Kornimate/medical-research-clean huggingface dataset:
efficacy of diclofenac potassium versus acetaminophen in febrile children with acute upper respiratory tract infections

Conditions: Fever

Summary: the purpose of this study is to assess if a single dose of diclofenac potassium (0.5 mg/kg) is more or as effective as a single dose of acetaminophen (10 mg/kg) in the reduction of fever during 2 hours, in the treatment of febrile children with acute upper respiratory infections. this is a comparative double blind, double dummy, randomized study on the effectiveness of diclofenac potassium versus acetaminophen in febrile children with acute upper respiratory tract infections. the patient will be randomized to either group: group a (diclofenac potassium (0.5 mg/kg) or group b (acetaminophen (10 mg/kg)). a health care professional trained will measure the temperature during 2 hours. during the study period, parents or legal representatives will be invited to fill a survey about the habits and knowledge regarding fever management at home.


Eligibility criteria:
inclusion criteria: * male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° c and no greater than 39.5° c, associated with acute upper respiratory tract infections * parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study exclusion criteria: * history of hypersensitivity to any drugs or excipients of the study * any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications * background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding * neurological and hemodynamics disorders * evidence of liver or kidney impairment or heart failure * patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), nsaids (up to 6 hrs) or antibiotic therapy (at least 12 hours) * any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk other protocol-defined inclusion/exclusion criteria may apply

Keywords: antipyretics fever diclofenac acetaminophen children acute upper respiratory tract infections
evaluation of the response to hypoxia at rest and during exercise in a healthy subject after a cryostimulation exposure

Conditions: Hypoxia; Cryostimulation; Metabolism; Autonomic Nervous System; Exercise; Adaptation

Summary: many information is available regarding human adaptations to cold or hypoxia. adaptations to these environments and physical exercise constitute responses to physiological stress aimed at amplifying the organism's reactions and improving its performance. however, studies conducted so far to understand these adaptations and their underlying mechanisms have been organized in a dissociated manner, with each study focusing on only one of these specific situations (cold, hypoxia, or exercise). understanding cross-adaptations is crucial, as human beings are often simultaneously exposed to several of these stimuli, and understanding this cross-exposure can be considered a prerequisite for pre-acclimatization strategies to these different environments. cross-adaptations has been defined as follows: "it simply involves considering that long-term exposure (either continuous or intermittent) to a given unfavorable environment not only increases tolerance to that particular environment but also leads to gains or losses of tolerance to other unfavorable factors that the adapted organism had never encountered before." when specifically examining cross-adaptations to cold and hypoxia, only one study focusing on the human model is available. the lack of perspectives and positions regarding the results calls for further investigations. the main objective of this study is to assess the effect of repeated exposures to cryostimulation on the variation of the respiratory exchange ratio in hypoxia during exercise.


Eligibility criteria:
inclusion criteria: * having a high level of physical activity according to the criteria of the world health organization, assessed using the global physical activity questionnaire (gpaq); * no exposure to cryostimulation or hypoxia (fio2 13.5%, equivalent to an altitude of 3500 m) in the last 90 days; * no planned sports competition during the 4 weeks of the protocol; * maintaining a stable physical activity level (regular training, without interruption or specific competition, including sports training programs) anticipated for 4 weeks; * no history of respiratory conditions (asthma, respiratory allergies, exercise-induced asthma, exertional dyspnea); * absence of any chronic medical condition; * no ongoing medication treatments; * covered by a french social security; * informed consent, signed by the subject after clear and fair information about the study. exclusion criteria: * subject under treatment; * simultaneous participation in another clinical research study; * individuals with enhanced protection, namely minors, individuals deprived of liberty by judicial or administrative decision, persons staying in a healthcare or social facility, adults under legal protection, and finally, patients in emergency situations; * subject presenting a contraindication to hypoxia and/or cryostimulation.
barriers to the implementation of complete insulin order sets

Conditions: Hyperglycemia

Summary: the major purpose of this quality improvement project is to begin to address the issues surrounding glycemic control in the hospital setting by collecting accurate, reliable and verifiable data on the occurrence of hyperglycemia (bg \>300 mg/dl), and whether or not cio is used (immediately before and 72 hours after the bg \>300 mg/dl).


Eligibility criteria:
inclusion criteria: * park nicollet methodist hospital patient * recorded bg \> 300 mg/dl during the study data collection period * admitted to general floor hospital units exclusion criteria: * birth center * intensive care units * eating disorder unit * pediatric patients \< 18 years of age * patients receiving insulin infusions
the impact of hybrid closed-loop insulin delivery in type 1 diabetes on glycemic control and proms

Conditions: Diabetes Mellitus, Type 1

Summary: since february 2019 the first hybrid closed-loop insulin pump, the medtronic minimed 670g system, has been offered to people with type 1 diabetes in belgium. despite previous studies, the impact of these new kinds of insulin pumps on glycemic control and patient-reported outcomes (proms) is still unclear. therefore, this study will evaluate the impact of the medtronic minimed 670g, medtronic minimed 780g and tandem control-iq systems on glycemic control and proms in people living with type 1 diabetes under real-life conditions. in a multicenter real-world observational study, 350 adults and 100 children with type 1 diabetes who are treated with each of these systems in one of 17 belgian centers, will be followed for a period of 24 months. the primary endpoint is the evolution of time spent in range (defined as a sensor glucose value between 70 and 180 mg/dl) from before start to 12 months after start of hybrid closed-loop therapy. since not much is known about the impact of hybrid closed-loop on partners of adults living with type 1 diabetes, an optional substudy (inrange-partner) will be performed investigating the quality of life in partners of adults of type 1 diabetes using hybrid closed-loop therapy. more specifically, the substudy will compare the quality of life of partners of type 1 diabetes patients both before and after implementation of hybrid closed-loop therapy.


Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes * patients aged 6 years or older * patients starting with hybrid closed-loop therapy (as part of routine clinical practice) in one of the 17 participating centers. note: the decision about which patient to start, is left to the clinical judgement of the treating health care professional. * patients who signed informed consent exclusion criteria: * patients without type 1 diabetes * patients under 6 years of age * patients not starting with hybrid closed-loop therapy in one of the 17 participating centers * patients who did not sign informed consent

Keywords: hybrid closed-loop
risedronate in the prevention of osteoporosis in osteopenic postmenopausal women

Conditions: Osteoporosis, Postmenopausal

Summary: to confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women to confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption to confirm general safety of 5 mg daily risedronate as compared to placebo


Eligibility criteria:
inclusion criteria: * ambulatory, healthy postmenopausal women with * natural menopause and more than 5 years after their last menstrual period * or surgical menopause and more than 5 years after surgery * osteopenia (lumbar spine t score between 1 and 2.5 sd below the mean value in normal young women). * with at least one risk factor for osteoporosis exclusion criteria: * women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2

Keywords: prevention of postmenopausal osteoporosis
external oblique intercostal plane block versus thoracic paravertebral block for post thoracotomy pain

Conditions: External Oblique Intercostal Plane Block; Thoracic Paravertebral Block; Post Thoracotomy Pain

Summary: the aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (eoipb)and thoracic paravertebral block (tpvb) for postoperative pain management in patients undergoing open thoracotomy.

acute thoracotomy pain is multifactorial in nature. it involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. the main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * both sexes. * american society of anesthesiology (asa) physical status i-iii. * scheduled for open thoracotomy exclusion criteria: * patients with neurological or intellectual disability. * infection at the injection site. * opioid addiction. * allergic reaction to local anesthetics. * coagulation abnormalities. * drug abuse. * pregnancy. * severe liver and/or renal failure. * uncontrolled hypertension. * severe cardiovascular problems. * diabetes mellitus.
jk-1201i compared with topotecan in patients with relapsed extensive stage small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this study was designed to compare the efficacy and safety of jk-1201i with topotecan in patients with relapsed extensive stage small cell lung cancer (es sclc).

this is a multicenter, randomized, positive-controlled, open-label, phase 3 study comparing jk-1201i with topotecan in patients with relapsed extensive stage small cell lung cancer that had relapsed or disease progression on or after platinum-based first-line chemotherapy. patients will be randomized by a ratio of 1:1 to receive jk-1201i or topotecan until disease progression. of jk-1201i compared with topotecan in patients with relapsed extensive stage small cell lung cancer after platinum-based first-line chemotherapy the primary objective of this study is to assess whether treatment with jk-1201i prolongs overall survival (os) compared with treatment of topotecan among patients with relapsed es sclc. the secondary objectives of the study are to further evaluate the efficacy, safety and population pharmacokinetics of jk-1201i.

Eligibility criteria:
inclusion criteria: participants must meet all the following criteria to be eligible for randomization into the study: 1. sign and date the informed consent form prior to the start of any study-specific qualification procedures. 2. male or female aged ≥18 years and ≤70 years. 3. histologically or cytologically documented sclc. 4. has received prior therapy with only one prior platinum-based line as systemic therapy for es sclc and disease progression on or after first-line platinum-based regimens (≤ 6 months). 5. has at least 1 measurable lesion according to recist v1.1. 6. has ecog ps of ≤1. exclusion criteria: participants who meet any of the following criteria will be disqualified from entering the study: 1. hypersensitivity to any ingredient of jk-1201i and topotecan. 2. has received prior treatment with dna topoisomerase i inhibitor agents. 3. has received prior therapy with ≥2 line as systemic therapy for extensive-stage sclc. 4. chemotherapy-free interval within 4 weeks before the first use of the study drug. radiotherapy with a limited field of radiation for palliation within 2 weeks before the first use of the study drug. used biotherapy drugs within 2 weeks before the first use of the study drug. 5. severe gastrointestinal illnesses as defined in the protocol within 6 months before the first use of the study drug. 6. local symptoms of tumors requiring radiotherapy or surgical treatment as defined in the protocol. 7. untreated or symptomatic brain metastases with exceptions defined in the protocol. 8. severe pulmonary illnesses within 6 months before the first use of the study drug. 9. uncontrolled hydrothorax and ascites. 10. unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to common terminology criteria for adverse events (ctcae) version 5.0 grade 1 with exceptions defined in the protocol. 11. severe infections within 4 weeks before the first use of the study drug.
evaluation of safety and efficacy, including pharmacokinetics, of nnc 0129-0000-1003 when administered for treatment and prophylaxis of bleeding in subjects with haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted globally. the aim of the trial is to evaluate the safety and efficacy, including pharmacokinetics (the exposure of the trial drug in the body) of nnc 0129-0000-1003 (n8-gp) in subjects with haemophilia a.


Eligibility criteria:
inclusion criteria: - male patients with severe congenital haemophilia a (fviii activity below 1%, according to medical records) - documented history of at least 150 eds (exposure days) to other fviii products - at least 12 years and body weight at least 35 kg (except for croatia, france, russia, israel and the netherlands where the lower age limit will be 18 years) exclusion criteria: - previous participation in this trial defined as withdrawal after administration n8-gp - any history of fviii inhibitors - fviii inhibitors above or equal to 0.6 bu/ml at screening - hiv (human immunodeficiency virus) positive, defined by medical records with cd4+ (t-lymphocyte subtype) count below or equal to 200/mcl or a viral load of more than 400000 copies/ml. if the data is not available in medical records within last 6 months, cd4+ will be measured at the screening visit - congenital or acquired coagulation disorders other than haemophilia a - previous significant thromboembolic events (e.g. myocardial infarction, cerebrovascular disease or deep venous thrombosis) as defined by available medical records - platelet count below 50,000 platelets/mcl (laboratory value at the screening visit) - alat (alanine aminotransferase) above 3 times the upper limit of normal reference ranges at central laboratory - creatinine level equal to or greater than 1.5 times above upper normal limit (according to central laboratory reference ranges) - ongoing immune modulating or chemotherapeutic medication
scapular pnf and activity oriented antiedema proprioceptive therapy on shoulder dysfunction post matectomy lymphedema

Conditions: Upper Limb Edema

Summary: ninety -three female patients suffering from shoulder dysfunction after breast cancer-related arm lymphedema, will national cancer institute (cairo university) be randomly distributed into three groups equal in number.

in this study the patients will be randomly assigned into three groups (thirty - one patient for each group): group (a): thirty-one patients will receive: scapular pnf technique, activity-oriented antiedema proprioceptive therapy (tapa) technique for the affected shoulder region plus conventional physiotherapy program in a form of (complex decongestive therapy (cdt). group (b): thirty-one patients will receive scapular pnf technique for the affected shoulder region plus conventional physiotherapy program in a form of (complex decongestive therapy (cdt)) group (c): thirty-one patients will receive activity-oriented antiedema proprioceptive therapy (tapa) technique for the affected shoulder region plus conventional physiotherapy program in a form of (complex decongestive therapy (cdt) .

Eligibility criteria:
inclusion criteria: the subject selection will be according to the following criteria: * age range between 40-60 years. * only female patients will participate in the study. * all female patients diagnosed as unilateral breast cancer. * all female patients operated on for bc with bcrl in stages i and ii. * all female patients suffering from shoulder dysfunction after breast cancer-related arm lymphedema. * all patients enrolled to the study will have their informed consent. exclusion criteria: the potential participants will be excluded if they meet one of the following criteria: * patients with health problems, diseases or dysfunctions that prevented them from participating in the intervention. * patients with bilateral lymphedema. * patients with previous primary lymphedema. * patients with metastasis. * patients whom staging was not possible due to atypical findings or poor image. * patients with active arm infection.
improving patient understanding of the surgical hospital experience: use of youtube video playlist

Conditions: Anxiety

Summary: this prospective randomized pilot clinical trial studied the effect on preoperative anxiety of watching a series of youtube videos designed to create a virtual hospital experience for patients undergoing primary total hip and knee arthroplasty as compared to routine preoperative education. hypothesis: preoperative anxiety related to hip and knee replacement surgeries can be reduced by patient exposure to a virtual hospital inpatient experience delivered by a series of youtube videos.

as high patient anxiety prior to surgery has been linked to more severe and persistent pain after joint replacement surgery, the orthopedic surgery department at mayo clinic in florida created a playlist of 16 youtube videos aimed at creating a virtual hospital experience for primary total hip and knee joint replacement patients. a pilot study was then performed to evaluate the potential impact of viewing this playlist on preoperative anxiety. methods: each patient completed a generalized anxiety disorder score (gad) assessment at the time of the routine preoperative clinic visit and were then randomized based on their gender, type of surgery, and initial gad score to either the control group of standard education (education at face-to-face clinical visits as well as printed educational materials) or the treatment group of standard education plus access to the youtube playlist. on the morning of the patient's surgery the same survey was repeated.

Eligibility criteria:
inclusion criteria: * patients undergoing primary total hip or total knee arthroplasty at mayo clinic in florida * patients must be able to give consent to the study * patients must agree to watch the videos prior to scheduled surgery * patients must agree to complete the questionnaire in the office and again prior to surgery on the day of surgery exclusion criteria: * no internet access at home * visual or auditory conditions which limit a patient's ability to view the you tube videos at home

Keywords: patient education preoperative anxiety
prevalence of potential cytochrome p450 pharmacokinetic incident drug-drug interactions among chronic low back pain patients taking opioid analgesics and associated economic outcomes

Conditions: Chronic Low Back Pain

Summary: this study explored the prevalence of ddes in a chronic pain population with clbp and associated healthcare utilization and costs using a healthcare claims database.


Eligibility criteria:
inclusion criteria: * chronic low back pain exclusion criteria: * pregnancy

Keywords: retrospective chronic low back pain
asthma and intimate partner violence

Conditions: Asthma; Domestic Violence

Summary: this is a cross-sectional observational study on adult asthmatics evaluating the relationship between asthma control and psychosocial factors to include intimate partner violence, stress, anxiety, depression, post-traumatic stress disorder.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma as defined as postbronchodilator response of at least 12% and 200 milliliters improvement in forced expiratory volume in 1 second (fev1) or forced vital capacity and/or evidence of positive airway hyperresponsiveness. exclusion criteria: * medical factors that would preclude participation as determined by the investigators. examples include blindness, mental illness that grossly impairs judgment, or active injury requiring treatment.
weight loss in obese subjects taking either gw869682 or placebo 3 times per day for 12 weeks

Conditions: Obesity

Summary: gw869682 causes glucose to be excreted in the urine. the purpose of this study is to see whether enough calories from glucose are excreted in the urine to cause weight loss.


Eligibility criteria:
inclusion criteria: * have a bmi within range 30.0 to 40.0kg/m2, inclusive. * females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition). exclusion criteria: * history of eating disorders. * recent history of weight loss or gain. * had gastrointestinal surgery for treatment of obesity. * type 1 or type 2 diabetes mellitus. * have a positive urine drug screen. * have liver disease. * have hepatitis b, hepatitis c, or hiv antibodies. * have a thyroid disorder that is not under control with medication. * have any disease (such as heart, liver, blood, nervous system, or kidney disease, or cancer). * are unable to participate in an exercise program. * have used weight loss drugs within 3 months before the start of the study. * are currently using warfarin, digoxin, oral anti-coagulants (other than aspirin and non-steroidal anti-inflammatory drugs), oral or injectable corticosteroids (inhaled \& intranasal corticosteroids are permitted), or antiretroviral medications. * used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication. * high or low blood pressure.

Keywords: hunger obesity sodium-dependent glucose transporter gw869682 body composition sglt2 inhibitor weight loss