Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics and pharmacodynamics of levobupivacaine during continuous caudal epidural analgesia in newborns

Conditions: Analgesia

Summary: the goal of this clinical trial is to learn about the pharmacokinetics of levobupivacaine in newborns during the continus caudal epidural analgesia. this type of analgesia is used for severly ill newborns. there is a need to lower the opioid doses for this population who is undergoing the surgery due to the life threading indication. in some cases it is considered to use the epidural analgesia for the sake of the patient. the main question is: is the commonly used dosing of 0,25% levobupivacaine in dose 0,2-0,3mg/kg/h the ideal dosing for these patients? is this type of dosing of epidural analgesia safe and effective for newborns?


Eligibility criteria:
inclusion criteria: * obtained informed consent of parent(s)/legal representative(s) * age younger than 45thweek of pma * age older than 25thweek of pma * body weight (bw) more than 500g * previous or planned operation with great demand on popm * other diseases demanding great popm (even without any need of surgery) * vital functions of the patient will be stable and there will be no suspicion, that patient current condition might be worsen by insertion of c-cela (every patient will be discussed with attending physician ) exclusion criteria: * decline of informed consent by parent(s) legal representative * age older than 45thweek of pma * age younger than 25th week of pma * body weight (bw) lower than 500g * congenital malformation of caudal part of spine ( spina bifida occulta , meningocele, meningomyelocele) * disease or congenital malformation significantly restricting liver functions (elevation of liver enzymes more than twice above the physiological range of the corresponding pma) * disease or congenital malformation significantly restricting kidney functions (elevation of urea and creatinine enzymes more than twice above the physiological range of the corresponding pma) * clinical condition, which doesn't long-term popm * meningism * patients with proven withdrawal syndrome caused by opiate administration * high risk of bleeding during insertion (coagulopathy) or known administrated anticoagulants which might be still active in the time of insertion of c-cela * substantial anemia (under 90g/l), which could lead to blood transfusion due to blood drawing * frequent blood tests associated with the treatment of the patient(with blood samples necessary for the purposes of the study together), which would exceed maximum * any hemodynamically unstable condition (for example septic shock)

Keywords: c-cela newborn analgesia epidural pain
a single-dose relative bioavailability study of gbt440 300 mg capsules in healthy subjects

Conditions: Sickle Cell Disease

Summary: the purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of gbt440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects.


Eligibility criteria:
inclusion criteria: * subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening * male subjects agree to use contraception * willing and able to give written informed consent exclusion criteria: * evidence or history of clinically significant metabolic, allergic, dermatological, hepatic, renal,hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder * history of hypersensitivity or allergy to drugs, foods, or other substances * history or presence of abnormal electrocardiogram or hypertension * history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 1 year of screening * participated in another clinical trial of an investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to screening
the effect of the release of the intrathoracic fascia on thoracic rotation mobility

Conditions: Fascia; Inflammation; Thoracic; Rotation

Summary: testing the effect of a specific stretch technique versus sham treatment, to objectify the influence of that specific technique on thoracic rotation mobility.

subjects in the experimental group will undergo a technique for stretching the intrathoracic fascia. before and after, a measurement will be performed with a goniometer, to see if there is a difference in thoracic rotation mobility. subjects in the placebo group get a different technique, where the hands of the therapists are simply placed on the thorax, but no manoeuvre will be performed. before and after, there is a measurement in thoracic rotation mobility. data will be compared and statistical analyse will be done to see of there is a difference in rotation. so the hypothesis that stretching intrathoracic fascia has an effect on thoracic rotation mobility, will be accepted or rejected.

Eligibility criteria:
inclusion criteria: * subjects between the age of 18 and 65 * both men and women exclusion criteria: * structural disease of cervical or/and thoracic spine and/or head and/or thorax * acute mobility restriction of cervical and/or thoracic spine * acute and/or intense pain * a history of trauma and/or operation on cervical and/or thoracic spine * treatment for cancer like chemo or radiation * baby's and children * elderly people
a study to assess the safety and efficacy of risankizumab for maintenance in moderate to severe plaque type psoriasis ( limmitless )

Conditions: Psoriasis

Summary: the purpose of this study is to investigate the long-term safety and efficacy of risankizumab in the treatment of moderate to severe chronic plaque psoriasis.

this is a phase 3, single-arm, multicenter open label extension (ole) study designed to investigate the long-term safety and efficacy of 150 mg risankizumab in the treatment of moderate to severe chronic plaque psoriasis. approximately 2200 participants who meet the entry criteria are planned to be enrolled in this study, rolling over from the preceding phase 2/3 studies.

Eligibility criteria:
inclusion criteria: * participants with a history of moderate to severe chronic plaque psoriasis, who have completed one of the preceding studies. * participants must be candidates for prolonged open label risankizumab treatment according to investigator judgment. * females of childbearing potential must have a negative urine pregnancy test result at baseline. if female, participant must be either postmenopausal, or permanently surgically sterile or for women of childbearing potential practicing at least one protocol specified method of birth control, starting at baseline through at least 20 weeks after the last dose of study drug. - participants must have signed and dated a written informed consent in accordance with good clinical practice (gcp) and local legislation prior to admission into the study. exclusion criteria: * premature discontinuation for any reason in the preceding study. * participants who have developed guttate, erythrodermic, pustular or drug-induced psoriasis as diagnosed by the investigator during the preceding study. * use of any prohibited medication or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator. * evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than psoriasis, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and ecg), or laboratory value outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the protocol or to complete the study, compromise the safety of the subject, or compromise the quality of the data. * previous enrollment in this study. * female subject who is pregnant, breastfeeding or is considering becoming pregnant during the study or within 20 weeks after the last dose of study drug. * time elapsed is \> 8 weeks since the completion visit in the preceding study. * participant is considered by the investigator for any reason, to be an unsuitable candidate for the study and not able to comply with the study protocol.

Keywords: abbv-066 bi 655066
drug use investigation on zithromac (azithromycin) in hiv patients

Conditions: HIV Infection

Summary: the investigation will be conducted for the purpose of determining the condition of occurrence of adverse events under the actual post-marketing use of zithromac 600mg tablet, verifying the therapeutic effects, detecting unknown adverse drug reactions and drug interactions and determining the factors affecting safety and efficacy.

all the patients whom an investigator prescribes the first zithromac tablets 600mg should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: patients need to be administered zithromac tablets 600mg in order to be enrolled in the surveillance. exclusion criteria: patients not administered zithromac tablets 600mg.

Keywords: hiv post marketing surveillance
observational study to evaluate the safety of levemir® in diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in africa, asia, europe, japan and south america. the aim of this observational study is to evaluate the incidence of serious adverse reactions (sars) while using levemir® (insulin detemir) under normal clinical practice conditions. study conducted globally in 26 countries. some countries participated in the study for only 3 months (austria, brazil, denmark, germany, israel, lebanon, slovenia, russia, and turkey), while others extended their participation to 6 (belgium/luxembourg, czech republic, greece, india, italy, netherlands, saudi arabia, south africa, south korea, sweden, tunisia, and united kingdom/ireland) and 12 months (finland, france, and japan), respectively.


Eligibility criteria:
inclusion criteria: * age according to approved label in each country and physician discretion * type 1 or 2 diabetes * recently started treatment with insulin detemir at the discretion of the investigator. before initiation of insulin detemir they should not have been treated with insulin * selection at the discretion of the physician exclusion criteria: * current treatment with levemir® (insulin detemir) * previously enrolled in the study * hypersensitivity to levemir® (insulin detemir)
a study of capecitabine (xeloda) and bevacizumab as a first-line therapy in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this 4 arm study assessed the efficacy and safety of oral capecitabine (xeloda) or intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (eloxatin) with or without iv bevacizumab (avastin), as a first-line treatment in patients with metastatic colorectal cancer. patients were randomized to receive 1) xelox (xeloda 1000 mg/m\^2 orally \[po\] twice a day \[bid\] on days 1-15 + oxaliplatin in 3 week cycles), 2) folfox-4 (oxaliplatin + leucovorin + fluorouracil \[5-fu\] in 2 week cycles), 3) xelox + bevacizumab (7.5 mg iv on day 1 in 3 week cycles), or 4) folfox-4 + bevacizumab (5 mg iv on day 1 in 2 week cycles).

this study was conducted in 2 parts: an initial 2-arm part in which patients were randomized to 1 of 2 different treatment groups (xelox or folfox-4), and a subsequent 2 x 2 factorial part, added to the study through a protocol amendment, in which additional patients were randomized into one of 4 different treatment groups (xelox + placebo, folfox-4 + placebo, xelox + bevacizumab, or folfox-4 + bevacizumab). due to the comparison of the oral agent capecitabine with bolus and infused fluorouracil, the study was not blinded with respect to these 2 treatments. the study was double-blind with regard to the administration of bevacizumab, ie, there was a placebo control for bevacizumab in the second part of the study. the study consisted of 3 phases, a primary study treatment phase, a post-study treatment phase, and a follow-up phase. primary study treatment phase patients were to receive up to 16 cycles (2-arm part of the study) or 24 cycles (4-arm part of the study) of treatment during the primary study treatment phase (48 weeks). post-study treatment phase patients who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. patients who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the patient withdrew consent. follow-up phase patients who terminated study treatment during the primary or post-study treatment phase were followed until disease progression or death.

Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age. * metastatic colorectal cancer. * ≥ 1 target lesion. exclusion criteria: * previous treatment with oxaliplatin or bevacizumab. * previous systemic chemotherapy or immunotherapy for advanced or metastatic disease. * progressive disease during or within 6 months of completion of previous adjuvant therapy.
study to assess effectiveness of therapy timely adjustment based on self-monitoring in patients suffering from mild-to-moderate ulcerative colitis (optimise study)

Conditions: Mild-to-moderate Ulcerative Colitis

Summary: the purpose of this study is to provide evidence that a therapy of ulcerative colitis (uc) disease adjusted on tight monitoring of non-invasive parameters, such as clinical symptoms and faecal calprotectin (fc) (substance that is released when intestines are inflamed and that can be measured in faeces), can provide significantly higher benefit for the participants in terms of disease control and quality of life (qol) improvement, compared to a symptom-based approach only.


Eligibility criteria:
inclusion criteria: * adult participants (≥ 18 years old) * participants with active mild-to-moderate uc (with rb and bowel inflammation confirmed by endoscopy) * participants with treatment with 5-aminosalicylic acid (5-asa) ≤ 2.4 g/day or with no treatment regimen at baseline * participants who agree to use fc home test (to dose fc in faeces as a marker of inflammation) * participants with internet access and smartphone with camera exclusion criteria: * participants currently enrolled in another interventional study * participants not willing to undergo an endoscopy at the end of study * participants with contraindications to treatment with 5-asa and/or 2nd generation corticosteroids * participants not willing to perform fc self-testing in faeces at home

Keywords: ulcerative colitis management strategies pragmatic trial
efficacy, safety, and tolerability of td1414 2% cream in impetigo and secondarily infected traumatic lesions (sitl)

Conditions: Impetigo; Secondarily Infected Traumatic Lesions

Summary: an international, multi-centre, prospective three arm parallel-group, phase ii proof of concept study comparing the efficacy and safety of two dosage regimens (bid 7 days and tid 7 days) of td1414 2% cream and one dosage regimen (bid 7 days) of bactroban® (mupirocin) 2% cream in adults and children down to 2 years of age with impetigo or sitl. furthermore an evaluation of the pharmacokinetics of td1414 2% cream tid for 7 days will be performed. a total of 664 patients will be enrolled in a stepwise manner according to age groups starting with the oldest age group.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent from patient and/or legally acceptable representative has been obtained * outpatients of any sex or ethnic origin * patients \>= 2 years of age (depending on study step) * patients must be suffering from primary bullous/non-bullous impetigo or sitl exclusion criteria: * presence of skin diseases at or near the investigational area * immunosuppressed state or other serious systemic disease * signs and/or symptoms of systemic infection * presence of skin infection/disorder not amenable to topical antibacterial treatment only * presence of secondarily-infected animal/human bite * presence of secondarily infected burnwound * topical or systemic use of medicinal or other products before or during the study which in the investigators opinion could confound the evaluation of the effect of the study drugs * known or suspected hypersensitivity to td1414 or any of the excipients in the td1414 2% cream * known or suspected hypersensitivity to mupirocin or any of the excipients in the bactroban® (mupirocin) 2% cream * participation in any other investigational drug study or use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to randomisation * patients previously enrolled/randomised in this study * abnormal ecg at baseline though the pr interval may be up to 220 ms, the qrs interval up to 110 ms and the qtc interval up to 450 ms
study of the feasibility of early lung ultrasound in neonatal respiratory distress in premature newborns born between 32 weeks of amenorrhea and 36 weeks plus 6 days of amenorrhea, hospitalized in the neonatal pediatrics and intensive care units of the dijon university hospital

Conditions: Neonatal Respiratory Distress; Preterm Birth

Summary: monocentric study carried out in the neonatal and intensive care units of the dijon university hospital. the objective is to evaluate the feasibility of performing a pulmonary ultrasound within 6 hours after admission in premature infants born between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days who are hospitalized for initial respiratory distress. pulmonary ultrasound is performed within 6 hours of admission and an ultrasound score is calculated according to the images observed. continued management according to protocols without taking into account the ultrasound data. follow-up of patients until discharge from hospital or d28 of life (whichever comes first)


Eligibility criteria:
inclusion criteria: * verbal consent from at least one legal guardian * premature infant (between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days) admitted for neonatal respiratory distress that began in the first 2 hours of life * hospitalized at the dijon university hospital in the neonatal pediatrics and intensive care units exclusion criteria: * individual is not affiliated to the national health care system * major intrathoracic or abdominal malformation
device for breathing frequency monitoring in muscular dystrophy

Conditions: Muscular Dystrophies

Summary: patients at risk of developing respiratory dysfunctions, such as patients with severe forms of muscular dystrophy, need a careful respiratory assessment, and periodic follow-up visits to monitor the progression of the disease. continuous monitoring of respiratory activity pattern at home could give additional understandings about disease progression, flanking traditional, intermittent, cardiopulmonary evaluations, allowing prompt clinical intervention, and anticipating respiratory dysfunction. the main objective of the present study is thus to investigate the feasibility of using an innovative wearable device for respiratory monitoring, especially breathing frequency variation assessment, in patients with muscular dystrophy. the comparison between the measurements of breathing frequency obtained by using the imu-based device and by using the reference method provided optimal results, in terms of accuracy errors, correlation and agreement. participants positively evaluated the device for what concerns ease of use, comfort, usability and wearability. moreover, preliminary results confirmed that breathing frequency is an interesting breathing parameter to monitor, at the clinic and at home, because it strongly correlates with the main indexes of respiratory function


Eligibility criteria:
inclusion criteria: * documented dmd or lgmd2 * loss of independent ambulation (wheelchair-bound patients) * ability to understand and follow test instructions and to report pain and discomfort. exclusion criteria: * presence of metal implants and cardiac pacemakers * relevant concomitant comorbidities (e.g.epilepsy) * behaviour and/or psychiatric disorders (e.g. emotional problems, anxiety, panic attacks).
swiss army physical fitness training

Conditions: Wounds and Injuries; Physical Activity; Mood (Psychological Function); Motivation; Motor Activity

Summary: the purpose of this study is to determine whether the new sport concept of the swiss armed forces influences the physical and psychological fitness of the recruits.

the physical and psychological demands in the swiss army basic military service are high. injury incidences in swiss army training schools are higher than in armed forces of other countries.there is evidence that progressive loading of physical demands at the beginning of basic military service and specific physical training can reduce injury incidences and attrition rates. a new sport concept by the swiss army takes into account these results of previous studies. therefore, the aim of this study is to investigate the influences of this new sport concept on the physical and psychological fitness as well as on the injury and attrition rates of the recruits.

Eligibility criteria:
inclusion criteria: * recruits of the swiss army rescue training schools 75 2/2015 and 3/2015 exclusion criteria: * none

Keywords: army sport physical fitness injuries psychological tests attrition