Kornimate/medical-research-clean huggingface dataset:
exploratory study for allergy relief onset

Conditions: Rhinitis, Allergic

Summary: the purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment.


Eligibility criteria:
inclusion criteria: * ambulatory healthy male and female subjects between 18 to 65 years of age inclusive; * self-reported to have seasonal allergic rhinitis for at least 2 years prior * documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal \> 4mm larger than the diluent within the previous 12 months * total symptom score (tss) ≥ 40 mm at the 90 or 120 minute time point during one of the priming visits and at 90 or 120 minute time points during ragweed challenge symptom induction phase of each treatment visit; * body mass index (bmi) in the range of 18 to 30 kg/m2 * female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. depo-provera®), or a double barrier and have a negative pregnancy test at screening and prior to imp administration on day 1 and day 7 ± 1 day. female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy exclusion criteria: * evidence or self-reported history of significant medical condition which, in the judgment of the investigator, is a contraindication to the use of chlorpheniramine, or might interfere with the trial. these may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease , symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, narrow-angle glaucoma, pyloroduodenal obstruction, or stenosing peptic ulcer; * known allergy to chlorpheniramine, dexchlorpheniramine, or any of its inactive ingredients * self-reported non-responders (lack of therapeutic effect) to antihistamines * administration of epinephrine is contra-indicated; * current use of oral steroids, including prednisone and prednisolone; * females who are pregnant or lactating * a history of anaphylaxis to ragweed allergen * subjects with a history of asthma, lower respiratory tract disease, emphysema or chronic bronchitis; at the discretion of the investigator, subjects with self-reported mild intermittent asthma or exercise induced asthma may be included.
sickle cell anemia and cerebral microcirculation : multimodal exploration

Conditions: Sickle Cell Disease

Summary: the aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at the microcirculatory level in children with sickle cell anemia (sca) using combined novel investigational tools: arterial spin labeling (asl) perfusion mr (magnetic resonnance) imaging, brain near infra-red spectroscopy (nirs) and red blood cell (rbc) rheological properties.

the investigators hypothesize that brain perfusion and/or oxygenation modifications may be evidenced in sca children who have no microarteriopathy and may correlate with hemorheological abnormalities and impaired vasomotion. a multimodal approach designed to study a. cerebral perfusion and oxygenation, b. flow motion properties and c. blood rheological parameters might help to describe the different processes involved in cerebral ischemia.

Eligibility criteria:
inclusion criteria: * ss or s-beta° genotype; * age 6-16 years; * steady state; * normal tcd (transcranial doppler); * parental study approval and written informed consent. exclusion criteria: * sc, sbeta+, sd punjab genotype * history of overt stroke, * intracranial or cervical arterial stenosis, * abnormal tcd at the time of the study.
computational modeling of cleft lip nasal deformity and assessment of nasal function and treatment outcomes

Conditions: Cleft Lip and Nose; Nasal Obstruction

Summary: the purpose of this study is to use computers to simulate airflow in 3d construction of your nasal cavity generated from cone beam ct images. the results from computer simulations will help researchers identify the severity of cleft-induced nasal dysfunction and assess the impact of current treatment in restoring breathing function. the ultimate goal is to improve post-surgery outcomes to restore nasal breathing function to normal levels.


Eligibility criteria:
inclusion criteria: * provide signed and dated informed consent form. * willing to comply with all study procedures and be available for the duration of the study. * male or female, aged ≥18 years of age. * clinical diagnosis of unilateral cleft lip nasal deformity (uclnd) * scheduled to undergo elective surgery for nasal obstruction * scheduled to have a cone beam computed tomography (cbct) as part of the pre- operative work-up for elective surgery. exclusion criteria: * prior cleft rhinoplasty or septoplasty for correction of nasal obstruction * pregnant women: a pregnancy test will be performed within 48 hours of baseline * patients unable or unwilling to comply with study procedures outlined in protocol
a study to evaluate the immunogenicity and safety of ev71 vaccine in pediatric subjects

Conditions: Enterovirus Infections

Summary: the objectives of this study are to evaluate the immune response and safety profiles of two injections of ev71 vaccine administrated with or without adjuvant al(oh)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.


