiv infected adult patient retrospectively identified as having stopped standard dosage of dtg (ie. 50mg od) due to npae (insomnia, depression, anxiety) (n=50). identification will be based on the interrogation of our prospective clinical database. exclusion criteria: * pregnancy at the time of inclusion or expected pregnancy within 12 months, for patients treated by dtg or bic during the study * liver failure (child-pugh a, b or c)

Keywords: integrase strand transfer inhibitors hiv dolutegravir bictegravir
impact of prenatal vitamin/mineral supplements on perinatal mortality

Conditions: Perinatal Mortality; Stillbirth; Neonatal Mortality

Summary: the purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid alone.

in the project area in china, the rate of perinatal mortality (stillbirths and infant deaths within 6 days of birth) is two times that of the united states. causes of perinatal mortality include, but are not limited to, low birth weight and preterm delivery. anemia (low hemoglobin) among pregnant women is associated with low birth weight and preterm delivery and also is elevated in the project area. supplements of iron, folic acid, and other vitamins and minerals can prevent anemia among pregnant women, but the effects of these supplements on other maternal and infant health outcomes are unclear. since 1993, the people's republic of china has recommended that newly married women, and those who plan pregnancy, take 400μg of folic acid daily through the first trimester of pregnancy. although who recommends that pregnant women take iron and folic acid supplements, there is currently no national recommendation that pregnant women in china take iron or other vitamin or mineral supplements (other than folic acid). unicef is now testing a prenatal vitamin and mineral supplement in programs to prevent low birth weight. our study will provide additional information about the health impact of the unicef prenatal supplement versus an iron and folic acid supplement versus folic acid alone. comparisons: * infants of women who receive daily prenatal supplements that contain 400μg folic acid alone, will be compared with infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid. * infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic acid will be compared with infants of women who receive a daily supplement containing 30 mg iron, 400μg folic acid and other vitamins and minerals (unicef formulation).

Eligibility criteria:
inclusion criteria: * live in one of the study counties (laoting, mancheng, fengrun, xianghe, yuanshi) * can follow instructions * can swallow pills exclusion criteria: * \>= 20 weeks gestation at enrollment * previous live birth * anemic (hemoglobin \[hb\] \<10 g/dl in 1st trimester and \< 9.5 g/dl in 2nd trimester) at enrollment * current use of iron or other vitamin or mineral supplements (except folic acid) * age \< 20 years at enrollment * under treatment for anemia at enrollment * refuse to participate

Keywords: pregnancy vitamins minerals supplements mortality prenatal perinatal anemia birthweight preterm iron micronutrients stillbirths early neonatal deaths
exercise in patients with a biventricular pacemaker

Conditions: Left Ventricular Failure

Summary: the investigators will evaluate the effects of an exercise program (walking on a treadmill) on the physical performance, the cardiorespiratory function, the proclivity to heart arrhythmias and the quality of life of patients with severely impaired left ventricular function and a bi-ventricular resynchronization pacemaker.


Eligibility criteria:
inclusion criteria: * left ventricular failure * resynchronization therapy with a biventricular pacemaker * ability to understand written german exclusion criteria: * age over 75 years * severe cardiac arrhythmia * all conditions which can be aggravated by an exercise program

Keywords: left ventricular failure chronic heart failure pacemaker resynchronisation therapy exercise endurance exercise
the role of thiamine after transcatheter closure in children with left-to-right shunt congenital heart disease

Conditions: Congenital Heart Disease; Thiamine Deficiency; Patent Ductus Arteriosus; Ventricular Septal Defect; Atrial Septal Defect

Summary: currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in indonesia, so it is necessary carried out this research. this research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. the parameters assessed were mmp-9, timp-1, and echocardiography to assess the structure and function of the left ventricle in chd patients with left to right shunt lesions.

specifically the investigators want to study about : 1. the differences in serum levels of matrix metalloproteinase-9 in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who received thiamine and those who did not receive thiamine. 2. the differences in serum tissue inhibitor of metalloproteinase-1 levels in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who received thiamine and those who did not receive thiamine. 3. the differences in left ventricular structure in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who receive thiamine and those who do not receive thiamine. 4. the differences in left ventricular function in patients with congenital heart disease with left to right shunt lesions after transcatheter closure who receive thiamine and those who do not receive thiamine.

Eligibility criteria:
inclusion criteria: 1. patients aged 6 months - 18 years. 2. patients diagnosed with left to right shunt lesion chd with heart failure based on ross or nyha criteria. 3. patients who will undergo intervention with transcatheter closure. exclusion criteria: 1. patients who experienced acute infections before the procedure. 2. there are other heart defects that require surgery. 3. there is a hereditary, genetic disorder, syndrome or other chronic disease.
affect-regulatory characteristics of deceptive placebos

Conditions: Social Anxiety; Depression

Summary: the study tries to identify whether specifically framed expectations, induced with an active placebo nasal-spray, have effects on affective regulation processes and rumination.

healthy volunteers are informed that a new application method for an antidepressant, specialized on positively influencing the experience of aversive emotional states would be tested. they will randomly be assigned to a no treatment control group (not taking a placebo) or to one of the two treatment groups: participants will be taking the antidepressant (which is in fact an active placebo) which will either protect them from experiencing intense emotional reactions and rumination (anticipatory group) or help them to regulate emotional states quicker as well as to distance themselves from ruminative thoughts (reactive group). then, an aversive emotional state is induced by an autobiographical recall of events which made the participants feel inadequate, bashful, and ashamed. currently experienced shame as well as state rumination are assessed before and after the negative recall task.

Eligibility criteria:
inclusion criteria: * healthy volunteers * fluent in german language exclusion criteria: * mental disorders * allergic to capsaicin * allergic to sesame oil * intake of psychopharmacological drugs in the last four weeks * intake of illegal drugs in the last two weeks * consumption of alcohol in the last twelve hours * students in medicine, pharmacy, or psychology * completed studies in medicine, pharmacy or psychology * current pregnancy or lactation * cardio vascular disease * kidney disease * liver disease
effect of aromatherapy on venopuncture pain and anxiety

Conditions: Pain

Summary: the effect of aromatherapy with lavender essential oil on pain and anxiety during venipuncture will be evaluated.

the anxiety and pain during venipuncture may be cause to the avoidance of the medical therapy in patient as well as adult. aromatherapy with lavender was shown that beneficial effects on chronic pain and anxiety. it's effect on acute pain and anxiety is not exactly known. in this study, the aromatherapy with the lavender will be compared with placebo to evaluate the analgesic and anxiolytic effect during peripheral venous cannulation before surgery.

Eligibility criteria:
inclusion criteria: * be scheduled for elective surgery * be accepted to inhale lavender exclusion criteria: * age \ 65 years * preoperative pain or consumption of analgesic medication * anxiety disorders or consumption of anxiolytic medications (i.e. ssri, benzodiazepine) * pregnancy or breastfeeding * asthma, chronic obstructive pulmonary disease * poor sense of smell * allergy to the lavender essential oil

Keywords: pain anxiety catheterization, peripheral
trial of belotecan/cisplatin in chemotherapy naive small cell lung cancer patient

Conditions: Carcinoma, Small Cell

Summary: belotecan (camtobell, ckd-602, chong kun dang pharm., korea) is a new camptothecin derivative, that exhibits anticancer effects by inhibiting topoisomerase i. the investigators will have a randomized prospective multicenter trial of belotecan/cisplatin versus etoposide/cisplatin in patients with previously untreated, extensive-stage small cell lung cancer. primary endpoints * to assess response rate secondary endpoints * to assess overall response duration, time to progression, overall survival


Eligibility criteria:
inclusion criteria: * ecog performance status 0\~2(those with performance status 2 must have been stable with no deterioration over the previous 2 weeks) * histologically or cytologically confirmed small cell lung cancer patient without chemotherapy and radiotherapy * measurable lesion according to recist with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site * life expectancy of at least 3 months * provision of written informed consent exclusion criteria: * as judged by the investigator, any evidence of severe or uncontrolled systemic disease * serum bilirubin greater than 3 times the upper limit of reference range(ulrr) * aspartate aminotransferase (ast/sgot) or alanine aminotransferase (alt/sgpt)greater than 2.5 times uln if no demonstrable liver metastases (or \> 5 times in presence of liver metastases) * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study * pregnancy or breast-feeding women(women of child-bearing potential). women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy * evidence of brain metastasis

Keywords: small cell lung cancer camptothecin response rate
a pilot study of a heparin dosing algorithm for hemodialysis

Conditions: Renal Failure Chronic Requiring Hemodialysis

Summary: during hemodialysis treatments, patients receive heparin to prevent clotting. the purpose of this pilot study is to determine if the amount of heparin administered during a patient's hemodialysis can be individualized using an equation for heparin dose adjustment.


Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * stable hemodialysis prescription prior to study enrollment * dialyzing through a native fistula or gore-tex graft * blood access must be able to provide a blood flow rate of 400 ml/min exclusion criteria: * non-compliance with dialysis * hematocrit less than 28% * active infection * diagnosis of heparin-induced thrombocytopenia (hit)

Keywords: anticoagulation heparin hemodialysis dialysis renal dialysis
a double blind clinical trial of dcs for food anxiety

Conditions: Anorexia and Bulimia Nervosa

Summary: this is a pilot study investigating if cycloserine (dcs; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. the investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the dcs relative to placebo condition (c) participants in the dcs condition will have a greater increase in body mass index.

this study investigated if dcs vs placebo augmented food exposure in individuals with eating disorders.

Eligibility criteria:
inclusion criteria: * diagnosed with anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified exclusion criteria: * pregnant or planning on becoming pregnant * psychotic or manic

Keywords: anorexia, bulimia, anxiety, exposure
a study to evaluate the safety and efficacy of fycompa® (perampanel) as add-on therapy in participants with epilepsy

Conditions: Epilepsy; Partial-onset Seizures

Summary: the purpose of the study is to evaluate the safety and efficacy of fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.


Eligibility criteria:
inclusion criteria: 1. male and female participants aged 12 years and older 2. participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures. 3. participants who were appropriate to receive fycompa® as an adjunctive treatment participants starting at visit 0 according to investigator's judgment. 4. participants who had provided written informed consent exclusion criteria: 1. participants not fit to receive fycompa® as per the latest prescribing information. 2. participants who were participating in a clinical trial, at the time of the study. 3. participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the investigators could affect the participant's safety or trial conduct. 4. participants who according to the investigators would not be able to comply with study procedures.

Keywords: e2007 fycompa perampanel partial onset seizures epilepsy seizures post marketing surveillance
comparison of two treatment strategies in hypertensive patients

Conditions: Hypertension

Summary: the purpose of the study is to determine whether a specific training of general practitioners (family physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high blood pressure in their patient population.


Eligibility criteria:
inclusion criteria: * • male or female patients \>18 years of age * hypertension defined by msdbp ≥ 90 and /or mssbp ≥ 140 mmhg for untreated patients, patients on diet and exercise, patients on current anti-hypertensive monotherapy or bitherapy treatment who remain uncontrolled or patients experiencing unacceptable side-effects, exclusion criteria: * • severe hypertension, secondary hypertension, type 1 diabetes mellitus * history of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc. * other protocol-defined exclusion criteria may apply.

Keywords: hypertension, valsartan+hydrochlorothiazide