bioihbjkbjnl/mcl2 huggingface dataset:
Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care
Condition: Depressive Symptoms; Anxiety; Post-traumatic Stress Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      This small randomized pilot study will evaluate feasibility and preliminary outcomes of an
      audio-delivered mindfulness program to reduce psychological distress for mothers with an
      infant in neonatal intensive care, as compared with an active control condition.
    

Detailed description: 
      An estimated 400,000-480,000 infants in the U.S. with serious medical conditions are cared
      for in neonatal intensive care units (NICUs) each year. Maternal stress exposure related to
      infants' NICU stays is an under-appreciated public health problem with negative implications
      for maternal and child health and wellbeing. Flexible, effective intervention strategies have
      potential to improve maternal mental health and parenting, promoting positive emotional and
      behavioral outcomes for both mothers and infants.

      In the investigators' successful pilot research, the investigators developed an
      audio-delivered mindfulness program to help NICU mothers reduce rumination and worry,
      cultivate a state of calm awareness, and promote self care. In this small randomized pilot
      study, the investigators will randomly assign mothers with an infant in the neonatal
      intensive care unit (NICU) to receive either the mindfulness intervention or an active
      control program (audio-delivered education on infant care and development).

      This study will evaluate feasibility of all key research aspects, including recruitment,
      randomization, intervention and control conditions, and assessments, in preparation for a
      future larger-scale study. This study will also assess preliminary intervention outcomes to
      identify potential program benefits.
    

Intervention name(s): Mindfulness Program; Infant Health Education Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists of two brief videos (one introducing the NICU portion of the program and one introducing the portion of the program addressing the transition home), as well as a series of mindfulness practices delivered via audio recordings to assist mothers in managing stress during the NICU stay and another series for the transition home.; The active control condition consists of two brief videos (one introducing the NICU portion of the program and one introducing the portion of the program addressing the transition home), as well as a series of audio recordings providing information on infant health and development for mothers to use during the NICU stay and another series for the transition home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: mindfulness; maternal depression
Effect of a Probiotic Strain Lactobacillus Paracasei K56 on Metabolic Symptom - a Pilot Study
Condition: Obesity; Adiposity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Recent data suggest that gut microbiota can function as an environmental factor that
      modulates the amount of body fat and obese individuals have an altered gut microbiota.The
      results of previous animal studies have suggest that a probiotic strain Lactobacillus
      paracasei K56 have reduced high-fat diet induced obesity.

      In this before-after pilot study, the participants were randomly assigned to 8 groups to
      compare the fat-reducing effect of the Lactobacillus paracasei K56 by continuously
      supplementing different product prototypes , and screen the best probiotic K56 prototype with
      the effect of fat reduction.
    


Intervention name(s): probiotic drink with Lactobacillus paracasei K56; maltodextrin; Probiotic powder E3; Probiotic powder E5; probiotic capsule E7; probiotic capsule E9; probiotic capsule E10; probiotic capsule E11
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic drink (K56 10^11CFU) 350ml/d for 60days; maltodextrin ,for 60days; Probiotic powder 3.0g/d (K56 10^10cfu) 60days;; probiotic powder 8g/day for 60days; probiotic k56 capsule, 2capsules/d (10^7cfu) for 60days; probiotic k56 capsule, 2capsules/d (10^9cfu) for 60days; probiotic k56 capsule, 2capsules/d (10^10cfu) for 60days; probiotic k56 capsule, 4capsules/d (10^11cfu) for 60days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obesity; lactobacillus paracasei; body fat; visceral fat area
A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous
      Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing
      colonoscopy.
    


Intervention name(s): Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution; Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
Intervention type(s): Drug; Drug
Intervention description(s): Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.; Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
Other intervention name(s): PREPOPIK®; PicoPrep®
Intervention MeSH terms: Picosulfate sodium; Magnesium Oxide; Sodium Citrate; Citric Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Early Feasibility Study of the "Easy Light" Fluorecence Imaging System
Condition: Uterine Cervical Neoplasms; Uterine Neoplasms
MeSH terms: Neoplasms; Uterine Cervical Neoplasms; Uterine Neoplasms
Study type: Interventional

Summary: 
      This is an early feasibility study to evaluate the device functionality of an open-field
      handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women
      with cervical and uterine cancers who underwent open surgery.
    

Detailed description: 
      This study was designed to clinically evaluate the functionality of an prototype of our
      near-infrared fluorescence device named Easy Light. In brief, this device is an open-field
      handheld wireless fluorecence imaging system that allows real-time visualization of
      fluorescent dyes such as indocyanine green (ICG) using smartphones and tablets. The handheld
      is a rechargeable device responsible for excitation of the operative field with infra-red
      lighting and for capturing the fluorescence emitted by de fluorescent dye to be visualized
      via wi-fi in the smartphones and tablets using a pre-installed application software.
      Following the standards of near-infrared fluorescence for detection of sentinel lymph nodes
      in gynecological malignancies, the hypothesis was the identification of sentinel lymph nodes
      after lymphatic mapping by interstitial indocyanine green injection in the cervix was
      feasible with the use of our device named Easy Light.
    

Intervention name(s): Sentinel Lymph Node Biopsy
Intervention type(s): Device
Intervention description(s): Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.
Intervention model: Single Group Assignment
Intervention model description: This is an early feasibility study.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Sentinel Lymph Node Biopsy; Fluorescence; Indocyanine Green
Single Ascending Dose Study of SRA-444 in Healthy Subjects
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-humans study of SRA-444. This study will provide an initial assessment of
      the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR
      formulation) after administration of ascending single oral doses to healthy adult subjects.
    


Intervention name(s): SRA-444
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Different Premedication in Pediatric Patients
Condition: Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional

Summary: 
      The investigators studied the effects of intranasal dexmedetomidine compared with oral
      midazolam with different doses for premedication in children. One hundred and twenty children
      aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal
      dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection
      midazolam group; no premedication group.

      Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation
      scale. A 4-point emotional state score was used to evaluate participators when they were
      separated from their parents and their response to intravenous cannulation or facemask
      application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium [PAED] scale) and POV
      were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal
      mask airway removal, discharge from the PACU and patients' satisfaction degree were also
      assessed.
    


Intervention name(s): dexmedetomidine; midazolam; midazolam; Saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2.5µg/kg intranasal dexmedetomidine group; 0.5mg/kg oral midazolam; 0.05mg/kg intravenous injection midazolam; no premedication
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Duloxetine for Postoperative Pain of Laparoscopic Cholecystectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      Recent studies on the impact of perioperative duloxetine for treatment of acute postoperative
      pain have yielded positive outcomes with respect to reduction opioid consumption. The aim of
      the present study is to investigate the role of perioperative duloxetine on the management of
      postoperative pain in patients undergoing LC.
    


Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg duloxetine; Placebo
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effects of Cannabidiol in Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of the proposed project is to begin rigorous study of the clinically relevant
      effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe
      alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is
      designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD
      to those of placebo in AUD patients. Participants with AUD will be randomized to receive
      either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO)
      for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD
      levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include
      circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and
      motoric function), and physiological and psychological domains relevant to AUD (including
      self-reported craving, depression, and anxiety, and responses to personalized scripts
      designed to elicit stress- and cue-induced craving and anxiety). Assessments will be
      conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs.
      placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks
      of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.
    

Detailed description: 
      There is increasing recognition of the roles of the endocannabinoid system in neurobiological
      processes and behavioral domains relevant to addiction. The non-psychoactive phytocannabinoid
      cannabidiol (CBD) has attracted considerable attention due to its lack of abuse potential,
      its excellent safety profile, its unique and complex pharmacology, and evidence that it
      affects anxiety and stress response in animal models and humans. There is a growing body of
      preclinical data demonstrating that CBD produces marked and persisting decreases in alcohol
      self-administration and preference for alcohol, and alcohol-, cue- and stress-induced
      reinstatement of alcohol-seeking behavior, yet there are few studies of the effects of CBD in
      humans with addictive disorders, and none in alcohol dependent patients.
    

Intervention name(s): Placebo; Phytocannabinoid cannabidiol (CBD)
Intervention type(s): Other; Drug
Intervention description(s): Saline taken by mouth (PO); CBD taken by mouth (PO)
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized proof-of-concept study
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Cannabidiol; Alcohol Use Disorder
Intestinal Sweet Taste Receptor Function and Adaptation to Dietary Sugars and Sweeteners
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to collect data that will help researchers better understand the
      various causes of obesity and diabetes; particularly to understand how consumption of NCASs
      affects the way the body uses nutrients.
    


Intervention name(s): Dietary: saccharin; Estimate glucose absorptions
Intervention type(s): Other; Other
Intervention description(s): Assess the glycemic and hormonal responses to an oral glucose load preceded by an oral solution of NCASs (saccharin).; Indirectly estimate the rate of glucose absorption and gastric emptying by using 3-O-methyglucose (3-OMG) and acetaminophen, respectively.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obesity, sweet taste receptors
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-54175446 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacodynamics of
      JNJ-54175446 after multiple consecutive dose administrations
    

Detailed description: 
      This will be a randomized, placebo-and comparator-controlled, double-blind, multiple dose
      study with JNJ-54175446 in healthy male participants. The study will consist of a Screening
      examination (28 to 6 days prior to dose administration), a baseline 20 mg amphetamine (AMPH)
      challenge at least 5 days before first dose administration, a double-blind treatment period
      (18 days; 11 days of dosing with JNJ-54175446, minocycline or placebo; amphetamine
      (AMPH)/AMPH placebo challenge sequence on Day 7 and Day 10 for each participant), and a
      follow-up examination between 14 and 21 days after last dose administration. The maximal
      study duration for each participant will not exceed 9 weeks. Safety, pharmacokinetics (PK)
      and pharmacodynamics of JNJ-54175446 will be primarily assessed. Safety will be monitored
      throughout the study.
    

Intervention name(s): JNJ-54175446; Minocycline; JNJ 54175446 Matching Placebo; D Amphetamine; D Amphetamine Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-54175446, at increasing dose levels using 2 oral formulations i.e. 0.5 mg/ml and 20 mg/ml as suspension for oral dose once daily.; Participants will receive minocycline 100 mg as capsule twice daily.; Participants will receive placebo matching with JNJ 54175446 once daily orally.; Participants will receive 20 mg d-amphetamine (AMPH) 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.; Participants will receive d-amphetamine (AMPH) matching placebo, 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
Intervention MeSH terms: Minocycline; Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-54175446
NEW MONITORING IN DIFFERENTIAL DIAGNOSIS OF HYPERLACTATHEMIA IN CARDIOPULMONARY BYPASS SURGERY
Condition: Etiology of Hyperlactathemia; Early Period After Cardiopulmonary Bypass Surgery; Washout Phenomenon
MeSH terms: Hyperlactatemia
Study type: Observational [Patient Registry]

Summary: 
      Objective: The objective of the study was to investigate a reverse correlation between blood
      lactate levels and rSO2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen
      in the early postoperative period.
    

Detailed description: 
      The objective of the prospective study was to investigate a reverse correlation between blood
      lactate levels and rSO2, and distinguish between hypoxic and non-hypoxic hyperlactatemia seen
      in the early postoperative period.

      Sixty American Society of Anesthesiologists (ASA) II-III patients were included in this
      study. Perioperative data, including age, weight, body surface area, gender, body
      temperature, preoperative co-morbidities, intraoperative and postoperative hemodynamic
      parameters, arterial blood gas analysis (ABG), cardiopulmonary bypass and aortic cross-clamp
      duration, flow rate, urine output, and blood product and inotropic agent usage, were
      recorded. Postoperative plasma lactate levels were measured simultaneously with cerebral
      tissue oxygen saturation (rSO2) in both cerebral hemispheres at 10 different time points.
    

Intervention name(s): Near infrared spectroscopy
Intervention type(s): Device
Intervention description(s): The rSO2 (cerebral oxygen satutation) was continuously monitored by NIRS (Near infrared spectroscopy) with a sensor positioned on the forehead of the patient
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who will undergo elective bypass surgery and extracorporeal circulation
      
Keywords: Early Hyperlactatemia; Cerebral Oxygen Saturation,; Cardiovascular Surgery
Cervical Spine Manipulation Affects on Balance and Proprioception
Condition: Neck Pain; Headache
MeSH terms: Headache; Neck Pain
Study type: Interventional

Summary: 
      Cervical spine manipulation (CSM) is utilized by many health care practitioners in the
      management of patients with neck pain and headache. How CSM works is not understood however,
      most researchers agree that there is likely a combination of mechanical, neurophysiological
      and placebo effects. This study will test for possible neurophysiological effects by
      examining for changes in a person's ability to reposition their head and neck in space, and
      maintain their balance following CSM.
    

Detailed description: 
      Consenting participants will have their proprioception tested through a joint repositioning
      error test for their cervical spine, and also have their balance tested through a Neurocom
      Balancemaster. Following these pre-intervention measures, they will receive in a random
      order, either a cervical spine manipulation (CSM) or a sham manipulation, and then have tests
      repeated to analyze for changes and differences between interventions.
    

Intervention name(s): Cervical Spine Manipulation; Manual Contact
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Manipulation; Balance; Proprioception
Nutritional Biomarkers of Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      This study proposes to characterize skeletal muscle amino acid kinetics to an EAA challenge,
      i.e., an oral amino acid tolerance test (OATT), in order to determine the state of muscle
      health. Analogous to the oral glucose tolerance test (OGTT) used to characterize alterations
      in glucose metabolism, the proposed OATT represents a potential low-cost solution to
      classifying patients' skeletal muscle health. The extrapolation of this work is the
      development of a simple analytical tool that would provide clinicians the ability to discern
      alterations in muscle amino acid kinetics prior to a loss of function.
    

Detailed description: 
      Sarcopenia increases the risk of a number of deleterious health conditions and represents a
      major financial cost to our healthcare system. Among older adults who are hospitalized, those
      with sarcopenia on admission are 5-fold more likely to incur higher hospital costs than those
      without. The operational definition of sarcopenia is defined as meeting the criteria for all
      of the following: low muscle strength, low muscle quantity or quality, and low physical
      performance. The diagnosis of sarcopenia requires techniques that are both expensive and
      operator-dependent. Simple measurements, such as BMI, do not necessarily identify sarcopenia.
      Importantly, current techniques can only identify sarcopenia after a physical/functional
      impairment has occurred. Skeletal muscle amino acid kinetics predict muscle health and
      functionality. Altered amino acid kinetics lead to decrements in muscle mass, quality, and
      performance. Muscle response to circulating essential amino acids (EAA) determines muscle
      amino acid kinetics. Thus, this study proposes to characterize skeletal muscle amino acid
      kinetics to an EAA challenge, i.e., an oral amino acid tolerance test (OATT), in order to
      determine the state of muscle health. Analogous to the oral glucose tolerance test (OGTT)
      used to characterize alterations in glucose metabolism, the proposed OATT represents a
      potential low-cost solution to classifying patients' skeletal muscle health. The
      extrapolation of this work is the development of a simple analytical tool that would provide
      clinicians the ability to discern alterations in muscle amino acid kinetics prior to a loss
      of function.
    

Intervention name(s): XS Muscle Multiplier
Intervention type(s): Dietary Supplement
Intervention description(s): Distributed by Amway; this product is a powder, sold in a 6.8 ounce (192g) container.
Intervention model: Single Group Assignment
Intervention model description: Three groups of subjects will be studied: young/health, older/healthy, and older/sarcopenic.
Masking: None (Open Label)
Primary purpose: Screening