bioihbjkbjnl/mcl2 huggingface dataset:
Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults
Condition: Safety
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Lactobacilli are commensal bacteria common to the gut of all mammals studied and
      traditionally associated with foods are considered safe.The established safe use on a
      diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus
      reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of
      humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as
      well as adults.

      Although the tolerability of DSM 17938 in a tablet formulation has earlier been established,
      it is desirable to repeat the assessment in this novel formulation.
    


Intervention name(s): Lactobacillus Reuteri DSM 17938
Intervention type(s): Dietary Supplement
Intervention description(s): One stick pack in the morning and one stick pack afternoon/evening for 28 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; tolerance; lactobacillus Reuteri
Multi-national Cirrhosis Study to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.
Condition: Hepatic Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre, multi-national, open study to assess the pharmacokinetics of NRL972
      in patients with hepatic cirrhosis CTP-classes A, B, and C (histologically confirmed by liver
      biopsy). The pharmacokinetics of NRL972 will be referenced to a Clinical Staging Matrix
      obtained during a clinical work-up of patients with hepatic cirrhosis. Patients to be studied
      will have histologically established hepatic cirrhosis or confirmed hepatic cirrhosis by an
      objective imaging study without confounding end-stage co-morbidity. Within 14 days of
      confirming eligibility, the investigations will be conducted over 2-5 days with the test
      procedures (clinical laboratory tests, ultrasound (US)-investigations, gastroscopy, NRL972-
      and MEGX'-test). Up to one week after the NRL972-test, a follow-up telephone call will be
      made.
    


Intervention name(s): NRL972
Intervention type(s): Drug
Intervention description(s): Single dose of 2 mg NRL972 administered intravenously. Total volume 5 mL.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope
      glycoprotein gp160. To evaluate the duration of antibody response and its relationship to
      dose and frequency of inoculation.

      Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates
      that, although serum anti-gp160 antibody responses were detected, the level and duration of
      those responses were limited. A preliminary observation suggests that weak functional
      antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a
      dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.
    

Detailed description: 
      Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates
      that, although serum anti-gp160 antibody responses were detected, the level and duration of
      those responses were limited. A preliminary observation suggests that weak functional
      antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a
      dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

      In the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5
      healthy volunteers receive alum placebo. At least 30 days later, 20 additional volunteers
      receive 1280 mcg gp160 vaccine and 5 volunteers receive placebo. Injections are given on days
      0, 30, 180, and 365.
    

Intervention name(s): gp160 Vaccine (MicroGeneSys)
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; HIV-1; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Consultation, Advice, and Tailored Support (CATS) for Cancer Survivors
Condition: Smoking Cessation; Social Stress
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this pilot clinical trial are: 1) To evaluate the feasibility and
      acceptability of a new approach to smoking cessation induction treatment in cancer survivors
      with low social resources, and 2) To assess the effectiveness of said treatment for key
      events in the process of smoking cessation.
    

Detailed description: 
      This is a pilot (Phase II) randomized clinical trial with randomization in a 1:1 ratio. The
      control group will receive a brief consultation (10-15 minutes via phone) about free or
      low-cost resources that may help them address unmet social support needs. Additionally, a
      written directory of a range of social support resources will be delivered to them via mail.
      The treatment group will receive the aforesaid intervention plus brief advice to quit smoking
      (10-15 minutes via phone). Additionally, a written summary of the benefits of smoking
      cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy
      (NRT) will be provided via mail. The treatment group will also receive a free, 2-week supply
      of nicotine patches and lozenges delivered via mail. As a pilot, this study focuses on the
      outcomes of feasibility (i.e., accrual and retention) and acceptability (e.g., participants'
      perceptions of appropriateness and effectiveness) as opposed to efficacy (though this is also
      important). The emphasis on smoking cessation induction (that is, the inducement or promotion
      of a quit attempt) is an important aspect of the study design and is appropriate for smokers
      across the continuum of motivation to quit.
    

Intervention name(s): Social Support; NRT Sampling
Intervention type(s): Behavioral; Drug
Intervention description(s): A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.; A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to "brief advice", a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was to verify if the test formulation of Levothyroxine sodium presents an
      equivalent rate and extension of absorption to the comparator formulation when administered
      with the same dosage and under fasting conditions and after baseline correction
      concentrations.
    


Intervention name(s): Puran T4®; Eutirox®
Intervention type(s): Drug; Drug
Intervention description(s): Participants who received a single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.; Participants who received a single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Eutirox®; Puran T4®; Levothyroxine
A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, safety and tolerability study in subjects with chronic stable
      sensorimotor deficits after ischemic stroke. It has been designed as a double-blind,
      placebo-controlled, 2-period crossover study.
    


Intervention name(s): placebo/dalfampridine-ER; dalfampridine-ER/placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart; Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Laparoscopic Banded Sleeve Gastrectomy
Condition: Obesity, Morbid; Surgery
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric procedure to treat
      morbidly obese patients. The main concern of LSG lies in the long-term weight regain which is
      reported to happen in up to 75.6% of patients after 6 years. The Investigators report the
      overall experience with Laparoscopic Banded Sleeve Gastrectomy (LBSG) using the Minimizer
      over a six-year period.
    

Detailed description: 
      Introduction. Laparoscopic sleeve gastrectomy (LSG) is now the most common bariatric
      procedure to treat morbidly obese patients. The main concern of LSG lies in the long-term
      weight regain which is reported to happen in up to 75.6% of patients after 6 years. The
      investigators report the overall experience with Laparoscopic Banded Sleeve Gastrectomy
      (LBSG) using the Minimizer over a six-year period.

      Methods. The investigators performed a retrospective review of data from a prospectively
      collected database. All patients submitted to primary LBSG were examined. Patients were
      submitted to LBSG between February 2014 and January 2020. Collected data included demographic
      factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and
      clinical outcomes in terms of short and mid-term weight loss.
    

Intervention name(s): Laparoscopic Banded Sleeve Gastrectomy
Intervention type(s): Procedure
Intervention description(s): The investigators performed Laparoscopic Sleeve Gastrectomy adding a MiniMizer Ring (Bariatric Solutions), a radiopaque silicone ring with four closing positions. The ring has a blue colour and for this reason it can easily be found back in revision surgery. The pulling lid is left in place with all closing positions in order to be adjusted postoperatively without having to place a new ring. The ring is slightly elastic and the fixation loops provide an anchorpoint to fix the ring in place which prevents it from slipping
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients submitted to primary LBSG were examined. Patients were submitted to LBSG
        between February 2014 and January 2020. Collected data included demographic factors,
        pre-operative weight, pre-operative BMI, operative time, surgical complications, and
        clinical outcomes in terms of short and mid-term weight loss.
      
Keywords: Sleeve gastrectomy; Banded sleeve gastrectomy; Laparoscopy; Bariatric Surgery; Obesity
Combining PAS to Non-invasive VNS
Condition: Spinal Plasticity
Study type: Interventional

Summary: 
      Vagus nerve stimulation (VNS) and paired associative stimulation (PAS) have been shown to
      have efficacy in improving the results of motor rehabilitation after stroke and spinal cord
      injury, respectively. Here we will investigate in healthy subjects the synergistic effect of
      these stimulation modalities on motor-evoked potential (MEP) potentiation.
    


Intervention name(s): PAS; VNS
Intervention type(s): Device; Device
Intervention description(s): Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS); Non-invasive vagus nerve stimulation delivered through cymba concha & cymba cavum of the ear.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Study of the Efficacy and Safety of Pregabalin as Add-On Therapy for Partial Onset Seizures in Children Ages 4-16 Years
Condition: Epilepsy, Partial Seizures
MeSH terms: Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      Study A0081041 is a double blind, placebo controlled, randomized, parallel group, multicenter
      study to evaluate the safety and efficacy of two dose levels of pregabalin administered in
      equally divided daily doses, in either capsule or oral liquid formulation, as adjunctive
      therapy in pediatric subjects 4 to 16 years of age with partial onset seizures.
    


Intervention name(s): Pregabalin add-on therapy; Pregabalin add-on therapy; Pregabalin add-on therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.; Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.; Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: safety; efficacy; partial onset seizures; pediatric; pregabalin; placebo-controlled; double-blind
The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
Condition: Change of Transit or Circulation; Obesity
Study type: Interventional

Summary: 
      The study will investigate the effect of cereal based prebiotic fibres on intestinal health
      and functioning and host metabolism.
    

Detailed description: 
      A human dietary intervention study will be performed in overweight to obese subjects with a
      slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs.
      placebo on gut health, including gut microbiota composition, gastrointestinal transit time,
      metabolic health and quality of life.
    

Intervention name(s): soluble wheat bran fibre; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 12 weeks daily intake of 15g of soluble wheat bran fibre; 12 weeks daily intake of 15g of maltodextrin
Other intervention name(s): Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials
Condition: Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      We aimed to compare efficacy and safety of combination therapy with oral ofloxacin, 400 mg
      twice daily, plus oral metronidazole, 500 mg twice daily, for 14 days, with moxifloxacin
      monotherapy, 400 mg once daily, for 14 days
    


Intervention name(s): Moxifloxacin; Ofloxacin; Metronidazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): daily 400 mg moksifloksasin; daily 800 mg oflaksasin plus 1000 mg metronidazol treatment; daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID
Other intervention name(s): new generetaion flouroquinolon antibiotics; floroquinolon antibiotics; anaerobic antibiotics
Intervention MeSH terms: Anti-Bacterial Agents; Moxifloxacin; Metronidazole; Ofloxacin; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Treatment, moksifloksasin
Clinical Evaluation of Some Local Antimicrobial Agents' Adjunctive Effects On Periodontal Parameters and Halitosis
Condition: Halitosis
MeSH terms: Halitosis
Study type: Interventional

Summary: 
      The aim of this trial was to establish the clinical efficacy of Listerine and chlorhexidine
      (CHX) when used as a cooling agent with ultrasonic instrumentation, on periodontal parameters
      and halitosis.

      Ninety patients with periodontal disease participated for the study. Individuals were
      randomly selected to a control and test groups. At baseline, all subjects completed a
      questionnaire and carried out an examination. Standard periodontal outcome variables were
      assessed. For both groups, the plaque index (PI), gingival index (GI), pocket depth (PD),
      bleeding on probing (BOP) and clinical attachment level (CAL) scores were enrolled at
      baseline and after 30 days. Volatile sulphur compound (VSC) levels were evaluated by a
      Halimeter (Interscan Corp., Chatsworth, CA, USA) at baseline (T0), immediately after
      treatment (T1), and at 7 (T2), 14 (T3) and 30 days (T4).
    


Intervention name(s): ultrasonic (Piezon Master 700) performed with Listerine; ultrasonic (Piezon Master 700) performed with CHX; ultrasonic (Piezon Master 700) performed with serum
Intervention type(s): Device; Device; Device
Other intervention name(s): EMS, Nyon; EMS, Nyon; EMS, Nyon
Intervention MeSH terms: Listerine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Listerine, CHX
Rapid Acclimatization to Hypoxia at Altitude
Condition: Physiological Function in Low Oxygen Environment
MeSH terms: Hypoxia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In low oxygen environments, such as altitude, some adults may become ill and suffer from
      acute mountain sickness. Further, all adults will find that exercising becomes much more
      difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of
      this investigation is to study the effects of two drugs that may help people adjust to
      high-altitude quickly, prevent them from becoming ill and improve their exercise performance.
      The drugs are Methazolamide and Aminophylline.
    


Intervention name(s): Placebo; Aminophylline; Methazolamide; Aminophylline+Methazolamide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Yellow corn meal in gel capsules; National Drug Code (NDC) 0143-1020-01; NDC 0781-1072-01; NDC 0143-1020-01 and NDC 0781-1072-01
Other intervention name(s): Yellow corn meal; Theophylline; Neptazane; Theophylline + Neptazane
Intervention MeSH terms: Aminophylline; Methazolamide; Theophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hypoxia; Altitude; Exercise
Effects of Exercise and Acupuncture on Chronic Insomnia
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Introduction: Chronic insomnia is a sleep disorder, characterized by difficulty in initiating
      and/or maintaining sleep, presence of non-restorative sleep, frequent awakenings or
      difficulty returning to sleep after each awakening, with a frequency of 3 nights/week, for at
      least 3 months. Pharmacologic therapy is the most commonly method used for its treatment,
      however, pharmacotherapy is associated with side effects. Thus, non-pharmacological therapies
      have been suggested as an alternative. Objective: To verify the effects of exercise
      associated with acupuncture on chronic insomnia. METHODS: 40 patients with chronic insomnia
      will be randomly assigned into two groups: CONTROL (n = 20) and ACUPUNCTURE (n = 20). The
      volunteers of the CONTROL group will be submitted to 12 weeks of aerobic exercise, performed
      on a treadmill, with frequency of 3 times / week and duration of 50 minutes / day.
      ACUPUNCTURE volunteers will perform aerobic exercise, following the protocol of the CONTROL
      group, plus acupuncture therapy once a week. The sleep evaluation will be evaluated by
      polysomnography and questionnaires. Expected Results: A 12-week combined therapy could
      potentiate the previously described positive effects of exercise in the treatment of chronic
      insomnia.
    


Intervention name(s): Exercise; Acupuncture
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The EXERCISE group will participate in an aerobic exercise program for 12 weeks, performed in intensity relative to 50% of reserve heart rate, on a treadmill.; The ACUPUNCTURE group will participate in an aerobic exercise program following the protocol of the EXERCISE group, plus acupuncture therapy once a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical activity; Disorders of onset and maintenance of sleep; non-pharmacological treatment; Acupuncture