Kornimate/medical-research-clean huggingface dataset:
effects of co-administration of canagliflozin 300 mg and phentermine 15 mg with placebo in the treatment of non-diabetic overweight and obese participants

Conditions: Obesity

Summary: the purpose of this study is to compare the effects of canagliflozin and phentermine to those of placebo to promote on a change in body weight over a 26 week period.

this is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin and phentermine co-administration in non-diabetic overweight or obese participants. the study will be conducted for about 33 weeks, approximately 344 participants will be randomly assigned in a 1:1:1:1 ratio to one of the four treatment groups: co-administration of canagliflozin and phentermine, canagliflozin alone, phentermine alone, or placebo. all participants will be also provided with diet and exercise counseling for weight loss (standardized non-pharmacological therapy).

Eligibility criteria:
inclusion criteria: * must have bmi \>=30 kg/m2 and \ =27 kg/m2 and \<50 kg/m2 at screening in the presence of a comorbidity of hypertension and/or dyslipidemia * must have stable weight, ie, change of \< =5% in the 3 months before screening * must agree to utilize a highly effective method of birth control exclusion criteria: * an established diagnosis of diabetes mellitus * has a history of obesity with a known secondary cause (eg, cushing's disease/syndrome) * has a history of hereditary glucose-galactose malabsorption or primary renal glycosuria * myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening * has an glycated hemoglobin (hba1c) greater than or equal (\>=) to 65 percent * an average of 3 seated blood pressure (bp) readings of systolic bp \>= 160 mm hg and/or diastolic bp \>= 100 millimeters of mercury at screening

Keywords: obesity overweight canagliflozin phentermine invokana®
rollover protocol for subjects who have responded on study 4218s - a phase 2 study

Conditions: Neuroendocrine Tumors

Summary: subjects achieving a clinical response in study ox4218s with a biomarker reduction or symptom response are eligible to enroll in this rollover study to continue once every three weeks fosbretabulin infusions for up to one year.

subjects enrolled in the pnet/gi-net study ox4218s received weekly dosing with fosbretabulin for up to 3 cycles or approximately 9 weeks. subjects achieving a clinical response with a biomarker reduction or symptom response based on investigator assessment are eligible to enroll in this rollover study (protocol ox4219s). subjects will receive fosbretabulin every three weeks for a maximum of approximately one year or until disease progression, unacceptable toxicity, consent withdrawal, protocol-noncompliance, or the investigator feels that it is no longer in the subject's best interest to continue therapy.

Eligibility criteria:
inclusion criteria: * subject has been treated in the oxigene-sponsored phase 2 study ox4218s exclusion criteria: * subject has not received fosbretabulin treatment in the study ox4218s

Keywords: pancreatic gastrointestional
effects of recoverben® on recovery after exhaustive exercise

Conditions: Healthy Volunteers; Muscle Fatigue; Muscle Soreness

Summary: the aim of the study is to investigate a pre and post workout supplementation (15 days) with recoverben® , a aloysia citriodora extract on recovery after exhaustive exercise. effects will be investigated with 400mg recoverben® and compared to placebo.

the aim of the study is to investigate a pre and post workout supplementation (15 days) with recoverben® , a aloysia citriodora extract on recovery after exhaustive exercise. effects will be investigated with 400mg recoverben® and compared to placebo. targeted parameter will be determined at the beginning of the study and after supplementation, each. parameter include maximal strength (mvc), muscle soreness (vas), pain sensitivity (algometry) and biomarkers (ck, il-6, glutathione peroxidase).

Eligibility criteria:
inclusion criteria: * subject is able and willing to sign the informed consent form prior to screening evaluations * health volunteers: subject is in good physical and mental health as established by medical his-tory, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology * men and women * age ≥ 22 and ≤ 50 years * bmi: 19-30 kg/m2 * physically active 1-3 times per week * nonsmoker * able and willing to follow the study protocol procedures exclusion criteria: * relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements (e.g. polyphenols, anti-inflammatory or anti-oxidative drugs or supplements, antihyper-tensive drugs) potentially interfering with this study at screening. * for this study clinically relevant abnormal laboratory, vital signs or physical findings at screening * diabetes or serious cardiovascular diseases * change of dietary habits within the 2 weeks prior to screening (for instance start of a diet high in vegetables and fruits (≥ 5 portions per day)) * diet high in vegetables and fruits ≥ 5 portions per day * participants anticipating a change in their lifestyle or physical activity levels during the study. * subjects not willing to abstain from intake of analgesic medication (e.g. aspirin) 24 hours prior to visit 2 until visit 5. * subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to co-operate during the study. * known hypersensitivity to the study preparation or to single ingredients * pregnant subject or subject planning to become pregnant during the study; breast- * known hiv-infection * known acute or chronic hepatitis b and c infection * blood donation within 4 weeks prior to visit 1 or during the study. * subject involved in any clinical or food study within the preceding month

Keywords: recovery muscle soreness lemon verbena
prevention of secondary foot ulcers in patients with diabetes using systematic measuring of skin temperature.

Conditions: Foot Ulcer, Diabetic

Summary: a randomised controlled pilot study on the feasibility of introducing a skin temperature device (temp touch) in secondary prevention of foot ulcers in people with diabetes who have had a foot ulcer in norway.

diabetes mellitus is linked to late complications from kidneys, eyes, nerves, feet, and an increased risk of cardiovascular disease. approximately 170 000 people in norway suffer from diabetes, and diabetic foot disease is one of the most common complications. it is estimated that between 400 and 500 amputations are performed yearly in norway, and most of the amputations are due to non-healing diabetic foot ulcers. efficient prevention in high-risk individuals includes follow-up in specialist foot clinics including training in self-care, adaptation of preventive footwear and insoles. a randomised trial testing the use of skin temperature measurement in addition to routine foot care for preventing new foot ulcers showing a highly significant reduction in recurrent foot ulcers in the temperature measuring group, has previously been performed in usa (lavery et al. diabetes care 2007;30:14). this study is planned as an open, randomised pilot study of minimum 40 patients testing the feasibility of implementing the use of skin temperature measurement for prevention of recurrent diabetic foot ulcers in a specialist clinical setting in norway. if this is the case, we are planning a larger study to examine if these measurements can contribute to reducing the number of recurrent ulcers in clinical practice in norway. we are in addition using a cognitive motivational method to examine if this model can increase the use of the temperature measuring device.

Eligibility criteria:
inclusion criteria: * previous neuropathic diabetic foot ulcer exclusion criteria: * ankle/brachial index \< 0.7. osteomyelitis, active charcot
efficacy of pregabalin for the treatment of acute herpetic neuralgia

Conditions: Herpes Zoster

Summary: all eligible herpes zoster patients will be randomized into two groups. group 1 will be the treatment group receiving pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except pregabalin. instead control group will receive placebo.

this study wants to see the role of pregabalin in acute herpetic neuralgia pain reduction and for the prevention of post herpetic neuralgia incidence as compared to placebo group. for this purpose, all eligible herpes zoster patients will be randomized into two groups (41 patients in each group i.e.82 total patients). group 1 will be the treatment group receiving pregabalin 75 mg twice daily for 4 weeks in addition to other routine treatment. whereas, group 2 will be the control group receiving all routine treatment similar to group 1 except pregabalin. instead of pregabalin, control group will receive placebo. the pain will be evaluated in all patients in each follow visits (weekly follow up for 4 weeks then monthly follow up for next three months). if it is difficult for the patient to present physically, telephonic follow up will be done to find the pain score in the required time. also, dlqi (dermatological life quality index) will be assessed at the first and last visit of the patient. at the end, pain score will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * patients of hz presenting within 72 hours of onset of rash, * with pain score 40 or above on 100 mm pain visual analogue scale at the screening visit, * giving written consent for the study. * age between 18-70 years exclusion criteria: * hz presenting after 72 hours of onset * pain score less than 40 at baseline * who took the stable doses of oral analgesics like: nsaids, acetaminophen, opioids and antidepressant within six hours of screening visit * using pregabalin and gabapentin within last 72 hours * nerve block therapy within the last 48 hours * history of hypersensitivity to the drug or its ingredients * use of topical medications within 12 hours * unable to come for follow up because of severe systemic illness * significant hepatic and renal disease, * bed ridden patients or those who are physically unfit for follow up visits. * ethically considered vulnerable members- pregnant/lactating mothers/newborn/children below 12 years /physically or mentally challenged individuals/hiv/ aids/iv drug users

Keywords: herpes zoster herpetic neuralgia pregabalin
a clinical trial to evaluate the pharmacokinetics and safety of fimasartan and rosuvastatin in healthy male subjects

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety of fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.

this is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. after day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Eligibility criteria:
inclusion criteria: 1. caucasian male 19-55 years of age. 2. body mass index (bmi) ≥ 18.5 and ≤ 32.0 kg/m2 at screening. 3. medically healthy with no clinically significant medical history. 4. understands the study procedures in the informed consent form (icf), and be willing and able to comply with the protocol. exclusion criteria: 1. history or presence of clinically significant medical or psychiatric condition or disease. 2. positive results at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv). 3. seated blood pressure is less than 90/60 mmhg or greater than 140/90 mmhg at screening. 4. plasma donation within 7 days prior to the first dose of study drug. 5. participation in another clinical trial within 28 days prior to the first dose of study drug(s).

Keywords: fimasartan
efficacy of different types of physiotherapy approaches in temporomandibular disorders

Conditions: Temporomandibular Disorder

Summary: the aim of this study is to investigate the efficacy of different types of physiotherapy approaches in cases with cervical myofascial painful tmd.

59 persons with tmd diagnosed by the dentist and with cervical myofascial pain, aged 18-30 years will be randomly allocated, 3 groups. the participants were randomly allocated only exercise group (eg) (n=20), low-level laser therapy plus exercise group (lllt) (n=17) and manual pressure release plus exercise group (mpr) (n=22). the cases were evaluated and treated by the same physiotherapist for 4 weeks (12 sessions). pain, pain pressure threshold, temporomandibular joint (tmj) mobility and disability, forward head posture, head rotation, neck disability, psychological status and quality of life were evaluated. evaluations were repeated before and after treatment.

Eligibility criteria:
inclusion criteria: * cases who have 3 or more symptoms related to tmj problems * cases who have trigger points in cervical and masticatory muscles * cases who tmd detected by the dentist, * being between the ages of 18-30, * volunteer to participate in the study exclusion criteria: * patients with a positive history of trauma in the face and neck area and neurological disorders * patients undergoing tmj or cervical region surgery in the last 3 months, * patients who used dental orthotics within 1 month, * patients who have tmj instability, * patients who have cervical and upper thoracic region, * patients who have active infection and chronic pain, such as trigeminal neuralgia

Keywords: temporomandibular disorders exercise low-level laser therapy
valacyclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy

Conditions: Congenital Cytomegalovirus Infection

Summary: the purpose of this study is to determine whether valacyclovir treatment, administered during pregnancy after proven primary maternal cytomegalovirus (cmv) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.

a randomized, double-blind, placebo-controlled study. participants: pregnant women over 18 years of age with serologically proven, primary cmv infection during the first trimester intervention: after informed consent and randomization, participants in the treatment group will receive valacyclovir at a dose of 8 g/d. participants in the control group will receive the same amount of daily pills containing placebo. treatment will continue until amniocentesis, which will determine if the fetus was infected.

Eligibility criteria:
inclusion criteria: * pregnant women over 18 years of age with serologically proven, primary cmv infection during the first trimester of pregnancy or periconceptionally exclusion criteria: * patients with preexisting liver disease, renal dysfunction, bone marrow suppression or sensitivity to acyclovir will be excluded from the study - as will patients receiving any antiviral therapy prior to the study.

Keywords: congenital cmv congenital cytomegalovirus
a study to evaluate virtual reality as adjunct to anesthesia during orthopedic surgery

Conditions: Knee Arthropathy; Hip Injuries

Summary: the purpose of this study is to obtain feedback from patients and orthopedic surgeons who agree to use virtual reality (vr ) as an adjunct to standard of care in orthopedic cases under regional or central neuraxial nerve block. this will serve as a preliminary study for future trials to compare outcomes between vr and standard of care vs standard of care only.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * patients scheduled for orthopedic procedure under regional or central neuraxial nerve block (anterior primary hip arthroplasty or primary knee arthroplasty). * subject willing to participate and able to provide informed consent. exclusion criteria: * age \< 18 years old. * history of motion sickness or blindness. * unable to consent due to cognitive difficulty. * current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of vr hardware and software. sensitivity to flashing light or motion. * recent stroke. * injury to the eyes, face, neck, or arms that prevents comfortable use of vr hardware or software, or safe use of the hardware (e.g., open wound, sores, or skin rash on face).

Keywords: virtual reality knee arthroplasty hip arthroplasty
observational study to evaluate therapeutic effectiveness and safety of monterizine cap.

Conditions: Perennial Allergic Rhinitis; Asthma

Summary: investigator examines the past prescription patterns and the reasons for the change of prescription to monterizine capsules for perennial allergic rhinitis patients with asthma who will be taking monterizine capsules to treat allergic rhinitis. after being given monterizine capsules, investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).

a multi-center, prospective, observational study

Eligibility criteria:
inclusion criteria: 1. male or female aged ≥ 15 years 2. perennial allergic rhinitis patients with asthma who will be prescribed monterizine capsules to treat allergic rhinitis 3. patients who provided a signed written informed consent form exclusion criteria: 1. highly sensitive patients to ingredients of monterizine capsules, hydroxyzine or piperazine derivatives 2. patients with renal failure(clcr,10ml/min) and hemodialysis patients 3. a female who is pregnant, may be pregnant, or is lactating 4. patients with genetic problems like galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption
ultrasound optimization of initial fluid challenge in sepsis

Conditions: Sepsis

Summary: initial sepsis treatment requires fluid challenge. while the surviving sepsis campaign indicates a 30 ml/kg volume, there is concerns on the efficacy and safety of this fixed volume. the aim of this study is to assess the difference between fluid volume determined par cardiac and lung ultrasound versus the fixed 30 ml/kg.

initial sepsis treatment requires fluid challenge (fc). while the surviving sepsis campaign (ssc) indicates a fixed 30 ml/kg volume, there is concerns on the efficacy and safety of this volume. actually, the required volume is highly dependent of cardiac and pulmonary comorbidities, infection focus localization and intensity. the importance of the initial volume is crucial: if too low, it could not restore the hemodynamic status, if too high, it could induce a lung edema responsible for an increased morbidity and mortality. cardiac ultrasound (us) has demonstrated its efficacy to approach cardiac output by measuring the velocity-time integral (vti) in the aortic chamber and its variations induced by the fc. while the vti induced variation by a 500-ml fc in 20 min is above 10%, the patient is still fluid responsiveness and fc has to be continued. conversely, when the variation is below 10%, fc has to be stopped. lung ultrasound can detect a sub-clinical pulmonary edema before oxygenation degradation by visualization of diffuses b lines. the combination of both techniques is thus able to individualize the actual needed fc volume. in patients with sepsis as defined by sepsis-3 and with hypotension (map \ 2 mmol/l), the fc of saline serum is individualized by the us technique. the volume is compared with the fixed 30 ml/kg.

Eligibility criteria:
inclusion criteria: * patients \>18 years old with sepsis as defined by sepsis-3 and with hypotension (map \ 2 mmol/l) exclusion criteria: * documented end-of-life * pregnancy * b/b initial profile to the first lung us

Keywords: sepsis treatment fluid challenge
effects of transcutaneous perineal stimulation versus anal stimulation

Conditions: Urinary Incontinence; Radical Prostatectomy; Pelvic Floor

Summary: this study evaluates whether surface perineal stimulation is as effective as anal stimulation in reducing urinary incontinence secondary to radical prostatectomy. half of participants will receive a treatment with surface perineal stimulation, while the other half will receive a treatment with anal stimulation.

pelvic floor muscle training is the most common non-invasive intervention for urinary incontinence secondary to radical prostatectomy. perineal stimulation has a significant positive impact on the early recovery of urinary continence after this intervention. the perineal stimulation can be applied with surface electrodes or with an intra-cavitary probe placed in the anus. the two techniques are commonly used. each techniques stimulates different anatomical points of perineum, and it is a question if both have the same effectiveness or, one of the two techniques has greater effect than the other.

Eligibility criteria:
inclusion criteria: * having undergone a radical prostatectomy surgical procedure. * presenting involuntary urine losses after radical prostatectomy intervention. (iu grade i, ii or iii) * do not exceed the year since the surgical intervention. * accept to participate in the study and grant signed informed consent. exclusion criteria: * follow a pharmacological treatment for the ui. * presenting anatomical malformations of the pelvic floor musculature. * carry pacemaker. * present anal fistulas. * suffer from serious psychic disorders. * presenting lower urinary tract infections.
fdg-pet/ct for simulation and radiation treatment planning of early breast cancer

Conditions: Breast Neoplasm

Summary: the purpose of the study is: * to assess the potential benefits of 18f-\[fdg\] pet/ct and pet/mri for operable breast cancer in order to define the size and location of the primary tumor, as well as axillary, supraclavicular and internal mammary lymph nodes. * to apply the imaging results to the simulation and the radiation treatment planning and partial breast for 3-d radiation treatment and partial breast irradiation with intensity modulated radiation treatment (imrt).

pre-operative fdg pet/ct, and in option pet/irm, are intended for women with histologically confirmed operable clinically node-negative breast cancer, in whom breast conserving and post-operative radiotherapy are planned.

Eligibility criteria:
inclusion criteria: * histologically confirmed breast carcinoma * clinical stage t1-2 n0 m0 * age \> 18 years * signed informed consent exclusion criteria: * who performance index 3 * premenopausal women without contraception * gestation * lactating * prior surgery or radiotherapy on the same breast * unable to understand study participation * bilateral breast cancer * prior ct thorax-abdomen and breast mri within 4 months of interview * presence of electromechanical implant and/or body ferromagnetic material * previous history of renal insufficiency requiring dialysis and/or hospitalisation * ureum and/or creatinine within 2 weeks of interview above lab's reference limits * history of contrast allergy * hyperthyroidy * claustrophobia.

Keywords: breast carcinoma fdg pet/ct pet/irm