Kornimate/medical-research-clean huggingface dataset:
serotype distribution of chest x-ray confirmed pneumococcal community acquired pneumonia in the adult population in greece, over 1 year.

Conditions: Pneumococcal Disease

Summary: serotype distribution and estimation of antimicrobial resistance in s. pneumoniae isolates and anticipated pcv7 and pcv13 coverage is difficult in greece, because invasive isolates collected each year are limited and depict a certain proportion of patients who have easy access to tertiary care or have underlying medical reasons which necessitate inpatient care. it is also probable that the real burden of pneumococcal disease is not well estimated especially among adults. new additions in the laboratory setting such as the pneumococcal urine antigen assay (binax now®) and the urinary antigen diagnostic assay (luminex) for the detection of 13 serotype specific polysaccharides in human urine developed by pfizer might be helpful in identifying more pneumococcal infections compared to the previous years. this nis is based on the unmet scientific need to describe the serotype distribution and the resistance profile of isolates from x-ray confirmed cap in the present circumstances.

for each surveillance period lasting for 12 months all adults presenting in the selected clinics with symptoms and signs suggestive of pneumonia (candidate cases) will be asked to participate in the study

Eligibility criteria:
inclusion criteria: * patients who agreed to participate in the study and agreed to sign an icd. * patients had to be ≥18 years of age (adults) * patients had to present or had been referred to a participating healthcare facility with suspected pneumonia based on the physician's assessment (including but not limited to specific signs and symptoms described in section 9.3 of the protocol) * patients must have had a posteroanterior or anteroposterior chest x-ray showing an infiltrate (if previous films were not available) or a new infiltrate (if recent film was available) * patients had to be tested positive for the binax now® assay (required post protocol amendment 2) exclusion criteria: * patients who did not sign an icd. * any patient who developed signs and symptoms of pneumonia after being hospitalized for ≥48 hours * any patient who was transferred to a study healthcare facility after already being hospitalized for ≥48 hours at another healthcare facility * patients who did not have a chest x-ray performed * patients who did not have the binax now® assay performed * patients with negative results for the binax now® assay (required post protocol amendment 2)

Keywords: pneumococcal serotypes community acquired pneumonia (cap)
preliminary testing of a novel device to detect epileptic seizures

Conditions: Epilepsy

Summary: official statistics report around 1000 deaths due to epilepsy in the uk each year (hanna et al 2002). most of these deaths are un-witnessed and in many cases are believed to have been avoidable with timely assistance (langan et al 2000). a major problem is detecting nocturnal seizures to allow body re-positioning, to maintain an open airway and to administer rescue medication. there are several seizure alarms commercially available but are often unreliable with many false alarms. the aim of this study is to investigate a novel seizure detection system with a unique algorithm.

two duplicate novel medical devices conforming to safety regulation bs en 60601 containing the unique algorithm will be evaluated in clinical trials at two hospitals over a 14 month period. each device is time synchronised with an electroencephalographic (eeg) videotelemetry system which is the gold standard in identifying different seizure types recording from scalp electrodes. the devices will be monitoring participants from 3 months and older (children and adults). the algorithm was created from results from a phd where 527 seizures were categorised into different seizure types. sensitivity of identifying seizures was 91% and specificity was 75% using an optimal trigger level and algorithm. this trial will investigate how reliable the algorithm is in practice and determine an optimal trigger level..

Eligibility criteria:
inclusion criteria: * frequent epileptic seizures 3 months and older informed consent for participation exclusion criteria: * infrequent seizures attacks are of a non-epileptic nature younger than 3 months has an implantable device no informed consent.

Keywords: seizure detection
study of khk7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis

Conditions: Secondary Hyperparathyroidism

Summary: this study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of khk7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.


Eligibility criteria:
inclusion criteria: * written informed consent * stable chronic renal disease patients receiving peritoneal dialysis for at least 16 weeks prior to the screening * intact parathyroid hormone value ≥ 240 pg/ml at the screening * corrected serum calcium ≥ 8.4 mg/dl at the screening exclusion criteria: * patients with primary hyperparathyroidism * patients who received cinacalcet within 2 weeks prior to the screening * patients who began to take or changed the dose/dosing regimen of active vitamin d/its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening * patients who underwent parathyroidectomy and/or parathyroid intervention * patients with uncontrolled hypertension and/or diabetes * patients with severe heart disorder * patients with severe hepatic disease * patients who take investigational drug in another clinical trial within 12 weeks prior to the screening * patients who have been judged ineligible to participate in the study by the investigator

Keywords: secondary hyperparathyroidism in patients receiving peritoneal dialysis
safety and pharmacokinetics of efinaconazole topical solution in subjects with mild to severe onychomycosis

Conditions: Onychomycosis

Summary: safety and pharmacokinetics (pk) of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

this is an open label, single-arm study designed to evaluate the safety and pk of a once daily topical application of efinaconazole in the treatment of pediatric subjects with mild to severe onychomycosis of the toenails.

Eligibility criteria:
key inclusion criteria: * male or female subjects of any race, 6 to 16 years of age (inclusive). pk subset: male or female subjects of any race, 12 to 16 years of age (inclusive). * verbal and written informed consent/assent obtained from the subject and/or their parent or legal guardian. * good general health, as assessed by the investigator, based on the subject's medical history, physical examination, and safety laboratory tests. * target great toenail for all subjects, and both great toenails for subjects in the pk subset, must have evidence of toenail growth, per subject's report that monthly clipping is needed. * subjects and their parents/legal guardians are willing to comply with study instructions and return to the investigational center for all required visits (a visit schedule with the length of each visit will be provided to ensure that the subject can meet the requirements and have adequate transportation). key exclusion criteria: * females who are pregnant, nursing an infant, or planning a pregnancy during the study period. * history of immunosuppression and/or clinical signs indicative of possible immunosuppression, as determined by the investigator, or known human immunodeficiency virus infection. * history of diabetes that is uncontrolled as determined by the investigator (diabetes that is controlled by diet or medication does not exclude a subject). * presence of any toenail infection other than or in addition to dermatophytes, such as scytalidium as determined by the investigator (candidal onychomycosis infection, concurrent with a positive dermatophyte culture, is acceptable).
a comparison of cognitive and dynamic therapy for depression in community settings

Conditions: Major Depressive Disorder

Summary: the goal of this study is to compare supportive-expressive therapy, a type of psychodynamic psychotherapy, with cognitive therapy for the treatment of depression in community mental health consumers. hypothesized mediators of treatment will also be examined.

the goal of this study is to conduct a randomized, comparative, non-inferiority clinical trial that tests the hypothesis that a widely used form of manualized dynamic psychotherapy (supportive-expressive psychodynamic therapy) is not inferior to cognitive therapy when implemented in community mental health settings for the treatment of major depressive disorder (mdd). the specific aims are (1) to conduct a randomized non-inferiority trial to compare supportive-expressive psychodynamic therapy and cognitive therapy for patients with mdd and (2) to assess the comparative effectiveness of supportive-expressive psychodynamic therapy and cognitive therapy on secondary measures of symptoms, patient functioning, and quality of life. patient mediators of outcome will also be examined through an additional grant awarded to paul crits-christoph, ph.d. this grant was funded by the national institutes of mental health - ro1mh092363-01. this grant is entitled:"the mechanisms of cognitive and dynamic therapy in community settings." recruitment will occur solely through community mental health clinics in and around philadelphia.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of major depressive disorder * able to read at the 4th grade level or higher * willingness to be randomized and participate in research exclusion criteria: * current or past diagnosis of schizophrenia, seizure disorder, bipolar disorder, psychotic features, or clinically significant organic pathology * significant suicidal risk/ideation requiring immediate referral for more intensive treatment, or specific gesture in the last 6 months * current substance abuse or dependence requiring immediate referral to substance abuse program * acute medical problem requiring immediate inpatient treatment * need for referral to a partial hospitalization program

Keywords: depression community mental health treatment psychotherapy mediators
4-week study to assess the effect of alendronate and vitamin d3 once weekly on fractional calcium absorption in postmenopausal osteoporotic women (0217a-230)

Conditions: Osteoporosis

Summary: to compare change in fractional calcium absorption following administration of mk0217a relative to matching placebo, in postmenopausal women with osteoporosis

placebo will be administered over a 4 week, single-blind run-in phase. calcium, as citrate-malate, will be administered throughout the study at an individualized dose supplementing the patient's daily dietary calcium intake to a total of approximately 1200 mg. at the end of the stabilization period, baseline calcium absorption will be determined and patients will be randomized to receive either mk0217a, or matching placebo once weekly for 4 weeks.

Eligibility criteria:
inclusion criteria: * the patient is a postmenopausal osteoporotic female * the patient is willing to limit direct sunlight exposure during the course of the study * the patient must be ambulatory * the patient has serum 25-hydroxyvitamin d =25 ng/ml exclusion criteria: * the patient is contraindicated to bisphosphonate therapy * the patient has a vitamin d deficiency * patient will be excluded if their weight is above 85 kg * the patient has a history of prior osteoporotic fracture * the patient is currently or has received in the past treatment with effects on bone or calcium metabolism * the patient has malabsorption syndrome * the patient has active thyroid disease * the patient has metabolic bone disease * the patient had a myocardial infarction within 6 months of screening visit * the patient has impaired renal function * the patient is currently or has been a smoker in the last year
a study of bms-986488 as monotherapy and combination therapy in participants with advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: this purpose of this study is to determine if experimental treatment with bms-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.


Eligibility criteria:
inclusion criteria: * participant must be ≥ 18 years of age. * histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. * part 1a: clear-cell renal cell carcinoma (ccrcc), clear-cell ovarian cancer (ccoc), non-small cell lung cancer (nsclc), colorectal cancer (crc), and pancreatic ductal adenocarcinoma (pdac). * parts 2a, 1d, 2d: ccrcc. i) part 1b: solid tumors with kras g12c mutation. ii) part 2b: nsclc with kras g12c mutation. iii) parts 1c, 2c: colorectal cancer (crc) with kras g12c mutation. * participants must have an eastern cooperative oncology groups (ecog) performance status of 0 or 1. * participants must have measurable disease per recist v1.1. exclusion criteria: * untreated central nervous system (cns) metastases. * leptomeningeal metastasis (carcinomatous meningitis). * impaired cardiac function or clinically significant cardiac disease. * for parts 1b, 1c, 2b, 2c only (combination with adagrasib):. i) history of pneumonitis or interstitial lung disease (ild). ii) history of prior severe cutaneous adverse reactions (scars), including stevens-johnson syndrome (sjs) and toxic epidermal necrolysis (ten). - other protocol-defined inclusion/exclusion criteria apply.

Keywords: colorectal cancer crc renal cell carcinoma rcc non-small cell lung cancer nsclc cancer oncology phase 1 solid tumor
efficacy and safety evaluating fispemifene in the treatment of hypogonadal men with erectile dysfunction unresponsive to pde5 inhibitors

Conditions: Hypogonadism; Erectile Dysfunction

Summary: the objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction (ed) unresponsive to pde5 inhibitors.


Eligibility criteria:
inclusion criteria: * hypogonadal (morning total testosterone levels ≤400 ng/dl) men age ≥20 with ed who are unresponsive to pde5 inhibitors, as demonstrated by international index of erectile function (iief) results for 28-day lead in period.

Keywords: hypogonadism erectile dysfunction
safety and efficacy of fluocinolone acetonide intravitreal implant vs standardized therapy

Conditions: Non-infectious Uveitis

Summary: this is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. the aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.


Eligibility criteria:
inclusion criteria: * males and non-pregnant females at least 6 years of age * history of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease * the more severely affected eye having had at least 2 separate recurrences * the more severely affected eye having been treated by systemic therapy for at least one month just before inclusion * visual acuity (va) of at least 1.4 logmar units at enrollment * at time of enrollment, \</=10 anterior chamber cells/hpf and vitrous haze\</= grade 2. exclusion criteria: * known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered * history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous * presence or history of uncontrolled iop while on steroid therapy resulting in loss of vision, or iop \>25 mm hg requiring at least 2 types of antiglaucoma medication to be reduced to \<25 mm hg * history of nipu only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze * infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye * ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment * monocularity * aids * pregnancy/lactation * potential for noncompliance * or participation in other clinical studies within 1 month of enrollment.
study of safety and efficacy of my008211a in patients with residual anemia despite anti-c5 antibody treatment

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the main purpose of this study is to evaluate the efficacy of my008211a in pnh patients with residual anemia despite treatment with anti-c5 antibody.

this is a multicenter, single-arm, open-label phase iii clinical trial. the purpose of this study is to determine whether my008211a is efficacious and safe for the treatment of pnh patients who are still anemia after anti-c5 antibody treatment.

Eligibility criteria:
inclusion criteria: 1. male and female participants ≥ 18 years of age and bmi ≥ 18.0 kg/m2 with a diagnosis of pnh confirmed by high-sensitivity flow cytometry with clone size ≥ 10%. 2. stable regimen of anti-c5 antibody treatment for at least 6 months before treatment, and hb was still \< 100 g/l. 3. the average hemoglobin level of at least two tests in 4 months before screening \< 100 g/l. 4. the average hemoglobin level of two tests in the central laboratory during screening \< 100 g/l. 5. vaccination against neisseria meningitidis infection is required prior to the start of study treatment. if not received previously, vaccination against streptococcus pneumoniae and haemophilus influenzae infections should be given. exclusion criteria: 1. patients with reticulocytes \<100x10\^9/l; platelets \<30x10\^9/l; neutrophils \<0.5x10\^9/l. 2. history of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus. 3. known or suspected hereditary complement deficiency. 4. previous bone marrow or hematopoietic stem cell transplantation. 5. previous splenectomy. 6. a history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
levosimendan pretreatment for weaning patients from cardio-pulmonary bypass

Conditions: Coronary Heart Disease

Summary: the study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.

levosimendan or placebo infusion is started at the time of induction of anesthesia.

Eligibility criteria:
inclusion criteria: * three vessel coronary artery disease. * indication for on-pump coronary artery bypass surgery. * ejection fraction below 50% exclusion criteria: * indication for any cardiac valve surgery * previous coronary artery bypass surgery

Keywords: levosimendan weaning cardio-pulmonary bypass
treatment of surgical scars using the pulsed dye laser

Conditions: Scar; Laser Therapy

Summary: the purpose of this study is to determine whether treatment of fresh surgical scars with a pulsed dye laser using purpura-inducing settings will improve clinical appearance better than one using non-purpura-inducing settings or no treatment.


Eligibility criteria:
inclusion criteria: * patients requiring mohs micrographic surgery or excisions for skin cancer or atypical nevi, with an expected post-excision scar of 4.5cm in length or more. * willing to participate. * able to give informed consent exclusion criteria: * location of excision or mohs surgery on the genitals, hands, or feet. * fitzpatrick skin type v or vi. * prior history of known light sensitivity.

Keywords: scar laser therapy lasers, pulsed dye
real-time assessment of lung structure and function in children and young adults with cf using electrical impedance tomography

Conditions: Cystic Fibrosis; Healthy

Summary: the purpose of this study is to determine the ability of electrical impedance tomography (eit) to identify structural and functional physiological changes that occur with disease progression in cystic fibrosis patients. the investigators also aim to determine whether eit can serve as an alternative for ct to identify regions of air trapping and consolidation, whether eit can provide clinically useful information about response to treatment for an acute pe, and whether eit can provide longitudinal information about structural changes in the lung.


Eligibility criteria:
inclusion criteria: cohort 1: * age 3-21 years * male or female * healthy subjects with no known or suspected chronic or temporary lung disease cohort 2: * age 3-21 years * male or female * cf as diagnosed based on sweat chloride value(\>60 mmol/l) or two known disease causing mutations cohort 3: * age 3-21 years * male or female * cf as diagnosed based on sweat chloride value (\>60 mmol/l) or two known disease causing mutations * experiencing a protocol defined pulmonary exacerbation and being started on oral or intravenous antibiotics exclusion criteria: * unwilling/refusal to sign consent * known congenital heart disease, arrhythmia, or history of heart failure * wearing a pacemaker or a metallic surgical implant in the chest * history of infection with burkholderia cepacia * developmental delays that could result in an inability to complete study procedures
the effects of sensory training on pain modulation, cognition and time to fatigue in healthy adults

Conditions: Healthy Participants

Summary: the study is a randomized clinical trial that is assessing the effects of sensory training on pain modulation, cognition, and physical endurance (time to fatigue) in healthy participants


Eligibility criteria:
inclusion criteria: * able to provide informed consent to participate in the study * able to perform physical activities such as cycling * 18-40 years old * bmi\<27 * practice of moderate intensity aerobic physical activity less than 150 minutes per week exclusion criteria: * hypertension * diabetes * cardiovascular disease * subjects with pacemakers, and/or implantable cardioverter-defibrillators * history of asthma with active symptomatology in the past year, pulmonary disease or use of inhalers * physical disability, neurological and/or psychological disorder that precludes safe and adequate testing * conditions that may impair the ability to feel pain * mental impairment with limited ability to cooperate * uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, or hyperthyroidism * pregnancy or trying to become pregnant in the next 6 months * history of alcohol or drug abuse within the past 6 months as self-reported * epilepsy * suffering from severe depression (with a score \>30 in the beck depression inventory) * history of unexplained fainting spells as self-reported * head injury resulting in more than a momentary loss of consciousness * history of neurosurgery as self-reported * use of antiepileptic and/or hypnotic medications like carbamazepine, valproate acid, gabapentin, zolpidem, etc. * use of medication with potential cardiovascular influence * active smoker, or history of smoking in the last 6 months * skin lesion or open wounds around or in area of electrode application * tattoos in upper limb or along the nerve tract