Kornimate/medical-research-clean huggingface dataset:
complete easy rub comparative efficacy study

Conditions: Myopia; Hyperopia; Astigmatism

Summary: the aim of this trial is to assess complete easy rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months. the hypotheses for this trial are: * lens cleanliness measures between solutions will be no different. * subjective ratings between solutions will be no different. * ocular response between solutions will be no different.


Eligibility criteria:
inclusion criteria: * able to read and comprehend english and give informed consent as demonstrated by signing a record of informed consent; * be at least 18 years old, male or female; * willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; * have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses; * is correctable to at least 6/12 (20/40) or better in each eye with contact lenses; * able to successfully wear one of the lens types to be used in this study on a daily wear (dw) basis in conjunction with any multi-purpose contact lens care solution (not including hydrogen peroxide-based systems) for at least one month prior to allocation of test or control solution; exclusion criteria: * any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses; * any systemic disease that adversely affects ocular health e.g. diabetes, graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, sjögrens syndrome and systemic lupus erythematosus. conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; * use of, or a need for, concurrent category s3 and above ocular medication at enrolment and/or during the study; * use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study
brain imaging to understand the role of inflammation in n-acetyl cysteine (nac) treatment of bipolar depression

Conditions: Bipolar Disorder; Depression

Summary: we are trying to understand what causes bipolar disorder and how medications treat bipolar depression. particularly, we are looking at the importance of inflammation in the process. if you participate, you will have two different brain scans (mri and pet scan). you will also have an experimental treatment for your depression named n-acetyl cysteine (nac). the study is funded by the columbia university irving institute to improve the treatment of bipolar disorder. please contact us if you are interested in participating. up to $600 in compensation if you are eligible and choose to participate. up to 6 months of treatment for depression at no cost to you.


Eligibility criteria:
inclusion criteria: * bipolar 2 disorder and meets criteria for a major depressive episode * age 18-60 * females of child-bearing potential must be willing to use an acceptable method of birth control throughout the study * not currently taking psychotropic medications besides those allowed in the clinical trial exclusion criteria: * failed trial or intolerable side effects of nac * diagnosis of other major psychiatric disorders such as lifetime schizophrenia, schizoaffective disorder, psychotic features of bipolar disorder, current drug or alcohol abuse or recent drug or alcohol dependence * significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease. any disorders with inflammation, malignancy, autoimmune or infectious etiology. systolic blood pressure \>140 or diastolic blood pressure \> 100 hemoglobin \<11 in females or \<13 in males * metal implants, pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body * current, past or anticipated exposure to radiation

Keywords: inflammation nac n-acetyl cysteine
acute effects of cortisol on heroin craving in opioid dependence (ghost-basel)

Conditions: Opioid Dependence

Summary: to investigate the effects of cortisol on heroin craving and stress reaction in heroin addicted subjects randomized, double-blind, placebo-controlled, cross-over, single administration of study medication study hypothesis:cortisol has an inhibiting effect on heroin craving and stress reactivity in opioid dependent subjects.


Eligibility criteria:
inclusion criteria: * age ≥ 18 * opioid dependency * participant in the janus heroin programme of the upk basel * able to control parallel consumption of other drugs * stable i.v. substitution for at least 3 months exclusion criteria: * co-morbid psychiatric disturbances * current medical conditions excluding participation * recent history of systemic or topic glucocorticoid therapy * known hypersensitivity to the imp under investigation (cor-tisol) * pregnancy, breast-feeding * inability to read and understand the participant's information
rad001 therapy of angiomyolipomata in patients with ts complex and sporadic lam

Conditions: Tuberous Sclerosis; Lymphangioleiomyomatosis

Summary: the purpose of this research study is to find out what effects rad001 has on angiomyolipomas of a person with tuberous sclerosis complex and to determine the safe dose of rad001 without toxicity. the hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly even cause regression.

tuberous sclerosis complex is a genetic disorder with a birth incidence of approximately one in six thousand. angiomyolipomas occur in eighty percent of persons with ts, and in up to 60% of persons with lam. they are fatty tumors that often occur in kidney or liver as well as other parts of the body. they can grow and cause damage to surrounding kidney tissue and even renal failure. they may also leak blood causing potentially life-threatening hemorrhage. laboratory studies have shown that rad001 suppresses the chemical that cause tumors to grow in tuberous sclerosis and sporadic lam. the primary goal of this study is to evaluate the clinical effectiveness of rad001 in a 24 month trial. although the primary goal is to determine if the drug rad001 has effects on angiomyolipomas, other diseases associated with tuberous sclerosis will be monitored too, specifically any change in involvement of your brain or lungs with tuberous sclerosis. the use of rad001 to treat angiomyolipomas in tuberous sclerosis or sporadic lam is considered experimental

