Kornimate/medical-research-clean huggingface dataset:
overlaying a visual wound trace onto its thermal image in a wound clinic

Conditions: Wounds and Injuries

Summary: the purpose of this study is to test and evaluate how well a medical imaging device that takes both visual and thermal pictures of wounds or body surface areas of interest can help collect added information about the wounds or body surface areas of interest in a wound clinic.


Eligibility criteria:
inclusion criteria: * age 18 or greater, of either gender and of any ethnic background * able to tolerate position change(s) and turns for up to 10 minutes comfortably * have an existing external wound or body surface area of interest: * external wound or body surface area of interest must be in separate body locations (ex: one on the right heel, one on the left heel, and the other on the sacrum) * have qualifying external wound or body surface area of interest: * external wound or body surface area of interest that fits entirely within the field of view and does not wrap around a body edge * no device or treatment will obscure the external wound or body surface area of interest exclusion criteria: * neonatal and pediatric patients * pregnant women * cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged) * on therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy * have a wound dressing or medical device which cannot or should not be removed as determined by site investigator * have an external wound with excessive or heavy exudate that cannot be controlled during the imaging session. excessive drainage can obscure external wound features. * if the patient has a complex external wound: * the external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view. * from visual assessment, the external wound edges are not definable and/or cannot be clearly distinguished from other conditions near external wound (e.g. breakdown or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of ulcers makes determining the edge of the external wound impossible). * have not provided signed informed consent * non-english speaking * subjects in isolation

Keywords: wounds thermal temperature periwound camera imaging
hiv resistance, molecular epidemiology and new treatment strategies in the eastern european region and in russia

Conditions: HIV-1-infection

Summary: cohort based prospective monitoring of the spread of hiv drug resistance during a phase when new anti-hiv drugs are introduced.

the patient cohort that has been set up includes both viral sequences and clinical/epidemiological data from diverse geographical regions in russia and ukraine, where continued prospective follow-up - both short-term and long-term - is warranted to monitor and investigate drug resistance and its impact on insti roll-out. likewise, continued collection of samples and data is fundamental to study the impact of drm (drug resistance mutations) in russia and the eastern european region for upcoming new drugs, in order to expand the knowledge and to get a representative pattern. in particular the promoter aims in the timeframe of 1 year at: * cohort based prospective monitoring of the spread of hiv drug resistance during a phase when new anti-hiv drugs are introduced. it requires a long-time follow up to identify any changing pdr (pre-treatment drug resistance) patterns. * cohort based prospective exploration of the temporal kinetics of subtypes and sub-subtypes in russia in order to define the coming molecular epidemiology of hiv-1. * expand the description of drm (natural polymorphisms, pre-existing, acquired and off-target mutations) in a larger number of patients mainly from russia. the samples and the collected data will be used to study the impact of drm on the phenotypic sensitivity for insti and other already diffused drugs (nrti/nnrti). * support the implementation and evaluation of the pdr surveillance plan which has been defined in accordance with who (world health organisation) directives.

Eligibility criteria:
inclusion criteria: * naïve patients starting 2nd generation insti treatment * first line patients under 2nd generation insti treatment with either viral rna sequence before therapy start, or pbmc available with pbmc sample date not more than 3 years from therapy start date (with reasonably sure history of no failure in the interval from therapy start date to pbmc sample date\]). exclusion criteria: * patients not having a signed informed consent for the eidb data repository, if required by local/national legislation in order to have data in the common data repository. * patients not having signed informed consent for the present study, if required by local authorities iii) persons aged \< 18 at baseline
safety and tolerability of crofelemer for hiv-associated diarrhea

Conditions: HIV Enteropathy; Diarrhea With HIV

Summary: this study is being conducted to evaluate the safety and tolerability of crofelemer 125 mg twice a day, taken orally, over 48 weeks of therapy in human immunodeficiency virus-positive (hiv+) subjects with diarrhea.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years old * history of hiv-1 infection * on an antiretroviral therapeutic regimen for treatment of hiv-1 disease and associated conditions (including prophylactic antibiotics for pneumocystis jirovecii or infection) for at least 4 weeks prior to screening * self-reported presence of diarrhea necessitating adm use for at least 4 weeks exclusion criteria: * cd4 counts \< 100 cells/mm3 * oral temperature greater than 38.0° c, or unintentional weight loss of 5.0 kg or greater during the prior 2 months * bright red blood per rectum judged not to be of an anal (e.g., hemorrhoid, fissure) origin * immediate need for gi surgery or intervention for active gi bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess

Keywords: hiv + hiv positive hiv associated diarrhea aids diarrhea
clinical evaluation of a silicone hydrogel daily wear monthly replacement contact lens

Conditions: Refractive Errors

Summary: the purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

subjects will be expected to attend 4 office visits: screening/baseline/dispense, week 1 follow-up, month 1 follow-up, and month 3 follow-up/exit. the total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Eligibility criteria:
key inclusion criteria: * successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day; * manifest cylinder equal to or less than 0.75 diopter (d) in each eye; * best spectacle corrected visual acuity (using manifest refraction) of 20/20 or better in each eye; * other protocol-defined inclusion criteria may apply. key exclusion criteria: * wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * habitually wearing biofinity lenses; * monovision or multifocal contact lens wearers; * other protocol-defined exclusion criteria may apply.

Keywords: vision correction contact lens
pediatric subjects with tinea corporis

Conditions: Tinea Corporis

Summary: the study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). the results will be compared to those seen with a placebo cream which has no active ingredient. safety of the cream will also be measured.

the objectives of this study are to evaluate the safety and efficacy of naftin (naftifine hydrochloride) cream, 2% applied once daily for 2 weeks, compared to its vehicle in the treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium hydroxide (koh), positive dermatophyte culture, and clinical signs and symptoms of tinea corporis.

Eligibility criteria:
inclusion criteria: * males or non-pregnant females 2 years of age to 17 years, 11 months, of any race. females of child bearing potential must have a negative urine pregnancy test. * presence of tinea corporis by clinical evidence of a tinea infection of at least moderate erythema, moderate induration, and mild pruritus. * koh positive and culture positive baseline skin scrapings obtained form the site with the mose severely affected lesion or a representative site of the overall severity. exclusion criteria: * tinea infection of the face, scalp, groin, and/or feet * a life-threatening condition in the opinion of the investigator (ex. autoimmune deficiency syndrome, cancer, etc) within the last 6 months. * subjects with abnormal findings- physical or laboratory- that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results * subjects with a known hypersensitivity or other contradictions to study medications or their components. * subjects who have a recent history or who are currently known to abuse alcohol or drugs. * uncontrolled diabetes mellitus. * hemodialysis or chronic ambulatory peritoneal dialysis therapy. * current diagnosis of immunocompromising conditions. * current evidence of compromised skin, atopic or contact dermatitis, eczema, impetigo, lichen planus, pityriasis rosea, pityriasis versicolor, psoriasis, seborrhoeic dermatitis and syphilis. * severe dermatophytoses, mucocutaneous candidiasis, or bacterial skin infection * patients with tinea corporis who have concurrent dermatophytosis of the scalp, beard or nails.

Keywords: tinea corporis ringworm
fatigue a long covid-19 symptom substudy of fsc19-kn trial

Conditions: SARS-CoV2 Infection

Summary: prospective, controlled follow-up observation of sars-cov-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization.

after informed consent is given, questionnaires will be obtained 6 months and 12 months after infection. for analyzing cognitive and motor fatigue, classified in mildly, moderately or severely fatigue the questionnaire will be calculated by the fatigue scale for motor and cognitive functions (fsmc). and the occurrence of major depressive disorder, other depressive syndrome or panic syndrome measured by brief patient health questionnaire. the fsc19-kn trial already included patients with positive test for sars-cov-2 by pcr and volunteers with negative sars-cov-2 antibody testing. verification of exclusion criteria had been completed in the main trial fsc19-kn. after the informed consent to participation in the sub-study is given all inclusion modalities are fulfilled.

Eligibility criteria:
inclusion criteria: patient must meet all of the following criteria. 1. participation in the fsc19-kn study 2. consent to participate in the survey exclusion criteria: 1. failure to give consent to the survey

Keywords: fatigue covid-19 disease
study protocol: study on incidence and risk factors of mold infections in children during leukemia treatment

Conditions: Leukemia, Myeloid, Acute; Acute Lymphoblastic Leukemia

Summary: the study aims to evaluate the occurrence, mortality, and risk factors for invasive mold infections (imi) in children treated with chemotherapy for acute leukemia in denmark. the study will be a retrospective nationwide survey study of all children who received first-line chemotherapy for acute leukemia from 2008 to 2022 in danish pediatric oncology units. the study population will include approximately 800 children under the age of 18. data will be collected from medical records, hospital databases, and national databases. when the imi subgroup has been identified, this will be compared to the leukemic group that did not develop imi. statistical analysis can then determine the occurrence, mortality rate, and possible imi risk factors.

chemotherapy can weaken children's immune system, making them vulnerable to infections, including invasive mold infections (imi), caused mainly by aspergillus spp. the at-risk population for imi in children with acquired immunodeficiency is patients with prolonged granulocytopenia due to hematologic malignancies treated with chemotherapy or allogeneic hematopoietic stem cell transplantation (hsct) recipients and children receiving long-term corticosteroid treatment. incidences and mortality rates are often reported as high. in a retrospective cohort study, we aim to obtain an epidemiological overview of imi in children receiving first-line treatment for acute myelogenous leukemia (aml) and acute lymphoblastic leukemia (all) in denmark from 2008 to 2022 and identify possible risk factors, including treatment-related adverse effects. objectives 1. to determine and compare the incidence of imi in childhood aml and all during first-line chemotherapy in denmark. 2. to determine and compare the mortality of imi in childhood aml and all during first-line chemotherapy in denmark. 3. to explore risk factors for imi in childhood aml and all during first-line chemotherapy in denmark.

Eligibility criteria:
inclusion criteria: * age \<18 years at the time of inclusion * received first-line treatment for all or aml * treatment at a danish tertiary pediatric oncology unit (rigshospitalet, aarhus university hospital, odense university hospital, and aalborg university hospital) * treatment initiation january 1st, 2008, to december 31st, 2022 exclusion criteria: * not meeting inclusion criteria

Keywords: leukemia childhood myeloid lymphoblastic pediatric invasive mold aspergillus
imaging biomarkers of tissue microstructure and vasculature as predictors of glioblastoma multiforme

Conditions: Glioblastoma

Summary: this study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. this study will use a new mri technique to compare the images of blood vessels and tumor structure to the effectiveness of bevacizumab.

this study is for subjects with a diagnosis of a brain tumor called glioblastoma that is being treated with bevacizumab. bevacizumab is a drug that your doctor believes is the best treatment option available to subjects at this time for this type of tumor. bevacizumab affects the growth of blood vessels by tumors such as glioblastoma, thus effectively starving the tumor of oxygen and food. magnetic resonance imaging (mri) is a test done by a machine in the radiology department that takes pictures of your body using special magnets, rather than x-rays. with a new mri scan technique the investigators can take very, very detailed images of the vessel and tumor structure. this project will allow us to compare the images of vessel and tumor structure to the effectiveness of bevacizumab as a treatment option. with this project the investigators will hopefully develop an accurate way to predict whether or not bevacizumab will be an effective treatment option for patients.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years of age * progressive glioblastoma patients who have been planned to receive bevacizumab * karnofsky performance status 50 or above (vd. appendix a) * established pathologic diagnosis of glioblastoma * prior treatment with radiation and chemotherapy * neuroimaging progression of glioblastoma * able and willing to provide informed consent (or consent of a guardian) exclusion criteria: * contraindication to mri * contraindication to bevacizumab therapy * concurrent enrollment in other neuroimaging trials * prior therapy with bevacizumab * known hypersensitivity to mri contrast * females who are nursing or pregnant

