bioihbjkbjnl/mcl2 huggingface dataset:
Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives
Condition: Uterine Fibroids; Arterial Embolization
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The purpose of this prospective non-randomised study is to examine whether two different
      microspheres (Bead-Block and Embosphere) are equally effective in the treatment of the
      uterine fibroid controlled with contrast-enhanced MR examination.

      Quantitative MR imaging, including dominant fibroid T1, T2 and contrast enhancement
      characteristics before intervention and 3 months after interventions will be analysed as a
      potential predictor of volumetric response after embolization.

      Another purpose is to determine long-term follow-up in all patient treated in a period from
      2001-2011 in OUH analysed retrospectively.
    

Detailed description: 
      Group 1: 26 patient will be treated with Bead-block microspheres - 700-900 µm microspheres or
      combinations of one vial 2 ml of 500-700 µm microspheres, follow by 700-900 µm microspheres
      until blood flow stop ( " cut the tree" appearance).

      Group 2: 26 patient will be treated with Embosphere; 500-900 µm until "near-stasis" flow stop
      in the uterine artery.

      Clinical and Technical success will be examined, and radiological follow-up 3 and 12 months
      after embolization using MR contrast-enhanced examination in a Bead Block group and only 3
      months control in Embosphere group to assess total fibroid burden infraction degree and
      eventually residual contracts fibroid enhancement.

      Quantitative MRI dominant fibroid characteristic for and 3 months after an intervention to
      examine eventually potential of as a possible predictor of the volumetric response of the
      uterine fibroid.

      Retrospective study compromised all patient treated between January 2001 until January 2011
      with follow up to January 2014, and re-intervention as well as complications rate analysis.
    

Intervention name(s): embolizations ,uterine fibroid; embolizations
Intervention type(s): Procedure; Procedure
Intervention description(s): 26 patients will be treat with Bead-block microspheres, 500-700 and 700-900µm until flow stop ( " cut the tree" appearance)
26 patients will be treat with Embosphere, 500-700µm and /or 700-900 until "near stasis " flow stop; comparison between the two microspheres
Other intervention name(s): microsphere, uterine fibroid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect
      on ambulatory activity in people with multiple sclerosis
    

Detailed description: 
      This is a parallel-group, double-blind, randomized controlled crossover trial with a 1:1
      randomization. There are two treatment periods of 4 weeks and a two-week off treatment
      washout period. Treatment periods are DER (dalfampridine ER) followed by placebo (group A)
      and placebo followed by DER (group B), respectively. All dosages will be administered twice a
      week. Purpose of the study is to see if using the study drug(dalfampridine Er) for a short
      period of time will improve the way subjects with multiple sclerosis (MS) walk.
    

Intervention name(s): dalfampridine ER; placebo
Intervention type(s): Drug; Drug
Intervention description(s): dalfampridine ER 10mg bid for 4 weeks; identical placebo tablet administered bid for four weeks
Other intervention name(s): Ampyra serial number 77948545; Sugar Pill
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ambulation
Effects of Roxithromycin on Quality of Life and Physiological Outcomes in Bronchiectasis
Condition: Quality of Life; Respiratory Function Tests
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 3

Summary: 
      roxithormycin 300 mg per day for 12 weeks could improve quality of life and physiological
      outcomes in bronchiectasis
    

Detailed description: 
      A randomized, double blinded, placebo controlled study was conducted to evaluate the effects
      of a 12-week administration of roxithromycin 300 mg once daily and a 12-week follow-up period
      in symptomatic stable bronchiectasis
    

Intervention name(s): Roxithromycin 300 MG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Roxithromycin 300 mg oral per day; Placebo one table oral once dialy
Other intervention name(s): Roxithromycin
Intervention MeSH terms: Roxithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised control study
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bronchiectasis; quality of life; pulmonary function tests
Intermittent Fasting in Hypertriglyceridemic Overweight or Obese Subjects
Condition: Hypertriglyceridemia; Overweight or Obesity
MeSH terms: Overweight; Hypertriglyceridemia
Study type: Interventional

Summary: 
      some studies have shown similar effects of intermittent fasting and continuous caloric
      restriction on body weight and plasma lipid profile, but there is still a wide controversy.
      Therefore,due to limited human studies and the lack of a study on hypertriglyceridemic
      patients, the present study aimed to determine the effects of using low-calorie diets in
      comparison with continuous caloric restriction on weight loss and plasma lipid profile in
      obese or overweight hypertriglyceridemic patients.
    

Detailed description: 
      a randomized clinical trial will be conducted in National Nutrition and Food Technology
      Research Institute, Tehran, Iran. after the review of inclusion and exclusion criteria, a
      written consent form will be completed. the participants will be 90 hypertriglyceridemic
      patients aged between 18-60. half of the participants will be under intermittent low-calorie
      diet which they will have 3 alternate days in the week eating only 30% of their total energy
      requirement and on the other days of the week they receive a total calorie of 100% of their
      energy requirement , therefore there will be a total of -210% TEE reduction in their received
      energy in the week. the other group will be under continuous calorie restriction meaning on
      all the days of the week they will be eating 70% of their total energy requirement resulting
      in a total of -210% TEE reduction in their received energy in the week. both groups will
      receive 3 consultation sessions with a nutritionist, also to prevent any deficiency,
      multi-vitamin-mineral supplements will be given to both groups participants.
    

Intervention name(s): intermittent fasting diet; low calorie diet
Intervention type(s): Other; Other
Intervention description(s): intermittent fasting diet; continuous low calorie diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: intermittent fasting; hypertriglyceridemia
Effect of Sitagliptin on Incretin Effect in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of the DPP-4 inhibitor sitagliptin on the
      incretin effect in patients with type 2 diabetes mellitus.
    

Detailed description: 
      Following a meal, gut-produced incretin hormones such as glucagon-like peptide-1 (GLP-1) and
      glucose-dependent insulinotropic polypeptide (GIP) are released into the circulation. Because
      GLP-1 and GIP mediate grossly 60% of the insulin-stimulatory action, the so-called incretin
      effect, both are crucial components of a natural endogenous system guaranteeing glucose
      homeostasis. In addition, GLP-1 lowers glucagon secretion from pancreatic alpha-cells and
      delays nutrient delivery from the stomach by inhibiting gastric emptying. The rise in insulin
      concentration enhances glucose clearance in peripheral tissues such as muscle, and the lower
      glucagon concentration combined with the rise in insulin reduces hepatic glucose production.
      By enhancing glucose clearance and lowering hepatic glucose production, the post-meal glucose
      excursion is reduced.

      Both GLP-1 and GIP are degraded by the enzyme dipeptidylpeptidase-4 (DPP-4). Inhibition of
      DPP-4 by the specific DPP-4 inhibitor Sitagliptin increases plasma levels of both GLP-1 and
      GIP, and reduces postprandial glycemia.

      Although important in healthy subjects, the role of the incretin hormones in patients with
      T2DM is unclear. In T2DM the insulinotropic efficacy of GIP is reduced and the postprandial
      release of GLP-1 is diminished.

      Therefore, the aim of this study in T2DM is to quantify the incretin effect with and without
      the DPP-4 inhibitor sitagliptin. The specific GLP-1 receptor antagonist exendin(9-39) will be
      used to quantify the contribution of both GLP-1 and GIP to the incretin effect in patients
      with T2DM.
    

Intervention name(s): Placebo tablet; Sitagliptin tablet; Saline infusion; Exendin(9-39) infusion
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): placebo PO (placebo control for sitagliptin) for three days; Sitagliptin 100 mg PO for three days.; Saline IV (placebo control for exendin(9-39)) on two consecutive study days; Exendin(9-39) IV on two consecutive study days.
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: diabetes mellitus; DPP-4 inhibitor; sitagliptin; exendin(9-39); GLP-1
Acute Safety, Tolerability, Feasibility and Pharmacokinetics of Intrath. Administered ATI355 in Patients With Acute SCI
Condition: Acute Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the acute safety, tolerability, feasibility and pharmacokinetics of
      6 dose regimens of ATI355 in acute spinal cord injury patients
    


