Kornimate/medical-research-clean huggingface dataset:
study of xmab942 in healthy participants and participants with ulcerative colitis

Conditions: Ulcerative Colitis (UC)

Summary: brief summary the phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of xmab942 in healthy volunteers (parts a and b). part c of this study will be a phase 2 study to evaluate xmab942 in participants with ulcerative colitis.

this study is a phase 1 randomized, double-blind, placebo-controlled, single ascending dose (sad) study in healthy volunteers, followed by a cohort of three repeating doses in healthy volunteers. the third part of this study will be a phase 2, randomized, placebo controlled, double blind evaluation of participants with ulcerative colitis with a dose determined from parts a and b. this study consists of 3 parts, as follows: part a: sad in healthy participants, will entail administration of xmab942 or matching placebo. part b: repeat dosing for up to 3 doses, will entail administration of xmab942 or matching placebo. part c: participants with uc to receive xmab942 or placebo with dose determined from part a and part b.

Eligibility criteria:
inclusion criteria: parts a and b * age 18-55 * must be in good health with no significant medical history * clinical laboratory values within normal range * bmi 18-35 (inclusive) * contraceptive use by men or women consistent with local regulations * able and willing to provide written informed consent part c * age 18-55 * must be in good health with no significant medical history * uc diagnosis * clinical laboratory values within normal range * bmi 18-35 (inclusive) * contraceptive use by men or women consistent with local regulations * able and willing to provide written informed consent exclusion criteria: parts a and b * any physical or psychological condition that prohibits study completion * history of suicidal behavior or suicidal ideation * heavy use of nicotine containing products * hiv, hepatitis b and hepatitis c positive * cardiac arrhythmia, or clinically significant abnormal ecg * active use of prescription medications within 14 days of day -1 * active use of over-the-counter, or herbal medication within 7 days of screening * other investigational products within 30 days * blood or plasma donation within 60 days * pregnant or breastfeeding part c * any physical or psychological condition that prohibits study completion * diagnosis of crohn disease, pouchitis, or indeterminate colitis * positive screen for clostridium difficile (c. difficile) * history of suicidal behavior or suicidal ideation * heavy use of nicotine containing products * hiv, hepatitis b and hepatitis c positive * cardiac arrhythmia, or clinically significant abnormal ecg * other investigational products within 30 days * blood or plasma donation within 60 days * pregnant or breastfeeding

Keywords: ulcerative colitis inflammatory bowel disease healthy volunteers
efficacy and safety evaluation of azimilide dihydrochloride in patients with implantable cardioverter defibrillators

Conditions: Arrhythmia

Summary: implantable cardioverter defibrillators (icds) have been developed to treat ventricular tachycardia or fibrillation (abnormal heart rhythms) by electrical shock or by pacing the heart. icd therapy is established as highly effective for stopping life-threatening arrhythmias, but it does not preclude the use of anti-arrhythmic drugs for prevention and to decrease the frequency of icd shocks. the safety and effectiveness of oral azimilide dihydrochloride in reducing the frequency of icd shocks has been investigated previously in a placebo-controlled study in patients with icds. these results need to be confirmed in this larger double-blind, placebo-controlled study with approximately 600 patients.


Eligibility criteria:
inclusion criteria: * currently have an icd implanted * have had a documented episode of symptomatic arrhythmias that triggered a spontaneous icd shock within 180 days of randomization. * if the icd implant is recent, the patient must have had a documented episode of sustained arrhythmias or cardiac arrest within 42 days before implantation of the icd exclusion criteria: * have severe heart failure * have a current diagnosis of psychosis * use illicit drugs * abuse alcohol * if female, are currently breast feeding, or plan to become pregnant during the study * are currently taking antiarrhythmic drugs or other drugs that prolong the qtc interval (a measurement taken from the ecg) * creatinine \>2.5 mg/dl (221 mmol/l) * potassium \ 5.5 meq * have a neutrophil count (anc) \< 100 ml (low count of a type of white blood cell) at time of randomization * have 2 or more consecutive qtc values \>440 msec
pharmacokinetics of boceprevir in pediatric subjects with chronic hepatitis c genotype 1 (p07614)

Conditions: Hepatitis C, Chronic

Summary: this is a study to determine the pharmacokinetics (pk) and weight-based dose of boceprevir following single oral dose administration in chronic hepatitis c virus (hcv) pediatric participants.


Eligibility criteria:
inclusion criteria: * documented chronic hepatitis c (chc) genotype 1 infection * treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks) * weigh between 10 kg to 90 kg inclusive at screening and baseline (day -1). * body mass index (bmi) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the center for disease control and prevention, usa * use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study exclusion criteria: * co-infection with the human immunodeficiency virus (hiv) or hepatitis b virus (hbsag positive). * treatment with ribavirin within 90 days, or any interferon-alfa within 30 days * discontinued from interferon treatment due to adverse events * currently receiving antiviral/immunomodulating therapy for hepatitis c * prior treatment with an hcv protease inhibitor * prior treatment with any known hepatotoxic agent (including herbal remedies) * use of investigational drugs within 30 days of enrollment into study * evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. * substance abuse (including but not limited to alcohol abuse, illicit drugs, inhalational drugs, marijuana use, etc) any time prior to entry into the study * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. * pregnant or breastfeeding female * meeting any of the laboratory exclusion criteria
empirical comparative study of variation blood level antibody vitamin d at scleroderma (ssc) patients compared healthy peoples

Conditions: Scleroderma

Summary: the aim is to find the presence of anti vitamin d antibodies in scleroderma patients and compare with control. a second goal is anti vitamin d levels in serum of scleroderma patients in relation to the clinical manifestations of the disease.

blood samples from 30 scleroderma patients compared to 30 healthy peoples to reach the target of variation of the blood level vitamin d antibody between this groups

Eligibility criteria:
inclusion criteria: study group 1. patients with ssc 2. age - 18 years old and older 3. sign icf control group - healthy people

Keywords: ssc= scleroderma icf+ informed consent form age 18 to 85 healthy
effect of osteopathic manipulative treatment on reduction of pain in complicated newborns: rct

Conditions: Prematurity

Summary: the aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.


Eligibility criteria:
inclusion criteria: * newborns born in the same hospital * either gender * diagnosis of any pathological/clinical medical condition exclusion criteria: * lack of guardian consent * newborn transferred to/from other hospital * lack of any of the inclusion criteria

Keywords: pathology newborn osteopathic manipulative treatment pain
preoperative and peroperative comparison between 3d spine reconstructions

Conditions: Scoliosis Idiopathic; Navigation, Spatial; Fusion of Spine; Safety Issues

Summary: the objective is to collect data from a per-operative navigation system called surgivisio during scoliosis surgeries. a research program is in progress in order super-impose pre-operative 3d reconstructions of the spine performed with the eos system on the per-operative 3d reconstructions performed with the surgivisio system. the purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.


Eligibility criteria:
inclusion criteria: * patients aged between 12 and 20 * adolescent idiopathic scoliosis * fusion surgery planned exclusion criteria: * patient under "tutelle" or privation of liberty * opposition of parents or patient
management of eczema by specific probiotic strains

Conditions: Eczema; Atopic Dermatitis

Summary: to investigate the therapeutic effect of a selected probiotic mixture on the severity of ad in infants aged 0-15 months. the probiotic mixture has been studied in laboratory setting and has proven il-10 stimulating effects. therefore it is thought to decrease ad severity in young children (beyond the conventional treatment).

atopic dermatitis (ad) is a highly prevalent chronic, itching, inflammatory skin disease that often presents in infancy. the disease can be the first manifestation of the so-called atopic march, the natural progression of allergic disorders, with subsequent development of asthma and allergic rhinitis. approximately 40% of the children with ad will develop asthma later in childhood. currently, topical corticosteroids are the mainstay treatment of atopic dermatitis; however, relapses are common and parents often fear possible side-effects, leading to non-compliance. there is increasing evidence that the intestinal microbiota plays an important role in the development of allergic diseases. modulation of the intestinal microbiota with probiotics, living micro-organisms with immunomodulatory effects, could possibly offer a new way of treatment of allergic disease. clinical trials investigating the preventive as well as therapeutic effect of probiotics on atopic dermatitis show inconsistent results. systematic (cochrane) reviews of all clinical trials (about treatment of ad by use of probiotics) concluded that the probiotic strains studied to date are not an effective treatment for ad; however, there is great heterogeneity between studies since many different probiotic strains are used. because of the known strain specific capacity in immunomodulatory effects, some strains might have a greater effect than others. better results can possibly be achieved by using a selected, (in laboratory setting) proven modulatory multispecies probiotic mixture, containing 6 different strains.

Eligibility criteria:
inclusion criteria: * children 0-15 months with mild to moderate eczema (scorad score 15-50 or equally easi score) for at least two weeks exclusion criteria: * use of topical steroids class ii or higher (which means treatment for severe eczema), * use of oral steroids or treatment with antibiotics prior to inclusion. * severe comorbidity * lack of knowledge of the dutch language

Keywords: infants adaptive immunology atopic dermatitis probiotics
adaptive, image-guided, intensity-modulated radiotherapy for head and neck cancer in the reduced volumes of elective neck

Conditions: Primary Non-operated Squamous Cell Carcinoma of Oral Cavity; Primary Non-operated Squamous Cell Carcinoma of Oropharynx; Primary Non-operated Squamous Cell Carcinoma of Hypopharynx; Primary Non-operated Squamous Cell Carcinoma of Larynx

Summary: severe acute and late dysphagia is now considered as a dose-limiting toxicity of radio(chemo)therapy for head and neck cancer that significantly affects patients' quality of life. we propose to preserve swallowing function by: * adapting (individualizing) treatment (intensity-modulated radiotherapy: imrt) to per-treatment changes occurring in the tumor and surrounding organs and tissues; * reducing the volumes of elective neck, that may result in significant decrease of severe acute and late dysphagia.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx. * primary non-resected tumor and/or patients refused surgery * stage t1-4, n0-3; for cancer of the glottis t3-4 or t any n1-3 * decision of curative radiotherapy or radiochemotherapy made by a multidisciplinary group of head and neck tumors at uz gent and uz gasthuisberg leuven * karnofsky performance status \>= 70 % * age \>= 18 years old * informed consent obtained, signed and dated before specific protocol procedures exclusion criteria: * treatment combined with brachytherapy * prior irradiation to the head and neck region * surgery of the primary tumor except lymph node dissection prior to radiotherapy * induction chemotherapy * history of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years * distant metastases * creatinine clearance (cockroft-gault) =\ 1,3 milligram/deciliter * known allergy to the ct-contrast agents * pregnant or lactating women * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits and unlikely to complete the study

Keywords: squamous cell carcinoma oral cavity oropharynx hypopharynx larynx
complementary and alternative medicine (cam) for fibromyalgia

Conditions: Fibromyalgia

Summary: this study is an acceptability and feasibility study of two adjunctive interventions: group education with stretching; and group acupuncture. the study population will be women with primary fibromyalgia who have not previously used acupuncture in the last 3 months. both interventions will be 10 weeks in length and will be conducted at the oregon health \& science university. the primary hypothesis is that both arms will be acceptable and feasible in the study population.


Eligibility criteria:
inclusion criteria: 1. having met american college of rheumatology (1990) criteria for the diagnosis of fibromyalgia 2. having a primary traditional chinese medicine (tcm) diagnosis of either liver qi stagnation, qi and blood stagnation, or qi and blood deficiency 3. female gender 4. reported average pain of 5 or higher over last week on a scale of 0 to 10 with ten indicating higher pain. 5. willingness to limit the introduction or change of any medications or treatment modalities for control of fibromyalgia symptoms during the study 6. no tcm in last 3 months (including acupuncture, chinese herbs or herbal tea pills, tuina (chinese massage), shiatsu (japanese massage), qigong and oriental food therapy) 7. ability to travel to the intervention and testing sites up to two times weekly 8. being over 18 and under 75 years of age, and 9. capability of giving informed consent. exclusion criteria: 1. presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture; 2. individuals with celiac disease 3. a score greater than 29 on the beck depression inventory 4. presence of concurrent autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, that causes pain and could potentially confound the analysis; 5. routine daily use of narcotic analgesics or history of substance abuse; 6. concurrent participation in other therapeutic trials; 7. pregnant and nursing mothers (verification of pregnancy status will be determined via a urine test); 8. severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years); 9. are undergoing disability determination, or are involved in litigation related to fibromyalgia 10. any impairment, activity or situation that in the judgment of the pi would prevent satisfactory completion of the study protocol 11. cognitive behavioral therapy in the last 6 months. 12. non-fluency in english

Keywords: fibromyalgia group acupuncture group education with stretching nociceptive reflex testing pain sleep fatigue
peptide-based immunization for colon- and and pancreas-carcinoma

Conditions: Colon Neoplasm; Colon Adenocarcinoma; Colon Cancer; Colo-rectal Cancer; Rectal Cancer; Rectal Neoplasms; Rectal Adenocarcinoma; Rectal Tumors; Pancreatic Cancer; Pancreas Cancer; Pancreatic Neoplasms; Pancreatic Adenocarcinoma

Summary: an international, multicenter study to identify tumor molecular particularities and neoepitopes among participants with colorectal and pancreatic tumors undergoing surgery.

colorectal and pancreatic cancers are among the most common causes of cancer-related death over the world. standard of care treatment for colon and pancreas cancer is stage dependent and includes surgical, chemotherapeutic, and radiation therapy. however, the current statistics underlines an urgent need for improved treatment. patient-individualized treatments and enhancement of the immune response via vaccination are among new therapeutic options. the enhancement of the immune response via vaccination is among new therapeutic options. here, either cell-specific antigens, over-expressed tumor specific antigens or mutated tumor-specific antigens (neoepitopes) can be employed. especially the latter possess the biggest potential for high specificity but presuppose an extensive characterization of the respective tumor. in order to identify a neoepitope-based vaccination approach for patient-individualized treatment options the molecular particularities of tumors have to be analysed. the aim of this study is to identify tumor molecular particularities and neoepitopes among patients with colorectal and pancreatic tumors undergoing surgery.

Eligibility criteria:
inclusion criteria: * informed consent is obtained from the participant * patients with pancreas or colorectal carcinoma undergoing surgery * the participant is older than 18 years old exclusion criteria: * inability to provide informed consent * the patient is not suffering from pancreas or colo-rectal carcinoma * patient has a condition contradicting surgery * the participant is younger than 18 years old * previously enrolled in the study

Keywords: neoepitopes vaccination tumor-specific antigens personalized medicine
study of intravenous rxdx-107 in patients with solid tumors

Conditions: Solid Tumor

Summary: this is an open-label, phase i/ib, dose escalation study of intravenous rxdx-107 administered to subjects with advanced solid tumors. the study is designed to explore the safety, maximum tolerated dose (mtd), pharmacokinetics, pharmacodynamics, and preliminary clinical activity of rxdx-107 and to define a recommended phase 2 dose (rp2d)


Eligibility criteria:
inclusion criteria: 1. confirmed relapsed or refractory locally advanced or metastatic solid cancer for whom no standard therapy is considered appropriate, or for whom standard therapy is considered intolerable. 2. \>18 years of age. 3. ecog performance status of 0 or 1. 4. life expectancy of at least 3 months. 5. received the last dose of previous treatment / therapy before day 1 of cycle 1: * 28 days for cytotoxic chemotherapy, immunotherapy, whole brain radiotherapy, anticonvulsive therapy, stereotactic radiosurgery and major surgery * 42 days for nitrosureas, mitomycin c, and liposomal anthracycline * 14 days for non-cytotoxic cancer therapies and radiotherapy 6. recovered from all toxic effects (excluding alopecia) of any prior anti-cancer therapy to grade ≤ 1 or to the baseline laboratory values. 7. adequate organ function and baseline laboratory values 8. women of childbearing potential must have a negative serum pregnancy phase 1b: patient must have measurable disease exclusion criteria: 1. receiving other experimental therapy 2. known symptomatic brain mets or leptomeningeal involvement 3. myocardial infarction in the previous 12 weeks. active ischemia or any other uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or chf. 4. another concurrent illness which would preclude study conduct and assessment, uncontrolled: medical condition, active infection, risk of bleeding, diabetes mellitus, or pulmonary disease, or alcoholic liver disease, or primary biliary cirrhosis. 5. malignancy within 3 years or active disease requiring treatment other than the target cancer. the exceptions are prostate cancer (gleason grade \< 6 with normalized psa levels), treated in situ cervical, breast carcinoma, squamous or basal cell skin cancer. 6. any condition that may compromise the ability to give written informed consent or to comply with the study protocol.

Keywords: phase 1/1b open-label dose-escalation pharmacokinetics solid tumor metastatic cancer chemotherapy nano formulation alkylator
study of molecular characterisation of early operable primary breast cancer in pakistani population

Conditions: Breast Cancer; Molecular Pathway Deregulation; Treatment

Summary: this study is looking at the biological characteristics of early operable primary breast cancer in pakistani population by using ihc


Eligibility criteria:
inclusion criteria: * women with confirmed diagnosis of breast cancer without history of taking neoadjuvant therapy good quality tumour samples available for ihc exclusion criteria: * patients received pre-operative chemotherapy or radiotherapy

Keywords: breast cancer molecular characterisation