bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of a Plant Protein Isolate on Muscle Protein Synthesis in Humans at Rest and After Resistance Exercise
Condition: Metabolism; Exercise; Dietary Supplements
Study type: Interventional

Summary: 
      Plant-based proteins contain several amino acids that are essential to signal growth,
      reconditioning, maintenance and preservation of skeletal muscle mass. This study aims to
      inform on the nutrient activation of muscle protein synthesis (MPS) by feeding a plant
      protein isolate equivalent to 0.33 g of protein per kilogram of body mass.
    

Detailed description: 
      Participants: 32 young, healthy men and women aged 18 - 35 years. Intervention: Plant protein
      isolate (PPI) and nonessential amino acid control (NEAA) Study Design: Block randomised
      control trial. Two group parallel design. Primary outcome: Myofibrillar fractional synthetic
      rate (myoFSR).

      Preliminary screening/familiarization consists of: medical history, dietary assessment and
      examination by a medical doctor and a qualified dietician, blood sample to be evaluated for
      health-related contraindications, body composition measurement by dual energy x-ray
      absorptiometry (DXA), isokinetic knee extensor strength tests.

      Pre-trial: A metered dose of deuterium oxide (5ml/kg) will be ingested and blood and/or
      saliva (~5ml) samples will be collected pre/post ingestion.

      Experimental trial: Blood, saliva and bilateral m.vastus lateralis microbiopsies (~100 mg)
      collected. A unilateral resistance-training session consisting of knee extensor contractions
      will be completed. Following exercise cessation participants will ingest 0.33 g/kg body mass
      of either: a nonessential amino acid formulation or a plant-protein isolate. A saliva sample
      and a 2nd set of bilateral m.vastus lateralis microbiopsies are collected 3 h postingestion.
    

Intervention name(s): NEAA; PPI
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Food grade mixture of non-essential amino acids in powdered form to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland; Food grade plant (legume - Fava) protein isolate to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland
Other intervention name(s): Plant Protein Isolate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Block randomized control trial, parallel group design
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: amino acids; deuterium oxide; humans; protein synthesis; plant proteins; resistance training; skeletal muscle
Time-limited Specific Oral Tolerance Induction in Children With Severe Egg Allergy
Condition: - Egg Hypersensitivity
MeSH terms: Hypersensitivity; Egg Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the efficacy of a 6-month specific oral tolerance induction (SOTI) protocol in
      inducing tolerance (maximal dose of raw egg emulsion tolerated) in children with severe
      IgE-mediated egg allergy and a history of at least 1 anaphylactic reaction after accidental
      exposure to egg.
    

Detailed description: 
      Oral immunotherapy consisted in the administration of increasing amounts of raw emulsion egg.
      The children started with 1 drop of undiluted raw egg emulsion (0.05 ml) flavored with
      vanilla and cacao, hidden by the parents in the child's breakfast (cow's milk, soymilk, fruit
      juice or other). The dose was doubled at intervals of about one month in the day hospital.
      The increases in dose were customized for each subject based on the frequency and severity of
      side effects, or when an inter-current illness or asthma worsening intervened during the
      SOTI.

      The investigators limited the SOTI protocol to six months for all patients, irrespective of
      the dose reached, in order to favor the adherence of families to the study.

      When objective symptoms seemed more important (grade 2, 3 and 4 reaction), medical treatment
      was given. Subjects were discontinued from the study in case of severe adverse reactions
      (grade 5 reaction). Parents were advised they could telephone investigators 24 hours a day
    

Intervention name(s): Specific oral tolerance induction
Intervention type(s): Other
Intervention description(s): Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg
Other intervention name(s): SOTI
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Egg allergy,specific oral tolerance induction
Liposomal Sirolimus in Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Dry eye disease is a very frequent pathology that importantly affects the quality of life of
      patients; in spite of the common use of eye lubricants to ameliorate symptoms, there is still
      a large number of patients who do not present improvement of the disease or they worsen.
      Although its etiology is varied, the imbalance of the immune system plays a substantial role
      in the development of dry eye disease. Rapamycin or sirolimus is an anti-inflammatory and
      immunomodulatory drug that has an enormous potential in ocular surface pathologies such as
      dry eye disease. The aim of the present study is to determine the effectiveness and security
      of subconjunctival application of a new formulated drug of liposomal sirolimus in patients
      with moderate and severe dry eye disease. This is a randomized placebo-controlled double
      blind clinical trial. Patients presenting data of moderate or severe dry eye disease will be
      randomized into two groups. One group will receive additional to the conventional treatment,
      subconjunctival injections of liposomal sirolimus; meanwhile the other group will receive
      subconjunctival placebo injections. After intervention the effectiveness and the security of
      the liposomal sirolimus will be evaluated.
    


Intervention name(s): Liposomal Sirolimus
Intervention type(s): Drug
Intervention description(s): Subconjunctival injections of liposomal sirolimus in patients with conventional treatment with moderate and severe dry deye disease
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Sirolimus; Liposomal; Subconjunctival
Phase Ia Dose-Escalation Safety, Pharmacodynamic and Pharmacokinetic Study of Imprime PGG™ Injection
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to the assess the safety, pharmacodynamics, and pharmacokinetics
      of escalating doses of Imprime PGG™ Injection in healthy volunteers.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and tolerability of a single
      intravenous dose of Imprime PGG versus placebo when administered to healthy adult subjects by
      assessing the frequency, type, and severity of treatment emergent adverse events.

      The secondary objectives are:

        1. to determine the pharmacodynamics of a single intravenous dose of Imprime PGG when
           administered to healthy adult subjects by assessing the number of subjects who
           experience a 15% or more increase from baseline in the percentage of neutrophils with
           primed CR3; and

        2. to derive the pharmacokinetic profile of a single intravenous dose of Imprime PGG when
           administered to healthy adult subjects by assessing the plasma concentration of Imprime
           PGG versus time.
    

Intervention name(s): Imprime PGG
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Healthy Volunteers
Umbilical Cord Blood Mononuclear Cell Transplant to Treat Chronic Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the feasibility, safety, efficacy and optimal
      dose of umbilical cord blood mononuclear cell transplant in the treatment of chronic spinal
      cord injuries.
    

Detailed description: 
      This is an open-label dose-escalating clinical trial. 20 patients will be randomly divided
      into 5 groups, 4 patient per group. The first three groups of four patients will receive
      transplants of increasing dose of HLA-matched umbilical cord blood mononuclear cells,
      starting from 4 spinal cord injection of 4µL of cell suspensions in Group A to 8µL in Group B
      and 16µL in Group C. If more than one subjects show neurological loss attributable to the
      cell injections, the trial will fall back to the previous dose. In the Group D, the highest
      volume of cells that do not cause neurological deficits (e.g. 16µL x4) along with a single
      bolus of 30 mg/kg methylprednisolone sodium succinate (MPSS) will be provided. Subjects in
      the Group E receive the same treatment as Group D plus a 6-week course of oral lithium
      carbonate. All subjects will enroll for three months intensive rehabilitation after the cell
      transplant.
    

Intervention name(s): Umbilical Cord Blood Mononuclear Cell; Methylprednisolone; Lithium Carbonate Tablet
Intervention type(s): Biological; Biological; Drug
Intervention description(s): 30mg/kg i.v. methylprednisolone; 6 weeks
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Lithium Carbonate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury; umbilical cord blood mononuclear cell; lithium carbonate
Association Between Mother-Infant Attunement During Interaction and the Quality of General Movements
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Observational [Patient Registry]

Summary: 
      The proposed research has the potential of contributing to the limited empirical literature
      on the relationship between maternal sensitivity and motor development of preterm infants. If
      indeed maternal attuned behaviors will be found to be associated with the quality of motor
      development, such a finding will support the effectiveness of physical therapy in guiding
      caregivers to attune their holding and touch of preterm infants.

      We hypothesize that mothers and infants' attunement during observed interaction will be
      related to the quality of preterm infants' spontaneous movements in the following ways:
      First, better maternal attunement to the infants needs, and in particular attunement of
      holding and touch will be associated with better quality of spontaneous movements of the
      infants. Second, more initiations and/or involvement of infants in interaction will be
      associated with better maternal attunement to the infant. Third, more initiations and/or
      involvement of infants in interaction will be associated with better quality of spontaneous
      movements and better achievements in developmental milestone. All hypotheses will be examined
      while controlling for maternal use of SSC method during hospitalization after birth and
      family demographic backgrounds.
    

Detailed description: 
      Sixty preterm infants at 3-4 months of corrected age and their mothers will be recruited.
      Infants will be evaluated for their spontaneous movements and their developmental milestones
      achievement, and mothers and infants will be evaluated for their attunement during observed
      interaction, especially on maternal attunement in holding and touching their infants. Mothers
      will report on demographic background of the family, temperament of their infants and
      previous Skin to Skin Contact treatment in the Neonatal Intensive Care Unit.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Preterm infants at a corrected age of 3-4 months and their mothers
      
Keywords: mother-infant interaction; general movements; preterm infants
A Multiple-Dose Study to Evaluate MK-1075 in Hepatitis C Virus (HCV) Infected Participants (MK-1075-004)
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to
      suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose
      administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and
      well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction
      is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration
      of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.
    


Intervention name(s): 200 mg MK-1075; 400 mg MK-1075; 800 mg MK-1075
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days; Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days; Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Rimonabant on Walking Abilities in Incomplete Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomized placebo-controlled safety and feasibility study with crossover design (3 arms).
      Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory
      efficacy will be tested using six-min walking test.
    

Detailed description: 
      Randomized placebo-controlled safety and feasibility study with crossover design (3 arms).
      Placebo or Rimonabant 2.5mg or Rimonabant 5mg will be administered for 5 days. Exploratory
      efficacy will be tested using six-min walking test.

      Main goal is to test safety of Rimonabant in a specific population (incomplete spinal cord
      injury).
    

Intervention name(s): Rimonabant
Intervention type(s): Drug
Intervention description(s): Rimonabant
Intervention MeSH terms: Rimonabant
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized crossover study with three arms
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal cord injury; Walking endurance; Incomplete SCI; Traumatic
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants
Condition: Central Nervous System (CNS) Demyelinating Disease; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Demyelinating Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the safety and tolerability of a single dose
      and multiple doses of BIIB033 administered to healthy adult Japanese participants. The
      secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of
      BIIB033 administered as single and multiple doses in healthy adult Japanese participants and
      to assess the single-dose and multiple-dose immunogenicity of BIIB033.
    


Intervention name(s): BIIB033; Placebo
Intervention type(s): Biological; Other
Intervention description(s): single or multiple dose; single or multiple dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Japanese; Single Ascending Dose (SAD); Multiple Ascending Dose (MAD)
Call- Associated Acute Fatigue in Surgical Residency
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Observational

Summary: 
      The study aimed to evaluate the effects of 24-Hour-Call-associated acute partial sleep
      deprivation on surgical residents' technical and cognitive performance in a virtual reality
      (VR) setting. Physiological parameters were used to quantify fatigue in respect to hours of
      sleep and subjective degrees of sleepiness. Technical performance and cognitive skills were
      assessed through low- and high fidelity tasks usig the VR- simulator LapSim. Objective
      alertness was measured by the standardized d2-Paper-Pencil-Test. Cited assessments were
      performed on three consecutive mornings- pre- and post-call as after 24 hours resting.
    

Detailed description: 
      Summary Background Data:

      The effect of acute partial sleep deprivation on surgical proficiency is still
      controversially discussed. The present study is the first to measure objective physiological
      parameters of fatigue in respect to subjective perceptions of sleepiness in VR- research of
      surgical performance.

      Methods:

      38 surgeons were explored on three consecutive mornings: prior to a 24-Hour- Call, post-call
      and after 24 hours resting. Hours of sleep were recorded. Subjective alertness was assessed
      using the standardized Stanford-Sleepiness-Scale (SSS). Saliva cortisol concentrations and
      pupillary activity were measured by ELISA and pupillography. The VR-simulator LapSim® was
      used to assess technical skills through defined low- fidelity VR-tasks "cutting", "clip
      applying" and cognitive skills through defined high-fidelity VR-tasks "intracorporal
      suturing", "VR-cholecystectomy". Objective alertness was measured by the standardized
      d2-Paper-Pencil-Test.
    

Intervention name(s): 24-Hour-Call
Intervention type(s): Other
Intervention description(s): one 24-Hour-Call within the regular surgical schedule
Other intervention name(s): LapSim
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        -  38 surgeons (20 male, 18 female)

          -  4 senior registrars, 15 junior registrars, 19 interns

          -  age 24-48 years; mean 30 years
      
Keywords: sleep-deprivation; virtual reality; residency; performance
Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
Condition: Surgery; Acute Phase Reaction
MeSH terms: Neuroinflammatory Diseases; Acute-Phase Reaction; Cognitive Dysfunction
Study type: Observational

Summary: 
      The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within
      48 hours after elective hip or knee surgery and that there is an association between
      exaggerated CNS inflammatory response or impaired inflammatory resolution and postoperative
      cognitive dysfunction within one week and at three months postoperatively.
    

Detailed description: 
      Patients at 50-85 years of age undergoing orthopedic surgery will be investigated in the
      perioperative period to detect signs of neuroinflammation using serial CSF and blood sampling
      for 48 hours in combination with cognitive testing preoperatively, at 3-7 days and after 3
      months.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        34 elective orthopedic patients undergoing hip or knee arthroplasty
      
Biospecimen description: 
      CSF and blood
Integrated vs Sequential Treatment for PTSD and Addiction
Condition: PTSD; Substance Addiction
MeSH terms: Substance-Related Disorders; Behavior, Addictive
Study type: Interventional

Summary: 
      The investigators are examining different treatment strategies of helping patients with PTSD
      and addiction.
    

Detailed description: 
      The investigators hypothesize that Veterans in the integrated conditions will show greater
      reductions in substance abuse and PTSD symptom severity at the end of treatment and at 6 and
      9 month follow-ups. The investigators further hypothesize that offering Veterans Prolonged
      Exposure (PE) at the onset of treatment in the integrated condition will leader to greater
      retention and satisfaction than in the sequential treatment design.
    

Intervention name(s): Prolonged Exposure; Motivational Enhancement Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders.; Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment; PTSD; Addiction
Dermacyd Silver Floral (Lactic Acid) - Compatibility.
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To demonstrate the absence of irritation potential (primary dermic irritability and cumulated
      dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Floral
    


Intervention name(s): LACTIC ACID(ND)
Intervention type(s): Drug
Intervention description(s): Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative for 6 weeks.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
hCG Supplementation in Frozen-Thawed Embryo Transfer Cycle
Condition: Fertility Agents, Female
Study type: Interventional
Phase: Phase 2

Summary: 
      The implantation rate after frozen-thawed embryo transfer cycles depends mostly on the
      receptivity of the endometrium and the embryo quality.The effects of human chorionic
      gonadotropins (hCG) on the endometrium have been investigated for several years. hCG was
      shown to up-regulate gene expression during the differentiation of human endometrial stromal
      cells into decidua. The aim of our study was to assess the benefit of hCG supplementation
      throughout the secretory phase of artificial frozen-thawed embryo transfer cycles.
    


Intervention name(s): s.c. human chorionic gonadotropin (Ovitrelle)
Intervention type(s): Drug
Intervention description(s): S.C. Ovitrelle 250 mcg once
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: In-Vitro Fertilization; human chorionic gonadotropin; frozen-thawed embryo transfer; implantation rate