Eligibility criteria:
inclusion criteria: * diagnosed with angiomyolipomas and have either tuberous sclerosis complex or lymphangioleiomyomatosis * angiomyolipoma one centimeter or greater in largest diameter * between the ages of 18 and 65 years old. * if female, documentation of negative pregnancy test prior to enrollment and, where applicable, use of appropriate non-estrogen containing birth control contraceptive regimen while on study. * adequate renal function (creatinine \< 3 mg/dl) exclusion criteria: * pregnant or lactating women * continuous requirement for supplemental oxygen * surgery within past 2 months * use of an investigational drug within last 30 days.

Keywords: tuberous sclerosis complex (tsc) lymyphangioleiomyomatosis mammalian target of rapamycin (mtor) rad001 angiomyolipmas
a study to investigate the safety and effectiveness of different doses of sprifermin in participants with osteoarthritis of the knee

Conditions: Osteoarthritis, Knee

Summary: this was a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial of sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and kellgren-lawrence grade 2 or 3. the trial was intended to investigate the efficacy and safety of different intra articular dosages of sprifermin in these individuals.

participants were equally randomized to either one of 4 treatment arms or a placebo arm. the trial consists of a screening period lasting up to 42 days, a two-year double-blind placebo-controlled (dbpc) treatment phase, which begins at randomization (week 0) and ends at year 2, and a 3-year extended follow-up phase.

Eligibility criteria:
inclusion criteria: * age from 40 to 85 years; of either sex * primary femorotibial osteoarthritis according to american college of rheumatology (acr) clinical and radiographic criteria , and meeting protocol-specified x-ray criteria in the target knee at screening * pain score in the target knee and/or the need for regular symptomatic treatment of knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory drugs (nsaids) including cyclooxygenase (cox)-2 selective inhibitors (coxibs), or tramadol on most days in the previous month (that is, more than half of the days in the previous month) * a history of pain due to osteoarthritis in the target knee for at least 6 months * a protocol-specified pain score for the target knee in response to question 1 of the womac pain index ("how much pain have you had \[in the target knee, over the past 48 hours\] when walking on a flat surface?") after washout of at least 5 half-lives of analgesic medication(s): acetaminophen, topical or oral nsaids, coxibs, opioids, and/or tramadol * women of childbearing potential must use a form of contraception with a failure rate of less than 1 percent per year throughout the trial exclusion criteria: * malalignment of greater than 5 degrees in the femorotibial axis of the target knee * clinical signs of inflammation (redness) in the target knee * intra-articular administration of corticosteroids or hyaluronic acid into either knee within 6 months before screening * planned knee surgery (affecting either the target or the contralateral knee) within the next two years * concomitant conditions or treatments deemed to be incompatible with trial participation * any contraindication to mri according to mri guidelines, including the inability to undergo a knee mri exam because of inability to fit in the scanner or knee coil * pregnancy or breastfeeding * participation in another clinical trial within the 30 days (or 5 half-lives of the investigated compound, whichever is longer) before screening * legal incapacity or limited legal capacity

Keywords: osteoarthritis of knee recombinant human fibroblast growth factor-18 (rhfgf-18) sprifermin placebo
reboxetine and citalopram as an adjunct treatment to second generation antipsychotics in the treatment of negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: main objective: to assess the efficacy of two antidepressants of different pharmacological families: citalopram (selective serotonin reuptake inhibitors, ssri) and reboxetine (norepinephrine reuptake inhibitor, nri) as adjunct treatments to risperidone and olanzapine for the treatment of negative symptoms of schizophrenia. secondary objectives: to assess the efficacy of citalopram and reboxetine as adjunct treatments to risperidone and olanzapine for the treatment of cognitive symptoms of schizophrenia. to compare the efficacy of reboxetine and citalopram as adjunct treatments for the treatment of negative and cognitive symptoms of schizophrenia. method: multicentric, randomized double-blind clinical trial compared to placebo with a six months follow-up. a total of 249 patients with a diagnosis of schizophrenia (dsm-iv criteria) and significant negative symptoms, will be recruited in the 9 participating centres. variables: sociodemographic and clinical variables (panss, sans, cgi global, gaf,lsp, hamilton scale, bacs)


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia (dsm-iv criteria) * stable doses of antipsychotic medication (olanzapine, risperidone)for at least 60 days prior to study initiation * presence of significant negative symptoms (defined as one or more negative symptom score grater than 4 in the panss scale) (kay 1987) * patients have to give written informed consent to participate in the study exclusion criteria: * patients with a substance abuse/dependence diagnosis in the previous six months. * mental retardation. * patients taking antidepressant in the last 4 months before the trial. * patients taking other antipsychotic medication, except: sinquan 100, entumine 40, largactil 100 and seroquel 200. * patients who score more than 20 in hamilton rating scale for depression. * pregnancy or lactation. * serious impaired kidney function. * history of hemorrhagic disorders. * reboxetine or citalopram allergy.
effect of high and low sodium diets on blood pressure in hypertensive patients treated with aliskiren

Conditions: Hypertension

Summary: this study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.


Eligibility criteria:
inclusion criteria: * male or female outpatients 18-60 years old * patients with systolic hypertension who met the 24 hour ambulatory blood pressure monitoring (abpm) criteria (abpm mean daytime systolic blood pressure (sbp) \>= 135 mmhg and \< 160 mmhg) exclusion criteria: * overt heart failure (hf) or a history of heart failure within preceding 6 months. * unstable angina pectoris. * type 1 or type 2 diabetes mellitus or abnormal hemoglobin a1c(hba1c) * body mass index (bmi) \> 30 kg/m2 * subjects taking more than 2 antihypertensive medications. * use of other investigational drugs within 30 days of the time of enrollment * use of tamsulosin hydrochloride and other alpha blockers. * use of antiarrhythmic drugs, including digoxin. * history of mi or cardiovascular attack (cva) within the preceding 6 months. * history of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin * pregnant or nursing (lactating) women

Keywords: high blood pressure, hypertension, aliskiren, low sodium diet
comparison of asthma-related outcomes and costs in pediatric subjects that received fluticasone propionate, budesonide or montelukast in a large managed care population

Conditions: Asthma

Summary: the objective of this study is to compare asthma-related exacerbations (emergency department (ed) or inpatient (ip) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg (fp44) or budesonide (bud) or montelukast (mon). this retrospective observational cohort analysis utilizes a large managed care database with linked pharmacy and medical claims. patients with ≥ 1 pharmacy claim fp44 or bud or mon between january 1, 2000 through june 30, 2008 (4-11 years old at time of index) with ≥ 1 diagnosis for asthma (icd-9 493.xx) in the pre-index period and continuously eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index. dose of each inhaled corticosteroid was not known in the database. follow-up was defined for each patient as the period beginning with the index date and ending with the last date of continuous claims history, switch to another asthma controller medication, or claim for an asthma related event (ed/ip visit or ocs use) post-index, whichever occurred first.


Eligibility criteria:
inclusion criteria: * icd-9 code for asthma * one or more outpatient pharmacy claims for fluticasone propionate 44mg or budesonide between january 1, 2000 and june 30, 2008 * ages 4 to 11 years exclusion criteria: * diagnosis of cystic fibrosis * ≥ 1 rx claim for any asthma controller in the pre-index period

Keywords: pediatric asthma outcomes inhaled cortcosteroids
a decentralized study to evaluate physical activity and cough frequency using wearable technology in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this study will evaluate the performance of wearable technology in cystic fibrosis (cf) participants taking commercial elexacaftor (elx)/tezacaftor (tez)/ivacaftor (iva) utilizing a fully decentralized trial design.


Eligibility criteria:
key inclusion criteria: * forced expiratory volume in 1 second (fev1) value greater than or equal to (≥) 30 percent predicted * participants with an approved cf transmembrane conductance regulator gene (cftr) genotype according to respective regional labels key exclusion criteria: * history of solid organ or hematological transplantation * non-ambulatory status other protocol defined inclusion/exclusion criteria may apply
patient reported outcomes for vascular malformations embolization (proven)

Conditions: Vascular Malformations; VM - Vascular Malformation

Summary: the purpose of this study is to develop a standardized assessment for patients treated for venous malformations (vm). venous malformations result from the abnormal development of veins which may result in pain, swelling, bleeding, functional impairment, disfigurement, and psychological distress. the impact of vm on patient quality of life varies based on the location and size of the malformation. a patient reported outcome (pro) is a patient's own account of patient's health condition. pro measures are valued to clinicians, as many treatment effects are known only to the patient. no studies to date have analyzed the validity of existing pro measures for vm patients. current assessment does not include all symptoms or take in to account the relevance of vm location. past studies show a discrepancy between treatment outcomes reported by patients and physicians. therefore, there is a need to develop vm-specific pros to better understand the effectiveness and benefits of treatment for vm.


