Kornimate/medical-research-clean huggingface dataset:
a trial investigating the pharmacokinetics and pharmacodynamics of rfviia in patients with haemophilia a or b with or without inhibitors

Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia A With Inhibitors; Haemophilia B; Haemophilia B With Inhibitors

Summary: this trial is conducted in europe. the aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rfviia (activated coagulation factor vii) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rfviia in patients with haemophilia.


Eligibility criteria:
inclusion criteria: * informed consent 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 patients with confirmed diagnosis of severe congenital haemophilia a or b (higher than 1% fviii or fix) with or without inhibitors to coagulation factors viii or ix, based on medical records exclusion criteria: * congenital or acquired coagulation disorder other than congenital haemophilia a or b * any clinical signs or known history of arterial thrombotic events or previous deep vein thrombosis or pulmonary embolism (as defined by available medical records) * use of any anticoagulant (e.g. un-fractionated or low molecular weight heparin, vitamin-k antagonists, direct thrombin inhibitors or factor xa inhibitors) * bleeding prophylactic treatment or fviii or fix immune tolerance induction (iti) treatment during the trial period
group versus traditional prenatal care for diabetes

Conditions: Pregnancy; Gestational Diabetes; Type 2 Diabetes

Summary: the investigators primary objective is to conduct a randomized trial to determine the effect of diabetes group prenatal care on glycemic control and postpartum weight retention in women with type 2 diabetes and gestational diabetes.

long term, the investigator aims to test the central hypothesis that group prenatal care, compared to traditional prenatal care, will improve, 1.) glycemic control and, 2.) postpartum weight retention in women with type 2 and gestational diabetes. the objective of this proposal is to conduct a randomized trial in two phases to determine the effect of diabetes group care (gc) on glycemic control in pregnant women with t2dm and gdm (antepartum phase) and the impact on postpartum weight retention (postpartum phase).

Eligibility criteria:
inclusion criteria: 1. english speaking 2. type 2 diabetes or gestational diabetes diagnosed by 2-step method(1) or likely pre-existing type 2 diabetes with one of the following during pregnancy and \</= 34 weeks: 1. 1 hour glucose challenge test \>/= 185mg/dl or 2. a1c \>/= 6.5% or 3. fasting plasma glucose \> 126mg/dl (2) 3. ability to attend group prenatal visit at specified days and times 4. willingness to be randomized at 22 weeks 0 days-34 weeks 0 days or initial visit between 24 weeks 0 days-34 weeks 0 days 5. ability to give informed consent exclusion criteria: 1. prior participation in diabetes group care 2. type 1 diabetes 3. multiple gestation 4. major fetal anomaly 5. serious medical co-morbidity necessitating more care than can be safely provided in group setting, as deemed by medical provider. 6. serious psychiatric illness including schizophrenia necessitating more care than can safely be provided in group setting, as deemed by medical provider.

Keywords: group prenatal care diabetes
the effect of isosorbide diesters based moisturizer on skin health

Conditions: Atopic Dermatitis

Summary: the overall objective of this study is to assess how a natural ingredient, isosorbide diesters (ideas), works in association with colloidal oatmeal for eczema.

the topical therapy of eczema largely focuses on the use of topical medications but there is demand for topical moisturizers and ingredients that can reduce the need for topical steroids. the goal of this study is to assess the use of a natural ingredient, isosorbide diesters (ideas), for eczema and if it can reduce the need for the use of topical steroids.

Eligibility criteria:
inclusion criteria: * men and women aged 18 or over * subjects with a diagnosis of mild to moderate eczema with a scorad between 1-50. exclusion criteria: * individuals who have a known allergy to isosorbide diesters. * individuals who have solely hand and/or foot eczema without evidence of eczema anywhere else on their body. * individuals who have been on topical calcineurin inhibitors or crisaborole to the predetermined areas within two weeks of initiation of participation or unwilling to undergo a washout period. * subjects with an ongoing secondary infection of the skin. * subjects who are on systemic therapy or who need systemic therapy at the discretion of the investigator. systemic therapies include cyclosporine, systemic steroids, methotrexate, and dupilumab. subjects who have been on cyclosporine, systemic steroids, or methotrexate in the month prior to initiation of study intervention or are unwilling to undergo a washout period. subjects who have been on dupilumab in two months prior to initiation of study intervention or are unwilling to undergo a washout period. * subjects with a diagnosis of scabies. * pregnant women * prisoners

Keywords: eczema skin dermatology isosorbide diesters skin microbiome
efficacy and safety of intraseasonal specific immunotherapy with depiquick® birch

Conditions: Allergic Rhinoconjunctivitis

Summary: this study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with depiquick® birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without intermittent asthma that have a clinical relevant ige-mediated allergic sensitization against birch pollen. the term "intraseasonal" means that patients will start with immunotherapy treatment during the birch pollen season, i.e. when the already experience allergic symptoms.


Eligibility criteria:
inclusion criteria: 1. patients must experience significant allergic symptoms on visit 2 2. medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens 3. specific ige against birch allergens (cap rast ≥ 2) exclusion criteria: 1. history of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens 2. fev1 or pef value ≤ 80 % 3. persistent asthma (gina ≥ 2) other protocol-defined inclusion/exclusion criteria may apply.
etanercept in new onset type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the investigators hypothesized that the administration of etanercept to children newly diagnosed with t1dm may be able to interdict the progression of t1dm. the aim of this study is to evaluate the feasibility and safety of etanercept administration to pediatric patients recently diagnosed with type 1 dm.

this is a double-blind randomized 24-week placebo-controlled feasibility and safety study. subjects received study drug for a 24- week period, followed by 4 and 12-week wash out periods.

Eligibility criteria:
inclusion criteria: * males and females subjects with t1dm aged 3-18 years * positive gad 65 and/or islet cell antibody * hba1c at diagnosis above 6% * insulin regimen with 3 injection of insulin daily (as described below) * white blood count between 3,000-10,000 and platelets \> 100,000 * normal alt and ast, creatinine \< 1.8 mg/dl * t1dm duration equal or less than 4 weeks exclusion criteria: * infection requiring iv antibiotics at diagnosis or within past 14 days from study entry * bmi over 85th percentile for age and gender * unstable household * unable to provide compliance with study drug, insulin and study visits, * evidence of psychiatric disease in the potential study subject and/or primary care taker * and chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis

Keywords: type 1 diabetes, etanercept, honeymoon period
stromal vascular fraction (svf) for treatment of recto-vaginal fistula

Conditions: Recto-vaginal Fistula

Summary: the purpose of this study is to determine safety of stromal vascular fraction (svf) for the treatment of recto-vaginal fistula.

sf-12 test

Eligibility criteria:
inclusion criteria: * signed informed consent * recto-vaginal fistula * men and women over 18 years old. good general state of health according to the findings of the clinical history and the physical examination * crohn's disease diagnosed at least 3 months before accepting the clinical criteria exclusion criteria: * presence of severe proctitis or dominant active luminal disease requiring immediately therapy * patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start * patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion * patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years * patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study. * patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study * patients with congenital or acquired immunodeficiencies. hiv, hepatitis b virus (hbv), hepatitis c virus (hcv) or treponema infection, whether active or latent * patients who have suffering major surgery or severe trauma in the prior 6 months * pregnant or breastfeeding women * patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug. * crohns disease activity index (cdai) index above 200

Keywords: recto-vaginal fistula adipose derived stem cells
effects of dosing and environment on gross motor and spasticity in spastic quadriplegic

Conditions: Spastic Cerebral Palsy

Summary: this study focuses on how enriched environment along with the traditional physical therapy improves the gross motor function in spastic quadriplegic cerebral palsy children. and how much dosing is required to gain that clinically significant improvement.

there is still a blurred area regarding dosage parameter in cerebral palsy rehabilitation. this study is focused primarily on the fact that level appropriate selection of time, type, frequency, and intensity of intervention (sensory and motor) plays a very vital role in developing gross motor functions. secondly it is very important to establish the impact of enriched environmental inputs and foster parent capacity as an early intervention taking into account cerebral palsy (cp) specific positioning and handling along with level appropriate sensory inputs.

Eligibility criteria:
inclusion criteria: age group between 7 months to 5 years. * spastic quadriplegia * gross motor function classification system (gmfcs) level iv and v * modified ashworth scale (mas): level 2 * both gender exclusion criteria: * history of fits * medications * dislocation and fracture * visual/auditory impairment * patients taking therapy from multiple places

Keywords: therapeutic dosing enriched environment
covid-19 vaccine response in sickle cell disease

Conditions: Sickle Cell Disease; COVID-19

Summary: the purpose of this study is to assess the antibody response to covid-19 vaccination in a cohort of patients with sickle cell disease (scd) and to assess vaccine and scd related complications around the time of vaccination.

sickle cell disease (scd) is a genetic disorder caused by a single base substitution of valine for a glutamine at the sixth amino acid of the gene encoding for the hemoglobin β chain. patients with hgb ss disease and other sickle hemoglobinopathies suffer from a variety of clinical complications related to this abnormal hemoglobin. these clinical manifestations include hemolytic anemia, painful vaso-occlusive crisis, and end organ damage. persons with scd generally auto-splenectomize in childhood secondary to infarctions from their hemoglobinopathy, thus increasing their risk of infection and rendering them immunosuppressed. data suggest that general immune function in scd patients may be impaired, and thus responses to vaccine may be suboptimal. patients with scd are considered at increased risk of complications from infection from sars-cov-2 infection and are therefore an important group to receive vaccination against the virus. understanding response to covid-19 vaccination is this high-risk group of patients can provide a more targeted approach to vaccination in order to achieve adequate protection.

Eligibility criteria:
inclusion criteria: 1. diagnosis of sickle cell disease (hbss, hbsc, hbsb0 thalassemia, hbsb+ thalassemia, hbs/other) 2. has not received any covid-19 vaccination prior to enrollment 3. scheduled for a covid-19 vaccination (type does not matter) as part of routine clinical care 4. willing and able to sign consent exclusion criteria: 1. unwilling to have labs drawn or complete study requirements. 2. previous therapy curative of scd (including bone marrow transplant and gene therapy) 3. previous receipt of anti-covid-19 antibody therapy
uemr vs. cemr for diminutive non-pedunculated colorectal polyps

Conditions: Colonic Polyps

Summary: this clinical trial is being conducted to compare the efficacy and safety of two standard methods of polypectomy，conventional endoscopic mucosal resection（emr）and underwater endoscopic mucosal resection（uemr），for small colorectal polyps.


Eligibility criteria:
inclusion criteria: patients age between 18-75 years old with non-pedunculated colonic polyps (measuring between 4 and 9mm), who willing to participate in this study. exclusion criteria: 1. pregnancy, 2. inflammatory bowel disease, 3. familial polyposis 4. the use of anticoagulant therapy or antiplatelet therapy 5. the absence of informed patient consent. 6. polyps showing signs of deep submucosal invasion
a novel individualized substrate modification approach for the treatment of long-standing persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to compare effectiveness of two substrate modification approaches in long-standing persistent atrial fibrillation patients, and hypothesized that a substrate-based, individualized substrate modification (ism)approach should be superior to traditional stepwise ablation(sa). to the best of investigator's knowledge, this was the first study to evaluate the "real" substrate by means of electro-anatomic mapping and to perform "true" substrate modification in long standing persistent atrial fibrillation ablation(lpaf).

catheter ablation (ca) is highly effective for paroxysmal atrial fibrillation(af), it is modestly effective for long standing persistent atrial fibrillation ablation(lpaf) even with complex or combined approaches, which is mainly attributed to the substrate underlying af remodeling. severity of atrial fibrosis is closely associated with clinical outcomes after ca for af . the more atrial scars and fibrosis present, the lower the success rate for af ablation. patients with lpaf have many more areas with scars and fibrosis than those with paroxysmal af or non-af controls. the mri delayed enhancement technique provides a non-interventional tool for evaluation of atrial fibrosis, however, it must be performed in sinus rhythm.three-dimensional electro anatomic mapping has proven as accurate as mri and can be performed easily during af ablation, thus providing a good tool for evaluation of atrial substrate during lpaf ablation. although electro-anatomic mapping provided a desirable surrogate for delayed enhancement mri to define af substrate, there was an important technical issue to be considered. there were no good techniques to predict a desirable tip-tissue contact before the contact force catheter was applied. a poor tip-tissue contact could render the results of voltage mapping less reliable. on the other hand, excessively high contact force could increase the risk of steam pop and cardiac perforation during ablation. hence it was important to use the contact force catheter to perform substrate mapping and ablation.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 72years * history of lpaf for ≥1 and ≤ 5 years * written informed consent provided * acceptance of catheter ablation treatment * acceptance of post-ablation follow-up exclusion criteria: * prior history of catheter ablation or surgical ablation * abnormal coagulation; contraindication for anti-coagulation * left atrium diameter ≥ 55mm * left atrium thrombus

Keywords: long standing persistent atrial fibrillation novel approach ablation
muscle inflammation and fat infiltration in patients affected by fshd

Conditions: Facioscapulohumeral Muscular Dystrophy 1a

Summary: facioscapulohumeral muscular dystrophy (fshd) is the second most common muscular dystrophy with approximately 500 patients in denmark. it is characterized by weakness and wasting of the facial muscles, the muscles in the shoulder region and of the legs. the primary aim of this study is to investigate possible links and order between inflammation and fat infiltration in the muscles in patients with fshd. approximately 15 patients with fshd will be recruited for repeated mri-scans during a year where the inflammation and fat infiltration in the muscles can be quantified.


Eligibility criteria:
inclusion criteria: * confirmed fshd exclusion criteria: * all contraindications for undergoing an mri scan
study to examine efficacy and safety of rituximab in participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this phase iv post-marketing, non-interventional, open label, non-comparative and prospective study will examine the efficacy and safety of rituximab in participants who had previously received rituximab in terms of everyday medical practice. efficacy and safety of rituximab will be determined 24 weeks after receiving the first infusion, 24 weeks after the second infusion repeated courses of treatment (if the participants receive another course of rituximab) and 24 weeks after the third infusion repeated courses of treatment (if the participants receive third course of rituximab). protocol does not specify the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab. rituximab will be administered at the discretion of treating physician according to approved label.


Eligibility criteria:
inclusion criteria: -participants receiving rituximab no longer than 4 weeks before the start of monitoring exclusion criteria: -not applicable
nowdx test for the detection of antibodies to covid-19 in lay persons

Conditions: COVID-19; SARS-CoV-2; Coronavirus

Summary: this study is designed to compare the performance of the nowdx covid-19 test to an emergency use authorized pcr test result. the intent is to show the rapid test device is comparable to a currently marketed device. the nowdx covid-19 test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to sars-cov-2 in human fingerstick whole blood at the point of care (poc); i.e. in patient care settings operating under a clia certificate of waiver, certificate of compliance, or certificate of accreditation; and at home.

this study is designed to compare the performance of the nowdx covid-19 test to an emergency use authorized pcr test result. the intent is to show the rapid test device is comparable to a currently marketed device. the nowdx covid-19 test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to sars-cov-2 in human fingerstick whole blood at the point of care (poc); i.e. in patient care settings operating under a clia certificate of waiver, certificate of compliance, or certificate of accreditation; and at home. the nowdx covid-19 test is intended for use as an aid in identifying individuals with an adaptive immune response to sars-cov-2, indicating recent or prior infection. at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. testing of human fingerstick whole blood is intended to be conducted in a home-like setting of a facility authorized to perform clia waived tests.

Eligibility criteria:
inclusion criteria: innate infection cohort\> * pcr positives: persons who were symptomatic for covid-19 and have tested positive for covid-19 with an eua or fda cleared pcr test; 7+ days post positive pcr test * pcr negatives: persons who have never had covid-19 and who have tested negative for covid-19 with an eua or fda cleared pcr test; within 0-6 days post negative pcr test * persons 2+ years old vaccination cohort\> * persons 7- 60 days post second dose of eua covid-19 vaccine * persons 18+ years old exclusion criteria: innate infection cohort\> * pcr positives: persons with a covid-19 positive test result \>45 days old * pcr negatives: persons with any prior covid-19 positive result * persons who have received covid-19 vaccine * persons \<2 years old vaccination cohort\> * persons symptomatic or previously infected with covid-19 prior to vaccination * persons \<18 years old
tramadol vs.tramadol with paracetamol

Conditions: Lumbar Disc Herniation

Summary: this study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

background: despite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate. aims: this study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery. study design: in this study we have randomized 60 patients into two treatment groups. in group tramadol patients received tramadol, in group tramadolparacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals. methods: severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists (asa) 1 or 2 status patients with single level lumbar disc herniation. exclusion criteria: patients who could not use a patient controlled analgesia (pca) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is ≥30 kg/m2 were excluded from the study.

Keywords: acetaminophen tramadol discogenic pain lumbar discectomy