bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers
Condition: Physiological Effects of Vitamin D
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is conducted to assess the effect of a vitamin D3 supplementation on the activities
      of two intestinal transporters and on the pharmacokinetics of the transporter substrates
      folic acid and fexofenadine.

        -  Trial with medicinal product
    


Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Combined Aerobic and Resisted Exercise in Breast Cancer Survivors
Condition: Breast Cancer; Exercise; Physical Function
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a combined aerobic and resistance
      exercise program in breast cancer survivors.
    

Detailed description: 
      Cancer and cancer treatment side effects are associated with fatigue, pain, decreased
      cardiovascular fitness and muscle strength, and overall quality of life. Furthermore, cancer
      survivors are at increased risk for cancer recurrence and for secondary effect such as
      cardiovascular disease, diabetes, obesity, osteoporosis, and functional decline. Increase
      physical activity or exercise is proposed to overcome the negative psychological and
      physiological effects. Preliminary research evidence shows that exercise in cancer survivors
      improves quality of life, cardiorespiratory fitness, physical functioning, and decrease of
      fatigue. However, the best exercise mode and intensity has not been well established. Little
      is known regarding the long term effect. No study investigated impact of exercise for breast
      cancer survivors on upper extremity function, and correlation between fitness, upper
      extremity function and quality of life.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): supervised combined aerobic and progressive resistance training for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: breast cancer; exercise; upper extremity function; quality of life
Topical Endoxifen in Women
Condition: Mammographic Breast Density
Study type: Interventional
Phase: Phase 2

Summary: 
      Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the
      pilot trial was to estimate time to mammographic density change. The primary objective was to
      determine the effect size of the breast density change between topical placebo and two doses
      of topical endoxifen.
    


Intervention name(s): Topical endoxifen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): topical solution; topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a monocentric open label study to assess the PK parameters of stiripentol and its
      metabolites (if any are detected) after multiple oral doses in 14 healthy male subjects.
    


Intervention name(s): Stiripentol
Intervention type(s): Drug
Intervention description(s): 1500 mg of stiripentol b.i.d.
Intervention MeSH terms: Stiripentol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dose-Response Study of Ibalizumab (Monoclonal Antibody) Plus Optimized Background Regimen in Patients With HIV-1
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigational product, ibalizumab, is a humanized IgG4 monoclonal antibody administered
      via intravenous infusion at 800 mg every 2 weeks or at 2000 mg every 4 weeks. In addition to
      study drug, all patients will receive an optimized background regimen (OBR), which is a
      standard-of-care regimen selected by the investigator prior to randomization that is
      comprised of 2-4 antiretroviral agents. These agents must have been approved by the local
      regulatory agency or be available through expanded-access programs for treatment of human
      immunodeficiency virus (HIV).
    

Detailed description: 
      The primary objectives of this study are to:

        -  Evaluate the dose-response relationship of antiviral activity of the ibalizumab dose
           regimens at Week 24 in order to determine the optimal dose and regimen. The primary
           evaluation of effectiveness will be based on the proportion of patients achieving
           undetectable viral loads at Week 24.

        -  Evaluate the safety and tolerability of two dose regimens of ibalizumab for dose
           selection

      The secondary objectives of this study are to:

        -  Evaluate changes from Baseline in viral load, CD4+ cell counts, and time to loss of
           virologic response (TLOVR)

        -  Characterize HIV-1 sensitivity/susceptibility changes associated with ibalizumab
           administration in combination with OBR

        -  Determine the presence and significance of anti-ibalizumab antibodies, if any
           (immunogenicity of ibalizumab)

        -  Assess CD4 receptor density and occupancy

        -  Determine the impact of ibalizumab on quality of life as assessed by patient-reported
           outcomes on questionnaires

        -  Evaluate the pharmacokinetic profile of two dose regimens of ibalizumab at steady state
    

Intervention name(s): Ibalizumab; Ibalizumab
Intervention type(s): Drug; Drug
Intervention description(s): Ibalizumab 800 mg IV every 2 weeks; Ibalizumab 2000 mg IV every 4 weeks
Other intervention name(s): TNX-355; Hu5A8; TNX-355; Hu5A8
Intervention MeSH terms: Ibalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; CD4; experienced; resistant; resistance; monoclonal; antibody; infusion; ibalizumab; TNX355; TNX-355; TMB355; TMB-355
Phase 3 Trial of a Bivalent HPV Vaccine (Cecolin®) in Young Girls
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This planned randomized controlled trial will evaluate a bivalent HPV vaccine, Cecolin®, in
      alternate 2-dose regimens, compared to an established HPV vaccine. Gardasil® used as the
      comparator vaccine, as this vaccine is most widely used in low- and low-middle income
      countries.
    

Detailed description: 
      This randomized, active-comparator controlled, open-label study will enroll total of
      approximately 1025 girls aged 9 to 14 years, in one country in Africa (Ghana) and one country
      in South/Southeast Asia (Bangladesh). Subjects will be randomized 1:1:1:1:1 to receive
      Cecolin® at 0 and 6 months, 0 and 12 months, or 0 and 24 months, Gardasil® at 0 and 6 months,
      or Gardasil® at 0 months and Cecolin® at 24 months. For each arm, blood will be collected for
      immunologic testing at baseline and one month following second dose. Additional blood
      collections will occur immediately prior to the administration of the second dose, as well as
      at additional later time points, for immunobridging to other published and ongoing trials.
      The study also aims to evaluate the performance of a mixed arm (group 5) of Gardasil®
      followed by Cecolin® and collect data on effects of interchangeability.

      Girls of target age will be identified, and their parents contacted to attend an
      informational session for individual discussion, informed consent, assent and randomization.

      The study will be conducted by the research groups in icddr,b in Bangladesh and Malaria
      Research Center (MRC) in Ghana.
    

Intervention name(s): Cecolin®; Gardasil®
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine; Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized
      low density lipoprotein: a randomized controlled trial in males and females with vitamin D
      deficiency
    

Detailed description: 
      Nothing is published in the literature about the combined effect of vitamin D3 (VD3) and
      omega-3 fatty acids (omega-3FA) on on lipid profile levels and oxidized low density
      lipoprotein

      This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each
      other on lipid profile levels and oxidized low density lipoprotein in Jordanian people with
      vitamin D deficiency.

      This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3
      weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on on
      lipid profile levels and oxidized low density lipoprotein
    

Intervention name(s): VD3; omega 3- FA; VD3 and omega- 3FA; no intervention
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): VD3 50000 IU/ week for 8 weeks; Omega 3 FA group 300 mg once daily for 8 weeks; 50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks; no intervention is given
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: vitamin D3; Vitamin D Deficiency; Lipid profile; oxidized low density Lipoprotein; omega-3 fatty acids
A Study of RO4607381 in Patients With Coronary Heart Disease (CHD) or a CHD Risk Equivalent.
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with
      coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12
      weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily
      for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level
      and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12
      months, and the target sample size is 100-500 individuals.
    


Intervention name(s): Placebo; dalcetrapib
Intervention type(s): Drug; Drug
Intervention description(s): po daily for 24 weeks; 900mg po daily for 24 weeks
Intervention MeSH terms: Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone
      HCl SR tablet
    

Detailed description: 
      eperisone hydrochloride(muscle relaxant)
    

Intervention name(s): fasting condition; fed condition
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): eperisone SR tablet 75mg administrated under fasting; eperisone SR tablet 75mg administrated fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: low back pain
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, randomized, open-label, active and placebo-controlled,
      parallel-group, conducted in healthy male volunteers who have been shown to be extensive
      metabolizers of dextromethorphan.
    


Intervention name(s): SC Methylnaltrexone (MNTX); IV Methylnaltrexone (MNTX); Oral Paroxetine; SC Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Naltrexone; Methylnaltrexone; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Gait Retraining With Auditory Feedback
Condition: Ankle Injuries; Ankle Inversion Sprain
MeSH terms: Ankle Injuries
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There is evidence to support individuals with chronic ankle instability (CAI) have altered
      gait biomechanics which may lead to re-injury and poor patient outcomes. Currently, there are
      no interventions specifically targeting these abnormal gait biomechanics. Evidence supports
      the use of an external focus of attention feedback to promote motor learning and retention.
      The overall purpose of randomized clinical trial is to determine the effects of a 2-week (8
      session) gait retraining protocol using an auditory external feedback instrument can (1)
      alter biomechanics during functional tasks (walking, step-down, lunge, lateral hops, and
      balance) (2) improve ankle cartilage measures and (3) improve patient-reported outcome
      measures.
    


Intervention name(s): Auditory Feedback; No Feedback
Intervention type(s): Other; Other
Intervention description(s): Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that does not cause the auditory tool to elicit a noise.; Participants will complete 8 sessions over a 2-week period of walking gait retraining on a treadmill while receiving no feedback. Participants will be instructed to walk on a treadmill at their desired pace in a manner that they perceive to be their normal walking speed and mechanics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Satiety Effects on the Neural Valuation of Food
Condition: Fasting; Fed
Study type: Observational

Summary: 
      Using fMRI, this study will explore the neural correlates of satiety when individuals make
      decisions about food. The investigators will also examine individual differences in satiety
      effects.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      (NA)
    
Keywords: fMRI; Satiety; Willingness to Pay; Incentive Delay; Dietary Disinhibition
Is Therapeutic Elastic Bandage As Effective As Corticosteroids Following Third Molar Surgery?
Condition: Third Molar Surgery
MeSH terms: Trismus
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study; Among the patients randomized because of severe postoperative sequelae
      expected as a result of radiological and clinical examinations; nonsteroid antiinflammatory
      drug prescribed group compared with preoperative single dose intraoral submucosal
      corticosteroid administration and therapeutic elastic bandage application considering
      inflammatory symptoms' severity and health related quality of life following surgical removal
      of impacted third molars. The study hypothesis was formed stating that corticosteroid
      injection and elastic bandage application would reduce the inflammatory symptoms more than
      NSAID.
    


Intervention name(s): Dexketoprofen Trometamol; Dexamethasone 21-Phosphate; Therapeutic Elastic Bandage
Intervention type(s): Drug; Drug; Device
Intervention description(s): Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.; Injections were administered in the immediate preoperative period as a single shot.; The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.
Other intervention name(s): Arveles 25 mg 20 tablets; Dekort 8mg/2ml Intramuscular (IM)/ Intravenous (IV); Kinesio Tex Gold Fingerprint (FP)
Intervention MeSH terms: Dexamethasone; Dexketoprofen trometamol; Dexamethasone 21-phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Among the patients randomized because of severe postoperative sequelae expected as a result of radiological examination prior to surgical extraction of lower third molar teeth; postoperatively nonsteroid antiinflammatory drug prescribed group compared with preoperative single dose intraoral submucosal corticosteroid administration and postoperative therapeutic elastic bandage application.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Dexamethasone; Applied Kinesiology; Non-Steroidal Anti-Inflammatory Agents; Teeth, Impacted; Edema; Trismus; Postoperative Pain
Electroencephalography Study Investigating the Effects of Vortioxetine in Healthy Male Subjects
Condition: Healthy Men
Study type: Interventional
Phase: Phase 1

Summary: 
      To explore a neurophysiological marker (electroencephalography) of cognitive effect of
      vortioxetine
    


Intervention name(s): Vortioxetine 10 mg; Vortioxetine 20 mg; Escitalopram 15 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Vortioxetine; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea Before and After Treatment With CPAP.
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to test the hypothesis that treatment with continuous positive airway pressure
      reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a
      fall in blood pressure patients with obstructive sleep apnea.
    


Intervention name(s): Continuous Positive Airway Pressure
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Obstructive sleep Apnea; Hypertension; Vasoactive hormones
Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy
Condition: Pediatric ALL; Radiotherapy Side Effect
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the effect of changes in the care environment in
      pediatric radiotherapy. The definitions of the changes is a part of the study, and is
      constructed in collaboration with the institute of design at Umeå University. The
      implementation is however not part of the study, but done as part of Clinical routine.

      The study consist of two parts, where the first 1.5 years are a Control phase where the
      changes are designed and also function as a baseline period. The following 1.5 years are the
      case period where the Changes that are accepted for Clinical implementation are implemented.

      The impact of the changes are evaluated using surveys and interviews of both parents and
      children
    

Detailed description: 
      The purpose of the study is to evaluate the effect of changes in the care environment in
      pediatric radiotherapy. The definitions of the changes is a part of the study, and is
      constructed in collaboration with the institute of design at Umeå University. The
      implementation is however not part of the study, but done as part of Clinical routine.

      The study consist of two parts, where the first 1.5 years are a Control phase where the
      changes are designed and also function as a baseline period. The following 1.5 years are the
      case period where the Changes that are accepted for Clinical implementation are implemented.

      The impact of the changes are evaluated using surveys and interviews of both parents and
      children. Interviews of the personnel regarding their experiences of the study and the
      changes is performed after the finalization of the case period.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All pediatric patients treated with radiotherapy at the study centres were candidates for
        the study.
      
Keywords: Pediatric radiotherapy
The Effect of Information on Physical Fitness Measures and Training in Overweight Children
Condition: Childhood Obesity
MeSH terms: Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      In the present study the investigators will examine the impact of varying information
      (positive compared to standard information) concerning a drink for improving physical fitness
      in overweight children.
    

Detailed description: 
      The present study will explore the short and medium term effects of receiving information
      concerning a drink (water) (positive compared to standard information) on the physical
      fitness in overweight children.

      Study subjects will be 30 overweight children aged 6 to 13, new participates in a
      nutritional, behavioral sport program,The control group of 30 normal weight children.

      The first stage of the study the investigators will examine the short-term influence of
      different types of information concerning water on subjects' fitness which will be measured
      by treadmill performance. First, the water will be presented to the participants children as
      an ordinary water while in the second case it will be presented as an "energy drink".

      The second stage of the study will examine the impact of varying information on the subjects'
      sports participation/level of physical activity over a 6 week period of training, Study
      subjects will be 30 over-weight children aged 6 to 13, who participate in a nutritional,
      behavioral sport program. During this period, information on the type of drink will be
      changed every week. Children will be assessed in all training sessions and their level of
      activity will be monitored to examine whether the information on the drink led to a different
      exercise behavior.

      The study hypothesis is that the use of these positive information will increase
      participants' fitness and levels of activity compared to standard information.
    

Intervention name(s): standard information; positive information
Intervention type(s): Other; Other
Intervention description(s): The participates will be given a standard information regarding the water drink before physical activity; The participates will be given positive information (the drink will be presented as an "energy" drink) regarding the drink before physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Physical fitness; Exercise; Childhood Obesity; Information