bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Laser Diode Effect on the Kinetics of Orthodontic Tooth Movement (Protocol CINELASER)
Condition: Class II Canine; Intermaxillary Strength; Elastics II; Multi Fasteners Orthodontic Treatment
Study type: Interventional

Summary: 
      It is a single-center, prospective clinical study of a medical device, controlled,
      randomized, non-stratified, double-blind (neither the patient nor the parents know which area
      is irradiated / practitioner who performs the measures and evaluates the class I achievement
      or non also ignores the irradiated area) .

      Children included in this clinical trial will be their own control, an area receiving LASER
      irradiation the other receiving a simulation LASER irradiation (placebo side, inactive laser)
      .

      In the maxilla, it will be segmented using a technique by the introduction of sectional side
      (portion of elgiloy arch supporting molars, canines and premolars) which serve as a support
      for Intermaxillary Strength II (or Intermaxillary Elastics II).

      The patient should put his own Intermaxillary Elastics II, force adapted to the amount of
      class II dental, and this 24h/24. The patient should position him/herself these
      intermaxillary elastics in the first mandibular molar to the maxillary canine ; their action,
      in case of maximum mandibular anchorage, is to reduce maxillary canine in order to obtain
      reports of class I. In the mandible, a maximum anchor will be realized. Maximum molar anchor
      is to place the roots of mandibular molars in the vestibular cortex in order to anchor them
      there. This allows the lower canines, premolars and maxillary molars under the action of FIM
      without causing mutual advancement of the mandibular arch.

      This procedure does not differ from the usual treatment. The application of laser diode
      appears, by biomodulatrice action, to show promising results on accelerating the kinetics of
      tooth movement during orthodontic treatment. The main hypothesis of the research is an
      increase in the rate of correction of Class II irradiated side, i.e. a 1-month shortest delay
      in obtaining the class I for irradiated areas vs. non irradiated ones.

      The main objective of this study is to evaluate the effect of the application of low energy
      laser (LLLT) on the time required to obtain a Class I canine on patients undergoing FIM II
      (Class II elastics)
    


Intervention name(s): (LLLT Low Level Laser Therapy) SiroLaser advance
Intervention type(s): Device
Intervention description(s): Irradiation scanning distance of the mucosa over an area ranging from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction, and the CEJ to the bottom of the vestibule in the vertical direction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Reliability and Validity of a Smart-phone Postural Control Assessment Application
Condition: Other Instability, Ankle and Foot
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the reliability and validity of smart-phone based
      system in postural control ability assessment on subjects with chronic ankle instability.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        chronic ankle instability group
      
Keywords: smart-phone; assessment; chronic ankle instability
Efficacy, Safety, and Tolerability of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Bipolar I Patients
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be a randomized, double-blind, placebo-controlled trial to assess the time to
      recurrence of any mood episode in subjects with bipolar I disorder who have maintained
      stability on aripiprazole IM depot for at least 8 weeks. This trial will include male and
      female subjects 18 to 65 years of age, inclusive, with a diagnosis of bipolar I disorder,
      according to DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric
      Interview (MINI), who have experienced at least one previous manic episode of sufficient
      severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic
      agent in addition to their current manic episode. All subjects must be experiencing a manic
      episode (per DSM-IV-TR criteria) with a YMRS total score ≥ 20 at trial entry. Both inpatients
      and outpatients are eligible for this trial.

      This trial will consist of a screening phase followed by 4 treatment phases. Subjects will
      undergo screening for eligibility, followed by a conversion to oral aripiprazole monotherapy
      phase, if needed, an oral aripiprazole stabilization phase, a single-blind aripiprazole IM
      depot stabilization phase, and, a double-blind, placebo-controlled phase.
    


Intervention name(s): Intramuscular (IM) Depot Aripiprazole; Intramuscular (IM) Depot Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Formulation: Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection; Formulation: Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aripiprazole; Intramuscular (IM) Depot; Bipolar
Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain
      suppression of viral replication to prevent the emergence of complications, which requires
      long-term therapy. Durable suppression of viral replication is achieved in the treatment of
      chronic viral diseases by preventing of the emergence of drug-resistant mutations. The
      clinical guidelines for the management of lamivudine resistant patients are variable. Some
      recommend switching to another agent without cross-resistance, while others recommend adding
      on another agent without cross-resistance. Limited clinical data exists to demonstrate
      whether tenofovir disoproxil fumarate (tenofovir DF; TDF) is an effective monotherapy for
      lamivudine resistant patients or if it should be used as part of a combination therapy
      regimen.

      This study is designed to evaluate the effectiveness, safety, and tolerability of tenofovir
      DF monotherapy versus emtricitabine (FTC)/tenofovir DF combination therapy in participants
      with chronic HBV with lamivudine resistance (presence of the rtM204I/V mutation with or
      without the rtL180M mutation) over a 240-week period. Participants in this study must be
      receiving lamivudine treatment at the time of enrollment.
    


Intervention name(s): TDF; FTC/TDF; TDF Placebo; FTC/TDF Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablet administered orally once daily; Emtricitabine (FTC)/TDF 200/300 mg fixed-dose combination tablet administered orally once daily; TDF placebo tablet administered orally once daily; FTC/TDF placebo tablet administered orally once daily
Other intervention name(s): Viread®; Truvada®
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tenofovir DF; Emtricitabine; Chronic hepatitis B; Combination therapy
A Study of E2027 in Participants With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) With or Without Amyloid Copathology
Condition: Lewy Body Disease; Parkinson Disease
MeSH terms: Parkinson Disease; Dementia; Lewy Body Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of study is to demonstrate the pharmacodynamic (PD) effects of E2027 on
      cerebrospinal fluid (CSF) cyclic guanosine monophosphate (cGMP) in participants with DLB and
      PDD with and without amyloid copathology after 9 weeks of treatment.
    


Intervention name(s): E2027
Intervention type(s): Drug
Intervention description(s): Oral hypromellose capsules.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: E2027; Amyloid Copathology; Parkinson's Disease Dementia; Dementia With Lewy Bodies
Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
Condition: Complicated Skin and Soft Tissue Infection
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin
      plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue
      infections.
    

Detailed description: 
      A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy
      and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in
      the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With
      Evidence of Systemic Inflammatory Response or Underlying Comorbidities
    

Intervention name(s): Ceftaroline fosamil; Vancomycin; Aztreonam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV ceftaroline 600mg every 8 hours; IV vancomycin 15mg/kg every 12 hours; IV aztreonam 1 g every 8 hours
Intervention MeSH terms: Vancomycin; Ceftaroline fosamil; Aztreonam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: complicated skin and soft tissue infections (cSSTI); skin infection; ceftaroline; wound infection; cellulitis; burn infection; bacterial infection; vancomycin
Pilot Study of Triphala and Rubia Cordifolia on Gut Microbiome and Skin
Condition: Sebum Production; Stool Microbiome; Transepidermal Water Loss; Facial Brrightness; Erythema; Wrinkles; Facial Shine
MeSH terms: Erythema; Facies
Study type: Interventional

Summary: 
      Few studies have assessed the effects of Triphala and Rubia Cordifolia from a skin
      biophysical perspective. Here, we aim to understand how these herbs can modulate the skin's
      barrier properties and the gut microbiome.
    

Detailed description: 
      Herbal supplements such as Rubia cordifolia and Triphala [a mix of Emblica officinalis
      (Amalaki), Terminalia bellerica (Bibhitaki), and Terminalia chebula (Haritaki)] are commonly
      used for skin based treatments in India. However, the scientific evidence for their specific
      effects on the skin are scant. Rubia cordifolia is a root that is used in skin care for
      pigmentation and inflammation.1 Triphala is thought to have antioxidant properties and reduce
      inflammation in general. Herbs have been shown to modulate the gut microbiome, as previous
      studies have suggested that triphala may modify the gut microbiome.2

      However, few studies have assessed the effects of these herbs from a skin biophysical
      perspective. Here, we aim to understand how these herbs can modulate the skin's barrier
      properties and the gut microbiome.
    

