Kornimate/medical-research-clean huggingface dataset:
posterior capsule opacification study

Conditions: Cataract

Summary: first object is to compare square edge pmma with round edge pmma iol where the materials are same. next objective is to compare square edge pmma iol with acrysof iol where the materials are different

cataract is the vision impairing disease characterized by gradual, progressive thickening of the lens. posterior capsular opacification (pco) remains the most frequent long term complication. this is initiated by the migration and proliferation of residual lens epithelial cells from the lens equator in the space between the posterior capsule and intraocular lens (iol) the combination of iol material and a sharp edged design is effective in preventing pco. aurolab has developed 360 degree square edge iol with polymethyl methacrylate (pmma) 100 bilateral senile cataract patients are going to be recruited. first group of 50 patients will receive square edge pmma in one eye and round edge pmma in fellow eye. another group of 50 patients will receive square edge pmma in one eye and acrysof in fellow eye. pco will be assessed during each follow up using epco software.

Eligibility criteria:
inclusion criteria: * age 40 to 65 years * bilateral senile cataract * pupil should be at least 7mm dilated * nuclear sclerosis grade i, ii and iii * patient willing for second eye surgery within 3 months exclusion criteria: * debilitated old patients * cardiac and serious illness * intraoperative complications including pc rent, zonular dialysis and rhexis tear * inherent zonular weakness * glaucoma patients * relative afferent papillary defect (rapd) * shallow anterior chamber * pseudoexfoliation * traumatic cataract * uveitis and complicated cataract * one eyed patients * corneal pathology * post segment pathology including diabetic retinopathy * dense posterior subcapsular cataract (pscc) and posterior polar cataract (ppc) * high myopic and hyperopic patient

Keywords: double-blind method clinical trials, randomized lenses, intraocular prospective studies pmma visual acuity
study to assess safety, tolerability and pharmacokinetics of apx001 administered by intravenous infusion to healthy subjects

Conditions: Fungal Infection

Summary: first in human (fih), randomized, double-blind, placebo-controlled single ascending dose (sad) and multiple ascending dose (mad) escalation study of approximately 80 subjects. the sad portion of the study will enroll six cohorts of eight healthy subjects per cohort, for a total of approximately 48 healthy subjects. the mad portion of the study will enroll four cohorts of eight healthy subjects per cohort, for a total of approximately 32 healthy subjects.


Eligibility criteria:
inclusion criteria: * women of childbearing potential must agree to avoid pregnancy during the study and to use contraception at least 2 weeks before the start of the study until 3 months after the last dose of study drug. * males with partner(s) of childbearing potential must agree to use appropriate barrier contraception from the screening period until 3 months after the last dose of study drug. * screening hematology, clinical chemistry, coagulation and urinalysis consistent with overall good health. * no significantly abnormal findings on physical examination, ecg and vital signs. * willing and able to provide written informed consent. exclusion criteria: * any uncontrolled or active major systemic disease including, but not limited to: cardiovascular, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential. * history or presence of malignancy within the past year. subjects who have been successfully treated with no recurrence of basal cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled. * use of prescription medication within 14 days prior to the first dose of study drug and throughout the study. * use of non-prescription or over-the-counter medications within 7 days prior to the first dose of study drug and throughout the study. * positive results on any of the following screening laboratory tests: serum pregnancy test, urine alcohol test, urine drugs of abuse, hepatitis b surface antigen, hepatitis c antibody, and human immunodeficiency virus (hiv) antibody.
efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy

Conditions: Cervical Radiculopathy

Summary: this intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. it is a randomized, parallel, 2-arm superiority trial study. the study will be conducted at the district general hospital in trincomalee, where patients with cervical radiculopathy seek medical care. patients who refer to the department of physical medicine (dpm) from the out patients department (opd), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. the study details will be explained to the subjects in the language that they best understand. written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly.


Eligibility criteria:
inclusion criteria: * 35-60 years * neck pain \> 3 months * clinical prediction rules - positive spurling's test (+) distraction test (+) upper limb tension test a (+) cervical rotation on affected side \< 60 exclusion criteria: presence of any signs or symptoms of medical red flags * less than 3(positive) items for the cpr * bilateral arm radiating pain * osteoporosis * tumor * whiplash injury * pregnancy woman * rheumatoid arthritis * post-surgery to cervical/thoracic spine
belgian screening project for the detection of anderson-fabry disease in hypertrophic cardiomyopathy

Conditions: Left Ventricular Hypertrophy

Summary: the purpose of this study is to determine the prevalence of fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography.this study is a screening study


Eligibility criteria:
inclusion criteria: * all patients over 18 years undergoing a routine echocardiography in the participating hospitals * both genders will be considered. * patients can be included if on 2d echocardiography the maximal septal wall thickness \> 13 mm and/or the posterior wall thickness \> 13 mm. the limit for inclusion is kept relatively low to detect early forms of fabry cardiomyopathy.

Keywords: fabry-anderson disease gen mutation left ventricular hypertrophy
a clinical trial evaluating efficacy and safety of mc2-01 cream

Conditions: Psoriasis Vulgaris

Summary: this trial is a randomized, investigator-blind, multicentre, vehicle- and comparator-controlled, parallel-group trial with the purpose of evaluating efficacy, safety and convenience of the mc2-01 cream.

the mc2-01 cream is designed for optimal patient satisfaction - it quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on in daily routines. in this trial, the mc2-01 cream will be compared to a marketed product cal/bdp combination and vehicle. the purpose of the trial is to compare the clinical efficacy, safety, and convenience of this cream to the marketed product. the trial will include a 8-week treatment period.

Eligibility criteria:
inclusion criteria: * provided written informed consent * generally healthy males or non-pregnant females, of any race or ethnicity, who are at least 18 years of age at the time of screening * have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6 months duration that involves the trunk and/or limbs that is amenable to topical treatment with a maximum of 100 g of trial medication per week * have a pga of disease severity of mild or moderate on the body (trunk and/or limbs) * an mpasi score of at least 2 * have a treatment area involving 2- 30% of the body surface area (bsa) exclusion criteria: * current diagnosis of unstable forms of psoriasis * other inflammatory skin disease in the treatment area that may confound the evaluation of the psoriasis vulgaris * presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the treatment areas * planned exposure to either natural or artificial sunlight * history of hypersensitivity to any component of the test product or reference product * current or past history of hypercalcemia, vitamin d toxicity, severe renal insufficiency, or severe hepatic disorders * systemic treatment with biological therapies * use of systemic treatments that suppress the immune system and other systemic chemotherapeutic antineoplastic therapy within 4 weeks prior to the baseline visit and during the trial * use of phototherapy within 4 weeks prior to visit 1/baseline and during the trial; * use of topical treatments, except for emollients and non-medicated shampoos, with a possible effect on psoriasis within 2 weeks prior to visit 1/baseline * clinical signs of skin infection with bacteria, viruses, or fungi * known human immunodeficiency virus (hiv) infection * any chronic or acute medical condition that may pose a risk to the safety of the subject, or may interfere with the assessment of safety or efficacy in this trial
four dimensions in schizophrenia

Conditions: Schizophrenia

Summary: observational, non-interventional, longitudinal, prospective,multicenter, open label (no treatment is involved). 4 assessment will be carried out , in months 0, 1, 3 and 6. the primary objective is to asses evolution of subjective well-being and depressive symptoms in schizophrenic patients for six months after an acute episode treated in outpatient psychiatric units. the primary endpoint is: total score in subjective well-being under neuroleptic treatment (swn-k) and calgary depression rating scale (cdrs) scales in assessment after 6 months vs baseline. secondary objectives include: to evaluate the relationship between subjective well-being and psychopathology, subjective clinical global impression, adverse events and compliance of treatment. also to compare the clinical global impression of psychiatrist and patient. in addiction to know the clinical, social and demographic factors involve in the subjective well-being and patient clinical global impression.


Eligibility criteria:
inclusion criteria: * provision of written inform consent * diagnosed of schizophrenia of schizoaffective disorder based on dsm-iv-tr * with an acute episode or worsening of clinical status. defined as change in clinical status that need a significant change in therapeutic plan. * able to understand and comply with requirements of the study exclusion criteria: * mental retardation * unstable somatic disease, that is not receiving adequate treatment, based on investigator opinion. * to have been recruited in a clinical trial in the last 4 weeks * to have planned the inclusion in a clinical trial during the follow-up of this study

Keywords: schizophrenia subjective well-being depressive symptoms schizophrenia course
monoclonal antibody therapy in treating patients with progressive small cell lung cancer (sclc)

Conditions: Lung Cancer

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: this phase i trial is studying the side effects of monoclonal antibody therapy in treating patients with progressive small cell lung cancer (sclc).

objectives: primary * determine the targeting, tissue distribution, and pharmacokinetics of monoclonal antibody hu3s193 in patients with progressive small cell lung cancer (sclc). secondary * determine the immunogenicity of of monoclonal antibody hu3s193 in patients with progressive small cell lung cancer (sclc). * determine tumor response of monoclonal antibody hu3s193 in patients with progressive small cell lung cancer (sclc). * determine the safety of tof monoclonal antibody hu3s193 in patients with progressive small cell lung cancer (sclc). outline: this is an open-label, pilot study. patients received monoclonal antibody hu3s193 (mab hu3s193) intravenously (iv) over 30 minutes on day 1 of weeks 1-4. patients also received indium-111 (111in) radiolabeled hu3s193 iv over 30 minutes on day 1 of weeks 1 and 4 and then underwent gamma camera imaging. treatment continued in the absence of disease progression or unacceptable toxicity. patients were followed at 1 and 4 weeks, every 3 months for 1 year, and then every 6-12 months thereafter.

Eligibility criteria:
inclusion criteria: small cell lung cancer, pathologically confirmed. measurable disease, including at least one lesion measuring ≥ 2 cm that has not been previously irradiated. progression of disease after one, two, or three prior chemotherapy regimens. at least 4 weeks since the last chemotherapy or radiation treatment. karnofsky performance status ≥ 70% (ecog 0 or 1). the following laboratory results within the last 2 weeks prior to study day 1: white blood cell count (wbc) ≥ 3,500/mm3; platelet count ≥ 100 x 10\^9/l; serum creatinine ≤ 2.0 mg/dl; serum bilirubin ≤ 2.0 mg/dl; international normalized ratio (inr) ≤ 1.3; women of childbearing potential with confirmed negative quantitative serum hcg on the day of administration of study agent. negative stool guaiac test (read by laboratory). tumor tissue positive for lewis y expression. exclusion criteria: clinically significant cardiac disease (new york heart association class iii/iv). uncontrolled brain or leptomeningeal metastases. gi bleed within the preceding 6 months. patients with history of receiving mouse monoclonal antibody. participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. women who are pregnant or breast-feeding.

Keywords: recurrent small cell lung cancer (sclc)
community study- a study to collect information for the cordio system

Conditions: Heart Failure

Summary: this is a multi-center, observational, non-interventional, prospective, single-arm, open study for database establishment for r\&d purposes. r\&d data will be analyzed retrospectively in order to validate algorithm efficacy. the study will be conducted in the following settings: outpatinets clinics


Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. symptomatic heart failure patient. 3. the patient is willing to participate as evidenced by signing the written informed consent. 4. male or non-pregnant female patient. exclusion criteria: 1. subject who, in the investigator's opinion, unable to comply with the daily use of the app due to mental disorders (e.g., depression, dementia). 2. patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit. 3. patient with severe alcohol or drug use. 4. psychological instability, inappropriate attitude or motivation. 5. patient with life threatening debilitating disease other than cardiac. 6. subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
application of circulating extracellular vesicles in early disease assessment and prognosis after traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the purpose of this study was to observe the relationship between the changes of circulating extracellular vesicles and disease development and outcome in patients with traumatic brain injury, and to find early serum markers and potential intervention targets for disease monitoring in patients with traumatic brain injury. in addition, explore the source of extracellular vesicles as much as possible to prepare for subsequent basic experiments.

to compare the changes of molecular markers and circulating-related cell phenotype molecules in the serum of patients with traumatic brain injury, to observe the relationship between the changes of circulating extracellular vesicles and the development and outcome of the disease in patients with traumatic brain injury, and to search for early serum markers of patients with traumatic brain injury and potential interventions.

Eligibility criteria:
inclusion criteria: 1. no systematic treatment before admission; 2. the patient is diagnosed with traumatic brain injury with imaging evidence; 3. age \> 18 years old; 4. the patient or family members agree to sign the informed consent. exclusion criteria: 1. infectious diseases within the past 1 month; 2. past head trauma, history of neurological diseases; 3. non-isolated traumatic brain injury; 4. the patient is not receiving treatment in this hospital; 5. severe disability, dementia, or organ dysfunction before the onset of the disease; 6. subject refuses to participate.

Keywords: molecular markers prognosis inflammation peripheral circulation
improving parental psychosocial functioning and early developmental outcomes in children with sickle cell disease

Conditions: Sickle Cell Disease; Cognitive Ability, General; Psychological Stress; Parenting

Summary: there are all significant risk factors for poor early cognitive development and, as such, neurocognitive deficits have been demonstrated in pre-school children with sickle cell disease (scd). this project assesses the efficacy of using an evidence-based early stimulation program, combined with components to help parents cope with stress, delivered during six routine monthly clinic visits to parents of children with sickle cell disease. it is hoped that this innovation will improve parental psychological outcomes, as well as child developmental outcomes.

children with sickle cell disease (scd) are at risk of various complications, many of which arise suddenly and call on the problem solving skills of their parents. they are also at risk of neurocognitive delays; these may become evident during the pre-school years. previous research by this group has demonstrated improved developmental outcomes after parental interventions incorporating play techniques in high risk and healthy pre-school children. the aim of the study is to determine usefulness in children with scd of similar developmental interventions augmented by lessons in problem solving. the study is a randomized controlled trial. parents of all infants with hb ss (homozygous sickle cell disease) or sβ0 -thalassemia disease identified by newborn screening during the initial year of the study will be invited to participate. they will be randomized to intervention or control. parental stress, infant's development and hemoglobin levels will be measured at recruitment and again after six months. the intervention will occur during monthly penadur (intramuscular benzathine penicillin) visits and will include supervised play with their children using an inexpensive toy and participation in solving a problem which may arise as they parent their child with scd. at the end of the study, all control dyads will also be given the toys used in the intervention. all parents will be given the results of their children's developmental assessments and appropriate referrals made if deficits are identified. the study is minimal risk. every effort will be made to maintain patient confidentiality. respect for, and the maximum protection of the best interests of the research subjects will be maintained.

Eligibility criteria:
inclusion criteria: * infant has sickle cell disease: ss or sβ0 thalassemia * attending sickle cell unit, jamaica for routine care exclusion criteria: * none

Keywords: scd early childhood intervention parental stress neurocognition
post-market follow up study on paragon crt® 100 (paflufocon d)

Conditions: Myopia

Summary: the main objective of this post market clinical study is to evaluate the effectiveness and safety of the paragon crt®100 contact lens.

this clinical study has two phases: prospective and retrospective. prospective phase - evaluates the post-market long-term effectiveness and safety of the paragon crt® 100 contact lenses, for temporary myopic refractive power reduction with minimum 12-month period follow-up. retrospective phase - evaluates the post-market long-term safety of the paragon crt® 100 contact lenses, for temporary myopic refractive power reduction.

Eligibility criteria:
inclusion criteria: 1. patient contact lens refraction should fit within the available parameters of the study lenses (spherical power within -4.00d and the cylinder power within 1.50d). 2. is willing to comply with the wear and visit schedule. 3. is willing to participate and signed the informed consent form. exclusion criteria: 1. age under 8 years old 2. any ocular abnormalities, undergone corneal surgery, or history of ocular trauma, active corneal infections (corneal inflammation), corneal curvature less than 40.00d or more than 46.00d 3. best corrected visual acuity less than 1.0d 4. pregnant, lactating or near-pregnancy 5. the eye has the following conditions: 1. acute and subacute inflammations or infection of the anterior segment of the eye 2. any eye disease, injury, or abnormality that affects the cornea, conjunctiva or eyelids, e.g. dacryocystitis, conjunctivitis, blepharitis and other inflammation, glaucoma, etc. 3. severe insufficiency of tears (tbut≤5s). 4. allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to care 5. any active corneal infection (bacterial, fungal or viral). 6. manifested strabismus 7. abnormal intra-ocular pressure 8. suffering from systemic diseases, resulting in low immunity, or affecting corneal re-shaping (such as acute and chronic sinusitis, diabetes, down syndrome, rheumatoid arthritis, mental patients, etc.) 9. under medications or long-term medications that lead to dry eye with clinical signs or affects vision and corneal curvature. 10. examination result indicate any contraindication or not suitable for orthok lens wear 11. participated in pharmaceutical clinical study 3 months before the date of the screening or participated any other medical devices research study within 30 days of the screening 12. only eye fulfills inclusion criteria 13. history of any ocular operations 14. unable to follow investigator's instruction 15. any other condition not suitable for the study per investigator's judgement