bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between Two Methods in the Acceleration of the Retraction of Upper Canines
Condition: Malocclusion, Angle Class II, Division 1
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      Patients at the Orthodontic Department of University of Damascus Dental School will be
      examined and subjects who meet the inclusion criteria will be included.

      Then, initial diagnostic records (diagnostic gypsum models, internal and external oral
      photographs, as well as radiographic images) will be studied to ensure that the selection
      criteria are accurately matched.

      The aim of this study is to compare flapless bone cutting by mechanical drills to evaluate
      the acceleration of the retraction of upper canines versus traditional bone cutting by
      piezo-surgery in comparison with a control group without bone cutting after extraction of
      upper first premolars in class II type I patients.
    


Intervention name(s): Cortico-alveolar perforations; Traditional Corticotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Mechanical drills will be used on a handpiece; Piezo-surgery will be employed following flaps' elevation.
Other intervention name(s): Flapless corticotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Aim of the study To investigate whether auricular acupuncture (AA) will reduce postoperative
      pain and analgesic requirement in comparison with sham AA in patients after elective knee
      arthroplasty

      Design Prospective randomized controlled blinded clinical trial

      Participants:

        -  Patients < 80 und > 50 years old

        -  scheduled for knee arthroplasty under general anesthesia with < 120 minutes duration

        -  Without previous opioid medication

        -  Able to give informed consent

      Outcome measures

        -  Postoperative analgesic requirement

        -  Incidence of side effects

        -  Physiological parameters
    


Intervention name(s): Auricular acupuncture; Sham auricular acupuncture
Intervention type(s): Device; Device
Intervention description(s): Auricular acupuncture with indwelling fixed needles at specific AA points; Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trodat 1 SPECT and Dopamine Polymorphism
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The study population will include 100 parkinsonian patients in early stage of disease, with
      total duration not exeeding 5 years.

      The patients will undergo neurologic examination and evaluation of disease severity using the
      unified PD rating scale. Subsequently a brain SPECT will be performed using Tc-99m-Trodat1.
    

Detailed description: 
      The study sample will include 100 Israeli Jewish patients with early idiopathic PD who were
      not treated with anti-parkinson drugs. The clinical diagnosis will be based on the criteria
      of the United Kingdom Parkinson Disease Society Brain Bank.5 All patients will undergo
      Tc-99m-Trodat1 SPECT. The severity of the motor symptoms will be assessed with the Unified PD
      Rating Scale (UPDRS). Genomic DNA is extracted from peripheral blood leukocytes for genetic
      analysis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 early Israeli PD patients Of jewish origin, males or females Undergoing DAT-scan
        examination in Wolfson medical center at early stage of disease, accompanied by a UPDRS
        evaluation at that stage,performed by a trained neurologist
      
Biospecimen description: 
      Blood samples with DNA
    
Keywords: Severity of disease
ESWT vs Cryo-US Therapy in the Treatment of Chronic Lateral Epicondylitis: One Year Follow up Study
Condition: Tendinopathy
MeSH terms: Tendinopathy; Tennis Elbow
Study type: Interventional

Summary: 
      Chronic lateral epicondylitis is usually managed conservatively. The purpose of this
      single-blinded, randomized, controlled study is to compare the clinical therapeutic effects
      of extracorporeal shock wave therapy (ESWT) in comparison with cryoultrasound (Cryo-US)
      therapy in chronic lateral epicondylitis (LE) during a period of 12 months.
    

Detailed description: 
      Eighty participants with chronic LE were randomly assigned to receive 3 ESWT sessions at
      48/72-hours intervals -2400 impulses at energy flux density 0.14-0.20 mJ/mm2 at each session-
      (ESWT Group, n=40) or 12 Cryo-US therapy sessions (4 daily sessions per week) in a continuous
      modality at 1.8 Watt/cm2 and -2˚C at each session- (Cryo-US Group, n=40). Visual Analogue
      Scale (VAS) and satisfactory results, considered as the sum of the excellent and good scores
      in the Roles and Maudsley score, were used as outcome measures at baseline and 3, 6, and 12
      months post-treatment.
    

Intervention name(s): MODULITH® SLK, STORZ MEDICAL AG, Switzerland; Cryoultrasound™, Medisport S.r.l., Italy
Intervention type(s): Device; Device
Intervention description(s): Three sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2, depending on the maximum tolerated pain of each patient. Analgesics or local anaesthetics were not administered before, during or after treatment.; Cryo-US therapy was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. The treatment was performed in 3 weeks (4 daily sessions per week).
Other intervention name(s): Focused Extracorporeal Shock Wave Therapy; ESWT; Therapeutic Ultrasound; Cryo-US therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elbow pain; lateral epicondylitis; conservative treatment; shock wave treatment; therapeutic ultrasound
Resveratrol With or Without Piperine to Enhance Plasma Levels of Resveratrol
Condition: Focus of the Study: Normal Volunteers
Study type: Interventional

Summary: 
      There is some evidence that when resveratrol (a substance which is found in red grapes,
      peanuts and chocolate) is combined with Piperine (a substance found in pepper) it is more
      effective in fighting cancer. The purpose of this study is to see if resveratrol in
      combination with piperine is more effective than taking resveratrol alone. Since
      investigators don't know what dose of piperine to use in combination with resveratrol, two
      different doses of piperine will be studied.

