Kornimate/medical-research-clean huggingface dataset:
trial investigating the safety of nnc 0113-0987 in healthy male subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of nnc 0113-0987 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ecg), vital signs, and blood and urinary laboratory assessments at the screening visit * body mass index (bmi) of minimum 18.5 and below 30 kg/m\^2 exclusion criteria: * male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication * the receipt of any investigational product within 90 days (or 5 half-lives of investigational drug, whichever is greater) prior to this trial (screening), or is currently enrolled in any other clinical trial * subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders that might have impact on the current trial, as judged by the investigator * subjects who are known to have hepatitis or who are carriers of the hepatitis b surface antigen (hbsag) or hepatitis c antibodies, or have a positive result to the test for human immunodeficiency virus (hiv) antibodies * history of chronic or idiopathic acute pancreatitis or amylase or lipase values above 3x upper normal range (unr)
the role of therapeutic drug monitoring in tuberculosis - a pilot study

Conditions: Active Tuberculosis

Summary: drug resistant tb is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (mic) determination may be of importance. this concept is defined as therapeutic drug monitoring (tdm). in this pilot study our hypothesis is that the ratio between mic and drug concentration data is correlated to the bacterial load measured as time to positive liquid culture (ttp). in two sites in sweden (linköping and karolinska hospital solna, stockholm), 25 patients with pulmonary tuberculosis will be recruited. mic-determination of mycobacterium tuberculosis will be performed in bactec 960 mgit and drug concentration will be determined at 2, 4 and 12 weeks after treatment initiation using lc-ms/ms methodology. sputum cultures will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and ttp will be measured in duplicate samples. clinical follow up according to who criteria will be performed 1 year after completion of treatment.


Eligibility criteria:
inclusion criteria: age\>18 years, culture verified tuberculosis exclusion criteria: other infectious diseases other than hiv or tuberculosis
a study to determine any effect of tafamidis on electrocardiographic intervals, specifically the rate corrected qt interval (qtc)

Conditions: TTR Cardiomyopathy

Summary: the purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected qt interval (qtc) in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy, nonsmoking, male and/or female subjects of non-childbearing potential. * body mass index (bmi) of 17.5 to 30.5 kg/m2. * total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. * an alt or ast measurement \>2 times the uln. * 12-lead ecg demonstrating qtc \>450 msec or a qrs interval \>120 msec at screening. * subjects at increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin. * history of risk factors of qt prolongation or torsades de pointes, congenital deafness and family history of sudden death.

Keywords: thorough qtc evaluation of tafamidis compared to the effects of moxifloxacin and placebo in healthy volunteers.
emergency physician-performed ultrasound-guided femoral nerve blocks in patients with hip fractures.

Conditions: Hip Fractures

Summary: in this prospective study, emergency physicians perform ultrasound-guided femoral nerve block for patients with hip fractures. we compare the effectiveness of analgesia and patient satisfaction of ultrasound-guided femoral nerve block with liberal use of the pain medicine in the emergency department. the primary outcome is the assessment of time to relief the pain with fewer adverse effects and less rescue pain medication use. the secondary outcome is patient satisfaction and adverse effects for different method of pain control.

the aim of this study is to compare the effectiveness of ultrasound-guided femoral nerve blocks performed by emergency physicians for pain control in the emergency department with traditional pain medicine. this study is a prospective before-and-after design. the enrollees are 20-year-old and older adult patients with hip fractures. we use numerical rating scale using a 0-10 scale to assess pain severity at the different time frame after giving pain medicine. the scale zero means "no pain" and scale 10 means "the worst pain imaginable". the primary outcome is assessed by the reduction of pain scale which are taken on a numeric rating scale every 30 minutes before and after pain management. the secondary outcome compares complications, adverse effects and patient satisfaction for different method of pain control.

Eligibility criteria:
inclusion criteria: * patients older than 20-year-old with hip fractures * stay in the emergency department for at lease two hours exclusion criteria: * hemodynamic unstable * major trauma in addition to hip fractures * the use of any pain management before the arrival of emergency department * chronic opioid use * inability to understood the numerical rating scale after instruction * allergy to local anesthetics * coagulopathy * injection site infection

Keywords: ultrasound-guided femoral nerve block
physical activity in children at risk of post-thrombotic sequelae (pact)

Conditions: Post Thrombotic Syndrome; Deep Vein Thrombosis

Summary: 'the pact trial' is randomized pilot trial to demonstrate the feasibility and potential effectiveness of a personal "fitness tracker" to improve adherence to an activity regimen following an initial acute dvt in children.

the feasibility of an innovative intervention of a validated fitness tracker, the fitbit, to improve adherence to a 12-week activity regimen in a pilot randomized controlled trial (rct) will be tested in 44 subjects with first, acute, proximal lower extremity deep vein thrombosis (dvt). the primary outcomes will consist of a) feasibility indicators determined a priori (eligibility, consent, adherence, retention) and b) estimates of effect size associated with the prescribed activity regimen, by describing within-subject change in qol and potential biomarkers of postthrombotic syndrome (pts) pre and post intervention in each group.

Eligibility criteria:
inclusion criteria: * a radiologically confirmed, acute, proximal first lower extremity dvt * 4 to 8 weeks after starting anticoagulation * out-patient ambulatory status exclusion criteria: * contraindication to increasing activity such as patients with juvenile arthritis, poor balance, congestive heart failure, etc.

Keywords: venous thromboembolism deep vein thrombosis lower extremity blood clot anticoagulation physical activity fitbit post-thrombotic syndrome post-phlebitic syndrome thrombosis
iron and vaccine response

Conditions: Iron Deficiency Anemia; Vaccine Preventable Disease; Vaccine Response Impaired; Iron Deficiency Anemia Treatment

Summary: vaccines often underperform in africa compared to high-income countries. why vaccines do not work as well in africa remains uncertain. malnutrition likely plays a role. our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to viral vaccines, and whether iron treatment improves their response.

group 1 (immediate iron treatment) will receive iron treatment before vaccination. women in both groups will receive two intramuscular vaccines (influenza and yellow fever). vaccine response will be measured 28 and 56 days after vaccine administration in both groups. group 2 (delayed iron treatment) will receive iron treatment at study end.

Eligibility criteria:
inclusion criteria: * 18-55 years old * zinc protoporphyrin \> or equal 40 mmol/mol heme * hemoglobin \< or equal 109 g/l * no malaria * no known hiv infection * no medical condition that precludes study involvement * no iron supplementation 1 week prior to study start * no recent tuberculosis infection * no vaccination of yellow fever or influenza prior to enrolment * not pregnant exclusion criteria: -
involvement of the translation initiation factors in resolution of inflammation in the elderly population

Conditions: Infection in the Elderly

Summary: aging cause specific changes in the immune system. processes like "immunoessence" and "inflammaging" offend the functioning of the immune cells and expose the elderly patient to infections that can lead to morbidity and death. protein translation regulation offers a strategic advantage to the immune cells, because it enables rapid activation or termination of synthesis of specific proteins, required for inflammation or its resolution. translation initiation depends on recruitment of eukaryotic initiation factor "eif4f" complex. the aim of the current study is to investigate the involvement of the translation initiation factors (eif4e and eif4g) in the process of recovery from acute infection in elderly patient admitted to the internal department with an acute infection.

1. blood samples of elderly patients diagnosed with acute infection (fever and leukocytosis) will be collected twice - at admittance to meir hospital and after recovery (24-48 hours without fever and leukocytosis). evidence of infection (chest x ray, urine and blood samples) will be collected. participants will be divided to two age groups: 65-80 yrs and very old patient \>85 yrs, and will be compared to younger patients aged 50-65. 2. peripheral blood samples will be separated to subpopulations of lymphocytes, monocytes and polymorphonuclears, and protein will be extracted. 3. protein lysates will be separated by sds-page electrophoresis and immunoblotted for phosphorylated and total eif4e and eif4g; their regulators: mnk 1/2, 4ebp1, mtor and targets: cyclin d1, c-myc, survivin, bcl2, vegfa, etc. 4. paired samples (within each age group) will be analyzed and correlated with clinical response of the patients. the source of the infection will also be considered. 5. comparison between age groups at admittance and upon recovery will be made (unpaired).

Eligibility criteria:
inclusion criteria: * patient aged 50 y and more with: * fever \>38c that started in the 48 hours prior to admission * leukocytosis \>10.0 k/microliter * suspected source of infection by symptoms, lab results or imaging * treatment with antibiotics started in the last 24 hours or is about to be started exclusion criteria: * patients who cannot sign the informed concent ( dementia) * patients with active malignancy * patients who are under chemotherapy

Keywords: elderly immune response acute infection
study to compare the addition of floseal to our standard of care to control post operative bleeding in tkr

Conditions: Intraoperative Bleeding; Post-operative Bleeding

Summary: the purpose of this study is to compare floseal to our standard of care (soc) to decrease intraoperative and immediate post-operative bleeding.

a prospective randomized single-blind clinical trial will be conducted at the hôpital du sacré-coeur de montréal and hôpital jean-talon. all patients admitted for total knee arthroplasty (tka) between january 2012 and september 2013 outcome variable: patient receiving floseal or soc variables under study: primary end point: need of transfusion post-op (yes/no, how many) patient will be transfused if : hg \ 100/min, hypotension (\< 90/60), hx : cva, cad) secondary end point: 1. efficacy (during hospital stay) * pre-op and post-op hg (\> 100; 80-100; \<80) * hemovac blood drainage (ml) * per operative bleeding (ml) 2. safety (follow up: 6wks, 6 ms, 12 ms, 24 ms) * post-op complications: infection, pain, oedema, allergic reaction. * functional outcomes: knee society score (kss), western ontario and mcmaster universities questionnaire (womac), international knee documentation committee form (ikdc)

Eligibility criteria:
inclusion criteria: * all subjects above 18 years old admitted for a tka between january 2012 and september 2013at hôpital du sacré-coeur de montréal (hscm) and hôpital jean-talon (hjt), montréal, quebec, canada. * tka done without the use of a tourniquet except while cementing only (±10 minutes) * tka done with smith and nephew "genesis ii" or zimmer "nexgen" total knee replacement implants exclusion criteria: * • prior osteotomy or knee surgery within last 6-8 wks * active, local infection or systemic infection * participation in any other pharmaceutical or clinical investigation * bleeding disorders (hemophilia a, hemophilia b, von willebrand disease, factor viii deficiency, vitamin k deficiency, thrombocytopenia (platelets \< 50 x 109 per litre) * patients with known allergies to materials of bovine origin

Keywords: total knee arthroplasty post-operative bleeding floseal
3 yr efficacy & safety study of zoledronic acid in post-menopausal women with osteoporosis treated with zol acid for 6 yrs

Conditions: Post-menopausal Osteoporosis

Summary: this second extension will evaluate the efficacy and long term safety of zoledronic acid in women with post-menopausal osteoporosis


Eligibility criteria:
inclusion criteria: * women who have received the 4th and 6th dose of zoledronic acid in study czol446h2301e1 exclusion criteria: * poor kidney, eye, liver health * use of certain therapies for osteoporosis in study czol446h2301e1 * abnormal calcium levels other protocol-defined inclusion/exclusion criteria may apply

Keywords: osteoporosis zoledronic acid post-menopausal
diagnostic imaging of bone metastases in prostate cancer patients

Conditions: Prostate Cancer Metastatic to Bone

Summary: an improved diagnosis of bone metastases in prostate cancer patients can have a significant impact on treatment strategy and probably survival as well. the primary purpose of the project is to determine the diagnostic accuracy of bone spect-ct, choline-pet-ct, psma-pet-ct, naf-pet-ct and whole-body mri in the diagnosis of bone metastases in prostate cancer patients.

the project is a prospective diagnostic test accuracy study. the project takes place at herlev hospital and is a collaboration between the department of radiology and the department of clinical physiology and nuclear medicine. the investigators want to include 300 prostate cancer patients referred to our standard diagnostic imaging (naf-pet-ct scan) by the clinicians. in addition to the standard diagnostic imaging (naf-pet-ct-scan), two project will be performed on all participants. the project has three arms with the following scanning combinations: a) whole-body mri + spect-ct b) whole-body mri + cholin-pet-ct c) whole-body mri + psma-pet-ct the recruitment of project participants takes place on the day when the patients are undergoing a naf-pet-ct scan in the course of regular clinical practice at our institution. all readers are experienced radiologists or specialists in nuclear medicine. patient identification on each scan will be anonymized and the reader will not have access to clinical and biochemical information or previous imaging studies.

Eligibility criteria:
inclusion criteria: a subject will be eligible for project participation if he meets all of the following criteria: * is either 1) a newly diagnosed prostate cancer patient in clinical suspicion of bone metastases or 2) a previously diagnosed prostate cancer patient in clinical suspicion of progression in the form of bone metastases. the subject must have been referred to the standard diagnostic imaging (18f-naf-pet-ct) at our institution for bone metastases. * the prostate cancer diagnosis must be biopsy-proven * the subject is willing and able to comply with the protocol as judged by the investigator exclusion criteria: a subject will be excluded from the protocol if he meets one or more of the following criteria: * has prior malignancy, except for adequately treated basal cell or squamous cell skin cancer * has pacemaker or implanted devices (eg. cardiac valves, neurostimulator or insulin pump) that cannot be removed, metal clips/metal prostheses from surgery that are not mri compatible or metallic foreign bodies in the eye (mri exclusion criteria) * has any condition that places the subject at an unacceptable risk if he undergoes a diagnostic ct-scan (e.g. history of severe allergic reaction to the contrast agent). * has severe obesity (\>195 kg is the weight limit for the scanner table) * has severe claustrophobia
manual therapy of spine with postural correction exercise compared with conventional therapy in patients with adhesive capsulitis - a randomised clinical trial

Conditions: Adhesive Capsulitis of Shoulder

Summary: adhesive capsulitis (ac) is often self-limited but can persist for years and may never fully resolve. the most effective treatment for adhesive capsulitis is uncertain till date. though neural links are being studied on one side and postural alteration too was postulated to cause shoulder pathology. however, the effectiveness of c5-c6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of ac. this study aimed to investigate whether c5-c6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(rom), and disability in patients with ac. the outcome of the study must provide valid information to enhance the prognostic value of adhesive capsulitis.

adhesive capsulitis (ac) is often self-limited but can persist for years and may never fully resolve. the most effective treatment for adhesive capsulitis is uncertain till date. though neurological control of the shoulder girdle muscles is mainly from cervical roots, particularly from c5/c6 roots, there was not sufficient research to associate this link with ac. evidence confirms that there is an association between posture and shoulder mobility. however, the effectiveness of c5-c6 and thoracic spine mobilization with postural correction remains unexplored in the treatment of ac. we aimed to investigate whether c5-c6 and thoracic spine mobilization with postural correction are more effective than conventional therapy in pain, range of motion(rom), and disability in patients with ac. methods the protocol is written according to the spirit statement to enhance transparency of content and completeness. two-group, randomized controlled trial with blinded assessors. a total of 66 adults with ac will be randomly assigned to experimental group to receive c5-c6 and thoracic spine mobilization with postural correction sessions (n=33) and the others(n=33) in control group to receive conventional therapy within a period of 3 weeks. primary outcomes are shoulder pain, range of motion (rom) of the shoulder joint and disability index (spadi) were to be measured at pre, postintervention following 3 weeks and 3 months..

Eligibility criteria:
inclusion criteria: * patients diagnosed with ac \& a positive for apley's scratch test. * adhesive capsulitis (with symptoms for at least three months and less than 12 months\[18\] * both gender * age 27-70 * sleep-disturbing night pain exclusion criteria: * patients who are unwilling to participate * patients with malignancy * ac secondary to fracture and uncontrolled hypertension. * unstable cardiac conditions * patient with neurological conditions * patient with reported concurrent cervical issues
effect of probiotic administration on patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Quality of Life; Food Intolerance; Flare Up; Ulcerative Colitis; Crohn Disease

Summary: the study is a single-center, randomized, single-blinded, controlled trial conducted at zhumc's endoscopy unit. it aims to assess the short-term effects of probiotic administration on disease course, quality of life, and nutritional status among patients diagnosed with inflammatory bowel disease (ibd), specifically ulcerative colitis (uc) and crohn's disease (cd). patients with uc and cd will be recruited from the endoscopy unit's outpatients and divided into two groups: a control group and an intervention probiotic group. the intervention probiotic group will receive the probiotic intervention for 2 months. during the study period, two visits will be scheduled for all patients. at each visit, medical and nutrition surveys will be filled out, and body composition measurements will be conducted. these assessments will help evaluate the impact of probiotic administration on the participants' disease progression, their quality of life, and their nutritional status. overall, the study aims to provide insights into the potential benefits of probiotic supplementation in managing ibd and improving the well-being of patients with these conditions.


Eligibility criteria:
inclusion criteria: * lebanese outpatients with histological diagnosis of crohn's disease or ulcerative colitis from at least 6 months prior to the trial. * have stable inactive disease. * have not used any probiotics within the two months before the investigation. exclusion criteria: * pregnant or lactating women * patients who use probiotics within the study period.
weaning from mechanical ventilation guided by lung ultrasound (brazilian weanlus)

Conditions: Acute Respiratory Failure

Summary: the present study aims to evaluate the impact of a weaning strategy based on identification of early signs of respiratory distress by lung ultrasound and the consequent implementation of a "clinical optimization" protocol as compared to usual care.


Eligibility criteria:
inclusion criteria: * mechanically ventilated \>48h exclusion criteria: * moderate/severe copd * spinal cord lesion * neuromuscular disease (previous) * lung fibrosis * tracheostomy * heart failure (ef\<50%) * lung/pleural cancer * inadequate "window"for lus

Keywords: mechanical ventilation weaning acute respiratory failure weaning failure lung ultrasound