Kornimate/medical-research-clean huggingface dataset:
hidradenitis suppurativa phase 2b study of izokibep

Conditions: Hidradenitis Suppurativa

Summary: izokibep is a potent and selective inhibitor of interleukin 17a (il-17a) that is being developed for treatment of hidradenitis suppurativa (hs). this study will evaluate the efficacy, safety, and immunogenicity of izokibep administered subcutaneously (sc) in adult subjects with moderate to severe hs.


Eligibility criteria:
inclusion criteria: general * subject has provided signed informed consent including consenting to comply with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. * 18 years to 75 years of age type of subject and disease characteristics * diagnosis of hidradenitis suppurativa (hs) for ≥ 1 year prior to first dose of study drug. * hidradenitis suppurativa lesions present in ≥ 2 distinct anatomic areas, one of which is hurley stage ii or iii. * a total abscess and inflammatory nodule (an) count of ≥ 5 at screening and day 1 prior to enrollment/randomization. * subject must have had an inadequate response to oral antibiotics or exhibited recurrence after discontinuation to, or demonstrated intolerance to, or have a contraindication to oral antibiotics for treatment of their hs. * must agree to use daily over-the-counter topical antiseptics. * subject must be willing to complete a daily skin pain diary for at least 3 days prior to day 1 visit. exclusion criteria: medical conditions * draining fistula count of \> 20. * outpatient surgery ≤ 8 weeks prior or inpatient surgery ≤ 12 weeks prior to enrollment/randomization. * other active skin disease or condition that could interfere with study assessments. * chronic pain not associated with hs. * uncontrolled, clinically significant system disease. * history of demyelinating disease or neurological symptoms suggestive of demyelinating disease. * malignancy within 5 years. * the subject is at risk of self-harm or harm to others. * active infection or history of certain infections. * tuberculosis or fungal infection seen on available chest x-ray taken ≤ 3 months of screening or at screening (exception: documented evidence of completed treatment and clinically resolved). * known history of human immunodeficiency virus (hiv). other protocol defined inclusion/exclusion criteria may apply.

Keywords: hidradenitis suppurativa izokibep
long term follow-up of pegylated-interferon alpha-2b

Conditions: Chronic Hepatitis B

Summary: the aim of this study was to investigate the long term outcome of peginterferon alpha-2b with or without the addition of lamivudine in patients with chronic hepatitis b

interferon alpha therapy is a generally accepted agent for the treatment of chronic hbv infection and effective in about one third of patients. recently, in the hbv 99-01 study, pegylated interferon alpha-2b (peg-ifn) has been shown to be effective in hbeag-positive patients with chronic hepatitis b. in this study, 266 patients were randomized to receive peg-ifn in combination with either lamivudine or placebo for 52 weeks. thirty-six percent of patients receiving monotherapy and thirty-five percent receiving combination therapy had lost serum hbeag at the end of the 26 week post-treatment follow-up period and there was no difference between treatment groups (p = 0.91). more patients on combination therapy initially seroconverted (44% of patients, compared with 29% on monotherapy; p = 0.01) at the end of treatment but relapsed during follow-up. similar response patterns were seen when response was assessed by dna suppression and change in alt levels. in contrast to nucleoside analogues, such as lamivudine and adefovir dipivoxil, the virological and biochemical response to standard alpha-interferon has been shown to be durable after treatment discontinuation.in addition, standard alpha-interferon leads to improved survival and reduction of hepatocellular carcinoma in chronic hepatitis b patients.pegylated interferons have shown to be effective in hbeag-positive chronic hepatitis b patients, but the durability of the response and long-term outcome of treatment have yet to be established.

Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis b who participated in the hbv 99-01 study

Keywords: chronic hbv peginterferon long term follow-up
safety and efficacy of remote ischemic conditioning treatment for community-based essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

at present, stroke has become the leading cause of death in china, with hypertension being the primary risk factor and one of the controllable risk factors. current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. thus it may exert anti-hypertensive effects through multiple mechanisms. the purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Eligibility criteria:
inclusion criteria: 1. age≥40 years, ≤ 75 years, regardless of sex; 2. having the history of essential hypertension and the systolic blood pressure of at least 140 mm hg on two consective days; 3. signed and dated informed consent is obtained exclusion criteria: 1. blood pressure ≥ 180/110mmhg; 2. planned adjustment of antihypertensive drugs in the next month; 3. severe hematologic disorders or significant coagulation abnormalities; 4. individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc; 5. pregnant or lactating women; 6. severe hepatic and renal dysfunction, or alt/ast \>3 times upper limit of normal, or serum creatinine \>265umol/l (\>3mg/dl); 7. patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial; 8. patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.

Keywords: essential hypertension, remote ischemic conditioning
the effect of dydrogesterone on sexual function in women with endometriosis

Conditions: Endometriosis; Sexual Dysfunction

Summary: this study aimed to assess the effects of dydrogesterone on sexual function in women with endometriosis using female function sexual index (fsfi).

sexual dysfunction is an important outcome for patients with endometriosis. in this study, we compare the fsfi (female sexual function index) questions and the scores before and after dydrogesterone treatment in patients with endometriosis. we aim to measure the effect of dydrogesterone in patients with endometriosis.

Eligibility criteria:
inclusion criteria: * no history of malignancies, * normal findings at gynecological examinations and transvaginal ultrasonography * normal uterine size, normal cervical smear results, * patients not use any contraception methods in the last 6 months exclusion criteria: * with a history of systemic and/or psychiatric diseases, * gynecological pathologies (myoma uteri, endometriosis, uterine anomalies, existing genital infections) * pelvic organ prolapse * pelvic surgeries
a 6-week study to evaluate the safety and efficacy of quillichew erct in 4-5 year old children with adhd.

Conditions: Attention Deficit Hyperactivity Disorder (ADHD); Attention Deficit Hyperactivity Disorder

Summary: a 6-week double-blind study to evaluate the safety and efficacy of quillichew extended release chewable tablets in 4-5 year old children with attention deficit hyperactivity disorder.


Eligibility criteria:
inclusion criteria: 1. male or female child 4-5 years of age at baseline. 2. signed and dated informed consent document. 3. meets dsm-v criteria for adhd based on the k-sads-pl. 4. adhd rs-iv preschool home version score at screening and baseline \>/= 90th percentile for gender and age in \>/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score. 5. peabody picture vocabulary test 4 (ppvt4)standard score \>/=70. 6. child global assessment scale (cgas) score \</= 55. exclusion criteria: 1. treated with atomoxetine within 30 days prior to the baseline. 2. received any investigational products or devices within 30 days prior to the baseline visit. 3. history of stimulant nonresponse, intolerability or hypersensitivity to any dose of quillichew erct or other stimulant. 4. an intelligence quotient (iq) \<70. 5. history of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality. 6. less than 5th percentile for height or weight at screening. 7. history of recent clinically significant self-harming behaviors.
b vitamin status in premature and small for gestational age(sga) infants

Conditions: Biochemical Cobalamin Status; Motor Neurodevelopment

Summary: premature birth and low birth weight implies insufficient intrauterine growth and fetal malnutrition. during the first months of life where the infant is breastfed, the low stores aquired during fetal life, may cause specific b vitamin deficiencies. in this study infants with a birth weight below 3000 g will be studied at 6 weeks, 4 and 6 months. at 6 months infants with biochemical signs of impaired cobalamin status (i.e.: thcy \> 97.5 percentile for cobalamin treated infants, i.e.: thcy\>6.5 µm/l) will be randomised to cobalamin treatment or placebo. at 7 months the investigators will evaluate the effect of cobalamin or placebo treatment according to infant biochemical status and neurodevelopment. study hypothesis: cobalamin treatment given to infants with biochemical cobalamin deficiency will normalize biochemical status and cause improved motor neurodevelopment.


