bioihbjkbjnl/mcl2 huggingface dataset:
Local Anesthetic Continuous Preperitoneal Infiltration and Wound Hyperalgesia
Condition: Pain, Postoperative
MeSH terms: Hyperalgesia; Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      In this multicenter, randomised, placebo-controlled, double-blind trial, hyperalgesia area
      around the scarce following colorectal laparoscopic surgery (piece removal) will be assessed
      in 3 groups of patients : group 1: continuous ropivacaine preperitoneal infusion, group 2 :
      intravenous lidocaine infusion, or group 3 : control group without local anesthetics. All
      patients will receive parenteral analgesia combining acetaminophen and morphine.
    

Detailed description: 
      Besides hyperalgesia assessment, immediate postoperative and long-term pain, morphine
      consumption, and endocrin-metabolic response will be evaluated in this study.
    

Intervention name(s): continuous ropivacaine preperitoneal infusion; intravenous lidocaine infusion; parenteral analgesia combining acetaminophen and morphine; NaCl
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours; Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours; parenteral analgesia combining acetaminophen and morphine; NaCl
Intervention MeSH terms: Acetaminophen; Lidocaine; Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain, postoperative; Local infiltration; Hyperalgesia, postoperative; Local anesthetic, ropivacaine, lidocaine; Colorectal laparoscopic surgery; Pain management after colorectal laparoscopic surgery
Physical Training in Sarcoidosis Patients
Condition: Sarcoidosis
MeSH terms: Sarcoidosis
Study type: Interventional

Summary: 
      Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent
      problems in sarcoidosis. These physical impairments are disabling and affect quality of life
      in a negative way. The aetiology of these physical impairments is multifactorial. Physical
      inactivity can cause deconditioning, resulting in more perceived fatigue and muscle weakness.
      These symptoms may be partially reversible following a structured physical training program.
      However, scientific studies about physical training in sarcoidosis are lacking. Therefore,
      the aim of the present study is to examine the changes in fatigue complaints, physical
      functioning and quality of life (QOL) in patients with sarcoidosis following a 13-week
      physical training program.

      After obtaining written informed consent, sarcoidosis patients will start a 13-week physical
      training program for three times a week. This training program includes peripheral muscle
      training for both the upper and lower extremities (starting at 40% of the multiple-repetition
      maximum) and endurance training consisting of walking on a treadmill (starting at 60% of the
      speed of the 6-minute walk test) or cycling on a ergometer (starting at 50% of the Wmax).

      Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after
      ending the training. During these assessments, patients perform muscle strength (m.
      quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance
      cycling test). They also complete several questionnaires:

      Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment
      instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical
      Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale
      (HADS)
    


Intervention name(s): Physical training; Physical training
Intervention type(s): Other; Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Training program; Resistance training; Endurance training; Muscle strength; Exercise capacity; Fatigue; Quality of life
Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine
Condition: Prevention of Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects
      aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose
      (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2
      doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine)
      at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
    

Detailed description: 
      A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects
      aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose
      (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2
      doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine)
      at 0 and 28 days of immunization program to observe the Immunogenicity and safety.

      Immunogenicity observation Venous blood (2.5-3.0ml) was collected from all subjects before
      the first dose and 30 days after the full dose, and serum was separated for detection of
      Hemagglutination Inhibition antibodies against four influenza virus serotypes (H1N1, H3N2, B
      (V), B (Y)).

      Safety observation All AE within 30 minutes of each dose, solicited adverse events at 0-7
      days, non-solicited adverse events at 0-28 days (first dose) /30 days (second dose), and all
      serious adverse events from the first dose to 6 months after the full dose were collected.
    

Intervention name(s): Investigational Vaccine(0.25ml/vial); Investigational Vaccine(0.5ml/vial); Active compared Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subjects were vaccinated with a dose of low-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.; Subjects were vaccinated with a dose of high-dose Investigational vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.; Subjects were vaccinated with a dose of active compared vaccine on day 0 and day 28 respectively.The site of inoculation for infants aged 6-11 months is the anterolateral thigh, and the site of inoculation for infants aged 12-35 months is the lateral deltoid muscle of the upper arm.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety Oral Contraceptive Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the study drug is effective in prevention
      of pregnancy in healthy women in reproductive age
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)
Intervention type(s): Drug
Intervention description(s): Oral administration of YAZ (0.02mg ethinyl estradiol-ß-cyclodextrin clathrate and 3mg drospirenone, 24 day hormone tablets followed by 4 days of placebo tablets for 13 cycles
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oral contraception
Inflammation and Daily Life Study
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      UCLA researchers looking for healthy individuals (age 45-60) to participate in a study
      investigating whether an anti-inflammatory medication can impact daily life experiences.

      Everyday for four weeks, participants will take either an anti-inflammatory medication
      (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily
      questions during the 2-week period. Participants will also fill out questionnaires and
      complete a few tasks on the computer: once prior to the 2-week period and once immediately
      after the 2-week period, both during online study sessions.
    

Detailed description: 
      Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will
      first complete a structured telephone interview in order to assess eligibility.

      The study will begin with filling out questionnaires, as well as an online session to
      complete some tasks. You will then be randomly assigned to take either an anti-inflammatory
      medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the
      following two weeks. You will also be contacted by text message to remind you to take your
      pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires
      once daily. After the two weeks are over, you will again complete questionnaires and the
      online study session with tasks. Finally, two weeks after the second session, you will
      receive an email to fill out questionnaires online.
    

Intervention name(s): Naproxen; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day); Half of the participants will be randomly assigned to receive a placebo pill twice daily
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Immune system; Social psychology; Health psychology
A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst
Condition: Blastocyst Disintegration
MeSH terms: Embryo Loss
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study was conducted to evaluate and compare cryo-survival, re-expansion, and
      implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM)
      according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama
      protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).
    

Detailed description: 
      Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using
      open system on cryotopvit. device and thawed with gradual thawing technique using HM
      according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast
      Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit.
      Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then
      transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple
      pregnancy and abortion were recorded.
    

Intervention name(s): home made vitrification & thawing kit; commercially made vitrification & thawing kit
Intervention type(s): Biological; Biological
Intervention description(s): home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too; commercially available vitrification & thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1 blastocysts were vitrified with the Vit (home made) HM according to shady grove protocol using open system on cryotop vit. device and thawed with gradual thawing technique using HM thawing media according to Kuwayama protocol.
Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kit using open system on cryotop vit. device and thawed using Global fast thaw kit. Blastocysts were assessed immediately for survival, subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.
Masking: Double (Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: vitrification; blastocysts; home-made media
Dietary Conjugated Linoleic Acid (CLA) Intake Among Students in Italy
Condition: CLA Intake From Different Food Sources
Study type: Observational

Summary: 
      40 healthy subjects were recruited using advertisements posted at the Catholic University of
      Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a
      Gima scale) of each subject were measured and the body mass index (BMI) was calculated
      (kg/m2). Subjects who satisfied inclusion criteria were instructed on how to document all
      food and drink consumed daily for 3 days using a diary previously used in the Italian
      National Survey INRAN-SCAI. They were asked to eat as usual in subsequent 3 days to emulate
      as best their habits. They were educated to report also the place, time, number and quantity
      of serving portions consumed. If they were not able to weight exactly each portion, a
      photographic atlas developed for the Italian component of the European Prospective
      Investigation into Cancer and Nutrition (EPIC) study was used. At the end of the three days
      the food diaries were checked and for each subject the energy intake was estimated.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        40 healthy students
Upper Extremity Force-velocity Profile in Swimmers
Condition: Upper Extremity Injury
MeSH terms: Arm Injuries
Study type: Observational

Summary: 
      The aim of this study was to measure the changes in the upper extremity force-velocity
      profile of young swimmers at different training periods during a training season
    

Detailed description: 
      Tested at each experimental test time point (Baseline: E1, post-general preparation: E2,
      post-specific E3 and post-competition season: E4). To measure the upper extremity
      force-velocity parameters, the countermovement push-up test was performed using the force
      plate
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Observational during 16 weeks
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Health young swimmers in competitive club
      
Keywords: swimming; performance; strength; plyometric
A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of the study is to demonstrate the bioequivalence of the proposed commercial
      neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet
      formulation (40 mg tablet strength x 6) under fed and fasted conditions in healthy subjects.
    

Detailed description: 
      The study will be an open label, randomized, 4 period, 4 treatment, 4 sequence (Williams
      design), cross over.
    

Intervention name(s): Neratinib; Neratinib; Neratinib; Neratinib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, a 240 mg single oral dose; Tablet, a 240 mg single oral dose; Tablet, a 240 mg single oral dose; Tablet, a 240 mg single oral dose
Other intervention name(s): HKI-272; HKI-272; HKI-272; HKI-272
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cohorts will be selected from healthy volunteers.
      
Biospecimen description: 
      Plasma
    
Keywords: Neratinib
Diagnostic Accuracy Comparison Between Telemedicine and Face-to-face Consultations in Respiratory Infection Patients.
Condition: Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      This is a randomized study that sought to analyze the diagnostic accuracy of the telemedicine
      consultation of patients suspected of respiratory tract infections during COVID-19 pandemic
      in comparison with the face-to-face evaluation at the emergency department.
    

Detailed description: 
      Unicentric, prospective and randomized study performed between September and November 2020
      with adult patients who sought care at emergency department. The inclusion criterion was the
      exhibition of any tract respiratory symptom. Patients older than 65 years, with chronic heart
      or lung diseases or immunosuppressed were excluded. Eligible patients were randomized 1:1 for
      a brief telemedicine consultation, blinded to subsequent face-to-face evaluation or direct
      face-to-face evaluation.
    

Intervention name(s): Telemedicine Consultation; Face-to-face Consultation
Intervention type(s): Other; Other
Intervention description(s): Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.; Direct face-to-face evaluation (without telemedicine consultation before).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Telemedicine; Respiratory Tract Infections; Emergency Medical Services; Referral and Consultation; COVID-19
An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic Hepatitis C Virus (HCV-1) and Human Immunodeficiency Virus (HIV-1)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome; HIV Infections; Coinfection; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given
      with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of
      hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human
      immunodeficiency virus (HIV-1).
    

Detailed description: 
      This is an open-label (both participant and investigator know the name of the medication
      given at a certain moment), single-arm, multicenter study in HCV treatment-naive and
      treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the
      efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist
      of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up
      period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given
      with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will
      continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or
      48 weeks depending on the patient's prior HCV treatment status, liver disease status, and
      individual on-treatment virologic response in this study (equal response guided therapy). The
      maximum total duration of participation in the study for an individual participant will be
      approximately 76 weeks (screening included). Approximately 150 patients infected with both
      chronic HCV-1 and HIV-1 are planned to be enrolled.
    

Intervention name(s): Telaprevir; Ribavirin; Pegylated-Interferon-alfa-2a
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.; Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.; Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Genotype 1 chronic hepatitis C; Treatment experienced with HCV-1/HIV-1 coinfection; Telaprevir; Pegylated-Interferon-alfa-2a; Ribavirin; HCV-1/HIV-1 coinfection; Hepatitis C
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy Adults
Condition: Healthy People
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety
      and pharmacodynamic of QL1206 and Xgeva® in healthy adults.
    

Detailed description: 
      This is a phase I,single center, randomized, double-blind and parallel group clinical trial .

      The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous
      injections of QL1206 or Xgeva® in healthy volunteers.

      The secondary objective are to assess the Clinical safety and immunogenicity similarity of
      single and subcutaneous injections of QL1206 or Xgeva® in healthy volunteers.

      Meanwhile，observing the pharmacodynamic similarities of QL1206 or Xgeva® preliminarily.

      Subjects would receive a single 120mg（1.7ml） of QL1206 or through subcutaneous injection.
    

Intervention name(s): QL1206; Xgeva®
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.; subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.
Other intervention name(s): Denosumab Injection
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
Condition: Hay Fever; Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal
      spray for long term use in relieving symptoms in perennial allergic rhinitis.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hay Fever; Allergic Rhinitis; Perennial Allergic Rhinitis; Ciclesonide