Eligibility criteria:
inclusion criteria: * male and female pediatric patients, aged between 0-17 with diagnosis of vascular malformations. * male and female adult patients aged 18-100 with diagnosis of vascular malformations. * vascular malformation symptoms significant enough to seek treatment. exclusion criteria: * patients with extensive vm not suitable for sclerotherapy. * prior therapy for treatment of a vm within 3 months. * condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).

Keywords: vascular malformation vm
effect of chewing gum on post-operative ileus (gumpi)

Conditions: Ileus

Summary: the purpose of this study is to determine whether chewing gum post-operatively decreases the time to first flatus or defecation in patients undergoing spine surgery as a indirect indicator of post-operative ileus.

the patients undergoing spine surgery are at risk of developing post-operative ileus, which will lengthen the hospital stay and cause gastrointestinal distress in patients. post-operative sham feeding in form of chewing a gum seems to increase the functionality of gastro-intestinal tract earlier in patients who have undergone gastro-intestinal and gynecological surgeries. this study will recruit patients undergoing spine surgery at the investigators medical center and allocate them randomly into two equal groups. patients in one group will be asked to chew gum after surgery and the other group will not be offered anything on chew on. both groups will be kept nothing per os (npo) otherwise till the first bowel movement. the first post-operative flatus and defecation time will be recorded as primary measures and other main outcomes will include first post-operative meal, length of stay and presence of ileus. the descriptive parameters of the two groups will also be recorded as related to relevant medical history, surgery, and post-operative care, to adjust for its effect on outcome measures. this study will identify any beneficial effect that chewing gum will have on post-operative ileus development and might be helpful in establishing better post-operative care protocols in patients undergoing spine surgery.

Eligibility criteria:
inclusion criteria: * patient 13 years of age or older * patients who will undergo spine decompression, laminectomy (cervical, lumbar and/or thoracic), discectomy, foraminotomy, or corpectomy, with or without arthrodesis, with or without instrumentation. exclusion criteria: * less than 13 years of age * patients who have undergone with abdominal surgery within the last month * patients with inability or problems with chewing and/or dysphagia * patients who are expected to be kept intubated after surgery * patients who are allergic to any chewing gum component

Keywords: chewing gum prevention
a post marketing surveillance study of invossa k inj.

Conditions: Osteoarthritis

Summary: this study is post-marketing surveillance of invossa k injection in patients with osteoarthritis.


Eligibility criteria:
inclusion criteria: 1. male or female patients over 19 years 2. patients who diagnosed with osteoarthritis will plan to invossa k inj. injection and suitable for following criteria : - moderate knee osteoarthritis (kellgren \& lawrence grade 3) with persistent symptoms (pain, etc.) in spite of conservative therapy (medication, physical therapy, etc.) for more than 3 months 3. patients (or substitute) who is provided all information regarding participation of this pms signed the informed consent form exclusion criteria: 1. pregnant or breastfeeding female 2. patients who have administered corticosteroid before invossa k inj. injection within the past 30 days 3. patients who have severe disease such as heart, liver, kidney disease or other severe complications 4. patients who rheumatoid arthritis, gouty arthritis, autoimmune disease associated arthritis except for osteoarthritis 5. patients with a medical history of allergic diseases or patients with a medical history of anaphylactic reactions (including patients with a history of hypersensitivity reactions to the components of this drug, including dimethylsulfoxide (dmso), mannitol, dextran 40 or bovine proteins) 6. patients who have been treated with injections to the target knee within the past three months or patients with a past history of surgery, including arthroscope, within the past six months 7. patients currently with leukemia or malignant tumors such as osteochondroma, chondroblastoma, cartilaginous mucinous fibrous tumor, chondroma and chondrosarcoma, which may be exacerbated by administration of invossa-k inj. or patients with a history thereof 8. patients with kellgran \& lawrence grade 4 osteoarthritis

Keywords: chondrocyte cells osteoarthritis gene therapy