bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare Self-administered and Nurse-administered Intradermal Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the immunogenicity and reactogenicity of
      self-administered intradermal influenza vaccine (Intanza)to nurse-administered.
    

Detailed description: 
      Participants will be randomized at visit one to either receive self-administered or
      nurse-administered intradermal influenza vaccine (Intanza). A blood sample will be taken
      prior to vaccination and 21 days post-vaccination. Participants will record information in a
      memory aid for 7 days including daily temperatures, solicited, unsolicited and general
      reactions. They will be called on study Day 8 to collect this information. Participants will
      return 21-24 days later for follow-up serology and review of adverse events.
    

Intervention name(s): Intanza; Intanza
Intervention type(s): Biological; Biological
Intervention description(s): 0.1 mL of Intanza intradermally at visit # 1; 0.1 mL of Intanza intradermally at visit #1
Other intervention name(s): Influenza Vaccine (Split Virion, Inactivated); Influenza Vaccine (Split Virion, Inactivated)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Cyclosporine A in Cardiac Arrest
Condition: Non Shockable Out of Hospital Cardiac Arrest
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesised that cyclosporine A administration at the onset of
      cardiopulmonary resuscitation, by inhibiting the mitochondrial permeability transition pore,
      could prevent the post cardiac arrest syndrome and improve outcomes.
    


Intervention name(s): Cyclosporine A; cardio-pulmonary resuscitation
Intervention type(s): Drug; Procedure
Intervention description(s): Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation; usual care of cardiac arrest
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac arrest; heart arrest; cyclosporine A; post cardiac arrest syndrome; protective agent; multiple organ failure; mitochondrial permeability transition pore; mitochondria; cardio-pulmonary resuscitation; cardioprotection; ischemia reperfusion; postconditioning
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      In the current practice patients with normal levels of ALT were not treated. However, a
      percentage of patients will present an advanced grade of fibrosis and cirrhosis.

      Another reason to treat is the similar response to the treatment than elevated ALT patients
      published recently in mono-infected patients.

      The investigators have not data concerning the evolution and response to the treatment in
      co-infected patients with normal ALT.

      In the story of treatment chronic hepatitis C of co-infected patients HCV/HIV, sometimes, it
      assumes a behavior similar between mono and co-infected patients and the results are
      different.

      In the case of normal ALT the investigators do not know if the natural history in co-infected
      patients is similar than the mono-infected patients, and also the response of the treatment.

      This study prospective and controls is the answer of this question. The main hypothesis is if
      the response of treatment in co-infected patients is not inferior than mono-infected
      patients.

      The objective is to evaluate the efficacy and safety of peginterferon alfa-2a and ribavirin
      in HIV positive patients with chronic hepatitis and persistently normal ALT. Every CASE
      (patient with normal ALT) will have a CONTROL (patient with elevated ALT), concerning
      genotype, gender and hospital.
    

Detailed description: 
      The treatment of co-infected patients with normal ALT would be very important because the
      evolution of cirrhosis in this patients is quicker and frequently than mono-infected
      patients.
    

Intervention name(s): Peginterferon alfa-2a + ribavirin in normal ALT; Peginterferon alfa-2a + ribavirin in elevated ALT
Intervention type(s): Drug; Drug
Intervention description(s): peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily; peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
Other intervention name(s): Pegasys + ribavirin; Pegasys + ribavirin
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis C; normal ALT; HIV/HCV patients
Monopolar Radiofrequency Versus Pulsed Dye Laser for Treatment of Acne Scars
Condition: Acne Atrophica
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      Background: The acne scar is a common disorder characterized by skin eruption or
      abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic
      appearance.

      Purpose: The main aim of this study was to investigate whether monopolar radiofrequency (MRF)
      or pulsed dye laser (PDL) is more effective in the cases suffering from acne scars in the
      form of reducing acne scars and improving the cosmetic appearance.
    

Detailed description: 
      Thirty patients suffering from moderate or severe acne scars were randomly assigned into two
      equal groups. Group A (MRF group): received 2 sessions per week with MRF for 8 weeks. Group B
      (PDL group): received 1 session per week with PDL for 8 weeks. The severity of acne scars was
      assessed before and after treatment by using the clinical evaluation scale for acne scarring
      (ECCA) scale and the self-assessment of clinical acne-related scars (SCARS) scale. Quality of
      life and the emotional impact of acne scars were evaluated by the facial acne scar quality of
      life (FASQoL) scale.
    

Intervention name(s): Monopolar radiofrequency; Pulsed dye laser
Intervention type(s): Device; Device
Intervention description(s): The RF electrode was moved randomly for 30 seconds over each scar. The total duration of the treatment session is only 5 minutes for each cheek. It takes 15 minutes if the forehead and 2 cheeks are affected.; PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Acne scars; Monopolar radiofrequency; Pulsed dye laser
The Effect of Aerobic Exercise, on Fitness and Functional Muscle Strength, in Patients With Muscular Dystrophy
Condition: Bethlem Myopathy
MeSH terms: Muscular Diseases; Contracture; Muscular Dystrophies
Study type: Interventional

Summary: 
      Muscular dystrophy is a group of disorders that are characterized by progressive muscle
      weakening and loss of muscle mass, caused by defects in muscle proteins. Muscular dystrophy
      is almost always inherited disorders, and so far, no curative treatments exist.

      Previous studies have shown that endurance training significantly improves fitness and
      self-assessed muscle function in a variety of muscular dystrophies. In this study, we wish to
      investigate whether patients with Bethlem myopathy (a specific form of muscular dystrophy)
      also benefit from endurance training.

      The study consists of two test days, a 10-week training period and five blood tests.

      Patients will be required to train, three times per week, for 10 weeks, on a bike ergometer
      with a specific training intensity, under pulse rate monitoring.

      The training period will be flanked by two test days, where we will determine, and compare
      the patients' muscle strength and fitness level, from before to after the training program.
      The patients conditioning level will be determined from a 15 minute cycle ergometer test and
      patients will undergo three functional tests to determine their functional muscle strength.

      We will as a safety measure analyze blood tests before, during and after the training program
      for the muscle enzyme creatine kinase (an indicator of muscle damage) and through adverse
      effects as reported by patients during weekly telephone-consultations with the Principal
      investigator.

      We anticipate, that Bethlem myopathy patients will have a similar rise in fitness level and
      functional muscle strength, as that seen in patients with other forms of muscular dystrophy,
      who undertake a similar training program.
    


Intervention name(s): Moderate-intensity training
Intervention type(s): Behavioral
Intervention description(s): Training at 70% of VO2max, for 1/2 hour, three times weekly, for 10 weeks, on a bike ergometer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Aerobic training; VO2max; Bethlem myopathy
Early Onset Preeclampsia and Nectin-4
Condition: Pre-Eclampsia; Early Onset Preeclampsia; Oxidative Stress; Immunologic Diseases in Pregnancy
MeSH terms: Pre-Eclampsia; Eclampsia; Immune System Diseases
Study type: Observational

Summary: 
      Early-onset Preeclampsia (PE) is a pregnancy disorder which may present with adverse
      pregnancy outcomes. Nectin-4 is an adhesion molecule mainly expressed in placenta. This study
      aimed to evaluate the relationship between early onset Preeclampsia and serum Nectin 4
      levels.
    

Detailed description: 
      Preeclampsia is assumed as a two-stage disorder arising from defective trophoblast invasion
      and failure of spiral artery remodeling as the main step responsible for the pathogenesis. PE
      is classified according to the disease onset time as early-onset PE before 34 weeks and
      late-onset PE after 34 weeks. Late-onset PE is more commonly seen and accepted as a mild
      maternal reaction to pregnancy. In early-onset PE, unlike the late-onset, due to the improper
      placental invasion, the diffuse placental ischemia and the resulting oxidative stress begin
      at early gestation. Thus, the early-onset PE may result in severe disease leading to
      perinatal and maternal morbidity and mortality.

      The nectins are calcium-independent immunoglobulin-like celladhesion molecules and have a
      pivotal role at cellular junctions, as well as physiological regulations(8). Placenta
      expressesfor types of nectins; nectin-1, nectin-2, nectin-3, and nectin-4. They are localized
      at tight junctions and gap junctions of syncitiotrophoblasts(9). Nectin-4 is a relatively
      novel member of nectin family which has been detected only in placenta and airway epithelium
      in healthy subjects.

      Despite, there has been no study published yet to reveal the soluble nectin-4 levels in
      preeclampsia as well as in early onset disease. In this study, we aimed to investigate the
      serum nectin-4 levels in early-onset preeclampsia in comparison of the healthy pregnancies.
    

Intervention name(s): serum marker levels
Intervention type(s): Diagnostic Test
Intervention description(s): two groups comparisons
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Comparison to the level of soluble nectin-4 in early-onset PE, compared to healthy
        pregnancies
      
Keywords: early onset preeclampsia; nectin-4; advers pregnancy outcome; hypertansion
A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows
      efficacy against malaria infection when tested in UK volunteers using sporozoite challenge
      experiments. It is a leading candidate vaccination strategy against malaria. In the field,
      Phase I studies have been conducted in adults in Kenya and The Gambia and children and
      infants in The Gambia. The vaccination strategy appears safe and well tolerated in these
      populations, and also shows impressive immunogenicity, not significantly different to that
      seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia
      shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be
      the ones to benefit most from such a vaccine against malaria. With this clinical development
      as background, the investigators now propose to evaluate efficacy against natural malaria
      infection in this important target group for an effective malaria vaccine, that is, 5-17
      month infants and children living in malaria endemic areas. The proposed study area, Banfora,
      Burkina Faso, is highly endemic for Plasmodium falciparum malaria.
    


Intervention name(s): ChAd63 ME-TRAP and MVA ME-TRAP; Rabies vaccine
Intervention type(s): Biological; Biological
Intervention description(s): ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 1 x 10^8 pfu heterologous prime-boost immunisation; Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled
      LAS100977 QD in patients with persistent asthma.
    


Intervention name(s): LAS100977 0.313 μg; LAS100977 0.625 μg; LAS100977 1.25 μg; LAS100977 2.5 μg; Salbutamol 400 μg; Salbutamol placebo; LAS100977 placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dry powder inhalation, once-daily, single-dose; Dry powder inhalation, once-daily, single-dose; Dry powder inhalation, once-daily, single-dose; Dry powder inhalation, once-daily, single-dose; Pressurized inhalation suspension, once-daily, single-dose; Pressurized inhalation, once-daily; Dry powder inhalation, once-daily
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD
Comparison of Emergence Agitation Between Sevoflurane and Desflurane Anesthesia After Orthognathic Surgery
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      Emergence agitation is a major concern in patients undergoing orthognathic surgery. The
      patients may experience the sense of suffocation during emergence due to nasotracheal
      intubation and orofacial edema. Postoperative pain is also associated with emergence
      agitation. Although there is a lot of studies about emergence agitation in children, there is
      a few in adults, furthermore, no data about comparison of emergence agitation between
      sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to
      compare the incidence and severity of emergence agitation between sevoflurane and desflurane
      anesthesia in adults after orthognathic surgery.
    


Intervention name(s): Sevoflurane; Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.; The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon
Condition: Hepatic Flexure Colon Cancer; Proximal Transverse Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and
      oncologically safe
    

Detailed description: 
      Our study is a single arm, single center clinical trial. The enrolled patients will accept
      laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative
      complications, 1-year local recurrence. The second endpoint: conversion to conventional right
      hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year
      disease free survival, R0 resection, Specimen morphometry
    

Intervention name(s): laparoscopic ileocecus-sparing right hemicolectomy
Intervention type(s): Procedure
Intervention description(s): The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatic flexure colon cancer; proximal transverse colon cancer; ileocecus-sparing; laparoscopic right hemicolectomy
Using Flexible Resin in Maxillary Obturators
Condition: Patients Who Had Undergone Partial or Complete Maxillectomy
Study type: Interventional

Summary: 
      Ten patients who had had maxillectomy will be assigned to two groups employing two types of
      'temporary obturators. The obturators in the first group will be made from heat cure acrylic
      resin, whereas those in the second group from flexible resin.

      A comparison will be made between the two materials in terms of oral-nasal seal using the
      drinking water test as well as the mirror test.
    

Detailed description: 
      Oral rehabilitation following partial maxillectomy presents numerous clinical and technical
      issues. Using soft-tissue undercuts in the palatal side of the upper jaw is so useful for
      prostheses' retention over and above the abutment teeth. The use of flexible materials can
      serve this aim. The current study aims to compare the efficacy of nasal-oral seal using
      flexible materials against the traditional method of using heat activated acrylic materials.
    

Intervention name(s): Flexible resin
Intervention type(s): Other
Intervention description(s): This material 'Flexible resin' is going to be used in the construction of the 'flexible obturators'.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single site, parallel randomized, double blinded comparison of the safety,
      pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57
      mg/kg dose of adalimumab (Humira®) reference product from North American and European
      sources. The study is open to healthy individuals on no medications that might confound the
      results of this safety study.
    

Detailed description: 
      This is a single site, parallel randomized, double blinded comparison of the safety,
      pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57
      mg/kg dose of adalimumab (Humira®) reference product from North American and European
      sources. The study is open to healthy individuals on no medications that might confound the
      results of this safety study.

      A total of 90 subjects will be randomized in a 1:1:1 ratio to from a centrally generated
      randomization schedule to SYN060 or adalimumab of American or European sources resulting in
      30 subjects in each group.
    

Intervention name(s): SYN060; Adalimumab North American source; Adalimumab European source
Intervention type(s): Biological; Biological; Biological
Intervention description(s): a single subcutaneous 0.57 mg/kg dose of SYN060; a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American source; a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from European source
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment