Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of multiple doses of bt061 in patients with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis Vulgaris

Summary: this phase ii clinical study is to test safety and efficacy of bt061 against psoriasis given as repeated doses.

patients are enrolled into escalating dose levels. improvement of pasi, physician's global assessment and itching score is evaluated after administration of bt061 or placebo. safety data are assessed by an independent data and safety monitoring board (dsmb).

Eligibility criteria:
inclusion criteria: * male and female patients with moderate, moderate to severe or severe chronic plaque psoriasis diagnosed ≥ 12 months prior to screening. * bsa (body surface area) involvement \> 10% for more than 6 months. * pasi ≥10. * age ≥ 18 to ≤ 75 years. * body mass index (bmi) of 18-30 kg/m2 with a body weight between 50 and 130 kg. exclusion criteria: * erythrodermic, guttate or palmar pustular psoriasis (mixed forms may be admissible if chronic plaque psoriasis clearly remains the predominant diagnosis * treatment with a biological within less than 30 days or within less than 5 half-lives of the respective compound prior to administration of bt061/placebo. * serious local (e.g. abscess) or systemic infection (e.g. pneumonia, septicaemia) within 3 months prior to the administration of bt061 or placebo. * presence or history of clinically significant immune deficiency or autoimmune disease (except psoriasis). * positive diagnosis for acute or chronic infections (i.e. hepatitis c virus \[hcv\], hepatitis b virus \[hbv\], human immunodeficiency virus \[hiv\]) at screening visit.

Keywords: chronic plaque psoriasis psoriasis vulgaris autoimmune disease
efficacy and safety of cadazolid versus vancomycin in subjects with clostridium difficile-associated diarrhea

Conditions: Clostridium Difficile Infection

Summary: this clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with clostridium difficile-associated diarrhea (cdad).

subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. at the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.

Eligibility criteria:
inclusion criteria: * signed informed consent. * male or female ≥ 18 years of age. females of childbearing potential must agree to use an adequate and reliable method of contraception. * subject with a diagnosis of mild-moderate or severe cdad (first occurrence or first recurrence within 3 months) with: diarrhea: a change in bowel habits with \> 3 liquid or unformed bowel movements (ubm) within 24 hours prior to randomization, and positive c. difficile toxin test on a stool sample produced within 72 hours prior to randomization. exclusion criteria: * more than one previous episode of cdad in the 3-month period prior to randomization. * evidence of life-threatening or fulminant cdad. * likelihood of death within 72 hours from any cause. * history of inflammatory colitides, chronic abdominal pain, or chronic diarrhea. * antimicrobial treatment active against cdad administered for \> 24 hours except for metronidazole treatment failures (mtf) * known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones. * unable or unwilling to comply with all protocol requirements. * any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Keywords: clostridium difficile infection post-antibiotic diarrhea
effect of diazoxide on the obesity secondary to hypothalamic-pituitary lesions

Conditions: Hypothalamic-pituitary Lesions; Craniopharyngiomas

Summary: in children treated for intracranial lesions, the 2 factors of the obesity are : the location of the lesion (hypothalamic-pituitary region) and craniopharyngiomas

approximately 80 % of the hypothalamic-pituitary lesions that occur in children are craniopharyngiomas with one or three cases per 1 million children each year. one major problem remains unsolved : the obesity this study is performed to optimize the management of the children with hypothalamic-pituitary lesions by reducing the hyperinsulinemia due to the lesion and the surgery

Eligibility criteria:
inclusion criteria: * age 6 to 18 years * obesity with body mass index \> 97 percentile or \> 2 sd * hypothalamic-pituitary lesions not evolutive * hyperinsulinemia defined by insulin peak after oral glucose tolerance test\>100 ui/l * absence of diabetes mellitus defined by basal plasma glucose \< 1.2 g/l and glucose peak after oral glucose tolerance test \< 2 g/l and hba1c \< 7 % * hormonal replacement therapy stable from at least three months excluding the treatment of diabetes insipidus which can be adjusted * normal plasma thyroxine * written informed consent of the children and the parents exclusion criteria: * evolutive lesion * recent surgery or radiotherapy (\< 6 months) * modification of hormonal replacement therapy during the three previous months * diabetes mellitus defined by basal plasma glucose \> 1.2 g/l and glucose peak after oral glucose tolerance test \> 2 g/l and hba1c \> 7 % * renal or hepatic failure * uncontrolled hypertension * hypersensitivity to benzothiazine drugs * pregnancy * difficulties to understand the protocol

Keywords: hypothalamic-pituitary lesions craniopharyngioma obesity diazoxide hyperinsulinemia pediatric neurosurgery oncology pituitary hypothalamus
induction chemotherapy followed by concurrent chemoradiotherapy for nasopharyngeal carcinoma (npc)

Conditions: Nasopharyngeal Carcinoma

Summary: the primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage iii, iva, ivb npc treated with neoadjuvant chemotherapy (tpf regimen) and concurrent chemoradiation. secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage iii,iva, ivb npc treated with this regimen. the third objective of this study is to evaluate who may benifit from this treatment regimen.

concurrent chemoradiation is the standard treatment for locally advanced npc. the survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. in the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage iii, iva and ivb npc.

Eligibility criteria:
inclusion criteria: * -histopathologically proved who type ii and type iii carcinoma of the nasopharynx. * stage ⅲ, iva and ivb disease * kps \>70 * age between 18-70 * patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (agc) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). bilirubin \ 50ml/min. * the primary tumor or involved lymph node must be more than 2cm in diameter. * no prior radiation treatment to the head and neck or any prior chemotherapy * patients with no prior malignancy (not include basal cell carcinoma of skin) exclusion criteria: * evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. * prior radiotherapy to the head and neck region for any reason. * initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. * patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. * pregnant women

Keywords: phase 2 clinical trial npc neoadjuvant chemotherapy concurrent chemoradiation
general practitioner-performed compression ultrasound for deep vein thrombosis

Conditions: Deep Vein Thrombosis

Summary: numerous studies have demonstrated excellent diagnostic accuracy of compression ultrasonography (cus) performed by hospitals doctors, skilled and unskilled in radiology. recently, it was demonstrated that adequately ultrasonography-trained general practitioners (gp) can perform reliable ultrasound to increase the speed and improve the quality of clinical management of various clinical conditions. to date, in the medical literature there are no studies that demonstrate the diagnostic accuracy of gp in performing cus for the diagnosis of deep vein thrombosis (dvt). therefore, we plan to perform a prospective, multicenter, cohort study in which a large number of consecutive outpatients with symptoms or signs of dvt are subject to the cus by the gp with the aim of evaluating the precision and the diagnostic accuracy compared to specialists in vascular ultrasound, which in this case will be the standard of reference.


Eligibility criteria:
inclusion criteria: * first episode of dvt of lower limbs exclusion criteria: * previous episodes of dvt * ongoing anticoagulation * age younger than 18 years * pregnancy

Keywords: deep vein thrombosis diagnostic accuracy general practitioner test compression ultrasonography ultrasound
primary tumor research and outcomes network

Conditions: Spinal Column Tumor

Summary: this project aims to establish a network of spine oncology centers dedicated to prospective multicenter research of patients diagnosed with a primary tumor of the spine and will include a comprehensive prospective clinical database which will serve as a shared research platform. demographic, clinical, diagnostic, and therapeutic variables will be used to answer questions about survival and local recurrence, as well as questions about adverse events (aes), morbidity data, and health-related quality of life (hrqol) outcomes.

objective: to prospectively investigate variables (clinical, diagnostic, and therapeutic) in patients diagnosed with primary spinal column and cord tumors that are associated with: * survival * local recurrence * morbidity data * patient reported outcomes outcome measures: variables applicable to primary spinal column tumor patients which will be collected in the registry include: * patient details * treatment status * details of previous treatment * diagnosis and biopsy types * tumor details * oncological staging * symptoms * treatment details * imaging information we aim to collect the following outcome measures: * overall survival data * local disease recurrence data * morbidity data * patient reported outcomes: * euroquol-5d-3l, eq-5d-y (if applicable) * euroquol eq-5d vas - quality of life * neck pain numeric rating scale (nrs) * arm pain nrs * back pain nrs * leg pain nrs * sf-36 version 2 * sosg outcome questionnaire (sosgoq) v1.0 and v2.0 * surverys on patient expectations and satisfaction

Eligibility criteria:
inclusion criteria * patient with a current primary spine tumor or history of a primary spine tumor, including tumors within or surrounding the spinal column and/or spinal cord. this includes extradural tumors, intramedullary tumors (i.e. astrocytomas, ependymoma, etc.) and extramedullary tumors (i.e. meningiomas, neurofibromas, schwannomas, etc.). * informed consent obtained, i.e.: * ability to understand the content of the patient information/icf * willingness and ability to participate in the registry according to the registry plan (rp) * signed and dated ec/irb approved written informed consent or * written consent provided according to the irb/ec defined and approved procedures for patients who are not able to provide independent written informed consent exclusion criteria: - patient diagnosed with a metastatic tumor of the spine.

Keywords: registry spine surgery medical oncology radiation oncology neoplasms systemic oncologic therapy radiation therapy tumor markers
specified drug-use survey of trelagliptin tablets "survey on long-term use in type 2 diabetes mellitus patients with severe renal impairment or end-stage renal disease"

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the long-term safety of trelagliptin tablets in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure in the routine clinical setting.

the drug being tested in this study is called trelagliptin tablet. this tablet is being tested to treat people who have type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure. this study is an observational (non-interventional) study and will look at the long-term safety of the trelagliptin tablet in the routine clinical setting. the planned number of observed patients will be approximately 100. this multi-center observational trial will be conducted in japan.

Eligibility criteria:
inclusion criteria: 1. participants must be type 2 diabetes mellitus patients meeting the following conditions: have severe renal impairment or end-stage renal disease, with serum creatinine (mg/dl) or creatinine clearance (ccr; ml/min) meeting the following criteria within 3 months before the start of treatment with this product * serum creatinine (mg/dl)\*: male: \> 2.4, female: \> 2.0 * ccr (ml/min): \< 30 in patients with end-stage renal disease, this product may be administered irrespective of the time of hemodialysis. * estimated values corresponding to the ccr (for persons aged 60 years weighing 65 kg) exclusion criteria: 1. participants with any of the following contraindications for trelagliptin will be excluded: 1. patient with severe ketosis, diabetic coma or pre-coma, or type 1 diabetes mellitus 2. patient with severe infection, perioperative status, or serious trauma 3. patient with a history of hypersensitivity to any ingredients of trelagliptin
dental anesthesia in heart failure patients

Conditions: Heart Failure

Summary: to investigate the occurrence of arrhythmias in dental treatment with local anesthetic.

heart failure is defined as the inability of the heart to offer blood supply required to meet metabolic demand of the tissues and thus exercise adequately its role as a pump. according to data collected from the single health system (datasus), approximately 6.4 million brazilians have heart failure. this large contingent of patients will require multi-professional treatment, in particular, careful with dental health heart failure is regarded as the final common pathway of most cardiovascular diseases and, after installation of symptoms (mainly in the stages of functional class nyha iii and iv) have poor prognosis with average survival of 1.7 years 3.2 years for men and for women. dental treatment often requires application of local anesthetic. the adrenaline, agent vasoconstrictor, is widely used in dental treatment and aims to extend the effect of local anesthetic. specifically in people with heart failure, there shortcomings of evidence in the literature, the harmful effects of adrenaline 1:100,000 added to the local anaesthetic lidocaine. among the potential complications, we can highlight: arrhythmias, systemic blood pressure elevation and elevation of heart rate. the main objective of this work will investigate the occurrence of arrhythmias by evaluating of electrocardiographic parameters. our secondary objectives will be assessing: variations of blood pressure by ambulatory blood pressure monitoring, cardiac frequency and chest pain. we will study 70 patients between 18 and 75 years with a diagnosis of congestive heart failure functional class nyha iii and iv and restorative dental treatment indication. a random picture in double-blind study, patients are divided into two groups, one group receives as local anesthetic lidocaine 2% with adrenaline 1 in comparison with the second group that will receive 2% lidocaine with vasoconstrictor.

Eligibility criteria:
inclusion criteria: * any race,nationality,profession, single or married. * class ii , iii or iv of new york heart association ( nyha) * minimum 45% ventricular ejection fraction * patient must be in a clinical treatment or hospital treatment * patient must need dental restorative treatment , mandible or maxilla, due to caries or need for substitution of a inadequate dental filling. exclusion criteria: * patients with history of heart attack within less than three months * acute myocardial infarction * unstable angina * significant ventricular dysfunction * severe ventricular arrhythmia * malignant hypertension * neoplasms * sepsis * pregnancy * allergy to lidocaine and epinephrine

Keywords: dental epinephrine local anesthetic lidocaine cardiac arrhythmias procedure
virtual reality experiences for anxiety and pain control

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this trial studies the impact of virtual reality experiences on anxiety before surgery and pain after surgery. the goal of this study is to examine how different virtual reality experiences may help reduce anxiety and improve pain control, which may help reduce the need for medications such as opioids.

primary objective: i. to measure the impact of a gaming virtual reality (vr) experience compared to a mindfulness vr experience on preoperative anxiety and postoperative pain. outline: patients are randomized to 1 of 2 arms. arm i: patients participate in a vr intervention (angry birds) over 15 minutes before standard of care surgery and then participate in a vr intervention (tripp) over 15 minutes after surgery. arm ii: patients participate in a vr intervention (tripp) over 15 minutes before standard of care surgery and then participate in a vr intervention (angry birds) over 15 minutes after surgery.

Eligibility criteria:
inclusion criteria: * adults (18 years or older and younger than 89) * able to consent * english-speaking exclusion criteria: * non-english speaking patients because the vr content is only available in english * have symptoms concerning for an active respiratory infection or are on contact or isolation precautions * any active eye discharge * a history of seizure, epilepsy, or hypersensitivity to flashing light * have a history of motion sickness or vertigo * have active nausea or vomiting * psychiatric conditions that may interfere with the ability to successfully participate in the study * have cardiac pacemakers * require hearing aids at all times that cannot be removed * have defibrillators * have wound dressings on the head or neck that prevent comfortable use of the vr headset
fludara (oral) phase ii study for indolent lymphoma

Conditions: Lymphoma

Summary: to assess the antitumor effect and safety of fludara in patients with indolent lymphoma.

as of 29 may 2009, the clinical trial sponsor is genzyme corporation. note: this study was originally posted by sponsor schering ag, germany, which was subsequently renamed to bayer schering pharma ag, germany.

Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma) * patients with measurable lesions (major axis \> 1.5 cm by ct) * patients who failed to have pr to previous chemotherapies or antibody therapies. patients with subsequent relapse after a previously attained cr or with subsequent recurrence after a previously attained pr * patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies) * patients who have ps grade 0 to 2 in the criteria of ecog * patients with adequately maintained organ functions exclusion criteria: * patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (dic), cns metastases, fever more than 38 degrees celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, aiha or the history of allergies to similar purine analogs * patients who are positive for hbs antigen, hcv antibody or hiv antibody * patients who received g-csf or blood transfusion within 1 week before the screening test * patients who had ever received previous therapy with fludarabine phosphate injection (fludara), pentostatin (coforin), cladribine (leustatin) or sh t 586 * patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception

Keywords: fludarabine purine analog indolent lymphoma
the safety and efficacy of snc-109 car-t cells therapy the recurrent glioblastoma

Conditions: Recurrent Glioblastoma Multiforme

Summary: this is a single arm clinical study to estimate the safety, tolerability and pharmacokinetic (pk) characteristics of chimeric antigen receptor-modified t cells (car-t) snc-109 in patients with recurrent glioblastoma (r-gbm) and preliminarily evaluate the effectiveness, the immunogenicity of the product, as well as their correlation between the changes of cytokines from baseline level after cellular infusion.

it is planned to recruit about 16 patients with rgbm subjects. the protocol consists of screening period, lymphocytes apheresis period, operation period, pre-infusion evaluation (-2\~-1 days), infusion (day 0), infusion observation (day 1-post infusion), and follow-up period (last infusion-720 days). the incidence of dose limitation toxicity (dlt) will be observed within 28 days after the first infusion. subjects in this study will receive multiple infusions, starting with 2×104 car+ t cells/dose in the first subject, and the safety review committee (src) will evaluate the subsequent dosing regimen, dose, infusion interval, and number of treatment cycles. subsequent subjects will be evaluated by the src on the basis of available pk and safety data, and the src will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤70，both sexes; * diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma world health organization (who) grade 4); * karnofsky (kps) ≥60; * the estimated survival time is ≥8 weeks; * blood pregnancy tests for women of childbearing age are negative; * the patient himself/herself, and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form. exclusion criteria: * known allergies to study drugs or drugs that may be used in the study; * severe concurrent diseases in the heart, lungs, liver, or other vital organs; * hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy; * in addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies; * long-term use of immunosuppressant drugs, or large doses of steroids; * received live or attenuated vaccine or other surgery had no related to gbm within 4 weeks prior to lymphocytes apheresis; * lymphocytes apheresis or cell infusion combined with infection or unexplained fever.

Keywords: car-t gbm
isolation of human recombinant therapeutic monoclonal anti-pseudomonas antibodies

Conditions: Pseudomonas Aeruginosa; Multi-antibiotic Resistance

Summary: pseudomonas aeruginosa is a pathogenic bacteria for human, especially in hospital settings. it can sometimes be multi-resistant to many or even to all antibiotics usually used for its treatment. the aim of the study is to isolate and produce therapeutic antibodies against the bacteria pseudomonas aeruginosa in order to provide an alternative treatment to antibiotics in case of infection with an antibiotic-resistant strain of pseudomonas aeruginosa.


Eligibility criteria:
inclusion criteria: * patient selected in the retrospective part of the study (patient with serum containing functional anti-pseudomonas aeruginosa antibodies) * patient with weight ≥ 32kg. * with a follow-up visit at grenoble university hospital with a blood sampling for its care * having given its written no objection to participate in the prospective phase of this project exclusion criteria: * legally protected patient (minor, pregnant or nursing woman, ward or ward curated, hospitalized under duress or deprived of liberty)

Keywords: pseudomonas aeruginosa monoclonal antibody