Eligibility criteria:
inclusion criteria: * birthweight \< 3000 grams * age 6 months (+/- 0.5 months) * plasma total homocysteine \> 6.5 umol/l exclusion criteria: * plasma total homocysteine \< 6.5 umol/l
cerebral oximetry in lower body negative pressure

Conditions: Hypovolemia

Summary: the study aims to describe hemodynamic effects of lower body negative pressure (lbnp). 1. if and how changes in cerebral oxygen saturation (sto2) measured by near infrared spectroscopy (nirs) relate to changes in blood flow in the carotid arteries during progressive lbnp. 2. if and how mean systemic filling pressure (msfp) can be measured by brief occlusion of blood flow to an arm and if this relates to lbnp-level. 3. if and how pulse pressure variations and photoplethysmographic amplitude variations during positive expiratory pressure (pep) and continuous positive airway pressure (cpap) relate to lbnp-level.

20 healthy volunteers will be included. the study protocol consists of two parts. 1. lbnp is applied stepwise (20 mmhg increments). at each lbnp-level, after 2 min stabilization, blood flow in internal and external carotid arteries is measured. thereafter, msfp is measured. lbnp is applied to -80 mmhg, but terminated sooner if the subject experiences signs of decompensation. changes in cerebral sto2 will be related to relative changes in blood flow in the carotid arteries. after these measurements, blood flow to one arm will be occluded for 30 s. venous pressure measured in an antecubital vein approximates msfp. this will be related to volume status (lbnp-level and stroke volume reduction). 2. lbnp is applied stepwise (20 mmhg increments). at each lbnp-level, after 2 min stabilization, pep and cpap are applied at 0, 5 and 10 cmh20. lbnp is applied to -80 mmhg, but terminated sooner if the subject experiences signs of decompensation. flow in carotid arteries is measured by ultrasound/doppler. skin blood flow in the forehead measured by laser doppler flowmetry and transcutaneous oxygen saturation. if possible, blood flow velocity in a. cerebri media will be measured by transcranial doppler. central venous pressure will be approximated by measuring pressure in the left subclavian vein ("half-way" catheter). cardiac stroke volume will be measured by suprasternal doppler. expiratory carbon dioxide (co2) will be measured and recorded. acral skin photoplethysmography performed using proprietary and custom-made photoplethysmographs. arterial blood pressure approximated by finger volume-clamp method. the measurements above will be used for analyses of possible physiological mechanisms and post-hoc analyses.

Eligibility criteria:
inclusion criteria: * healthy volunteer (informed consent) exclusion criteria: * disease/physical condition limiting normal physical activity or requiring medication (except allergies/contraceptives) * history of syncope (except with obvious vasovagal etiology) * cardiac arrhythmia * pregnancy * skin infections in the elbow crease
testing of insti™ hiv-1 antibody test kit in volunteer subjects at risk for hiv infection

Conditions: HIV Infections

Summary: each year up to 22 million persons in the us are tested for hiv. currently available "rapid" tests do not provide test results for at least 30 minutes from the collection of serum and plasma from the subject. providing accurate test results in less than a minute would make it easier to make timely decisions about treatment and counselling. this study will compare results of an experimental rapid test to existing standards to determine if the test can reliably and accurately diagnose hiv in less than one minute.

the primary objective is to determine if insti™ performed with finger-stick whole blood, venous whole blood, and plasma demonstrates at least 98.0% sensitivity and specificity compared to an fda-approved hiv testing algorithm. the study will have two parts. the first part of the study will be conducted in institutions where hiv testing is routinely performed and where hiv counseling is offered \[i.e. point of care (poc) centers\]. the second part of the study will be conducted in a central laboratory that routinely conducts laboratory-based hiv testing using an fda-licensed hiv-1 elisa and western blot test. geographically diverse pocs will be selected in the usa. approximately 15-20 pocs are planned. approximately 2,500 subjects will participate in the study including 1,500 subjects with unknown hiv status and 1,000 seropositive subjects. across these poc sites, voluntary testing of 1500 subjects with unknown hiv status is planned with at least 500 of these subjects being high risk. samples will be obtained from consenting subjects in the voluntary testing population including high-risk and known hiv 1 seropositive individuals. each subject is to receive an insti™ on finger-stick blood and parallel hiv testing of edta-treated venous whole blood and plasma samples will be conducted at a central laboratory. the results of insti™ will not be given to the subject. the subject will be given the results of the poc hiv test only, per their standard of care procedures. subsequent subject care decisions will not be based on the results of insti™.

Eligibility criteria:
inclusion criteria: * unknown hiv status who are undergoing voluntary testing for hiv infection in a poc clinic setting or known hiv seropositive subjects willing to be re-tested. * ability to give proper informed consent, or have legal parent or guardian provide consent. * willingness to participate in a poc standard of care hiv counseling and testing program and receive poc standard of care test results * willingness to provide the necessary volume of whole blood collected through venous blood draw and finger stick (approximately 10 ml) exclusion criteria: * subject self-report of history of multiple myeloma * subject self-report of history of long-term anti-retroviral therapy with known low or non-existent antibody titre (sero-inversion)

Keywords: hiv 1 aids assay rapid test hiv-1 hiv seronegativity
clinical trial to evaluate the efficacy and safety of ckd-333 tablet

Conditions: Hypertensive Patients With Dyslipidemia

Summary: to evaluate the efficacy and safety of ckd-333

a randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of ckd-330 and d086 combination therapy in hypertensive patients with dyslipidemia

Eligibility criteria:
inclusion criteria: 1. patients with a mean sitting systolic blood pressure (mssbp) ≥ 140 mmhg measured on selected arms after run-in period 2. lipid levels measured after run-in period were: * group 1: hypertension + dyslipidemia only → fasting ldl-c ≥ 160 mg / dl * group 2: hypertension + dyslipidemia + cardiovascular risk factor more than 1 → fasting ldl-c ≥ 130mg / dl * group 3: hypertension + dyslipidemia + coronary artery disease or equivalent or 10-year risk assessed by framingham point score greater than 20% → fasting ldl-c ≥ 100 mg / dl exclusion criteria: 1. patients whose blood pressures measured at visit 2 were: * patients with mssbp ≥ 180 mmhg and / or msdbp ≥ 110 mmhg 2. patients who had lipid levels measured at visit 2 * patients with fasting ldl-c \ 250 mg / dl and / or tg ≥ 500 mg / dl
pronostic value of type i anti-interferon antibodies in patients with covid-19 acute respiratory failure

Conditions: Acute Respiratory Failure

Summary: severe sars-cov-2 infections are frequently associated with the acute respiratory distress syndrome (ards), which leads to a mortality of 30-40%. an altered type i interferon (ifn) response has been demonstrated in patients with severe covid-19, together with a high viral load. the aim of the current work is, in a large cohort of patients with severe covid-19 admitted in the icu, to determine the prevalence of patients with positive anti-ifn antibodies and to determine their outcome, as compared to patients having negative anti-ifn antibodies.

severe sars-cov-2 infections are frequently associated with the acute respiratory distress syndrome (ards), which leads to a mortality of 30-40%. an altered type i interferon (ifn) response has been demonstrated in patients with severe covid-19, together with a high viral load. a recent study revealed that 10% of patients admitted in the intensive care unit (icu) for severe covid-19 had positive type i anti-ifn antibodies. such finding has potentially important therapeutic implications, as patients having positive anti-ifn antibodies could benefit from targeted interventions, including plasmapheresis. the aim of the current work is, in a large cohort of patients with severe covid-19 admitted in the icu, to determine the prevalence of patients with positive anti-ifn antibodies and to determine their outcome, as compared to patients having negative anti-ifn antibodies.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * sars-cov-2 infection with a positive pcr * patient admitted in the icu for acute respiratory failure (spo2≤90% and need for supplemental oxygen or any kind of ventilator support) * patient or next of keen was informed of study inclusion exclusion criteria: • patient with sars-cov-infection but no acute respiratory failure

Keywords: covid-19 acute respiratory failure ards
assessment of the impact of rna genomic profile on treatment decision-making in her2 equivocal breast cancer patients

Conditions: Breast Cancer

Summary: the american society of clinical oncology (asco) and the /college of american pathologists (cap) recommend that her2 status (negative or positive) must be determined in all patients with invasive breast cancer. the knowledge of her2 status will help the oncologist in prescribing or not a her2-targeted therapy to patients. presently, two main methods are used to assess her2 status: immunohistochemistry (ihc, protein expression) and in situ hybridization (ish, gene expression) in order to classify tumor sample as positive, negative or equivocal. when a tumor is classified her 2+ by ihc method, a second test is performed using ish methods (fish, sish, cish). in case of her2 equivocal result with ish method (4 ≤her2 gene number copy \<6), the patient is eligible to an anti-her2 therapy after discussed during md-mm. this decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence. based on molecular classification, rna expression could help to discriminate breast cancer subtypes (luminal a, luminal b, her2-overexpressed and triple negative). prosigna is a genomic test, developed by nanostring® based on the pam50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the her2 status. this study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a her2 equivocal population. in addition, concordance tests will be performed. the aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in her2 equivocal patients using genomic testing.


Eligibility criteria:
inclusion criteria: * performance status ≤ 2 (according to who criteria) * patient with early invasive breast cancer histologically confirmed stage i to iiia) * positive or negative lymph node involvement * positive or negative hormonal receptors (estrogens and/or progesterone), * equivocal her2 status (ihc score 2 and equivocal ish defined as her2/chr17 ratio \<2 and 4 ≤ her2 gene number copy \< 6) as assessed on surgical specimen * adequate hematological, hepatic, renal and cardiac functions * patient potentially eligible for an anti-her2 therapy * patient eligible to receive an adjuvant therapy * signed informed consent * patient with social insurance. exclusion criteria: * non-measurable tumor * unknown hormonal receptors * unknown node involvement * positive or negative her2 status (score 0, 1 or 3 ihc, or negative or positive ish) * disease stage ≥iiib * patient not able to follow the trial.

Keywords: equivocal her 2 genomic test
the use of an inhaled salt solution to treat viral lung infections in infants.

Conditions: Bronchiolitis

Summary: bronchiolitis is a common viral lung infection in infants. standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. inhalation of a more concentrated salt solution (hypertonic saline) has been successfully used to treat other types of lung disease in children and adults. the purpose of this study is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more quickly.

bronchiolitis is a common illness in infants and is associated with a significant morbidity. standard therapy is controversial and largely ineffective; care is mostly supportive although nebulized medications continue to be commonly used. these medications are typically mixed with normal saline to produce a sufficient volume for efficient nebulization. inhaled hypertonic saline has been used to aid airway clearance in children with cystic fibrosis. it has also been used, in low dose, in two small studies in children with bronchiolitis. the current study is a randomized, double-blind, placebo-controlled, multi-center trial comparing frequent dosing with 3% hypertonic saline compared to normal saline in the treatment of infants hospitalized with bronchiolitis.

Eligibility criteria:
inclusion criteria: * corrected age maximum 18 months, plus * history of preceding viral upper respiratory tract infection, plus * presence of wheezing and/or crackles on auscultation, plus * respiratory distress assessment instrument (rdai) score of 4 or greater, or oxygen saturation of 93% or less in room air, plus * admitted to hospital exclusion criteria: * prior history of wheezing, or * history of chronic cardiopulmonary disease or immunodeficiency, or * critical illness at presentation requiring admission to icu, or * use of nebulized hypertonic saline within previous 12 hours, or * prematurity (gestational age 34 weeks or less).

Keywords: bronchiolitis hypertonic saline