bioihbjkbjnl/mcl2 huggingface dataset:
Effect Of Combination of Morphine+Fentanyl on Emergence Delirium in Patients of Cleft Lip and Palate Repair
Condition: Anesthesia Emergence Delirium
MeSH terms: Cleft Lip; Delirium; Emergence Delirium
Study type: Interventional

Summary: 
      Emergence Delirium And Recovery Profile In Patients Undergoing Cleft Lip And Cleft Palate
      Repair With Either Combination Of Morphine Plus Fentanyl Or Fentanyl Alone
    


Intervention name(s): MORPHINE PLUS FENTANYL; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Effect Of Morphine Plus Fentanyl On Emergence Delirium; Effect Of Fentanyl Only On Emergence Delirium
Intervention MeSH terms: Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Chewing the Tapioca Pearls in Bubble Tea Drinks
Condition: Saliva
Study type: Interventional

Summary: 
      Bubble tea drinks contain tea and tapioca pearls. Chewing tapioca pearls in bubble tea drinks
      may increase salivary components. Because of its proteins, inorganic components, and enzymes,
      saliva plays an important role in the body's defense against bacteria and viruses. This study
      aims to analyze the effect of chewing the tapioca pearls in bubble tea drinks on salivary
      C-reactive protein (CRP) and calcium (Ca) levels.
    

Detailed description: 
      Sixty saliva samples were collected from 15 subjects. The inclusion criterion was 18-25 years
      of age. The exclusion criteria were receiving medication, using dentures, a history of dry
      mouth, smoking and systemic disease. In the first week of the experiment, subjects drank
      bubble tea as the intervention group. In the second week, the same subjects drank tea without
      pearls as the control group. Each subject drank the bubble tea for 5 minutes per day over 3
      days. Saliva samples were collected on the first day before bubble tea consumption (pretest)
      and on the third day after tea consumption (posttest). Saliva collection was performed in the
      morning (09:00 a.m.-12:00 p.m.) for 1 minute. Salivary CRP levels were measured using an
      ELISA kit, and Ca levels were determined using a test kit.
    

Intervention name(s): chewing tapioca pearls in bubble tea drinks; drink tea without chewing tapioca pearls
Intervention type(s): Other; Other
Intervention description(s): Saliva was collected on the first day before bubble tea consumption (pretest) and on the third day after bubble tea consumption (posttest); collection was conducted in the morning (09:00 a.m.-12.00 p.m.).; Saliva was collected on the first day before drink tea without tapioca pearl (pretest) and on the third day after tea consumption (posttest); collection was conducted in the morning (09:00 a.m.-12.00 p.m.).
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: In the first week of the experiment, subject chewing tapioca pearl inthe bubble tea. In the second week, the same subjects drink tea without chewing tapioca pearl
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bubble tea; salivary C-reactive protein; salivary calcium
Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The objective of this surveillance is to determine the following items in all patients
      receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset
      (frequency, severity and other details) of adverse events, 3) factors considered to affect
      the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other
      details) of the followings will be key issues of this surveillance:Infection (tuberculosis,
      opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor,
      interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and
      application site reactions.
    


Intervention name(s): Enbrel (etanercept)
Intervention type(s): Drug
Intervention MeSH terms: Etanercept
Time perspective: Prospective
To Investigate the Effect of Far-infrared Radiation on Lower Extremity Acupoints on the Blood Circulation of Lower Extremities in Patients With Hemodialysis
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      This study intends to irradiate the acupoints of both lower extremities of hemodialysis
      patients with far-infrared therapeutic apparatus to explore its effect on foot blood
      circulation, peripheral artery occlusion disease (PAOD) symptoms and ankle-brachial index
      (Ankle-Brachial Index, ABI) value.
    

Detailed description: 
      After irradiating the lower extremity acupoints of hemodialysis patients with far-infrared
      rays, it is expected to improve the blood circulation of the lower extremities of
      hemodialysis patients, thereby improving the symptoms of indirect claudication and raising
      the ankle-brachial index to the normal range, and reducing the incidence of peripheral
      arterial disease in hemodialysis patients. The results of this study can provide an empirical
      reference for future clinical care.
    

Intervention name(s): far-infrared radiation
Intervention type(s): Device
Intervention description(s): far-infrared radiation on foot acupoints (Yinlingquan and Sanyinjiao acupoints) during dialysis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The dialysis day was W 1.3.5 as the control group and W 2.4.6 as the experimental group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemodialysis; peripheral arterial occlusion disease; far-infrared radiation; lower extremity acupoints; ankle-brachial index; Edinburgh claudication questionnair
The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is evaluation of the safety and the efficacy of transanal total
      mesorectal excision.
    

Detailed description: 
      Subjects will have their rectal cancer removed using a technique combining surgery through
      the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the
      end of the procedure, the rectum will be removed though the anus or ileostomy formation site,
      the bowel will be re-connected to the anus, and a temporary diverting stoma will be created,
      which is standard of care following surgery for this type of cancer.
    

Intervention name(s): Transanal total mesorectal excision
Intervention type(s): Procedure
Intervention description(s): Laparoscopy-assisted transanal total mesorectal excision
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal Neoplasms; Colorectal Neoplasms; transanal surgery
A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a double-blind, randomized, placebo-controlled, 2-way crossover study to
      evaluate the safety of CVT-301 levodopa (l-dopa) when co- administered with the first daily
      dose of oral levodopa/carbidopa for early morning OFF symptoms in patients with Parkinson's
      disease (PD).
    

Detailed description: 
      An "OFF state" is defined as the time when medication is no longer providing benefit with
      respect to mobility, slowness, and stiffness. OFF episodes may be heralded by non-motor
      symptoms (e.g., pain, anxiety) prior to the appearance of motor symptoms.
    

Intervention name(s): CVT-301, LIP; Placebo
Intervention type(s): Drug; Other
Intervention description(s): All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA); All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Hericium Erinaceus on Microbiota and Cognition
Condition: Cognitive Decline, Mild
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The study evaluates the effects of Hericium erinaceus on microbiota, cognition, and other
      health parameters in older adults. All measurements will be performed at baseline and ten
      weeks after daily consumptions of either Hericium erinaceus or placebo.
    

Detailed description: 
      Hericium erinaceus, a well-known edible mushroom, has numerous biological activities.
      Yamabushitake (Hericium erinaceus) is a mushroom that grows on both living and dead broadleaf
      trees. Yamabushitake is used as food in Japan and China. Hericenones and erinacines stimulate
      nerve growth factor synthesis, and therefore it is expected that H. erinaceus have some
      effects on brain functions and autonomic nervous system. Hericium was tested in several
      applications, such as dementia, Alzheimer's disease, Parkinson's disease, multiple sclerosis,
      neuropathy and neurasthenia. The ancient Chinese knew about these possibilities and used it
      to support mental functions and memory, concentration. It is also very good for various
      digestive problems, such as gastritis, stomach ulcers, heartburn, reflux and improvement of
      digestion.

      Therefore, the aim of our study is to evaluate the effects of Hericium erinaceus on
      microbiota, cognition and related parameters in elderly. The stool samples will be taken at
      baseline and after ten weeks of daily consumption of Hericium erinaceus or placebo. In
      addition, cognitive tests, anthropometric measurements, and blood analysis (lipid profile,
      glucose levels and neurotrophic factors) will be measured at the same time points.
    

Intervention name(s): Hericium erinaceus; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 capsules per day, 3 times two after breakfast, lunch and dinner; 6 capsules per day, 3 times two after breakfast, lunch and dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized placebo controlled
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
LC Bead Embolization Agent With Doxorubicin in the Treatment Liver Metastasis From Melanoma
Condition: Stage IV Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      The purpose of this study is to determine if LC beads loaded with Doxorubicin are a safe and
      effective treatment for melanoma that has spread to the liver.
    

Detailed description: 
      In this study, trans-arterial chemoembolization will be used to deliver LC beads loaded with
      Doxorubicin directly into liver tumors resulting from malignant melanoma.
    

Intervention name(s): LC beads loaded with Doxorubicin
Intervention type(s): Device
Intervention description(s): During each TACE, 2 vials (1 vial, 75mg Doxorubicin) of 100-300 micrometer size LC beads loaded with doxorubicin will be delivered to the liver tumor(s). Total Doxorubicin dose for each TACE is 150mg
Intervention MeSH terms: Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic melanoma; stage IV melanoma; metastatic melanoma to the liver
Transgender Health: an Educational RCT
Condition: Transgender; Health Attitude
Study type: Interventional

Summary: 
      The investigators will conduct a randomized controlled trial (RCT) comparing two different
      educational approaches on the healthcare of transgender and gender expansive (TGE) youth.
      Finding best practices to educate healthcare providers and the community at large stand to
      make an impact on the mental health of TGE youth by helping them feel more welcome and better
      understood by the communities in which they live.

      The study aims are to evaluate two educational interventions: 1) The inclusion of a video
      clip component of two TGE youth (Video [V] vs No video [N]) into a one-hour didactic; and 2)
      The delivery of the same didactic content by a cis- [C] vs a trans-gender [TG] woman.
    

Detailed description: 
      This will be a randomized control trial (RCT) of equal allotment to one of four parallel
      didactic conditions. The investigators will randomly assign participants to one of three
      teaching conditions: 1) Trans Video [TV]; 2) Cis Video [CV]; and 3) Cis No video [CN].
      Participants will complete a baseline assessment (PRE) before the start of the same didactic
      content, but delivered in the three different ways described above. This design will help the
      investigators make comparisons across video use (yes/no), about type of presenter
      (trans/cis), and about the interaction of the two approaches. For the 'no video' condition
      (CN), the didactic will not include the videos until after completion of the POST assessment.

      The study design will ensure that all participants will receive the exact same didactic
      content during whichever session they attend. All participants will then receive a follow up
      questionnaire two weeks later (2WK POST) to assess content retention.
    

Intervention name(s): Short videos
Intervention type(s): Other
Intervention description(s): As an educational RCT, the didactic content will be the same across the four arms, but its deliver will vary by:
TRANS- vs CIS-gender female instructors
With or without short videos of transgender youth embedded into the didactic [TV or CV]; for the group with no embedded videos [NV], the same videos will be shown AFTER completion of the post measures)
No-intervention control, in which TV will be delivered *after* collection of pre/post measures.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT of three different education / training approaches
Masking: Double (Participant, Investigator)
Primary purpose: Other
Romidepsin Plus 3BNC117 Phase 2a Study
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this protocol is to evaluate the effects of romidepsin plus 3BNC117 or romidepsin
      alone on delaying or preventing viral rebound in ART-treated HIV-1-infected individuals
      during an analytical interruption of ART.
    

Detailed description: 
      This is a randomized interventional phase 2a trial of 3BNC117 and romidepsin in human
      immunodeficiency (HIV-1) infected patients on ART, conducted as a multi-center study at the
      Department of Infectious Diseases, Aarhus University Hospital, Denmark, the Rockefeller
      University Hospital, USA, and the University Hospital of Cologne, Germany.

      Participants will be randomized 1:1 in a non-blinded fashion to receive one of two regimens:

      A) Two treatment cycles each consisting of one 3BNC117 infusion (30mg/kg) + three romidepsin
      infusions (5mg/m2); or

      B) Two treatment cycles each consisting of three romidepsin infusions (5mg/m2).

      ART will be discontinued 16 weeks after the start of the second treatment cycle (analytical
      treatment interruption, ATI) and subjects will be monitored weekly for safety and viral
      rebound. The targeted enrollment is 30 subjects (15 per arm).

      Leukapheresis will be performed before and after the two treatment cycles to guarantee
      sufficient material to investigate changes in the reservoir after the interventions.

      The following criteria will require resumption of ART:

        -  CD4+ T cell-count <350 cells/mm³ (confirmed by repeat measurement)

        -  2 consecutive plasma HIV-1 RNA measurements ≥ 200 copies/mL or above their setpoint
           viremia (if documented)

        -  Subject request

        -  Continued ART interruption will, in the opinion of the investigator or study advisers,
           pose an unacceptable risk to the subject.

      If HIV-1 RNA remains undetectable at week 36, subjects will be offered to continue off ART
      with close monitoring, in conjunction with the subject's primary medical provider, as long as
      HIV-1 viral rebound does not occur. ART resumption will follow same criteria as detailed
      above. All subjects will be followed for a total of 48 weeks from enrollment.
    

Intervention name(s): 3BNC117; Romidepsin
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Infusion of 3BNC117; Intravenous Infusion of Romidepsin
Other intervention name(s): Monoclonal Antibody; HDAC inhibitor
Intervention MeSH terms: Romidepsin; Histone Deacetylase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Romidepsin; 3BNC117; Broadly neutralizing antibody
Texas Childhood Obesity Research Demonstration (TX CORD) Project -Primary Prevention Study
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      A systems approach emphasizes the linkage between individual behavior change strategies and
      social and physical environmental changes, which act synergistically to facilitate (or
      inhibit) healthy eating and active living. We hypothesize that among low income, ethnically
      diverse overweight and obese children, aged 2-12 years, a systems approach to child obesity
      will reduce BMI compared to primary prevention alone.
    


Intervention name(s): Enhanced CATCH Elementary School Program; CATCH Early Childhood (CEC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Enhanced CATCH Elementary School Program is a Coordinated School Health Program that includes the CATCH Coordination Guide.; Implementation of the CATCH Early Childhood coordinated nutrition and physical activity program for Early Care and Education (ECE) centers.
Other intervention name(s): CATCH; Coordinated School Health Program; CEC, CATCH EC
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pediatric obesity; Diet; Physical activity; Schools; Early care and education
The Relationship Between Osteoporosis and Chronic Oral Anticoagulation Therapy With Warfarin
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      The purpose of this study is to determine if osteoporosis is an unrecognized complication of
      chronic anticoagulation with warfarin.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients on warfarintherapy in the SIUH coumadin center
      
Keywords: warfarin use
Evaluation of a Psychotherapeutic Intervention Model in Nursing
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing
      on the nursing diagnosis "Anxiety". A randomised controlled trial will be carried out to do
      so.
    

Detailed description: 
      This study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing
      on nursing diagnosis "Anxiety" (according to International Classification for Nursing
      Practice (ICNP)/North American Nursing Diagnoses Association (NANDA) standardized nursing
      language). A randomised controlled trial will be carried out to do so. In a single-blinded
      nurse-led 6 months controlled trial, conducted at a hospital outpatient setting in Portugal,
      approximately 60 patients with anxiety will be randomised to the intervention (n=30) or
      control groups (n=30). The objective is to compare the outcomes associated with
      "treatment-as-usual" and the benefits of implementing the psychotherapeutic intervention
      model in nursing previously developed (5 sessions), which will be evaluated using Nursing
      Outcomes Classification (NOC) outcomes "Anxiety Level" and "Anxiety Self-Control" (Portuguese
      version).
    

Intervention name(s): NIC Psychotherapeutic Intervention(s) for Anxiety; Psychopharmaceuticals (any drugs prescribed by the psychiatrist)
Intervention type(s): Behavioral; Drug
Intervention description(s): Patients will be treated by NIC psychotherapeutic intervention(s) for anxiety (e.g. anxiety reduction) plus psychopharmaceuticals prescribed by their psychiatrist.; Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.
Intervention MeSH terms: Psychotropic Drugs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychotherapy; Nursing; Nursing Care; Nursing Model; Randomised Controlled Trial
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      A single-arm prospective, interventional clinical trial to evaluate the safety and
      performance of obtaining hemostasis following prostate resection using the AQUABEAM for
      treatment of LUTS resulting from BPH.
    

Detailed description: 
      PROCEPT BioRobotics has developed the AQUABEAM, a personalized image-guided waterjet
      resection system that utilizes a high-velocity saline stream to resect and remove prostate
      tissue in males suffering from LUTS due to BPH. The AQUABEAM System is intended for the
      resection and removal of prostate tissue in patients experiencing lower urinary tract
      symptoms (LUTS).The primary objective of this study is to evaluate the safety and performance
      of obtaining hemostasis with catheters following prostate resection using AQUABEAM for the
      treatment of LUTS resulting from BPH. Up to 50 participants will be included in the trial at
      one clinical study site. All patients will be followed up for 30 days for safety assessment
      prior to study exit. The trial is a single-arm prospective, interventional clinical trial.
    

Intervention name(s): AquaBeam System
Intervention type(s): Device
Intervention description(s): The AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Image-guided; BPH; Aquablation; AQUABEAM; LUTS; Tissue resection; Robotics