bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric Cardiac Surgery Comparing Short 24-hour Antibiotic Prophylaxis to Extended Antibiotic Prophylaxis
Condition: Antibiotic Prophylaxis
Study type: Observational

Summary: 
      The objective of antibiotic prophylaxis is to prevent bacterial proliferation in order to
      reduce the risk of postoperative infection.

      Numerous recent recommendations show a benefit of a reduced duration of antibiotic
      prophylaxis in surgery, particularly in pediatrics.

      The study focuses on the incidence of postoperative infection by comparing antibiotic
      prophylaxis with 2nd generation cephalosporin (G2G) for 48 hours to a short antibiotic
      prophylaxis protocol limited to 24 hours.

      The bacterial infections considered were those said to be care-related, according to the
      criteria of the French Society of Anesthesia and Intensive Care if they occurred within the 3
      months postoperative interval and were not present before the surgery:

        -  sepsis

        -  superficial or deep surgical site infection (mediastinitis, sternitis, scar infection)

        -  catheterization infection,

        -  urinary tract infection or

        -  respiratory infection such as pneumopathy acquired under mechanical ventilation

      The hypothesis is that reducing the duration of antibiotic prophylaxis does not expose
      patients to an increased risk of infection and limits exposure to antibiotics
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Minor patient, under 18 years of age, operated for cardiac surgery at the University
        Hospital of Strasbourg between January 2015 and June 2019, by sternal approach (sternotomy)
      
Keywords: Antibiotic Prophylaxis; Bacterial proliferation; Bacterial infections; Postoperative infection; Pediatric cardiac surgery
A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      A vaccine called Prevenar is already approved for use in China for vaccination of children
      younger than 6 years old against infections caused by Streptococcus pneumoniae.

      This study is to measure the amount of antibodies (antibodies help people fight off diseases)
      Chinese children aged between 121 days and 6 years (72 months) produce when given Prevenar.
      The study will also provide more data on how safe and well tolerated Prevenar is in Chinese
      children.
    


Intervention name(s): Prevenar; Prevenar; Prevenar; Prevenar
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
4 doses starting from 121 to < 212 days of age; Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
3 doses starting from 212 days to < 12 months of age; Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
2 doses starting from 12 months to < 24 months of age; Dosage form: intramuscular injection Dosage: 0.5 ml
Frequency:
1 dose starting from 24 months to < 72 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevenar; catch-up; pneumococcal; pneumonia
The Effects of Anodal and Cathodal tDCS Combined With Conventional Physical Therapy in Patients With Acute Stroke
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The objective of the study is thus to compare the effects 5 consecutive sessions of anodal
      and cathodal tDCS combined with conventional physical therapy on upper and lower limb motor
      performance in acute stroke at immediate, and 1-month followup.
    

Detailed description: 
      Stroke is a major cause of long-term disability in stroke survivors that related with motor
      impairment. After stroke, the cortical excitability of ipsilesional hemisphere is decreased;
      in contrast, the cortical excitability of contralesional hemisphere is increased.
      Conventional physical therapy is beneficial to motor recovery, but early rehabilitation was
      not always help the patients get full recovery. tDCS is an adjuvant tools which deliver weak
      direct current through scalp to promote motor recovery in stroke rehabilitation. The
      anodal-tDCS increases cortical excitability, while the cathodal-tDCS decreases cortical
      excitability. Previous studies demonstrated that both monocephalic techniques of tDCS can
      improve motor function in chronic, subacute, and acute phase, but it is still inconclusive
      that which monocephalic montages had better effect, especially in acute phase. There are
      several studies supported the benefits of monocephalic tDCS combined with rehabilitation
      programs on upper and lower limbs motor function in acute stroke. However, there is no
      evidence that directly compared the effect of monocephalic tDCS in acute stroke patients. The
      objective of the study is to compare the effects of anodal and cathodal tDCS combined with
      conventional physical therapy for 5 sessions on motor performance in acute stroke at
      immediate, and 1-month follow-up.
    

Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Cathodal/Anodal tDCS will be applied in 1.5 mA, 20 mins before conventional physical therapy for 5 days. All experiments will be performed in random order for each subject.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single Dose Pharmacokinetic (PK) Study
Condition: Angelman Syndrome; Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Angelman Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is a Phase 1 Single Dose PK Study in Adolescent Subjects with Fragile X syndrome
      (FXS) or Angelman syndrome (AS).

        -  The primary objective of the study is to evaluate the pharmacokinetics (PK) of OV101
           following a single 5 mg dose of OV101 in adolescents with FXS or AS.

        -  Secondary objectives are to determine the safety and tolerability of a single 5 mg dose
           of OV101 in adolescents with FXS or AS.
    


Intervention name(s): OV101
Intervention type(s): Drug
Intervention description(s): Single-dose 5 mg OV101
Other intervention name(s): Gaboxadol
Intervention MeSH terms: Gaboxadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator
Condition: Vocal Cord Paralysis
MeSH terms: Vocal Cord Paralysis; Paralysis
Study type: Interventional

Summary: 
      People who had paralysis of the vocal cords are often prevented from breathing by this
      problem because the cords will not open, and the patients have to wear a tracheostomy (neck
      breathing tube) to bypass this airway obstruction. This study examines the effects of vocal
      cord opening triggered by a pacemaker implanted over the chest wall. The device is connected
      to a nerve taken from a muscle close to the larynx (voice box) and implanted into the
      paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a
      few weeks, the stimulator is turned on and the level of vocal cord opening is assessed.
      Airway improvement is checked by pulmonary function tests and measurements of vocal cord
      opening. The ultimate goal of the study is to lead to situations where patients with
      bilateral vocal fold paralyses could get rid of the neck breathing tube to have less
      complications, be more comfortable and socially acceptable.
    

Detailed description: 
      Data pending
    

Intervention name(s): pacemaker
Intervention type(s): Device
Intervention description(s): Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Device Feasibility
Keywords: Bilateral vocal cord paralyses; Implanted laryngeal stimulator; vocal cord opening; pulmonary function tests
The Role of Probiotics in the Eradication of Helicobacter Pylori
Condition: Helicobacter Pylori Infection
Study type: Interventional

Summary: 
      All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2,
      Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be
      randomised into two groups. The first group will receive one capsule of probiotics x2 two
      hours before or after meal for 15 days and the second group placebo (capsule with same
      composition and colour with probiotic) x2, two hours before or after meal for 15 days as
      well.

      The probiotic (Lactolevure, Uni-Pharma, Athens) contains four probiotic strains known for
      their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium
      Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and
      Lactobacillus Plantarum (0.5 BU/capsule).
    

Detailed description: 
      Patients with H.Pylori infection establised after a uper GI endoscopy and gastric biopsy will
      receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2,
      Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two
      groups. The first group will receive one capsule of probiotics x2 two hours before or after
      meal for 15 days and the second group placebo (capsule with same composition and colour with
      probiotic) x2, two hours before or after meal for 15 days as well.

      The probiotic contains four probiotic strains known for their effectivness and safety,
      Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule),
      Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5
      BU/capsule).

      Patients will report in a specific questionnare the presence or absence of symptoms
      suggestive of side effects associated with the Abx administered (i.e flatulance, abdominal
      pain, diarrhoea, regurgitation, vomiting).

      All patints will be subjected to urea breath test one month after the completion of treatment
      in order to verify HP eradication.
    

Intervention name(s): Caps Lactolevure; Caps Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One group will receive Caps Lactolevure x2 and the other group Caps Placebo x2.; Caps Placebo
Other intervention name(s): Probiotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Helicobacter Pylori; Probiotics; Eradication treatment of H.Pylori; Antibiotics; Proton pump inhibitors; Saccharomyces boulardii; Bifidobacterium lactis; Lactobacillus acidophilus; Lactobacillus plantarum
Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome (MDS); Hodgkins Lymphoma; Non-Hodgkins Lymphoma
MeSH terms: Lymphoma; Leukemia; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Study type: Interventional

Summary: 
      By doing this study, researchers hope to learn the following:

        -  If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC)
           transplant will help to improve the homing process

        -  The safety of HBO administration in the setting of the UBC transplant

        -  The effects of HBO therapy on the engraftment process
    

Detailed description: 
      Research has suggested that high levels of erythropoietin (EPO) decreases the ability of
      infused umbilical cord stem cells to home to the bone marrow. The investigators will
      investigate the use of hyperbaric oxygen (HBO) therapy to decrease the plasma concentrations
      of EPO prior to UBC transplant and evaluate the resulting impact on UBC homing.
    

Intervention name(s): Administration of hyperbaric oxygen
Intervention type(s): Device
Intervention description(s): Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
Other intervention name(s): Monoplace Hyperbaric Chamber Model 3200 and 3200R
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Umbilical Cord Blood (UCB) Stem Cell Transplant; Hyperbaric oxygen; Leukemia; Lymphoma; MDS
Counseling During Pulmonary Rehabilitation
Condition: COPD
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if a physical activity counseling program during
      pulmonary rehabilitation increases the physical activity level in daily life in patients with
      Chronic Obstructive Pulmonary Disease.
    

Detailed description: 
      Participants performed a 12 weeks outpatient pulmonary rehab (PR) according to guidelines.
      Participants allocated to intervention received PR plus physical activity (PA) counselling.
      PA counselling was performed using "motivational interviewing" techniques and was provided by
      two experiences physiotherapists independant to the rehab team. After PR and three months
      follow-up was evaluated if PA counselling during PR increases PA elvel (primary outcome:
      steps per day) in daily life.

      Furthermore, individual, semi-structured interviews were performed in a subgroup of
      participants in order to gain more detailed information about barriers and enablers of
      participation in daily-life activities. Participants were invited to two interviews, one
      right after PR the other after 3 months follow up. A content analysis was performed.
    

Intervention name(s): physical activity counseling; Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 face-to-face sessions a 30 minutes during 12 weeks pulmonary rehabilitation program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Norepinephrine Transporter Blockade, Autonomic Failure (NETAF)
Condition: Neurogenic Orthostatic Hypotension
MeSH terms: Hypotension, Orthostatic; Pure Autonomic Failure; Hypotension
Study type: Interventional
Phase: Phase 2

Summary: 
      Drug therapy for patients suffering from autonomic failure and neurogenic orthostatic
      hypotension are scarce and not effective. If left untreated, these patients have the highest
      risk of syncope, falls and fall-related injuries. The proposed study will determine the
      clinical benefit of a commercially available drug, atomoxetine, to reduce symptoms associated
      with neurogenic orthostatic hypotension in patients with autonomic failure.
    

Detailed description: 
      Autonomic failure is a group of rare neurodegenerative disorders that primarily affect the
      autonomic nervous system. These patients develop neurogenic orthostatic hypotension (OH)
      because of impaired autonomic reflexes that control cardiovascular and neuro-humoral
      adaptation to upright posture. The treatment of neurogenic OH is challenging; the therapeutic
      options are scarce, and some patients are refractory to treatment.

      Atomoxetine is a selective norepinephrine transporter inhibitor that increases the
      availability of norepinephrine in the synapse by blocking its reuptake. Our preliminary data
      in sixty-five patients with primary autonomic failure and neurogenic OH showed that
      atomoxetine was more effective than midodrine, standard of care, in improving standing SBP
      (+7.5 mm Hg). Notably, only atomoxetine and not midodrine induced a significant reduction in
      OH-related symptoms (lightheadedness and dizziness) compared with placebo. In this proposal,
      we will test the hypothesis that prolonged administration of the norepinephrine transporter
      blocker, atomoxetine, improves OH-related symptoms and OH-impact on daily activities compared
      with placebo in autonomic failure patients. We propose a randomized, double-blind,
      placebo-controlled, 2x2 crossover study.
    

Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): norepinephrine transporter inhibitor; placebo
Other intervention name(s): strattera; non active medication
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: norepinephrine transporter inhibitors
PET Study to Determine the Relationship Between Plasma Concentrations and Muscarinic Type 1 Receptor (M1AChR) Occupancy of PIPE-307 in Healthy Volunteers
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, open-label, adaptive-design PET study to investigate the
      occupancy of brain muscarinic Type 1 receptors (M1AChR) by PIPE-307 in healthy volunteers.
    

Detailed description: 
      This is a Phase 1, single-center, open-label, adaptive-design study to investigate the
      occupancy of brain M1AChR after a single oral dose of PIPE-307 in healthy volunteers by
      positron emission tomography (PET) using the radioligand [11C] PIPE-307.

      This study will have an adaptive design to adequately evaluate the relationship between
      PIPE-307 exposure and brain M1AChR occupancy.
    

Intervention name(s): PIPE-307
Intervention type(s): Drug
Intervention description(s): Each dose cohort will receive a single oral dose of PIPE-307. Doses to be tested in subsequent cohorts will be determined by the analysis of the exposure from PK data and the PET scans with [11C] PIPE-307.
Subjects will receive an intravenous dose of the radioligand [11C] PIPE-307 prior to PET imaging.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis
A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and
      2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If
      the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy
      volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b,
      dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.
    


Intervention name(s): ABI-H2158; Placebo for ABI-H2158
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg or 25 mg tablets; Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CHB; HBV; hepatitis B; HBeAg positive
ArcadiusXP L Post Market Clinical Follow-Up
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      The purpose of this study is to collect clinical and radiological mid-term (2 years) data on
      the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF)
      limited to 32 patients.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients
Electro-acupuncture for Central Obesity
Condition: Central Obesity
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      In this study, a 8-week, single blinded, randomized controlled clinical trial will be
      conducted to examine the efficacy and safety of body acupuncture in the treatment of central
      obesity in Hong Kong.
    

Detailed description: 
      This is a pilot single-blind, randomized, sham-controlled trial. 168 central obesity patients
      will be randomly assigned to acupuncture group or control group. The duration of the
      treatment will be 8 weeks with 2 session per week and the follow-up period will be 2 weeks.
    

Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.
We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-blinded, randomized, sham-controlled clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I)
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the absorption, systemic pharmacokinetics and
      accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5%
      solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with
      onychomycosis.
    

Detailed description: 
      For this study, the case definition of onychomycosis included moderate to severe distal
      subungual onychomycosis including subjects with evidence of subungual dermatophytoma or
      yellow spikes, lateral and proximal onychomycosis and severely dystrophic nail plates.
      Subjects with only superficial white onychomycosis were excluded. Confirmation of the
      clinical diagnosis of onychomycosis of at least one great toenail included a positive KOH wet
      mount.
    

Intervention name(s): AN2690
Intervention type(s): Drug
Intervention description(s): AN2690 7.5% Solution, once daily for 28 days
Intervention MeSH terms: Tavaborole
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Onychomycosis; Fungal Nail