Kornimate/medical-research-clean huggingface dataset:
automated retinal image analysis system (eyequant) for computation of vascular biomarkers

Conditions: Mild Cognitive Impairment; Alzheimer Disease; Vascular Dementia

Summary: this study aims to provide clinical validation of eyequant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, alzheimer's disease, and vascular dementia.


Eligibility criteria:
inclusion criteria: - patients older than 18 years and diagnosed with mild cognitive impairment (mci), alzheimer's disease (ad), or vascular cognitive impairment and/or dementia (vad). exclusion criteria: * children and subjects with other diagnoses than those mentioned in the inclusion criteria. * patients without the means to visit the clinic on the assigned dates. * patients who are pregnant or are expecting to become pregnant.
drug to drug interaction study with asp1941 and metformin

Conditions: Type 2 Diabetes Mellitus

Summary: a study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when asp1941 is administered as add-on therapy to metformin.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * stable disease under metformin monotherapy (between 1500-3000 mg/day) or dual therapy with metformin (1500-3000 mg/day) and a sulfonylureum derivative (sud) for at least 3 months * fasting serum glucose: 7-11.5 mmol/l (after wash-out) * stable fasting blood glucose (fbg) at the end of wash-out * bmi between 18.5 and 40.0 kg/m2, inclusive exclusion criteria: * subjects with type 1 diabetes * any diabetes related macro-complications, painful diabetic neuropathy, diabetic macular edema or diabetic proliferative retinopathy * clinical significant renal disease (clcr \<60 ml/min as assessed during a 24h creatinine clearance on day-2 * recent evidence (e.g. within the last 6 months) of severe hypoglycemia, for example plasma glucose \<3 mmol/l (\<55 mg/dl) or requiring hospitalization * pulse \ 90; systolic blood pressure \>160 mmhg; diastolic blood pressure \> 100 mmhg

Keywords: pharmacokinetics metformin drug to drug interaction asp1941
evaluation patient satisfaction after passive bladder catheter removal compared to active removal

Conditions: Urologic Diseases

Summary: in usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. the nurse deflates the balloon and removes the catheter from the urethra by manual traction. to date, there are no solid data on the impact of passive catheter removal on patient satisfaction. it is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. the effect on pain and anxiety will also be compared between the two techniques. the methodology used was that of an open-label randomized controlled trial.


Eligibility criteria:
inclusion criteria: 1. male ≥ 18 years old 2. with an indwelling urinary catheter placed after any of the following procedures: a uro-endoscopic surgery from the list below: * endoscopic prostate resection (or transurethral prostate resection). * laser prostate enucleation * prostate thermotherapy by radiofrequency * a high-intensity focused ultrasound treatment for prostate cancer * cervico-prostatic incision or internal urethrotomy * endoscopic/transurethral resection of bladder tumor (turbt) * surgical treatment of bladder stones, ureter stones (rigid ureteroscopy) and kidney stones (flexible ureteroscopy with laser stone fragmentation) 3. patient who has given written consent to participate exclusion criteria: 1. patient who is unable to perform intimate hygiene alone in a standing position 2. patient with a painful genital lesion 3. patient with an extended pelvic pathology 4. need to remove the indwelling urinary catheter at the patient's home instead of hospital 5. patient under guardianship or curator 6. patient unable to understand the objectives of the study or unwilling to comply with postoperative instructions

Keywords: bladder catheter
examination of foot posture's change on balance in different disorders

Conditions: Back Pain; Knee Osteoarthritis

Summary: foot; it is a terminal joint that opposes external resistance in the lower kinetic chain. it plays a primary role in weight transfer and ground response between the body and the ground.

to investigate the extent to which foot posture affects balance and foot function in different disease groups. the amount of studies examining the effect of the postural structure of the foot and balance seen in different disease groups in the literature is insufficient.

Eligibility criteria:
inclusion criteria; * being between the ages of 45 - 65, * volunteer. exclusion criteria; * having a musculoskeletal or neuromuscular disease that limits mobility, * presence of lower extremity sequelae,

Keywords: back pain knee osteoarthritis
korea post-marketing surveillance for xeljanz (registered) in ulcerative colitis patients

Conditions: Ulcerative Colitis

Summary: as required for new medications approved by the ministry of food and drug safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 september 2022). out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of xeljanz.

this is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in korean health care centers by accredited physicians (ie, investigators). the study population will be adult patients with moderately to severely active uc who have had an inadequate response or intolerance to the basic treatments or biological agents. clinical severity of ulcerative colitis is classified as mild, moderate, or severe based on the mayo score or partial mayo score. xeljanz will be administered according to the "dosage and administration" of the approved labeling. there is no visit or activity mandated by this study. the investigator will collect patient data and record the information on each patient's case report form (crf).

Eligibility criteria:
inclusion criteria: * adult ulcerative colitis patients with moderately to severely active disease who has received at least 1 dose of xeljanz according to the local labeling exclusion criteria: * patients meeting any of the following criteria as per local labeling will not be included in the study. 1. patients with a history of hypersensitivity to any ingredients of this product. 2. patients with serious infection (sepsis, etc.) or active infection including localized infection. 3. patients with active tuberculosis. 4. patients with severe hepatic function disorder. 5. patients with an absolute neutrophil count (anc) \<1,000 cells/mm3. 6. patients with a lymphocyte count \<500 cells/mm3. 7. patients with a hemoglobin level \<9 g/dl. 8. pregnant or possibly pregnant women. 9. because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.

Keywords: ulcerative colitis autoimmune diseases immune system diseases tofacitinib molecular mechanisms of pharmacological action jak inhibitor safety
vr-based remote rehabilitation for pediatric abi

Conditions: Acquired Brain Injury

Summary: the primary objective of this study is to evaluate the feasibility and effectiveness of an at-home program of vr-based vestibular and oculomotor rehabilitation on improving postural stability, ocular motility and activities of daily living for children with mild to severe abi


Eligibility criteria:
inclusion criteria: * they are alyn patients undergoing physiotherapy for mild to severe abi; * they experience symptoms of vestibular function such as vertigo, postural instability, or impaired ocular motility; * they are between the ages of 8 and 18; * the time since injury/event is between 10 days and 1 year after the injury/event; * they are able to maintain stable and dynamic positioning of the head; * they able to walk with or without assistive equipment, or use a wheelchairs with no need for head support, defined by a lss (level of sitting scale) score of 3 or greater (scale range: 1-8); * are able to understand basic instructions; * have sufficient visual acuity and visual field to identify and track mid-size objects on a screen. exclusion criteria: * psychological, neurological or cognitive disorders which could impede participation, such as a history of epileptic seizures; * untreated benign paroxysmal positional vertigo (bppv); * are in early post-operative stages (to avoid risk of bleeding or cerebrospinal fluid leak); * hearing impairment.

Keywords: pediatric
pet-ct and circulating tumor cells in colorectal cancer

Conditions: Colorectal Cancer; Metastasis

Summary: the purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and recist criteria.

1. to determine if measuring both tumor metabolic response (via fdg-pet scan) \& circulating tumor cells (cirtc) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (crc) who are undergoing first-line oxaliplatin-based chemotherapy. 2. to determine if a new method of assessing drug response (measuring tumor metabolic response via fdg-pet \& cirtc at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'response evaluation criteria in solid tumors' - recist).

Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer patients not received prior drug treatment for metastatic crc * age \>= 18 years * (ecog) performance status of 0-2 * measurable tumor sites by recist criteria * adequate bone marrow, renal \& hepatic functions exclusion criteria: * patients with diabetes mellitus * presence of hyperglycemia * pregnant or lactating patients

Keywords: identifying an early indicator of drug efficacy
investigation of the safety, tolerability and potential therapeutic effects of jnj-40411813 in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to explore the safety, tolerability, and potential clinical efficacy of jnj 40411813 in schizophrenic patients.

this is a first-in-human study of jnj-40411813 in schizophrenic patients who are not currently receiving antipsychotic drug treatment (referred to as "(sub) acute" patients) and in patients who are currently taking antipsychotic drug treatment (referred to as "stable" patients). the study will consist of 2 parts: part a and part b. part a will be open-label (patients will know the identity of study treatment), and (sub)acute schizophrenic patients will receive monotherapy (treatment with one drug) with jnj-40411813. part b will be double-blind (patient and study staff will not know the identity of study treatment) and will randomize (assign by chance) patients with stable but symptomatic schizophrenia to receive treatment with jnj-40411813 or a placebo (treatment identical in appearance to jnj-40411813 but does not contain active drug) as add-on therapy to their currently prescribed antipsychotic medication. parts a (jnj-40411813 monotherapy) and b (jnj-40411813 add-on therapy) will run simultaneously. patients will take jnj-40411813 and placebo capsules orally (by mouth) twice daily (bid) with a meal. part a: patients will take jnj-40411813 50 mg (1 capsule) bid up to 150 mg (3 capsules) bid for up to 12 weeks. part b: patients will take jnj-40411813 50 mg bid or placebo bid for 4 weeks. after 4 weeks, the dose of jnj-40411813 may be increased up to 150 mg bid for 6 weeks, and patients assigned to placebo may take jnj-40411813 50 mg bid to 150 mg bid for up to 10 weeks.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18 and 35 kg/m2 inclusive * medically stable on the basis of physical examination, medical history, vital signs, 12-lead ecg and clinical laboratory tests * in- or outpatients who have been diagnosed with schizophrenia according to diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) at least 1 year prior to screening. exclusion criteria: * a current dsm-iv axis i diagnosis other than schizophrenia * any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as crohn's disease, liver disease, or renal disease * relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases * panss score \ 120 * other significant and/or unstable systemic illnesses

Keywords: jnj-40411813
safety and effectiveness of azidothymidine (azt) in hiv-positive patients with hemophilia

Conditions: HIV Infections; Hemophilia A

Summary: the purpose of this study is to see if giving azidothymidine (azt) to hiv-positive patients with hemophilia is safe and if it is effective in lowering hiv levels and boosting the immune system. hiv infects and inactivates certain blood cells that are part of the body's immune system. the damage to the body's immune system can result in unusual infections and/or unusual forms of cancer. a large percentage of hemophiliacs are hiv-positive and there is a clear risk for the development of aids in these patients. azt may be effective in lowering hiv levels and boosting the immune system but its side effects are not understood in these patients.

there is a clear risk for development of aids in hemophilic patients. azt administration has been shown to inhibit hiv replication in vitro. patients taking azt have experienced fewer opportunistic infections and improvements in measures of immunity. the most common laboratory abnormalities observed with azt are hematologic. however, the clinical and laboratory toxicity of azt remains poorly understood in hemophiliacs. hepatitis and liver dysfunction are more common in this population compared to other groups at risk for hiv infection. because azt is largely metabolized in the liver, drug pharmacokinetics needs to be evaluated in this patient population. both hemophiliacs and non-hemophiliacs take azt for a period of 12 weeks. the first dose is administered intravenously. azt is then given orally every 4 hours while awake (5 doses per day). patients are evaluated by physical examinations and laboratory assessments. these include hiv culture of blood and leukocyte counts, lymphocyte counts, and lymphocyte subsets measured at study entry and every 4 weeks thereafter. patients are hospitalized for pharmacokinetic studies at study entry and at weeks 6 and 12. each of these studies involves both intravenous and oral administration within 48 hours of one another. blood is sampled at 0, 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours after each administration and urine is collected every 2 hours for 12 hours.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * have a bleeding disorder such as hemophilia a or b, a lack of factor viii (a blood clotting factor), or severe von willebrand's disease. * will be available for follow-up for at least a year. * are at least 12 years old (consent of parent or guardian required if under 18). * are willing to use an effective method of birth control during the study. exclusion criteria you will not be eligible for this study if you: * have a life-threatening opportunistic (aids-related) infection or aids-related symptoms. * have taken certain drugs within 30 days prior to study entry including chemotherapy and interferon. * are taking acetaminophen or drugs containing acetaminophen. * are pregnant or breast-feeding.

Keywords: drug evaluation zidovudine hemophilia a
prospective study of an investigational daily disposable contact lens

Conditions: Myopia

Summary: the purpose of this study is to evaluate the performance of an investigational daily disposable contact lens.


Eligibility criteria:
inclusion criteria: * subjects with normal eyes who are not using any ocular medications. * be of legal age of consent and sign informed consent document. if under legal age of consent, legally authorized representative must sign informed consent document and subject must sign assent document. * willing and able to wear spherical contact lenses for at least 5 days per week. * willing and able to wear spherical contact lenses within the available range of powers of -1.00 diopter(d) to -6.00d in 0.25d steps. * best spectacle-corrected visual acuity greater than or equal to 20/25. * manifest cylinder less than or equal to 0.75d. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any active anterior segment ocular disease that would contraindicate contact lens wear. * any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator. * history of refractive surgery or irregular cornea. * history of pathologically dry eye. * eye injury within twelve weeks immediately prior to enrollment for this trial. * currently enrolled in any clinical trial. * participation in a contact lens or contact lens care product clinical trial within the previous 30 days. * other protocol-defined exclusion criteria may apply.
video-based consensus opinion for hand and upper extremity problems

Conditions: Pain

Summary: the investigators would like to determine if there is a difference in patient satisfaction among patients who have puzzling pain conditions and receive one evaluation from their treating physician, and those that receive an evaluation from their treating physician and from a group of consulting physicians by video. the investigators expect to enroll 128 patients at massachusetts general hospital.

before visiting a specialist, patients have assumptions regarding diagnosis, etiology, prognosis, and preferred treatment for their condition. naturally, some of these assumptions may be inaccurate or incomplete or there may be room for debate and disagreement even among specialists. we are looking for ways to make unexpected and indeterminate aspects of an illness less unsettling for patients. when the hand surgeon's advice doesn't ring true, the patient may lose confidence in that provider. sometimes the interaction can feel disrespectful and even adversarial. we are curious whether patient's satisfaction with diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from many surgeons at once. one feasible way to do that would be to show an edited and anonymized video to a set of hand surgeons for their opinions on diagnosis and treatment. primary study question: 1. among patients with initially puzzling pains, there is no difference in satisfaction with diagnosis between patients that receive a video based consensus opinion and those that receive routine care from a single hand surgeon controlling for psychological factors, demographics, and initial and final diagnosis. secondary study questions: 2. among patients with initially puzzling pains, there is no difference in pain intensity and disability one month after the initial visit between patient that receive a consensus diagnosis and those that receive routine care from a single surgeon. 3. there is no variation in diagnosis between observers (observers are hand surgeons viewing the visit video and consulting on the diagnosis).

Eligibility criteria:
inclusion criteria: * all patients (\>18 years) presenting to dr. david ring with painful conditions that are puzzling (a puzzling pain condition is defined as dr. ring being puzzled about what is causing the pain. subject eligibility based on this criterion will be determined by dr. ring). * english fluency and literacy * able to provide informed consent exclusion criteria: * pregnant women

Keywords: patients puzzling conditions
effect of infant formula with bovine lactoferrin and low iron concentration on infant health and immune function

Conditions: Health of Formula-fed Children; Infant Infections in Formula-fed Children; Iron Status of Formula-fed Children

Summary: breast milk is the gold standard of early infant nutrition and breastfed infants have advantages in several short and long term outcomes compared to those formula-fed. the first aim of this study is to evaluate the effect of adding bovine lactoferrin to infant formula. the general hypothesis is that bovine lactoferrin reduces some of the previously observed differences between formula-fed and breast-fed infants with regard to health and development. the main outcome studied is the effect on immune function. the second aim is to study the effects of lower iron concentration in infant formula and to test the hypothesis that iron can be lowered without negative effects on health and development. the main outcome studied here is iron status. other outcomes in this trial are microbiota composition, metabolomics, growth, body composition and cognitive development. to test the lactoferrin hypothesis, formula-fed infants will be recruited and fed a low iron (2 mg/l) control formula, or the same formula supplemented with bovine lactoferrin. to test the iron hypothesis, a third group will be fed the same formula (no lactoferrin) with higher iron concentration (8 mg/l). group allocation for all formula-fed infants will be double-blind randomized. additionally, breast-fed infants will be recruited and used as a reference group (gold standard).


Eligibility criteria:
inclusion criteria: formula-fed healthy infants at 6 +/- 2 weeks of age with: * birth weight 2500-4500 g * gestational age at birth ≥ 37 completed weeks * no chronic disease or neonatal diagnoses believed to affect any outcome * no given blood transfusions or iron supplements exclusion criteria: -

Keywords: lactoferrin infant formula iron