Kornimate/medical-research-clean huggingface dataset:
phase 1 study of pk and safety of spr206 in subjects with various degrees of renal function

Conditions: Renal Impairment

Summary: evaluation of the pharmacokinetics (pk) of spr206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (esrd) receiving hemodialysis (hd) therapy.


Eligibility criteria:
key inclusion criteria: * bmi ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive) * medically healthy without clinically significant abnormalities (healthy volunteers) or medically stable without clinically significant acute or chronic illness (subjects with varying degrees of renal disease) * normal renal function with egfr ≥90 ml/min/1.73m2 (cohort 1), or renal insufficiency with egfr 60 to \<90 ml/min/1.73m2 (cohort 2), 30 to \<60 ml/min/1.73m2 (cohort 3), or \<30 ml/min/1.73m2 (cohort 4), calculated using modification of diet in renal disease (mdrd). subjects with esrd must be receiving hemodialysis at least 3 times per week for at least 3 months at screening (cohort 5 only) * non-smoker for at least 1 month prior to screening for the study * ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food * other inclusion criteria per protocol key exclusion criteria: * any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject * electrocardiogram (ecg) with qtcf interval duration equal or greater than 500 msec * hemoglobin (hb), hematocrit (hct), white blood cell count (wbc), or platelet count less than the lower limit of normal range of the reference laboratory (cohort 1). hb \<8.5 gm/dl, wbc ≤3,000 cells/μl or platelet count ≤100,000 cells/μl (cohorts 2-5) * results of biochemistry tests for alanine aminotransferase (alt), aspartate aminotransferase (ast) and bilirubin greater than 1.5 x the upper limit of normal (uln) for the reference laboratory * recent history (within 6 months) of known or suspected clostridium difficile infection * history of chronic liver disease, cirrhosis, or biliary disease * history of seizure disorder except childhood history of febrile seizures * positive urine drug/alcohol testing * positive testing for human immunodeficiency virus1/2 (hiv 1/2), hepatitis b surface antigen (hbsag) or hepatitis c (hcv) antibodies * history of substance abuse or alcohol abuse * known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication * other exclusion criteria per protocol

Keywords: end state renal disease (esrd) renal insufficiency renal impairment renal disease hemodialysis
repetitive transcranial magnetic stimulation for treating resistant bipolar depression

Conditions: Bipolar Depression

Summary: the aim of this randomized, single-blind trial is to evaluate the effectiveness and tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation (rtms) in patients with resistant bipolar depression. patients will be assigned to receive either high or low frequency rtms for 20 consecutive workdays (4 weeks). 10 hz (high) frequency rtms and 1 hz (low) frequency rtms will be given over the left or right dorsolateral prefrontal cortex (dlpfc), respectively. patients will be assessed with several psychometric instruments at baseline, and at weeks 5 and 9.


Eligibility criteria:
inclusion criteria: * men or women aged 18 to 70 years * current major depressive episode (mde) in the context of a bipolar disorder type i or ii (according to the dsm-iv-tr) that has not improved after more than 2 adequate pharmacological trial(s) in the current episode (failure is defined as a lack of significant clinical improvement after the use of standard mood stabilizers, atypical antipsychotics and/or antidepressants given at their minimum effective dosage or higher for at least 4 weeks of duration) * baseline score ≥ 13 on the quick inventory of depressive symptomatology - clinician-administered (qids-c), i.e., a mde of at least moderate intensity exclusion criteria: * psychotic features in the current episode * lifetime history of a non-mood-related psychotic disorder * substance or alcohol abuse/dependence in the past 6 months * unstable medical disease (e.g., cardiovascular, renal) * presence of mood cycles of \< 30 days duration * pregnancy and/or lactation * presence of a specific contraindication for rtms (e.g., personal history of epilepsy or convulsion, metallic head implant) * hearing loss

Keywords: repetitive transcranial magnetic stimulation bipolar depression randomized trial rtms neuromodulation
the combination therapy of fractional laser and prp compared with nanofat grafting and prp synergy in treating striae gravidarum.

Conditions: Treatments of Striae Gravidarum

Summary: nowadays, multiple treatment modalities have been applied clinically to treat striae gravidarum, such as laser therapy, microdermabrasion, platelet-rich plasma injection(prp), etc. to some extent, these treatments can improve striae gravidarum. in this clinical trial, the investigators are going to treat striae gravidarum by using two different kinds of combination therapies. one is fractional laser and prp injection synergy, and the other one is treated by nanofat grafting with prp injection.

the investigators will pick out two areas of most severe striae gravidarum on a participant's abdomen. one of the areas will be treated by fractional laser once every three months for 2 times combined with prp injection once a month for 6 times. another area will be treated by nanofat grafting once every three months for 2 times and prp therapy once a month for 6 times. the participants were asked to come back 1、3、6、9 months after treatment for further follow-up. before and after the treatment, the striae gravidarum will be assessed subjectively by satisfaction assessment, dermatoscope and ultrasound, and objectively by immunohistochemical analysis.

