bioihbjkbjnl/mcl2 huggingface dataset:
An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
Condition: Anxiety; Stress; Memory Deficits; Cortisol Overproduction
MeSH terms: Memory Disorders; Adrenocortical Hyperfunction
Study type: Interventional

Summary: 
      The Smart Supplement has 20 vitamins and minerals that have strong track records of
      demonstrating positive health effects, both physiologically and cognitively. This twelve-week
      trial will examine the effectiveness and efficacy of Heights Smart Supplement on both
      biomarkers and subjective experiences from participants.
    


Intervention name(s): Heights Smart Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): The ingredient list of the product includes the following:
Algae oil Blueberry Extract Methylcobalamin (Vitamin B12) Cholecalciferol (Vitamin D3) Ascorbic acid (Vitamin C) Retinol acetate (Vitamin A) Calcium L-methylfolate (Folic Acid) D-biotin Pyridoxine hydrochloride (Vitamin B6) Calcium pantothenate (Vitamin B5) Nicotinamide (Vitamin B3) Riboflavin (Vitamin B2) Thiamine hydrochloride (Vitamin B1) D-Alpha tocopheryl acetate (Vitamin E) Chromium picolinate Potassium iodide Iron Citrate Sodium selenite Zinc citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: memory; stress; anxiety; mood; focus
Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability
      and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with
      periodontitis.
    

Detailed description: 
      Open-label, uncontrolled, single arm study to evaluate PerioSept® as adjunct to Scaling and
      Root Planing in Subjects with moderate to severe Periodontitis.

      Up to 12 adult subjects will be enrolled to obtain at least 10 evaluable subjects.

      4 study visits will take place for each enrolled subject (V1-V4 within 120 days). An
      additional optional follow-up visit (V5) at 6 Months might be added later on. On the baseline
      visit at Day 1 (V2) and if needed Day 2 (V2a) patients will undergo full mouth SRP followed
      by administration of PerioSept® 3% gel into gingival dental pockets. Treatment of PerioSept®
      3% (without SRP) will be repeated at V3.

      Eligible subjects must have a minimum of 4 qualifying target teeth defined as a tooth with at
      least one periodontal pocket with a probing pocket depth (PPD) >= 6mm and bleeding on probing
      (BOP) at baseline defined as study pockets. All study pockets will be treated with SRP and
      PerioSept®. Additional teeth identified by investigator as needing SRP per standard of care
      but not meeting target teeth criteria will be defined as non-target teeth/treatment sites and
      may also be treated with SRP and PerioSept®.

      Dental parameters will only be assessed on the target teeth and each of the 6 sites
      associated with these teeth (assessment sites). Thus, each eligible patient will have at
      least 4 Target teeth, a minimum of 4 study pockets and a minimum of 24 assessment sites (6
      sites per tooth x 4 target teeth, inclusive of the 4 study pockets) that will be assessed for
      all study outcome measures.

      Overall for all 10 evaluable patients there will be at least 40 target teeth, 40 study
      pockets and 240 sites for which the study outcome measures will be assessed as specified
      further below.

      Assessments will be conducted over a 12 weeks' and optional 24 weeks' (3 and 6 months
      respectively) period including safety assessments, assessments of dental parameters (PPD,
      Clinical attachment level, BOP, recession, Plaque index, Gingival Index) and tolerability
      assessment.
    

Intervention name(s): PerioSept(r)
Intervention type(s): Drug
Intervention description(s): Scaling and root planing followed by 3% PerioSept(r) administration
Other intervention name(s): Taurolidine
Intervention MeSH terms: Taurolidine
Intervention model: Single Group Assignment
Intervention model description: single arm, uncontrolled, open-label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontitis; taurolidine; PerioSept
Application of the Propofol Precise Infusion Model
Condition: Propofol Overdose of Undetermined Intent
MeSH terms: Drug Overdose
Study type: Observational

Summary: 
      Propofol is one of the most commonly used anesthetics in the world. However, the
      dose-response of propofol was remarkable variety. Herein, this study aims to investigate the
      possible association of gene polymorphism and propofol susceptibility, and to research more
      precise infusion model of this drug.
    

Detailed description: 
      Patients undergoing gastrointestinal endoscopy will be recruited. Anesthesia is induced with
      propofol via TCI at 1.5µg/ml, and increases 0.5µg/ml for every 3min until OAA/S score 0.
      During this period, OAA/S score will be evaluated every 1min until OAA/S score 0. At this
      moment, the blood concentration of propofol, the doses of propofol, the onset time and BIS
      are recorded, and blood sample for gene polymorphism detection were required.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): anesthesia induction is initiated with intravenous infusion propofol at 1.5µg/ml, and increased 0.5µg/ml every 3min until OAA/S score 0.
Other intervention name(s): Diprivan
Intervention MeSH terms: Propofol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients who will undergo gastrointestinal endoscopy with propofol
      
Biospecimen description: 
      whole blood sample
The Effect of Stevia Rebaudiana Extracts on Different Variables Related to Caries: an in Vitro and in Vivo Evaluation.
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the present investigation was to evaluate the effect of stevioside and
      rebaudioside on several variables related to caries development. Two approaches were
      performed: an in vitro evaluation of the growth of a culture of mutans streptococci and in
      vivo randomized study on the effect of a single rinse containing stevioside and rebaudioside
      on plaque-pH.
    


Intervention name(s): Effect of Stevioside and Rebaudioside on plaque pH
Intervention type(s): Dietary Supplement
Intervention description(s): After measuring baseline plaque pH, the subjects rinsed for 1 minute with the sucrose solution. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: dental caries; Stevioside; Rebaudioside; plaque pH; Streptococcus mutans
ACCeptation and Qualitative Evaluation of Phone-delivered Intervention
Condition: Suicide
MeSH terms: Suicide
Study type: Interventional

Summary: 
      Background: Previous suicide attempt is known to be a strong risk factor for repetition and
      repetition is common within the first year after an episode of deliberate self-harm (DSH).
      There has been growing interest in brief interventions for this population that are focused
      on maintaining long-term contact and/or offering re-engagement with services when needed.
      Despite telephone-delivered interventions have shown promising results in suicide reattempt
      prevention, subjective impact of such brief contact interventions and effectiveness
      mechanisms have never been evaluated.
    

Detailed description: 
      Semi-structured in-depth interviews with 20 patients previously receiving a
      telephone-delivered intervention from our team. Six weeks and 3 months after a DSH, people
      included in telephone-delivered process will be interviewed by a social science researcher.
      Qualitative analysis using thematic analysis will be independently performed by two
      researchers.
    

Intervention name(s): Semi-directed interview performed by a social sciences researcher
Intervention type(s): Behavioral
Intervention description(s): Two semi-directed interviews performed by social sciences researcher:
first interview performed 6 weeks after the suicide attempt, in an suicide prevention unit, duration 1 to 1.5 hour
second interview performed 3 month after the suicide attempt, in a suicide prevention unit, duration 1 to 1.5 hour
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: suicide; prevention
The Effect of 10 cm Catheter Mount on Malfunction of Capnometers Under the Conditions of Water
Condition: Cardiopulmonary Resuscitation; Pulmonary Edema; Hemorrhage
MeSH terms: Pulmonary Edema; Hemorrhage
Study type: Interventional

Summary: 
      Capnometer has been used to assess the success of intubation and the quality of
      cardiopulmonary resuscitation. However, capnometers can malfunction under the conditions such
      as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water.
      Investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of
      capnometers under the conditions of water.
    


Intervention name(s): No-DCCM; DCCM; Water 5ml in tracheal tube; Water 10ml in tracheal tube
Intervention type(s): Device; Device; Other; Other
Other intervention name(s): Proximal capnometer of DCCM; Abbreviation: DCCM, direct connect catheter mount; Distal capnometer of DCCM; Abbreviation: DCCM, direct connect catheter mount
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Capnography; Catheters; Intubation
Dosage of Epidural Morphine in Elderly Patients
Condition: Age Problem; Abdominal Cancer
MeSH terms: Abdominal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This a clinical trial that evaluates the efficacy and safety of three different doses of
      morphine, namely 1.5 mg, 3 mg and 4.5 mg, via the epidural route regarding reducing pain in
      elderly patients after a cancer surgery in the lower abdomen
    

Detailed description: 
      Acute postoperative pain is a common complaint for several days after surgery. However, acute
      postoperative pain remains even more under controlled in elderly patients, especially those
      with cognitive impairment and malignancy. Geriatric population is reported to be at higher
      risk for unwanted side effects from analgesic treatments compared to younger patients due to
      different major risk factors such as: decline in organ function, polypharmacy,
      pharmacokinetics, drug sensitivity, and frailty. Despite of the higher risk of opioids,
      especially morphine, causing toxicity and adverse effect; they are still the cornerstone
      treatment of severe acute postoperative pain. Morphine in those patients is very likely to
      cause toxicity because of accumulation of its active metabolites compared to other opioids
      with fewer or no active metabolites. Epidural morphine is an effective route for an effective
      drug. Furthermore, unwanted side effects with neuraxial opioids are minor and managed easily.
      Regarding clinical outcomes, clinical studies showed a lot of improvements associated with
      postoperative opioid analgesia. Now, there is a clinical necessity to achieve the best
      management of acute postoperative pain in elderly patients with the least possibility of
      adverse side effects. We aim in this randomized, assessor blinded, clinical trial at Assuit
      University to determine the optimum dose of epidural morphine for the highest control of
      acute postoperative pain in geriatrics who are planned to have lower abdominal cancer
      surgery.
    

Intervention name(s): 1.5 mg of Morphine Sulfate; Normal saline; 3 mg of Morphine Sulfate; 4.5 mg of Morphine Sulfate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.5 mg of Morphine Sulphate will be given epidurally.; Normal saline will be given epidurally.; 3 mg of Morphine Sulphate will be given epidurally.; 4.5 mg of Morphine Sulphate will be given epidurally.
Other intervention name(s): A; D; B; C
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Injections, Epidural; Morphine Sulfate
Exercise Training for the Treatment of Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of 6 weeks of endurance or strength
      training and a wait list comparison condition on symptoms of Generalized Anxiety Disorder
      (GAD).
    


Intervention name(s): Strength Training; Endurance Training
Intervention type(s): Other; Other
Intervention description(s): 6 weeks of strength training exercise sessions involving leg press, leg curl, and leg extension exercises twice weekly at an intensity progressing from 50% to 75% of predicted one-repetition maximum across the 6 weeks of the trial.; Six weeks of lower-body dynamic cycling exercise completed on an electronically-braked cycle ergometer twice weekly. The intervention will be matched to the strength training intervention on total work completed, total time actively engaged in exercise, a focus on leg muscles, and load (intensity) progression across the 6 week training protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder; Exercise Training; Strength Training; Mental Health
A Sleep Hygiene-based Intervention Program for Infants and Toddlers
Condition: Sleep
Study type: Interventional

Summary: 
      Sleep problems during infancy are associated with behavior and emotional problems, poor
      language development , parental distress and mood disturbances, and overweight and obese
      children. The investigators proposed that children who receive the light, activity, and sleep
      training (LAST) intervention program in this study will have less parent report of problem
      sleep behaviors and longer duration of nighttime sleep compared to children with no
      intervention provided.
    

Detailed description: 
      Sleep problems are reported in 71.65% of our nation's infants and toddlers, and the
      prevalence is much higher than the 20-30% reported in Western countries. The investigators'
      preliminary findings also show that approximately 53-55% of parents of children between 6 and
      12 months of age consider their child sleep a problem with about 4% not knowing whether their
      child sleep is a problem. Sleep development during infancy is characterized by increasing
      day-night differences in sleep-wakefulness such as longer bouts of sleep and fewer awakenings
      at night, and is driven by neurobiological maturation and environmental interactions. By 3
      months of age, nearly 58% of infants can sleep continuously between 24:00-05:00 hours. When
      infants do not sleep through the night by 17 months of age, they are less likely to be able
      to do so at 29 months of age and beyond. Without proper intervention, sleep problems during
      infancy can persist to toddler and preschool age. Various interventions have been developed
      and tested in Western and Asian Countries to address the sleep problems in infants and young
      children, but none are in Taiwan.
    

Intervention name(s): Sleep hygiene
Intervention type(s): Behavioral
Intervention description(s): LAST intervention (light, activity, and sleep training) consists of behavioral and educational strategies for increasing light exposure and physical activity, minimizing television viewing and reducing television viewing time to < 2 hours per day, and engaging activities suitable to the child's motor development to minimize sleep disturbance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sleep; Infants; Toddlers; Behavioral intervention
Stress Management and Resiliency Training for Depression vs Treatment as Usual in the Treatment of Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Researchers are trying to find out if a Stress Management and Resiliency Training (SMART-D)
      therapy will help with major depression treatment.
    


Intervention name(s): Stress Management and Resiliency Training for Depression (SMART-D) Therapy
Intervention type(s): Behavioral
Intervention description(s): 6 SMART-D group therapy sessions over 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Crystalloids Versus Colloids During Surgery
Condition: Fluid Overload; Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to test whether colloid-based goal-directed intraoperative fluid
      management leads to less perioperative morbidity compared to crystalloid-based goal-directed
      intraoperative fluid management. Goal-directed therapy is based on measurements by an
      Esophageal Doppler Device.
    

Detailed description: 
      For a long time there is a raging debate whether crystalloid solutions or colloid solutions
      are better suited for fluid therapy. Early proponents both for crystalloids [Shires 1961] and
      colloids [Shoemaker 1979] deserve credit for elucidating important facts about volume
      replacement therapy - without answering the primary question. Elaborate reviews comparing
      crystalloid and colloid therapy for critically ill patients have been performed in the late
      nineties and updated recently [Roberts 2004]. However, it has been suggested that both
      questions and answers of reviews leave us none but wiser [Webb 1999]. Although a plethora of
      studies comparing crystalloid vs. colloid therapy in the last decades have been published,
      volume replacement therapy is still considered to be based on dogma and personal beliefs
      [Boldt 2003].

      Goal-directed intraoperative fluid therapy monitored by Esophageal Doppler identifies
      volume-responders, thereby decreasing length of stay in hospital in orthopedic [Sinclair
      1997], cardiac [Mythen 1995], and abdominal surgery patients [Gan 2002, Wakeling 2005,
      Noblett 2006]. However, all these studies have been performed with a colloid to be the
      substance applied. Thus, it has been questioned whether monitoring with the Esophageal
      Doppler monitor, or the application of additional colloid improved outcome [Horowitz, Kumar
      2003].

      Consequently, the researchers will use Esophageal Doppler Monitoring for intraoperative
      goal-directed fluid therapy to compare the effects of crystalloid vs. colloid therapy on
      various organ systems, assessing combined perioperative morbidity [Bennett-Guerrero 1999] .
    

Intervention name(s): Lactated Ringer's Solution; Hydroxyethylstarch 6% 130/0.4
Intervention type(s): Drug; Drug
Intervention description(s): Arm Nr 1: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Lactated Ringer's Solution will be administered.; Arm Nr 2: If corrected flow time (fTc), measured by esophageal doppler, falls below 350 msec, 250 ml of Hydroxyethylstarch 6% 130/0.4 will be administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intraoperative care; Ringer's lactate; Voluven; Cardiovascular diagnostic technique; Doppler effect
Randomized, Parallel Group, Placebo Control, Unicentric, Interventional Study to Assess the Effect of Expanded Human Allogeneic Adipose-derived Mesenchymal Adult Stem Cells on the Human Response to Lipopolysaccharyde in Human Volunteers
Condition: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, randomized, parallel group, placebo control, unicentric, interventional study.
      Thirty two healthy male volunteers aged between 18-35 years will be randomized into the eASCs
      or placebo group if they meet all the inclusion criteria at a 3:1 ratio.

      The treatment administration will be infused intravenously to the following groups after
      randomization:

        -  First arm: 250,000 cells/kg

        -  Second arm: 1 million cells/kg

        -  Third arm: 4 million cells/kg

        -  Fourth arm: placebo according to their weight.

      An hour after the end of the eASCs administration, all subjects will be given an intravenous
      dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable
      by the investigator.
    

Detailed description: 
      Medicinal product Suspension of expanded adipose-derived allogeneic adult stem cells (eASCs)
      at a single dose of 250,000 cells/kg, 1 million cells/kg or 4 million cells/kg by intravenous
      infusion after suspension in Ringer's lactate solution.

      Control Placebo (Ringer's lactate solution) Objectives To investigate the effect of eASCs on
      the inflammatory response to intravenous LPS in humans.

      Design Phase I, randomized, parallel group, placebo control, unicentric, interventional
      study. Thirty two healthy male volunteers aged between 18-35 years will be randomized into
      the eASCs or placebo group if they meet all the inclusion criteria at a 3:1 ratio.

      The treatment administration will be infused intravenously to the following groups after
      randomization:

        -  First arm: 250,000 cells/kg

        -  Second arm: 1 million cells/kg

        -  Third arm: 4 million cells/kg

        -  Fourth arm: placebo according to their weight.

      An hour after the end of the eASCs administration, all subjects will be given an intravenous
      dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable
      by the investigator.
    

Intervention name(s): Intravenous infusion of cells
Intervention type(s): Other
Intervention description(s): The treatment administration will be infused intravenously to the subjects after randomization:
An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment