Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety, tolerability, and pharmacokinetics of oral abp-745 administration in healthy volunteers

Conditions: Gout

Summary: a randomized, double-blind, placebo-controlled, dose-escalation study will be conducted in healthy volunteers. this study will evaluate the safety, tolerability, and pharmacokinetics (pk) of abp-745 following single (part 1) and multiple (part 2) oral doses.


Eligibility criteria:
inclusion criteria: * healthy male or female volunteers, aged 18 and 55 years (inclusive) at the time of signing the informed consent form (icf). * body mass index (bmi) range within 18 \~ 30 kg/m2 (inclusive), and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female. * generally healthy based on medical history, physical examination, vital signs, 12-lead ecg, and clinical laboratory tests. * female volunteers of child-bearing potential must agree to use effective contraceptive methods from the screening period to 90 days after the last dose of the investigational product (ip). exclusion criteria: * difficulties in venous blood collection or history of dizziness when encountering blood or needles. * has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 times half-life (whichever is longer) prior to the first dose of ip. * has a history of gastrointestinal (such as duodenal ulcer, alimentary tract hemorrhage, gastro esophageal reflux disease (gerd), etc.), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs as determined by the investigator (or sub-investigator). * has the medical history (including past and present) of other significant diseases (including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological, endocrinological and metabolic disease, immunological, dermatological, malignant diseases, mental and nervous systems, and other related diseases) or any other disease/ailment at the discretion of the investigator (or sub-investigator). * any medication (prescription and nonprescription) within 14 days or 5 times the half-life (whichever is longer) prior to the first dose of ip. (excluding oral contraceptives, or topical ointments at the discretion of the investigator (or sub-investigator)). * a known history of drug abuse within 2 years before the screening; or positive drug abuse test at screening. * blood donation or blood loss of more than 400 ml within 3 months before the screening. * smoking history (≥ 5 cigarettes per day) within 3 months before the screening, or cannot abstain from any tobacco products during the study. * positive screening test for human immunodeficiency virus (hiv) antibody, hepatitis b surface antigen (hbsag), hepatitis b core antibody (hbcab), or hepatitis c virus (hcv) antibody.

Keywords: tophi, gout flares, gout chronic pain
transcranial direct current stimulation therapy for bipolar depression

Conditions: Depression, Bipolar; Bipolar Disorder; Mood Disorders; Mental Disorder

Summary: bipolar disorder is a severe and disabling disorder. the course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. the most common treatments are medications. however, for many individuals, combinations of medications are often required, and full recovery is infrequent. the novel brain stimulation treatment, transcranial direct current stimulation (tdcs), is a potential first-line treatment for bipolar depression. the present research question is whether tdcs can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.

the novel brain stimulation treatment, transcranial direct current stimulation (tdcs), is a potential first-line treatment for bipolar disorder. tdcs generates a small electric current which modulates how easy it is for active brain cells to discharge. the device is a headband worn over the forehead with two electrodes, which are small metal discs, where the current comes from. tdcs does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ect) and it does not induce brain cells to discharge like transcranial magnetic stimulation (tms). clinical studies have shown that tdcs treatment could help to improve the symptoms of depression. the main side effects have been redness, skin irritation or sensations (itching, tingling or burning) under the electrodes. less commonly reported side effects include headache or tiredness. tdcs is a portable and safe treatment. the studies to date have mostly looked at tdcs treatment which has been provided in a research setting. this is a problem because the treatment requires daily sessions for several weeks which could limit whether individuals would be able to go every day. as tdcs is a portable and safe treatment, it could be provided in the community. the present study is a proof-of-concept trial to assess the efficacy, acceptability and safety of tdcs treatment for bipolar depression within a community-based setting.

Eligibility criteria:
inclusion criteria: * diagnosis of bipolar disorder based on dsm-5 criteria * minimum score of 18 on the madrs * being on a stable dosage of mood stabilizing medication for a minimum of two weeks exclusion criteria: * comorbid psychiatric disorder * significant risk of suicide or self harm * any contraindications to tdcs, including implanted electronic medical devices * history of epilepsy
study to evaluate the effect of voxelotor administered orally to patients with sickle cell disease (gbt_hope)

Conditions: Sickle Cell Disease

Summary: a phase 3, double-blind, randomized, placebo-controlled, multicenter study of voxelotor administered orally to patients with sickle cell disease

this is a randomized, placebo-controlled, double blind, parallel group, multicenter study of participants, age 12 to 65 years, with scd. the key purpose for the study is to establish efficacy and safety of voxelotor as compared with placebo.

Eligibility criteria:
inclusion criteria: 1. male or female study participants with sickle cell disease 2. participants have had at least 1 episode of vaso-occlusive crisis (voc) in the past 12 months. 3. age 12 to 65 years 4. hemoglobin (hb) ≥5.5 and ≤10.5 g/dl during screening 5. for participants taking hydroxyurea (hu), the dose of hu (mg/kg) must be stable for at least 3 months prior to signing the icf. exclusion criteria: 1. more than 10 vocs within the past 12 months that required a hospital, emergency room or clinic visit 2. patients who are receiving regularly scheduled blood (rbc) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or have received a rbc transfusion for any reason within 60 days of signing the icf 3. hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the icf (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the icf) 4. hepatic dysfunction characterized by alanine aminotransferase (alt) \>4 × upper limit of normal 5. severe renal dysfunction (estimated glomerular filtration rate at the screening visit; calculated by the central laboratory) \<30 ml/min/1.73 m\^2 or on chronic dialysis
olfactive stimulation interventions with mothers' milk on preterm pain response

Conditions: Pain, Acute; Preterm Infant; Breast Milk

Summary: repeated and untreated pain can lead to long-term consequences in preterm infants, such as pain hypersensitivity and impaired motor and intellectual development. studies on the pharmacological and non-pharmacological interventions for pain management in preterm infants are limited. thus, we investigated an intervention based on olfactive stimulation with mothers' milk. the aims of this study are: a) evaluate the effectiveness of an olfactive stimulation intervention with mothers' milk odor on preterm procedural pain; b) evaluate the effectiveness of adding a period of familiarization previous to the olfactive stimulation intervention with mothers' milk odor on preterm procedural pain. preterm infants will be recruited and randomly assigned to three groups 1) mothers' milk odor during the nine hours before and during heel-prick, 2) mothers' milk odor during heel-prick, 3) standard care. pain will be measured using a scale of pain adapted for preterm infants. this procedure with mothers'milk odor is inexpensive and easily performed.this study will significantly contribute to the advancement of knowledge on preterm infants pain management.


Eligibility criteria:
inclusion criteria for mothers * 18 years or older, * speak, understand and write french or english * express their milk exclusion criteria for mothers - pathology or condition that contraindicates the use of their breast milk (hiv, drugs...) inclusion criteria for preterm * 29 to 36 weeks of gestation * apgar \> 6 at 5 minutes * less than 21 days exclusion criteria for preterm * intubated, under continuous positive airway pressure or nasal oxygen, * surgery in the first day of life * congenital disease * intraventricular hemorrhage \> grade ii * leukomalacia * sedation within 48 hours prior to heel prick * pharmacologic treatment for pain within 12 hours prior to heel prick * being under phototherapy treatment during the familiarization stage
validity and reliability in measuring iliotibial tract by using ultrasound

Conditions: Knee Injuries

Summary: the purpose of this study is to estimate the validity and reliability in measuring the iliotibial tract by using ultrasound.


Eligibility criteria:
inclusion criteria: * patients with knee injuries who need magnetic resonance imaging (mri) evaluation exclusion criteria: * patients who have an iliotibial tract lesion

Keywords: iliotibial tract
the significance of defensin alpha 4 in the pathophysiology of the adrenal insufficiency in inflammatory lung diseases

Conditions: Adrenal Insufficiency; Inflammatory Lung Diseases

Summary: the pathophysiology of the adrenal insufficiency of patients with critical diseases remains unclear. in a prior exploratory study investigating patients with exacerbation of chronic obstructive pulmonary disease (copd), the investigators demonstrated a highly significant correlation between the expression level of defensin-alpha 4 (defa4) mrna in blood and the adrenal function assessed via low-dose acth tests. the aim of this prospective study is to demonstrate that defa4 measured both at the mrna level (rt-pcr) and at the protein level (western blot/elisa) is a reliable biomarker for the prediction of adrenal insufficiency in inflammatory lung diseases (patients with copd and pneumonia).


Eligibility criteria:
inclusion criteria: * patients 18-80 yo * patients diagnosed with pneumonia or exacerbated copd * healthy controls 18-80yo * signed informed consent exclusion criteria: * pregnant or lactating females * life threatening severe disease * known primary or secondary adrenal insufficiency * systemic steroid therapy in the last 8 weeks * systemic therapy with opioid * systemic therapy with ketoconazol, mitotane, metopyron, etomidat, rifampicin * in healthy controls: relevant respiratory disease or known adrenal insufficiency or indication of infection * allergic reaction to acth * missing informed consent

Keywords: demonstrate that defa4 is a reliable biomarker for the prediction of adrenal insufficiency
remote intervention for weight regain after sleeve gastrectomy

Conditions: Obesity

Summary: the study is designed to assess the effect of a 3-month remote comprehensive intervention program by a multidisciplinary team combined with mobile supportive text messages aimed to raise the level of happiness and subjective wellbeing, on weight outcomes and physical and behavioral parameters among bariatric surgery patients after sleeve gastrectomy who had a weight regain of ≥10% from nadir, compared to a control group which will receive standard care of a single meeting with the study's registered dietitian at the clinic and then be advised to continue follow up.

one hundred patients will be recruited to the study and randomized to intervention or control group. the comprehensive 3-month remote intervention program by the multidisciplinary study team includes 6-weeks of online meetings with the study registered dietitian, sleep and physical activity consultants, followed by another 6-weeks of online meetings with the study rd, overall 12 weeks containing a total of 12 remote consultations (6 dietitian, 3 physical activity consultant, 3 sleep consultant). in addition, the intervention group will receive weekly text messages to their mobile phone, meant to enhance happiness and subjective wellbeing. the control group will receive standard care of a single meeting with the study's registered dietitian at the clinic including nutrition and behavioral recommendations and then advised to continue follow up, engage in physical activity and general lifestyle recommendations. both groups will undergo comprehensive tests at baseline and at the end of intervention after 3 months. patients from both groups who will arrive to the follow-up appointment after 3 months will receive a participation reward which will include a gift card on the sum of 154 nis for purchasing a multivitamin package for bariatric patients. finally, 3 and 6 months after intervention completion, self-reported data will be collected via phone calls including weight, physical activity (type, times per week and duration per time), professional follow up and adherence to bs recommendations.

Eligibility criteria:
inclusion criteria: * age at the time of bs ≥18 years * patients who underwent primary sg at least 2 years ago and regained at least 10% weight from nadir. * read and speak hebrew. exclusion criteria: * patients who underwent more than one bs in their past. * use of weight loss drug therapy currently or 1-month prior to trial entry. * currently attending a weight loss program and lost more than 5% of weight at the last month. * current pregnancy and women who gave birth in the last 6 months. * medical contraindications such as active cancer, organ transplant or unbalanced psychiatric disorders.

Keywords: bariatric surgery weight gain telemedicine
french observatory of familial hypercholesterolemia in cardiology

Conditions: Familial Hypercholesterolemia

Summary: the family hypercholesterolemia remains poorly diagnosed disease with an outlet sometimes suboptimal care. however, the family hypercholesterolemia exposes patients concerned at increased cardiovascular risk. the frequency of familial hypercholesterolemia in cardiologic is little studied and remains unknown, and there is little data on the profile of patients, diagnostic methods and management. main objectives: * establish a monitoring patients with hypercholesterolemia family cardiology in france * characterize the family hypercholesterolemia in cardiology, including assessing the frequency of the most severe forms, which are at higher cardiovascular risk.


Eligibility criteria:
inclusion criteria: * coronary patients * who agreed to participate * high ldl-c levels: \* ldl-c\> = 1.9g / l without lipid lowering treatment according to the diagnostic score of family hypercholesterolemia these coronary patients with ldl\> 1.9g / l may possibly or probably be achieved hypercholesterolemia family. or \* ldl-c\> = 1.6g / l in lipid-lowering treatment, the reduction of ldl-c average expected under standard lipid-lowering therapy (statin alone) being 30-40% of these patients had therefore pretreatment levels greater than 2 g / l or greater than 2.5 g / l and may possibly or probably be achieved family hypercholesterolemia after the diagnostic score. exclusion criteria: * expressed refusal to participate in the observatory * age ≤ 18

Keywords: cardiology family hypercholesterolemia
esophagus deviation during radiofrequency ablation of atrial fibrillation - easy af study

Conditions: Atrial Fibrillation

Summary: to assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.


Eligibility criteria:
inclusion criteria: * male or female age ≥ 22 years and \< 80 years * clinical decision to proceed with af ablation procedure. * ablation procedure to be completed with general anesthesia * ablation procedure to be completed with use of radiofrequency catheter ablation exclusion criteria: * history of various esophageal pathology such as esophageal achalasia, varices, strictures, web, carcinoma, tumor/mass, scleroderma, mallory-weiss tear, barrett's esophagitis, diverticulum, banding, laceration, perforation, balloon dilatation. * presence of a ph probe deployed in the esophagus * planned af ablation procedure to be completed with laser energy or with cryo-energy * acute or uncontrolled psychiatric illness * unable to undergo upper endoscopy * enrollment in another fda clinical trial * unstable medical condition(s) that precludes safely completing study protocol * subject is incarcerated * subject is pregnant * subject is unable to comprehend the details of the study * the investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the investigational device procedure and study-related follow up visit requirements
characterization of the sleep-wake cycle in traumatic brain injury patients with a disorder of consciousness

Conditions: Trauma, Nervous System; Brain Trauma

Summary: each year in france, 160,000 peoples suffer from a mild or severe traumatic brain injury (tbi). sleep plays a crucial role in the process of brain plasticity, which is essential for neurological and cognitive recovery. however, the sleep-wake cycle is rarely, if ever, evaluated in patients with tbi and consciousness disorders within post-resuscitation rehabilitation units (srpr). caregivers develop, on a daily basis, an intuitive understanding of the patient's overall condition. this expertise deserves to be validated using objective sleep assessment tools (actigraphy). if proven accurate, it could lead to the implementation of a sleep-wake cycle evaluation protocol within srprs.


Eligibility criteria:
inclusion criteria: * admission to the post-resuscitation rehabilitation unit or the neurological intensive care unit * consciousness disorders: vegetative state or minimally conscious state (according to the crs-r) * traumatic brain injury * patient aged 18 years or older * presence of relatives able to express non-opposition to the study * subjects affiliated with a social security scheme (or beneficiaries) exclusion criteria: * admission for status epilepticus * individuals admitted to a healthcare or social care facility for purposes other than research * adults under legal protection measures (guardianship, conservatorship) * individuals not affiliated with a social security scheme or not benefiting from a similar scheme

Keywords: traumatic brain injury disorders of consciousness vegetative state minimally conscious state
safinamide renal impairment trial

Conditions: Renal Impairment

Summary: the primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the compound in the body) of safinamide in subjects with different degrees of renal impairment in comparison to matched subjects with normal renal function.


Eligibility criteria:
inclusion criteria: 1. renally impaired subjects - subject with different degrees of renal impairment: moderate and severe renal impairment as assessed by estimated glomerular filtration rate (egfr) according to modification of diet in renal disease (mdrd) equation at screening 2. healthy subjects - subject is in good age-appropriate physical and mental health as established by medical history, physical examination, electrocardiogram (ecg) and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to dosing 3. all subjects have given written informed consent before any study-related activities are carried out exclusion criteria: 1. any other clinically relevant disease, condition, or therapy, which in the investigator's opinion would exclude the subject from the trial, may pose a risk to the subject or interfere with the trial objectives. 2. existence of surgical or medical condition, which, in the judgment of the investigator, might interfere with the absorption, metabolism, or excretion of the drug and/or gastrointestinal motility 3. renally impaired subjects - acute renal failure of any etiology (including viral, toxic, or drug induced), renal transplantation within the previous 12 months, uncontrolled diabetes mellitus as judged by the investigator, use of any drug affecting gastric acid secretion, such as proton pump inhibitors and antacids received within 48 hours prior to drug administration and for 24 hours after administration, chronic heart failure (chf) new york heart association (nyha) class iii and iv despite treatment at screening, change in used medication (prescribed by a physician or over-the-counter \[otc\] medication) within 14 days prior to safinamide administration. concomitant medication used for the treatment of renal impairment and accompanying diseases may be continued during the trial. 4. healthy subjects - use of any medication, including multi-vitamin preparations, received within 21 days prior to drug administration (or within six times the elimination half-life, whichever is longest), except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before trial drug administration.

Keywords: safinamide pharmacokinetics renal impairment moderate and severe renal impairment
dose escalation with remicade® and orencia®

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to describe infliximab and abatacept dosing patterns (i.e., dosing amount and frequency) and costs among a population of managed care enrollees with ra. this study will also identify changes in infliximab and abatacept dosing over time and the implication these changes may have on the costs of medication administration.

this study will be conducted in two parts. the primary analysis is a longitudinal analysis, where patients' health care claims from a period during which the patient was continuously enrolled in the health plan will be used to evaluate the primary outcome (i.e., dose escalation). the second analysis will be cross-sectional, where patients' health care claims from a fixed period of time (i.e., 2008) will be used to examine health care cost. the final enrollment for the longitudinal portion of the study was 2,001 (1,306 infliximab and 695 abatacept patients). final enrollment for the cross-sectional portion was 3,450 (2,646 infliximab and 806 abatacept patients). there may be some overlap in these numbers.

Eligibility criteria:
inclusion criteria: * commercial health plan enrollees with medical and pharmacy coverage * at least 3 claims on separate days for infliximab (hcpcs j1745) or abatacept (hcpcs c9230, j0129, j3590) administration during the subject identification period * the 3 initial claims for abatacept occurred within a 6-week period inclusive of the index date and the three initial claims for infliximab occur within a 9-week period inclusive of the index date * presence of a diagnosis of ra (icd-9-cm 714.xx) * continuous enrollment during the baseline and follow-up periods * at least 18 years of age or older on the index date exclusion criteria: * prior exposure to the index medication during the baseline period * diagnosis of psoriasis (icd-9-cm 696.1), psoriatic arthritis (696.0), ankylosing spondylitis (720.0), crohn's disease (555.x), or ulcerative colitis (556.x) in any position at any time during the study period * exposure to alefacept (hcpcs j0215, c9211, c9212) or efalizumab (hcpcs s0162) at any time during the study period