Kornimate/medical-research-clean huggingface dataset:
ledipasvir/sofosbuvir fixed-dose combination ± ribavirin in participants with chronic genotype 1 hcv who participated in a prior gilead-sponsored hcv treatment study

Conditions: HCV Infection

Summary: the primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed-dose combination (fdc) with or without ribavirin (rbv) in participants with chronic genotype 1 hepatitis c virus (hcv) infection who have participated in a prior gilead-sponsored hcv treatment study, and who did not achieve sustained virologic response (svr24), defined as hcv rna \< lower limit of quantification (lloq) 24 weeks after last dose of study drug (svr24).


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * infection with hcv genotype 1 * hcv rna \> lloq at screening * participation in a prior gilead-sponsored study * screening laboratory values within defined thresholds * use of two effective contraception methods if female of childbearing potential or sexually active male * must be of generally good health, with the exception of chronic hcv infection, as determined by the investigator * must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments key exclusion criteria: * pregnant or nursing female or male with pregnant female partner * co-infection with hiv or hepatitis b virus (hbv) * current or prior history of clinical hepatic decompensation (groups 1 and 2 only) * hepatocellular carcinoma (hcc) * history of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: genotype 1
prospective evaluation of reduced impedance noninvasive cortical electrostimulation (rince) to reduce fibromyalgia effects - extension study

Conditions: Fibromyalgia

Summary: the purpose of this open label study is to provide up to 24 active treatments of noninvasive cortical electrostimulation therapy only to those fibromyalgia patients who experienced inadequate pain reduction in a sham controlled double blinded lead in study, npt-201 (nct01825954). the therapy will be provided by the neuropoint device using the same protocol as that used in active treatment arms of npt-201. the study's primary outcome measure will be the patient's change from baseline in self-reported 24-hour average pain intensity. the study will provide active treatment to those participants who received sham therapy in npt-201, and will test whether or not additional therapy applications might further improve pain in those participants who previously received active therapy, but did not achieve adequate pain relief.


Eligibility criteria:
inclusion criteria: * patient must have successfully completed study npt-201 and had an inadequate pain response, defined as \<50% reduction in pain from baseline during participation in npt-201. * patient must provide written informed consent and privacy authorization prior to participation in the study. * female patients of childbearing potential must be willing to use an acceptable method of birth control for the duration of their study participation. acceptable birth control includes a vasectomized partner, contraceptives (oral, parenteral, or transdermal), intrauterine device, or double barrier method including condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream. patients considered not of childbearing potential must be surgically sterile (total hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or greater than one year post-menopausal, defined as a complete cessation of menstruation for at least one year. * patients must be willing to refrain from all excluded therapies for the duration of the study. * in the opinion of the investigator, the patient is willing and able to comply with all protocol-specified requirements. exclusion criteria: * patient has a current significant psychological or psychiatric disorder (e.g., severe, unstable or poorly controlled depression, severe anxiety or obsessive-compulsive disorder. * patient has a score of 2 or 3 on item 9 of the bdi, or, based on the investigator's judgment, the patient is at risk of suicidal ideation or behavior. * patient has resumed treatment with duloxetine, milnacipran, pregabalin, gabapentin, sodium oxybate or prohibited narcotics. * female patient who is pregnant, planning a pregnancy, or breastfeeding. * any anticipated need for surgery that might confound results or interfere with patient's ability to comply with the protocol. * the occurrence of a major protocol violation during the lead-in study indicating a lack of compliance or other significant concern that precludes the patient's ongoing participation.

Keywords: pain
assessment of venous drainage in idiopathic intracranial hypertension

Conditions: Intracranial Hypertension

Summary: intracranial hypertension (iih) is a disorder producing a syndrome of increased intracranial pressure secondary to a compressive intracranial lesion or said to be idiopathic. the most common symptoms are headaches, blindness, pulsatile tinnitus or papillary edema. there are many options for the treatment of iih, especially neurosurgery (derivation of cerebrospinal fluid or stent placement). currently, idiopathic iih has no clear etiology but the hypothesis of sino-venous insufficiency is more and more recognized. the assumption of venous insufficiency has not been demonstrated so far. therefore the investigators propose to demonstrate that cerebral venous drainage pathways are altered in adult patients with idiopathic intracranial hypertension in comparison to healthy individuals having normal circulation. assessment will be performed using magnetic resonance imaging which is part of the patient care.

the investigator working hypothesis is an impairment of the cerebral venous drainage in iih compared to the circulation observed in healthy volunteers considered as the reference. the research will focus on adult patients referred to the imaging department for intracranial hypertension assessment. mri support is common for this type of request the reference will be established in a population of healthy volunteers for whom mri blood flow measurements will be performed. in addition to the primary objective, the investigators assess the impact of iih on csf dynamics the study does not present any risk for the subject, any contraindication to mri examination being respected. the subjects will undergo mri examination including morphological and flow sequences without contrast injection. the flow sequences, in planes located at the c2-c3 and aqueductal levels, will be used to measure vascular flows (venous and arterial) and csf oscillatory volumes. image post-processing will be performed on a semi-automatic software allowing to extract fluid dynamics parameters.

Eligibility criteria:
inclusion criteria: * age : \>18 years old * adult patients referred to the imaging department for intracranial hypertension assessment * adult control subjects without history of cerebral or vascular pathology exclusion criteria: * history of cerebral or vascular pathology for the control subjects * pregnant woman * claustrophobia * major obesity * any contraindication to mri exam

Keywords: intracranial hypertension venous drainage mri blood flow cerebrospinal fluid flow
financial incentives to exercise for adolescents

Conditions: Insulin Resistance; Obesity; Sedentary Lifestyle

Summary: among youth populations, american indians have the highest prevalence of diabetes in the united states. this study will use exercise as the principal lifestyle modification approach to reduce the risk of diabetes in this population. the choctaw nation of oklahoma has several excellent, but underutilized wellness facilities in their health services area in rural southeast oklahoma, a low socioeconomic region. it has been established that exercise lowers diabetes risk, and many overweight/obese, insulin resistant american indian youth who live in this region would benefit from an increase in regular exercise. the challenge is to modify behavior so that routine exercise is established and maintained. the proposed study will test whether monetary incentives can elicit greater frequency and duration of exercise in american indian youth when transportation and access barriers are reduced.

study participants in the intervention arm of the study will be asked to exercise on 3 days per week for 48 weeks. clinical and physical assessments will be performed at baseline and after 16, 32 and 48 weeks. participants will be randomized into one of two groups. each group will receive payment for exercise sessions completed but one group will be on a fixed schedule of compensation and the other will have a schedule that incentivizes frequency or duration of exercise. in addition, two reference groups of age-matched participants who are normal weight and subclassified as having either low or high levels of physical activity and fitness will be tested. the reference groups will complete baseline tests and will not enter the exercise intervention program.

Eligibility criteria:
inclusion criteria for exercise intervention cohort: * 11.0-20.9 years old * overweight or obese * family history of diabetes (primary or secondary relative) * not in sports or exercise program (3 or fewer days per week of moderate-to-vigorous intensity physical activity, mvpa) for prior 3 months * tanner stage 2 or above inclusion criteria for reference group cohort: * 11.0-20.9 years old * normal weight * for low physical activity subgroup: not in sports or exercise program (3 or fewer days per week of mvpa) for prior 3 months * for high physical activity subgroup: \>30 minutes of structured mvpa on \>3 days/week over the preceding 3 months * tanner stage 2 or above exclusion criteria for all participants: * metabolic, endocrine, cardiovascular, kidney disease * orthopedic problems that limit physical activity * medications or treatments that would interfere with the outcomes and interpretations * smoking or tobacco use * alcohol or illicit drug use * pregnancy
westlake precision nutrition study

Conditions: Healthy; Overweight and Obesity

Summary: this is a dietary intervention study, which aims to explore different diet challenges for glucose metabolism, including carbohydrates and intermittent fasting (if) dietary pattern. considering the glucose responses to the same food are largely heterogeneous among people, this study integrates the concepts of precision nutrition and n-of-1 design. the study also aims to explore differences in brain structure and function between participants with different body mass index (bmi) from the perspective of gut-brain axis.

this study aims for precision nutrition. participants will be required to wear continuous glucose monitoring (cgm) for 14 days. the diet intervention will be carried out after wearing cgm on day 1. individual n-of-1 trial design will be employed during day 2 to day 7 to compare the difference of postprandial glucose response to white bread or plain oats. these two breakfasts will appear in alternating order every successive 2 days, and these successive 2 days will be defined as one set. there will be 3 sets during day 2 to day 7. between lunch and dinner will be the wash out period for the remaining effect of the last breakfast intervention on blood glucose homeostasis. in this period, participants will be allowed to choose foods without restrictions, but dietary records are required. the period during day 8 to day 14 is defined as intermittent fasting (if) period, and participants will experience moderate fasting on day 9 and day 13 with total energy intake restrained within 500-600 kcal. in these two fasting days, participants will be provided with daily three meals. investigators will closely monitor participants' latent adverse response and compliance to ensure the intervention will be completed with adequate safety and high compliancy. oral glucose tolerance test (ogtt) will be conducted in the morning of day 8 and day 14 to test the changes of glucose tolerance before and after one set of if intervention. electroencephalogram (eeg) and functional magnetic resonance imaging (fmri) scanning will be conducted as per standard procedure at baseline.

Eligibility criteria:
inclusion criteria: * participants reside in hangzhou * participants have no traveling plans within 3 months exclusion criteria: * refusing or unable to give informed consent * participants with chronic gastrointestinal diseases and take daily relevant medications * participants with metabolic diseases including diabetes, hypertension and cardiovascular diseases (cvd) * participants with craniocerebral trauma, cancer, liver disease, kidney disease, or other critical illness, or history of operation or medication * participants with bulimia nervosa, post-traumatic stress disorder (ptsd), chronic anxiety and depression or other critical neuronal disorder or history of relevant medication * being or to be pregnant or lactating. * participants with history of alcohol or drug addiction, or smoke above 15 cigarettes per day * concurrently participating other clinical trials.

Keywords: glucose metabolism intermittent fasting personalized nutrition brain gut microbiome
pre- and post tavi cognitive functioning and intraoperative carotid flow measurements

Conditions: Cognitive Impairment; Older People--Abuse of; Aortic Stenosis, Severe

Summary: purpose: 1. measuring and optimize the usability of the bamcog (games to measure cognitive functioning) 2. concurrent validation of bamcog with moca to see if bamcog can serve as a monitoring instrument/screener 3. determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements


Eligibility criteria:
inclusion criteria: * \> 65 years old * scheduled for tavi surgery * able to play games on a tablet * for usability part \> moca score of 26 or higher * near native dutch speaker exclusion criteria: * mental disorder (unable to play games) * alcohol abuse (women \ 22 alcoholic drinks/week) * no informed consent * atrial fibrillitation (for ultrasound doppler)
high-dose erythropoietin in extremely premature infants to prevent/attenuate brain injury: a phase ii study

Conditions: Infant, Premature; Erythropoietin; Brain Injury; Intraventricular Hemorrhage; Periventricular Leukomalacia; Neurodevelopmental Outcomes; Randomized Clinical Trial

Summary: the highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability, and without adequate treatment modalities. research in recent years suggest in both animal and human studies that erythropoietin (epo) may have significant neuroprotective effects. given the historical safe medical profile of epo when used for anemia of prematurity but the likely need for a greater dosage regimen for activation of neuroprotective pathways against neonatal brain injury, we therefore propose this phase ii study of high-dose epo in very low birth weight infants for the prevention and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.

eligible extremely premature infants will be enrolled in this double-blind, placebo-controlled randomized trial from the neonatal intensive care unit at morristown memorial hospital (morristown, new jersey). subjects will be enrolled within the first 24 hours of life and randomly assigned to receive epo or saline vehicle placebo. standard nicu care will be provided to all subjects. serial exams, cbc-d, reticulocyte counts, serum epo levels, serial hus, and head mri will be collected at established time points during the study period. at 18 to 22 months corrected age, subjects will undergo a neurodevelopmental evaluation assessing for cerebral palsy, bayley scores of infant development-ii (bsid-ii) mental development index (mdi), bsid-ii psychomotor development index (pdi), bilateral hearing aid use, and visual impairment.

Eligibility criteria:
inclusion criteria: * 500 to 1250 grams at birth * less than 32 weeks gestation at birth * less than 24 hours of life at time of enrollment exclusion criteria: * congenital anomalies (chromosomal, cns, cardiac, gi, pulmonary) * seizures within first 24 hours of life * severe neutropenia (anc \< 500 cells/microl) within first 24 hours of life * polycythemia (hct \> 65%) within first 24 hours of life * thrombocytopenia (platelets \< 50k cells/microl) within first 24 hours of life * hypertension (sbp \> 100mmhg) without vasopressor support within first 24 hours of life

Keywords: extreme prematurity erythropoietin perinatal brain injury intraventricular hemorrhage periventricular leukomalacia neurodevelopmental outcomes randomized clinical trial
effectiveness of bonding-based education intervention

Conditions: Preterm; Bonding

Summary: the study aimed to determine the impact of the father-preterm newborn bonding programme (b-prebap) on fathers' parenting behaviours, stress levels, and support needs. additionally, the study aimed to investigate the effect of b-prebap on the stress levels of preterm newborns.

this study constitutes a part of the doctoral thesis titled "development of father-preterm newborn bonding model".

Eligibility criteria:
inclusion criteria: 1. characteristics of the father; turkish speaking literate 18+ open to communication and co-operation fathers who agree to participate in the study will be included 2. characteristics of the preterm newborn hospitalised in the nicu from the first postnatal day preterm newborns born between 32 and 33 weeks exclusion criteria: 1. characteristics of the father; has a diagnosed psychiatric diagnosis having twin preterm newborns 2. characteristics of the preterm newborn intubated

Keywords: father bonding neonatal intensive care unit
burnout syndrome among anesthesiology residents in turkey: a cross-sectional study

Conditions: Burnout, Professional; Burnout, Psychological

Summary: burnout syndrome is a condition in which an individual experiences loss of self-esteem, chronic fatigue, feelings of helplessness, and hopelessness in their professional work life and human relationships. this study aims to evaluate the prevalence of burnout syndrome among anesthesiology residents working in turkey, analyze the potential causes and adverse consequences of this syndrome's increase, and provide recommendations for its reduction.


Eligibility criteria:
inclusion criteria: * agreed to participate by completing the online survey form * proficient in the turkish language * anesthesiology and reanimation residents currently practicing in the republic of turkey exclusion criteria: • participants who do not provide consent to share the requested information in the survey form
emergency administration of epi-743 to a single patient with leber's hereditary optic neuropathy [lhon]

Conditions: Leber's Hereditary Optic Neuropathy

Summary: expanded access protocol to treat lhon subjects with epi743

emergency use administration of epi-743 to subjects with lhon. this protocol was originally developed to treat a single subject but was expanded to treat several at a single institution.

Eligibility criteria:
inclusion criteria: * emergency treatment for subjects with lhon who are actively losing site in one eye exclusion criteria: * allergy to epi-743 or sesame oil * clinical history of bleeding or abnormal pt/ptt * hepatic insufficiency with lfts greater than 2-times normal * renal insufficiency requiring dialysis * fat malabsorption syndromes * any other concurrent inborn erros of metabolism * severe end-organ hypo-perfusion syndrome secondary to cardiac failure resulting in lactic acidosis * anemia with a hct \<25
preperitoneal umbilical mesh area

Conditions: Ventral Hernia; Umbilical Hernia; Ventral Incisional Hernia

Summary: the aim of this study is to measure the mesh shrinkage and the visualization of the mesh with mri scan at 1 month and 13 months after robot assisted preperitoneal hernia repair using the visible cicat mesh (dynamesh®).

the study will be conducted in the department of surgery in het az maria middelares, ghent, belgium. dr. filip muysoms will personally select and operate all patients eligible for this study. he will inform all patients about the surgery and the follow-up with mri scan thereafter. dr. beckers will perform all mri examinations of the patients at 1 month and 13 months post-operatively and will be available for questions from the patient. we want to show that with this type of mesh it is possible to visualize the preperitoneal placed mesh in a safe manner. furthermore, the positioning of the mesh, mesh shrinkage or mesh shifting will be monitored with this technique. this provides long-term benefit and provides early treatment possibilities in case of post-operative complications related to the mesh position.

Eligibility criteria:
inclusion criteria: * primary umbilical hernias up to 2 cm * incisional hernias limited to zone m3 (ehs classification) and smaller than 2 cm exclusion criteria: * \<18 years * emergency surgery (incarcerated hernia) * clean-contaminated, contaminated or dirty procedures (according to the cdc classification) * lateral hernias * hernias close to the sternum or the pubic bone * hernias bigger than 2 cm in diameter. * hernias that need a component separation technique. * previous mesh repair on the midline * asa score\> 4 * pregnancy * no patient informed consent * life expectancy of less than 2years * contraindications for mri

Keywords: mesh shrinkage abdominal wall surgery
the cryoice™ cryoanalgesia study for pain management in post thoracic procedures via intercostal cryoanalgesia (frost)

Conditions: Pain

Summary: the investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoice® probe (atricure®, inc., 7555 innovation way, mason, ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.

completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.

Eligibility criteria:
inclusion criteria: * age 18 - 85 years male or female * patients undergoing unilateral thoracotomy cardiac procedures (with the exception of aortic aneurysm repair as sole treatment) * acceptable surgical candidate, including use of general anesthesia * willing and able to provide written informed consent * willing and able to return for scheduled follow-up visits exclusion criteria: * cardiac valve surgical procedure via conventional full sternotomy * procedures that require a posterolateral thoracotomy * current pregnancy * current use of prescription opioids * fev1 \< 40% predicted * documented myocardial infarction within 30 days of signing informed consent form (icf) * documented psychiatric disease * documented chronic pain syndrome * documented history of substance abuse * patient currently enrolled in another research study that could directly affect results of either study * physical or mental condition that would interfere with patient's self-assessment of pain * disqualifying medical condition per investigator

Keywords: cryoanalgesia thoracotomy forced expiratory volume (fev1) visual analog scale (vas)