Kornimate/medical-research-clean huggingface dataset:
optimizing hydroxyurea dosage with pharmakokinetic in patients suffering of moderate to severe sickle cell anemia

Conditions: Sickle Cell Disease (SCD)

Summary: the goal of this study is to evaluate if patients with sickle cell disease can achieve a maximum tolerate dose of hydroxuyrea (hu) over a period of 12 months faster with pharmacokinetic testing than the standard of care bloodwork follow-up. pharmacokinetic test is used to evaluate the process by which drugs are absorbed, distributed in the body, localized in the tissues, and is excreted. patient will be a randomized (coin toss method) into 2 groups. group a will have an increase of their hu dosage with pharmacokinetic results and group b will have an increase of their hu dosage following the standard of care bloodwork follow-up. group c will include patient with sickle cell disease that has been taking hu for at least 12 months and will undergo a pharmacokinetic dosage to check the level of hu only one time.


Eligibility criteria:
inclusion criteria (group a and b) : * have had confirmed diagnosis of scd at chu sainte-justine biochemistry lab with hemoglobin electrophoresis. * be patients with ss, sbthal0. * agree to take hydroxyurea for a period of 12 months * be between age of 6months old and 18 years old. * have consented for participation in the study. inclusion criteria (group c) : * have had confirmed diagnosis of scd at chu sainte-justine biochemistry lab with hemoglobin electrophoresis. * be patients with ss, sbthal0. * have taken hydroxyurea for a period of at least 12 months, and have received hu at a stable dose and at mtd for at least 6 months. * be between age of 6months old and 18 years old. * have consented for participation in the study. exclusion criteria: * patients with sickle cell genotype other than ss or sbthal0 (sc, sbthal+, se or sd) * patients on chronic transfusion program * patients have received a blood transfusion in the last 4 weeks of study enrollment. * have received a hematopoietic stem-cell transplantation * creatinine \>2x normal for age * alt\>2x normal for age * sexually active females unwilling to comply with reliable method of birth control * pregnancy * conditions which in the opinion of the investigator, would compromise participation in the study will be excluded.

Keywords: hydroxyurea pharmacokinetic sickle cell disease
intravenous fluid therapy for the treatment of emergency department patients with migraine headache

Conditions: Migraine Headache

Summary: the purpose of this study is to determine whether patients in the emergency department with migraine headache who are administered an intravenous fluid bolus will report greater improvement in pain scores than control patients.

the investigators intend to perform a small-scale pilot study assessing the effectiveness of iv fluid therapy for patients presenting to the ed with migraine headache. patients will be randomly allocated to receive a bolus of 1000 ml normal saline or no fluid bolus. patients and outcome assessors will be blinded to the assigned study group. research assistants will assess pain scores, nausea, and functional disability at time 0 (just prior to starting the intervention), 60 minutes, and 120 minutes. participants will be contacted 48 hours after leaving the ed to assess symptom burden following discharge.

Eligibility criteria:
inclusion criteria: * age 18 or older * fluent in english * meets international classification of headache disorders (3rd ed) criteria for migraine headache: a. at least five attacks fulfilling criteria b-d b. headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) c. headache has at least two of the following four characteristics: unilateral location pulsating quality moderate or severe pain intensity aggravation by or causing avoidance of routine physical activity (e.g. walking or climbing stairs) d. during headache at least one of the following: 1. nausea and/or vomiting 2. photophobia and phonophobia e. not better accounted for by another ichd-3 diagnosis. exclusion criteria: * intravenous fluids are contraindicated in the opinion of the emergency department physician caring for the patient (ex patient has an exacerbation of congestive heart failure). * intravenous fluids are required in the opinion of the emergency department physician caring for the patient (ex patient has intractable vomiting, patient has severe dehydration). * have already received greater than or equal to 500 ml of intravenous fluid during this emergency department visit, prior to enrollment. * currently pregnant

Keywords: intravenous fluid headache
mk0431 (sitagliptin) pioglitazone add-on study for patients with type 2 diabetes mellitus (0431-055)(completed)

Conditions: Type 2 Diabetes Mellitus

Summary: the clinical study determines the safety and efficacy of mk0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.


Eligibility criteria:
inclusion criteria: * patients have type 2 diabetes mellitus * on diet/exercise therapy and pioglitazone as monotherapy exclusion criteria: * patients have type 1 diabetes mellitus
the treatment preferences of women diagnosed with ovarian cancer

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Summary: the primary objective of this study is to apply best-practice stated-preference methods to quantify the extent to which women with ovarian cancer accept the risks, side effects, and out-of-pocket costs associated with treatment in return for progression-free survival benefit afforded by a treatment, regardless of whether there is an overall survival benefit.

the investigators propose to perform a preferences survey to be administered to women with ovarian cancer.the investigators anticipate that about 1/3 of the study cohort will include patients who are receiving treatment with an oral adp-ribose polymerase inhibitors (parpi). the investigators will begin by conducting interviews with 5 pilot subjects as they test the preferences survey. based on their feedback the survey may be updated for clarity. during the final survey phase, subjects will be recruited and invited to participate in the choice experiment by biologics, inc., a specialty pharmacy company that dispenses oral parpis. subjects may also be recruited through researchmatch.org and at the gynecologic oncology division at duke. up to 300 women may be included in this study, at least 100 women will have received treatment with a parpi. discrete choice experiment (dce) questions generate limited dependent-variable, cross-section/time-series data. the study team will use random-parameters logit (rpl) to analyze the choice-format conjoint data collected in the dce survey. unobserved variation in preferences across the sample can bias estimates in conventional conditional-logit choice models. rpl avoids this potential bias by estimating a distribution of preferences around each model parameter that accounts for variations among individual preferences not accounted for by the variables in the model. the flexible correlation structure of rpl also accounts for within-sample correlation in the question sequence for each respondent. there are no physical risks to subject participation in this survey protocol.

Eligibility criteria:
inclusion criteria: * diagnosis of ovarian, fallopian tube, or primary peritoneal cancer exclusion criteria: * does not read and understand english

Keywords: patient preferences
rationalization of the treatment pathway of patient suffering from rare skin disease with telemedicine

Conditions: Skin Disease

Summary: the investigators want to demonstrate that a new organization with telemedicine could rationalize the treatment pathway of patient suffering from rare skin disease. a diagnosis and a personalised treatment pathway could be performed before the consultation in the hospital.


Eligibility criteria:
inclusion criteria: * new patients suffering from a rare skin disease whatever pathology or age, which needs a take-over by this centre * or patients already take-over by the centre but lost to follow-up for more than one year * patients (and/or parents) who give their consents * patients (and/or parents) able to fill in questionnaires exclusion criteria: * pregnant or breast-feeding women. * patients subject to a judicial safeguard order * patients who need an emergency take-over * patients followed by a doctor who does not have a computerized system or refuse to send data via the secured messaging

Keywords: skin disease telemedicine
melatonin for prevention of postoperative agitation and emergence delirium in children

Conditions: Emergence Delirium

Summary: postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. the symptoms are common with a reported incidence of approximately 25%. some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. melatonin has a low bio-availability of approximately 15 %. the safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. the aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. the study is designed as a randomised, double-blind, placebo-controlled clinical trial.


Eligibility criteria:
inclusion criteria: * patients aged 1-6 years * elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia maintained with sevoflurane exclusion criteria: * any known allergy or contraindication to study treatment or excipåients * current daily medication with melatonin

Keywords: anesthesia melatonin sevoflurane postoperative pain child ponv
assessing a length artificial intelligence algorithm to estimate length of children

Conditions: Growth; Stunting, Nutritional

Summary: an exploratory study to explore the possibility of using computer vision algorithms to estimate a child's length using images taken by a healthcare professional or parents.

this is an exploratory, observational, pilot study that aims to evaluate the performance of a length artificial intelligence (lai) algorithm in a real world setting. images will be collected by parents or healthcare professionals, together with physical length measurements. this data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. data on the acceptance and experience of the using the algorithm will be collected for improvements.

Eligibility criteria:
inclusion criteria: 1. children aged 0 to 18 months old. 2. parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires, take images and upload images. 3. parent(s) should be able to comprehend the content of the study and to complete the study questionnaires in english. 4. written consent from parent. exclusion criteria: 1. parent(s) incapable of completing the study questionnaires and uploading of the images using smart phone or tablet with internet. 2. children unable to undergo length measurement (e.g. children with structural abnormalities of the lower limbs or orthopedic conditions such as club foot, hip dysplasia, etc).

Keywords: growth length artificial intelligence algorithm
exercise training program for cerebellar ataxia

Conditions: Cerebellar Ataxia

Summary: the purpose of this study is to determine whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises.

the cerebellum is important for coordination of movement and for motor learning. no medications systematically improve cerebellar ataxia, and little is known about the effectiveness of rehabilitation exercises, which are often the only treatment option. here, we ask whether a person's ability to adapt (i.e. short term motor learning) predicts their ability to benefit from physical therapy exercises. this pilot-clinical trial will test a subject's ability to adaptively learn a new walking pattern in a single session, and then any improvement of walking and balance over a 13 week time period during which they participate in a specialized home exercise training program. our prediction is that those individuals with some preserved adaptive learning ability will be the best rehabilitation candidates.

Eligibility criteria:
inclusion criteria: * cerebellar damage from stroke, tumor, or degeneration * able to stand and take steps with or without assistance * age 18-95 exclusion criteria: * extrapyramidal symptoms * peripheral vestibular loss (e.g. absence of vor) * congestive heart failure * peripheral artery disease with claudication * pulmonary or renal failure * unstable angina * uncontrolled hypertension ( \> 190/100 mmhg) * dementia (mini-mental state exam \> 22) * severe aphasia * orthopedic or pain conditions * pregnancy * prisoner * evidence of chronic white matter disease on mri

Keywords: ataxia exercise training cerebellar rehabilitation
colorectal surgical site infection

Conditions: Surgical Site Infection

Summary: surgical site infection (ssi) is one of the most common postoperative complications in surgery, with high morbidity. in the tertiary-center that the investigators evaluated they had a significant rate of surgical site infection. because of that the investigators created a care bundle of measures in order to improve the outcomes.

prospectively the investigators implemented a care bundle of measures with retrospective analysis, to decrease ssi . the superficial, deep and organ/space infections were evaluated and compared before and after care bundle implementation. between january 1, 2016 and december 31, 2020, 1139 patient records relating to surgical incisions were submitted for analysis.

Eligibility criteria:
inclusion criteria: * patients submitted to elective colorectal surgery between 2016, january 1 and 2020, december 31 * age \> 18 years * at least 30 days of follow-up exclusion criteria: * patients submitted to urgent colorectal surgery
a study to assess the pharmacokinetics, pharmacodynamics, and safety of canagliflozin (jnj-28431754) in volunteers with varying degrees of kidney function

Conditions: Renal Insufficiency; Healthy

Summary: the purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (jnj-28431754) after administration of a single dose to non-diabetic volunteers with normal kidney function and non-diabetic volunteers with varying degrees of kidney impairment (including volunteers with end-stage renal disease requiring hemodialysis).

this study will be an open label (all volunteers and study staff know the identity of the assigned treatment), single-dose, multicenter (the study will be conducted at more than one center), parallel-group study (each group of volunteers will be treated at the same time) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in volunteers with varying degrees of kidney function. the study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. volunteers will be assigned to 1 of 5 groups (depending on kidney function): group 1 will have normal kidney function; group 2 will have mild kidney impairment; group 3 will have moderate kidney impairment; group 4 will have severe kidney impairment; and group 5 will comprise volunteers requiring hemodialysis. volunteers in groups 1 through 4 will receive a single dose of canagliflozin on day 1. volunteers in group 5 will receive a single dose of canagliflozin following dialysis and then, approximately 10 days later, they will receive a second dose before dialysis. volunteers in groups 1 through 4 will participate in the study for 27 days. volunteers in group 5 will participate in the study for 40 days.

Eligibility criteria:
inclusion criteria: * volunteers must have a body mass index (bmi = weight in kg/height in m2) between 20 and 40 kg/m2 (inclusive), and body weight not less than 50 kg * volunteers must smoke no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration exclusion criteria: * history of or currently active illness considered to be clinically significant by the investigator or any other illness that the investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results * volunteers with end stage renal disease receiving dialysis treatment other than intermittent hemodialysis * volunteers with end stage renal disease who have received a renal transplantation within 1 year before screening * volunteers with end stage renal disease diagnosed with renal carcinoma within 1 year before screening * volunteers with end stage renal disease receiving immunosuppressive medications, including steroids

Keywords: renal insufficiency healthy canagliflozin (jnj-28431754) pharmacokinetics pharmacodynamics dialysis
effects of marihuana use on optic nerve parameters and ocular blood flow

Conditions: Intra Ocular Pressure

Summary: purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, optic nerve fibers thickness and choroidal thickness.

purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, retinal nerve fiber layer (rnfl) thickness, optic nerve fibers thickness and choroidal thickness. adult patients with no ocular pathology that are being treated in the neurology or pain clinics with medical cannabis for different indications, were examined in the eye clinic. first examination took place after the patient was not smoking for 5 hours. three more examinations took place 1 hour 3 hours and 5 hours after smoking cannabis. the following parameters were checked: blood pressure, pulse, visual acuity, intra ocular pressure, corneal thickness, axial length, slit lamp examination of anterior segment, fundoscopy and optical coherence tomography (oct) of the retina, and optic nerve.

Eligibility criteria:
inclusion criteria: * age over 18 * treated with medical cannabis for approved medical indications exclusion criteria: * known ocular pathology * topical or systemic treatment for intra ocular pressure * previous topical, intra ocular or systemic steroid treatment

Keywords: cannabis intra ocular pressure ocular perfusion blood pressure
observational study to estimate the rates of outcomes in patients undergoing percutaneous coronary intervention (pci) with drug eluting stent (des) implantation who take statins

Conditions: Dyslipidemia; Coronary Heart Disease

Summary: to estimate the rates of percutaneous coronary intervention (pci) outcomes in patients after drug-eluting stents implantation who take statins.


Eligibility criteria:
inclusion criteria: * stable angina with indication to pci * hospitalization to russian cardiological research center (ркнпк) for pci procedure with drug-eluting stents implantation * statin therapy initiated for at least one month prior to pci * written informed consent provided prior the start of participation in the study. exclusion criteria: * subjects who are unwilling or unable to provide informed consent. * presence of acs during the current hospitalization * severe chf (nyha iii/iv) or lvef\<40 % * stroke within 6 months before pci * acute or chronic inflammatory disease * anti-inflammatory medications intake, with the exception of aspirin * severe liver or muscle disease * severe kidney disease / renal failure with creatinine \> 3 mg/dl * history of oncologic disease * conceivable impossibility to come in touch with the patient or his family at 1-year after the intervention

Keywords: statins coronary heart disease percutaneous coronary intervention (pci)
biomarker approach to screening for the early detection of hpv-related oropharyngeal cancer (bash opc)

Conditions: Oropharyngeal Cancer; HPV-Related Carcinoma

Summary: investigators seek to determine the sensitivity and specificity of a combined hpv 16 dna and host gene methylation oral biomarker panel to distinguish early oropharyngeal cancer (opc) cases from controls among 100 early and 100 late disease pre-treatment opc cases, and 200 controls matched by sex, age, race/ethnicity, and tobacco use collected from the moffitt cancer center (moffitt) and the university of pittsburgh medical center hillman cancer center (pittsburgh).


Eligibility criteria:
inclusion criteria: cases: * aged at least 18 years * newly diagnosed primary tumor, histologically confirmed squamous cell carcinoma of the oropharynx (stages i-iv) * has not received treatment (surgery, chemotherapy, radiation, or immunotherapy) within the previous four weeks * provided written informed consent under moffitt cancer center (mcc) 17716 biomarker/biobanking study or is identified and enrolled at the university of pittsburgh medical center hillman cancer center * aged at least 35 years * have no previous diagnosis of hnc or hpv-related cancer * fully understands study procedures * voluntarily agrees to participate by giving written informed consent under moffitt cancer center (mcc) 17716 biomarker/biobanking study or is enrolled at the university of pittsburgh medical center hillman cancer center exclusion criteria: * not meeting all of the above inclusion criteria for either the case or control group

Keywords: oropharyngeal cancer early detection screening