Kornimate/medical-research-clean huggingface dataset:
early mobilisation in intensive care unit : interest of cyclo-ergometry in patients with septic chock

Conditions: Sepsis

Summary: cycloergometer is a validated method for different care. this kind of device allow passive and active care for patient. the interest of cycloergometer for patient hospitalized in intensive care unit for sepsis has never been demonstrated. the main objective of this study is to determine the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy, on the icu length in patients with septic shock the secondary objectives of this study are to assess the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy on: 1. the duration between hemodynamic stability\* and the removal of sedation 2. the duration between the removal of sedation and icu discharge 3. the mechanical ventilation duration (invasive and noninvasive)


Eligibility criteria:
inclusion criteria: * patient hospitalized in icu * septic shock diagnosed more than 24 hours before inclusion * patient hemodynamically stable, before the 72th hour following the diagnosis of septic shock * mechanical ventilation by tracheal intubation * patient sedated with a rass score inferior or equal to -2 * age ≥ 18 years * bmi ≤ 40 kg / m² * informed patient having signed the consent * effective contraception in women of childbearing age (pregnancy test by b-hcg will be done; for menopausal women, a diagnosis of confirmation must be obtained). exclusion criteria: * bmi\> 40kg / m² * patient reduced by one or two lower limbs * rheumatological pathology, trauma or surgery of the lower limbs, pelvis or spine resulting of any limitations of the range of motions or strict immobilization * brain-injured patient and / or medulla injured * hemodialysis continues with a femoral catheter without possibility of changing the catheter location * moribund patient, stop or limitation of active therapeutics' decision * contraindications to standard physical therapy or the cyclo-ergometer * untreated orthopedics: deep vein thrombosis of the member concerned * dermatological: severe lesions or complex dressings in the sector concerned * patient with extracorporeal membrane oxygenation (ecmo) * pregnant or breastfeeding women * patient participating in another trial with the same main objective

Keywords: cycloergometer
restless legs syndrome exercise intervention

Conditions: Restless Legs Syndrome; Insomnia

Summary: a pilot study of an aerobic exercise intervention to moderate symptoms and improve sleep quality among patients with restless legs syndrome (rls). we, the researchers at northeastern ohio universities college of medicine, hypothesize that, relative to a control group, rls sufferers who participate in an aerobic exercise intervention will demonstrate: 1. reduced rls symptoms; 2. improved sleep quality; 3. reduced daytime sleepiness.

we will implement an exercise intervention among persons who suffer from rls. study members will be veterans, over the age of 40, who have been identified as rls cases as part of our larger study of "the prevalence and outcomes of restless legs syndrome among veterans." we will use a cross-over design in which veterans will be randomly assigned to the exercise intervention or control. each arm of the study will be 3 months duration. the protocol for the intervention will consist of twice weekly supervised exercise sessions. the goal for exercise participants will be to engage in continuous aerobic exercise for 45 minutes at an intensity of approximately 60% of vo2max. the control will be weekly support group meetings. outcomes will be measured using standardized sleep scales, actigraphy, and daily sleep and exercise logs.

Eligibility criteria:
inclusion criteria: * meets case definition for rls with symptoms at least one day a week * age 40 and older * moderate or severe insomnia * able to engage in moderate exercise * permission of primary care physician to participate in exercise. exclusion criteria: * serum ferritin below 50 ng/ml * body mass index (bmi) greater than 40 * history of recent myocardial infarction or stroke * alcohol use, more than 3 drinks a day * current use of medications for sleep

Keywords: restless legs syndrome insomnia daytime sleepiness exercise
jaktinib hydrochloride cream for atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study includes a dose escalation part and a dose extension part.

in the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.subjects in each group were observed for 4 weeks after administration. when the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.otherwise, idmc will decide whether to continue the next set of tests.subjects in each group were randomly assigned to receive either jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.a total of 32 subjects are expected to be enrolled in 6 centers. the dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).it is estimated that a total of 60 subjects will be enrolled in about 15 centers. this part is divided into two stages.stage 2 test (9 \~ 16 weeks) : extension test.

Eligibility criteria:
inclusion criteria: * 18\~ 65 years old (including boundary value), gender is not limited; * have a clinical diagnosis of atopic dermatitis; * have a pga(physician's global assessment) score of 2 (mild) or 3 (moderate) at baseline; * the total area of atopic dermatitis is about 10%\~20% of the total area of the body surface at baseline. exclusion criteria: * evidence of certain skin conditions/infections at baseline; * have certain laboratory abnormalities at baseline; * females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception; * other conditions that the investigators considered inappropriate to participate in the trial.

Keywords: atopic dermatitis jaktinib
omarigliptin (mk-3102) clinical trial - add-on to oral antihyperglycemic agent study in japanese participants with type 2 diabetes mellitus (mk-3102-015)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will examine the safety and efficacy of the addition of omarigliptin in japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy.

the treatment period is composed of a 24-week double-blind period (phase a) and a 28-week open-label period (phase b). during phase a, participants will received either omarigliptin 25 mg or a matching placebo. during phase, b all participants will receive omarigliptin 25 mg. all participants will remain on a stable dose and administration of a single oral antihyperglycemic basal medication.

Eligibility criteria:
inclusion criteria: * has type 2 diabetes mellitus * has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic agent monotherapy exclusion criteria: * history of type 1 diabetes mellitus or a history of ketoacidosis * history of any of the following medications: thiazolidinediones (tzd) (for participants whose basal medication is not tzd) and/or insulin within 12 weeks prior to study participation, omarigliptin anytime
the effects of mindfulness-based stress reduction in interstitial cystitis patients

Conditions: Interstitial Cystitis

Summary: this is a prospective cohort study to investigate differences in the bladder environment (i.e. urinary microbiome) amongst women with interstitial cystitis (ic) before and after undergoing mindfulness-based stress reduction (mbsr) treatment, including yoga and meditation practices.

interstitial cystitis (ic), or painful bladder syndrome (pbs) is a debilitating condition of the bladder that is estimated to affect 3-8 million women in the united states. the pathophysiology of the disease is poorly understood, and thus treatment modalities and treatment efficacy vary widely. lately, much attention has shifted toward investigating how the bladder 'environment' differs amongst women with ic compared to those who do not suffer from ic. mindfulness-based stress reduction (mbsr), a complementary alternative medicine (cam)-based therapy, is a standardized program including components of meditation and yoga. recent studies show that mbsr improves symptoms in the ic patient population. the purpose of this study is to compare measurable differences in the urinary microbiome among women with ic before and after mbsr treatment.

Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * english-speaking * established patient of cincinnati urogynecology associates, trihealth inc. * current diagnosis of ic/pbs, as defined by the american urological association (aua) * negative urinalysis or urine culture within 2 months of enrollment * currently undergoing first or second-line treatment for ic, as defined by the aua * willingness to participate in study exclusion criteria: * non-english speaking * unwillingness to participate in study * pregnancy or breastfeeding * physical or mental impairment that would affect the subject's ability to participate in the mbsr treatment, including patients with dementia, parkinsonism, or those who have impaired mobility or hearing * current or expected prolonged catheterization * expected travel or surgery that would hinder the ability to attend all eight mbsr sessions * undergoing third-, fourth-, fifth-, or sixth-line treatment for ic as defined by the aua * subjects on antibiotics currently or prior use within one week of consenting
physiological constraints associated with trail running

Conditions: Muscle Fatigue

Summary: the practice of mountain running or "trail" is in full development in france and elsewhere in the world. this sporting practice associates specific physiological constraints related in particular to the duration of the efforts made (several hours) and to the ground (important elevation, technical ground, average altitude). some studies have allowed the last 10 years to initiate the exploration of the physiological consequences of this type of practice, especially from a muscular point of view. however, some important questions remain to be clarified such as the impact of these sports events on fatigue and muscle recovery, cardiovascular, energy and water balance disturbances caused, induced sleep changes and the kinetics of recovery of the various parameters. . these elements remain in particular to be studied in very different racing contexts as currently developed by the organizers, namely race in one stage from long to very long distances (40 to 160 km) and race in stages (4 days, 4 x 40 km) as encountered in the grenoble ut4m race (ultra tour des 4 massifs).


Eligibility criteria:
inclusion criteria: * man or woman * 18-55 years * absence of chronic cardiovascular, respiratory, metabolic or neuromuscular disease * \> 3 years of trail running (at least 1 race\> 40 km / year completed and a race\> 100 km completed (trail group 160 km) * medical certificate of no contraindication to the practice of the trail * subjects available in grenoble before and within 15 days after the race * subjects affiliated to a social security scheme * subjects able to sign informed consent. exclusion criteria: * cardiorespiratory, metabolic and neurological diseases * non-echogenic subjects * subjects with chronic sleep disorders * psychiatric pathologies or atcd of behavioral disorders * persons refusing to sign the information sheet and the participation agreement, * persons under guardianship or not subject to a social security scheme, * pregnant woman, parturient, breastfeeding mother * person deprived of liberty by judicial or administrative decision, * person subject to a legal protection measure, who can not be included in clinical trials.
the effect of adenomoyosis on pregnancy outcomes

Conditions: Adenomyosis; Pregnancy Complications

Summary: adenomyosis can be defined as the settling of endometrial gland cells in the myometrium and deformity in the uterus and the prevalence of adenomyosis is according to the patient population and countries around 20%. there are recent publications reporting that this rate increases up to 50% in women dealing with infertility. in adenomyosis, where uterine morphology is affected, it is not thought that the uterus, which is expected to provide many morphological adaptations during pregnancy, will not be affected. therefore, in this prospective study, it was planned to investigate the effects of adenomyosis during pregnancy. for this study the presence of adenomyosis will be questioned by using ultrasonographic morphological uterine limitation (musa) in women who apply to the outpatient clinic with suspicion of pregnancy and undergo transvaginal ultrasonography for the diagnosis of pregnancy before sixth gestational week. patients will be divided into two groups according to the presence of adenomyosis and pregnancy complications such as preterm labor, premature rupture of membranes, cesarean section rates, preeclampsia, fetal malpresentation and preeclampsia will be compared between the groups.


Eligibility criteria:
inclusion criteria: * age between 18-35 years * being diagnosed before the 6th gestational week * having all pregnancy follow-ups and deliveries in our hospital exclusion criteria: * previous uterine surgery * multiple pregnancies * pregnant women with uterine malformations * pregnant women with fetal anomalies * those who got pregnant using assisted reproductive technique

Keywords: adenomyosis pregnancy complications musa classification ultrasound
a clinical trial to evaluate the safety and efficacy in subjects with chronic cough

Conditions: Chronic Cough

Summary: a randomized, double-blind, placebo-controlled, two-period crossover, phase 2 clinical trial to evaluate the safety, tolerability, and efficacy of adx-629 administered orally to subjects with chronic cough

a phase 2, multicenter, randomized, double-blind, placebo controlled, two-period crossover trial to evaluate the safety, tolerability, and efficacy of adx-629 (300 mg) administered orally, twice-a-day to eligible participants with refractory or unexplained chronic cough. patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Eligibility criteria:
inclusion criteria: * adults ≥18 to ≤80 years of age * history of refractory or unexplained chronic cough * historical chest radiograph or ct scan that does not demonstrate any abnormality considered to be significantly contributing to chronic cough * not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable * agree to discontinue antitussive medications for the trial duration exclusion criteria: * current smoker (including cannabis products) or previous smoker having recently given up smoking or has a history of smoking of \>20 pack-years * history of significant cardiovascular disease or any clinically significant abnormalities in rhythm or conduction * history or presence of significant hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. * history of any malignancy within 5 years of screening except for basal cell or squamous cell in situ skin carcinomas or carcinoma in situ of the cervix that has been treated with no evidence of recurrence. * recent history of drug or alcohol abuse or a positive urine drug test at screening * positive serology test for hepatitis b virus (hbv), hepatitis c virus (hcv), or hiv-1 and hiv-2 * currently taking an angiotensin converting enzyme inhibitor (acei) or has used an acei within 3 months of screening.

Keywords: refractory cough cough hypersensitivity adx-629 unexplained cough reactive aldehyde species crossover inflammation
a study in healthy male volunteers to investigate a new drug for the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: the main purpose of the study is to identify the best dose of v81444 to use in future trials in patients with parkinson's disease. the study will also explore the effects of v81444 on brain activity and blood flow with tests of mental ability ("cognitive function tests"). it will also check how safe v81444 is and how well it is tolerated after dosing.

in this phase i, single-centre, open-label, adaptive, single-dose study at multiple dose levels, the relationship between dose and plasma concentration of orally administered v81444 to brain a2a ro was investigated in 6 healthy male volunteers. in addition, the effects of v81444 on regional brain activity and perfusion during tests of cognitive function, and the safety and tolerability of v81444 were assessed. for each subject, the study consisted of a screening visit, a baseline visit, a treatment period, and a safety follow-up visit. the dose of v81444 and timing of scans performed were defined in the protocol for the first 2 subjects only. the dose, nature and timings of assessments for subsequent subjects were determined based on review of emerging receptor binding, pharmacokinetic (pk), pharmacodynamic (pd) and safety information. in each treatment period, subjects were admitted to the unit on the day before dosing (day -1), received a single oral dose of v81444 on day 1 and, subject to satisfactory medical review, were discharged a minimum of 12 h after dosing. overall, 3 doses of v81444 were assessed (250 mg, 50 mg, and 100 mg), with 2 subjects included at each dose level. pd assessments were performed at baseline and after each dose of v81444 using pet (with the a2a radioligand, to measure brain a2a ro, as well as mri techniques to investigate the effects of v81444 on regional brain activity and perfusion during cognitive function tests. pk parameters were assessed by assay of v81444 concentration in plasma. safety and tolerability were assessed by monitoring physical examination findings, adverse events (aes), vital signs, 12 lead electrocardiogram (ecg) and clinical laboratory safety tests.

Eligibility criteria:
inclusion criteria: * healthy male volunteers: aged 25 to 55 years, in good general health as determined by medical history, physical examination and screening investigations, and taking no regular medication. * confirmation to be sought for all volunteers that their general practitioner has provided an acceptable medical history. exclusion criteria: * any significant medical condition or a history of such a condition that the investigator considers should exclude the subject from the study. specific exclusion criteria relate to * usual caffeine intake and willingness to abstain from caffeine * history or evidence of clinically significant gastro-intestinal disease * presence of structural brain abnormality * contraindications or cautions for mri scanning * clotting test results * exposure to significant levels of ionising radiation in the past
be well with migraine: brain education and wellness with migraine

Conditions: Migraine

Summary: the goal of this randomized clinical trial is to evaluate two different non-drug, virtual treatment options designed to improve the lives of patients with migraine. both interventions involve 8 weekly sessions and an online platform with additional content and learning. participants can stay on all their medications during this study. information from this study may help determine how to better treat migraine.

this study involves 8 weekly virtual sessions \& an online platform designed to improve the lives of patients with migraine. participants from across the united states with migraine may be eligible to participate. this study does not require any in-person visits. all assessments and surveys will be completed virtually and/or online. participants will independently complete an initial online screen. participants will attend a scheduled phone or videoconferencing call with a study team member to complete the baseline assessment and learn how to use the online platform. participants will keep an online daily headache log and complete several online surveys throughout the study.

Eligibility criteria:
inclusion criteria: * diagnosis of migraine with or without aura by with headache frequency of 4-20 days/month * at least 1 year of migraine * at least 18 years old * able to participate in 8 weekly online classes * willingness to complete baseline headache logs * headache-related disability (headache impact test (hit)-6) score \>50 * fluent in english * completion of technology onboarding with the online platform * pregnant women who are less than or equal to 16 weeks gestation at enrollment are allowed to participate exclusion criteria: * major unstable medical/psychiatric condition that could be unsafe for participants or for the group environment. * medication overuse headache, with migraine treatment * pregnant women who are more than 16 weeks gestation at enrollment * unstable migraine treatment at enrollment: any preventive treatment (oral or injectable medication or neuromodulatory device) started within 12 weeks or acute treatment within 4 weeks to ensure stability * unwillingness to maintain stable current medication dosages for study duration * failure to complete baseline headache logs * heavy alcohol and illicit drug use * participation in another intervention clinical trial or one that would interfere in this study * experience with stress reduction training (daily meditation practice, regular use of a mindfulness app, or prior experience with mbsr) * any, and all other diagnoses or conditions which, in the opinion of the site investigator, would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study participant: covid-positive test within 30 days of enrollment

Keywords: migraine migraine without aura migraine with aura behavioral mind-body integrative virtual online
temozolomide chronotherapy for high grade glioma

Conditions: Glioma; Glioblastoma Multiforme

Summary: temozolomide (tmz) is the chemotherapy drug approved by the fda to increase survival in glioblastoma (gbm) patients beyond surgical resection and radiation therapy alone. give its activity in astrocytomas, tmz is commonly used in grade iii anaplastic astrocytoma (aa) as well. both grade iii aa and grade iv gbm are high grade gliomas (hgg). the short half-life of this drug and known oscillations in dna damage repair make it an ideal candidate for chronotherapy. chronotherapy is the improvement of treatment outcomes by minimizing treatment toxicity and maximizing efficacy through delivery of a medication according to the timing of biological rhythms within a patient. chronotherapy has improved outcomes through the reduction of side effects and increase in anti-tumor activity for a variety of cancers, but has never been applied to the treatment of gliomas. based on the preliminary preclinical data for chronotherapeutic tmz treatment of intracranial glioma xenografts and the success of chronotherapy in the treatment of other cancers, the invesitgators hypothesize that the timing of tmz treatment will alter its efficacy and toxicity.


Eligibility criteria:
inclusion criteria: * newly diagnosed and recurrent high grade gliomas (who grades iii \& iv) and high risk who grade ii gliomas who are to begin treatment with monthly high dose temozolomide therapy. * scheduled to receive adjuvant temozolomide therapy after having completed concurrent temozolomide and radiation therapy. * at least 18 years of age. * karnofsky performance status ≥ 60% * ability to understand and willingness to sign an irb approved written informed consent document exclusion criteria:. -pregnant and/or breastfeeding. women of childbearing potential must have a negative pregnancy test within 14 days of study entry.