      Twenty-four participants, equal numbers of males and females, will receive a single dose of
      resveratrol (2.5 grams) without piperine, resveratrol (2.5 grams) with piperine (5 mg), or
      resveratrol (2.5 grams) with piperine (25 mg).
    


Intervention name(s): Resveratrol; Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose; Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Resveratrol 2.5 grams; Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose; Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose
Intervention MeSH terms: Resveratrol; Piperine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Resveratrol; Piperine
Study to Evaluate the Safety and Pharmacokinetics of Oral OPRX-106 (TNFR-Fc Fusion Protein) in Healthy Volunteers
Condition: Human Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      : This is a Phase I, study to evaluate the safety and pharmacokinetics of oral OPRX-106 in
      healthy volunteers. Up to 18 healthy male subjects (age 18 years and older) will be
      randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving OPRX-106
      doses equivalent to 2mg, 8mg or 16mg Tumor Necrosis Factor receptor-Fc fusion protein.
      Subjects will receive once daily oral administrations of OPRX-106 for 5 consecutive days.
      Subjects will remain at the clinical center for 24 hours after the first administration (Day
      1) of OPRX-106 including PK sampling and then return to the site daily for additional
      administrations and study procedures.
    


Intervention name(s): OPRX-106
Intervention type(s): Drug
Other intervention name(s): TNF receptor-Fc fusion protein (TNFR-Fc)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants
Condition: Influenza Infection
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular
      injection of TAK-850 in healthy pediatric Japanese participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-850, that is under development as a vaccine
      for influenza infection. This study will evaluate the safety and immunogenicity of TAK-850 in
      healthy Japanese children when given as an intramuscular injection.

      The study will enroll approximately 99 participants (33 per treatment group) to receive
      TAK-850 in open label fashion, The participants will be assigned to each treatment group as
      follows:

        -  a single intramuscular injection of TAK-850/0.5 mL in 13 to 19 years old healthy
           Japanese children,

        -  Two injections of TAK-850/0.5 mL in 3 to 12 years old healthy Japanese children,

        -  Two injections of TAK-850/0.25 mL in 6 to 35 months old healthy Japanese children.

      The overall time to participate in this trial is 22 days (13-19 years old) or 43 days (6
      months to 12 years old). Participants will make up to 2 visits (13-19 years old) or 3 visits
      (6 months to 12 years old) to the site.
    

Intervention name(s): TAK-850 0.5 mL injection; TAK-850 0.25 mL injection
Intervention type(s): Drug; Drug
Intervention description(s): TAK-850 injection; TAK-850 intramuscular injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention
Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Dependent Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Nephrotic syndrome in children is primarily caused by minimal change disease. Majority of
      these patients respond well to corticosteroids. However, as many as 70% of children with
      nephrotic syndrome experience at least one relapse, and 30% develop a more complicated course
      with frequent relapses (FRNS)(≥2 relapses/ 6 months) with or without steroid dependency
      (SDNS)(relapse during tapering or within 2 weeks after discontinuation of corticosteroids).
      Repeated and prolonged courses of steroids in these children often result in long-term
      complications. The goal of the treatment is to reduce the rate of relapses, the cumulative
      dose of corticosteroids, and the incidence of serious complications. In order to minimize the
      side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide,
      calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in
      SDNS. Whereas CNI are usually considered the steroid sparing drug class of first choice,
      rituximab is increasingly used as alternative to minimize CNI toxicity. Various prospective
      studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and
      effective alternative to steroid or immunosuppressants to achieve and maintain remission in
      this population.Single rituximab course have been shown to be efficacious for 6 to 12 months
      and the side effect profile observed to date is very benign. Studies comparing the usefulness
      of these agents are lacking. In our proposed randomized controlled trial, the investigators
      want to compare the efficacy and safety of CNI to that of Rituximab in treating children with
      SDNS.
    


Intervention name(s): Tacrolimus; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tacrolimus (Tablet form) 0.2mg/kg/day starting dose. Targeting trough level of Tacrolimus (T0) 5-7 ng/ml.; Two rituximab infusions will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2). Circulating B cells will be measured 24 hours after rituximab administration. If >5 B cells per mm3, it will be measured again after 1 week. If count is still >5 B cells per mm3, third & fourth doses of rituximab will be given.
Other intervention name(s): Calcineurin inhibitor; anti CD20 monoclonal antibody
Intervention MeSH terms: Rituximab; Tacrolimus; Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AZD6140 Oral Contraceptive Interaction Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effect of co-administration of AZD6140 and
      Nordette® on the blood levels of certain female hormones.
    


Intervention name(s): AZD6140; Levonorgestrel and Ethinyl Estradiol (Nordette®)
Intervention type(s): Drug; Drug
Intervention description(s): 90 mg tablet taken by mouth 2 times a day for 21 days per cycle; 1 tablet taken by mouth once a day for 28 days per cycle
Other intervention name(s): Nordette®
Intervention MeSH terms: Ticagrelor; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oral contraceptive; birth control; Healthy volunteers
Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      African American (AA) children carry a disproportionate burden of mortality and morbidity in
      asthma. A major contributor to racial disparity in asthma is lack of adherence to
      guideline-recommended use of daily inhaled corticosteroids (ICS). Symptom-based adjustment
      (SBA) of ICS is a recently described patient-centered approach to asthma therapy in which
      patients adjust their ICS on a day-to-day basis guided by their symptoms. The overall goal of
      our study is to identify an acceptable, pragmatic and effective approach to asthma management
      in high-risk AA children. Our primary hypotheses are that SBA of ICS use is more acceptable
      than provider-based adjustment (PBA), equally effective in improving pediatric asthma
      outcomes, and will reduce the cumulative dose of ICS needed for asthma control. Therefore, in
      the Asthma Symptom based adjustment of Inhaled Steroid Therapy in African American children
      (ASIST) study, we propose a randomized, open-label, 2-arm, parallel, pragmatic trial in which
      we will randomly assign 200 AA children to either receive SBA or PBA for 12 months. The
      primary outcome is asthma control as measured by the Asthma Control Test (ACT). We propose
      that asthma control in the SBA group will be equivalent to the PBA group after 12 months.
      Secondary outcomes include monthly cumulative ICS dose, exacerbation rate, quality of life,
      lung function, adherence and satisfaction with the treatment plan.
    


Intervention name(s): Asthma controller medication (Beclomethasone) adjustment strategy; Provider-based adjustment
Intervention type(s): Other; Other
Intervention description(s): The participant will adjust the dose of Beclomethasone based on symptoms; The provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion
Condition: Central Venous Catheter Thrombosis
MeSH terms: Thrombosis; Upper Extremity Deep Vein Thrombosis
Study type: Observational

Summary: 
      A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass
      Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of
      central venous catheters in hemodialysis patients with thoracic central venous occlusion.
    


Intervention name(s): inside-out-access technique with inside-out access device (Surfacer (R)); access technique including Sharp recanalization
Intervention type(s): Procedure; Procedure
Intervention description(s): inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular); access technique with Sharp recanalization via interventional radiology
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Hemodialysis patients with thoracic central venous occlusion requiring vascular access
      
Keywords: thoracic central venous occlusion; Dialysis access
Effectiveness Of Osteopathic Manipulative Treatment In NICU: A Multicenter Clinical Trial
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The use of complementary and alternative medicine in neonatal ward has been steadily rising
      during the last decade. This integrated medicine approach has been shown to be helpful to
      improve neonatal health care. Osteopathic manipulative treatment (OMT) has been applied to
      premature infants to reduce the length of stay and to cope with clinical complications.
      Results from previous studies documented the positive association between OMT and shorter
      period of hospitalisation as well as improvement of clinical conditions. The aim of this
      nationwide multicenter study is to demonstrate the effect of OMT on length of stay (LOS) in
      premature infants across 3 neonatal intensive care units (NICU).
    


Intervention name(s): osteopathic manipulative treatment; Usual care
Intervention type(s): Other; Other
Intervention description(s): Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.; Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: prematurity; OMT; complementary and alternative medicine; neonates; length of stay
Trazodone Once a Day in Major Depression Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The study objective is to evaluate the efficacy and safety of trazodone OAD vs venlafaxine
      extended release (venlafaxine XR) after an 8-week treatment period in patients with major
      depressive disorder.
    

Detailed description: 
      This randomized, venlafaxine-controlled, double-blind, parallel design study consists of a
      Pre-Treatment Phase (screening, wash-out) and a double-blind Treatment Phase (randomization
      to trazodone OAD or to venlafaxine XR, treatment for 8 weeks and tapering for 1 to 3 weeks).
      During the Pre-Treatment Phase, patients who sign an informed consent form will undergo
      initial screening. Potential candidates will be instructed to discontinue antidepressants or
      prohibited medications (wash-out) for a period specific to taper schedule (based on 5
      elimination half-lives of the used medication). On the last day of the Pre-Treatment Phase,
      patients will be evaluated for the final eligibility, and those qualified will be randomly
      allocated in a 1:1 proportion to trazodone OAD 300 mg/day (1 week of tapering with trazodone
      OAD 150 mg/day) or to venlafaxine XR 75 mg/day once daily. After 3 and 5 weeks of treatment,
      subjects will be evaluated for the response. For non responding patients dose increases (in
      increments of 75 mg/day) will be done till to reach the maximum of 225 mg/day for venlafaxine
      XR and 450 mg/day for trazodone OAD. Patients non responding to treatment at the final visit
      will have their study medication tapered from 1 to 3 weeks, according to the maximum dose
      reached during the study. In order to prevent relapse of depression symptoms, responders at
      the final visit may continue the treatment. In this case, an unblinded third party Dispenser
      will open the treatment code and will prescribe the same medication taken by the patients
      during the trial, according to the formulation available on the market.
    

Intervention name(s): Trazodone; Venlafaxine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Trazodone; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trazodone; Venlafaxine; Major depressive disorder