bioihbjkbjnl/mcl2 huggingface dataset:
Heart Failure (HF) Outpatient Monitoring Evaluation (HOME) Study
Condition: Heart Failure; Systolic Heart Failure; Acute Decompensated Heart Failure
MeSH terms: Heart Failure; Heart Failure, Systolic
Study type: Interventional

Summary: 
      The purpose of this study is to determine if heart failure subjects whose treatment is
      assisted by home BNP measurements integrated into a home health management system will have
      better clinical outcomes than subjects whose treatment includes home health management
      without BNP or than subjects treated by standard care.
    

Detailed description: 
      Systolic dysfunction heart failure subjects with low ejection fraction and elevated BNP
      levels admitted to hospital or treated as outpatient for decompensated Heart Failure (HF) are
      at hight risk for recurrent decompensation and readmission. The objective of this study is to
      investigate if these patients may benefit from enhanced home monitoring of their HF status.

      In the 3 study arms (BNP, Health Management and control groups) home fingerstick BNP levels
      will be obtained so that frequent data points are available for analysis of trends and
      variability. These results will remain blinded to the subjects in all study arms and their
      care providers in the health management and control arms, the investigator and staff will
      have access to the BNP results only for subjects in the BNP arm and will use this information
      to aid in therapy decisions.

      Subjects are monitored for 180 days as this time period is likely sufficient to differentiate
      normal biological variation in BNP changes due to impending decompensation.

      Patients will be assessed at Day 30,90 and 180 after randomization HF status, patient
      clinical outcome and treatment adjustments are recorded.

      Follow-up telephone calls to subjects at 3 and 6 months after completion of home testing will
      be conducted in order to determine the possible long-term benefit of home health management
      with daily BNP testing.
    

Intervention name(s): Interventions with heart failure medications
Intervention type(s): Other
Intervention description(s): Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Fingerstick BNP test; Home Health Management System; Acute Decompensated Heart Failure; Hospital Readmission; Prevention
An Exploratory Investigation of a Supplement to Enhance Sleep Quality and Quantity
Condition: Sleep; Sleep Disturbance; Sleep Hygiene
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      This double-blind study will examine the effectiveness of Dream Powder and Dream Powder Extra
      Strength over a six week period. The main outcomes of interest will be sleep quantity and
      quality, as well as self-reported changes in sleep across the study period.
    


Intervention name(s): Beam Organics Dream Powder; Beam Organics Dream Powder Extra Strength; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern; The Dream Powder and Dream Powder Extra Strength both use nano hemp, reishi, magnesium. L-theanine, and melatonin to promote a healthy sleep pattern; The main ingredients in the placebo are:
Coconut milk powder, cocoa, cinnamon, monk fruit, natural vanilla flavor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Sleep; Sleep Disturbance; Sleep Quality; Sleep Quantity
Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study
Condition: Facial Rhytids
MeSH terms: Facies
Study type: Interventional
Phase: Phase 2

Summary: 
      A 16-week single-blind, split-face, randomized study. Each patient served as their own
      control, receiving onabotulinumtoxinA and abobotulinumtoxinA randomized to either the left or
      right side of the face. Patients received intradermal BTXA injections at week 0 and
      intramuscular BTXA injections at week 2. The objective is to examine the effectiveness of
      intradermal botulinum toxin type A (BTXA) injection in improving skin texture and midface
      lift while reducing pore size and sebum production, as well as investigate the differences in
      effectiveness between onabotulinumtoxinA and abobotulinumtoxinA using intradermal and
      intramuscular injection methods.
    


Intervention name(s): onabotulinumtoxinA; abobotulinumtoxinA
Intervention type(s): Drug; Drug
Intervention description(s): OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.; AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.
Other intervention name(s): Botox; Dysport
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: botulinum toxin type A, intradermal
Effect of Cyclosporine on the Pharmacokinetics (PK) of AT-527 (R07496998)
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of cyclosporine on the PK of AT-527 (R07496998) in
      healthy male subjects
    


Intervention name(s): AT-527 550 mg + cyclosporine; AT-527 550 mg + cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): 550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered simultaneously on Day 7 Other Names: AT-527 is also known as R07496998; 550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder; Stepped Care Cognitive Behavioral Therapy
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this research study is to determine how well children with OCD can be helped
      using therapy that requires less clinic visits. The investigators are testing a Stepped-Care
      Cognitive Behavioral Therapy (SC-CBT) approach in which children receive a full course of
      parent-led, therapist-guided treatment for OCD. The goal is to see if therapy can be done in
      fewer visits to the clinic. Children receiving SC-CBT will start with Step One, which
      includes three therapy sessions over six weeks. Those who do not get better in Step One will
      "STEP UP" to Step Two which involves coming in to meet with a therapist for the remaining
      sessions. Youth receiving SC-CBT will be compared to youth receiving standard CBT in the
      clinic through this study. It is expected that Stepped Care will be an acceptable,
      cost-effect, and feasible treatment with outcomes similar to standard CBT.
    

Detailed description: 
      Below is a summary of assessment and interventions as part of the study (separated by
      condition). Two thirds will receive SC-CBT, one-third standard CBT (determined at random
      following the initial phone screen).

      A. Phone Screen (with parent)

      B. Informed Consent and Initial Assessment

      C. Randomization to either SC-CBT or Standard CBT

      D. Treatment Phase (either 1 or 2 determined at random following 'C')

        1. SC-CBT

           Children who are randomized into SC-CBT will receive Step One:

             -  3-in-office sessions - 1 hour each (over 6 weeks)

             -  6 weekly phone calls (15 minutes or less)

             -  Post assessment (at the end of the 6 weeks)

             -  3-month follow up

           Children are "stepped up" to Step Two of SC-CBT if we determine more therapy is needed
           (following the post assessment). Step Two is a continuation of therapy and will include:

             -  9-in-office weekly sessions - 1 hour each (over 9 weeks)

             -  Post assessment (after session 9)

             -  3-month follow up

           OR

        2. Standard CBT

      Children who are randomized into the standard CBT group will receive:

        -  12-in-office weekly sessions - 1 hour each (over 12 weeks)

        -  Midpoint Assessment (after 6 weeks)

        -  Post assessment (at the end of the 12 weeks)

        -  3-month follow up
    

Intervention name(s): Stepped Care Cognitive Behavioral Therapy; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder; Cognitive Behavioral Therapy; Stepped Care CBT; Exposure and Response Prevention; Psychotherapy; Counseling
Preemptive Analgesia in Cruciate Reconstruction
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The aims of this study was to compare analgesic efficacy of preoperative administration of
      etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior
      cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate
      ligament injury will randomized into 3 groups using opaque envelope. Both patients and
      surgeon were blinded to the allocation. All of the patients will be operated by one
      orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120
      mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain
      intensity, time to first dose of analgesic requirement and numbers of analgesic used for
      rescue pain control and adverse events will be recorded periodically to 48 hours after
      surgery.
    


Intervention name(s): Celecoxib; etoricoxib
Intervention type(s): Drug; Drug
Intervention description(s): celecoxib 400 mg 1 cap before surgery; 120 mg 1 tab before surgery
Intervention MeSH terms: Celecoxib; Etoricoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: preemptive analgesia; cruciate ligament
Effects of Gut Peptides on Bone Remodeling
Condition: Healthy
Study type: Interventional

Summary: 
      We will investigate effects of gut hormones on bone remodeling.
    


Intervention name(s): Glucagon-Like Peptide-2 (GLP-2); Glucose-dependent insulinotropic polypeptide (GIP); GLP-2+GIP; Placebo
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Glucagon-Like Peptide-2 (GLP-2) injection.; Glucose-dependent insulinotropic polypeptide (GIP) injection.; GLP-2+GIP injection.; Placebo injection.
Intervention MeSH terms: Glucagon; Gastric Inhibitory Polypeptide; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A

      This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study
      (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses
      compared to narafilcon A or delefilcon A spherical lenses.
    

Detailed description: 
      The aim of this study is to evaluate the clinical performance of stenfilcon A compared with
      narafilcon A and delefilcon A.

      The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60
      subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.

      Study groups:

      Group 1: stenfilcon A vs. narafilcon A

      Group 2: stenfilcon A vs. delefilcon A
    

Intervention name(s): stenfilcon A; narafilcon A; delefilcon A
Intervention type(s): Device; Device; Device
Intervention description(s): contact lens; contact lens; contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study participants will be allocated in to 2 parallel groups: Group 1: stenfilcon A and narafilcon A, and Group 2: stenfilcon A and delefilcon A. Each participant will be randomized to wear either lens pair in a bilateral design for 1 week, and then cross over to the alternative pair.
Masking: None (Open Label)
Primary purpose: Other
VivaSight Double Lumen Tube for Single Lung Ventilation
Condition: Double Lumen Endotracheal Tube; Single Lung Ventilation
Study type: Interventional

Summary: 
      This prospective, randomized, comparative study is intended to enroll a total of 50 patients
      undergoing thoracic surgery that necessitates single lung ventilation. The efficacy and
      performance of the VivaSight DLT will be compared to the conventional double lumen tube. Use
      of fiberoptic bronchoscopy for initial tube positioning and subsequently during the case will
      be recorded. The attending thoracic surgeon will judge the quality of lung deflation. The
      occurrence of any malposition and subsequent maneuvers will be recorded. A standardized
      anesthetic protocol that is usual and customary for the type of operation the patient is
      having will be provided to the anesthesia teams of enrolled subjects. The remainder of the
      anesthetic care of the subject will not deviate from the standard of care.
    


Intervention name(s): Conventional Double Lumen Tube; VivaSight Double Lumen Tube
Intervention type(s): Device; Device
Intervention description(s): Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery; Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
The Effects of Synaquell on Brain Function of Ice Hockey Players
Condition: Healthy
Study type: Interventional

Summary: 
      This research is being done to investigate the dietary supplement, Synaquell (TM), for
      effects on brain function in youth ice hockey players.
    

Detailed description: 
      This randomized clinical trial will compare a brain health supplement (Synaquell) with
      placebo in both male and female ice hockey players over the course of an entire season. The
      repeated measure design will compare pre- and post-season objective brain health parameters,
      including quantitated EEG (Neurocatch), blood biomarkers and a rapid number naming test (King
      Devick).
    

Intervention name(s): Synaquell; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 7.9 grams (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).; 7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Ice Hockey; Cognitive Function; Cognition; Brain; Supplement; Contact Sport Athletes
Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether cabergoline is effective in reducing the
      incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe
      cases; and to derive biomarkers for the risk of developing OHSS.
    

Detailed description: 
      Severe ovarian hyperstimulation syndrome (OHSS) occurs in up to 2% of in-vitro fertilisation
      (IVF) cycles, resulting in accumulation of fluid in peritoneal, pleural and pericardial
      cavities, haemo-concentration with resultant venous thromboembolic phenomena, reduced
      perfusion of vital organs, renal failure, acute respiratory failure, and even death.

      The long term aim is to develop a comprehensive strategy in reducing the incidence and
      severity of OHSS in in-vitro fertilisation (IVF) cycles. Our short term aim (2-3 years) is to
      test the ability of the dopamine receptor agonist cabergoline in reducing the incidence and
      severity of OHSS in high risk women undergoing controlled ovarian hyperstimulation (COH) in
      fresh IVF cycles through a reduction in vasoactive cytokine levels, specifically in serum
      vascular-endothelial growth factor (VEGF).

      Specifically we will:

        1. Conduct a randomised double-blind placebo-controlled trial in women at high risk of
           developing OHSS during a fresh COH-IVF cycle

        2. Investigate the serum and follicular fluid levels for potential biomarkers of OHSS.
    

Intervention name(s): Cabergoline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.; 1 tablet daily for 8 days.
Other intervention name(s): Dostinex
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Treatment of Adolescent Suicide Attempters (TASA)
Condition: Depression; Suicide, Attempted
MeSH terms: Suicide; Suicide, Attempted
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the effects of three types of treatments for
      depressed teenagers who have attempted suicide.
    

Detailed description: 
      Suicide is the third leading cause of death in adolescents and is a major public health
      problem. Depression is the most common diagnosis for adolescent suicide attempts. Little is
      known about what treatment is best for these adolescents since they are usually excluded from
      participation in research studies.

      Participants in this study will be randomly assigned to receive carefully monitored
      antidepressant medication with routine support and management, cognitive behavioral therapy
      (CBT), or a combination of antidepressant medication plus CBT.
    

Intervention name(s): fluoxetine; sertraline; citalopram; escitalopram; bupropion; mirtazapine; venlafaxine; lithium; Cognitive Behavioral Therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Behavioral
Intervention MeSH terms: Mirtazapine; Citalopram; Bupropion; Fluoxetine; Venlafaxine Hydrochloride; Sertraline; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dysthymic Disorder; Adolescent
Efficacy of Mydriatic Drops in Premature Infants
Condition: Retinopathy of Prematurity
MeSH terms: Retinal Diseases; Retinopathy of Prematurity
Study type: Observational

Summary: 
      Because of the neonatologists reported that some infants had suffered from vomiting,
      bradycardia, hypotonia, and aspiration risk about 30-60 minutes after the fundus examination
      in the intensive care unit. The investigators observed the pupil dilation effects and side
      effects of tipple instillation of phenylephrine 2.5% plus tropicamide 0.5% ophthalmic drop
      combination which the investigators routinely used in ROP examination.
    

Detailed description: 
      Purpose: To determine effect and vital change after topical application of phenylephrine 2.5%
      and tropicamide 0.5% three times for retinopathy of prematurity (ROP) examination in preterm
      infants.

      Methods: Pupillary diameter, blood pressure, pulse rate, and oxygen saturation were monitored
      before, and after up to 24 hours 60 ROP screening examinations.
    

Intervention name(s): Drug used in the examination of premature infants.
Intervention type(s): Drug
Intervention description(s): to investigate side effects of eye drops used
Other intervention name(s): Tropicamide and mydfline used
Intervention MeSH terms: Tropicamide
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        tertiary health center in the west Black Sea region
The Efficacy and Safety of New Herbal Formula (KBMSI-2) in the Treatment of Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: KBMSI-2, which is the herbal formular consisted of Ginseng Radix Rubra, Dioscorea
      tenuipes, Cornus officinalis Sieb. Et Zucc, Lycium Chinese Mill, Curcuma logna Linn, Honey,
      improved the erectile function by preserving the smooth muscle content and inhibiting the
      fibrosis of the corpus cavernosum in STZ-induced diabetic rat model. In this study, the
      researchers investigated the efficacy and safety of the herbal formula (KBMSI-2) in the
      treatment of ED.

      Material and Methods: Patients were instructed to take investigational products (KBMSI-2 6g
      or placebo) twice a day for 8 weeks at least 1 hour after food intake. The primary efficacy
      variable was the change in the EF domain scores of the IIEF questionnaire from baseline.
      Secondary efficacy measures included change in all domain scores of the IIEF from baseline,
      change in question 2 and 3 of the SEP2,3, from baseline.
    


Intervention name(s): KBMSI-2
Intervention type(s): Drug
Intervention description(s): The KBMSI-2 capsules (6gm/capsule) and placebo were provided by Korean Bio Medical Science Institute (Seoul, Korea). KBMSI-2 was analyzed by high-performance liquid chromatography. KBMSI-2 contained major ginsenoside-Rb1: 260.53ug/g, -Rb2: 543.91ug/g, -Rc: 424.92ug/g, -Re: 377.32ug/g, -Rf: 1160.55ug/g, -Rg1: 703.97ug/g, Curcumin 60.73ug/g, Allantoin 98.66ug.g, and Loganin 744.13ug/g. During the study period, two capsules were taken daily for 8 weeks. The placebo capsules were identical in shape, color, and taste.
Other intervention name(s): Better man (brand name)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment