bioihbjkbjnl/mcl2 huggingface dataset:
Intrathecal Dexmedetomidine Versus Transversus Abdominus Plane Block (TAP) for Postoperative Analgesia After Cesarean Section.
Condition: Pain Management in Adult Females in Child Bearing Period Aging From 20 to 45 Years Who Are Scheduled for Elective Cesarean Section
Study type: Interventional

Summary: 
      Spinal anesthesia is the most commonly used technique for lower abdominal surgeries as it is
      very economical and easy to administer. However, postoperative pain control is a major
      problem because spinal anesthesia using only local anesthetics is associated with relatively
      short duration of action, and thus early analgesic intervention is needed in the
      postoperative period The transversus abdominus plane (TAP) block is a regional analgesic
      technique which blocks T6-L1 nerve branches and has an evolving role in postoperative
      analgesia for lower abdominal surgeries
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): 60 Patients will be randomly divided into three equal groups:
Group A (n=20) : spinal anesthesia with Dexmedetomidine (5µg ) added to local anesthetic (bupivacaine Hcl ) (10 mg) given intrathecally .
Group B (n=20) : spinal anesthesia using local anesthetic( bupivacaine Hcl) (20 mg) combined with TAP block using Dexmedetomidine (20µg ) after the cesarean section
Group C (n=20) (controlled group ) : Spinal anesthesia using only local anesthetic (bupivacaine Hcl ) (10 mg) .
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Investigational Study of Hydrocortisone
Condition: Adrenal Insufficiency
MeSH terms: Adrenal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate a new drug called Infacort®; a newly-developed immediate release
      formulation of a well-established drug called hydrocortisone. Hydrocortisone is used as a
      replacement treatment for people whose adrenal glands are not producing enough natural
      cortisol - a condition known as adrenal insufficiency. The study will assess how Infacort®
      acts once inside the body, by measuring cortisol and other hormone levels in the body,
      compared to already marketed hydrocortisone tablet and hydrocortisone intravenous (through
      the vein) injection.

      The population who are eligible to take part in the study are healthy male volunteers, aged
      between 18 and 60 years of age.
    

Detailed description: 
      The study will evaluate the normal physiology, PK and metabolism of cortisol, investigate the
      PK and bioavailability of cortisol from the test Infacort® Granules (hydrocortisone) and the
      reference hydrocortisone tablets and i.v injection in healthy adult male volunteers and
      explore the role of cortisol in the regulation of metabolic pathways.
    

Intervention name(s): Hydrocortisone granules; Hydrocortisone Tablet; i.v. Hydrocortisone Injection; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Multi-particulate granules; Standard hydrocortisone tablets; Standard hydrocortisone solution for intravenous injection; Challenge agent
Other intervention name(s): Infacort; Commerical supply; Commerical supply; Non-IMP
Intervention MeSH terms: Dexamethasone; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A phase IV, randomization, single center, controlled clinical trial to compare the safety,
      immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with
      one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young
      adults, and to evaluate the immunogenicity of a booster dose.
    

Detailed description: 
      Healthy undergraduate students aged 16 to 25 years with anti-HAV negative were randomly
      divided into three groups. Group A and B were administrated with one-dose inactivated and
      live attenuated hepatitis A vaccines respectively; Group C was immunized with two doses of an
      inactivated vaccine with 6 months apart. Blood samples were collected at month 1, and 12, 24
      and 36 for anti-HAV titers determination. Safety observation in 30 minutes' duration after
      vaccinations and injection-site reactions and systemic reactions for three consecutive days
      were recorded to assess the safety of investigational vaccines. At Month 36, subjects who
      received one dose of inactivated or live attenuated HAV were administrated a booster dose and
      then were taken blood samples one month later for anti-HAV titers determination.
    

Intervention name(s): Inactivated HAV vaccine; Live attenuated HAV vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Hepatitis A vaccine (Healive), 500 u per dose per 0.5 millilitre. Vaccines will be administered with one-dose or two-dose regimen of the arm 6 months apart in the deltoid muscle.; Live attenuated hepatitis A vaccine, 6.50 lgCCID50 per dose per 0.5 millilitre. Vaccines will be administered with one-dose regimen in the deltoid muscle.
Other intervention name(s): Inactivated hepatitis A vaccines; Live attenuated hepatitis A vaccines
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: inactivated HAV vaccine; live attenuated HAV vaccine; immunogenicity; safety
Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis
Condition: the Treatment of Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The incidence of cartilage pathology has grown due to the ageing population, and the increase
      in sports participation and its associated trauma. The aim of the treatment of symptomatic
      osteoarthritis consists in reducing pain and improving the knee function in order to limit
      the sport, professional and social negative impact in the youngest patients.

      The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti
      inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular
      injections are proposed.

      Intra articular injections of hyaluronic acid are recommended by the American College of
      Rheumatology and the European League against Rheumatism for the treatment of knee
      osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the
      duration of clinical improvement which does not exceed 6 months.

      The articular cartilage has a limited capacity for self-repair due to the low mitotic
      activity of chondrocytes and its avascularity.

      Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and
      the cytokines, liberated by platelet degranulation. The influence of these growth factors in
      the cartilage repair is being widely investigated in vivo and in vitro. These factors could
      stimulate the chondral reparation via a neovascularization, a collagen synthesis and an
      activation of the chondrocytes.

      The hypothesis is that the intra articular injection of PRP, with its capacity to enhance
      articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the
      treatment of knee osteoarthritis resisting the oral drugs.

      Material and methods: We intend to conduct a comparative, monocentric prospective randomized,
      double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results
      of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.
    


Intervention name(s): platelet-rich plasma; durolane
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the
      safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid
      arthritis (RA).
    


Intervention name(s): NNC0114-0006; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. The trial comprises dose escalation up to four dose levels. Progression to next dose will be based on safety evaluation.; Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Menstrual Phase and Postoperative Pain
Condition: Acute Postoperative Pain; Chronic Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Fluctuations of female sex hormones during the menstrual cycle influence pain perception.
      Endogenous pain is pronounced in the follicular phase of the menstrual cycle. The
      investigators tested the primary hypothesis that the women having surgery during their
      follicular phase have more acute pain and require more opioids than those in the luteal
      phase, and secondarily the investigators tested that women who have surgery during their
      follicular phase have more incisional pain at 3 month postoperatively.
    

Detailed description: 
      127 adult females having laparoscopic cholecystectomy were randomized to have surgery during
      the luteal or follicular phase of their menstrual cycle. Standardized anesthesia and pain
      management regimen was given to all patients. Pain and analgesic consumption were evaluated
      in PACU and every four hours in first 24 hours. Adverse effects were also questioned every
      four hours. Time to oral intake and ambulation were recorded. Post-surgical pain, hospital
      anxiety and depression scale, and SF-12 questionnaire were also evaluated at 1- and 3-month
      visits.
    

Intervention name(s): HAD scale; The SF 12 test; Visual analogue score
Intervention type(s): Other; Other; Other
Intervention description(s): The anxiety/depression scale (HAD) was used to assess anxiety and depression.; The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.; Visual analogue score vas used to evaluate pain.
Other intervention name(s): The anxiety/depression scale; SHORT FORM 12; VAS score
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: chronic postoperative pain; menstrual cycle
Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
Condition: Renal Transplantation
Study type: Observational

Summary: 
      This study is designed to define groups of patients (among patients with a heart or kidney
      graft or a glomerular disease and nephrotic range proteinuria) who would either not profit
      from a therapy with mycophenolate-mofetil (MMF) or need a higher than conventional dose to
      respond.

      Mainly there are 2 possible explanations for inter-patient differences in responsiveness to
      MMF therapy:

        1. Based on a mutation (in this study single nucleotide polymorphisms-SNPs-) in the inosine
           monophosphate dehydrogenase 2 (IMPDH 2) transcript as the target enzyme of mycophenolic
           acid (MPA) pathway, MMF cannot exert its effect.

        2. Based on a high enzyme activity of IMPDH 2 a higher MMF dose than in the conventional
           regimens is needed.

      To study the significance of these possible explanations there are 4 objectives in this
      study:

      Objective 1: Since there are no data on SNPs with functional relevance in IMPDH 2 transcript,
      we will first sequence all 14 exons of this gene in their entirety in 100 gender and age
      matched healthy individuals.

      Objective 2: The functional relevance of a detected SNP will be tested in vitro in a
      lymphocyte proliferation assay using various MPA concentrations.

      Objective 3: These functionally relevant SNPs will be searched in patients with kidney graft
      in a retrospective as well as prospective manner.

      Objective 4: Parallel to the genotyping experiments, IMPDH 2 activity and MPA plasma levels
      will be measured in all patients recruited in the study prospectively.

      An association between these SNPs or various IMPDH 2 activity / MPA plasma levels with MMF
      responsiveness will be examined.

      Objective 5: Strongyloides IgG titers are screened to evaluate the prevalence of helminth
      carriers in patients with immunosuppressive therapy.
    


Intervention name(s): MPA SNP
Intervention type(s): Genetic
Intervention description(s): Functional relevant MPA SNP will be sought in patients DNA isolated from leucocytes
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a de novo kidney transplantation
      
Keywords: kidney transplantation; immunosuppression; single nucleotide polymorphism; IMPDH
The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial
Condition: Obstructive Sleep Apnoea; Hypopnoea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      This study aims to investigate the role of the Mediterranean diet in obese patients with
      Obstructive sleep apnoea-hypopnoea syndrome.
    

Detailed description: 
      Obstructive sleep apnoea-hypopnoea syndrome (OSAHS) is considered to be one of the most
      prevalent sleep-related breathing disorders, with an enormous effect on public health.
      Approximately 2-4% of the general adult population experiences some degree of this syndrome.
      This percentage increases even more with obesity, up to 20-40%, especially in individuals
      with an excessive body mass index (BMI) > 30 kg/m2. OSAHS is associated with significant
      systemic consequences, including cardiovascular morbidity and mortality, and the risk
      increases with the severity of the syndrome. The pathophysiology underlying the link between
      OSAHS and the cardiovascular system is attributed largely to systemic inflammation and
      oxidative stress, which are both contributors to endothelial dysfunction. The treatment
      modalities of OSAHS include continuous positive airway pressure (CPAP), weight loss, upper
      airway surgery, and medication. CPAP is the first line therapy, as a means of maintaining
      upper airway patency, and it is well known that this intervention reduces morbidity and
      mortality. In severe cases of OSAHS the weight loss strategy is essential and must accompany
      CPAP treatment. A growing body of evidence in OSAHS supports the beneficial role of weight
      reduction, induced by diet alone or in combination with exercise, leading to a reduction in
      apnoeas and hypopnoeas.We aim to evaluate the effect of the Mediterranean diet compared with
      that of a prudent diet on obese OSAHS patients who were treated with CPAP while receiving
      counselling to increase their physical activity.
    

Intervention name(s): Prudent diet group; Mediterranean diet group
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep apnoea/hypopnoea syndrome; Mediterranean diet; exercise; weight loss; continuous positive airway pressure; lipid peroxidation
Pulmonary Surgery and Protective Mechanical Ventilation
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The purpose of this trial is to evaluate the efficacy and the safety of lung protective
      ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung
      cancer.
    

Detailed description: 
      Extended description of the protocol could be provided by the URC-EST, SAINT ANTOINE
      HOSPITAL, University of Paris-VI and by principal investigator.

      Pneumonectomy or lobectomy is associated with a high risk for postoperative complication. The
      benefit of lung protective ventilation with low tidal volume has been demonstrated in
      patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Recent
      clinical studies have suggested that mechanical ventilation with low tidal volume may also
      profit in others setting. Lung protective ventilation during anaesthesia has been found to
      limit the inflammatory response in the lung and to decrease postoperative systemic
      inflammatory response. However, others trials did not found benefit of protective ventilation
      strategy during anaesthesia.

      This study will be a randomized, controlled, doubled blind trial comparing two management
      ventilator strategies during anaesthesia for thoracotomy. Only patients undergoing
      pneumonectomy or lobectomy for lung primitive cancer will be included in this trial. During
      anesthesia, one group will receive mechanical ventilation with low tidal volume (5 ml/kg of
      ideal body weight) plus PEEP and the other will receive tidal volume of 10 ml/kg of ideal
      body weight without PEEP. After surgery, data concerning oxygen delivery, blood analysis,
      complications, cancer recurrence and death will be collected.
    

Intervention name(s): mechanical ventilation; tidal volume
Intervention type(s): Procedure; Other
Intervention description(s): mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP; tidal volume of 10 ml/kg of ideal body weight without PEEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: interoperative care; Tidal volume; Postoperative complications; Pneumonectomy; Lobectomy; Mechanical ventilation
Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.
Condition: Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)
MeSH terms: Communicable Diseases; Infections
Study type: Interventional

Summary: 
      We put forward that probiotics have an effect on infectious episodes evolution in subjects
      aged 60 years or over. The main objective of this research is to observe the effect of
      consumption of the probiotic on the average number of days with infectious episodes.
    


Intervention name(s): Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033; Starch of potato
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 pill per day for 12 weeks; 1 pill per day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Combining radiation
      therapy with chemotherapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation
      therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the time to progression, local control, and survival of patients with locally
           advanced, unresectable pancreatic cancer treated with induction gemcitabine and
           irinotecan followed by gemcitabine and concurrent radiotherapy.

      OUTLINE: Patients receive induction gemcitabine IV over 30 minutes and irinotecan IV over 90
      minutes on days 1 and 8. Treatment repeats every 3 weeks for 2 courses in the absence of
      disease progression or unacceptable toxicity.

      Within 2 weeks of completing induction chemotherapy, patients receive gemcitabine IV over
      30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32. Patients undergo concurrent
      radiotherapy 5 days a week for 5.5 weeks.

      Patients are followed every 8 weeks for 6 months and then every 3 months for 1.5 years.

      PROJECTED ACCRUAL: Approximately 60-120 patients will be accrued for this study within 1-2
      years.
    

Intervention name(s): gemcitabine hydrochloride; irinotecan hydrochloride; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Gemcitabine; Irinotecan
Primary purpose: Treatment
Keywords: stage III pancreatic cancer
Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-680 After Multiple Oral Doses"
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of five doses of PBF-680 (5 mg, 10 mg, 20 mg, 40 mg and
      60mg) after repeated (8 days) single daily oral dose administration in young male and female
      healthy subjects.
    


Intervention name(s): PBF-680; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5, 10, 20, 40 and 60 mg of PBF-680; placebo for the dose of 5, 10, 20 and 40 mg of PBF-680
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Adenosine A1 receptor antagonist; adenosine receptor modulator; Asthma; COPD