bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Novel Supplement on Glycemic Variability Measured by Continuous Glucose Monitoring
Condition: Healthy
Study type: Interventional

Summary: 
      This is a two-cohort, crossover pilot study to determine interstitial glucose levels
      coincident with the consumption of a novel carbohydrate blocking supplement.
    

Detailed description: 
      This two-cohort study will evaluate a novel supplement developed for metabolic support using
      measures of glycemic variability, fasting glucose, and fasting insulin. In the first cohort,
      over the course of two weeks, these endpoints will be determined by continuous glucose
      monitoring (CGM) and blood/urine analyses in healthy adults using a carbohydrate blocking
      supplement (CBS). Following an interim analysis, the CBS will be evaluated for an additional
      two months in healthy volunteers using the same measures outlined above.
    

Intervention name(s): Carbohydrate blocking supplement (CBS); Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The CBS is composed of a Hypromellose outer shell, and filled with mulberry leaf extract, berberine HCl, cinnamon bark powder, and cinnamon bark essential oil.
Mulberry leaf extract (Reducose) - 250 mg Berberine HCl (97%)(Berberis aristata root extract)- 25 mg Organic cinnamon powder (Cinnamon (Cinnamomum loureirii) bark powder) - 20 mg Essential oil blend (Grapefruit (Citrus paradisii) peel oil, Lemon (Citrus limon) peel oil Peppermint (Mentha piperita) aerial (leaf/stem) oil), Ginger (Zingiber officinale) root oil, Cinnamon (Cinnamomum zeylanicum) bark oil) - 5 mg; The placebo is composed of a Hypromellose outer shell filled with extra virgin olive oil.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Carbohydrate blocking supplement; Continuous Glucose Monitoring; Interstitial glucose levels
Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19
Condition: Covid19; Vertical Transmission of Infectious Disease; Neonatal Infection; Pregnancy Related
MeSH terms: COVID-19; Communicable Diseases; Infections
Study type: Observational

Summary: 
      A case-control trial was conducted to test the early postpartum period clinical outcomes of
      newborns born to pregnant women with and without COVID-19.
    


Intervention name(s): Reviewed clinical records and laboratory results
Intervention type(s): Diagnostic Test
Intervention description(s): Retrospectively reviewed clinical records and laboratory results
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Newborns born to pregnant women with and without COVID-19 at Denizli State Hospital between
        March 11, 2020 - March 11, 2021.
      
Keywords: Childbirth; COVID-19; Neonatal outcomes; Newborn; Pregnant women; Vertical transmission
The Nutritional Effect of Parental Use of Food as a Reward
Condition: Children's Nutrition Intake
Study type: Observational

Summary: 
      Control rules are common parental practices that use food as reward to encourage children to
      conduct parents' preferred behaviors. This field observational study aims to examine whether
      control rules are associated with children's increased fat, carbohydrate and total energy
      intake in everyday eating, and whether this effect is moderated by individual differences in
      sensitivity to reward, and by gender differences.
    

Detailed description: 
      Control rules are parental practices that use food as an instrumental reinforcer to encourage
      children to behave in a normative manner in non-food domains. Since food high in fat or sugar
      is usually chosen as a reinforcer for control rules, these rules may lead to children's
      increased preference and every day intake of food high in sugar/fat. Research propositions
      were examined in 207 six to twelve-year-old children (97 boys and 110 girls). Their parents
      reported the children's everyday dietary intake through a food frequency questionnaire, and
      provided information regarding the children's sensitivity to rewards as well as an indication
      of how frequently they enforce family control rules.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The parents or guardians of 207 children (97 boys and 110 girls) aged from 6 to 12 (M=8.98,
        SD=1.67) completed the study. Participants were recruited from metropolitan Montreal,
        Canada.
      
Keywords: children dietary pattern; control rules; instrumental learning; food reinforcement
OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Condition: Pain; Cancer
MeSH terms: Breakthrough Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent
      fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid
      tolerant.
    

Detailed description: 
      The objective of this study is to determine the tolerability and safety of OraVescent
      fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.
    

Intervention name(s): OraVescent fentanyl citrate
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Pain
Comparing Analgesic Effects of Caudal and Erector Spinae Plane Blocks in Pediatrics Undergoing Upper Abdominal Surgery
Condition: Anesthesia, Local
Study type: Interventional

Summary: 
      Upper abdominal surgeries are painful and pediatric patients who undergo these operations
      require effective postoperative pain control. Epidural and caudal blocks are considered to be
      the gold standard regional analgesia techniques. Currently, ultrasound guidance is commonly
      used for caudal block performances to demonstrate the cannula placement and the deposition of
      local anesthetic. Additionally, erector spinae plane block can be a safer alternative for
      blocking the similar dermatomes. In this study, the aim is to compare postoperative analgesic
      effects of these two ultrasound-guided techniques in pediatric patients. The primary outcome
      of this study is the follow-up of FLACC/VAS pain scores. Secondary outcomes are time to first
      analgesic requirement, number of patients who require rescue analgesic, possible side
      effects, time to first mobilization, length of hospital stay and chronic pain due to incision
      after 2 months.
    

Detailed description: 
      Upper abdominal surgeries are painful and pediatric patients who undergo these operations
      require effective postoperative pain control. Blockade of dermatomes between T6 and L1
      commonly provides effective postoperative analgesia. Epidural and caudal blocks are
      considered to be the gold standard regional analgesia techniques as they provide both somatic
      and visceral analgesia. Currently, ultrasound guidance is commonly used for caudal block
      performances to demonstrate the cannula placement and the deposition of local anesthetic.
      Additionally, erector spinae plane block can be a safer alternative for blocking the similar
      dermatomes. In the present study, the aim is to compare postoperative analgesic effects of
      these two ultrasound-guided techniques in pediatric patients undergoing upper abdominal
      surgery. The primary outcome of this study is the follow-up of FLACC/VAS pain scores.
      Secondary outcomes are time to first analgesic requirement, number of patients who require
      rescue analgesic, possible side effects (nausea, vomiting, itching, urinary retention,
      bradycardia, hypotension, respiratory depression), time to first mobilization, length of
      hospital stay and chronic pain due to incision after 2 months.
    

Intervention name(s): Bupivacaine 0.7 ml/kg; Bupivacaine 0.5 ml/kg
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine 0.25% 0.7 ml/kg; Bupivacaine 0.25% 0.5 ml/kg
Other intervention name(s): Marcaine; Marcaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RANDOMISED DOUBLE BLINDED INTERVENTIONAL
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Erector Spinae Plane Block; Caudal Block; Ultrasound guidance; Postoperative analgesia; Upper abdominal surgery
Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.
Condition: NASH
Study type: Interventional
Phase: Phase 1

Summary: 
      A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of
      concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam,
      caffeine, and rosuvastatin in healthy human volunteers.
    


Intervention name(s): Midazolam; Caffeine; Rosuvastatin; EDP-305
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each subject will receive midazolam on Days 1 and 12.; Each subject will receive caffeine on Days 1 and 12.; Each subject will receive rosuvastatin on Days 2 and 13.; Each subject will receive EDP-305 on Days 5 through 15.
Intervention MeSH terms: Midazolam; Caffeine; Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: drug-drug interaction
Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare
      the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge
      model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety
      profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.

      The aim of this study is to compare the effect, safety and tolerability of 14 days treatment
      with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.
    


Intervention name(s): BLX-028914; BLX-028914; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg capsules, p.o, daily, 14 days; 15 mg capsules, p.o, daily, 14 days; capsules, p.o, daily, 14 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg Syndrome
Condition: Restless Legs Syndrome; Pregnancy Related; Sleep Disorder
MeSH terms: Sleep Wake Disorders; Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of this project is to determine the effect of compression stockings on the
      complaints, well-being and sleep quality of pregnant women with restless legs syndrome (RLS).
      The research is a pretest-posttest randomized placebo-controlled experimental study. The
      study will be carried out with a total of 70 people, 35 in the compression stocking group and
      35 in the placebo stocking group. Study data will be collected with RLS Diagnostic Criteria
      Questionnaire Form, Research Criteria Compliance Form, Personal Information Form, RLS
      Severity Rating Scale, Pittsburgh Sleep Quality Index (PUKI), WHO-5 and Implementation
      Satisfaction Form. Pregnant women in both groups will wear the stockings given for three
      weeks after the first interview.

