Kornimate/medical-research-clean huggingface dataset:
the pharmacology and hemodynamics of dexmedetomidine in children with congenital heart disease

Conditions: Cardiac Transplant; Patent Ductus Arterious; Atrial Septal Defect; Bidirectional Cavopulmonary Anastomosis

Summary: the purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

while opioid analgesia is currently the mainstream for management of pain in the perioperative setting, it often leads to significant morbidity, including opioid tolerance and hyperalgesia. looking at ways to decrease the need for opioids with the use of adjunct medications allows for the long-term goal of decreasing physiologic tolerance in children. this is especially relevant in the pediatric congenital heart population. dexmedetomidine is in a class of drugs known as alpha-2 agonists and is known to provide analgesia, attenuate opioid tolerance and inhibit the sympathetic stress response. while there are numerous published case studies of dexmedetomidine validating its effectiveness and safety, the pharmacologic and pharmacodynamic profile has not been established. this study will examine the hemodynamics, pharmacokinetics, and pharmacogenomics of dexmedetomidine in patients with congenital heart disease. the dose-ranging effect of dexmedetomidine will also be investigated. the three groups being studied will be: patients with bi-directional cavopulmonary anastomosis or a fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect. comparison: compare both invasive and noninvasive hemodynamic parameters at baseline sevoflurane and during maintenance dosing on dexmedetomidine. the pharmacokinetics of dexmedetomidine in the pediatric population following escalating loading doses and continuous infusion at timed intervals will be estimated. the efficacy of dexmedetomidine will be estimated by the amount of rescue doses of propofol that are given.

Eligibility criteria:
inclusion criteria: * age is birth to 18 years * \> or = 6 kg. * american society of anesthesiology (asa) i, ii, or iii * undergone prior cardiac transplant, fontan or has a patent ductus arterious or atrial septal defect. * scheduled for cardiac catheterization exclusion criteria: * subject or family history of malignant hyperthermia * known hepatic disorder determined by history physical exam or laboratory tests * pregnant or lactating female * receiving inotropic agents or has a pacemaker * weighs less than 6 kg.

Keywords: dexmedetomidine congenital heart disease pharmacokinetics pharmacodynamics pediatric bidirectional cavopulmonary anastomosis fontan physiology cardiac transplant
efficacy and safety of bi 1356 (linagliptin) versus placebo in type 2 diabetic patients with insufficient glycemic control

Conditions: Diabetes Mellitus, Type 2

Summary: to investigate efficacy, safety and tolerability of bi 1356 versus placebo


Eligibility criteria:
inclusion criteria: * male or female patients with type 2 diabetes and insufficient glycaemic control. * age 18 or over and not older than 80 years exclusion criteria: * use of more than one oral antidiabetic agent within 10 weeks prior to informed consent, insulin, glitazones or glp-1 analogues within 3 months. * myocardial infarction, stroke or transient ischaemic attack within 6 months prior to informed consent.
feasibility study of metronomic chemotherapy for locally advanced her2- positive breast cancer (traq-me 01)

Conditions: Locally Advanced HER2-positive Breast Cancer

Summary: the purpose of this study is to evaluate the safety, effectiveness and cost-effectiveness of metronomic chemotherapy combined with trastuzumab as neoadjuvant therapy for locally advanced her2-positive breast cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of locally advanced breast cancer * t \> 2 cm (any n), or any t and positive node(needle biopsy is required if tumor size is less than 2cm) * non-metastatic disease confirmed by computerized tomography and bone scan * her2 positive by ihc (+++) and/or fish (+) according to international definitions (asco 2007) * normal left ventricular ejection fraction (lvef) * indication of preoperative chemotherapy * multifocal tumors acceptable provided that the largest tumor is her2-positive * ecog 0-1 exclusion criteria: * another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast) * clinically significant comorbidities such as cardiovascular diseases, copd, renal or liver impairment, psychiatric disorders * lvef value below institutional limits of normal range * detected or suspected distant metastasis * neutrophils lower than 1,500/µl, platelets lower than 100,000/µl, hemoglobin lower than 10 g/dl, ast higher than 2.5x upper limit of normal (uln), total bilirubin higher than uln, alkaline phosphatase more than 1.5x uln

Keywords: metronimic chemotherapy locally advanced her2-positive breast cancer
correlation of memory cd8+ t cells with sepsis severity and mortality: a single-center, unblinded, prospective, non-interventional, observational study

Conditions: Sepsis; Inflammatory Response

Summary: sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (icu). sustained excessive inflammation and immune dysfunction have been confirmed to play a key role in organ damage and early death of sepsis patients. therefore, it is important to reduce excessive inflammatory response mediated by immune cells and pro-inflammatory cytokines in the acute phase of sepsis. single-cell rna sequencing performed on both septic patients and mice suggest that changes in tcm (cd3+ cd8+ cd44+ cd127+ cd62l+) and tem (cd3+ cd8+ cd44+ cd127+ cd62l -) in the acute phase of sepsis may play an important role in sepsis. in addition, animal researches showed that tcm and tem decreased decreased continuously at 24, 48 and 72h after cecal ligation and perforation (clp) in mice, and the adoptive transfer of tcm , sorting from spleen of mice 24h after clp , but not tem improved 7-day survival rate of sepsis mice. this observational study is aimed to investigate the quantity and proliferation of tcm and tem in the acute phase of sepsis and their correlation with severity level and mortality of septic patients in icu.


Eligibility criteria:
inclusion criteria: patients aged 18-60 years old without restriction of gender, race, religion, creed or nationality; no sedative drugs with elimination half-life were used before inclusion in the study; patients and/or their family members know and agree to participate in the trial. exclusion criteria: history of solid organ or bone marrow transplantation; diseases that may affect immune-related indicators, such as autoimmune diseases such as rheumatoid arthritis and sle, or hematological malignancies such as leukemia and lymphoma; have received radiotherapy or chemotherapy within the past 30 days, or have received immunosuppressive drugs (tripterygium, mycophenolate, cyclophosphamide, fk506, etc); pregnancy or lactation; chronic nephrosis; severe chronic liver disease (child-pugh: grade c); alcohol or opioid dependence, mental illness, or severe cognitive impairment; patients and/or their family members refuse to participate in the trial.

Keywords: sepsis cd8+ t cell central memory cd8+ t cell inflammatory response
thalidomide for patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a 24-week, randomized, double-blind, placebo-controlled study of the effect of thalidomide and placebo on csf (cerebral spinal fluid) and plasma biomarkers in patients with mild to moderate alzheimer's disease. this study will evaluate the effects of 24 weeks of treatment with thalidomide on plasma biomarkers.

a lumbar puncture will be done before treatment (baseline), and at 24 weeks to collect csf for the quantification of biomarkers. as an exploratory effort, we will test the effects of thalidomide on the same biomarkers in the plasma and will determine if detectable changes mirror changes observed in the csf.

Eligibility criteria:
inclusion criteria: * subjects must have a screening diagnosis of probable alzheimer's disease according to national institute of neurological and communicative disorders and stroke-alzheimer's disease and related disorders association (nincds/adrda) criteria. * subjects must have a mini-mental state examination (mmse) score of 12-26 * subject must live at home. * must have a caregiver to participate in this study
osteoarticular infections on material in children

Conditions: Osteoarticular Tuberculoses

Summary: the management of osteoarticular infections on equipment is complex. in order to optimize the management of these infections, the french national authority for health (has) has published good practice recommendations for prosthesis infections in adults. however, in the pediatric population, this type of infection is rarer and their management less well codified. the aim of this retrospective and descriptive monocentric study is to identify all osteoarticular infections in children under 16 years of age managed at the montpellier university hospital from 2014 to 2021, to study the epidemiology and bacterial ecology of these infections and to evaluate the effectiveness of the therapeutic strategy and side effects, long-term sequels


Eligibility criteria:
inclusion criteria: * osteoarticular infections on material in children under 16 years old * hospitalized at the chu of montpellier exclusion criteria: * over 16 years of age * other types of osteoarticular infections

Keywords: children
safety of sofosbuvir ,daclatasvir in hcv patients and ravs in resistent and relapsed cases

Conditions: HCV

Summary: to identify side effects of sofosbuvir/ daclatasvir treatment regimen of chronic hcv gt-4 infection. * to assess the occurrence and the prevalence of ravs in patients with treatment failure and relapse after sofosbuvir and daclatasvir with assessment of their types . * to examine the gt4 subtypes by phylogenetic analysis and baseline sequence variability among subtypes and their potential impact on treatment outcome and development of viral resistance in patients who received a regimen of sofosbuvir/ daclatasvir for treatment of chronic hcv gt-4. * to assess the differences in patient demographics across gt4 subtypes.

hepatitis c virus (hcv) chronically infects approximately 120-130 million individuals worldwide .mortality related to hcv infection has been estimated at approximately 300,000 deaths per year.. direct antiviral agents (daas) effectively eradicate hcv and rapidly improve residual liver functions. current hcv eradication rates have exceeded 90% in a very short time . hepatitis c virus genotype 4 (gt4) is genetically diverse, with 17 confirmed subtypes, and comprises approximately 13% of infections worldwide \[3\]. in egypt, gt4 accounts for approximately 90% of infections, with subtype 4a predominating . sofosbuvir and daclatasvir are generally well tolerated with only a few adverse effects reported. hepatitis c virus resistant associated variants (ravs) are seen in most patients who do not achieve sustained virological response (svr). these resistance-associated mutations depend on the class of direct-acting antiviral drugs used and also vary between hepatitis c virus genotypes and subtypes. donaldson et al performed an analysis on four phase iii clinical trials in search of common ravs against sofosbuvir, discovering l159f, c316n, and v321a were associated with virological failure. interestingly, this study also verified s282r mutation as associating with failure. ns5a ravs can be very common, with y93h detected in up to 15% of the population and l31m in up to 6.3%. other ravs tend to also be fairly common detected in approximately 0.3%-3.5% of the population

Eligibility criteria:
inclusion criteria: * anti hcv positive patients either chronic hcv or liver cirrhosis. • detectable hcv rna by quantitative polymerase chain reaction (pcr) prior to treatment exclusion criteria: * co-infection with hepatitis b virus . * presence of malignancy before treatment. * end-stage liver disease (child score more than 9). * major co-morbid disease e.g heart failure

Keywords: hcv sofosbuvir safety ravs daclatasvir
influence of creatine monohydrate supplementation on androgens and global hair assessments

Conditions: Dihydrotestosterone; Testosterone; Hair Loss

Summary: this study is a randomized, double-blind, placebo-controlled trial examining the effects of creatine monohydrate supplementation on androgens and hair loss in free-living adult males. participants will complete 6 months of supplementation of 5 grams per day of creatine monohydrate while following their normal lifestyle practices. at baseline and six months after study initiation, participants will complete laboratory assessments. these assessments will include a standard blood draw for evaluation of total testosterone (t), free t, dihydrotestosterone (dht), and dht:t ratios in the blood, as well as global photography and questionnaires to evaluate hair loss. this study will examine the claim that creatine increases dht concentrations and and dht:t ratio, as well as provide novel data regarding whether creatine promotes hair loss.


Eligibility criteria:
inclusion criteria: * male between the ages of 18 and 35 * weight of at least 110 pounds * generally healthy (defined as an absence of a disease or medical condition which could potentially be negatively influenced by study participation or confound study results) * low levels of habitual creatine consumption, defined as consuming an average of \<10 g/week of creatine from all supplemental sources within the three months prior to study initiation * willingness to report to baseline and final assessments with a similar haircut (i.e. willingness to replicate baseline haircut prior final assessment, to the best of his ability) and one that allows for evaluation of hair growth patterns (e.g., not a completely shaved head that disallows visualization of the hairline) * willingness to adhere to the supplementation protocol for the duration of the study (i.e., 6 months of daily supplementation with 5 grams per day of creatine monohydrate or placebo) and abstain from additional creatine supplement ingestion during this time. * willingness to abstain from any treatments related to hair loss or hair growth for the duration of the study * willingness to maintain normal practices regarding hair products (i.e. continue to use regular shampoo, conditioner, and other products over the duration of the study and abstain from switching products during the study if at all possible) exclusion criteria: * failing to meet any of the aforementioned inclusion criteria * presence of pacemaker or any electrical device (due to electrical currents administered by bioimpedance devices used to assess body composition) * individual currently participates in any type of hair loss treatment or procedure or has undergone any such treatment or procedure within the last 12 months
cortical plasticity in a complex intervention for endometriosis

Conditions: Endometriosis

Summary: the aim of the study is to test, if patients suffering from endometriosis show changes in their brain function, when being treated with sart (systemic autoregulation therapy), a complex intervention consisting of interventions from traditional chinese medicine (tcm) and western hypnotherapy. functional and structural brain changes are assessed using magnetic resonance imaging data which are analyzed by means of voxel-based morphometry (vbm), connectivity and perfusion analysis. a third outcome measure are changes of patients' heart rate variability, indicating the activity of their autonomic nervous system. with a number of questionnaires, changes in dysmenorrhea, chronic pelvic pain, menstruation regularity, dyspareunia, defecation pain, and quality of life are assessed during the sart treatment. during the treatment, we expect to see changes in cortical thickness, functional connectivity and perfusion of pain-related areas of the cortex, that correlate with the changes in heart rate variability.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * clinically or histologically ensured diagnosis of endometriosis * preoperative and postoperative recurring ailments related to endometriosis * no hormone therapy (gnrh analogues, contraceptives) * sufficient understanding of the german or english language * persisting pain during menstruation (also in between) * voluntary participation after information on the possible benefits and risks of the examination and intervention * written informed consent exclusion criteria: * alcohol addiction, drug addiction * pregnancy * diseases and other criteria, preventing an mri examination: * pacemaker * neurostimulator or drug pump * metal parts in the body (implants, splinters, etc.) * claustrophobia

Keywords: endometriosis pain sart autonomic nervous system fmri perfusion connectivity hypnotherapy traditional chinese medicine
effects of pioglitazone on insulin and glucose metabolism in women with polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovary Syndrome

Summary: our hypothesis is that hyperinsulinemia increases the renal clearance of d-chiro-inositol (dci) in women with polycystic ovary syndrome (pcos) and that this leads to a reduction in circulating insulin-stimulated d-chiro-inositol-containing inositol phosphoglycan (dci-ipg) release. to assess the effects of a chronic reduction in circulating insulin on dci metabolism, we propose to reduce circulating insulin in obese women with pcos by improving insulin sensitivity with the drug pioglitazone. pioglitazone is a thiazolidinedione that improves peripheral insulin sensitivity, presumably by activation of the peroxisome proliferator-activated receptor gamma (pparγ) receptor. administration of pioglitazone to women with pcos has been shown to improve insulin sensitivity, reduce insulin secretion, and decrease both fasting and post-prandial serum insulin concentrations.

this protocol focuses on the hypothesis that a deficiency in a putative inositolphosphoglycan (ipg) mediator of insulin action, namely a d-chiro-inositol-containing ipg (dci-ipg), contributes to the insulin resistance of some women with pcos. our interest in this area stems directly from our previous studies, which demonstrated that administration of the precursor, d-chiro-inositol (dci), to both obese and lean women with pcos improved glucose intolerance while reducing circulating insulin, and simultaneously improved ovulatory function and decreased serum androgens. these findings were recently confirmed in a large-scale study by an independent group. the findings of these three studies suggested that administration of dci improved insulin sensitivity in pcos, which then resulted in an improved hormonal and metabolic milieu.

Eligibility criteria:
inclusion criteria: 1. obese (body mass index or bmi greater than or equal to 30 kg/m2) women with pcos between 18-40 years of age: * oligomenorrhea (less than 8 menstrual periods annually) * biochemical hyperandrogenemia (elevated total or free testosterone) * normal thyroid function tests and serum prolactin; and * exclusion of 21a-hydroxylase deficiency by a fasting 17a-hydroxyprogesterone less than 200 ng/dl.51, 2. acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (complete blood chemistry or cbc, comprehensive metabolic panel denoted sma20, urinalysis, negative pregnancy test). 3. signed, witnessed informed consent. 4. ability to comply with study requirements. exclusion criteria: 1. diabetes mellitus by fasting glucose or oral glucose tolerance test (ogtt), or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer). 2. current use of oral contraceptives. 3. documented or suspected recent (within one year) history of drug abuse or alcoholism. 4. ingestion of any investigational drug within two months prior to study onset.
study to evaluate dt-216 in adult patients with friedreich ataxia

Conditions: Friedreich Ataxia

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of intravenous dt-216 in adult patients with friedreich ataxia. this single ascending dose study is randomized, double-blind, placebo-controlled.


Eligibility criteria:
inclusion criteria: * genetically confirmed diagnosis of friedreich ataxia with homozygous gaa repeat expansions * body mass index (bmi) between 17 and 32 kg/m2 * stage 5.5 or less on the functional staging for ataxia (fsa) exclusion criteria: * has any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study * has clinically significant abnormal laboratory results * has significant cardiac disease * received an investigational drug within 3 months of screening note: other protocol defined inclusion/exclusion criteria may apply.