Intervention name(s): ATI355
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute spinal cord injury;
UVB Light and Sunscreen
Condition: Vitamin D Status
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients need vitamin D which is normally produced in the skin in response to ultraviolet
      light from the sun. Vitamin D is important for calcium absorption and good bone health.
      Physicians have been using sunscreens to protect patients from skin cancer and the aging
      effects of sunlight for a least a half a century. Dermatologists have promoted sunscreen use
      to restrict sunlight exposure especially in white Caucasians. If this behavior is done 100%
      of the time when outdoors individuals may suffer from vitamin D deficiency. It is impossible
      to influence persons' behavior to wear sunscreens all the time when outdoors. With the use of
      sunless tanning agent (DHA), once a week, we can obtain a continuous sunscreen in the top
      layer of the skin that will not wash off, can't be removed with soap and water, or removed by
      perspiration. Under these circumstances we can answer the scientific question, will sunscreen
      use inhibit the production of vitamin D in the skin?
    


Intervention name(s): Tanning spray; UVB
Intervention type(s): Other; Other
Intervention description(s): using 3% DHA twice a week for the 1st week and then once a week for 4 weeks and receiving 40mJ UV-B phototherapy three times a week for four weeks; receiving 40mJ UV-B phototherapy three times a week for four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin tone; Vitamin D
Metabolic and Cardiovascular Effects of Armolipid Plus in Subjects With Metabolic Syndrome
Condition: Metabolic Syndrome; Insulin-resistance; Left Ventricular Hypertrophy
MeSH terms: Hypertrophy, Left Ventricular; Metabolic Syndrome; Insulin Resistance; Syndrome; Hypertrophy
Study type: Interventional

Summary: 
      Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in
      patients with MetS and increased LV mass.

      168 patients will be enrolled in this randomized, double-blind, parallel-group,
      placebo-controlled trial and treated for 24 weeks.
    

Detailed description: 
      Metabolic syndrome (MetS) is a highly prevalent condition characterized by visceral obesity,
      abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events.
      Such findings appear to be associated with a decrease in insulin sensitivity. Management of
      metabolic syndrome is currently aimed at treating individual components of the disease
      without addressing this underlying pathophysiologic mechanism; this translates into multidrug
      regimens, high costs and patient compliance issues.

      A complication of hypertension is hypertrophy of the left ventricle (LV), which is closely
      related to the incidence of cardiovascular events whose regression results in a proportional
      reduction of the risk. But also other factors contribute as sex, age, race, genetics, diet
      and insulin resistance.

      MetS is closely related to hypertrophy of the LV. Therefore it is possible that the treatment
      of MetS may be an effective strategy for the prevention of organ damage.

      Armolipid Plus (an association of berberine 500mg, red yeast rice titled in 3 mg monacolin
      K,- policosanol 10 mg, coenzyme Q10 2mg,astaxanthin 0,5mg, folic acid 0,2mg) has been found
      to be effective at reducing blood cholesterol and triglycerides, and at improving endothelial
      function; subgroup analyses also suggested a benefit on glucose metabolism, myocardial mass
      and improved diastolic function in subjects with MetS and early organ damage.

      Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in
      patients with MetS and increased LV mass.

      168 patients will be enrolled in this randomized, double-blind, parallel-group,
      placebo-controlled trial; active treatment will consist of Armolipid Plus (1 tbl qd).

      Primary end point will be the reduction of the insulin resistance in patients with metabolic
      syndrome and increased LV mass.
    

Intervention name(s): Armolipid Plus; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
Condition: Type 2 Diabetes Mellitus; Coronary Atherosclerosis
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aimed to prospectively investigate the prevalence of myocardial scar on
      Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients
      with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery
      disease on Cardiac Computed Tomography Angiography (CCTA).
    

Detailed description: 
      Patients underwent a cardiac MRI examination with Dotarem within 60 days after screening
      visit. The myocardial CCTA examination with Xenetix 350 was performed within 1 to 30 days
      (but no sooner than 24 hours) after the MRI examination.
    

Intervention name(s): iobitridol; gadoterate meglumine
Intervention type(s): Drug; Drug
Intervention description(s): Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.; Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)
Other intervention name(s): Xenetix; gadoteric acid; Dotarem
Intervention MeSH terms: Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery
Condition: Obese; Exercise; Bariatric Surgery Candidate
MeSH terms: Obesity
Study type: Interventional

Summary: 
      In this study, our primary aim is to investigate the effects of structured core stabilization
      exercise program on functional capacity, body composition, muscle strength, endurance,
      balance, quality of life in adult obese individuals expecting bariatric surgery. Our
      secondary aim is to provide the individual with exercise habits and increase the level of
      physical activity in daily life with the exercise program planned according to the needs of
      the individual.
    


Intervention name(s): Core-Stabilization Exercise; Counseling of physical activity
Intervention type(s): Other; Other
Intervention description(s): A program consisting of core stabilization exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.; Only physical activity counseling will be given to the subjects in this group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obese; core stabilization; bariatric surgery; exercise
Primary Care Online Emotion-regulation Treatment
Condition: Mental Health Issue
Study type: Interventional

Summary: 
      We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental
      health problems.
    

Detailed description: 
      Mental health problems in youth are a global problem, causing incalculable suffering in youth
      and families, harming long-term prospects of youths, and are creating substantial economic
      costs to society. Existing treatments are not fully addressing these problems because they
      focus on a subset of mental health problems; they are limited in efficacy; and are not
      provided to most youth in need. Transdiagnostic digital treatments that address mechanisms
      underlying mental health problems, such as emotion regulation, have been called for to
      address these problems. As an initial pilot study we will include 60 participants aged 12-17
      years and their parents in a randomized controlled feasibility trial comparing a 6-week
      Primary care Online Emotion-regulation Treatment (POET) to a 6-week active Supportive
      Treatment (ST). Both interventions will be delivered in blended format combining online
      therapist-supported treatment modules with a video-link session. The primary study aims are
      to examine the feasibility and acceptability of study protocol and treatment protocols.
      Preliminary utility of the experimental condition will be evaluated by youth-reported,
      parent-reported, and clinical-reported outcomes.
    

Intervention name(s): Therapist-supported digitally delivered transdiagnostic emotion regulation treatment; Therapist-supported digitally delivered supportive treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Please see description of experimental arm (arm one); Please see description of active comparator arm (arm two)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Transcutaneous Electrical Nerve Stimulation for Pain Relief During the Active Phase of Labor
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical
      Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research
      will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant
      women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be
      divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and
      will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of
      cervical dilation. The evaluation will be performed by numerical category scale, location and
      Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a
      questionnaire of customer satisfaction.
    

Detailed description: 
      Pain in the work appears as a subjective experience of interaction, involving a wide
      individual influences physiological, psychosocial and environmental factors, representing a
      major clinical signs of this phase. Despite presenting an important biological function, is
      now well established the need for their relief, since its persistence is associated with
      detrimental effects for both mother and fetus. Among non-pharmacological resources available,
      the investigators highlight the massage therapy that has shown positive effects in relieving
      pain and promote comfort of the mother. The objective of this research is to evaluate the
      efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early
      active phase of labor. The research will be of type randomized controlled trial, consisting
      of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in
      Ribeirão Preto. Mothers will be divided into two groups (lumbosacral massage) and control
      (routine maternity) and will be evaluated before and after therapy, which corresponds to 30
      minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical
      category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the
      delivery will be a questionnaire of customer satisfaction. After collecting the data, the
      groups are statistically analyzed using the linear regression model with mixed effects (fixed
      and random), taking into account a value of p <0.05 for statistical significance of 5%.
    

Intervention name(s): Experimental TENS
Intervention type(s): Other
Intervention description(s): Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: pain; electric stimulation; nervous; transcutaneous; humanized childbirth