Keywords: glioblastoma imaging biomarkers bevacizumab mri
open-label, chronic exposure, safety study of clonicel (clonidine hcl sustained release) in children and adolescents with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this 12-month, multi-center, open-label study is to evaluate the safety of clonicel (clonidine hcl sustained release) when administered chronically under regular clinical conditions either as monotherapy or in combination with stimulant therapy to children and adolescents with attention deficit hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria: * male or female subject who has completed either study clon-301 or study clon-302, or discontinued early for reasons other than adverse events necessitating discontinuation * age between 6 and 17 years, inclusive * diagnosis of attention deficit hyperactivity disorder of the hyperactive or combined inattentive/hyperactive subtypes according to diagnostic and statistical manual of mental disorders iv (dsm iv) criteria * general good health as judged by the principal investigator * body mass index (bmi) ≥ 5th percentile of the subject's age group according to the cdc growth chart. bmi is calculated using the formula: weight (kg) / \[height (m)\]2 * subject as well as parent/guardian able to sign informed assent or consent form exclusion criteria: * if female of child-bearing potential, pregnant or lactating or does not agree to use a medically acceptable form of birth control, such as hormonal medication, double-barrier method, or intrauterine device * presence of a clinically significant illness or abnormality on physical examination or clinical laboratory evaluations that, in the opinion of the investigator, would increase the safety risks from clonidine administration or interfere with the ability of the patient to take part in the study. * presence of clinically significant abnormality on centrally interpreted electrocardiogram readings * history or presence of a concomitant psychiatric disorder requiring psychotropic medication or a severe concomitant axis i or axis ii disorder that could interfere with study assessments in the judgment of the principal investigator * presence of a disorder that would interfere with the absorption, metabolism, or excretion of clonidine * presence of alcohol or drug abuse.

Keywords: clonicel attention deficit hyperactivity disorder clonidine hcl sustained release
mitochondrial membrane protein neurodegeneration (mpan)

Conditions: MPAN

Summary: the purpose of this case study was to investigate the effects of therapeutic intervention in 9- and 12-year-old brothers with mpan. the main hypothesis it aims to answer is: -a 6-week balance and coordination focused rehabilitation program improves independence and gait parameters in patients with mpan.

neurodegeneration with brain iron accumulation (nbia) comprises a heterogeneous group of disorders with accumulation of iron in the brain, mostly basal ganglia. mutations within c19orf12 have recently been identified in patients with nbia. this c19orf12 gene -located in mitochondria and endoplasmic reticulum- encodes a mitochondrial membrane protein and the abbreviation mpan. pathogenic mutations in this gene are postulated to cause dysfunction of lipid homeostasis in mitochondria. patients with mpan typically present with gait disturbance due to lower limb spasticity and dystonia, parkinsonism with subsequent spastic paresis, dysarthria, cerebellar ataxia, behavioral problems, dementia, psychomotor delay, peripheral neuropathy, visual changes like optic atrophy as well as bowel/bladder incontinence; however, mpan has a greater variability compared with other nbia cases in terms of age of onset (age three to 30 years) and speed of progression. this study aims to investigate the effects of therapeutic intervention in male brothers, age 9 and 12, with mpan. in particular, this study tested the following hypotheses after 6 weeks of rehabilitation by measuring muscle strength, muscle tone, range of motion , balance and coordination: (1) after the training period, muscle strenght, muscle tone and range of motion would be improved, (2) these developments in body function can lead to increase balance and coordination, and (3) due to the these improvements, functional independency may increase.

Eligibility criteria:
inclusion criteria: * being diagnosed with mpan exclusion criteria: * being involved in any other rehabilitation program

Keywords: mpan exercise therapy balance and coordination
sitagliptin and the risk for hypoglycaemia in type 2 diabetes patients

Conditions: Pharmacological Action

Summary: sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of hypoglycemic episodes in the case that they should occur. the endpoints have defined such that consequences of this hypothesis can be measured.


Eligibility criteria:
inclusion criteria: * male or female subject with diabetes mellitus type 2. * age between 18 and 64 years, both inclusive. * hba1c \<= 8.5%. * stable treatment with insulin glargine (any dose) and metformin (\>= 1500 mg/day or at highest tolerated dose) for at least 3 months prior to inclusion into the trial with or without additional oral glucose-lowering agents (except thiazolidinediones). * considered generally healthy (apart from diabetes mellitus type 2 and associated conditions such as hypertension, hyperlipidaemia and hyperuricaemia) upon completion of medical history, physical examination, vital signs, ecg and analysis of laboratory safety variables, as judged by the investigator. exclusion criteria: * known or suspected hypersensitivity to sitagliptin or related products. * more than one episode of severe hypoglycaemia with seizure, coma or requiring medical assistance of another person during the past 6 months or hypoglycaemic unawareness as judged by the investigator. * current or previous treatment (less than 3 months prior to screening) with insulin products other than insulin glargine and/or with glucagon-like peptide (glp) 1 receptor agonists and/or with thiazolidinediones. * unwillingness to wash-off any oral glucose-lowering agents other than metformin.