Intervention name(s): Placebo Oral Tablet; Rubia Cordifolia; Triphala
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Group A: Placebo group (n = 10)
Supplement appearing similar to Herbal formulations
Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating.
Dose: subjects in this group will take 4 placebo tablets per day; Group B: R. cordifolia group (n = 10)
2,000 mg R. cordifolia per day - supplied by Banyan Botanicals and following standard supplementation doses on commercially available supplement (https://www.banyanbotanicals.com/manjistha-tablets/)
Each tablet contains 500 mg of R. cordifolia per tablet.; Group C: Triphala group (n= 10)
Tablets of Triphala will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/triphala-tablets-11/)
Each tablet contains mix Emblica officinalis, Terminalia bellerica, and Terminalia chebula
Dose: subjects will take 4 tablets per day, with a total dose of 2,000 mg of total herb.
Other intervention name(s): Manjistha
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Thirty (30) subjects meeting the inclusion criteria without any of the exclusion criteria will be enrolled in this study. This study will be a double blinded study. Each subject will be randomized a priori to receive either placebo, Rubia cordifolia, or Triphala tablets.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
How Much The Self-Reported Physical Activity Change in Patients With Physical Disabilities Hospitalized for Rehabilitation in A Physical Medicine and Rehabilitation Clinic
Condition: Disability Physical; Impairment; Physical Activity; Rehabilitation; Televisit
Study type: Observational

Summary: 
      Disability was defined by WHOas a restriction or lack of ability to perform daily activity,
      but this definition was later changedto problems in functioning in the WHO classification of
      Functioning, Disability and Health (ICF). Osteoarthritis, back pain, neck pain, rheumatologic
      diseases, neurologic disorders (stroke, spinal cord injury, multiple sclerosis, Parkinson
      diseases) can cause physical disabilities.Recent studies have shown that; high levels
      ofdisability is related with low levels of physical activity.Individuals with disability are
      commonly hospitalized ininpatients clinicsfor rehabilitation, which aims to achieveoptimal
      functional level ofpatients within their own limitations.A rehabilitation program can be an
      excellent opportunity to integrate post-rehabilitation physical activity into their
      lifestyle.This study aimed to examine the short term effect of inpatient rehabilitation
      program on self -reported physical activity both participants with physical disabilities due
      to musculoskeletal, and neurological disorders
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with physical disabilities, due to neurologic or musculoskeletal diseases and
        hospitalized in PMR clinic for rehabilitationbetween September 2020 andMarch 2021were
mHealth Messages to Sustain Recent Weight Loss - Phase 2
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      To assess the feasibility to translate an automated weight loss message intervention to a
      weight loss clinic population.

      Aim 1: To assess feasibility of translating the intervention in a clinic for patients who
      recently completed a structured weight loss program.

      Aim 2: To assess the ability to capture a trajectory of self-reported weight over 6 months
      through an automated intervention.
    

Detailed description: 
      The investigators will recruit 100 participants who are clients at the Duke Diet and Fitness
      Center. At baseline the investigators will collect demographic information such as, their
      age, weight, education. When participants complete their respective program at the DFC they
      will receive a daily weight loss sustaining text message at 8:00 A.M. for 60 days.
      Participants will also receive weekly messages for 6 months asking them to self-report their
      weight. Thereafter, they will receive an automated message monthly for 18 months asking them
      to self-report their weight.
    

Intervention name(s): mHealth Texting for Weight Loss
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mobile Technology; Diet and Fitness
Safety and Immunological Effects of Two Mistletoe Preparations in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this clinical trial is to describe safety, tolerability and the course of
      parameters of the immune system during administration of different doses of two
      subcutaneously administered mistletoe preparations (Iscucin populi and Viscum Mali e planta
      tota) in healthy volunteers, compared to placebo.
    


Intervention name(s): mistletoe preparations
Intervention type(s): Drug
Intervention description(s): 1 ampoule (1ml) twice per week subcutaneously
Other intervention name(s): 1. Mistletoe from the poplar tree; 2. Mistletoe from the apple tree
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Mistletoe; Anthroposophical medicine
Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence,
      crossover, multicentric experimental bioequivalence study.
    

Detailed description: 
      The objective of this study was to compare the bioavailability and characterise the
      pharmacokinetics profile of the sponsor formulation Quetiapine fumarate tablets 300 mg of Dr.
      Reddy's Laboratories Limited, India with respect to reference formulation Seroquel tablets
      300 mg of Astrazeneca Pharmaceuticals, USA in adults schizophrenia patients under fasting
      condition.

      54 subjects were dosed and were enrolled in the study.
    

Intervention name(s): Quetiapine fumarate
Intervention type(s): Drug
Intervention description(s): Quetiapine fumarate tablets 300mg
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Quetiapine fumarate; crossover
Treatment of Muscle Injury Following Arthroplasty for Hip Fracture (HF)
Condition: Hip Fracture
MeSH terms: Fractures, Bone; Hip Fractures
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to assess the efficacy, safety, and tolerability of PLX-PAD
      intramuscular administration for the treatment of muscle injury following arthroplasty for
      HF.
    

Detailed description: 
      This will be a Phase III, multinational, randomized, double-blind, placebo-controlled study,
      assessing the efficacy, safety, and tolerability of intramuscular (IM) administration of
      allogeneic PLX-PAD cells for the treatment of muscle injury following arthroplasty for HF as
      compared to placebo treatment. Both treatment arms will receive standard of care treatment
      per local practice.

      The study will comprise 2 periods:

        1. Main study period - from Screening to 52 weeks post-treatment. During this period, the
           subjects will have the following study visits: Screening, Day 0 (treatment and surgery
           day), Day 1, Day 5, Week 6, Week 12, Week 26 and Week 52.

        2. Safety follow-up period - from Week 52 to Week 104. During this safety follow-up period,
           there will be a phone call visit at Week 104 and Only survival and quality of life data,
           serious adverse events (SAEs) and new malignancy adverse events will be collected.

      The main study period will comprise 4 periods:

        1. Screening and pre-surgery time

        2. Surgery and treatment with PLX-PAD or placebo (Day 0)

        3. Hospital follow-up until Day 5±1, at least

        4. Follow-up period up to 52 weeks following study treatment administration. Subjects will
           be assessed for study eligibility before the emergency surgery for HF. After being found
           eligible, subjects will be randomized using a 1:1 allocation scheme to either 150×106
           PLX-PAD cells or to placebo treatment, respectively. Within 48 hours of admission and up
           to 72 hours following fracture, subjects will undergo HA or THA. During the surgical
           procedure, the subjects will receive the investigational product in accordance with the
           treatment group to which they were randomized. Thereafter, visits will be conducted at
           Days 1 and 5±1, and at Weeks 6, 12, 26, 52 and 104.
    

Intervention name(s): PLX-PAD; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PLX-PAD (120 subjects): 150×10^6 PLX-PAD cells (10×10^6 cells/mL) in a mixture containing 10% DMSO (v/v), 5% HSA (w/v) and PlasmaLyte; Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: , subjects will be randomized using a 1:1 allocation scheme to either 150×10^6 PLX-PAD cells or to placebo treatment, respectively
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Abdominal Wall Evaluation in Low Back Pain
Condition: Abnormally Decreased Muscle Contraction
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The purpose of this study was to evaluate feed-forward contraction of the transversus
      abdominis and thickness of the transversus abdominis, obliquus internus, and obliquus
      externus during calm and standardized respiration in low back pain patients and pain-free
      subjects.
    

Detailed description: 
      Low back pain patients have alterations in abdominal wall function, especially in the
      feed-forward activation of transversus muscle during limbs movements. However, there are no
      reports on the abdominal function in low back pain patients during physiological respiratory
      movement.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds in China
Condition: Correction of the Moderate to Severe Nasolabial Folds
Study type: Interventional

Summary: 
      The objectives of this study are to evaluate the effectiveness and safety of Radiesse for the
      correction of nasolabial folds (NLFs).
    


Intervention name(s): Radiesse injectable implant (dermal filler); Restylane injectable implant (dermal filler)
Intervention type(s): Device; Device
Intervention description(s): Subdermal injection.; Subdermal injection
Other intervention name(s): Calcium hydroxylapatite particles suspected in an aqueous based gel carrier.; Hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Split-face
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment