bioihbjkbjnl/mcl2 huggingface dataset:
Crossover Study to Evaluate the Relative Bioavailability and Palatability of a Lenvatinib Suspension Compared to the Capsule Formulation in Adult Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted in adult healthy participants and will consist of two phases:
      Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods: a
      Screening Period and a Baseline Period. The Randomization Phase will consist of 2 Periods
      (each 6 days long) separated by a 1-day long Baseline Period and End of Treatment (EOT)
      Period. A total of 60 participants will be enrolled into one of three arms. Arms 1 and 3
      consist of 2 sequences, and Arm 2 consists of 4 sequences (as this is an incomplete block
      design with 2 factors [number of capsules and whether water or apple juice is used as
      vehicle]). Each participant will be randomized into one of 8 sequences.
    


Intervention name(s): Lenvatinib
Intervention type(s): Drug
Intervention description(s): All participants will receive one single dose in each of the 2 treatment periods (total of 2 doses). The total duration of the treatment periods is 12 days (6 days per period) in healthy adult volunteers.
Other intervention name(s): Lenvima; E7080
Intervention MeSH terms: Lenvatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability of Lenvatinib suspension; Palatability of Lenvatinib suspension; Lenvatinib; Lenvima; E7080; Capsule formulation; Healthy volunteers
Impact of Two Recall Intervals on Dental Caries Incidence, Anxiety and Quality of Life of Preschool Children
Condition: Dental Caries; Quality of Life; Anxiety
MeSH terms: Dental Caries; Anxiety Disorders
Study type: Interventional

Summary: 
      Objectives: To assess the effectiveness of two recall intervals on dental caries incidence
      (primary outcome) in preschool children with low and moderate caries risk. The level of
      anxiety, oral health related quality of life (OHRQoL), time and cost (secondary outcomes)
      according to each interval will also be assessed. Methods: The sample will consist of 224
      children between 3-5 years of age, of both genders, with low and moderate caries risk
      according to the clinical criteria adapted from the Secretary of Health of São Paulo.
      Children will be randomly allocated into two study groups: Group 1 (G1) - oral clinical
      examination + orientation for oral health and diet on the recall of 12 months; and Group 2
      (G2) - oral clinical examination + orientation for oral health and diet on the recall of 18
      months.
    

Detailed description: 
      An examiner calibrated and blinded to the study groups and the secondary outcomes will
      perform the clinical examinations, which consist of: the gingival bleeding index, dental
      plaque index, detection of caries and its activity according to the ICDAS (International
      Caries Detection and Assessment System) and the clinical features of active and inactive
      caries lesions will be associated with the criteria discribed in ICDAS Commitee manual. An
      external dentist will conduct the assessment of the anxiety levels assessed by the Facial
      Image Scale, the OHRQoL measured by B-ECOHIS (Brazilian Early Childhood Oral Health Impact
      Scale), the time and costs. All groups will be followed for a period of 36 months. All
      analyzes will be performed with the intention of treatment (ITT) and considering the
      sensitivity analyzes to assess the differences between the ITT analyzes and the complete
      cases analyzes.
    

Intervention name(s): Oral clinical conditions
Intervention type(s): Procedure
Intervention description(s): Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
Other intervention name(s): Caries incidence; dental anxiety; oral health related quality of life; time and costs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Survival and PN Dependence in SBS Patients
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Observational

Summary: 
      Short bowel syndrome (SBS) is a rare condition resulting from the loss of portions of the
      small intestine, and can cause a spectrum of metabolic and physiologic disturbances.The
      objective of this study was to determine the longterm survival and parenteral nutrition
      dependence of adult patients with SBS.
    

Detailed description: 
      Short bowel syndrome (SBS), the most common form of intestinal failure, is a rare condition
      resulting from the loss of portions of the intestine, typically because of extensive surgical
      resection or loss of intestinal function. Patients with SBS often stuffer from intestinal
      insufficiency or intestinal failure because they are unable to maintain fluid and nutrient
      balances on a normal diet. SBS can cause various metabolic and physiologic disturbances.
      Although parenteral nutrition is a life-saving measure for many patients with SBS, patients
      with SBS is associated with decreased survival and parenteral nutrition (PN) dependence. Few
      studies have reported the survival and PN dependence in adult SBS patients in China.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with SBS caused by extensive bowel resection with a remnant small intestine length
        of <200cm.
The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety, tolerance, durability of the viral load response and the antiviral
      activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To
      determine the clinical efficacy of the two regimens as measured survival, disease
      progression, weight growth velocity, and neuropsychological or neurological changes. To
      assess the development of viral resistance and relative pharmacokinetics associated with each
      regimen.
    

Detailed description: 
      Patients are randomized to receive blinded treatment with ZDV/3TC alone or in combination
      with 1592U89, orally for 16 weeks. If after the 16-week period certain criteria are met,
      patients may have the option to switch to open-label treatment for the remainder of the study
      period.
    

Intervention name(s): Abacavir sulfate; Lamivudine; Zidovudine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Abacavir
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: HIV-1; Drug Therapy, Combination; Zidovudine; Lamivudine; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load; Child Development; abacavir
Self-Centering Guide Catheter Feasibility Study
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis
Study type: Interventional

Summary: 
      An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a
      guide wire across a stenotic native aortic valve into the left ventricle.
    

Detailed description: 
      A prospective, open-label, single-arm feasibility study evaluating the Self-Centering Guide
      Catheter. All subjects who are candidates for transcatheter aortic valve replacement (TAVR)
      of a native valve with a transcatheter aortic valve that is introduced percutaneously via the
      femoral artery using conventional catheterization techniques will be evaluated for enrollment
      in this study. The Self-Centering Guide Catheter is intended to facilitate delivery of a
      guidewire across a stenotic native aortic valve and into the left ventricle.
    

Intervention name(s): Self-Centering Guide Catheter
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
The Influence Of Physiological And Psychological Factors On Fall Syndrome
Condition: Fall
MeSH terms: Syndrome
Study type: Observational

Summary: 
      Most of previous studies are cross-sectional studies, and rarely explore the changes in
      physical activity, mental state, cognitive and motor functions over time after a fall.
      Therefore, we hope to find out what changes in the elders' physiological and psychological
      functions after a fall.
    

Detailed description: 
      Falls are the main cause of accidental injuries that are common among the elderly. In Taiwan,
      the incidence of falls is about 15% to 34%. Falling can cause subsequent serious injuries and
      post-fall syndromes. Post-fall syndrome is common after a fall. The symptoms of
      self-restricted activity for fear of falling again affect about one-fifth of older fallers.
      This syndrome develops within a short period of time after a fall, which not only causes
      serious problems but also affects psychological symptoms and dependence on daily life
      functions. All of these reduce the function of movement and increase the chance of falling
      again. However, most of the past studies are cross-sectional studies, and rarely explore the
      changes in physical activity, mental state, cognitive and motor functions over time after a
      fall. Therefore, the study will investigate the changes in physiological and psychological
      functions after a fall among older adults who experiences a recent fall within 2 months.
      Additionally, the physiological and psychological functions will be compared between older
      adults with and without a history of falls.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Older participants with a history of fall within 2 months will be recruited from the
        emergency department in a regional hospital and older participants without a history of
        fall in the past year will be recruited from the community daycare centers.
      
Keywords: Fall Syndrome, elderly,Physiological,Psychological
Mechanisms of the Effect of Physical Activity on the Adaptation to a High-Fat Diet
Condition: Healthy
Study type: Interventional

Summary: 
      The study is designed to determine the effect of high physical activity level vs. low
      physical activity level on the adaptation to a high fat diet.
    

Detailed description: 
      A high fat diet is linked to weight gain and obesity. An adjustment to the acute exposure to
      high fat diet is not abrupt and takes time. In a previous study from our laboratory, it has
      been shown that high level of physical activity can accelerate the adaptation to a high fat
      diet by increasing fat oxidation. In this study we will determine the mechanism involved in
      this adjustment. Our hypotheses are:

        1. High fat diets decrease skeletal muscle glucose metabolism and decrease mitochondrial
           biogenesis through the upregulation of PDK4 and downregulation of PGC1α; increased
           physical activity will prevent these deleterious effects.

        2. A high fat diet will increase hepatic and skeletal muscle lipid; increased physical
           activity will prevent these deleterious effects.

        3. These effects are more pronounced in individuals with a low mitochondrial content
    

Intervention name(s): Physical Activity Level
Intervention type(s): Other
Intervention description(s): High vs. low physical activity during a high fat diet consumption.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Basic Science
Keywords: adaptation to high fat diet; activity; exercise
A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared
      to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with
      metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once
      weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their
      prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will
      be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly)
      The anticipated time on study treatment is 12 months, and the target sample size is 100-500
      individuals.
    


Intervention name(s): placebo; taspoglutide
Intervention type(s): Drug; Drug
Intervention description(s): sc once weekly; 10mg sc once weekly for 4 weeks, then 20mg sc once weekly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Long-Term Study to Evaluate the Safety of Asoprisnil and Estrogen Administration to Postmenopausal Women
Condition: Postmenopause
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the long-term safety of asoprisnil 10 mg when
      administered to postmenopausal women with Premarin® 0.625 mg
    

Detailed description: 
      The objective of this study is to determine the long-term safety of asoprisnil 10 mg (2-5mg
      tablets) when taken with Premarin® 0.625 mg, by postmenopausal women, for 6 months after an
      initial 12 weeks in Study M00-198. Pharmacodynamic effects to be assessed include uterine
      bleeding pattern, endometrial biopsy results, and endometrial thickness. Safety assessments
      will include clinical laboratory results, physical examination with vital signs, pelvic and
      breast examinations, ultrasound results, and adverse events.
    

Intervention name(s): Asoprisnil/Premarin
Intervention type(s): Drug
Intervention description(s): 10 mg (2-5mg tablets) asoprisnil and 0.625 mg Premarin tablets, oral daily for 6 months
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postmenopausal; Amenorrhea; Hormone replacement therapy; HRT; asoprisnil; Estrogen Replacement Therapy, postmenopause
Effectiveness of Virtual Reality Training in Gait Improvement of Post Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This single group quasi-experimental study was conducted at Rafsan Neuro Rehab Center,
      Peshawar from October 2021 to February 2022. The sample size of study was 40 post stroke
      patients who were diagnosed on physical findings and other investigation like CT and MRI. The
      inclusion criteria were set as post-stroke patients for more than 3 months with 20 and above
      score on MAS scale and age of 55 to 65 years, while the exclusion criteria were defined as
      participants having traumatic brain injuries, degenerative brain diseases, post craniotomy
      tumor patients leading to hemiplegia, patients having recurrent episodes of stroke, stroke
      patient with dementia and score on MAS scale below 20.
    


Intervention name(s): Virtual Reality Training
Intervention type(s): Device
Intervention description(s): In intervention the participants took part in the VR training. The X-BOX 360 (Augmented virtual reality) device was used. The participants were guided about the virtual reality training including Kinect sports gamming (Trail 1. badminton, beach volley ball, Soccer goal keeping). Each training was performed for 15 minutes with 5 minutes break time. The whole training was performed for 8 weeks. After eight weeks final assessment was done through outcome measuring tools (TUG test, MAS scale, forward stepping test and Functional reach test).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SUBLIVAC FIX Mite Mixture Dose Tolerability Study
Condition: House Dust Mite Allergy
MeSH terms: Dust Mite Allergy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an
      immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy
      and specific immunotherapy (IT). IT represents the only treatment that might alter the
      natural course of the disease. The amount of administered allergen is crucial for both
      efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for sublingual
      IT (SLIT) and is indicated for the treatment of allergic disorders such as allergic rhinitis
      and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM) allergens.

      According to the European Medicines Agency Guideline on the clinical development of products
      for specific IT for the treatment of allergic diseases, products should be tested at
      different dosages to provide preliminary data on safety and tolerability with regard to the
      maximum tolerated dose and suitable dose escalation scheme. This trial is designed to
      investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.
    


Intervention name(s): SUBLIVAC FIX Mite mixture; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.; Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Immunotherapy; Allergic rhinitis/rhinoconjunctivitis
Substituting Mushrooms for Meat to Control Body Weight
Condition: Obesity
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      This is a one-year clinical trial to assess weight-loss, weight-maintenance, and biochemical
      parameters following a weight-control diet using either standard food guide pyramid alone, or
      standard food guide pyramid with substitution of mushrooms for meat.
    

Detailed description: 
      This intervention study has a primary aim to assess omnivorous adult males and females'
      ability to control their weight over a period of 1 year. The control group will be required
      to use 90% lean ground beef a few times per week for one year while maintaining their
      personalized diet plans. The experimental group will have to follow their personalized diets
      as well, but will be required to substitute mushrooms for meat at least three times per week.
      Biochemical measures will also be assessed in response to the diet and weight loss.
    

Intervention name(s): Weight-loss and weight-maintenance diets
Intervention type(s): Behavioral
Intervention description(s): Participants will be given a personalized diet plan, with or without use of mushrooms as part of the diet, at a calorie level sufficiently restricted to result in a 20 lb weight loss over a period of 6 months, followed by a weight maintenance diet for a further 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; weight; weight-loss; mushroom; oxidative; stress; immune; function; inflammation
Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively
Condition: Anxiety; Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to compare the effect of melatonin, diazepam, and placebo
      on the level of anxiety in patients undergoing surgery. The main question it aims to answer
      is:

      • Is melatonin effective in reducing the anxiety of patients undergoing surgery? Participants
      will be asked to answer a questionnaire then they will receive either melatonin, diazepam, or
      placebo, and then after an hour, they will answer the same questionnaire again.

      Researchers will compare melatonin, diazepam, and placebo to see if melatonin is as effective
      in reducing the level of anxiety as diazepam in patients undergoing surgery.
    

Detailed description: 
      Anxiety is a tense unpleasant sensation experienced by many individuals secondary to their
      concerns or due to the anticipation of an unpleasant experience like a surgery. Even with the
      advancement of medical treatment, preoperative anxiety remains a widespread complaint that
      affects the patients psychologically and physically, and at the same time adversely affecting
      the outcome of the operation and the experience of the patient.

      In this triple-blind, randomized clinical study, we aim to compare melatonin to diazepam
      regarding its efficacy in reducing preoperative anxiety, as well as assessing multiple other
      effects such as sedation, orientation, and cognition, by applying validated tools to patients
      undergoing elective surgeries before and after administering the premedication.
    

Intervention name(s): Placebo; Diazepam; Melatonin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The placebo pill will be given to the patients 1 hour prior to their planned surgery.; Diazepam will be given to the patients 1 hour prior to their planned surgery.; Melatonin will be given to the patients 1 hour prior to their planned surgery.
Intervention MeSH terms: Diazepam; Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Preoperative anxiety; Anxiolytic; Melatonin; Diazepam; Sedation; Premedication