Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of chf 1535 200/6µg in not adequately controlled asthmatic patients

Conditions: Asthma

Summary: the purpose of this study is to show the superiority of chf 1535 (bdp/ff) pmdi over bdp hfa pmdi in terms of lung function considering change from baseline to the entire treatment period in average pre-dose morning pef in adult asthmatic patients not adequately controlled on high doses of ics or on medium dose of ics+laba.


Eligibility criteria:
main inclusion criteria: * male or female patients aged \> 18 years. * patients with persistent asthma not optimally controlled (gina 2010) on high doses of ics or medium dose of ics+laba at a stable dose for at least 4 weeks prior to screening. * patients with fev1 \>= 40% and \< 80% of predicted for the patient normal value and at least 0.9 l. * patients with a documented positive response to the reversibility test, defined as δfev1 \>= 12% and \>= 200 ml over baseline, within 30 minutes after administration of 400 μg of salbutamol pmdi. * at screening and at the end of the run-in period, patients with not adequately controlled asthma according to gina 2010 and with score at the asthma control questionnaire (acq)\> 0.75 main exclusion criteria: * history of near fatal asthma or of a past hospitalisation for asthma in intensive care unit or of frequent exacerbations (3 or more asthma exacerbations/ year). * hospitalisation, emergency room admission or use of systemic steroids (more than 3 days) for asthma exacerbation in the 4 weeks prior to screening visit and during the run-in period. * symptomatic infection of the lower airways in the 4 weeks before the screening visit. * current or ex-smokers with total cumulative exposure equal or more than 5 pack-years and /or having stopped smoking one year or less prior to screening visit. * patients with a clinically significant abnormality at 12-lead ecg or presenting a qtcb interval value in ecg \> 450 msec in males or \> 470 msec in females).

Keywords: adults, not adequately controlled, pre-dose morning pef
comparison of different oral rehydration solutions

Conditions: Short Bowel Syndrome

Summary: compliance is the biggest challenge in patients with short bowel syndrome (sbs) on home parenteral nutrition. these patients need to hydrate themselves to meet the excess fluid loss due to their anatomy. oral rehydration solution (ors) is prescribed to all these patients. the investigators believe that taste of the standard ors is the biggest reason why these patients are not complaint. the new ors in the market has been prepared with this in mind. the investigators want to study if this new ors will improve the compliance in this patient cohort.


Eligibility criteria:
inclusion criteria * all patients with short bowel syndrome treated by the hpn program. exclusion criteria * participants who have do not provide written consent. * participants who lack the ability to provide informed consent * participants who are not anticipated to be on hpn for at least 6 months (determined by principai investigator). * pregnant women * participants with pre-existing congestive heart failure, acute/ chronic kidney failure. (determined by the principai investigator)

Keywords: home parenteral nutrition compliance short bowel syndrome oral rehydration solution
dose study of acam2000 smallpox vaccine in previously vaccinated adults

Conditions: Smallpox

Summary: the objective of this study is to determine the minimum dose of acam2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.

specifically, the objectives of this study are to: 1. compare the safety and tolerability of four dose levels of acam2000 and a standard dose of dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis. 2. determine the immunogenicity of four dose levels of acam2000 and a standard dose of dryvax® in healthy adults at least 28 years of age by comparing: 1. the proportion of subjects at each dose level who develop a major cutaneous reaction 2. the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between baseline and day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on day 30. 3. determine the minimum dose of acam2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination.

Eligibility criteria:
inclusion criteria: * have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar. * females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children. * agree to be available for the entire study and agree to comply with all requirements. exclusion criteria: * children 1 year of age or younger in the household or be in close contact * smallpox vaccination within ten years * known or suspected human immunodeficient virus (hiv) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above. * renal disease * current or past history of eczema or a household member or direct contact who has eczema. * known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin b * known allergy or past allergic reaction to blood products. * known allergy to cidofovir or sulfa-containing drugs. * history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or stevens-johnson syndrome. * transfusion of blood or treatment with any blood product. * current or history of drug or alcohol abuse * innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.

Keywords: smallpox vaccines dryvax® orthopoxvirus vaccinia virus acam2000
impact of surgical position on stone-free rates in retrograde intrarenal surgery

Conditions: Stone, Kidney; Stones, Kidney; Stone;Renal

Summary: the goal of this clinical trial is to determine whether the surgical position during retrograde intrarenal surgery (rirs) affects stone-free rates in adults with kidney stones. the main questions it aims to answer are: * does the modified lithotomy position result in a higher stone-free rate compared to the standard lithotomy position? * are there differences in complication rates between the two surgical positions? researchers will compare patients undergoing rirs in the standard lithotomy position to those in the modified lithotomy position (30-degree trendelenburg with elevated surgical side) to assess its impact on stone clearance and surgical outcomes. participants will: * be randomly assigned to one of two surgical positions * undergo rirs with standard surgical procedures * have follow-up imaging to assess stone clearance after surgery this study aims to improve surgical techniques and patient outcomes in kidney stone treatment.


Eligibility criteria:
inclusion criteria: * presence of single or multiple kidney stones, with the largest stone ≤2 cm * age ≥18 years * provided written informed consent to participate in the study * indicated for retrograde intrarenal surgery (rirs) as a treatment approach exclusion criteria: * severe cardiovascular disease (e.g., heart failure) * congenital kidney anomalies (e.g., horseshoe kidney, ectopic kidney) * concurrent ureteral stones * pregnancy or planning pregnancy * history of previous kidney surgery on the same side * active urinary tract infection (uti) * coagulopathy or use of anticoagulant therapy that cannot be stopped before surgery
effects of ly2062430 in subjects with mild-to-moderate alzheimer's disease and in healthy volunteers

Conditions: Alzheimer's Disease

Summary: to study the safety of ly2062430 in patients with mild-to-moderate alzheimer's disease and in healthy volunteers.


Eligibility criteria:
inclusion criteria: * at least 50 years of age and diagnosed with mild to moderate alzheimer's disease or healthy volunteers * fluent in reading and speaking english * ad patients must have a reliable study partner who will be in frequent contact with the patient and comply with protocol requirements * ad patients who have received acheis or memantine for at least 4 months and on stable therapy for at least 2 months prior to starting study drug exclusion criteria: * have a history of serious infectious disease affecting the brain, head trauma, cancer, drug or alcohol abuse in the past 5 years * have serious or uncontrolled health problems or laboratory tests * multiple or severe drug allergies * prior participation in an active immunization study
changes of transforming growth factor b1 and procollagen iii in patients with acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: transforming growth factor-b1 (tgf-b1) is involved in the development of acute lung injury and in the fibroproliferation during acute respiratory distress syndrome (ards). procollagen iii peptide (piiinp) is a validated marker of fibroproliferation. piiinp is associated with death in ards patients. the simultaneous changes of tgf-b1 and piiinp were never studied in patients with ards. the relationships between tgf-b1 and the outcome of ards are unknown. the aim of the study is to analyse the changes of tgf-b1 and piiinp during ards and to show the relationships between tgf-b1 - piiinp and the outcomes of ards.

primary outcome: to analyse the changes of transforming growth factor b1 and procollagen iii during the acute respiratory distress syndrome.

Eligibility criteria:
inclusion criteria: * ards with a pao2/fio2 \< 200 mmhg at a positive end-expiratory pressure (peep) ³ 5 cm h2o * ards criteria from less than 24 hours * informed consent exclusion criteria: * pregnancy * chronic interstitial or fibrosis lung diseases * hepatic chronic disease * neutropenia £1 g/l * corticosteroid (more than 200 mg/day of hydrocortisone or equivalent, less than 2 weeks before inclusion) * immunosuppressive therapy within the last 30 days * participation in any investigational drug or devices study within 30 days prior study entry
age-related changes in sleep-wake regulation

Conditions: Sleep Deprivation

Summary: a sleep deprivation protocol combined with state-of-the-art, simultaneous positron emission tomography and magnetic resonance spectroscopy imaging will be employed to investigate the effects of sleep deprivation and aging on hypothesized molecular markers of sleep need.


Eligibility criteria:
inclusion criteria: * healthy male individuals * age: 20-35 or 60-70 years * right-handed * non-smokers * moderate caffeine/alcohol consumption * normal bmi exclusion criteria: * sleep/circadian rhythms disturbances * former brain injuries with loss of consciousness and brain anomalies * drug intake/consumption * medication intake * cardiac pacemaker * neurological disorders * prior participation (during past 2 years) in radiological or nuclear experiment

Keywords: positron emission tomography magnetic resonance spectroscopy aging
characteristics of hypophosphatasia in adult patients in rheumatology and their value in developing an algorithm to hpp-diagnosis - the cohir multi-center study

Conditions: Hypophosphatasia

Summary: non-interventional, prospective, multi-center investigation with exploratory data analysis to assess the proportion of patients with hypophosphatasia presenting at departments of rheumatology and to establish an algorithm to hpp diagnosis

acronym: expansion: hpp =hypophosphatasia cohir ="characteristics of hypophosphatasia in adult patients in rheumatology" alpl =alkaline phosphatase

Eligibility criteria:
inclusion criteria: * written informed consent * age \> 18 years * clinical suspicion of hypophosphatasia * evidence of an abnormal alp (alp below lln) within the clinical routine screening exclusion criteria: * failure to meet the inclusion criteria listed above

Keywords: hypophosphatasia hypophosphatasemia musculoskeletal complaints genetic disorder rare disease alkaline phosphatase gene alp alpl gene rheumatology cohir study cohir multi-center study cohirnational study prevalence diagnostic algorithm metabolic bone diseases
transplantation of cultured gut microflora to repeat antibiotic-induced diarrhea due to clostridium difficile

Conditions: Clostridium Difficile

Summary: patients who have received antibiotics and thereafter developed diarrhea are investigated for presence of clostridium difficile toxin. primary treatment is given with oral metronidazole/vancomycin. in case of relapse, secondary treatment is given with either cultured gut microbiota rectally or oral vancomycin in sequence. in those cases where secondary treatment with vancomycin fails cultured gut microbiota is given as final treatment. as an extension treatment, all failures were treated with cluttered gut microbiota through the upper route. in both cases as an alternative cultured gut microbiota may be given via the duodenal route. follow-up is carried out after 7, 30 and 90 days with interview and stool collection for analysis of clostridium difficile.


Eligibility criteria:
inclusion criteria: * antibiotic-induced diarrhea * positive fecal analysis for clostridium difficile toxin exclusion criteria: * antibiotic treatment * probiotic treatment * intestinal infection other than clostridium difficile * inflammatory bowel disease (ulcerative colitis, crohn's disease * immunodeficiency (drug- och disease-related) * pregnancy * unable to accept endoscopic procedures * unable to give informed consent

Keywords: antibiotic-induced diarrhea clostridium-difficile toxin pseudomembranous colitis
efficacy and safety of sofosbuvir/velpatasvir ± ribavirin for 12 weeks in adults with chronic hcv infection and decompensated cirrhosis

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) with or without ribavirin (rbv) for 12 weeks in adults with chronic hepatitis c virus (hcv) infection and decompensated cirrhosis.


Eligibility criteria:
key inclusion criteria: * chronic hcv-infected males and non-pregnant/non-lactating females * treatment naive or treatment experienced individuals * child-pugh-turcotte score 7-12 at screening note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: communicable diseases hepatitis hepatitis c virus diseases liver diseases digestive system diseases hepatitis, viral, human velpatasvir rna virus infections ribavirin sofosbuvir antiviral agents antimetabolites molecular mechanisms of pharmacological action anti-infective agents decompensated cirrhosis
a post-authorization, long-term study of ozanimod real-world safety

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to determine the rates of adverse events of interest (aeis) in a real-world population of participants with relapsing remitting multiple sclerosis (rrms) receiving ozanimod, sphingosine-1 phosphate (s1p) receptor modulator, compared to the rates of these events in two population of participants: * participants not exposed to ozanimod with rrms who have received treatment with other s1p-receptor modulators disease modifying treatments (dmts) * participants not exposed to ozanimod with rrms who have received treatment with other non-s1p-receptor modulators disease modifying treatments (dmts)


Eligibility criteria:
inclusion criteria: * have a diagnosis of multiple sclerosis (ms) recorded on or before the index prescription * have at least 6 months of continuous enrollment in the data source (thereby providing medical and dispensing/prescription history data, along with an operational definition of new use) before the index date exclusion criteria: • participants with dispensing/prescription of more than one cohort defining drug on the index date other protocol-defined inclusion/exclusion criteria apply

Keywords: relapsing-remitting multiple sclerosis ozanimod serious opportunistic infections serious acute liver injury malignancy macular edema
treatment of posttraumatic stress disorder (ptsd) in adult survivors of early chronic interpersonal trauma

Conditions: Posttraumatic Stress Disorder (PTSD)

Summary: eye movement desensitization and reprocessing (emdr) and trauma-focused cognitive-behavioural therapy (tf-cbt) have both been found to be effective in treating post-traumatic stress disorder (ptsd) following single-event traumas and to be more effective than pure anxiety management or stabilization treatments. however, much less is known about the efficacy of the different treatment approaches in survivors of repeated or chronic interpersonal trauma. recent evidence suggests that a combination of stabilization treatment + tf-cbt is efficacious in this population. although emdr is also often used in survivors of chronic interpersonal trauma, evidence on its efficacy are still poor. the aim of the current study is to compare the efficacy of (1) stabilization + tf-cbt and (2) stabilization + emdr using a randomized controlled trial in a routine clinical setting.


Eligibility criteria:
inclusion criteria: * meeting dsm-iv criteria for ptsd * having experienced repeated or chronic interpersonal trauma (e.g., sexual or physical abuse) * at least 18 years of age * having sufficient fluency in dutch to complete treatment and research protocol * participants using prescribed anti-depressant medication are required to be on a stable dose for at least 2 weeks before the beginning of treatment and remain on this dose throughout the treatment. exclusion criteria: * psychiatric problems that may interfere with the study participation or that require more intensive care than can be offered in the present study, including dementia, psychotic symptoms, depression with suicidal ideation, full-blown borderline personality disorder, substance dependence * current use of tranquilizers
surgery in treating patients with liver metastasis from a gastrointestinal stromal tumor

Conditions: Gastrointestinal Stromal Tumor; Metastatic Cancer

Summary: rationale: surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor. purpose: this phase ii trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

objectives: * to evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor. outline: this is a multicenter study. patients undergo surgical resection of hepatic metastasis.

Eligibility criteria:
disease characteristics: * diagnosis of gastrointestinal stromal tumor (gist) * hepatic metastasis meeting the following criteria: * clinically diagnosed as surgically resectable with no macroscopic residual tumor * no more than 3 hepatic metastases * synchronous hepatic metastasis allowed provided primary tumor is also resectable * does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease * no extrahepatic metastasis * no history of gist recurrence patient characteristics: * ecog performance status 0-1 * leukocyte count ≥ 3,000/μl * neutrophil count ≥ 1,500/μl * hemoglobin ≥ 8.0 g/dl * platelet count ≥ 75,000/μl * total bilirubin ≤ 2.0 mg/dl * alt and ast \< 120 iu/l * gtp \< 210 iu/l * not pregnant * no poorly controlled diabetes mellitus * no nyha class iii-iv cardiac function * no hepatitis b or hepatitis b carriers * no other malignancy requiring treatment prior concurrent therapy: * see disease characteristics * no prior interventional radiology for metastatic disease * no prior or concurrent imatinib mesylate * no other concurrent treatment

Keywords: gastrointestinal stromal tumor liver metastases
azd9668 relative bioavailability

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study is designed to investigate the pharmacokinetic behaviour of the free base formulation of azd9668. the study will compared the relative bioavailability of the free base formulation at two different dose levels compared to the tosylate salt formulation.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study-specific procedures * female subjects may be of non-child bearing potential (i.e. post menopausal or surgically sterile). * body mass index (bmi) ≥ 18.0 and ≤ 30.0 kg/m2 calculated from height and weight at the screening visit; minimum weight 50 kg. * clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol, cotinine and negative test results for hepatitis b surface antigen, antibodies to hepatitis c virus and antibodies to hiv-1/2 at the screening visit * be a none smoker or ex-smoker who has stopped smoking for \>6 months prior to visit 2 (pre-entry) exclusion criteria: * any clinically significant disease or disorder (eg infections/viral disease, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment), which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the absorption, distribution, metabolism and excretion of drugs. * any clinically relevant abnormal findings in physical examination, vital signs, clinical chemistry, haematology, urinalysis, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study * history of cardiac arrhythmia

Keywords: copd
optimization of de-ctpa images and diagnostic pathway: using low concentration iodine contrast material

Conditions: Pulmonary Embolism

Summary: the investigators aimed to compare the image quality and diagnostic performance of dectpa using lower concentration iodine contrast materials and using normal concentration iodine contrast materials in the evaluation of suspected pulmonary embolism.

all patients met the inclusion and exclusion criteria will be given written informed consensus. the enrolled patients will randomly receive one of the three injection protocols: a: 30ml iomeprol (iomeron 300, bracco imaging, milano, italia) injected at a flow rate of 4ml/s; b: 50ml iomeprol (iomeron 300, bracco imaging, milano, italia) injected at a flow rate of 4ml/s; c: 50ml ioversol (ioversol 350, hengrui, jiansun, china) injected at a flow rate of 4ml/s. a and b groups are both lower concentration iodine contrast material groups, with different total iodine loads.

Eligibility criteria:
inclusion criteria: * age greater than 18 years old * clinical suspicion of pulmonary embolism suggests ctpa examination (wells score\>4 or d-2 polymer elevation) * patient's general physical condition tolerates ctpa examination exclusion criteria: * allergy to iodine contrast agents * hyperthyroidism * pregnancy * weight greater than 80kg * heart failure patients, nyha heart function level iii or iv

Keywords: pulmonary embolism computed tomography contrast materials