Kornimate/medical-research-clean huggingface dataset:
study of the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation

Conditions: Graft Versus Host Disease

Summary: objectives: i. determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation. ii. correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.

protocol outline: patients begin a mycophenolate mofetil (mmf)-containing regimen within the first 5 days after transplantation. patients have blood drawn on postoperative days 7, 21, 42, 70, 98, 126, and 154. urine is collected on postoperative days 7, 21, and 42. patients with t-tube bile externalization also have bile collected on postoperative day 7.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- orthotopic liver or kidney transplant recipients who started on a mycophenolate mofetil-containing immunosuppressive regimen within 5 days after transplant kidney transplant recipients will serve as study controls --prior/concurrent therapy-- * no concurrent bile acid sequestrants * no mycophenolate mofetil as part of rescue therapy regimen * no concurrent albumin replacement therapy --patient characteristics-- renal: urine output at least 500 ml/day or creatinine less than 2.5 mg/dl other: * not pregnant * no mental incompetency * no prisoners or parolees hiv negative * no active infection defined as: temperature above 101 f with wbc greater than 12,000/mm3 and left shift or two or more positive cultures of a single isolated organism from blood, urine, or sputum

Keywords: disease-related problem/condition graft versus host disease rare disease
assessment of small bowel healing in crohn's disease patients treated with cimzia using wireless capsule endoscopy

Conditions: Crohn's Disease

Summary: wireless capsule endoscopy has been the most reliable diagnostic standard for small bowel crohn's disease. endoscopic healing is an important endpoint to measure response to treatment.


Eligibility criteria:
inclusion criteria: * adults aged 18-70 with confirmed crohn's disease that includes small bowel disease * moderately to severely active disease (cdai score \>220 and \< 450) * stable doses of steroids, 5-asa, antibiotics, immunosuppressants exclusion criteria: * any and all contraindications to the use of certolizumab pegol (including but not limited to hepatitis, infection, abscess, malignancy, congestive heart failure \[chf\], cytopenia) * small bowel obstruction, stricture, or any contraindication for capsule endoscopy * previous treatment with certolizumab pegol * are pregnant or lactating

Keywords: crohn's inflammatory bowel disease
correlation and rapid analysis of neurological injury using markers

Conditions: Traumatic Brain Injury (TBI) Patients

Summary: each year, approximately 69 million people worldwide suffer from traumatic brain injuries (tbi), representing a significant burden on public health, society, and the economy. timely and accurate care can influence short-, medium-, and long-term outcomes, making the reduction of diagnostic delays crucial. tbi diagnostics require careful consideration, as initial evaluations may differ from final assessments, and patient conditions may evolve over time. in this monocentric, observational, post-market follow-up study we aim to evaluate the abbott i-stat™ tbi plasma test in detecting circulating brain biomarkers (gfap and uch-l1) in adult patients with tbi. the study involves recruiting 200 adult patients (aged 18-65 years) presenting to the emergency department with tbi over a two-year period. for each participant, a blood sample will be collected as part of routine clinical care and analyzed using the abbott i-stat™ tbi plasma test within 12 hours of the trauma. the results will be compared with those obtained from cranial ct scans, the gold standard for diagnosing intracranial injuries. specifically, the study aims to assess the diagnostic accuracy of the test in excluding intracranial injuries, particularly in cases of mild tbi, and to explore potential correlations between biomarker presence and injury severity. no additional procedures beyond routine clinical care are required, and all collected data will be used exclusively for the study's predefined objectives.

post-market performance follow-up study

Eligibility criteria:
inclusion criteria: * patients aged 18 to 65, male and female, presenting to the emergency department due to tbi, defined as trauma caused by an external force leading to temporary or permanent alterations in consciousness and/or neurological function. tbi severity is evaluated using the glasgow coma scale (gcs). * sign of informed consent by patient or legal tutor exclusion criteria: * pediatric patients (\<18 years). * patients \>65 years, to avoid potential confounding factors such as elevated gfap levels associated with alzheimer's disease.

Keywords: biomarkers traumatic brain injury
clinical trial of autologous intravitreal bone-marrow cd34+ stem cells for retinopathy

Conditions: Non-exudative Age-related Macular Degeneration; Diabetic Retinopathy; Retina Vein Occlusion; Retinitis Pigmentosa; Hereditary Macular Degeneration

Summary: this pilot study is to determine whether it would be safe and feasible to inject cd34+ stem cells from bone marrow into the eye as treatment for patients who are irreversibly blind from various retinal conditions.

in this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous cd34+ stem cells isolated from bone marrow aspirate under good manufacturing practice conditions. this study will determine whether there are any major safety and feasibility concerns using this therapy. patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.

Eligibility criteria:
inclusion criteria: * age \>18 years of age * visual acuity 20/100 to cf * duration of vision loss \> 3 months * vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy * the study eye has the worse visual acuity * no active eye or systemic disease * no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months * no significant media opacity * no coagulopathy or other hematologic abnormality * no concurrent immunosuppressive therapy * able to keep follow-up for 6 months exclusion criteria: * allergy to fluorescein dye * other concurrent retinal or optic nerve disease affecting vision

Keywords: stem cells intravitreal bone marrow cd34+ cells retinal disease clinical trial autologous
extracellular signal-related kinase biomarker development in autism

Conditions: Autism Spectrum Disorders

Summary: the purpose of this research study is to establish a way to help the development of targeted treatments in autism spectrum disorders. this may also help in early diagnosis of autism and may possibly predict severity. the study will compare subject's erk (extracellular signal-related kinase) signaling to age- and gender-matched neurotypical controls and intelligence quotient (iq)-matched developmental disabilities.

autism spectrum disorder subject criteria: inclusion criteria: * diagnosis of autism spectrum disorder, based upon a clinical interview utilizing the diagnostic and statistical manual-v (dsm-v) * age 3-25 years * stable dosing of psychotropic drugs for greater than or equal to 5 half-lives exclusion criteria: * diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on diagnostic and statistical manual-v criteria * use of lithium, riluzole or other known modulators of erk activation age-matched neurotypical control subjects: * age matched to the age of an autistic disorder subject * history of normal development iq-matched control subjects: * those subjects who are included in the study based on having an iq and age that matches the iq and age of an autistic disorder subject who has an iq less than 70 * all iq-matched control subjects will then also have an iq less than 70

Eligibility criteria:
inclusion criteria (asd subjects): * diagnosis of autistic disorder as confirmed by a clinical interview, utilizing the dsm-v * age 3-25 years * stable dosing of psychotropic drugs for 5 half-lives or greater exclusion criteria (asd subjects): * diagnosis of schizophrenia, another psychotic disorder, bipolar disorder, or alcohol or other substance abuse based on dsm-v criteria * use of lithium, riluzole or other known modulators of erk activation iq-matched control subjects: those subjects who are included in the study based on having an iq and age that matches the iq and age of an autistic disorder subject who has an iq less than 70. all iq-matched control subjects will then also have an iq less than 70. iq-matched control subjects participate in a screen/baseline visit only. age-matched neurotypical control subjects: those subjects who are included in the study based on having an age matched to the age of an autistic disorder subject and a history of normal development. age-matched neurotypical subjects participate in a screen/baseline visit only. shipped biomarker control group subjects: for these shipping control samples, blood samples will also be drawn from adult parent/guardians of participating subjects.
consequences of dna repair and telomere defects on the function of the immune system: application to cvid and immune deficiencies with dysmorphic syndromes

Conditions: Immune Deficiency and Early BMF in Childhood

Summary: the molecular mechanisms participating in the various aspects of the dna damage response (ddr) are absolutely essential to maintain the genome dynamics essential to all living organisms. the most commonly studied consequence of faulty ddr is genome instability participating in cancer onset. in the present proposal, we wish to explore another aspect of ddr, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system. the most "spectacular" consequences of faulty dna repair processes with respect to the immuno-hematopoietic tissue are the complete block of b and t lymphocytes maturation owing to defective dna joining phase during v(d)j recombination resulting in patients with severe combined immune deficiency (scid). the objectives of this study are to increase our knowledge on the role of the various dna repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these dna repair processes result in human severe conditions such as cvid, locid or other manifestations of immune disorders such as autoimmunity. the explorations of dna repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. this is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.


Eligibility criteria:
inclusion criteria: * immune deficiency and early bmf in childhood * common variable immunodeficiency (cvid) * genetic patients exclusion criteria: * refusal to consent.
assessment of novel biomarkers in participants undergoing targeted lung health checks

Conditions: Lung Cancer

Summary: low-dose ct (ldct) screening for lung cancer (lcs) has been shown to reduce lung cancer specific mortality in multiple randomised controlled trials. however, although ldct screening has been demonstrated to reduce cancer- specific mortality, there remain outstanding questions regarding how screening can be implemented. in particular, indeterminate nodules are common, and can be challenging to distinguish from benign nodules on ct appearances alone. furthermore, distinguishing cancers which are likely to become clinically significant from those that will remain indolent is challenging, but essential to prevent over-treatment and overdiagnosis. there is significant interest in using a multi-modal approach to lcs, incorporating biomarkers obtained from minimally-invasive samples alongside ldct to improve ability to recognise clinically-significant lung cancers at an early stage. the targeted lung health check (tlhc) programme is an nhs programme with the aim of using ldct screening in appropriately high-risk individuals to improve early diagnosis and survival in lung cancer. the north central london tlhc programme started in december 2022. the purpose of the alpine study is to develop a platform to allow collection of minimally-invasive samples from participants undergoing screening within the north central london tlhc programme. the use of such biomarkers in the diagnosis of lung cancer is a rapidly developing field and novel techniques and technologies are continuously under development. the alpine study will generate a cohort with matched biosamples, ct scans and clinical data which will be uniquely well placed to serve to develop or validate biomarkers in lung cancer screening and risk prediction.


Eligibility criteria:
inclusion criteria: * attended one of more visits as part of the ncl nhs tlhc programme * adults aged between 55 years and 74 years and 364 days * have capacity and can provide written consent exclusion criteria: * declines participation in alpine * lacking capacity and unable to provide written consent * patients who are considered by the clinician to be unfit/not suitable for enrolment in alpine
single cell landscape of hbv-related acute-on-chronic liver failure patients

Conditions: HBV Related Acute-on-chronic Liver Failure

Summary: this study aimed to profile the peripheral blood immune cells of patients with hbv related acute-on-chronic liver failure using single-cell rna sequencing to reveal the immunopathological mechanisms of hbv related acute-on-chronic liver failure.

acute-on-chronic liver failure (aclf) is a complex clinical syndrome characterized by acute deterioration of liver function in patients with chronic liver disease, exhibiting liver and extrahepatic organ failure and a high short-term mortality. immune imbalance plays an important role in the progression of hbv-related aclf. further investigation of the immune cell characteristics of hbv-related aclf is helpful to understand its pathogenesis, and may provide reference for the effective therapeutic agent. single-cell rna sequencing (scrna-seq) is the quantitative analysis of transcription at the single-cell level, which could provide systematic analyses of transcriptomic profiles, infer cell-cell interactions. this study will combine single cell transcriptomics and molecular biological experiment to elucidate the immunopathological cell states associated with hbv-related chronic liver disease vs. aclf.

Eligibility criteria:
inclusion criteria: acute liver failure is a well-defned medical emergency which is defned as a severe liver injury, leading to coagulation abnormality usually with an inr ≥ 1.5, and any degree of mental alteration (encephalopathy) in a patient without pre-existing liver disease and with an illness of up to 4 weeks duration exclusion criteria: * associated with other types of hepatitis virus infection or hiv infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ patients with incomplete data and patients unable to participate in the experiment.
two studies to determine if verteporfin pdt is effective & safe in treating multiple basal cell carcinoma of the skin.

Conditions: Basal Cell Carcinoma; Nevoid Basal Cell Carcinoma Syndrome; Gorlin Syndrome

Summary: the purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.

basal cell carcinoma (bcc) of the skin is the most common type of cancer that can be treated with various therapies including surgical removal. a number of factors can lead to the development of multiple bcc of the skin, including genetic disorders (e.g., nevoid basal cell carcinoma syndrome). treatment of multiple bcc becomes much more challenging. in these trials, the experimental therapy: verteporfin pdt is compared to placebo pdt. pdt or photodynamic therapy in these studies is the combination of the photoactive drug verteporfin (given intravenously) and red light exposure of skin tumors. the primary objective is to assess whether verteporfin pdt can completely eliminate multiple bccs. eligible subjects will have at least 3 bccs. study subjects won't know which treatment they have been been assigned to - this is done randomly (like flipping a coin). after study treatment, the bccs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment. safety will be assessed by testing blood samples before and after study treatment, and analyzing adverse events and skin reactions to the study treatment.

Eligibility criteria:
inclusion criteria: * currently has at least 3 eligible bcc skin tumors that have never been treated * is willing to have these tumor sites surgically removed exclusion criteria: * has xeroderma pigmentosum * has bcc tumors that are the result of prior radiotherapy or immunosuppression due to an organ transplant * is immunosuppressed * has abnormal liver function * is receiving systemic chemotherapy or has received chemotherapy within the last two years

Keywords: verteporfin pdt multiple basal cell carcinoma nevoid basal cell carcinoma syndrome
mid-line excision versus karydakis operation for pilonidal sinus

Conditions: Pilonidal Sinus

Summary: the trial compares excision in the midline at surgery for pilonidal disease versus excision lateral of the midline (karydakis operation) at surgery for pilonidal disease by randomly allocating patients with pilonidal disease to two groups of surgeons, each group being trained for one of the two methods.

excision in the midline and primary suture is a long proven method of treating pilonidal sinus. however it's associated with high incidence of post operative infection and recurrence. on the other hand karydakis operation (excision lateral of the midline, transposition flap and primary suture) is just a slightly more complicated procedure but has five times less recurrences reported in case series. the purpose of the present study is to compare the surgical results and costs of the two surgical methods utilized. in addition the investigators aim to compare the quality of life at defined time points after surgery. eligible patients are randomized to two groups of surgeons, well trained in either the midline operation or the karydakis operation (expertise based design). the design of the study allows wide inclusion criteria for participants, a cost-utility approach in the analysis, and a high external validity of the conclusions reached. comparison: midline excision andd primary suture compared with the karydakis operation (excision lateral of the midline and primary suture) for pilonidal disease.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * surgery is considered the best available treatment. * the patient understands trial information and is capable of making a decision for informed consent after having received information. * the patient wants to undergo surgery for pilonidal sinus and accepts participation in the trial. exclusion criteria: * patient has had a pilonidal abscess during the last four weeks before the planned day of surgery * patient has had surgery (excision) for pilonidal sinus more than once before.

Keywords: sinus, pilonidal pilonidal sinus pilonidal cysts pilonidal disease midline excision karydakis operation expertise based study surgery therapy
msc and kidney transplant tolerance (phase a)

Conditions: Chronic Renal Failure

Summary: the general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (mscs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. mscs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. from these samples, mscs will be expanded in good manufacturing practice (gmp) approved facilities and used for the present study in patients undergoing kidney transplantation. the proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (phase a), ii) a pilot efficacy phase (phase b).


Eligibility criteria:
inclusion criteria: * first single kidney transplant; * capable of understanding the purpose and risk of the study; * written informed consent. exclusion criteria: * pra \>10%; * specific contraindication to msc infusion; * any clinical relevant condition that might affect study participation and/or study results; * childbearing potential without effective contraception; * pregnant women and nursing mothers; * unwillingness or inability to follow study protocol in the investigator's opinion.

Keywords: mesenchymal stromal cells kidney transplantation tolerance
effect of topical besifloxacin on ocular surface bacterial microbiota prior to cataract surgery

Conditions: Microbial Disease; Cataract Senile

Summary: describe the efficacy of the use of topical besifloxacin in reducing the conjunctival microbiota as a prophylactic measure in patients scheduled for cataract surgery.

randomized double-blind clinical trial. study carried out in a single center between january and april 2017. 60 eyes were included that were randomly divided in a 1: 1 ratio into two groups. the first group received placebo (hydroxypropylmethylcellulose drops) while the second group received 0.6% besifloxacin drops four times a day for 3 days. all of them had a conjunctival cul-de-sac culture before and after treatment.

Eligibility criteria:
inclusion criteria: * subjects over 18 years of age scheduled for cataract surgery in the established study period. * subjects physically and mentally capable of applying the eye drops or having a person available to help in the correct administration of the eye drops 4 times a day. exclusion criteria: * - active eye infection (bacterial, viral, fungal or parasitic) such as blepharitis and / or conjunctivitis. * known allergy or any contraindication to the use of quinolones or any of the components of the drugs.

Keywords: besifloxacin prophylaxis cataract surgery
controlled study to assess the efficacy and safety of s-ibuprofen topical gel 5% (ap0302) in the treatment of doms

Conditions: Pain, Acute

Summary: phase 2 study designed to evaluated analgesic efficacy and safety of s-ibuprofen topical gel 5%

the purpose of this randomized, double-blind study is to evaluate the efficacy and safety of s-ibuprofen topical gel 5% in reducing pain/soreness associated with delayed onset muscle soreness (doms).

Eligibility criteria:
inclusion criteria: * history of pain/soreness after exercise * bmi between 18-30 * negative drug, alcohol, pregnancy screens * other protocol-defined inclusion criteria may apply exclusion criteria: * upper extremity workout in last 3 months * job or hobby requiring heavy lifting * history of muscle disorders * allergy or intolerance to nsaid or study drug * history of recent pain medication use * other protocol-defined exclusion criteria may apply