bioihbjkbjnl/mcl2 huggingface dataset:
Obstetric Anaesthesia And Analgesia Month Attributes - International
Condition: Obstetric Anesthesia Care
Study type: Observational

Summary: 
      A national survey of current practices, preferred drug and technique choices for obstetric
      anesthesia and analgesia in Czech Republic and Slovak Republic.
    

Detailed description: 
      A one month-long project monitoring an obstetric anesthesia practices in obstetric/anesthesia
      departments throughout the Czech Republic.

      Electronic Case Report Form (eCRF) is used to collect data on all obstetric anesthesia
      procedures in peripartal period and obstetric and anesthesia complications. All consecutive
      cases in each participating center during the study period are recorded. Each record is
      related to parturient and contains the following sections: history, form of labour analgesia,
      type of anesthesia for Cesarean section and anesthesia in third stage of labor.
    

Intervention name(s): Obstetric anesthesia and analgesia
Intervention type(s): Procedure
Intervention description(s): All anesthesia procedures during labor: labor analgesia, anesthesia for Cesarean section, anesthesia for procedures in third stage of labor
Intervention MeSH terms: Anesthetics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women in labor
Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
Condition: Skin Aging
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will confirm the efficacy and safety of a single topical administration of
      botulinum toxin type A compared to placebo control for the treatment of moderate to severe
      crow's feet lines
    


Intervention name(s): Placebo; Botulinum Toxin Type A
Intervention type(s): Drug; Drug
Intervention description(s): Placebo, Dose B; dose applied to the lateral canthal lines; Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess up to 12 different oral formulations of apremilast to determine how
      much apremilast is absorbed by the body compared to a reference formulation.
    

Detailed description: 
      This will be a single-center, open-label, crossover, single modified-release-dose study in
      adult males to evaluate the pharmacokinetics (PK) of prototype modified-release (MR)
      formulations compared to the reference immediate-release (IR) apremilast formulation. Within
      4 separate groups, participants will be randomly assigned to a treatment sequence. A total of
      up to 12 test MR formulations may be evaluated.

      Group 1: A 4-sequence, 4-period design to compare three modified-release prototypes with the
      reference immediate-release formulation. A total of 16 participants will be enrolled to
      obtain at least 12 participants who complete all 4 periods.

      Group 2: A 4-sequence, 4-period design to compare three MR prototypes with the reference IR
      formulation. Sixteen participants will be enrolled to obtain at least 12 participants who
      complete all four periods.

      Group 3: A six-sequence, three-period design to compare two MR prototypes with the reference
      IR formulation. Eighteen participants will be enrolled to obtain at least 12 participants who
      complete all three periods.

      Group 4: A 10-sequence, 5-period design to compare four MR prototypes with the reference IR
      formulation. Thirty participants will be enrolled to obtain at least 20 participants who
      complete all five periods.
    

Intervention name(s): Apremilast Immediate Release; Apremilast Modified Release 1; Apremilast Modified Release 2; Apremilast Modified Release 3; Apremilast Modified Release 4; Apremilast Modified Release 5; Apremilast Modified Release 6; Apremilast Modified Release 8; Apremilast Modified Release 9; Apremilast Modified Release 11; Apremilast Modified Release 12; Apremilast Modified Release 13; Apremilast Modified Release 14
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 30 mg immediate release tablets; 75 mg oral tablet of prototype modified release (MR) 1; 75 mg oral tablet of prototype MR 2; 75 mg oral capsule of prototype MR 3; 75 mg oral capsule of prototype MR 4; 75 mg oral capsule of prototype MR 5; 75 mg oral capsule of prototype MR 6; 80 mg oral capsule of prototype MR 8; 80 mg oral capsule of prototype MR 9; 80 mg oral capsule of prototype MR 11; 80 mg oral capsule of prototype MR 12; 80 mg oral capsule of prototype MR 13; 80 mg oral capsule of prototype MR 14
Other intervention name(s): Otezla; CC-10004
Intervention MeSH terms: Thalidomide; Apremilast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Apremilast; Healthy male subjects; Pharmacokinetics
Effects of Systemic Lidocaine on Postoperative Quality of Recovery After Robot-assisted Thyroidectomy
Condition: Thyroid Cancer
MeSH terms: Thyroid Neoplasms
Study type: Interventional

Summary: 
      Systemic lidocaine infusion may improve the patients' recovery quality and chronic post
      surgical pain after robot-assisted thyroidectomy
    


Intervention name(s): Systemic intravenous lidocaine infusion; normal saline infusion
Intervention type(s): Drug; Drug
Intervention description(s): In group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia. After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU.; In group C, the patients receive same volume of normal saline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Systemic lidocaine, Intravenous lidocaine infusion, postoperative pain, quality of recovery, Robot-assisted thyroidectomy, thyroid cancer
Internet-administered CBT for Young Adults With Low Self-esteem
Condition: Self Esteem
Study type: Interventional

Summary: 
      The study will investigate a CBT based treatment approach for low self-esteem among young
      adults.
    


Intervention name(s): Cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): Internet-based CBT intervention based on CBT theory, self-determination theory and self-compassion therapy for low self-esteem among young adults.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Activity and Cardiovascular Risk in Black Girls
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To conduct a longitudinal study investigating the physical activity patterns, the
      psychosocial predictors of physical activity, and the effects of physical activity changes on
      blood pressure and body fatness in a cohort of African-American girls, ages 11-17.
    

Detailed description: 
      BACKGROUND:

      The study contributed to an underdeveloped area of research. Physical activity is recommended
      as a nonpharmacological means to modify hypertension and obesity, two cardiovascular risk
      factors. African-American women have low levels of physical activity and high rates of
      obesity, hypertension, and mortality from coronary heart disease, diabetes, and hypertensive
      diseases. In 1992, there was an absence of longitudinal data about the physical activity
      habits of African-American girls even though a decline in physical activity during
      adolescence had been reported in other subpopulations.

      DESIGN NARRATIVE:

      Within the framework of puberty and maturation, the study: 1) described longitudinal patterns
      of physical activity; 2) assessed longitudinal changes in physical activity and concomitant
      changes in blood pressure and body fatness; and 3) determined psychosocial predictors of
      changes in physical activity. The investigators hypothesized that there would be a monotonic
      decrease in physical activity and that psychosocial variables would predict changes in
      physical activity. The study population consisted of 189 sixth grade, mostly
      African-American, girls in Fort Bend Independent School District, Missouri City, Texas. The
      girls were measured for four and a half years, ages 11 or 12 at entry of the study.
      Anthropometry, sexual maturation, blood pressure, physical activity habits and psychosocial
      predictors were measured twice a year for a total of nine examinations. Data on dietary,
      smoking and drinking habits were collected annually. Activity patterns, psychosocial
      predictors and other habits were assessed by interviews and questionnaires. Sexual maturation
      was assessed by menarche and the Tanner stages. Skinfold and circumference measures
      determined body fatness and body fat distribution.
A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the multiple dose pharmacokinetics (PK) of two
      gefapixant (AF-219) formulations; to assess the effect of omeprazole on the multiple dose PK
      of two gefapixant formulations; and, to assess the safety and tolerability of gefapixant.
    


Intervention name(s): Omeprazole; Gefapixant; Gefapixant
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg oral capsules administered once daily for 8 days; Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 5 days; Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days
Other intervention name(s): Prilosec; AF-219; MK-7264; AF-219; MK-7264
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteers
Clinical Pilates Exercises On Posture In Patients With Shoulder-Neck Posture Problem
Condition: Posture; Exercise
Study type: Interventional

Summary: 
      This study was designed to investigate the effect of clinic pilates exercise in adult
      patients whith shoulder- neck posture problem. 51 patients with forward head posture(FHP) and
      rounded shoulder posture(RSP) were included in this study and they were randomly divided into
      two groups as clinical pilates (group 1, n=26) and classical posture exercises (group 2,
      n=25). Patients' demographics were recorded. Deep neck fleksor muscle(DNFM) endurance was
      evaluated by pressure biofeedback unit (PBU). Head, neck and shoulder posture were evaluated
      with wall- tragus, wall-acromion, tragus-acromion and chin-sternal notch distance.
      Flexibility for shoulder region was evaluated with back scratch test. The patients were
      evaluated both before the study and 6 weeks later.
    

Detailed description: 
      Fifty-one individuals aged between 20-55 years whose FHP and RSP problems were determined by
      lateral posture analysis were included in the study. However, a total of 12 individuals, 6
      from each of the 2 groups, were excluded from the study because they could not complete the
      treatment sessions. The study was completed with 39 participants.Individuals aged between
      20-60 years, whose FHP and RSP problems were determined by lateral posture analysis, were
      included in the study. Those with severe pain in the neck and shoulder girdle, scoliosis and
      neurological problems and those who had undergone any surgery in the relevant regions were
      not included in the study. The individuals included in the study were randomized by lot and
      divided into 2 groups. Group 1 was given clinical pilates exercises, and Group 2 was given a
      program consisting of classical posture exercises. The exercise programs of both groups were
      performed by the same physiotherapist, and pre- and post-exercise evaluations were made by a
      different physiotherapist.
    

Intervention name(s): Clinical Pilates Exercises; Classic Posture exercise
Intervention type(s): Other; Other
Intervention description(s): clinical pilates exercises methods applied to the 1st group, classical posture exercises methods to the 2nd group for 3 days / week for 6 weeks.; clinical pilates exercises methods applied to the 1st group, classical posture exercises methods to the 2nd group for 3 days / week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Posture; Head and Shoulder; Pilates Based Exercises
Validation of a Novel Diagnostic Tool for the Evaluation of Post Renal Transplant Immunosuppression: The ImmuKnow Assay
Condition: Renal Transplant Recipients
Study type: Observational

Summary: 
      Patients undergoing renal transplantation at London Health Sciences Centre, University
      Hospital and who are participating in the study "A Comparison of Effects of Standard Dose vs
      Low Dose Advagraf with IL-2 Receptor Antibody Induction, MMF and Steroids, With or Without
      ACEi/ARB-based Antihypertensive Therapy on Renal Allograft Histology, Function, and Immune
      Response" will be evaluated with the ImmuKnow Assay to assess the ability of this assay to
      predict underimmunosuppression (rejection) or overimmunosuppression determined by this test
      and to determine retrospectively whether decision making utilizing this novel assay would
      have improved outcomes over standard techniques.

      This study is designed to evaluate an in vitro assay (Cylex®ImmuKnow Assay) for the
      measurement of cell-mediated immune response in renal transplant patients receiving
      immunosuppressive therapy. This assay measures ATP as an activation response of CD4+ cells to
      stimulation with phytohemagglutinin (PHA) in whole blood samples as a reflection of the
      immune system of the patient at any point in therapy. The natural history of the immune
      status of the renal transplant recipient as reflected by the ImmuKnow assay will be
      determined at specific time points of interest including: pre and post transplant, as an
      adjunct to therapeutic drug monitoring, and pre and post infectious or rejection episode.
      Analysis of the results of the assay at these time points will allow us to retrospectively
      study the effects of routine immunosuppressive agent modulation on immune function, and its
      subsequent effects in times of renal allograft insult.
    


Intervention name(s): Cylex ImmuKnow Assay
Intervention type(s): Other
Intervention description(s): This is not an interventional study. However the assay being tested on the samples of all enrolled participants in the Cylex ImmuKnow Assay
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All participants enrolled in this study will be undergoing renal transplantation and will
        have already been consented to the study entitled, "A Comparison of Effects of Standard
        Dose vs Low Dose Advagraf with IL-2 Receptor Antibody Induction, MMF and Steroids, With or
        Without ACEi/ARB-based Antihypertensive Therapy on Renal Allograft Histology, Function, and
        Immune Response."
      
Biospecimen description: 
      Collected blood samples will be discarded immediately following testing
    
Keywords: renal transplant; kidney transplantation; immune status; immunosuppressive medications
Do Benzodiazepines Improve the Outcome of Mechanical Physiotherapy for Lumbar Disk Prolapse
Condition: Pain; Disability; Paresis
MeSH terms: Intervertebral Disc Displacement; Paresis; Prolapse
Study type: Interventional
Phase: Phase 2

Summary: 
      Sixty patients were randomized to receive either placebo or diazepam in addition to
      mechanical physiotherapy and analgesics for the first 7 days of conservative treatment of
      clinically and radiologically confirmed lumbar disk prolapse
    


Intervention name(s): benzodiacepine
Intervention type(s): Drug
Intervention description(s): diazepam (2 x 5 mg/ die)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: physiotherapy; Tuebingen concept; benzodiazepines; muscle relaxants; disc herniation
Energy Value of Lentils and Chickpeas
Condition: Healthy Adults
Study type: Interventional

Summary: 
      This study is being conducted to determine the digestibility of and available energy from
      pulses.
    

Detailed description: 
      Previous studies have demonstrated that the metabolizable energy (energy available to the
      body) from tree nuts is less than predicted by the Atwater factors (the standard approach to
      determining calorie value of a food). The Atwater approach is over 100 years old and is
      inaccurate for some foods. This study will be conducted to determine the metabolizable energy
      from two pulses, lentils and chickpeas. The study will be a human nutrition intervention
      involving consumption of a controlled diet followed by collection of urine and feces.
    

Intervention name(s): Control Diet; Lentil Containing Diet; Chickpea Containing Diet
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans.; Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.; Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
Condition: Healthy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and
      Children (Bridging Study)
    

Detailed description: 
      Too see percentage of subjects with HI titer >= 1:40, 28 days after two doses in infants and
      children (6 months-8 years old) and one dose in children 9-11 years old for each strain.
    

Intervention name(s): Vaccine
Intervention type(s): Biological
Intervention description(s): Flubio (Influenza HA) Vaccine
The vaccine will be given intramuscularly.
Other intervention name(s): Flubio
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Flubio Vaccine (Influenza HA); Infants; Children; Safety; Immunogenicity
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
Condition: Hyperopia; Myopia
MeSH terms: Hyperopia
Study type: Interventional
Phase: Phase 4

Summary: 
      The current study aims to systematically investigate the diurnal variation in the optical
      quality of soft contact lenses on eye throughout the day. Subject reported quality of vision
      will also be evaluated.
    


Intervention name(s): Lotrafilcon B; lotrafilcon B with Hydraluxe
Intervention type(s): Device; Device
Intervention description(s): commercially available contact lens; commercially available contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study
Condition: Pediatric Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Taking part in recommended levels of physical activity in youth with MS may have an important
      and positive impact on disease symptoms, long-term disability and health outcomes.
      Unfortunately, youth with MS are highly inactive. In order to address this issue, the
      investigators have developed an MS-specific mobile application for teens called Active Teens
      with Multiple Sclerosis (ATOMIC). In this research the investigators will evaluate the
      feasibility of using the ATOMIC program in youth with MS. The results of this pilot study
      will provide the data necessary to ensure the ATOMIC program aligns with the needs of youth
      with MS.
    


Intervention name(s): ATOMIC mobile app
Intervention type(s): Device
Intervention description(s): (a) PA Coach, One-on-one Chats. Coaches will conduct three one-on-one phone or video conferencing sessions and will also conduct a text messaging session once per week to reinforce and follow-up on the one-on-one phone sessions during the course of the intervention. (b) PA-Self Monitoring. An activity tracker (Fitbit Charge 2) will be used to allow participants to monitor their activity behaviors (e.g. step counts). (c) PA Information. In addition the coach will send weekly tailored PA informational posts/messages aligned with Social Cognitive Theory (SCT) to all participants. (d) Educational Modules. MS specific web-based interactive PA modules will be provided to patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Trial for Studying Pharmacokinetic Effects of Ketoconazole on CG100649
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the
      pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.
    

Detailed description: 
      -  Adverse Events The whole study discontinuation is determined based on the following
           criteria with Adverse Events classified using US NCI (National Cancer Institute) 'Common
           Terminology Criteria for Adverse Events (CTCAE)

        -  Pharmacokinetic assessment Real sampling times will be used to calculate pharmacokinetic
           parameters. Concentrations below the lower limit of quantification, samplings which are
           not applicable, or missing data will be substituted by "<LLOQ", "NA", or "MD"
           respectively. Pharmacokinetic analyses will be performed on CG100649 only.
    

Intervention name(s): CG100649; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time; I period: ketoconazole + CG100649 II period: CG 100649
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy male volunteers