bioihbjkbjnl/mcl2 huggingface dataset:
N-Acetylcysteine and Smoking Reduction
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      N-acetylcysteine is an inexpensive agent with a benign side effect profile with preliminary
      studies in humans suggesting efficacy for the treatment of cocaine dependence.
      N-acetylcysteine has been used in clinical medicine for nearly three decades to treat chronic
      lung conditions, acetaminophen overdose, and experimentally to treat cocaine dependence. It
      is generally safe and well tolerated. The present pilot study seeks to explore safety and
      tolerability, ad lib smoking, visual cue reactivity, and smoking reduction rates in a group
      of nontreatment seeking, nicotine dependence smokers who are willing to undergo a brief trial
      with oral N-acetylcysteine 1200 mg twice daily.
    


Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2400mg (1200mg b.i.d., 600mg capsules, p.o.); Identically appearing placebo capsules, packaged in an N-acetylcysteine "slurry" so that placebo has similar odor as active NAC capsules
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nicotine; N-acetylcysteine; smoking reduction
Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial
Condition: Healthy Lifestyle; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Cardiovascular disease continues to be the principal cause of death in the world. At present,
      the risk factors for cardiovascular disease continue to appear at an earlier age permitting
      prevention activities and the promotion of healthy habits to focus on children. Numerous
      studies have shown that these factors can be controlled in children through school-based
      interventions. At the same time, data shows that there is a persistence of unhealthy
      lifestyles (ie sedentary lifestyles, the use of tobacco, etc…) that begin in childhood and
      are perpetuated until adulthood. Therefore, the acquisition of healthy lifestyles should
      begin as early as possible. The SI Program for Preschool Education is an intervention that is
      both school and home based designed to improve the habits, knowledge and attitudes in four
      key areas: Food (diet), Physical Activity, Knowledge of the Body and Managing Emotions. This
      intervention will be implemented in children from three to five years of age, in their
      parents and in their teachers. To evaluate the efficacy of this intervention, the principal
      aim of the phase of evaluations is to quantify the behavior changes in the three
      groups/populations mentioned. The evaluation has been designed according to the controlled
      intervention model, in which twenty-four schools from the Community of Madrid will be
      randomized to implement the Program si! for Preschool Education or to function as control
      schools.
    


Intervention name(s): Program SI! educational intervention
Intervention type(s): Behavioral
Intervention description(s): School-based educational program to improve the knowledge, the attitudes, and the habits of children, their parents and teachers, with respect to a healthy lifestyle behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diet; Physical activity; Knowledge; Attitudes; Habits; Lifestyle; School-based
Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects and tolerability of exercise on side
      effects of injectable disease modifying treatments in multiple sclerosis. The investigators
      main hypothesis is that controlled exercise is safe and can be well tolerated in patients
      with multiple sclerosis and it can improve disease modifying treatment related side effects
      such as fatigue.
    

Detailed description: 
      Patient compliance with disease modifying treatment largely depends on relatively common side
      effects of such treatments such as fatigue. Regular exercise can potentially improve these
      side effects. However, Safety and effects of exercise has not been studied in patients with
      multiple sclerosis. Our main aim is to study the safety, tolerability and effects of exercise
      on side effects of subcutaneous interferon-b1b in patients with Multiple Sclerosis.
    

Intervention name(s): Physical exercise training
Intervention type(s): Other
Intervention description(s): Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis
Other intervention name(s): Betaseron b1b-interferon; Aerobic exercise
Intervention MeSH terms: Interferons; Interferon beta-1b
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Multiple Sclerosis; b1b-interferon; Fatigue; Exercise
Phase II Study of Adenovirus/PSA Vaccine in Men With Recurrent Prostate Cancer After Local Therapy APP21
Condition: Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether vaccination with the Ad/PSA vaccine will
      induce an anti-PSA immunity that will result in the destruction of the remaining prostate
      cancer cells.
    

Detailed description: 
      Subjects will be randomized to Arm A (vaccine only) or Arm B (androgen deprivation therapy
      plus vaccine). On Arm A, subjects can begin the three vaccinations immediately. On Arm B,
      subjects will be started on androgen deprivation therapy (ADT) 14 days prior to beginning the
      vaccinations.

      Subjects will be vaccinated three times, each injection administered at 30-day intervals.
      Based upon our earlier clinical trial, the vaccine is considered safe and should not induce
      any major side effects. The investigators hope that vaccination with this PSA virus will
      cause the body to produce immunity to the PSA and that immunity will destroy any cell that
      produces PSA. Since the only cells left in the body that produce PSA will be the cancer
      cells, the investigators propose that the vaccination and ensuing anti-PSA immunity will kill
      the prostate cancer cells. Importantly, this treatment should not cause any major side
      effects as would treatment with anti-cancer drugs.
    

Intervention name(s): Adenovirus/PSA Vaccine
Intervention type(s): Biological
Intervention description(s): 1x10E8pfu in Gelfoam subcutaneously on day 0, 30, 60
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; vaccine; immunotherapy
Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean
Condition: Uterine Scar Defect
Study type: Interventional

Summary: 
      There are different surgical techniques of uterine closure during cesarean. Currently data
      suggest that the double layer unlocked closure technique is associated with better uterine
      scar healing, and this technique is considered the gold standard.

      This study compares two techniques of uterine closure on myometrium thickness:

        1. Double layer unlocked suture;

        2. Purse suture of the uterus with a first continuous purse suture of the deep portion of
           the myometrium and a second unlocked continuous suture including the remaining part of
           the myometrium.

      The primary outcome is the mean residual myometrium thickness at the site of the uterine scar
      evaluated by transvaginal ultrasound at six months after cesarean.
    


Intervention name(s): Double layer closure of the hysterotomy; Purse closure of the hysterotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.; Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: niche
Comparison Between Tramadol Hcl and Other Analgesics in the Treatment of Renal Colic
Condition: Renal Calculus
MeSH terms: Kidney Calculi; Nephrolithiasis; Calculi; Renal Colic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Tramadol Hcl is as effective as Voltaren a
      non-steroidal antiinflammatory drug, and Dipyrone in amelioration of the pain caused by acute
      renal colic.
    

Detailed description: 
      Renal stones is a common condition affecting up to 1% of the american population. The main
      symptom is renal colic. Acute treatment is based on the administration of analgesics mainly
      those belonging to non-steroidal antiinflammatory drugs (NSAIDs). Tramadol is an analgesic of
      the opioid class of analgesics (i.e morphine) and it is considered to cause less side effects
      with more or less the same analgesic potency. In the present study the analgesic effect of
      intramuscular Tramadol will be compared with Voltaren (NSAID)in patients attending the
      Emergency Department (ED) for acute renal colic (Stage I). Most of these patients will not
      pass their stone during their visit to the ED and they are prone to develop another attack of
      renal colic.In the second phase of the study (Stage II)patients who improved, and are ready
      to go home, will be enrolled to get Dipyrone or Tramadol orally for the prevention of further
      pain.
    

Intervention name(s): Tramadol Hcl
Intervention type(s): Drug
Intervention description(s): Active Comparator
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal; Colic; Calculi; Treatment
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Co-morbid Anxiety Symptoms
Condition: Primary Anxiety Disorders; Mood Disorders With Comorbid Anxiety Symptoms
MeSH terms: Anxiety Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this study are to evaluate the efficacy and safety of quetiapine extended
      release tablet versus placebo as adjunct to selective serotonin reuptake
      inhibitors/serotonin/norepinephrine reuptake inhibitors (SSRI/SNRI) in the augmentation
      treatment of patient with primary anxiety disorders or mood disorders with co-morbid anxiety
      symptoms.
    


Intervention name(s): Quetiapine extended release tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Quetiapine extended release tablet of 50-300mg/day; Placebo orally, as adjunct to the same antidepressant at the same dose.
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary Anxiety Disorders; Mood Disorders with Comorbid Anxiety Symptoms
Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant
      hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2
      months with a booster at month 12
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): HBsAg formulated with different concentrations of MPL and Aluminium Salts; Engerix™-B
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Hepatitis B; Engerix™-B; Recombinant Hepatitis B vaccine; Adjuvant
Ill-health Related Job Loss
Condition: Job Loss Noticed by the Occupational Physicians
Study type: Observational

Summary: 
      The current study aimed to estimate the one-year incidence of unfitness for the job in an
      occupational health service, and to describe their aetiology and the characteristics of the
      unfit employees
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        all the workers followed up in an occupational health center of Montpellier
      
Keywords: job loss; unfit for a job
SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients
Condition: Non Small Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a
      second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid
      Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type
      of tumor.
    


Intervention name(s): Gefitinib
Intervention type(s): Drug
Intervention description(s): Gefitinib tablet 250mg once daily orally
Intervention MeSH terms: Gefitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carcinoma; Non Small Cell Lung; EGFR mutation; Gefitinib
Evaluation of Socket Shield Technique With Immediate Implant Placement in the Esthetic Zone
Condition: Alveolar Bone Resorption
MeSH terms: Bone Resorption
Study type: Interventional

Summary: 
      The study was conducted on 20 immediate implant placement sites in the anterior maxillary
      region. In the study group, 10 implants were inserted using socket shield technique, while in
      control group, 10 implants were inserted using conventional immediate placement technique.
      All patients received immediate and 6 months post-operative CBCT to assess horizontal bone
      loss, vertical bone loss, and measurement of bone density. Implant stability quotients (ISQs)
      was measured immediately, 1st, 3rd and 6 months post-operatively.
    

Detailed description: 
      Unrestorable tooth extraction with immediate implant placement is considered one of the best
      treatment options in restoring the esthetics and function. Extraction socket resorption is
      considered a challenging procedure when it involves the esthetics zone. The preservation of
      the entire attachment apparatus for complete preservation of the alveolar ridge makes socket
      shield technique a promising procedure that helps to maintain anatomy, esthetics and
      function. Socket shield technique, eliminate the negative consequences of bone resorption of
      the buccal plate of bone; leading to maintaining hard and soft tissue contours and provides a
      perfect pleasing esthetic result with good function. It is a highly promising technique in
      terms of maintaining pink and white esthetics through preservation of the interdental papilla
      during preparation of the interdental socket shield. It is considered a minimally invasive
      surgical procedure and offers the advantages of immediate implant placement.
    

Intervention name(s): Immediate implant placement using socket shield technique
Intervention type(s): Procedure
Intervention description(s): Evaluation of socket shield technique with immediate implant placement at the esthetic zone in comparison with the conventional immediate implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immediate implants, sockets shield technique, esthetic zone
Westlake Sailing Cohort
Condition: Microbiome; Glucose Metabolism; Mood; Environment
Study type: Observational

Summary: 
      Little is known about the dynamic change of human microbiome in different body sites
      including skin, mouth and gut during sailing. The present study aims to reveal the change of
      human microbiome in response to the sailing environment in a 1-month period, and its
      implication for human health.
    

Detailed description: 
      This study will recruit a number of participants who are going to sail for mariana trench
      from Shenzhen, China. Characteristics of the participants will be described by a series of
      index of stool, urine, skin microbiota and tongue coating. All the biospecimen will be
      collected before and during the voyage. Stool at the 2nd, the 4th and the 12th week after the
      voyage and blood sample at the baseline will also be collected. Participants' mood states,
      health-related quality of life, fatigue score and sleep quality will be investigated with
      questionnaires throughout the 1-month period. Participants are asked to record diseases and
      symptoms, if any, when sailing. All the data will be used to analyse how microbiota change
      and be involved in human health during a voyage.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals who will sail by Shenkuo, a scientific research ship, December 2020.
      
Biospecimen description: 
      serum, plasma, white cells, urine, faeces, tongue coating, skin microbiome
A Study of a Prebiotic, a Probiotic and a Synbiotic Upon the Gut Microbiota and Immune Response of Healthy Volunteers
Condition: Gut Microbiota; Bowel Function; Immune Function; Plasma Lipids
Study type: Interventional

Summary: 
      Healthy volunteers will be recruited to a study where they will be given four different
      treatments over a 28 week period. These treatments include: a prebiotic, a probiotic, a
      synbiotic (prebiotic + probiotic) and a placebo. Faecal samples, blood and saliva will be
      collected and analysed for changes in faecal microbial populations and selected immune
      responses.
    

Detailed description: 
      The primary objective of this study is to determine the effect of XOS (administered at
      8g/day), B. lactis BI07 (administered at 109 CFU/day) and the synbiotic combination of both
      (8g/day XOS and 109 CFU/day B. lactis BI07) on the human gut microbiota.

      A double-blind, placebo-controlled, randomized crossover study will be conducted in 44
      healthy volunteers. The placebo will be maltodextrin (a food grade ingredient, administered
      at 8g/day).

      Changes in the gut microbiota will be determined by measuring bacterial population levels in
      human faeces using fluorescence in situ hybridisation (FISH) with 16S rRNA targeted
      oligonucleotide probes. Concentrations of short chain fatty acids (SCFA) will be quantified
      using gas chromatography (GC).

      In addition to analyses performed on the samples at the University of Reading, analyses on
      microbial metabolites and selected members of the microbiota will also be performed at
      Danisco Finland, Kantvik. University of Reading will therefore provide Danisco Kantvik with
      faecal samples of appropriate size.

      The secondary objective of this study is to examine the effects of XOS (8g/day), B. lactis
      BI07 (109 CFU/day) and the synbiotic (8g/day of XOS and 109 CFU/day of B. lactis BI07) on
      bowel function, immune function and plasma lipids in 44 healthy volunteers. This will be
      achieved using volunteer diaries of bowel function and mood, and by investigating total
      plasma lipids, mucosal immunity (salivary and faecal IgA), total leukocyte numbers,
      expression of cell surface markers on immune cells to identify cell subsets and activation
      markers, production of inflammatory markers by whole blood cultures, plasma chemokines,
      phagocytosis and oxidative burst by monocytes and granulocytes, plasma/serum immunoglobulins,
      acute phase proteins, complement proteins and soluble adhesion molecules.
    

Intervention name(s): Prebiotic; Bi-07; Synbiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 8g/day xylo-oligosaccharide; 10^9 CFU B. lactis / day; 8g/day xylo-oligosaccharide + 10^9 CFU Bi-07; 8g/day maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety, Tolerability and Pharmacokinetics of BI 655066/ABBV-066 (Risankizumab) in Healthy Asian and Caucasian Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability and pharmacokinetics of single dose of BI 655066/ABBV-066 (risankizumab)
      in healthy Chinese, Japanese and Caucasian male volunteers.
    


Intervention name(s): ABBV-066; ABBV-066; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SC injection; IV infusion; SC injection (stage 1); IV infusion (stage 2)
Other intervention name(s): BI 655066; risankizumab; BI 655066; risankizumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ABBV-066; BI 655066; risankizumab