Kornimate/medical-research-clean huggingface dataset:
evaluation of the immunopharmacology of edp1815 and edp2939

Conditions: KLH and Imiquimod Induced Skin Inflammation in Healthy Volunteers

Summary: a single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.

this study will evaluate the pharmacodynamic effects of multiple doses of edp1815 and edp2939 on immunological responses to keyhole limpet hemocyanin (klh) and imiquimod (imq) dermal challenges in healthy volunteers. edp1815 is an essentially non-live, specific strain of prevotella histicola, a natural human commensal organism. edp2939 is a pharmaceutical preparation of microbial extracellular vesicles. four cohorts of volunteers (n=18 per cohort) will be studied using different capsule formulations and doses, administered for 60 days. volunteers will be immunised with intramuscular klh. intradermal klh re-challenge and topical imq challenge will commence on day 57 with serial pharmacodynamic assessments to day 60. responses will be evaluated using dermal imaging (laser speckled contrast imaging; lsci, and multi-spectral photography), as well as dermal and systemic immunological biomarkers.

Eligibility criteria:
key inclusion criteria: * capable of giving signed informed consent, and willing to comply with requirements of the study. * age 18 years to 45 years, inclusive. * body mass index of 18 to 35 kg/m2, inclusive. * caucasian. * healthy based on medical history, physical examination, blood pressure, ecg and blood and urine laboratory tests. key exclusion criteria: * use of aldara® (imiquimod cream) within 3 weeks prior to the study. * has previously received immucothel® or klh. * allergy to alhydrogel® or aldara® (imiquimod cream). * current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas. * previous diagnosis of psoriasis. * history of pathological scar formation (e.g. keloid scar). * history of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma). * significant bowel disease (e.g. inflammatory bowel disease, coeliac disease) * currently has an infection or has needed antibiotics within 6 weeks before the study. * current smoker of more than 5 cigarettes per day * tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of the study * history of schistosomiasis.
efficacy of atomoxetine for adhd in adolescents and young adults with sud

Conditions: Attention Deficit Hyperactivity Disorder; Substance Use Disorder

Summary: the primary objective of the study is to investigate the efficacy of atomoxetine (atmx) in the treatments of adolescent and young adult attention deficit hyperactivity disorder (adhd) with comorbid substance use disorder (sud). the secondary objective of the study is to determine the efficacy of atmx in preventing sud relapse. as previous pre-clinical work has demonstrated that atmx has led to significant improvement in adhd in children and lacks abuse liability, the investigators hypothesize that atmx will be efficacious in treating adhd in adolescents and young adults with sud, and that atmx will also be efficacious in preventing sud relapse.


Eligibility criteria:
inclusion criteria: * male and female outpatients 15-30 years. * subjects with a dsm-iv diagnosis of adhd (combined or inattentive subtype) as determined by clinical evaluation and/or adhd module of structured diagnostic interview, completed by the study clinician. * subjects with a current or recent (within three months) substance use disorder (drugs or alcohol) as determined through clinical evaluation and/or ascertained through structured diagnostic interview. * subjects with an adhd cgi-s of \>= 4 (moderate impairment). exclusion criteria: * pregnant or nursing females. * subjects with a clinically unstable medical condition that will either jeopardize patient safety or affect the scientific merit of the study, or who undergo a change in treatment during the study. * recent history of intravenous drug use, or subjects who have current dsm-iv criteria for abuse or dependence of cocaine, mda, mdma, gammahydroxybutyrate, methamphetamines, amphetamines, opioids, pcp, or benzodiazepines that in the opinion of the investigator will interfere in their ability to participate safely in the study. * subjects with mental retardation or organic brain syndromes. * subjects who are psychotic or have a history of bipolar disorder. * participants who are taking any psychotropic or anti-sud medications will be excluded from the study. * current dsm-iv diagnosis of major depression, depressive disorders, or anorexia as manifested by clinical interviews.
cgm evaluation of glucose excursions in basal insulin treated t2dm at fasting glucose target

Conditions: Type 2 Diabetes

Summary: this is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.

in many clinical trials, basal insulin is titrated to only a fasting glucose goal. the usual final dose is \>0.4u/kg. in carefully cgm monitored/titrated studies in both basal insulin alone or in pump-treated t2dm, we have found the basal insulin dose to be \<0.3u/kg. this suggests that if guided by a single daily fasting glucose, titration may result in an excessive basal dose. this study will examine that issue.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * age 18 years and above * concurrently on +/-thiazolidnedione +/-ddp iv inhibitors +/-metformin +/- glinides and basal insulin analogs * a1c 10% or below * capable of self monitoring glucose at least 4 x a day * previously compliant with clinical recommendations * fasting blood glucose \<110mg/dl average for 3 consecutive days * bmi \<45 kg/m exclusion criteria: * urinary ketosis * current or expected alternation in insulin sensitivity such as major surgery, infection, renal failure, glucocorticoid treatment, recent serious hypoglycaemic episode * currently participating in another clinical trial * using rapid insulin insulin * pregnancy or nursing or the intention of becoming pregnant or not using adequate birth control * significant liver or heart failure.

Keywords: type 2 diabetes continuous glucose basal insulin
a multicenter, prospective, observational study to assess the clinical activity and impact on symptom burden and patients' hrqol of treatment with trabectedin in asts in a real world setting in greece

Conditions: Advanced Soft Tissue Sarcoma

Summary: this non-interventional study aims primarily at assessing the clinical effectiveness and the impact of the therapy on cancer-related symptoms and patients' hrqol. in addition, it represents an attempt towards gaining experience on the routine use of trabectedin in daily clinical practice in a representative sample of greek subjects with asts.


Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study have to meet all of the following criteria: * adult outpatients (18 years and older) of either gender; * patients with a histologically confirmed diagnosis of advanced (locally advanced or metastatic) soft tissue sarcoma who have failed treatment with anthracyclines and ifosfamide or who are unsuited to receive these drugs; * patients for whom the decision to prescribe therapy with trabectedin (yondelis®) according to the locally approved product's summary of product characteristics (smpc) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study; * patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol; * patients must have signed an informed consent document; * patients must be able to read, understand and complete the study specific questionnaires. exclusion criteria: a patient who meets any of the following criteria will be excluded from participation in this study: * patients who have received more than one cycle of trabectedin at the time of enrolment into the study; * patients that meet any of the contraindications to the administration of the study drug according to the approved smpc; * patients who currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with trabectedin.
digital vs. printed photographs: impact on skin self-examinations

Conditions: Melanoma

Summary: the primary aim is to determine the impact of using digital photographs on a mobile device versus printed photographs on skin self-examination rates. the ease-of-use and overall satisfaction with the two exam modalities will be evaluated. secondarily, the impact on melanoma thickness at detection, melanoma detection, biopsy, and office visit rates will be evaluated. the study involves patients in the pigmented lesion clinic that have received total body photography for skin monitoring.


Eligibility criteria:
inclusion criteria: * patients presenting to the penn dermatology pigmented lesion clinic who have a mobile device for personal use that either: * (1) already have total body photography images, have a compact disc (cd) of digital versions of these images, and who do not already conduct proper monthly skin exams at home, and * (2) patients that are having new images taken exclusion criteria: * patients that are children or adolescents * patients that are court-ordered to attend residential alcohol or other drug treatment facilities and therefore considered prisoners * patients that are incompetent to provide informed consent and health insurance portability and accountability act (hipaa) authorization
effectiveness accompaniment perioperative patients with psychiatric illness on the lives perioperative

Conditions: Psychiatric Disorders

Summary: the experimental strategy is to develop a specific device about the anesthetic and surgical acts for a subject with a documented psychiatric condition and to benefit from surgery. this device is based on 3 stages: pre-operative phase, phase perioperative and postoperative phase. a nurse anesthetist will come into contact with the subject the day before surgery. this contact will be concomitant with the pre-anesthesia visit. she explained about the general organization of the arrival in the operating room. the interview will be a minimum of 15 minutes and beyond if necessary. this will be accompanying this the next day in the operating room in order to optimize its hospitality and installing the block, guide the subject through all the steps before falling asleep. finally, even accompanying will be present upon awakening the subject in the recovery room.


Eligibility criteria:
inclusion criteria: * adult subject; * subject with chronic mental illness defined by icd-10 classification \[icd-10, 1992\], corresponding to psychoses say no emotional or affective psychoses say; * subject to which mental pathology is evolving for more than 6 months; * topic targeted for elective surgery; * topic judged capable of performing a self-administered questionnaire; exclusion criteria: * minor, pregnant or nursing women, about not being affiliated to the social security scheme, subject under guardianship; * subject with a mental illness do not belong to sections of icd-10 contained in "inclusion criteria"; * subject to benefit from surgery as part of the emergency;
safety and feasibility trial of adipose-derived regenerative cells in the treatment of chronic myocardial ischemia

Conditions: Myocardial Ischemia

Summary: this is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial.

to assess the safety and feasibility of adipose-derived regenerative cells (adrcs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.

Eligibility criteria:
key inclusion criteria: 1. males or females 20-80 years of age 2. significant multi-vessel coronary artery disease not amenable to percutaneous or surgical revascularization in the target area 3. ccs angina functional class ii-iv and/or nyha stages of heart failure class ii or iii 4. on maximal medical therapy for anginal symptoms and or heart failure symptoms 5. hemodynamic stability (systolic blood pressure ≥ 90 mm/hg, heart rate \ 95) 6. ejection fraction ≤ 45 7. left ventricular wall thickness ≥ 8 mm at the target site for cell injection, confirmed by 2d contrast echo within 4 weeks prior to enrollment, free of thrombus key exclusion criteria: 1. atrial fibrillation or flutter without a pace maker that guarantees a stable heart rate 2. unstable angina 3. lv thrombus, as documented by echocardiography 4. planned staged treatment of cad or other intervention on the heart 5. platelet count \< 100,000/mm3 6. wbc \< 2,000/mm3 7. tia or stroke within 90 days prior to randomization 8. icd shock within 30 days of randomization 9. any condition requiring immunosuppressive medication 10. a high-risk acute coronary syndrome (acs) or a myocardial infarction within 60 days prior to randomization 11. revascularization within 60 days prior to randomization 12. inability to walk on a treadmill except for class iv angina patients who will be evaluated separately 13. hepatic dysfunction, as defined as aspartate aminotransferase (ast) and /or alanine aminotransferase (alt) \> 1.5 times the upper limit of normal range (x uln) prior to randomization

Keywords: ischemic heart disease coronary artery disease chronic heart failure cardiovascular disease adult stem cells adipose derived regenerative cells
study to test a marketed drug in the treatment of menstrual migraine (0462-072)

Conditions: Migraine

Summary: the purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.


Eligibility criteria:
inclusion criteria: * female patient at least 18 years old * patient has menses approximately monthly * patient has at least a 6 month history of migraine and at least a 6 month history of menstrual migraine exclusion criteria: * pregnant and/or nursing mother * cardiovascular disease * uncontrolled hypertension
a study for absorption of intranasal epinephrine compared to conventional intramuscular epinephrine

Conditions: Anaphylaxis

Summary: this study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (in) comparing with intramuscular (im) route in healthy adult volunteers.

patients are reluctant to use epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. other route of administration of epinephrine (epi) may be more benefit such as intranasal route.

Eligibility criteria:
inclusion criteria: 1. healthy subjects 2. 18-30 years-old exclusion criteria: 1. pregnancy 2. subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine

Keywords: intranasal epinephrine plasma epinephrine level
long-term results of the stapled transanal rectal resection (starr) operation proposed in the treatment of a rectocele

Conditions: Rectocele; Female

Summary: rectal static disorders, including the rectocele, represent a frequent functional pathology which affects the quality of life of affected patients. among vaginal treatments, the starr technique corresponds to rectal resection by transanal approach using a stapler. the american gastroenterology association (aga) has concluded that service to patients is insufficient. the technical and functional results published are mostly short-term studies. the investigators seek to assess the technical and functional results of operation starr, based on a series of consecutive expert center cases, to confirm or refute the conclusions of the aga recommendations.


Eligibility criteria:
inclusion criteria: * patient operated for rectocele for 10 or more * age 18 and over * informed patients exclusion criteria: * patient objection
the long-term evaluation of glucosamine sulphate study

Conditions: Osteoarthritis, Knee

Summary: the primary aim of this study is to determine if the dietary supplements, glucosamine sulphate and/or chondroitin can limit or reduce structural disease progression whilst providing symptomatic benefit in people with osteoarthritis (oa) of the knee. the specific hypotheses to be tested in the proposed double blind, placebo-controlled, randomised clinical trial are that, compared to participants allocated to placebo, participants allocated to either or both of these dietary supplements will demonstrate: * reduced medial tibio-femoral joint space narrowing at 2 years and; * reduced knee pain over 1 year these benefits will be achieved by participants allocated to glucosamine sulphate and/or chondroitin (the study treatments) without concomitant: * increased use of analgesics * reduced health-related quality of life * reduced participation in leisure-time physical activity

the legs study is a double blind, placebo-controlled randomised clinical trial using a 2 x 2 factorial design. participant will be randomly allocated to one of the four possible treatment combinations: * glucosamine and chondroitin (double active) * placebo glucosamine and chondroitin * glucosamine and placebo chondroitin * placebo glucosamine and placebo chondroitin (double placebo) each allocation involves taking 4 study treatment capsules once a day for two years. a total of 600 participants with symptomatic knee oa will be recruited by general media advertising and by general practitioners through the new south wales divisions of general practice.

Eligibility criteria:
inclusion criteria: * knee pain, or taking nsaids/ analgesia for knee pain on most days past month * knee pain 4-10 on 10cm vas * medial tibio-femoral compartment joint space narrowing in symptomatic knee exclusion criteria: * unstable diabetes * \<2mm medial tibio-femoral compartment joint space width

Keywords: osteoarthritis, knee glucosamine chondroitin disease progression nsaids
effect of language and confusion on pain during peripheral intravenous catheterization (kthype)

Conditions: Anaesthesia

Summary: the purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (hypnosis), an other with negative connotation (nocebo) and at least with neutral connotation (neutral).

clinicians used to warn patients of pain or discomfort before potentially painful procedures like peripherical intravenous catheterization (pivc). however, suggestions for negative perceptual experiences causes more pain and anxiety. during this does not improve at all the real-life experience of the act. on the contrary, the use of gentler words improves pain perception and subjective patient experience. furthermore, hypnosis has been demonstrated as efficient and the pain perception seems to be modulate by hypnotic suggestions.

Eligibility criteria:
inclusion criteria: * at least 18 years * peripheral intravenous catheterization of 20 g on the dorsal face of the hand before a planned surgery * written and informed patient consent non inclusion criteria: * patient unable to communicate in french * difficult vein access characteristics * premedication * pregnant, breast-feeding woman * patient subject of legal protection exclusion criteria : * failed of the first attempt of peripheral intravenous catheterization

Keywords: communication confusion intravenous catheterization comfort
bone regeneration with mesenchymal stem cells

Conditions: Mandibular Fractures

Summary: mandible fractures are a common cause of facial injury in adults. the autologous mesenchymal stem cell (amsc) transplantation, is proposed as an alternative to the conventional graft treatment, improving bone neoformation.the objective was to evaluate the effectiveness of amscs application in mandibular fractures to reduce regeneration time and increase bone quality.

single blinded controlled clinical trial in patients with mandibular angle fracture. the patients were divided into: study group (sg): fracture reduction plus application of amscs, control group (cg): same procedure without amscs. amscs were obtained from adipose tissue , 24 hrs before the procedure. intensity and density were evaluated in normal bone and fractured bone, at 4 and 12 weeks after surgery using panoramic radiography and computed tomography. (ct) a total of 20 patients, 10 in each group were included. sg with a mean age of 31.2 ± 6.3 years and cg 29.7 ± 7.2 years, all patients were male. bone quality at week 4 sg 108.82 ± 3.4 vs cg 93.92 ± 2.6 (p = 0.000) by panoramic radiography, sg 123 ± 4.53 vs cg 99.72 ± 5.72 (p = 0.000) by ct. at week 12: sg 153.53±1.83 vs cg 101.81±4.83 (p= 0.000) by panoramic radiography, sg 165.4 ± 4.2 vs cg 112.05±2.1 (p= 0.000) by ct. the application of amscs presented at week 4 similar ossification values compared with normal bone and a 36.48 % higher ossification rate at week 12.

Eligibility criteria:
inclusion criteria: * entitled patients to the mexican institute of social security * patients with mandibular condyle fractures associated or not to other initial fracture that required open reduction and internal fixation * ages from 17 to 59 years * both female and male gender * patients who gave their consent to be part of this trial exclusion criteria: * patients younger than 17 years and older than 59 years * chronic-degenerative diseases, active smoking, collagen disorders * patients with signs of infection in the aimed area to treat and in whom the fracture occurred in a longer period than 10 days before their surgery.

Keywords: mesenchymal stem cells treatment
a study to assess the effect of tocilizumab + methotrexate on signs and symptoms in patients with moderate to severe active rheumatoid arthritis currently on methotrexate therapy

Conditions: Rheumatoid Arthritis

Summary: this 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (mtx) in patients with moderate to severe active rheumatoid arthritis (ra) currently on mtx therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-tnf) agent. patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. all patients will also receive methotrexate 10-25mg/week. the anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients at least 18 years of age with moderate to severe active ra for at least 6 months; * inadequate response to current anti-rheumatic therapies, including mtx; * inadequate response or intolerance to treatment with 1 or more anti-tnf therapies within 1 year of entering study; * on stable mtx for at least 8 weeks before entering study; * patients of reproductive potential must be using reliable methods of contraception. exclusion criteria: * major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study; * women who are pregnant or breast-feeding.