Kornimate/medical-research-clean huggingface dataset:
an assessment of residual spherical aberration, postoperative total high order aberrations, and functional vision correlation following intraocular lens (iol) implantation

Conditions: Cataracts

Summary: the purpose of this study was to evaluate total residual spherical aberration (tsa) post-iol implantation, and to determine if an association exists between tsa, postoperative high order aberrations (hoa), and functional vision following iol implantation in patients grouped by pre-operative corneal spherical aberration (csa).

patients will be grouped by pre-operative corneal spherical aberration (csa) measures, i.e., ≤0.230 micron and ≥0.270 micron.

Eligibility criteria:
inclusion criteria: * age-related cataract grade 3 or lower in at least one eye; * planned cataract removal via phacoemulsification with an implantation of an aspheric iol; * able to have an operation within 30 days of preoperative evaluation; * good ocular health, with the exception of cataracts; * ≤ 1.50 diopter (d) of preoperative astigmatism by keratometry; * willing and able to understand and sign an informed consent; * willing and able to attend postoperative examinations per protocol schedule; * able to achieve 6.5mm dilated pupil; * other protocol-defined inclusion criteria may apply. exclusion criteria: * preoperative ocular pathology as specified in protocol; * preoperative corneal pathology as specified in protocol; * keratometric astigmatism exceeding 1.50 diopter; * planned postoperative refraction for mono-vision; * uncontrolled diabetes; * use of any systemic or topical drug known to interfere with visual performance; * contact lens use during the active treatment portion of the trial; * any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis; * any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results; * participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial; * intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye; * pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control; * other protocol-defined exclusion criteria may apply.

Keywords: intraocular lens cataracts total residual spherical aberration high order aberrations
neurodynamic interventions for multiple sclerosis

Conditions: Multiple Sclerosis

Summary: a randomized, parallel-group, clinical trial will be conducted to compare the immediate effects of the inclusion of a neurodynamic intervention into a multimodal physiotherapy program on pressure pain sensitivity, pain and manual dexterity in patients with multiple sclerosis


Eligibility criteria:
inclusion criteria: * a diagnosis of multiple sclerosis according to the modified mcdonald criteria; * symptoms of paresthesia and lack of sensitivity in the upper extremity; * expanded disability status scale (edss) between 0 and 6.5 points; * absence of cognitive deficit. exclusion criteria: * any exacerbation of multiple sclerosis during the previous 3 months; * previous hand surgery or steroid injections treatment in the upper extremity; * multiple diagnoses on the upper extremity (e.g., cervical radiculopathy); * cervical, shoulder, or upper extremity trauma; * other comorbid musculoskeletal medical conditions; * mini-mental state examination \<25

Keywords: neurodynamics pain
characterization of immunogenicity of tnf inhibitors in arthritis patients with poorer treatment response.

Conditions: Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylitis, Ankylosing

Summary: the aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (tnfis) can be explained by high degree of inflammation, human leucocyte antigen (hla) type, autoantibodies, tnf and tnfi concentration and presence of ada.

tumor necrosis factor inhibitors (tnfis) have been uses with success since 1999 in denmark in treatment of various inflammatory diseases, eg. rheumatoid arthritis (ra), chrohn's disease, psoriasis, psoriatic arthritis (psa) and ankylosing spondylitis (as). tnfis block a central cytokine in the inflammatory process, tumor necrosis factor (tnf). because the drugs are large proteins, they are prone to trigger an immune response and elicit anti-drug antibodies(ada). epidemiologic studies have revealed that groups of patients (women, tobacco smokers, obese patients) with inflammatory rheumatic diseases have a lower response to tnfis. the reasons for this are not fully elucidated. the hypothesis is that immunogenicity and changed pharmacokinetic of tnfi are causes of the inferior response. the investigators will carry out a prospective clinical studies of 120 arthritis patients (ra, psa and as) initiating treatment with adalimumab or infliximab. the patients will be followed for 12 months and will be registered in danbio as normal praxis. blood samples will be collected at baseline, 2, 4 and 12 months or at termination of the treatment. genotypes, autoantibodies, inflammation markers, tnfi and ada will be measured. the aim of the study is to explore: a: if differences between men and women with respect to different markers of inflammation, human leucocyte antigen (hla), autoantibodies, tnfi concentration and presence of adas can explain the lower response and adherence to the treatment among women. b: if differences between smokers and non-smokers with respect to different markers of inflammation, hla, autoantibodies, tnfi concentration and presence of adas can explain the lower response and adherence to the treatment among patients with arthritis who smoke tobacco. c: if differences between obese and normal weight patients with respect to different markers of inflammation, hla, autoantibodies, tnfi concentration and presence of adas can explain the lower response and adherence to the treatment. the study will contribute with new knowledge, which hopefully can make the treatment more personalized and efficient.

Eligibility criteria:
inclusion criteria: * patients \> 18 years * diagnosed with ra, psa or as. * starting treatment with infliximab or adalimumab. * co- treatment with csdmard or glucocorticoid is acceptable. * no new bdmard is initiated at the time of sampling. exclusion criteria: -
evaluation of the effect of polyvinylpyrolidone and sodium hyaluronate gel on palatinal wound healing

Conditions: Palatal Wound

Summary: the aim of this clinical study was to evaluate the effect of polyvinylpyrrolidone sodium hyaluronate gel on palatal wound healing, pain, and bleeding after free gingival graft surgery. this study included 32 systemically healthy patients who required free gingival graft surgery. after the operation, the test group received polyvinylpyrrolidone sodium hyaluronate gel in addition to chlorhexidine gluconate mouthwash, whereas the control group received only chlorhexidine gluconate mouthwash. vas scale was used to evaluate palatal pain, burning, and chewing discomfort, whi was used to evaluate wound healing, and h2o2 foaming test was used to evaluate epithelialization. vas and bleeding values were recorded on postoperative day 1; vas, whi, h2o2, and bleeding values on postoperative days 3, 7, and 14; and whi, h2o2, and bleeding values on postoperative day 28.


Eligibility criteria:
inclusion criteria: * able to adapt to the study, not having a physical or psychological condition that would prevent surgical procedure under local anesthesia, and being able to follow the planned operation and control sessions * patients who consciously accept and sign the detailed informed consent form regarding the study that will be explained to them verbally * insufficiently attached gingiva on the mandibular or maxillary vestibular teeth and implant surfaces exclusion criteria: * presence of infection and inflammation in the recipient and donor area * presence of systemic disease * women who are pregnant, suspected of being pregnant or breastfeeding * smoking * orofacial neurological symptoms

Keywords: wound heali̇ng sodium hyaluronate polyvinylpyrrolidone free gingival graft palatal
study to compare resection versus preservation of the middle turbinate in surgery for nasal polyps

Conditions: Nasal Polyps; Sinusitis

Summary: endoscopic sinus surgery (ess) has become the standard of care for patients suffering of chronic rhinosinusitis with nasal polyposis (crswp) who have failed medical therapy. the goal of surgery is now to widely marsupialize the sinus cavities in order to optimize topical steroid irrigation treatment in the postoperative period. with that being said, the true extent of surgery needed for optimal patient outcome has yet to be elucidated. more specifically, in the last 30 years, people have argued about the best way to manage the middle turbinate. some state that it should be preserved at all times to protect the sinus cavities from inhaled irritants and allergens and keep this surgical landmark untouched for future surgeries. on the other hand, there are defenders of routine resection of this turbinate, whether it is affected by polypoid changes or not. many studies have looked at the potential risks of resecting the middle turbinates such as iatrogenic frontal sinusitis, anosmia, or atrophic rhinitis but the more recent literature does not show such significant associations. a recent topic of debate is whether partial removal of the anterior and inferior portion of the middle turbinate affects nasal polyps recurrence or improves long-term outcomes by further facilitation of post-operative topical therapies. some retrospective data has shown that its resection could prolong the time before the need for revision surgery and improve both endoscopic and olfaction scores. a few prospective studies have also been published but unfortunately none of these were randomized, thus introducing a significant selection bias. thus, there is a need for a formal randomized, controlled trial to elucidate this question.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic rhinosinusitis with nasal polyposis * obtained consent for bilateral complete endoscopic sinus surgery (maxillary antrostomy, complete sphenoethmoidectomy and frontal recess surgery) * primary or revision surgery exclusion criteria: * allergic fungal sinusitis * patients with previous surgery which included partial or complete middle turbinectomy, uni- or bilateral * pregnant or lactating women
clinical effect of a nasal former in nasal deformities

Conditions: Nose Deformity

Summary: investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery. * trial with medicinal product


Eligibility criteria:
inclusion criteria: * healthy adults with skewed, humped or broad nose, who are able to attend all follow-ups exclusion criteria: * inability to keep the research plan * allergies to components of the nasal brace * diseases of the bone metabolism * medication affecting bone metabolism * drugs or alcohol abuse
prospective single-center long-term follow-up study of a series of cases previously included in the qualvidon study

Conditions: Dry Eye; Neuropathic Pain

Summary: dry eye affects millions of people around the world. some dry eye patients complain of neuropathic eye pain that can affect their quality of life. from august 2016 to june 2017, the qualvidon study (nct03296111), conducted at the adolphe de rothschild foundation hospital, assessed pain and its impact on quality of life using self-administered questionnaires in a series of dry eye patients. this 2nd study, entitled qualvidon2, focuses on the outcome of patients previously included in qualvidon.


Eligibility criteria:
inclusion criteria: * patients previously included in the qualvidon study with the following characteristics: * with characteristics of idiopathic neuropathic eye pain associated with dry eye * give informed consent * affiliated or beneficiary of the french social security exclusion criteria: * pregnant or nursing woman * patient under legal protection

Keywords: dry eye neuropathic eye pain quality of life
a research study to compare a new medicine oral semaglutide to a dummy medicine in children and teenagers with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). semaglutide will be tested to see how well it works compared to the dummy medicine. the study will also test if semaglutide is safe in children and teenagers. participants will either get semaglutide or the dummy medicine - which one is decided by chance. participants will take 1 tablet of the study medicine every morning on an empty stomach. they have to wait 30 minutes before they eat, drink or take any other medication by mouth. the study will last for about 1 year and 3 months (66 weeks). participants will have 12 clinic visits and 8 phone calls with the study doctor. at all 12 clinic visits, participants will have blood samples taken. participants will also be asked some questions.


Eligibility criteria:
inclusion criteria: * informed consent from parent(s) or legally acceptable representative (lar) and child assent from the subject obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * male or female, aged 10 to below 18 years at the day of randomisation * hba1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive) * diagnosed with type 2 diabetes mellitus according to the american diabetes association criteria and treated with: * stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening) or * stable metformin dose and a stable dose of basal insulin (stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed) or * stable dose of basal insulin exclusion criteria: * diagnosis of type 1 diabetes * maturity onset diabetes of the young (mody) * positive insulinoma associated-protein 2 (ia-2) antibodies or anti-glutamic acid decarboxylase (anti-gad) antibodies.
a study of ly3007113 in participants with advanced cancer

Conditions: Metastatic Cancer

Summary: this study evaluates the safety and tolerability of different doses of an experimental treatment in participants with advanced cancer.


Eligibility criteria:
inclusion criteria: * have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic for which available standard therapies have failed to provide clinical benefit for their disease * for dose escalation (part a): cancer, either a solid tumor or a lymphoma * for dose confirmation (part b): cancer, either a solid tumor or a lymphoma * have the presence of measureable or non-measureable disease (part a) or measureable disease (part b) as defined by the response evaluation criteria in solid tumors or the revised response criteria for malignant lymphoma * have adequate hematologic, hepatic and renal function * have a performance status less than or equal to 2 on the eastern cooperative oncology group scale * have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents * have an estimated life expectancy of greater than or equal to 12 weeks * are able to swallow capsules exclusion criteria: * have an echocardiogram with clinically significant abnormalities * for dose escalation (part a): have central nervous system malignancy or metastasis * for dose confirmation (part b): have symptomatic central nervous system malignancy or metastasis * have an acute leukemia * have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and stopped all therapy for that disease for a minimum of 3 years * have received an autologous or allogeneic stem-cell transplant within 75 days of the initial dose of study drug
cognitive behavioural therapy for social phobia in people with bipolar disorder

Conditions: Social Phobia; Bipolar Disorder

Summary: we are doing this study to find out how well cognitive behavioural therapy for social phobia works in people with bipolar disorder, who also have social phobia.

social phobia is a very prevalent anxiety disorder in people with bipolar disorder and is associated with adverse outcomes. yet, social phobia is treatable by cognitive behavioural therapy or antidepressant medication. as antidepressants are often contra-indicated in people with bipolar disorder, cognitive behavioural therapy is the likely first choice treatment for social phobia in this population. however, people with bipolar disorder were excluded from previous clinical trials on treatment of social phobia. our aim is to evaluate the acceptability and to provide a rough estimate of efficacy of cognitive behavioural therapy protocol for social phobia in people with bipolar disorder in a systematic case series. we will also prepare pilot data for evaluating the impact of treatment of comorbid social phobia on the long-term course of bipolar disorder.

Eligibility criteria:
inclusion criteria: * a diagnosis of bipolar disorder i or ii according to dsm-iv criteria and established in a structured interview * bipolar disorder in remission for at least 12 weeks; defined as absence of depressive or manic episode according to dsm-iv criteria established in a structured interview and confirmed by montgomery-åsberg depression rating scale score ≤ 12 and young mania rating scale score ≤ 7 * stable medication regime for at least 4 weeks prior to commencing cbt * current diagnosis of social phobia according to dsm-iv criteria and established in a structured interview, including duration of social phobia of at least 6 months irrespective of age. * social phobia is one of the primary complains (when bipolar disorder is in remission), justifying a therapeutic focus on this disorder. * ability and willingness to consent to treatment * ability to speak and write english exclusion criteria: * current substance use disorder * a previous adequate course of cbt for social phobia (at least 8 sessions) delivered by a trained therapist * currently receiving any psychological therapy * cognitive impairment that would preclude psychological therapy * actively suicidal

Keywords: social phobia bipolar disorder cognitive behavioural therapy
study of tlk199 tablets in myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndrome (MDS)

Summary: the purpose of this study is to determine the safety and efficacy of tlk199 tablets in patients with myelodysplastic syndrome (mds)

this phase 1-2a study is an open label, dose-ranging study of tlk199 tablets in patients with all world health organization or french-american-british classification types of myelodysplastic syndrome (mds). in phase 1, the safety, pharmacokinetics, and hematologic response rate with tlk199 tablets will be evaluated. the phase 1 dose-ranging stage is designed to determine the maximum tolerated dose or optimal biologic dose of tlk199 tablets. evaluation of the pharmacokinetics of tlk199 tablets will be conducted. in phase 1, an additional 12 patients will undergo pharmacokinetic evaluation under fed conditions at the selected phase 2a dose. in phase 2a, further safety and hematologic responses by the modified international working group mds response criteria will be studied.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of mds * documented significant cytopenia for at least 2 months * adequate liver and kidney function * ineligible for stem cell bone marrow transplantation * at least 18 years of age * discontinuation of growth factors (e.g., g-csf) within 3 weeks of study entry exclusion criteria: * prior bone marrow transplant * failure to recover from any prior surgery or any major surgery within 4 weeks of study entry * pregnant or lactating women * other investigational drugs within 14 days of study entry * chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
ftih of ecc5004 in healthy and diabetic participants

Conditions: Type 2 Diabetes Mellitus

Summary: this is a phase 1, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study of ecc5004 in healthy participants and in patients with type 2 diabetes mellitus

this study will be conducted in two cohorts of single ascending dose (sad) with a dose range from 1mg to 300mg, and in four cohorts of multiple ascending dose (mad) with a dose range of 10mg to 150mg to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ecc5004 in healthy participants and in patients with type 2 diabetes mellitus

Eligibility criteria:
inclusion criteria: * healthy male and female participants of non-childbearing potential * age of 18 to 65 years * bmi of 18.0 to 32.0 kg/m2 * hemoglobin a1c ≤ 6.0% * female participants who are postmenopausal, confirmed by fsh test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence * male participants agree to use contraception, or agree to practice true abstinence * no clinically significant findings in physical examination, 12-lead electrocardiogram (ecg), vital sign measurements, laboratory tests, or medical/psychiatric history * able to understand and sign and date informed consent additional inclusion criteria for part 2 (mad) * diagnosed type 2 diabetes mellitus of 18 to 70 years of age inclusive * type 2 diabetes mellitus with lifestyle modification only or with stable dose of metformin for ≥ 2 months prior to the study treatment * bmi of 24.0 to 40.0 kg/m2 with a minimum body weight of 50.0 kg (110 lbs) * hba1c ≥ 7.0% and ≤ 10.5%, and fasting plasma glucose ≤ 270 mg/dl * blood pressure (bp) with or without medication: systolic bp ≤ 160 mmhg, and diastolic bp ≤ 100 mmhg * not taking any active treatment regimen exclusion criteria: * concomitant participation in any investigational study of any nature * blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing * unable to refrain from taking any non-metformin anti-diabetic medication including insulin within ≥ 3 months prior to the study treatment * serum calcitonin \> 20 ng/l * clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems * diagnosis of t1dm or secondary forms of diabetes * individual or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia 2 (men2), or suspected mtc * history of pancreatitis * significant allergic reaction to active ingredients or excipients of the study drug. * any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the investigator would prevent the participants from participating in the study.