      Data analysis obtained in the research will be performed in TURCOSA statistical software
      (Turcosa Analytics Ltd Co, Turkey, www.turcosa.com.tr).In comparisons, a value of p <0.05
      will be considered statistically significant. In order to conduct the study, the necessary
      Academic Committee decision, Ethics Committee approval (December 08, 2021 and number
      2021/781) and institutional permission were obtained. The individuals included in the study
      will be informed about the purpose of the research, their verbal consent will be obtained and
      the participant's informed consent form will be signed.
    


Intervention name(s): Compression stocks; Knee socks
Intervention type(s): Device; Other
Intervention description(s): Pregnant women in the compression stockings group will wear the socks given for 3 weeks.; Pregnant women in the Knee socks group will wear the socks given for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS) Trial
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I)
      slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study
      participants will be followed for 2 years once enrolled. They will receive either placebo or
      the active IGF-I. Examinations will take place at approximately 6-month intervals.
    

Detailed description: 
      The objective of this trial was to determine whether IGF-1 (MyotrophinTM) slows progression
      of weakness in amyotrophic lateral sclerosis (ALS). Three hundred thirty patients with ALS
      from 20 medical centers participated in this double blind, placebo-controlled two-year study.
      Half the patients received IGF-1 and the other half received placebo. The drug will be
      administered twice a day.

      ALS is a neurodegenerative disorder that causes progressive muscle weakness and loss of motor
      neurons. IGF-1 is a neurotrophic factor essential for normal development of the nervous
      system and shows protection of motor neurons in animal models and cell culture systems. It is
      thought to block cell death pathways and promote muscle re-innervation and axonal growth and
      regeneration.
    

Intervention name(s): Insulin like growth factor, type 1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.05 mg per kg body weight given subcutaneously twice daily; The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.
Other intervention name(s): Mycotrophin
Intervention MeSH terms: Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: amyotrophic lateral sclerosis; ALS; progressive weakness; insulin-like growth factor-1; IGF-I; Myotrophin
Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine
Condition: Panic Disorder; Agoraphobia
MeSH terms: Panic Disorder; Agoraphobia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine whether clonazepam and paroxetine are effective in
      the treatment of panic disorder. Efficacy was evaluated in short-term, long-term and
      post-treatment.
    

Detailed description: 
      The current study consisted of three steps. The first step was a naturalistic, prospective,
      randomized, open clinical trial with clonazepam and paroxetine. Subjects received either
      flexible dose clonazepam (0.5 - 2 mg/day) or paroxetine (10 - 40 mg/day), in monotherapy for
      eight weeks. In the second step, those who responded to monotherapy in the short-term study
      continued with the same drug and dose. Partial responders or non-responders were invited to
      receive combined pharmacological treatment with clonazepam and paroxetine. Patients received
      the maximum tolerated doses of clonazepam and paroxetine. The doses were flexible, ranging
      from 0.5 to 2 mg/day for clonazepam and from 10 to 40 mg/day of paroxetine. All patients were
      treated for 34 months in the second step. Patients who completed the second step and were in
      remission were included in the third step. For a period of four months all medications were
      tapered off. These patients were followed for 6 years with evaluations once a year. Those who
      relapsed were treated on a naturalistic basis, with drugs or psychotherapy.

      This study was conducted in accordance with the ethical principles established by the
      Declaration of Helsinki and the Brazilian National Ethics Committee (Conselho Nacional de
      Ética em Pesquisa - CONEP) guidelines. The local Ethics Committee approved the study
      protocol. Written informed consent was obtained from all patients.
    

Intervention name(s): Clonazepam; Paroxetine
Intervention type(s): Drug; Drug
Intervention description(s): Administration of clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 36 months. If no remission after 8 weeks augmentation with paroxetine once a day, flexible dose (10 - 40 mg/day), for 34 months.; Administration of paroxetine once a day, flexible dose (10 - 40 mg/day), for 36 months. If no remission after 8 weeks augmentation with clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 34 months.
Intervention MeSH terms: Clonazepam; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: panic disorder; agoraphobia; clonazepam; paroxetine
Low Versus Moderate-intensity Aerobic Training in Post-discharge COVID-19 Subjects
Condition: COVID-19; Aerobic Exercises; Elderly
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The main purpose of this study is to compare the impact of low versus moderate-intensity
      aerobic training in post-COVID 19 older subjects.

      On exercise adherence and changes in physical fitness, psychological status, and quality of
      life after a 10-week intervention.
    


Intervention name(s): aerobic exercise
Intervention type(s): Other
Intervention description(s): participants will perform different dosage of the same intervention, one group will perform moderate intensity and the other will perform low intensity aerobic training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Hypnosis Versus General Anesthesia in Pediatric Surgery: Clinical and Medico-economic Interests
Condition: Minimally Invasive Surgery
Study type: Interventional

Summary: 
      In adults, it is common to perform a number of superficial and non invasive surgeries under
      local anesthesia in order to limit the use of general anesthesia.

      Hypnosis is a nonpharmacological therapies that can be used during surgery to improve the
      patient comfort and experience. The benefit of this practice has been widely demonstrated in
      adults, decreasing perioperative anxiety, postoperative pain scores as well as nausea and
      vomiting.

      In pediatric surgery, hypnosis is an effective technique for the management of preoperative
      anxiety. It is used by many teams in their daily practice, particularly during anesthetic
      induction.

      For 2 years, the team of pediatric anesthesia and surgery of the Montpellier University
      Hospital also offers for selected short and superficial non-invasive surgeries, an
      intraoperative management under hypnosis in association with ocal anesthesia as an
      alternative to general anesthesia. If this clinical practice of hypnosis is fully accepted
      and recognized in our intraoperative surgical unit, to date, no studies have evaluated the
      benefits of this technique compared to general anesthesia.

      The objective of the study is to compare the impact of these techniques (hypnosis vs. general
      anesthesia) on postoperative experiences of children (rehabilitation time, anxiety, pain,
      nausea and vomiting, negative behavioral disorders).
    


Intervention name(s): Local anesthetic + Hypnosis; General anesthesia
Intervention type(s): Other; Drug
Intervention description(s): Modified state of consciousness allowing to be at the same time here and somewhere else. The individual is going to dive into his imagination to extract of an uncomfortable situation. And local anesthetic (solution of Xylocaine with adrenaline 1 % dabbed in 20 % of bicarbonate of sodium 4,2 %, maximal dose of 0,5ml / kg); Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Keywords: Hypnosis; Pediatric surgery; Anesthesia
SMA Flow Patterns in Neonatal Transfusion
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Observational

Summary: 
      This study aims to measure the changes induced by packed red blood cell (PRBC) transfusion in
      the superior mesenteric artery (SMA) flow velocity and intestinal oxygenation indices in
      premature neonates. These changes will be measured in relation to feeding, before and after a
      blood transfusion. Overall reduction of intestinal perfusion is a risk factor for necrotizing
      enterocolitis (NEC) - a condition with significant mortality and long term morbidity.
      Identifying specific patterns of flow velocity and tissue oxygenation changes will allow for
      planning, studying and implementing risk avoidance and minimization strategies.
    

Detailed description: 
      Hypothesis: In preterm neonates the anticipated physiologic post-prandial increase in each
      SMA flow and intestinal perfusion is blunted post transfusion. This is worse in SGA infants
      and/or in the presence of a PDA.

      Questions: 1) Does PRBC transfusion alter postprandial SMA flow increases and intestinal
      oxygenation indices in preterm infants receiving enteral feeds? 2) Is there a difference in
      postprandial SMA flow and intestinal perfusion changes in recently transfused SGA infants
      compared to AGA infants, and in those with and without a PDA? Primary Outcome: Post-prandial
      SMA flows changes before and after PRBC transfusion.

      Secondary outcomes: Pre-post prandial changes in near-infrared spectroscopy (NIRS)-measured
      intestinal oxygenation parameters before and after PRBC transfusion.
    

Intervention name(s): Observational Study
Intervention type(s): Other
Intervention description(s): Ultrasound and NIRS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prematurity (<34 completed weeks of gestation at birth) Need for PRBC transfusion