bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Zumba Dance Program for Postmenopausal Women With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of a 12-week Zumba dance intervention on
      fitness, anthropometric and psychometric parameters and eating behavior.
    


Intervention name(s): Zumba dance
Intervention type(s): Other
Intervention description(s): Twelve weeks, 3 times weekly 1 hour training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiorespiratory fitness; weight; quality of life; depression; menopausal symptoms; exercise barriers; executive functions
Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
Condition: Malnourishment
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 2

Summary: 
      Adequate nutrition is one of the critical biological processes to learning and cognitive
      development of children. And is understandable that malnourishment affect these processes.
      Moreover, in recent decades it has been investigated the beneficial effects of Omega-3 in
      cognitive development and academic performance. However, studies have been limited. Therefore
      is of interest to know the effects that has supplement with Omega-3 for children 8-12 years
      with malnutrition in a randomized, blind, placebo-controlled.
    

Detailed description: 
      Adequate nutrition is one of the most critical biological processes to learning and cognitive
      development of children, and malnourishment is understandable these processes are affected.
      Moreover, in recent decades is has been investigated the beneficial effects of Omega-3 in
      cognitive development and academic performance. However, studies have been limited. The
      present study will investigate the efficacy of omega-3 fatty acids supplement on cognition
      and academic performance in children attending elementary school.

      The study will follow a randomized, double-blind, placebo-controlled design in which children
      aged 6-12 years will followed for a period of three months to assess cognitive development,
      academic performance and nutritional status . Intervention will take place in elementary
      schools, where children will receive two intervention products daily and one more in their
      houses. The products will contain omega-3 fatty acids, placebo, or only neuropsychological
      evaluation (control group with normal nutrition children). At baseline, and 3months cognitive
      tests will be administered and assess nutritional status. Compliance will be measured weekly.

      We hypothesize that after 12 months of intervention, children consuming omega-3 fatty acids
      will have statistically significant higher improvement in scores on cognitive tests, than
      placebo and normal nutrition children.
    

Intervention name(s): Omega 3
Intervention type(s): Dietary Supplement
Intervention description(s): measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Omega-3; Cognition; Malnourishment
A Study to Evaluate the Effect of ACT-709478 in Photosensitive Epilepsy Patients
Condition: Photosensitive Epilepsy
MeSH terms: Epilepsy; Epilepsy, Reflex
Study type: Interventional
Phase: Phase 2

Summary: 
      The main study objective is to assess the effect of ACT-709478 in male and female subjects
      with photosensitive epilepsy following single dose administration
    


Intervention name(s): ACT-709478 for oral use; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg; Matching placebo available as matching capsules for oral administration
Intervention MeSH terms: ACT-709478
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
A Study of KY1005 in Healthy Volunteers
Condition: Immune System Diseases
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single and multiple ascending dose, placebo-controlled, double-blind, Phase 1 study
      to evaluate the safety and tolerability of KY1005 in healthy volunteers.
    


Intervention name(s): KY1005; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A human anti-OX40 ligand monoclonal antibody; Matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Safety, Pharmacokinetics, and Immunogenicity of BITS7201A in Healthy Volunteers and Participants With Mild Atopic Asthma
Condition: Mild Atopic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, observer-blinded, placebo-controlled, single and multiple ascending-dose
      study will be conducted in two parts to evaluate the safety, pharmacokinetics, and
      immunogenicity of BITS7201A. Part A will be an ascending, single-dose, sequential-group study
      where participants will be randomly assigned to active drug or placebo. Part B will be an
      ascending, multiple-dose, sequential-group study where participants will be randomized to
      active drug or placebo. Total length of the study is anticipated to be approximately 12
      months.
    


Intervention name(s): BITS7201A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.; Placebo matched to BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
Other intervention name(s): RO7040547
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Comparison of the Videolaryngoscopes With Manual In-line Stabilization
Condition: Oral Surgery; Maxillofacial Surgery
Study type: Interventional

Summary: 
      Videolaryngoscope is useful to improve the laryngeal view, especially during difficult
      intubation. There are several kinds of videolaryngoscopes and it is applicable during
      nasotracheal intubation. In this study, the investigators will compare the McGrath
      videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in
      patients with manual in-line stabilization.
    


Intervention name(s): MILS; McGrath videolaryngoscope; Pentax AWS videolaryngoscope; Macintosh laryngoscope
Intervention type(s): Procedure; Device; Device; Device
Intervention description(s): MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.; McGrath videolaryngoscope will be used for intubation; Pentax AWS videolaryngoscope will be used for intubation; Macintosh laryngoscope will be used for intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Overcoming Gait Freeze in Parkinson's Disease Using Responsive Cueing
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The aim of this pilot/feasibility study is to test if delivering rhythmic vibration cues to
      the lower legs, specifically in response to gait defects (rather than continuously), can
      improve walking quality and overcome gait freezing in Parkinson's disease.

      During the study, people with Parkinson's disease that suffer from regular (daily) gait
      freezing will undertake a series of walking/activity circuits, receiving continuous cueing,
      responsive cueing (delivered in response to gait freezing), no cueing and no device.
      Vibration cueing is provided by a non-invasive wearable device prototyped at the University
      of Oxford, worn on the lower legs during 3 circuits. A series of walking metrics will be
      analysed.
    

Detailed description: 
      Parkinson's disease (PD) is a progressive, neurodegenerative disorder that impairs the
      ability to control movement. Gait freezing is an inability to walk spontaneously and
      continuously, and affects nearly half of PD patients, reducing quality of life and
      contributing to increased fall risk. Cueing (with visual, auditory or somatosensory stimuli)
      is an effective way to improve walking quality in people with PD. In this pilot study we aim
      to test if delivering rhythmic vibration cues acutely, specifically in response to gait
      defects, can improve walking quality and overcome gait freezing in PD.

      During the study, people with PD that suffer from regular (daily) gait freezing, but who are
      able to stand and walk with minimal assistance, undertake 4 walking/activity circuits. During
      each of the circuits participants receive either continuous cueing, responsive cueing
      (delivered in response to gait freezing), no cueing and no device. Cueing is provided by a
      non-invasive wearable movement-tracking cueing device prototyped at the University of Oxford
      (approximately the size of a smart phone), worn on the lower legs during 3 circuits. The
      ordering of the interventions/circuits are systematically alternated for each participant.
      The impact of responsive cueing on walking ability can be determined by analysis of walking
      metrics across the circuits.
    

Intervention name(s): Rhythmic vibration cueing (lower leg)
Intervention type(s): Device
Intervention description(s): A non-invasive wearable device worn against both gastrocnemius muscles provides rhythmic vibrations when triggered.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Parkinson's Disease; Gait freezing; Cueing; Gait
Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare and evaluate the single-dose oral bioavailability
      of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories
      Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fasting
      conditions in healthy adult human subjects.
    

Detailed description: 
      Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose,
      Crossover, Oral Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets (Dr. Reddy's
      Laboratories Limited, India) With the Reference Formulation ZOLOFT® 100 mg Tablet (Pfizer,
      USA)Under Fasting Conditions in Healthy Human Adult Subjects. 32 healthy, adult, human male
      subjects were enrolled in the study and all the subjected completed all the periods.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention description(s): Sertraline Hydrochloride Tablets 100 mg
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Sertraline; crossover
Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will consist of two parts:

      A pilot study in a three-way cross over trial to determine the highest well tolerated dose of
      Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the hemodynamics and hence the
      design of the final study.

      The final study is planned as a three-way crossover trial to investigate and compare the
      cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the
      pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).
    


Intervention name(s): Ritodrine; Atosiban; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ritodrine (Pre-Par), maximum 400 µg/minute, IV; Atosiban (Tractocile), maximum 300 µg/minute, IV; Glucose 5%, IV
Intervention MeSH terms: Atosiban; Ritodrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hemodynamics and arterial function of healthy females
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
Condition: Shingles; Herpes Zoster; Vaccine-Preventable Diseases
MeSH terms: Herpes Simplex; Herpes Zoster; Vaccine-Preventable Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1
      and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes
      zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and
      without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).
    


Intervention name(s): Z-1018; Z-1018; Z-1018; Z-1018; Shingrix
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg; contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg with aluminum hydroxide (alum); contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 6000 mcg; contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 6000 mcg, with aluminum hydroxide (alum); a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Attentive Eating for Weight Loss
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      This trial examined whether a smartphone application designed to encourage a more attentive
      eating style could help people to lose weight, compared to a control group.
    

Detailed description: 
      There is evidence that enhancing memory for recent eating and focusing attention on food
      being consumed influences later energy intake. Studies have shown that attending to food
      being eaten can reduce food intake. This has since been implemented into a smartphone based
      'attentive eating' application. In a feasibility trial of this mobile phone application,
      adults with overweight or obesity were encouraged to eat attentively by photographing their
      meals and making satiety ratings after they had eaten. Participants were also required to
      review what else they had eaten that day before entering their next meal, with an overall aim
      of encouraging a more attentive eating style. Adherence data and qualitative interviews
      suggested that the mobile phone app was generally acceptable to participants and easy to use.
      Participants reported that they felt the application increased their awareness of what they
      had been eating. There was also an average weight loss of 1.5kg across the 4 week period that
      participants used the application for. Given that the previous feasibility trial included no
      control condition, the aim of the current trial was to examine initial proof of concept for
      effectiveness of an attentive eating smartphone weight loss application.

      In the current study the investigators hypothesised that participants randomised to the
      attentive eating smartphone based condition (experimental condition) would lose significantly
      more weight than participants randomised to the control condition.

      The study is a single centre, parallel, two arm, individually randomised 8 week controlled
      trial in adults with overweight and obesity in the Merseyside area of England.
    

Intervention name(s): Attentive eating smartphone application.; Standard dietary advice and text tips.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A smartphone application that encourages a more attentive eating style.; Standard dietary advice for weight loss booklet and weekly text tips containing dietary advice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: attentive eating; e-health; weight loss; food intake
Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual
      to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis.
      Non-diabetics with IR are at risk, but can be difficult to diagnose.

      A major problem with the use of IR as a predictor or marker of disease is the lack of a
      simple, robust test that can be used to quantify this parameter in a wide variety of clinical
      situations. The current 'gold standard' methods for measuring insulin sensitivity, such as
      the hyperinsulinemic-euglycemic (H-E) clamp, are complex, time consuming and costly.
      Alternative, simpler methods, such as the Homeostasis Model Assessment (HOMA-IR) score, may
      be less accurate and are not widely accepted.
    

Detailed description: 
      A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel
      Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8
      Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight
      Controls, Healthy Obese Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM).
    

Intervention name(s): rosiglitazone maleate
Intervention type(s): Drug
Intervention description(s): Rosiglitazone tablets 4 mg dose will be administered orally by subjects
Intervention MeSH terms: Rosiglitazone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: total body water; T2DM,; Healthy Obese,; Insulin Resistance,; Rosiglitazone maleate,; Glucose Disposal,; hyperinsulinemic-euglycemic clamp,
Safety and Efficacy of WIN-901X in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is designed to evaluate the efficacy, dose-response and safety of
      WIN-901X in Asthma patients.
    

Detailed description: 
      Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical
      Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
    

Intervention name(s): WIN-901X dose level 1; WIN-901X dose level 2; WIN-901X dose level 3; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100mg Bid, PO, 12weeks; 200mg Bid, PO, 12weeks; 300mg Bid, PO, 12weeks; Bid, PO, 12weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases
Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate efficacy and safety of a testosterone patch as treatment
      for low libido in surgically menopausal women who are taking estrogen therapy.
    

Detailed description: 
      Women with hypoactive sexual desire disorder (HSDD) who had undergone bilateral
      salpingo-oophorectomy and hysterectomy were randomized into a 24-week, multicenter,
      multinational, double-blind (DB), parallel-group, placebo-controlled study. Patients were
      stratified based on their use of oral or transdermal ET and randomized to receive placebo or
      testosterone transdermal system. Patients had to maintain a stable dose of estrogen
      throughout the study. Patients who completed the first 24 weeks of the study were given the
      opportunity to participate in a 3.5 year open-label (active treatment) study extension which
      was added to the protocol by amendment. Safety was assessed by adverse events, lipids, serum
      chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology.
      Physical exam including clinical assessments of facial hair and acne were monitored.
    

Intervention name(s): Testosterone Transdermal System; placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): testosterone patch (300 mcg/day), patch changed twice a week for six months; placebo patch replaced every 3-4 days for 6 months
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Surgical menopause; HSDD