Eligibility criteria:
inclusion criteria: * the striae gravidarum was appeared within 3 years * age ≤ 35 years old * not in lactation * not pregnancy within one year exclusion criteria: * skin allergy * skin inflammation or wound * platelet dysfunction syndrome * take anticoagulant drugs * acute or chronic infection * chronic liver disease * photodermatosis * active vitiligo, psoriasis, systemic lupus erythematosus * other clinical trial

Keywords: striae gravidarum fractional laser platelet-rich plasma (prp) nanofat graft combination therapy
registry for analysis of quality of life, normal organ toxicity and survival of pediatric patients treated with proton therapy

Conditions: Pediatric Cancer Patients

Summary: the study aim of this study is to evaluate the effect of proton therapy on quality of life and long-term normal tissue toxicities of the pediatric cancer patients. based on these results, the predictive model of long-term normal tissue toxicities, survival, and quality of life could be recognized. risk-adapted treatment strategy based on the predictive model in pediatric cancer patients could be established.


Eligibility criteria:
inclusion criteria: * less than 18 years of age * patient who is planned to receive proton therapy at samsung medical center * informed consent exclusion criteria: * refuse to participate this cohort study
effects of urocortins on forearm arterial blood flow in healthy volunteers (protocol 2)

Conditions: Vascular Disease; Heart Disease

Summary: impairment of the heart's pumping capacity (heart failure) remains a major clinical problem with a poor prognosis and the search for novel treatments remains an important area of research. urocortins are proteins that appear to increase blood flow and heart pumping activity. there has been particular interest in the role of urocortins 2 \& 3 (subtypes of urocortins) in heart failure. in this study, we will examine the effects and mechanisms of urocortins 2 \& 3 and the corticotrophin releasing hormone receptor type 2 (crh-r2) receptor (through which urocortins act) on forearm blood flow and release of natural blood clot dissolving factors in the forearm circulation of healthy volunteers. in this study, we will look at the role of the lining of the blood vessel (endothelium) in response to urocortin types 2 and 3. we hypothesise that urocortins 2 \& 3 act via the endothelium to cause dilatation of the blood vessels and release of tissue-plasminogen activating factor (blood clot dissolving factor). we also hypothesise that urocortins have a role in maintaining the normal baseline level of blood flow in forearm arteries. in addition to the above, we will also look at the effect of temporarily blocking the effect of urocortins, using a specially designed blocker drug (astressin 2b). utilising the well-established technique of 'forearm venous occlusion plethysmography', we will be able to focus on the local effects of urocortins on arterial blood flow in forearm vessels, without affecting this system in the body as a whole.


Eligibility criteria:
inclusion criteria: * healthy male volunteers between 18 - 65 years (inclusive) exclusion criteria: * lack of informed consent- age \ 65 years * current involvement in a clinical trial * severe or significant co-morbidity including bleeding diathesis, renal or hepatic failure * smoker * history of anaemia * recent infective/inflammatory condition * recent blood donation (prior 3 months) * positive baseline urine test for drugs of abuse (including cannabinoids, benzodiazepines, opiates, cocaine and amphetamines)

Keywords: urocortin 2 urocortin 3 astressin 2b forearm blood flow plethysmography vascular heart failure
interest of the virtual reality headset in the management of perioperative stress in patients candidates for total thyroidectomy

Conditions: Thyroid Cancer; Thyroidectomy

Summary: study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the aqua® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy


Eligibility criteria:
inclusion criteria: * patient\> 18 years old * man or woman * patient candidate for a total thyroidectomy, or a thyroid totalization * preoperative euthyroidism * can justify outpatient care: score of the american society of anesthesiology (asa) 1, 2 or 3 stable; accompanied for return at home; can be watched by a loved one the night after returning home; reachable by telephone; living within an hour of transportation from a hospital and having a good level of understanding. * no history of parathyroid or recurrent pathology * signature of informed consent before any specific procedure related to the study * subject affiliated with a health security system exclusion criteria: * patient with a submerged goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound) * patient with uncontrolled infectious pathology * pregnant or breastfeeding woman or lack of contraception during genital activity * patient with illnesses or conditions that hinder their ability to understand follow and / or comply with study procedures * patient with personality disorders and / or psychiatric pathology * patient deprived of liberty or placed under the authority of a guardian

Keywords: virtual reality headset stress hypnose
the study of giving birth, a study about treatment of labor dystocia

Conditions: Dystocia

Summary: labor dystocia is an intransigent, high-profile issue in obstetric care, which causes significant maternal morbidity in low resource settings and maternal dissatisfaction, and increased healthcare costs worldwide. amniotic fluid lactate, (afl), values have recently been shown to reflect the metabolic status of the uterus and high levels have a strong association with subsequent need for operative intervention due to dystocia. in sports medicine, it is known that lactic acid can affect muscular performance but be decreased by bicarbonate given orally before physical activity. main outcome measures: if an intake of bicarbonate, one hour before stimulation with oxytocin in cases with a high afl value, changes the afl levels and enhances delivery outcome in dystocic deliveries. design: randomized controlled trial

primary question: whether high afl values (\>12mmol/l) in women with observed dystocic labor are best treated by 1. to handle childbirth according to the clinic's current guidelines in case of labor dystocia, i.e. with oxytocin stimulation 2. an intake of bicarbonate (samarin) dissolved in water given 1 hour before the oxytocin is started primary outcome variable a comparison of the frequency of spontaneous vaginal delivery in the observed two described intervention groups.

Eligibility criteria:
inclusion criteria: * dystocic labor with a need of oxytocin \>=34w of gestation exclusion criteria: * nondystocic labors. * women who don't understand swedish or english * premature deliveries (\<34w)
the changes of treg cells frequency and function during antiviral therapy

Conditions: Chronic Hepatitis B Infection

Summary: pegylated interferon α-2a(peg-ifn-α) not only inhibit viral replication, but also play an important role in immune regulation, while nucleoside analog(ue) drugs only inhibit viral replication. in hepatitis b infection, treg cells regulatory t cells played a negative role in immune. this study was aimed at investigating the changes of treg cells frequency and function, and the expression of costimulatory molecules during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, the investigators wanted to verify whether peg-ifn-α suppressed the virus, which led to the decline of treg cells frequency and function;negative regulation of tregs for immune cells diminished, hence, the function of immune cells recovered.

pegylated interferon α-2a(peg-ifn-α)and nucleoside analog(ue) drugs can inhibit viral replication , but peg-ifn-α also play an important role in immune regulation . in hepatitis b infection, treg cells play an important role in immune regulation.peg-ifn-α recommended as the first-line treatment has a higher chance to achieve hbeag seroconversion and even hbsag disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of treg cells in the case of hepatitis and the function enhancement of treg cells during peg-ifn-α therapy. this study was aimed at investigating the changes of treg cells frequency and function, and the expression of costimulatory molecules during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, the investigators wanted to verify whether peg-ifn-α suppressed the virus, which led to the decline of treg cells frequency and function;negative regulation of tregs for immune cells diminished, hence, the function of immune cells recovered.

Eligibility criteria:
inclusion criteria: * hbsag and hbeag positive for more than 6 months, hbv dna detectable with alt level abnormal lasted for three months and at least time190 iu/l or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled. exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitis b hepatitis b virus treg cells pegylated interferon α-2a nucleoside analogues
expiratory airflow limitation in subjects with obesity

Conditions: Obesity

Summary: the purpose of this study is to investigate posture dependent small airway obstruction in subjects with obesity, and to study the capacity of fot as a measurement tool for small airways obstruction.

obesity is a cause of dyspnea due to mechanical impairment of pulmonary ventilation. one of the causes of this impairment is expiratory flow limitation, which is related to decreased lung volume. as a result, obesity can cause an asthma-like symptoms. therefore, some patients with obesity are misdiagnosed as asthma-patients, and treated with asthma medication. the effects of bronchodilators on the mechanical airway obstruction in obese subjects have not been well established. posture also has effect on lung volumes: they are decreased in supine position. therefore, the interaction of obesity and supine posture might result in a larger decrease in lung volumes, and thereby a more increased airflow limitation. it has been suggested that both obesity and supine posture result in an obstruction of peripheral airways. such an obstruction can be measured by spirometry, using the ratio of forced expiratory flow between 25 and 75% and vital capacity. this measure is highly variable, however. the forced oscillation technique (fot) is a non-invasive method to measure the resistance and reactant of the respiratory system. particularly the reactance has been shown useful in the measurement of airflow limitations. the investigators hypothesize that obesity causes a posture dependent end- expiratory airflow limitation due to a mechanical compression of lung tissue, resulting in increased resistance and reactance in the airways. therefore, the investigators expect no protective effect of bronchodilation by salbutamol. the investigators expect that reactance measured by fot detects differences in airflow limitation and correlates with airflow limitation as measured by spirometry.

Eligibility criteria:
inclusion criteria obese population: * male/female, age 25-60 * bmi (body mass index) 30-40 kg/m2 * non or ex smokers with \< 10 packyears inclusion criteria control population: * male/female, age 25-60 * bmi (body mass index) 18.5-25 kg/m2 * non or ex smokers with \<10 packyears exclusion criteria obese population: * asthma * copd (fev1/fvc\<0.70) * reversibility \>9% in fev1 (400 microgram salbutamol) * other significant neuromuscular, cardiac or lung disease exclusion criteria control population: * asthma * copd (fev1/fvc\<0.70) * other significant neuromuscular, cardiac or lung disease * reversibility \>9% in fev1 (400 microgram salbutamol)

Keywords: obesity expiratory flow limitation efl posture small airways obstruction fot
effects of amazonian dance on motor and non-motor symptoms of people with parkinson's: study protocol

Conditions: Parkinson Disease

Summary: this randomized controlled trial aims to evaluate the effects of a 12-week amazonian dance program on cognitive and motor symptoms in people with parkinson's disease (pd), comparing outcomes between participants in the intervention and those in an alternative control intervention.

experimental design: randomized controlled single-blind trial with four parallel groups. study sites include the federal university of rio grande do sul (south region, brazil) and the federal university of pará (north region, brazil). participants: 80 adults aged 50 to 80 years with a clinical diagnosis of idiopathic parkinson's disease, in stages i-iii of the hoehn \& yahr scale, under stable pharmacological treatment for at least one year. participants will be recruited from community health services, parkinson's associations, and university-affiliated health units in northern and southern brazil. interventions: amazonian dance groups (north and south): participants will engage in twice-weekly dance sessions for 12 weeks (24 sessions total), including movement practices inspired by lundum and carimbó dances, choreographic improvisation, and activities involving memory, storytelling, balance, and mobility. control groups (north and south): participants will receive a structured non-dance intervention over the same 12-week period. this control activity will consist sessions related to general well-being, physical activity, and quality of life, without dance training. outcomes: primary outcome: cognition (assessed by moca, stroop, and tab-cat tools). secondary outcomes: language (tell), depressive and anxiety symptoms (gds-15, pas), quality of life (pdq-39), functional mobility (tug), fear of falling (fes-i), and freezing of gait (fogq). experience with dance, sociodemographic and clinical data will also be collected. data analysis: descriptive statistics will report means and standard deviations. group comparisons over time will be analyzed using generalized estimating equations (gee) with bonferroni post-hoc tests. statistical significance is set at p\<0.05. effect sizes will be interpreted using cohen's d (small = 0.2, medium = 0.5, large = 0.8), with 95% confidence intervals reported. analyses will include intention-to-treat, considering participants with at least 80% adherence.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pd according to the london brain bank criteria; * able to understand the verbal instructions for the tests; * hoehn and yahr (h\&y) stages i-iii * ≥ 1 year undergoing medical treatment for pd with regular use of anti-parkinsonian drugs * capability to participate will be based on the unified parkinson's disease rating scale -motor examination exclusion criteria: * recent surgeries, * deep brain stimulation (dbs); * other associated neurological diseases or chronic diseases * fitted with a pacemaker; * prostheses in the lower limbs;

Keywords: dance cognition non-motor symptoms
investigation of the neurovegetative pattern in patients with thoracic aortic aneurysms (taa)

Conditions: Rare Diseases; Aortic Aneurysm, Thoracic

Summary: the goal of this observational cross-sectional study is to learn about vagal features in patients with syndromic and non-syndromic taa. the main question it aims to answer is to highlight a functional condition that could help stratify patients with taa on the risk of aortic complications. participant will take part by standing in supine position for 10 minutes and during active standing for 10 minutes. in this period of time, it will be possible to acquire the signals continuously and non invasively through recorded non-invasive blood pressure and piezoelectric sensor breathing belt.

changes in blood pressure (bp) are tightly controlled by a neural surveillance system that triggers changes in response to heart rate, vascular tone, and respiration. therefore, studies in literature have investigated the regulatory effects of the sympathetic system on the tone of the vessels as well as on the bp, but further analysis are needed in order to describe its potential impact on the structure of the aortic wall and, in particular, its potential implications on aneurysms and risk of aortic dissections. considering that, in the population with taa, the neurovegetative pattern influences the responses to different stressors (environmental, occupational and emotional) and also acts on the bp, which represents a risk factor for the taa population, its analysis would allow to identify attitudes and behavioral predispositions and therefore response to stressors. the non-invasive analysis of sympatho-adrenergic patterns could help to highlight a functional condition related to the "environmental stressors" which could help to stratify patients with taa based on the level of pathological reactivity with effects on risk of aortic complications.

Eligibility criteria:
inclusion criteria: * patients aged 18-65 years with syndromic and nonsyndromic taa; * signed informed consent; * patients on regular pharmacological prophylaxis (with losartan) or naïve patients with a first diagnosis exclusion criteria: * acute and chronic inflammatory diseases such as: liver disease, chronic renal insufficiency (creatinine \> 1.5 mg/dl) and diseases affecting the thyroid system.

Keywords: thoracic aneurysms heart rate variability autonomic nervous system