Eligibility criteria:
inclusion criteria: 1. healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and \< 7 years old) for part a,and from 2 to 35 months old (i.e. ≥ 2 months old and \< 36 months old) for part b at the time of first vaccination. 2. subject's guardians are able and willing to comply with study procedures and provide the signed informed consent. 3. subject is able and can comply with the requirements of the protocol. 4. subject with body temperature ≤38°c. exclusion criteria: 1. subject with previous known exposure to enterovirus 71 (ev71). 2. subject with a history of herpangina, hand-foot-mouth disease,and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months. 3. subject with gestation \< 37 weeks. 4. subject with birth weight \<2.5 kg. 5. subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 6. family history of seizures or progressive neurological disease. 7. family history of congenital or hereditary immunodeficiency. 8. severe malnutrition or dysgenopathy. 9. major congenital defects or serious chronic illness, including perinatal brain damage. 10. subject diagnosed of having autoimmune disease (e.g., celiac disease, type i diabetes, lupus (sle), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (jia), immune (or idiopathic) thrombocytopenia purpura). 11. bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with im injections or blood draws. 12. any acute infections 7 days prior to administrating the first vaccination. 13. use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period. 14. administration of any vaccines within 14 days prior to randomization. 15. use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period. 16. chronic administration (defined as \> 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination or planned use during the study period. 17. subjects who had ever received investigational ev-71 vaccine prior to randomization. 18. under anti-tuberculosis prevention or therapy. 19. any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.

Keywords: foot-and-mouth disease vaccines hand, foot and mouth disease ev71 vaccine
stimulation for colonic motility

Conditions: Neurogenic Bowel Dysfunction

Summary: the investigators are testing the effect of electrical stimulation of the rectum on colonic motility. most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. this slowed movement may result in chronic constipation and difficulty emptying the bowels. individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. the investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. therefore, this study will compare the two methods. if electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.


Eligibility criteria:
inclusion criteria: * diagnosed neurogenic bowel dysfunction and using digital rectal stimulation * neurologically stable * skeletally mature * suprasacral spinal cord injury, stroke, or multiple sclerosis * at least 6 months post neurological injury or disease diagnosis exclusion criteria: * active sepsis * open pressure sores on or around pelvis * significant colon trauma or colostomy * history of autonomic dysreflexia
association of lunar phases with post-surgical morbidity

Conditions: Hemorrhage

Summary: the potential influence of lunar phases on human life has been widely discussed by the lay press. the purpose of this study was to evaluate a possible relation between the lunar cycle and the hemorrhagic complication rate and surgical outcome. patients and methods: the investigators tested this hypothesis by evaluating the complication rate for 18760 patients who underwent surgery from january 2001 to december 2008 (103 lunar phases) at the national institute for cancer research in genoa. the date of definitive surgery was allocated to the lunar phases.


Eligibility criteria:
inclusion criteria: * none exclusion criteria: * none

Keywords: surgery moon phases hemorrhage
inflammatory markers in pregnant women destined to develop preeclampsia

Conditions: Preeclampsia

Summary: the purpose of this study is to assess the predictive role of serum inflammatory markers in pregnant women who subsequently develop preeclampsia.


Eligibility criteria:
inclusion criteria: * caucasian, * nulliparous exclusion criteria: * preexisting cardiovascular diseases, * diabetes, * hypertension, * inflammatory bowel diseases, * serious organ diseases, and * development of separate gestational diabetes and/or hypertension.

Keywords: prognostic marker
the effect of plaquenil on serum inflammatory markers and goiter in euthyroid young women with hashimoto's thyroiditis

Conditions: Hashimoto's Thyroiditis

Summary: hashimoto's thyroiditis (ht) is a common form of autoimmune thyroid disease, which affects up to 2% of general population. the annual incidence of ht worldwide is estimated to be 0.8 - 3.5 cases per 1000 persons. the thyroid gland attacked by a variety of cell- and antibody-mediated immune processes. various auto-antibodies may be present against tpo and tg, and adcc is a substantial factor behind the apoptotic fall-out of ht. activation of cytotoxic t-lymphocytes in response to cell-mediated immune response affected by helper t-cells is central to thyrocyte destruction. recent studies showed higher pro-inflammatory cytokines in serum of patients with ht, and suggested ht is associated with regulatory t-cells dysfunction, imbalance of ratio of th1 cell and th2 cell, overexpression of th17 cells. several studies suggested that pregnant women with ht, even at euthyroid state had higher risk of spontaneous miscarriage, more frequent post-partum depression and higher depressive, anger, and total mood disturbance risk compared to those without ht. presence of thyroid auto-antibodies is also associated with negative pregnant outcomes including gestational hypertension, late abortion, fetal death, premature delivery and neonatal respiratory distress. neonates from mothers with atd have higher rate of transient hypothyroidism. children of mothers with atd had higher risk of positive serum thyroid auto-antibodies and development of goiter and thyroid dysfunction. however, there is no suggested treatment for subjects with ht who have normal thyroid function. low-iodine diet and regularly follow-up were suggested. plaquenil (hydroxychloroquine) is an anti-malarial agent, and has been used to treat several autoimmune diseases, including lupus erythematosus and rheumatoid arthritis for more than a century. it reduced lymphocytes, production of auto-antibodies, cytokines, and immune mediators, nk cell activity, and inhibits antigens presenting to cd4 t-cells of b cells, dendritic cells and monocytes. this study focuses on the effect of plaquenil on thyroid auto-antibodies, inflammatory markers, cytokines, and goiter size in euthyroid women with ht.


Eligibility criteria:
inclusion criteria: * newly diagnosed (within 1 year) hashimoto's thyroiditis by positive serum anti-tpo antibody or anti-thyroglobulin antibody * euthyroid state by serum free t4 and tsh level within normal limit exclusion criteria: * pregnant, planning pregnant within 1 year, or lactating women * renal insufficiency, abnormal liver function test * hematologic diseases: anemia, agranulocytosis, thrombocytopenia * g6pd deficiency, porphyria cutaneous tarda * allergy to 4-aminoquinoline compounds * known retinopathy or visual field defect disorders * already receive immunosuppression therapy

Keywords: hashimoto's thyroiditis plaquenil
internet addiction and sleep disorders

Conditions: Internet Addiction

Summary: this is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated.

we will check sleep disorders among patients presenting internet dependence. diagnosis will be followed by a specific treatment during three months. this treatment is expected to reduce prevalence of internet dependence and associated addictive disorders (alchohol, nicotine) . rate of sleep disorders is also expected to decrease under treatment. this is an open label randomized controlled trial, comparing two modes of treatment for internet addiction (gaming or gambling online) with sleep disorders associated. patients will be randomised in two arms : controls (cbt treatment of internet dependence) and intervention (cbt treatment of addiction plus cbt treatment of sleep disorders).

Eligibility criteria:
inclusion criteria: * internet addiction (young scale ≥5) * online compulsive gambling ( dsm iv scale for pathological gambling and sogs) and/or addiction to online gaming (problem video game playing ≥ 5) * sleep latency \>45 min/night and more than 3 nights a week * subjective total sleep time \<6h30/night more than 3 nights a week * adult patient exclusion criteria: * cognitive impairments, memory disorders, non french-speaking patients * already known and on treatment sleep pathologies * somatic conditions non compatible with clinical evaluation * cybersex dependance * treatment with dopaminergic agents * patients under jurisdictional assistance * patients non covered by the french health system * non consenting patients * history of healthcare for internet dependence * patients already treated for internet dependance * pregnant or lactating women * patients already participating in other studies on internet dependance and sleeping disorders * suicide attempt before inclusion

Keywords: internet dependence sleep disorders pathological gambling
the effects of ketone ester supplementation during a 5 week live high, train low altitude training camp

Conditions: Hypoxia; Exogenous Ketosis

Summary: this study aims to investigate the effects of post-exercise and pre-sleep exogenous ketosis via oral ketone ester supplementation during a 5 week simulated altitude training camp.

altitude training camps, where you train at sea level but live at altitude, have become a popular way for athletes to prepare for upcoming races or events. the main aim of such training camps is to benefit from the adaptations following prolonged hypoxic exposure (increased epo concentrations leading to an increase in oxygen carrying capacity in the blood). recently, ketone bodies have been shown to cause similar adaptations. therefore, this study aims to investigate whether the combination of exogenous ketosis and an altitude training camp is more beneficial compared to an altitude training camp on its own. participants will follow a 5 week simulated altitude training camp where they spend 75 hours per week at altitude (2000-3000 meters), while taking ketone or placebo supplements after every training sessions and before going to sleep. during these 5 weeks, they will adhere to a prescribed training plan, consisting of 5 to 7 training sessions per week. before, after and 1 week after the training camp, their exercise performance, epo concentrations, hemoglobin mass and vo2max will be tested.

Eligibility criteria:
inclusion criteria: * physically fit and regularly involved in physical activity (2-5h per week) * good health status confirmed by a medical screening * non-smoking exclusion criteria: * any kind of injury/pathology that is a contra-indication to perform high-intensity exercise * any kind of injury/pathology that is a contra-indication for exposure to hypoxia * ongoing pregnancy or breastfeeding * intake of any medication or nutritional supplement that is proven to affect exercise performance during the last month prior to the start of the study * involvement in elite athletic training at a semi-professional or professional level * exposure to altitudes higher than 1500 m during the 3 months prior to the start of the study * blood ferritin levels below 30 ng/ml * current participation in another research trial * any other argument to believe that the subject is unlikely to succesfully complete the full study protocol

Keywords: altitude training camp exercise live high, train low epo
efficacy and safety of camrelizumab for injection, apatinib mesylate and tegio for first-line refractory patients with advanced gastric cancer

Conditions: Gastric Cancer

Summary: this is a prospective, single-center, single-arm, open-label clinical study, aiming at evaluating the efficacy and safety of camrelizumab for injection, apatinib mesylate and tegio for first-line refractory patients with advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * 1. aged 18-75; * 2. ecog score 0-2; * 3. pathologically diagnosed late-stage adenocarcinoma of stomach or gastroesophageal junction, with extra-gastric measurable lesions (spiral ct scan≥10 mm, meeting recist 1.1 criteria); * 4. patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that are refractory to first-line chemotherapy; * 5. patients who received no previous treatment with apatinib or other vegfr inhibitors, e.g. sorafenib and sunitinib; * 6. normal blood routine examination: neutrophil count ≥ 1.5 × 109 / l; hemoglobin ≥ 80 g / l; platelet count ≥ 100 × 109 / l; total bilirubin ≤ 1.5 × uln; alt, ast≤2.5×uln； * 7. without severe dysfunction of heart, lung, liver or kidney, without jaundice and digestive tract obstruction, and without acute infection. exclusion criteria: * 1. kps \< 60, or estimated survival \< 3 months; * 2. patients with cardiovascular and cerebrovascular events within half a year; patients with uncontrollable hypertension (systolic pressure \> 140 mmhg, diastolic pressure \> 90 mmhg), coronary heart disease above grade i, arrhythmia (including qtc interval prolongation \> 450 ms in men, 470 ms in women) and grade i cardiac dysfunction; patients positive of urine albumin; * 3. patients with definite tendency of gastrointestinal bleeding, local active ulcer focus, and occult blood in stool (+ +); patients with history of black stool and hematemesis within 2 months; * 4. abnormal coagulation (inr \> 1.5, aptt \> 1.5 uln), with bleeding tendency; * 5. patients with factors that can affect the absorption of oral-intake drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); * 6. patients with nervous and mental diseases or with severe infection; * 7. pregnant or lactating women or those who have fertility requirements during the study period.
frailty in older hiv-infected individuals

Conditions: HIV Infections

Summary: frailty has been proposed as a measure of biological (as opposed to chronological) aging. in this study the investigators plan to: (1) measure frailty in a cohort of older hiv-infected individuals in hong kong, and its association with mortality and quality of life; (2) identify risk factors predictive of development of frailty in hiv-infected individuals in hong kong; and (3) determine the outcomes of hiv-infected individuals in hong kong with and without frailty. the following assessment will be done: 1. physical examination including measuring height, weight, hip and waist circumference. 2. grip strength, chair stand test, gait speed test, balance tests, and neurocognitive tests 3. geriatric syndromes, screening for depression, disability and quality of life. 4. blood tests during fasting state to measure metabolic parameters. this is a prospective longitudinal observational study that lasts for 10 years.


Eligibility criteria:
inclusion criteria: * hiv infection with positive anti-hiv antibody * age ≥50 years exclusion criteria: * refuses to consent
a long term follow up study of patients who have completed the pep005-020 study

Conditions: Actinic Keratosis

Summary: this study is designed to follow up patients, who have achieved complete clearance of ak lesions (lesion count of 0) at day 57 in the pep005-020 study, over a 12 month period to assess both recurrence of actinic keratosis (ak) lesions and long term safety in the selected treatment area.


Eligibility criteria:
inclusion * patient has provided informed consent documented by signing the informed consent form (icf) prior to any study-related procedures * patient achieved complete clearance of ak lesions (lesion count of 0) in the selected treatment area at the day 57 visit in study pep005-020 exclusion * concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous peplin ak study) * early termination from study pep005-020

Keywords: peplin actinic keratosis pep005