bioihbjkbjnl/mcl2 huggingface dataset:
The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Aim of the present study is to investigate the neuronal correlates of self and of personal
      meaning as well as the role of the serotonin (5-HT) 2A receptor system in these processes
      using functional magnetic resonance imaging (fMRI) and psychometric and cognitive measures.
    

Detailed description: 
      The present study aims at identifying the contribution of the 5-HT2A receptor system to the
      formation of self and personal meaning in normal and altered states of consciousness.
      Specifically, the effect of the 5-HT2/1/6/7 receptor agonist lysergic acid diethylamide (LSD)
      on self-consciousness, perception and the making of meaning will be assessed in 25 healthy
      subjects using a randomized, placebo-controlled, double blind, cross-over design.
      Furthermore, the contribution of the 5-HT2A receptor to these functions shall be assessed by
      pretreatment with the specific 5-HT2A antagonist ketanserin.
    

Intervention name(s): Placebo; LSD; Ketanserin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules containing mannitol looking identical to LSD per os; 100µg per os, single dose; 40mg per os, single dose looking identical to LSD per os
Other intervention name(s): Lysergic acid diethylamide; Sufrexal
Intervention MeSH terms: Ketanserin; Lysergic Acid Diethylamide
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pilates Exercises on Postpartum Fatigue, Maternal Functioning and Quality of Life
Condition: Maternal Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of the study is to determine the effect of Pilates exercises on postpartum fatigue,
      maternal functioning and quality of life.
    

Detailed description: 
      the effect of Pilates exercises in reducing postpartum fatigue is not well known however in
      recent study Pilates exercises alone was quantified which was based on home exercises and had
      a positive effect, it was conducted in primiparas women, there was also possibility of recall
      bias due to self report nature of data
    

Intervention name(s): Pilates excercises, streching and breathing; stretching and breathing
Intervention type(s): Other; Other
Intervention description(s): international group receive Pilates exercises, stretching and breathing two times a week (30 min per session) perform 3 to 5 reps of Pilates exercises under supervision; control group guided with stretching and breathing home based program both group till 8 week both groups
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pilates; maternal fatigue; maternal functioning
Evaluation of Diolaze XL Blended Mode for Hair Removal
Condition: Hair Removal
Study type: Interventional

Summary: 
      The objective of this clinical study is to evaluate safety and efficiency of Diolase XL
      blended modes for hair removal. The handpieces tested were a blend of 755nm/810nm and
      810nm/1064nm. At least 30 female subjects seeking hair removal treatment will be enrolled.
      Treatment sites will be o groins and axillae. Study design included 3 treatment sessions 4
      weeks apart and follow-up after 3 months.
    


Intervention name(s): Diode laser
Intervention type(s): Device
Intervention description(s): Diolaze XL blended modes diode laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Sugammadex During Transcranial Electrical Motor Evoked Potential Monitoring in Spinal Surgery
Condition: Sugammadex
Study type: Interventional

Summary: 
      Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during
      neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its
      potential interference with signal interpretation. However, full blockade offers increased
      anesthetic management options and facilitates surgery. Here, investigators want to assess the
      effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate
      rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing
      thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control
      group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium
      to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium
      infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in
      sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in
      control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs
      in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.
    


Intervention name(s): Sugammadex
Intervention type(s): Drug
Intervention description(s): Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP
Other intervention name(s): Bridion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Extensively Hydrolyzed Liquid Human Milk Fortifier on Growth and Tolerance in Moderately Premature Infants
Condition: Complication of Prematurity
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is for the researchers to examine the safety and efficacy of liquid
      human milk fortifier (HMF) in moderately preterm infants compared to powdered human milk
      fortifier.
    

Detailed description: 
      This is a prospective, randomize, double-blinded study in preterm infants born between 28-34
      weeks gestation admitted to the NICU at the University of Kansas Hospital. After obtaining
      informed consent, babies will be randomized to either liquid or powdered HMF using opaque,
      sealed envelopes with preassigned randomization. The feeding protocol as established in the
      KU NICU will be followed, beginning with initiation of trophic feeds, and advancement of
      enteral feeds depending on the gestational age and preceding illnesses. Once infants reach
      80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding
      either liquid or powdered fortifier. The beginning of the study(Study day 1) will be defined
      as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either
      liquid or powdered fortifier. Enteral feeds will be advanced per unit protocol until they
      reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on
      the documented weight to provide energy and protein requirements as recommended by the
      ESPGHAN guidelines. Babies will be followed up until the time of NICU discharge.
    

Intervention name(s): Powder HMF; Liquid HMF
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): powder human milk fortifier; Liquid human milk fortifier
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: prematurity; growth; nutrition; human milk fortifier
Preventing Substance Use and Risky Behavior Among Rural African American Youth
Condition: Risky Sexual Behavior
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The Rural African American Families Health (RAAFH) Project is a federally funded research
      study designed to evaluate the effectiveness two prevention programs designed for rural
      African American families. One program, FUEL, helps teens develop lifestyles that prevent
      health problems such as heart disease, diabetes, and being overweight. This program deals
      with diet and exercise, the influence of TV and magazines on eating habits, and handling
      stress. The second program, the Strong African American Families Teen Program (SAAF-T), helps
      teens learn how to develop plans for the future and to avoid drug use and unsafe sex. The
      sessions deal with goal setting, peer pressure, and staying in school.
    


Intervention name(s): Strong African American Families-Teen Program; FUEL
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 week educational program for teens and their caregivers.Each meeting lasts approximately 2 hours.; 5 week educational program for teens and caregivers. Each weekly session lasts approximately 2 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Asthma Biomarker Study
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The main objective of the trial is to explore if any of the biomarkers assessed are
      sensitively linked to the asthma phenotypes. This would potentially alone or in addition to
      other clinical or biofluid markers indicate if and how asthma endotypes are linked to
      phenotype such as eosinophilic, neutrophilic, or paucigranulocytic phenotypes. Further
      exploratory markers will be analysed for better understanding of physiological levels of
      proteins and markers playing a role in regard to disease characterization in asthma. As a
      basis for further development of a biomarker for asthma, The sponsor plans to conduct this
      exploratory biomarker trial to determine levels and reference ranges of biomarkers
      potentially associated with asthma phenotypes. The trial aims at generating a panel of serum
      biomarkers that can be evaluated in subsequent interventional studies. The longitudinal
      design will be used to ascertain stability and test-retest reliability.
    

Detailed description: 
      Purpose:
    

Intervention name(s): Biofluid sampling
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Asthma and healthy subject
      
Biospecimen description: 
      Blood and sputum
Virtual Peer-to-Peer (VP2P) Support Mentoring for Adolescents With Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      The overall aim of this research program is to develop and examine the impact of a Cancer
      virtual peer-to-peer (VP2P) Support Program on health-related quality of life (HRQL) in
      adolescents with cancer (AWC). In the current proposal, the feasibility of trialing the
      Skype-based VP2P program providing peer-support from mentors and the magnitude of program
      effect estimates will be evaluated in a pilot randomized control trial (RCT). This pilot RCT
      will enable us to refine the program and determine the appropriate sample size for a future
      large-scale RCT, which will compare the effectiveness of VP2P to a waitlist control group at
      a major Children's Oncology Group- affiliated centers in Canada and the United States.
    

Detailed description: 
      The aim of this project is to develop and examine the impact of a virtual peer support
      program on health outcomes and quality of life of adolescents with cancer using a waitlist
      randomized controlled trial. In addition to standard medical care, adolescents in the
      experimental group will receive a manualized peer mentorship program that will provide
      modelling and reinforcement by trained young adults aged 18-25 years who have learned to
      function successfully with their pain. Mentoring sessions consist of 10 sessions of 30-45
      minute Skype calls over 8 weeks. Feasibility of the program will be measured in addition to
      quality of life, physical and emotional symptoms, pain coping, self-efficacy, social support,
      and self-management skills.
    

Intervention name(s): Virtual Peer-to-Peer Support Mentoring
Intervention type(s): Behavioral
Intervention description(s): The mentorship program will encourage mentored participants to develop and engage in self-management and transition skills and support their practice of these skills. The mentors will present information to mentored participants in a monitored virtual interaction using Skype for 8 weeks (10 total Skype sessions of 45 minutes each) to encourage participation in skill building tailored to their needs. All mentors will complete a paid 1.5 day training course and will be supported throughout the duration of the study (consultations with research staff to deal with unforeseen concerns). Mentored participants will complete online outcome measures prior to randomization (T1) and upon study completion (T2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Adolescent; Online Peer Support; Managing Cancer; Mentor
Food Structure of Pulses and Satiety
Condition: Appetitive Behavior
Study type: Interventional

Summary: 
      Diets containing (whole) pulses have been associated with the potential to increase satiety
      (and acute food intake). In vitro digestion studies of pulses have shown that (thermal)
      processing has the potential to modulate macronutrient digestion kinetics. Changes in food
      (micro)strucutral properties have been identified to retard nutrient release, with a possible
      effect on appetite sensations. Based on distinct in vitro digestion behaviour, two
      differently processed pulse meals were chosen to be investigated in humans with the aim to
      confirm in vitro findings and gain a mechanistic understanding of the influence of structural
      aspects of pulses on appetite sensations.
    


Intervention name(s): Pulse flour; Pre-processed pulse flour
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Traditionally processed pulse flour in vitro digestion conditions were related to potentially influence appetite sensations.; Pre-processing of pulse flour was related to altered in vitro digestion conditions and thus suggested to potentially influence appetite sensations.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single-blind, randomised crossover design with one arm.
Masking: Single (Participant)
Primary purpose: Prevention
Endothelial Function and Vein Graft Remodeling
Condition: Peripheral Arterial Disease; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Observational

Summary: 
      The purpose of this study is to better understand why some vein bypass grafts develop
      narrowing. Evidence suggests that there is a relationship between inflammatory markers in the
      blood and the narrowing that occurs in blood vessels. In this study, we will look at
      inflammatory markers in the blood and how well the vein graft functions.
    

Detailed description: 
      Despite the acceptance of catheter-based approaches to lower extremity reconstruction, bypass
      with autogenous vein remains the most durable option. In the United States alone there are
      approximately 100,000 lower extremity bypass procedures performed yearly. However, 30-50% of
      these grafts either occlude or require revision in the first 5 years.

      Traditional Framingham cardiovascular risk factors such as dyslipidemia and diabetes do not
      predict which grafts are at risk for failure. Therefore other variables such as hemodynamic
      factors or endothelial function may be important in identifying vulnerable vein grafts. The
      applicant has previously noted that vein grafts undergo dramatic geometric remodeling within
      the first month after implantation into the arterial circulation. This is partly driven by
      hemodynamic forces such as shear stress and is thought to be related to endothelial function.
      Shear stress is positively correlated with early (0-1 month) luminal enlargement. This
      adaptive response is important to maintain bypass graft patency. However, there is
      considerable amount of variability in this response unaccounted for by shear stress alone.
      The applicant has further shown that baseline systemic inflammation dampens the ability for
      adequate vein graft luminal expansion and therefore may uncouple the mechano-chemical signal
      transduction at the endothelial level. Therefore, this study will examine the relationship
      between circulating levels of inflammatory mediators and endothelial function in a cohort of
      patients undergoing lower extremity arterial reconstruction with autogenous vein.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Vascular Surgery clinic
      
Biospecimen description: 
      A segment of vein that would usually be discarded will be taken to a lab for testing of
      endothelial reactivity and quantification of endothelial coverage through CD31 staining.
Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI
Condition: Subacute/Chronic Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate
      dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed
      enhancement cardiac Magnetic Resonance Imaging
    


Intervention name(s): Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)
Intervention type(s): Other
Intervention description(s): Other (Diagnostic)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Tiotropium Respimat Versus HandiHaler on SaO2 and Sleep in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study was to compare the tiotropium Respimat Soft Mist Inhaler and the
      HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality
      in patients with COPD.
    

Detailed description: 
      Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a
      result of various alterations in oxygenation parameters and sleep macro- and
      micro-architecture. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the
      HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality
      in patients with COPD. In a randomized, parallel-group trial involving 200 patients with mild
      to moderate COPD (resting arterial oxygen tension >60 mmHg while awake), we compared the
      effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality.
    

Intervention name(s): tiotropium; Handihaler; Respimat
Intervention type(s): Drug; Device; Device
Intervention description(s): Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.; Inhalation via the HandiHaler once daily; Inhalation via the Respimat once daily
Other intervention name(s): Spiriva
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic obstructive pulmonary disease; sleeping oxygen saturation; sleep quality
A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral
      efficacy of the PGDM1400 and PGT121 and VRC07-523LS mAbs for HIV prevention and therapy.
    

Detailed description: 
      This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral
      efficacy of the PGDM1400, PGT121 and VRC07-523LS mAbs for HIV prevention and therapy.
      PGDM1400, PGT121 and VRC07-523LS mAbs are recombinant human IgG1 monoclonal antibodies that
      target V1V2 (PGDM1400), a V3 glycan-dependent epitope (PGT121) and the CD4 binding site
      (VRC07-523LS) epitope region of the HIV envelope protein. PGT121, PGDM1400 and VRC07-523LS
      mAb were chosen for this study because of their potency, their ability to neutralize a wide
      array of cross-clade HIV viruses in a complementary pattern and their proven antiviral
      activity in animal studies e.g., their capacity to robustly prevent and treat simian-human
      immunodeficiency virus (SHIV) in rhesus monkeys.
    

Intervention name(s): PGDM1400/Placebo (3mg/kg IV); PGDM1400/Placebo (10mg/kg IV); PGDM1400/Placebo (30mg/kg IV); PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV); PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV); PGDM1400 + PGT121/Placebo (30mg/kg + 30mg/kg IV); PGDM1400 + PGT121 + VRC07-523LS (20mg/kg + 20mg/kg + 20 mg/kg IV); PGDM1400 + PGT121 (MTD IV)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3/1 (6/2 if DLT); 3/1 (6/2 if DLT); 3/1 (6/2 if DLT); 3/1 (6/2 if DLT); 3/1 (6/2 if DLT);; 3/1 (6/2 if DLT); 3 (max 9); 3 (max 9)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Histological Outcome of the Use of Different Biomaterials for Fresh Socket Regeneration. A Split-mouth Design
Condition: Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      Purpose: The aim of this study was to analyze the quality of bone regeneration in fresh
      sockets using four different materials and at different times points.

      Materials and Methods: A split-mouth clinical trial was designed to evaluate the histological
      and histomorphometrical characteristics of fresh sockets from 30 patients. One socket per
      patient will healed spontaneously (control) and, at least, one fresh socket, will be grafted
      with platelet-rich growth factor (PRGF), PRGF+autologous bone, autologous bone or
      PRGF+demineralized freeze dried bone allograft (DFDBA). The day of the implant placement,
      biopsies will be taken at different time points divided into three assessment groups: short
      duration (2-4 months), intermediate duration (5-6 months) and long duration (7-12 months).
      The histologic findings will be assessed to quantify the trabeculae pattern, the degree of
      mineralization and the quality of bone regeneration.
    


Intervention name(s): dental socket regeneration
Intervention type(s): Procedure
Intervention description(s): after a dental extraction the fresh socket is filled with graft materials and compared with the spontaneous healing (control)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment