bioihbjkbjnl/mcl2 huggingface dataset:
Microcurrent and Aerobic Exercise Effects in Abdominal Fat
Condition: Obesity, Abdominal
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      The purpose of this study was to analyze microcurrent short term effects used with aerobic
      exercise on abdominal fat.
    

Detailed description: 
      Nutritional patterns have been changed during twenty-first century with sugar and fat's high
      proportions that allied to sedentary lifestyle increased body fat. There is already a well
      establish relationship between total body fat excess, cardiometabolic diseases and increased
      mortality, knowing that abdominal fat (android pattern), different from body index, presents
      an additional influence to health risks. Women with their abdominal adipocytes (visceral fat)
      show an increased lipolytic activity that releases free fat acids to the systemic and portal
      circulation leading to a metabolic syndrome, increasing the risk of cardiovascular diseases.

      Aerobic exercise is a way to decrease fat as it stimulates lipolysis through an increase in
      catecholamine's level resulting from a sympathetic system nervous activity raise. The most
      used exercise for lipid elimination is the prolonged aerobic moderate exercise with a minimum
      of 30 minutes.

      Nevertheless aerobic exercise practice reduce globally lipidic sources and not locally .

      Electrolipolysis using microcurrent has been used in clinical practice as a technique to
      reduce abdominal fat. This technique can be applied transcutaneously or percutaneously
      seeming that the former is not so effective as skin can be an obstacle to the current effect
      on visceral and subcutaneous fat .

      Abdominal fat excess is associated with cardiometabolic diseases and can be prevented using
      microcurrent and aerobic exercise to stimulate lipolysis.
    

Intervention name(s): Transcutaneous microcurrent; Aerobic exercise
Intervention type(s): Device; Device
Intervention description(s): Microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensitivity threshold and a maximum of 1 mA. Every 15 minutes changed from 25 Hz to 10 Hz.; 50 minutes of aerobic moderate-intensity exercise (45-55% of maximal oxygen consumption (VO2 max)) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13), Polar® heart monitors to control heart rate and K4b2 to analyze the quantity of oxygen (O2) consumption and carbon dioxide (CO2) produced during exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Abdominal fat; Metabolic syndrome; Microcurrent; Aerobic exercise; Lipolysis
Comparing the Pain Experience Between Patients Who Have and Who Have Not Undergone Dermatologic Procedures
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare the pain experience of patients who have not had
      dermatologic procedures (previously "unexposed") using energy devices (lasers,
      radiofrequency, ultrasound, etc.) with patients who have previously had procedures
      (previously "exposed") using energy devices. Based on previous clinical encounters,
      individuals with no prior experience with cosmetic procedures appear to experience more pain.
      However, no study to date has thoroughly examined this observation. As a result, this study
      has been designed to find a possible difference in pain perception between previously exposed
      and unexposed patients undergoing cosmetic procedures using energy devices.
    

Detailed description: 
      Twenty subjects will be enrolled in the study: 10 subjects who have had cosmetic procedures
      in the past and 10 subjects who have not had such procedures. For each subject, pain
      tolerance in three areas will be assessed: temple, midface/cheek, and abdomen. In two areas
      of the face (temple and midface/cheek), a small sterile needle will be inserted into the skin
      along with three applications of the following devices that are FDA approved for use on the
      face: an ultrasound device (Ulthera), a pulsed dye laser (VBeam), and a radiofrequency
      (Thermage) device. Additionally, the abdomen will receive three of these four devices in a
      randomized order: small sterile needle insertion, a pulsed dye laser (VBeam) pulse, and a
      radiofrequency (Thermage) exposure (the ultrasound device, Ulthera, will not be used on the
      abdomen because it is currently not FDA approved for this indication). Subjects will then be
      asked to rate their pain after each application at each individual site using a pain scale.
      In addition, subjects will complete a questionnaire regarding their pain experiences and
      other possibly related factors before and after the procedures.
    

Intervention name(s): Thermage; Needle Application; VBeam Laser; Ulthera
Intervention type(s): Device; Other; Device; Device
Intervention description(s): Radiofrequency Device - specific setting will be determined by the location and thickness of skin. Periorbital: 58-140 J/cm2 Midface: 81-124 J/cm2 Abdomen: 95-181 J/cm; 30-gauge needle insertion into skin; Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20; Ultrasound Device at the following settings:
Transducer Frequency Depth Image Depth DS 7-3.0 7 MHz 3.0mm 0-8mm DS 4-4.5 4 MHz 4.5mm 0-8mm DS 7-4.5 7 MHz 4.5mm 0-8mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: pain experience; energy devices; Ulthera; Thermage; VBeam
Study Evaluating Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Less Than 60 Years of Age
Condition: Acute Myeloid Leukemia (AML)
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      Sorafenib is a multikinase inhibitor which is acting on various cellular pathways involved in
      the genesis of acute myeloid leukemia (AML). Sorafenib is therefore a promising candidate for
      improvement of chemotherapy results in AML. This clinical trial evaluates the efficacy of
      sorafenib added to standard chemotherapy for AML in patients between 18 and 60 years of age.
      Patients are randomised to receive either sorafenib capsules or placebo in addition to their
      chemotherapy. The placebo and the sorafenib group will be compared regarding event-free
      survival and other clinical outcomes. An event is either treatment failure or relapse or
      death. According to the study hypothesis, the sorafenib group will have less events than the
      placebo group.
    


Intervention name(s): sorafenib; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Standard AML chemotherapy plus sorafenib 400 mg BID; Standard AML chemotherapy plus placebo
Other intervention name(s): nexavar
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AML; sorafenib
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Healthy Women
Condition: Group B Streptococcus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine.
    


Intervention name(s): Group B streptococcus (GBS) vaccine- low dose; Group B streptococcus (GBS) vaccine- High dose; Placebo- Saline
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Group B streptococcus; GBS; Vaccine; Group B streptococcus (GBS) disease
Study of Transdermal Testosterone Patches in Menopausal Women With Low Libido
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the efficacy and safety of 2 doses of the transdermal
      testosterone patch in naturally or surgically menopausal women with low libido who are not
      receiving systemic estrogen or estrogen progestin therapy.
    

Detailed description: 
      Detailed Description:

      Hypoactive sexual desire disorder (HSDD) is a condition suffered by as many as 32% of the
      menopausal population. It is generally defined as a low libido which causes distress.
      Testosterone therapy (transdermal patch) is currently under investigation for this disorder
      and results of three phase 3 trials have shown evidence of efficacy in menopausal patients on
      hormone replacement therapy. Low libido does not discriminate between those women utilizing
      hormone replacement therapy and those who do not. This study is designed to evaluate the
      efficacy and safety of 2 doses of the transdermal testosterone patch in naturally or
      surgically menopausal women with low libido who are not receiving systemic estrogen or
      estrogen progestin therapy. Persons could elect to go into a single blind study for one year
      after completing the first yeat double blind
    

Intervention name(s): Testosterone (transdermal patches); Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): Testosterone patch (300mcg/day, changed twice a week for one year; placebo patch changed twice a week for one year
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Low Libido; Low Desire; Distress
Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was a dose-ranging efficiacy study in patients with essential hypertension to
      assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and
      placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to
      placebo.
    


Intervention name(s): LCZ696; Valsartan; AHU377; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension, valsartan, LCZ696
Clinical Translation of 18F-Labeled Hydroxyphenethylguanidines
Condition: Autonomic Peripheral Nervous System Diseases
MeSH terms: Nervous System Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to perform first-in-human PET imaging studies of two new cardiac
      sympathetic nerve imaging agents, 4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG)
      and 3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG).
    

Detailed description: 
      In this study, PET imaging studies of two structurally related
      18F-hydroxyphenethylguanidines, 4-[18F]fluoro-meta-hydroxyphenethylguanidine ([18F]4F-MHPG)
      and 3-[18F]fluoro-para-hydroxyphenethylguanidine ([18F]3F-PHPG) will be performed. All
      studies will be performed in normal healthy volunteers.

      PET stands for Positron Emission Tomography which is a type of imaging that uses a
      radioactive tracer. This is also called a radiotracer which is a compound linked to a
      radioactive element. Most compounds are short-lived, meaning that the radioactivity breaks
      down quickly or is excreted from the body.

      In the first stage of the study, dynamic PET imaging for 90 min will be done with
      [18F]4F-MHPG (n = 4) and [18F]3F-PHPG (n = 4).

      Data from these studies will assess each radiotracer's imaging properties, pharmacokinetics
      and metabolic breakdown in plasma. Application of tracer kinetic analysis methods to the
      kinetics of each tracer in heart and plasma will be studied to see if these methods can
      provide accurate measurements of regional nerve sympathetic nerve density in the hearts of
      human subjects. Results from these initial studies will be used to select the lead compound
      for further studies in patient populations.

      In the second stage of the study, whole-body PET imaging studies (n = 4) with the selected
      lead radiotracer will be performed to acquire data necessary for generating more accurate
      human radiation absorbed dose estimates.
    

Intervention name(s): [18F]4F-MHPG; [18F]3F-PHPG
Intervention type(s): Drug; Drug
Intervention description(s): IV injection of [18F]4F-MHPG; IV injection of [18F]3F-PHPG
Other intervention name(s): 4-[18F]fluoro-meta-hydroxyphenethylguanidine; 3-[18F]fluoro-para-hydroxyphenethylguanidine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Fluid Optimization With Crystalloids and Colloids in Neurosurgery
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      Fluid optimization in neurosurgical patients has an important impact on preservation of
      cerebral perfusion pressure and minimization of cerebral oedema during and after the
      craniotomy. The investigators would like to know if crystalloids or colloids are equally
      useful for goal directed therapy in this patients. The investigators will record haemodynamic
      stability, volume loading and postoperative complications and compare two groups of patients.
      One group will be optimised with crystalloids and the second with colloids. The investigators
      will compare also hospital stay and mortality in the two groups.
    

Detailed description: 
      Hemodynamic stability and maintenance of cerebral perfusion pressure (CPP) are important in
      neurosurgical patients. Fluid management includes maintenance of intravascular volume,
      preservation of cerebral perfusion pressure and minimization of cerebral oedema. Fluid
      management of the neurosurgical patient has advanced from "run them dry" to "run them
      isovolaemic, isotonic and iso-oncotic, but the induction of potential complications by
      current strategies are still unknown. Advanced techniques provide goal directed fluid therapy
      which is currently the gold standard in fluid strategy. In patients undergoing craniotomy
      diuretics, preoperative fasting, induction of general anaesthesia and intraoperative bleeding
      may lead to hypovolemia and poor cerebral perfusion. On the other hand fluid overload
      increases complications and hospital stay after surgery. It is, therefore, important that
      optimal fluid levels are achieved.

      The aim of the study was to compare intraoperative hemodynamic stability, volume loading and
      postoperative complications between group optimised with crystalloids and group optimised
      with colloids in patients undergoing neurosurgical procedure. The investigation will include
      80 patients, 40 optimised with crystalloids and 40 with colloids.

      Hemodynamic stability, volume loading, pooperative complications, hospital stay and mortality
      will be monitored during and aftre the surgery.
    

Intervention name(s): Sterofundin (Bolus of crystalloids); Voluven (Bolus of colloids)
Intervention type(s): Drug; Drug
Intervention description(s): Bolus of 250 ml crystaloids infused regarding the measures; Bolus of 250 ml colloids infused regarding the measures
Other intervention name(s): Sterofundin; Voluven
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: one group will get crystalloids and one grou will get colloids for fluid optimisation
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients
Condition: Diabetes Type 2; NAFLD
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Patients with type 2 diabetes and non-alcoholic fatty liver disease will be enrolled.

      According to a parallel design, the participants will be randomized to a Portfolio diet or a
      monounsaturated fatty acid (MUFA)-rich diet (used as control) for 8 weeks.

      At the beginning and at the end of the trial, the participants will undergo a MRI
      spectroscopy to evaluate fatty liver content. Moreover, the participants will undergo a test
      meal resembling the nutritional composition of the assigned diet to evaluate fasting and
      postprandial metabolic response.
    


Intervention name(s): Portfolio Diet; MUFA Diet
Intervention type(s): Other; Other
Intervention description(s): Medium-term (8 weeks ) nutritional intervention; Medium-term (8 weeks ) nutritional intervention used as control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
MK-0954A in Japanese Patients With Essential Hypertension Not Adequately Controlled With Losartan (MK-0954A-352)
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to evaluate the efficacy of MK-0954A in essential hypertension
      participants who are not adequately controlled with losartan.
    


Intervention name(s): MK-0954A; Losartan; Placebo to MK-0954A; Placebo to losartan 100 mg; Placebo to losartan 50 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily; Tablet containing losartan potassium (100 mg), once daily; Placebo tablet to match MK-0954A, once daily; Placebo tablet to match losartan 100 mg, once daily; Placebo tablet to match losartan 50 mg, once daily
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Essential hypertension; Uncontrolled hypertension; Antihypertensive agents; Blood pressure
Feldenkrais vs Back School for Treating Chronic Low Back Pain: a Randomized Controlled Trial
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study study is to determine whether the Feldenkrais method is effective
      on pain control, functional recovery and quality of life in patients with chronic low back
      pain by comparing it with a Back School program.
    


Intervention name(s): Feldenkrais Method; Back School
Intervention type(s): Other; Other
Intervention description(s): The program of Awareness Through Movement ® chosen for this study, teaches the basic movements of the column. The aim is to stimulate changes in the chronic pathological patterns and in the distorted kinesthetic perceptions that so often hinder the rehabilitation of chronic non-specific low back pain. The patients will be treated in outpatient with the Feldenkrais method. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.; The rehabilitation program of Back School is divided into two parts: one theoretical and one practical. To obtain an effective action not only in reducing pain but also in preventing relapse, the Back School acts on the typical risk factors of chronic non-specific low back pain, such as incorrect postures and movements, psychological stress, poor physical fitness, overweight, obesity, smoking, and insufficient knowledge of the spine. The patients will be treated in outpatient with a Back School program. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.
Other intervention name(s): Awarness through movement program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: low back pain; quality of life; rehabilitation; exercise
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
Condition: Nasal Polyps; Chronic Rhinosinusitis
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of omalizumab compared with
      placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have
      had an inadequate response to standard-of-care treatments.

      Study GA39855 (POLYP 2; NCT03280537) was another Phase III study by the Sponsor with
      identical objectives and design and was run in parallel with this study.
    


Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table.; Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table.
Other intervention name(s): Xolair; IGE025; RO5489789
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Intravenous Magnesium on Postoperative Sore Throat After Thyroidectomy
Condition: Thyroid Neoplasms
MeSH terms: Thyroid Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of this study is to investigate the effect of intravenous magnesium on
      postoperative throat pain after thyroidectomy.

      The secondary purpose of this study is to investigate the effect of intravenous magnesium on
      total dose of fentanyl in recovery room after thyroidectomy.
    


Intervention name(s): Magnesium Sulfate; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h; the same bolus and infusion volumes of normal saline
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment