bioihbjkbjnl/mcl2 huggingface dataset:
Sugammadex ED90 Dose in the Obese Patients
Condition: Incomplete Reversal of Neuromuscular Block
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the minimum effective dose of sugammadex, an
      antagonist of neuromuscular blockade used during anesthesia practice, in obese patients,
      considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg
      but no studies were found with obese patients.
    

Detailed description: 
      Prospective study with the sequential design method up-and-down of the biased coin aimed to
      determine the minimum effective dose in 90% of patients (ED90).

      The following doses were chosen: 2.0 mg.kg-1, 2.2 mg.kg-1, 2.4 mg.kg-1, 2.6 mg.kg-1, 2.8
      mg.kg-1.

      The complete reversal of moderate rocuronium-induced neuromuscular blockade (NMB) considered
      a T4/T1 ratio ≥ 0.9 with the peripheral nerve stimulator and accelerometer (monitor of
      sequential electric stimuli) "train-of-four" (TOF).

      After induction of general anesthesia and the calibration of the peripheral nerve stimulator
      and accelerometer, rocuronium 0.6 mg.kg-1 was injected.

      Continuous intravenous infusion of the anesthetics propofol and remifentanil, and
      intermittent bolus of rocuronium were offered throughout the procedure.
    

Intervention name(s): sugammadex ED90
Intervention type(s): Drug
Intervention description(s): The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.
Other intervention name(s): ED90
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dose-Response Relationship; Drug; Obesity; Cyclodextrins
Immersive Virtual Reality Bicycling for Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This study has four objectives about healthy younger and older adults during immersive
      virtual reality bicycling:

      Determine the effect of visual feedback and competition for younger healthy adults during
      virtual bicycling on user experience, motivation, enjoyment, perception of effort, and
      neuromuscular and cardiovascular intensity

      Determine the effect of visual feedback and competition for older healthy adults during
      virtual bicycling on user experience, motivation, enjoyment, perception of effort, and
      neuromuscular and cardiovascular intensity

      Compare younger and older during visual feedback and competition bicycling in terms of: user
      experience, motivation, enjoyment, perception of effort, neuromuscular and cardiovascular
      intensity

      Determine if attention differs in visual feedback bicycling compared to competition bicycling
      for younger and older healthy adults
    

Detailed description: 
      Participants will attend one session lasting about 1.5 hours. They will complete a
      competitiveness assessment and a questionnaire about physical activity. They will then
      exercise in three different virtual reality augmented bicycling conditions while wearing a
      head mounted display (goggles). Each of the three conditions will last approximately 5
      minutes and will be followed by questionnaires about the participant's experience.
    

Intervention name(s): Virtual reality bicycling
Intervention type(s): Other
Intervention description(s): This is a single arm study in which all participants will execute the same three bicycling tasks over one session (see arm/group description).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: competition; exercise; bicycling; aging; virtual reality
A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
Condition: Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorder, Intrinsic
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias; Dyssomnias; Sleep Disorders, Intrinsic; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the long-term efficacy and safety of treatment with esmirtazapine (Org 50081,
      SCH 900265, MK-8265) compared to placebo, in participants with chronic primary insomnia.
      Primary efficacy variable is Total Sleep Time (TST).
    

Detailed description: 
      Insomnia is a common complaint or disorder throughout the world. About one third of the
      population in the industrial countries reports difficulty initiating or maintaining sleep,
      resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer
      chronically from their complaints.

      The maleic acid salt of Org 4420, code name Org 50081 (esmirtazapine), was selected for
      development in the treatment of insomnia. The first clinical trial with esmirtazapine was a
      proof-of-concept trial with a four-way cross-over design. All 3 esmirtazapine dose groups
      showed a statistically significant positive effect on TST (objective and subjective) and Wake
      Time After Sleep Onset (WASO), as compared to placebo.

      The current study is designed to assess the long-term efficacy and safety of esmirtazapine in
      a double-blind, randomized, placebo-controlled, parallel group outpatient trial in
      participants suffering from chronic primary insomnia. During the 6-month treatment period,
      participants are randomly assigned to receive either esmirtazapine or placebo. Then, during
      the 7-day discontinuation period, participants who received esmirtazapine in the 6-month
      treatment period are randomly assigned to receive either esmirtazapine or placebo, while
      participants who received placebo in the 6-month treatment period continue to receive
      placebo.
    

Intervention name(s): Esmirtazapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One esmirtazapine 4.5 mg tablet once a day; One placebo tablet once a day
Intervention MeSH terms: Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: placebo controlled; randomized; double blind
A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected Women
Condition: HIV; AIDS
Study type: Observational

Summary: 
      The purpose of this research sub-study is to learn about the levels of an antiretroviral
      (ARV) medication called Raltegravir, and response to HIV virus in the genital tract of
      HIV-positive women.

      We would like to see how this study medication is tolerated, and how the body processes the
      study medication in women who are HIV-positive. More specifically, we are interested in how
      Isentress® might penetrate into the female cervicovaginal secretions thereby potentially
      reducing the amount of HIV in those secretions. A reduction in the amount of HIV in genital
      secretions may prevent female subjects from transmitting HIV to their sexual partners. This
      information will help the research team know how a medication such as Isentress® might be
      used to prevent the sexual transmission of HIV.
    

Detailed description: 
      Purpose: This study aims to characterize the pharmacokinetics of raltegravir in
      cervicovaginal fluids of HIV-infected women, and compare this to the blood plasma
      pharmacokinetics being obtained in the main study, CID 0706.

      Participants: Six HIV-positive women from the CID 0706 study Procedures: During the
      pharmacokinetic visit to obtain blood plasma in the CID 0706 study, women will be asked to
      self-collect cervicovaginal samples using a vaginal aspirator at the following timepoints:
      pre-dose and 1, 2, 4, 6, 8, and 12 hours after raltegravir 400mg dose administration.
    

Intervention name(s): Raltegravir (Isentress®)
Intervention type(s): Drug
Intervention description(s): 400 mg p.o. BID x 7 days
Other intervention name(s): ISENTRESS; MK-0518
Intervention MeSH terms: Raltegravir Potassium
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        UNC ID Clinic, Durham County Health Department, Wake County Health Department
      
Biospecimen description: 
      blood specimens and cervicovaginal fluids
    
Keywords: Pilot; Pharmacokinetics; Raltegravir; Cervicovaginal; HIV; Women
Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection
Condition: Colorectal Cancer; Adenomatous Polyps; Adenoma; Advanced Adenoma
MeSH terms: Colorectal Neoplasms; Adenoma; Adenomatous Polyps
Study type: Observational

Summary: 
      Exploration of a novel rbcDNA liquid biopsy technique for early detection of colorectal
      cancer is a promising development in the field of disease diagnosis and screening. This
      technique has the potential to establish an efficient and sensitive system for the early
      detection of colorectal cancer, which can provide a new perspective for individual health
      monitoring.
    

Detailed description: 
      Patients who are at high risk of developing colorectal cancer and willing to undergo
      colonoscopy examination will be asked to collect a stool sample prior to bowel preparation
      for commercially available FIT (fecal immunochemical test) assay, as well as a blood sample
      for rbcDNA testing. The colonoscopy and histopathologic examination will be used as a
      reference for the results obtained from these tests.
    

Intervention name(s): rbcDNA test
Intervention type(s): Diagnostic Test
Intervention description(s): fecal immunochemical test
Other intervention name(s): FIT
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects advanced adenomas and patients with confirmed CRC
Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on
      Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes
      mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
    


Intervention name(s): Sotagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sotagliflozin 400 mg, once daily before the first meal of the day; Placebo, once daily before the first meal of the day
Other intervention name(s): LX4211
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
PK/PD Study of Gan & Lee Insulin Aspart Injection vs. US & EU NovoLog®/NovoRapid® in Healthy Males
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin
      Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference
      Products) in healthy male subjects

      Secondary objectives:

      To compare the PK and PD parameters of the three insulin aspart preparations

      To evaluate the single dose safety and local tolerability of the three insulin aspart
      preparations
    


Intervention name(s): Gan & Lee Insulin Aspart
Intervention type(s): Drug
Intervention description(s): All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.
Other intervention name(s): NovoRapid® EU; NovoLog® US
Intervention MeSH terms: Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Insulin; Diabetes Mellitus; Basal; Bolus
CO-ADAPT: Adaptive Environments and Conversational Agent Based Approaches for Healthy Ageing and Work Ability
Condition: Work Related Stress; Psychologic Adaptation
MeSH terms: Occupational Stress
Study type: Interventional

Summary: 
      The purpose of this study is to identify effective methodologies to help people improve their
      ability to adapt to psychological stress.
    

Detailed description: 
      The subjects involved will follow a Stress Management Training (SMT) to learn some techniques
      to manage stress in the workplace and to increase the effectiveness of the intervention will
      use an APP and a Conversational Agent (CA) an Artificial Intelligence (AI).

      The purpose of the smartphone Application (APP) and CA will be to help people identify their
      thoughts, help them understand their emotions and the events that generated them.

      The data collected and analyzed will be integrated into artificial intelligence to improve
      understanding of what people are writing.

      Based on these analyses, it will be possible to identify the many different variables that
      interact in cases where a subject shows signs of stress related to adapting to change in the
      work environment and possible resilience factors that contribute to decreasing the state of
      stress.

      Tests will be administered at the beginning, at the end of the meetings, and 3 months after
      the end of the sessions. Subjects will be divided into various groups to understand whether
      APP and CA have a significant impact in increasing psychological well-being and stress coping
      strategies.
    

Intervention name(s): SMT; App CA
Intervention type(s): Behavioral; Device
Intervention description(s): Standard 8 SMT (Stress Management Training) psychological interviews.; An APP together a CA (Conversational Agent).
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Subjects who will participate in the study voluntarily will be given some pre-intervention tests (T1) to assess their psychological well-being, to understand the main coping strategies they employ to manage stress, general stress, and the presence of cognitive impairment. Questionnaires will be used to collect data and exclude those subjects who do not meet the inclusion criteria.
Subjects included in the research will be randomly divided into 4 groups, one group will receive a standard 8 SMT (Stress Management Training) psychological interviews, one group will receive 8 (SMT) psychological interviews and subjects will use an APP together with a CA (Conversational Agent), one group will receive only the APP and the CA, one group will be placed in waiting-list.
After the closing of the pathway (T2) the subjects will receive the same questionnaires they received at the beginning and again after 3 months (T3).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: work related stress; Psychological Adaptation
Efficacy and Safety of the Combined Oral Contraceptive (COC) NOMAC-E2 Compared to a COC Containing DRSP/EE (292001)(COMPLETED)(P05724)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding
      patterns (cycle control), general safety and acceptability of the nomegestrol
      acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged
      18-50 years.
    


Intervention name(s): NOMAC-E2; DRSP-EE
Intervention type(s): Drug; Drug
Intervention description(s): Nomegestrol Acetate and Estradiol Tablets, 2.5 mg
NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).; Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year).
Other intervention name(s): SCH 900121; SCH 900121
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Investigate Drug-Drug Interaction Between MT-7117 and Test Drugs in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Study is to investigate drug levels in the blood after taking single or multiple doses of the
      study drug, MT-7117, in healthy adults when taken together with another drug. This study will
      also look at the safety and the body's ability to tolerate MT-7117
    


Intervention name(s): MT-7117
Intervention type(s): Drug
Intervention description(s): MT-7117
Other intervention name(s): Dersimelagon
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Primary purpose: Other
Depression Treatment and Economic Empowerment
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      This pilot study randomized 48 depressed rural Bangladeshi housewives to either intervention
      or control groups. The intervention groups received depression treatment and a financial
      empowerment intervention.
    

Detailed description: 
      This study was conducted in the rural Sirajganj region of Bangladesh. Working with the
      International Centre for Diarrhoeal Disease Research, Bangladesh and a local NGO, we
      recruited 48 depressed rural housewives for the study. Participants were randomized into
      intervention in control groups. The intervention groups (n=24) received 12 sessions of
      evidence based depression treatment, financial literacy education, agricultural training and
      skill building. They opened bank accounts and saved for six months. At the end of the six
      month period, participants who had met savings and attendance requirements received a cash
      transfer of approximately $186, which was used to purchase a productive asset. 22
      participants purchased an agricultural animal, usually a goat; 1 financed a small retail
      business, and 1 leased land to grow crops for sale. Depression scores on the PHD-9 were
      sharply reduced. The study had 100% retention.
    

Intervention name(s): Group based treatment
Intervention type(s): Behavioral
Intervention description(s): 12 sessions of group based therapy that included cognitive restructuring, behavioral activation, and interpersonal therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 48 women randomized to either intervention or control.
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability of Lacidipine and Telmisartan Fixed Dose Combination Tablets Relative to Separate Tablets in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to compare the bioavailability of Lacidipine and Telmisartan administered as fixed dose
      combination tablets with the separate Telmisartan and Lacidipine tablets.
    


Intervention name(s): Lacidipine and Telmisartan fixed dose combination (FDC) tablet; Lacidipine; Telmisartan
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Telmisartan; Lacidipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Emerging adulthood is a period of heightened vulnerability for problematic alcohol use.
      Considerable research has been devoted to reducing alcohol risks in college student
      populations, though far less effort has focused on their noncollege-attending peers. Research
      targeting nonstudent emerging adults is critical as this group is at risk for experiencing
      alcohol-related harms. Consequently, the main objective of the present study was to examine
      the preliminary efficacy of a brief personalized feedback intervention (PFI) tailored for
      nonstudent at-risk drinkers.
    


Intervention name(s): Personalized Feedback Intervention
Intervention type(s): Behavioral
Intervention description(s): The current intervention included personalized feedback regarding their alcohol consumption, alcohol-related consequences, gender-specific normative drinking comparisons, personal risk factors (e.g., dependence symptoms, family history of alcoholism), and alcohol expectancies. The intervention also included didactic material related to alcohol (e.g., effects at different BAC levels, tolerance) and drinking moderation strategies. The feedback was presented graphically in a feedback report with the individual's information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention