Kornimate/medical-research-clean huggingface dataset:
topical composition therapy for the treatment of cutaneous mastocytosis

Conditions: Cutaneous Mastocytoses

Summary: the purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis.


Eligibility criteria:
inclusion criteria * biopsy proven cutaneous mastocytosis with or without evidence of systemic disease * male and female patients 18 to 80 years of age * no uvb treatment of the skin for 6 months prior to study entry * no use of topical or systemic corticosteroids for 1 month prior to study entry * good general health as confirmed by medical history * female patients of child-bearing potential with negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom (for men) or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence. * patients who are willing and capable of cooperating to the extent and degree required by the protocol; and * patients who read and sign an approved informed consent for this study exclusion criteria * vulnerable study population * exposure to ultraviolet b (uvb) radiation to any region of the skin surface for 6 months * regular use of skin lightening agents within 1 month of study entry, including * topical corticosteroids * topical bleaching products * topical retinoids * use of systemic preparations within 1 month of study entry, including: * systemic corticosteroids * systemic cyclosporine, interferon * systemic acitretin, etretinate, isotretinoin * systemic methotrexate, * systemic photoallergic, phototoxic and/or photosensitizing drugs * uv light therapy and sunbathing * inability to communicate or cooperate with the principal investigator and/or investigators due to language problems, poor mental development or impaired cerebral function * pregnant or nursing women * women planning a pregnancy within the study period
oleocanthal rich olive oil acute effects on hyperglycemia and platelet activation in t2dm

Conditions: Diabetes Mellitus, Adult-Onset; Platelet Dysfunction; Postprandial Hyperglycemia; Lipidemia; Inflammation; Oxidative Stress

Summary: this is a pilot acute dietary intervention study with a randomized cross-over design aiming to investigate whether acute supplementation of extra virgin olive oil (evoo) rich in oleocanthal could attenuate postprandial hyperglycemia and activation of platelets in t2dm patients. for this reason, non-insulin dependent diabetic patients (10-15) will be randomly assigned to consume in five different days white bread (50 g cho) with butter, butter with ibuprofen, refined olive oil and olive oil with oleocanthal (250 mg/kg 500 mg/kg). blood samples will be collected pre- and post-intervention up to 4 hours in order to determine platelet aggregation, postprnadial glycemia, lipemia, inflammation and oxidative stress. taking into account the strong anti-inflammatory and anti-platelet properties of oleocanthal, this study will assess whether oleocanthal-rich olive oils could exert similar effects under real in vivo conditions in t2dm patients. it will also assess whether these effects are achieved through improvement of postprandial glycemia and lipemia.


Eligibility criteria:
inclusion criteria: * adult patients diagnosed with t2dm * stable weight the last two months * smokers or not * no restriction regarding the menopause exclusion criteria: * insulin therapy * antiplatelet, anti-coagulant, anti-inflammatory and anti-depressant medication * chronic inflammatory disease * autoimmune diseases * cancer * uncontrolled thyroid disease. * supplement consumption the last two months

Keywords: type 2 diabetes mellitus diabetic platelet platelet aggregation oxidative stress inflammation postrpandial hyperglycemia extra virgin olive oil oleocanthal polyphenols dyslipidemia
personalized targeted immunomodulation in covid-19 ards

Conditions: COVID-19 Acute Respiratory Distress Syndrome

Summary: rationale: in covid19 single-targeted immunomodulation, mostly via an il-6 receptor blocker, was used by a one-size fits all non-targeted approach. in future pandemics the same might occur. however, for individual patients, this might not yield optimal treatment. objectives: this project aims to identify a way to individualize and target immunomodulation, using covid19 as a testcase for the future. * identify immunological pathways which are associated with outcome in c-ards. * test whether an individualized biomarker-based approach has an effect on outcome and costs when using single-target immunomodulation in c-ards(tocilizumab, anakinra, etc.). * explore whether other immunological pathways were present in patients with c-ards which could have been intervened with medication which is already available and has been described in ards or similar diseases. study type: retrospective observational multicenter study in the netherlands. study population: adult patients (≥ 18 years) hospitalized and admitted to the icu with covid-19 and acute respiratory distress syndrome (ards) (i.e., receiving invasive mechanical ventilation) will be included. intervention (if applicable): not applicable (retrospective study design). nature and extent of the burden and risks associated with participation, benefit and group relatedness: given the retrospective nature of the study, no burden, risks or benefits for the patient are associated with participation. the target population of this study is specific to hospitalized patients with covid-19.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * admitted to icu due to covid induced moderate or severe ards * requiring mechanical ventilation exclusion criteria: - refusing participation

Keywords: immunomodulation tociluzimab biomarker complement inhibitors il-6 inhibitors il-1 inhibitors jak inhibitors
a phase ii study of abraxane gemcitabine combination in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to evaluate the efficacy and toxicity of abraxane combined with gemcitabine in the patients with metastatic breast cancer.

this study is to investigate the efficacy and toxicity of abraxane combined with gemcitabine in the patients with metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * female between 18 and 70 years old; * patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery; * ecog (eastern cooperative oncology group) 0\~1; * normal functions with heart, liver,renal and bone marrow:wbc≥3.5×109/l；hb≥90 g/l；plt≥100×109/l; * got icf (informed consent form) before enrollment; * life expectancy more than 12 weeks exclusion criteria: * pregnant or breast-feeding women or positive serum pregnancy test; * uncontrolled brain metastases. patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling; * participation in any investigational drug study within 4 weeks preceding treatment start; * concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer; * serious uncontrolled intercurrent infections; * poor compliance
comparison of the effect of intra articular steroid injection and pericapsular nerve group block for hip osteoarthritis

Conditions: Hip Osteoarthritis

Summary: the most common cause of hip joint dysfunction in the elderly is degenerative osteoarthritis of the hip. innervation of the hip joint capsule is provided by the obturator nerve, the accessory obturator nerve, and the femoral nerve. with pericapsular nerve group block (peng), by blocking the femoral nerve and the accessory obturator nerve, analgesia is successfully provided for the hip joint. intra-articular injection of corticosteroids; it is used as an alternative to surgical interventions because it reduces inflammation and short-term pain and is a minimally invasive method. the investigators aim to compare and report patients who underwent ultrasound-guided intra-articular steroid injection and peng block in terms of post-procedural pain scores and patient satisfaction.


Eligibility criteria:
inclusion criteria: * hip pain nrs \> 4 * no pathologies in the laboratory and coagulation parameters exclusion criteria: * rheumatological disease with hip involvement * systemic active infection * malignancy * history of hip joint surgery * history of traumatic hip injury * platelets values \< 150.000 / µl * history of bleeding disorder
aloe vera in irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of the present study is to study the effect of aloe vera in the treatment of ibs patients in a randomized, double-blind placebo controlled study.

there is limited knowledge of the ibs pathophysiology, absence of biological markers and therefore few effective treatment options. ibs therefore contributes to difficulties in the management of the patients. aloe vera has a long association with herbal medicine, from the ebers papyrus from 16th century bce. it is alleged to be effective in treatment of wounds, to improve blood glucose levels in diabetics, and it may reduce symptoms and inflammation in patients with ulcerative colitis. evidence of the effects of aloe vera in the treatment of ibs, is however limited and contradictory.

Eligibility criteria:
inclusion criteria: * ibs according to the rome iii criteria * adults exclusion criteria: * other gi disorders * other medical conditions * were pregnancy or breast-feeding * food allergy or intolerance to other than lactose * ongoing intake of aloe vera products
blood and stool sample collection in subjects participating in colorectal cancer screening: act bold

Conditions: Colorectal Cancer

Summary: the primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (crc).

subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. approximately 7,500 subjects will be enrolled.

Eligibility criteria:
inclusion criteria: * subject is male or female, 40 years of age or older. * subject is at average or increased risk for development of crc. * subject presents for screening or surveillance colonoscopy. * subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy. * subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator. exclusion criteria: * any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years. * subject has a diagnosis or personal history of any of the following conditions, including: 1. familial adenomatous polyposis (also referred to as "fap", including attenuated fap and gardner's syndrome). 2. hereditary non-polyposis crc syndrome (also referred to as "hnpcc" or "lynch syndrome"). 3. other hereditary cancer syndromes including but are not limited to peutz-jeghers syndrome, myh-associated polyposis (map), turcot's (or crail's) syndrome, cowden's syndrome, juvenile polyposis, neurofibromatosis and familial hyperplastic polyposis. * subject has a family history of: 1. familial adenomatous polyposis (also referred to as "fap"). 2. hereditary non-polyposis crc syndrome (also referred to as "hnpcc" or "lynch syndrome"). * subjects with cronkhite-canada syndrome. * iv contrast (e.g. ct and mri) within 1 day \[or 24 hours\] of blood collection. * subject has any condition that in the opinion of the investigator should preclude participation in the study

Keywords: blood draw sample collection stool dna
diabetes go mobile! pilot study

Conditions: Diabetes

Summary: the purpose of this study is to examine whether a behavioral lifestyle intervention using mobile smart phone technology for self-monitoring can lead to greater improvements in diabetes outcomes.

the investigators will conduct a pilot randomized controlled clinical trial to examine the feasibility and preliminary efficacy of a behavioral lifestyle intervention on weight, glycemic control, and vascular inflammatory marker outcomes. a total of 26 overweight or obese patients with type 2 diabetes will be recruited from an underserved minority community health center in houston, tx. they were randomly assigned into one of the three groups: 1) behavior intervention with smart phone based self-monitoring, 2) behavior intervention with paper diary based self-monitoring, and 3) usual care group. both mobile and paper groups received a total of 11 group sessions and 1 individual session in a 6-month intervention. mobile group received an android-based smart phone with two applications loaded to help them record their diet, physical activity, weight, and blood glucose, while the paper group is using paper diaries for these recordings.

Eligibility criteria:
inclusion criteria: * 21 to 74 years of age * bmi≥ 25 kg/m2 * self-reported being diagnosed with type 2 diabetes for at least 6 months * currently monitor blood glucose and has a blood glucose meter * be able to read and write in english exclusion criteria: * previously participated in a structured lifestyle intervention, such as look ahead in the last 12 months * current pregnant /nursing or plan to become pregnant in the next 6 months * in addition to their diabetes condition, presence of a current serious illness or unstable condition requiring supervision on a special diet and limiting their ability to perform physical activity level. * current treatment for a severe psychological disorder * planned vacation, absences, or relocation in the next 6 months
collection of gingival crevicular fluid from periodontitis patients

Conditions: Gingival Diseases

Summary: to collect gcf (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.


Eligibility criteria:
inclusion criteria: * be aged 18 to 65 years inclusive * have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present * give written informed consent * be in good general health * no known history of allergy to personal care/consumer products or their * ingredients, relevant to any ingredients in the test products as determined by the * dental/medical professional monitoring the study exclusion criteria: * medical condition which requires pre-medication prior to dental visits/procedures * advanced periodontal disease * 5 or more decayed, untreated dental sites * diseases of the soft or hard oral tissues * orthodontic appliances * abnormal salivary function * use of prescription drugs. * use of antibiotics one (1) month prior to or during this study * use of any over the counter medications other than analgesics * erratic use of vitamin supplements * pregnant or breastfeeding. * participation in another clinical study in the month preceding this study * allergic to common dentifrice ingredients * immune compromised individuals (hiv, aids, immuno suppressive drug therapy)
an evaluation of pf-03715455 in moderate to severe uncontrolled asthma

Conditions: Asthma

Summary: the study proposes to evaluate the safety and efficacy of pf-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.

study terminated on 7th april 2015. the termination was due to business reasons. no safety or efficacy concerns contributed to the termination of the study

Eligibility criteria:
inclusion criteria: * subjects with a physician documented history or diagnosis of persistent asthma (according to gina, 2014 definition of asthma), * pre bronchodilator fev1 of greater than or equal to 50 and less that 80% of predicted. * subjects defined as gina step 4 on a stable dose of either fluticasone/salmeterol combination therapy, or budesonide/formoterol combination therapy or mometasone/formoterol combination therapy. * subjects who are defined as uncontrolled as evidenced by; juniper asthma control questionnaire (5 item version, acq) score greater than or equal to 1.5 and less than or equal to 3.0) exclusion criteria: * subjects diagnosed with chronic pulmonary disease (copd) and/or other chronic pulmonary diseases (eg, occupational asthma, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis (abpa), pneumoconiosis, sarcoidosis, tuberculosis). * subjects who are current smokers.

Keywords: asthma staged withdrawal of background therapy
study to identify the genetic variations associated with phantom limb pain

Conditions: Phantom Limb

Summary: the purpose of this study is to determine if there is a genetic component to phantom limb pain. dna will be analyzed for single nucleotide polymorphisms (snps) between the control and phantom limb pain group. total rna will also be isolated and profiled to asses the degree to which our gene(s) of interest are expressed in the presence or absence of phantom limb pain. some proteins, such as inflammatory antibodies or the neurotrophin brain-derived neurotrophic factor (bdnf), will also be assessed for their association(s) with phantom limb pain.

most patients (90-95%)with major limb amputations experience a phantom limb--the vivid impression that the limb is still present. in many cases, the sensation is painful for reasons that are currently not well understood. a small subset of amputees (\<10%) never experience phantom limb pain (plp), the painful sensation felt in the amputated limb. this difference suggests that there may be a genetic component that precludes some patients from ever experiencing plp. understanding the genetic components of plp may help in predicting which patients will experience plp and which amputees will respond to the various treatment options available. in order to understand the genetic aspects and ultimately develop more effective treatment options in the future, patients with and without plp will be asked to give 30 mls of blood after overnight fasting. these blood samples will be de-identified and sent to the national institutes of health (nih) in bethesda, maryland, where all of the genetic analyses will take place.

Eligibility criteria:
chronic plp group: * at least 18 years of age. * written informed consent and written authorization for use or release of health and research study information * single or multiple upper and/or lower limb amputation * at least three months post-amputation * ability to follow study instructions and likely to complete required visit(s) * experienced plp for at least one month and at least 3 times per week * phantom limb pain differentiated from residual limb pain by physical exam. * subjects taking blood thinners or other medications that do not increase risk during a blood draw. non-chronic plp group: * at least 18 years of age. * written informed consent and written authorization for use or release of health and research study information * single or multiple upper and/or lower limb(s) amputation * at least three months post-amputation * ability to follow study instructions and likely to complete required visit(s) * experienced plp less than 10 times total and/or for less than two weeks * subjects taking blood thinners or other medications that do not increase risk during a blood draw.

Keywords: phantom limb genetic variation dna sequence analysis amputation, traumatic single nucleotide polymorphism visual analog pain scale brain-derived neurotrophic factor inflammatory antibody peripheral nerve damage
the efficacy of integrated behavioral therapy for selective mutism

Conditions: Selective Mutism

Summary: this study examines the efficacy of the integrated behavioral therapy for selective mutism protocol (bergman et al., 2013). participants are 60 children, aged 4-8 years, diagnosed with selective mutism (sm). the level of sm symptoms is assessed during first arrival to the sm unit of schneider children's medical center of israel (intake), at the first treatment session, at sessions 12, and at the end of treatment. a secondary aim of this study is to assess the contribution of parent's characteristics (anxiety and depression levels, parenting style) to the childrens' sm symptoms level and to treatment achievements.

all study procedures have been approved by the institutional review board of schneider children's medical center of israel. participants are recruited from the selective mutism unit at schneider children's medical center of israel, during their first visit to the clinic. both parents of eligible children sign informed consents. each child is evaluated by a clinical psychologist, using a semi-structured interview (adis), designed to diagnose the child and to determine the level of symptom severity. the parents who are identified as the main-caregiving, complete questionnaires assessing the child's levels of sm symptoms and social anxiety (smq, sasc), the parents' levels of social anxiety (lsas, spin) and depression (bdi), parent's authority style (paq), parental accommodation (fasa) and parental playfulness (ppq). the child's teacher completes questionnaires assessing the child's sm levels (ssq). participants are than assigned either to the treatment or the waiting list group (by chance). the assessment of sm levels is repeated in both groups at 1 week from baseline, 12 weeks from baseline, and 24 weeks from baseline. participants of the waiting list group will commence treatment following the 24 weeks waiting period.

Eligibility criteria:
inclusion criteria: * selective mutism diagnosis (dsm-5) * age 4-8 years exclusion criteria: * autism spectum disorder * psychotic disorder * commenced other psychiatric or psychological treatment at the last month