bioihbjkbjnl/mcl2 huggingface dataset:
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
Condition: Hepatic Failure; Hepatic Impairment; Chronic Hepatitis C Infection With Hepatic Coma
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Failure; Hepatic Insufficiency; Hepatic Encephalopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective was to determine if hepatitis C virus (HCV) infection or mild to severe hepatic
      impairment (Child-Pugh Classes A, B, and C) altered the PK of buprenorphine,
      norbuprenorphine, or naloxone.
    

Detailed description: 
      This will be a multi-center, open-label study. After providing informed consent, subjects
      will undergo an outpatient screening period of up to 21 days. Screening procedures will
      include an assessment of mental status which will be repeated before dosing. Eligible
      subjects will then undergo hospital intake procedures and reside at the investigational site
      until Day 5. Subjects will be enrolled in 5-treatment groups as follows: (1) Group 1:
      Subjects with hepatic impairment classified as Child-Pugh A; (2) Group 2: Subjects with
      hepatic impairment classified as Child-Pugh B; (3) Group 3: Subjects with hepatic impairment
      classified as Child-Pugh C; (4) Group 4: Subjects with Hepatitis C Virus (HCV) infection but
      without hepatic impairment; and (5) Group 5: Subjects without hepatic disease or impairment.
      Group 5 is used as a control group
    

Intervention name(s): 2.0mg Buprenorphine/0.5mg Naloxone; Promethazine
Intervention type(s): Drug; Drug
Intervention description(s): Each participant received a single sublingual dose of Suboxone® on Day 1 following a fast of at least 8 hours prior to dosing and 2 hours after dosing.; Each participant received a 25-mg or 50-mg promethazine oral dose 30 minutes before Suboxone® administration and then 25-mg promethazine orally or by rectal suppositories every 4 hours as needed for nausea and vomiting during the first 48 hours after Suboxone® administration.
Other intervention name(s): Suboxone®
Intervention MeSH terms: Promethazine; Diphenhydramine; Buprenorphine; Naloxone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic; Hepatitis C Virus; Suboxone; Buprenorphine; Naloxone
Comparison of Deep Neuromuscular Block and Moderate Neuromuscular Block on Quality of Recovery in Patients Undergoing Robotic Gastrectomy
Condition: General Anesthesia
Study type: Interventional

Summary: 
      The purpose of this study is to investigate and compare the postoperative quality of recovery
      between the deep neuromuscular blockade and moderate neuromuscular blockade during robotic
      gastrectomy.
    


Intervention name(s): Deep neuromuscular blockade; Moderate neuromuscular blockade
Intervention type(s): Drug; Drug
Intervention description(s): neuromuscular blockade will be performed using a continuous infusion of rocuronium. Post-tetanic count 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 4 mg/kg will be administered to reverse neuromuscular blockade.; neuromuscular blockade will be performed using a continuous infusion of rocuronium. Train-of-four 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.
Intervention MeSH terms: Iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Safety and PK Trial With Injectable ZX003 (Risperidone-SABER®) Compared to Risperdal® Consta® in Stable Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multiple dose, PK and safety study in patients with chronic, stable
      schizophrenia or schizoaffective disorder.
    

Detailed description: 
      Approximately 75 male and female patients with schizophrenia or schizoaffective disorder on
      antipsychotic maintenance medication will be enrolled into the study. There will be 4 planned
      cohorts of 14 patients per cohort.

      In Cohorts 1-3, patients' planned participation in the study is for a total of approximately
      22 weeks, including a Screening period of up to 35 days, and a study treatment period of 120
      days (including follow-up).

      In Cohort 4 planned participation in the study is for a total of approximately 18 weeks
      including a Screening period of up to 35 days and a study treatment of 92 days (including
      follow-up).
    

Intervention name(s): ZX003 (Risperidone-SABER®); Risperdal Consta; Oral Risperidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ZX003 administered as a SC injection; Risperdal Consta administered as a IM injection; Oral Risperidone given to ensure adequate therapeutic plasma concentrations from Risperdal Consta
Other intervention name(s): Relday; risperidone; risperdal
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Yoga on Stress Management in Adolescents
Condition: Adolescent Behavior; Adolescent Problem Behavior
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The World Health Organization (WHO, 2013) defined the 10-19 age group as "adolescent" and the
      15-24 age group as "youth". Adolescence period; It is a period of rapid growth, development
      and maturation in terms of physical, mental, biochemical and social aspects.10-20% of
      children and adolescents living in the world have mental health diseases such as generalized
      anxiety disorders, depression, eating disorders, and post-traumatic stress disorders.In
      adolescents, yoga is practiced as a relaxing tool to reduce stress, especially for exam
      anxiety.In Turkey, there are no yoga-based experimental studies to prevent anxiety, stress
      and depression in adolescents.
    

Detailed description: 
      The aim of the study is to examine the effect of the Yoga-Based Stress Management Program on
      the ability to cope with stress in adolescents.Stress management sessions of the Adolescent
      Health Promotion-Physical Activity, Nutrition, Stress Management (COPE HEALTH-TEEN) program
      will be used in the stress management training to be explained in the program. There will
      also be yin yoga exercises.

      The general population of the research will be high school senior students in Safranbolu
      district of Karabük province in the 2021-2022 academic year. First of all, the stress,
      anxiety and depression levels of the adolescents will be calculated. The research will be
      carried out in a total of 14 high schools. Each school will be determined as a "cluster" and
      7 experimental and 7 control schools will be randomly selected. Simple random draw method
      will be applied in the selection of experimental and control schools. Adolescents who meet
      the inclusion criteria will be included in the study.
    

Intervention name(s): Yoga Based Stress Management Program
Intervention type(s): Behavioral
Intervention description(s): Yoga-based stress management program is applied to the intervention group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      multiple doses of PNU-100480 given for 14 or 28 days. Killing activity against the bacterium
      that causes tuberculosis (TB) will also be measured. The effect of adding an additional
      tuberculosis (TB) agent (given for 2 days) in addition to PNU-100480 will be evaluated.
      Linezolid open label to determine activity in whole blood assay (WBA).
    

Detailed description: 
      Evaluate safety, tolerability, pharmacokinetics and whole blood activity (WBA) of PNU-100480
      given for 14 or 28 days; evaluate WBA of PNU with pyrazinamide; evaluate WBA of linezolid
    

Intervention name(s): PNU-100480; Placebo; PNU-100480; Placebo; PNU-100480; Placebo; PNU-100480; Placebo; PNU-100480; Placebo; PNU-100480; Placebo; Linezolid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100 mg BID for 14 days; to match 100 mg BID for 14 days; 300 mg BID for 14 days; to match 300 mg BID for 14 days; 600 mg BID for 14 days; to match 600 mg BID for 14 days; 1200 mg QD for 14 days; to match 1200 mg QD for 14 days; 600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28; placebo to match 600 mg BID for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28; PNU-100480 dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28; placebo to match dose up to total of 1200 mg daily for 28 days with pyrazinamide (25 mg/kg up to 2 g) QD on Days 27-28; 300 mg QD for 4 days (open label)
Intervention MeSH terms: Linezolid; Oxazolidinones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety tolerability pharmacokinetics (PK) pharmacodynamics whole blood activity (WBA) PNU-100480 linezolid pyrazinamide multiple dose
Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous FL058 Administered in Healthy Subjects(SAD/MAD)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety,tolerability and pharmacokinetics of single-multiple intravenous doses
      of FL058 in healthy Chinese subjects.
    

Detailed description: 
      This study is divided into two parts: A and B.Part A discusses the safety and tolerability of
      IV FL058 single ascending dose (SAD) in two cohorts. Part B discusses the safety and
      tolerability of intravenous injection of FL058 in multiple dose (MAD) in three cohorts.
    

Intervention name(s): FL058; Placebo; FL058; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2500mg、3000mg; empty bottle; 500mg、1000mg、2000mg; empty bottle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immunogenicity and Safety of V70P5 Revaccination Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and immunogenicity of children previously primed in the
      V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.
    


Intervention name(s): Adjuvanted seasonal influenza vaccine
Intervention type(s): Biological
Intervention description(s): Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Trivalent; Adjuvanted; Vaccine; Children
Compressive Cryotherapy Versus Conventional Cryotherapy After Total Knee Arthroplasty
Condition: Knee Arthropathy; Cryotherapy Effect
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      In the postoperative period of a total knee arthroplasty, subjects present limitations of
      articular amplitudes, swelling, pain and functional limitations. Functional rehabilitation is
      unanimously recommended, including the use of cryotherapy. However, there is no consensus
      regarding the methods of application of cryotherapy. Thus the objective of the study is to
      compare 2 cryotherapy techniques associated with a classic rehabilitation on the improvement
      of mobility, swelling, pain and functional parameters. The 2 cryotherapies were a compressive
      cryotherapy and a so-called classic cryotherapy by cold pack.
    


Intervention name(s): cryotherapy
Intervention type(s): Other
Intervention description(s): cryotherapy was added to rehabilitation*. One group received compressive cryotherapy and the other conventional cold pack cryotherapy.
* rehabilitation includes (="classic rehabilitation") passive and active of mobilization of knee and patella, treat arthrogenic muscular inhibition, learn to lock the quadriceps, progressive muscular strengthening of the periarticular muscles of the knee, stretching of the quadriceps and the posterior muscular chain, proprioceptive exercises with bi- and unipodal balance, transfer of support and resumption of the walking pattern.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      The Objective of this study is to study the safety of FCM in patients with anemia caused by
      chronic kidney failure
    


Intervention name(s): Ferric Carboxymaltose; Standard Medical Care (SMC)
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Anti-inflammatory Effects of High-fat Nutrition; Towards a Clinical Application
Condition: Trauma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated
      inflammatory response, which is potentially lethal to the individual. Recently our group
      demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates
      severe inflammation, gut barrier loss and hepatic damage. High fat feeding releases
      cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently
      activates the efferent vagus nerve. The activated efferent fibers inhibit tissue macrophages
      via binding of acetylcholine to the alpha7-nicotinergic receptor.

      In this study the cholecystokinin release in healthy volunteers is monitored in response to
      low fat and high fat food products.
    


Intervention name(s): nutritional intervention with Respifor and Diasip
Intervention type(s): Dietary Supplement
Intervention description(s): Four nutritional interventions on four separate days per test person
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CCK release
Biological Response to Meal Ingestion: Gender Differences
Condition: Healthy
Study type: Interventional

Summary: 
      Aim: to determine the effect of gender on the sensory and metabolomic responses to a standard
      probe meal. Participants (12 men and 12 women) will be instructed to eat a standard dinner
      the day before, to consume a standard breakfast at home after overnight fast, and to report
      to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will
      be conducted in a quiet, isolated room with participants sitting on a chair. Participants
      will ingest a standard probe meal (750 Kcal). Perception of homeostatic sensations
      (hunger/satiation, fullness) and hedonic sensations (digestive well-being, mood) will be
      measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals
      up to 60 min after the probe meal. Heart rate variability, blood pressure and body
      temperature were measured before and after the meal. Blood samples for metabolomic analysis
      were taken before and 30 min after the meal.
    


Intervention name(s): Probe meal
Intervention type(s): Other
Intervention description(s): The probe meal (total caloric content 750 Kcal) will be ingested at a standard rate in 10 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: meal ingestion; metabolomic responses; hedonic sensations; homeostatic sensations
Effects of Antigravity Treadmill Training on Gait and Balance in Patients With Diabetic Polyneuropathy
Condition: Diabetic Polyneuropathy
MeSH terms: Polyneuropathies; Diabetic Neuropathies
Study type: Interventional

Summary: 
      Aging can be defined as sequential deterioration that occurs in elderly people including
      weakness, loss of mobility, decline of physical capabilities, increase susceptibility to
      disease and many other age-related physiological changes .The beginning of old age in most
      developed countries is about 60 or 65 years old. Diabetes mellitus (DM) and most commonly
      type 2 DM is one of the most common chronic non-communicable diseases affecting old people in
      Saudi Arabia which might be resulted from decline in physical activities. Polyneuropathy (PN)
      and its serious consequences represent the most common complication in diabetic mellitus
      which could contribute to an increased gait abnormality and risk of falling.
    

Detailed description: 
      Disability and reduction of quality of life are the largest costs of diabetes and its
      complications. So taking active intervention to reduce the risk of falls, improve gait
      performance and improve the quality of life in elderly with DPN is very important. Lower
      extremity aerobic exercise training via treadmill aiming for improving patients' physical
      activity levels is an important part in the rehabilitation program to enhance balance and
      walking functions and reducing the fall risk, .Treadmill training using s low-load walking
      provided by an emerging technology called lower body positive pressure (LBPP) that
      effectively reduces body weight could be preferable than other methods of unweighting
      treadmill because the air pressure is applied uniformly over the lower body. This kind of
      anti-gravity treadmill is ideal in reducing the formation of pain and pressure points that
      are common with harness-based unweighting systems. Many other advantages are also associated
      with this unique type of antigravity technology that could give it the superiority than the
      other types of unweighting treadmills in enhancing walking performance, reducing the risk of
      fall and improving quality of life in Saudi elderly people with DPN.
    

Intervention name(s): Antigravity treadmill training; Conventional exercise program
Intervention type(s): Other; Other
Intervention description(s): This group received antigravity treadmill training 100% weight bearing; This group received the conventional exercise program only.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Pilot-Testing a Family-Based Intervention to Improve Child Outcomes and Increase Family Activity
Condition: Smoking; Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to examine the feasibility and acceptability of a family-based
      program to improve physical activity and tobacco outcomes in a small pilot of middle school
      students and their families.
    

Detailed description: 
      Low income ethnic minority youth tend to be at greater risk for obesity, physical inactivity,
      high risk behaviors such as tobacco and substance use and resulting cardiovascular and
      chronic disease. In this study we modified a tobacco and substance use risk prevention
      program to develop a tailored intervention (Healthy Families DC) that also included promotion
      of physical activity (PA) for DC middle-school students referred by school staff as
      over-weight and at risk for problem behaviors. The program included an initial family
      assessment, a family feedback session with family PA goal setting and 6 phone/text based
      booster sessions. A pilot study with 18 families, comprised of at least one caregiver and
      target child, was conducted to examine feasibility, acceptability, and trends in preliminary
      outcomes such as PA via self-report and accelerometry, health risk behaviors (e.g., tobacco
      use), health goal setting, and changes in family functioning (e.g., youth positive behaviors,
      parenting).
    

Intervention name(s): Healthy Families DC Program
Intervention type(s): Behavioral
Intervention description(s): A tailored family-based intervention for health promotion goal setting, substance use prevention, and promotion of physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Biosignatures of Latuda for Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      The study proposes to conduct a pilot study of biological predictors of lurasidone response
      in bipolar depression.
    

Detailed description: 
      The study proposes to enroll 20 participants with a bipolar disorder who are currently in an
      episode of major depression.Magnetic resonance imaging (MRI), recordings of brain electrical
      activity (EEG), and psychological testing to explore possible predictors of lurasidone
      treatment response will be conducted. Blood samples will be collected for a future study of
      blood protein predictors of response. After testing, participants will receive an open-label
      8-week trial of lurasidone (Latuda™) at approved dosage levels. Participants who attain
      remission of their major depressive episode will be eligible for a six-month continuation
      phase to explore predictors of sustained response to continuation treatment. Data analyses
      will use statistical testing to explore potential biological predictors of lurasidone
      response. This will provide a framework for clarifying which patients are best suited to this
      treatment and begin to develop a model for precision treatment of this difficult-to-treat
      disorder.
    

Intervention name(s): Lurasidone (Latuda)
Intervention type(s): Drug
Intervention description(s): Antipsychotic medication approved for use with Bipolar disorder
Other intervention name(s): Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar Disorder; depression; Bipolar depression