bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Suprascapular Nerve Block and Subacromial Injection in Hemiplegic Shoulder Pain
Condition: Hemiplegia; Pain
MeSH terms: Shoulder Pain; Hemiplegia
Study type: Interventional

Summary: 
      Hemiplegic shoulder pain is the most common poststroke painful condition. Hemiplegic shoulder
      pain reduces range of motion (ROM) and hand function, resulting in limited daily life
      activity and decreased quality of life.

      In the literature, the effectiveness of suprascapular nerve block and subacromial injection
      in hemiplegia patients with shoulder pain has been previously evaluated, but these injection
      treatments have not been compared.

      Therefore, the aim of this study is to compare the effectiveness of suprascapular nerve block
      and subacromial injection on pain, shoulder (ROM), function and quality of life in hemiplegia
      patients with shoulder pain.
    

Detailed description: 
      Patients will be randomly assigned Subacromial injection group or Suprascapular nerve block
      group

      In the suprascapular nerve block group, suprascapular nerve block will be performed with a
      MyLab60 model a high resolution 7-12-MHz linear probe ultrasonography device. After the
      suprascapular fossa will be observed by ultrasonography, a betamethasone dipropionate plus
      betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 %
      bupivacaine (2 mL) and physiological serum (2 mL) will be injected with an in-plane technique
      using a 22 gauge 90-mm injector.

      In the subacromial injection group, subacromial injection will be performed with a MyLab60
      model a high resolution 7-12-MHz linear probe ultrasonography device. After the subacromial
      bursa will be observed by ultrasonography, a betamethasone dipropionate plus betamethasone
      sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and
      physiological serum (2 mL) will be injected with an in-plane technique using a 21 gauge 38-mm
      injector.

      A home exercise program will be given both groups. The exercise program consisted of passive
      and active-assistive ROM exercises (3 sets daily, 20 times in each set).
    

Intervention name(s): Suprascapular nerve block; Subacromial injection
Intervention type(s): Procedure; Procedure
Intervention description(s): A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 22 gauge 90-mm injector; A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 21 gauge 38-mm injector.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)
Condition: Post-Traumatic Headache
MeSH terms: Post-Traumatic Headache; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to
      evaluate the safety and efficacy of fremanezumab in adult participants aged 18 to 70 years,
      inclusive, for the prevention of PTH. The study will include a double-blind (DB) treatment
      period (12 weeks) and an open-label (OL) treatment period (12 weeks).
    


Intervention name(s): Fremanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fremanezumab will be administered per dose and schedule specified in the arm.; Placebo matching to fremanezumab will be administered per schedule specified in the arm.
Other intervention name(s): TEV-48125
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: posttraumatic headache (PTH)
Methionine Metabolism in Enterally Fed Pediatric Sepsis
Condition: Sepsis; Critical Illness
MeSH terms: Sepsis; Critical Illness
Study type: Observational

Summary: 
      Critically ill children have abnormal utilization of nutrients such as glucose, lipids and
      protein. Protein synthesis is increased mainly in the form of immune and signaling proteins,
      while muscle and structural protein synthesis is decreased. The metabolism of sulfur amino
      acids through the splanchnic area and specifically methionine and cysteine have not been
      investigated in critically ill septic children, despite that sulfur amino acids have
      important roles in thiol, antioxidant and epigenetic reactions. Methionine metabolism in sick
      children will be influenced by its rate of utilization through different pathways. Our study
      aims to investigate the metabolism of methionine and cysteine when both amino acids are given
      by the enteral route in critically ill septic children. The investigators are focused on the
      rates of transmethylation, remethylation and transsulfuration in critically ill septic
      children, and if the current standard nutrition maintains methionine nutritional balance and
      functional requirements in critically ill children fed by the enteral route.
    

Detailed description: 
      This is a prospective, translational study on the splanchnic metabolism of methionine to
      determine the rates of the different pathways and synthesis rates of glutathione when
      critically ill children are fed by the enteral route, and the difference among various age
      groups. The study size will include 45 critically ill septic, pediatric patients (15 infants
      at 1 month-3 years of age, 15 children at 4-12 years of age and 15 adolescent at 13-19 years
      of age), males and females admitted to the pediatric intensive care unit (PICU) at Children's
      Medical Center, Dallas. The minimal subject's weight will be 4 kg. The number of subjects
      includes an expected drop out rate of about 20%, in order to obtain 15 patients with complete
      data in each group. Patients will receive nutritional support as per standard care. This
      study will yield important knowledge and may lead in the future to changes in the current
      practice on the management of critically ill pediatric patients in the PICU.
    

Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Observational, Translational non-treatment study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Septic pediatric patients: A total of 45 critically ill children age 1 month-19 years with
        diagnosis of sepsis, as defined by the International Sepsis Consensus Conference.
      
Biospecimen description: 
      Blood samples.
    
Keywords: Methionine Metabolism; Enteral Nutrition; Pediatric; Pediatrics; Sepsis; Observational Study
Pain After Root Canal Obturation With Sealer Containing or Not 1% Enoxolone
Condition: Root Canal Obturation
Study type: Interventional

Summary: 
      This study aims to assess the efficacy of a zinc oxide eugenol sealer containing Enoxolone, a
      non-steroidal anti inflammatory drug (NSAID) on the pain relief after endodontic treatment.

      The study design is a multicenter, doubled blinded randomized controlled trial. The
      comparator is the equivalent zinc oxide eugenol sealer without NSAID (allocation ratio is
      1:1). The conventional endodontic treatment, using gutta percha and sealer, is done. Patients
      assess their pain for 7 days after permanent root obturation.
    


Intervention name(s): SEALITE Regular; SEALITE Ultra
Intervention type(s): Device; Device
Intervention description(s): Patients are treated with SEALITE Regular sealer (zinc oxide eugenol sealer). The SEALITE Regular powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control.; Patients are treated with SEALITE Ultra sealer (zinc oxide eugenol sealer containing 1% Enoxolone).
The SEALITE Ultra powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subject will be randomized in a 1:1 allocation ratio between the two treatment groups.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transcranial Direct Current Stimulation in Reduction of Pain and Postoperative Opioids Consumption After Spine Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The experience of pain derives from changes in brain excitability. Therefore, modulating the
      excitability of cortical areas involved in pain processing may become an attractive option in
      the context of multimodal analgesia during the postoperative period.
    

Detailed description: 
      The combination of analgesic drugs acting on different mechanisms can potentiate the effects
      of analgesia. Moreover, the understanding of pain physiology at the molecular level supports
      the development of new specific drugs. Indeed, new neurophysiological models of pain
      processing by the brain are becoming exquisitely refined and are supported by
      electrophysiological and functional brain imaging studies. One of the interesting concepts
      that stemmed from these studies is the evidence that the experience of pain is reflected in
      the central nervous system by widespread activations and excitability changes within a
      network of interconnected cortical areas and subcortical structures. The network processing
      of noxious information and their limbic and emotional consequences has been termed the "pain
      matrix." The continuous observation of the activity and excitability changes that parallel
      the pain experience led to the development of a new therapeutic approach: the use of central
      nervous system stimulation techniques.
    

Intervention name(s): tDCS sham motor cortex; active prefrontal cortex stimulation; active motor cortex stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): the intervention 25 participants will be subjected to spine surgery then participants will be subjected to sham stimulation targeting left motor cortex area using the transcranial direct current stimulation device for 30 seconds then stop for 20 minutes.; the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left dorsolateral prefrontal cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min; the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left motor cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of Indinavir Taken With or Without DMP 266
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if it is safe and effective to add DMP 266 to an anti-HIV
      treatment program of indinavir and nucleoside reverse transcriptase inhibitors (NRTIs).
    

Detailed description: 
      In this double-blind, placebo-controlled study, 300 patients are randomized to 1 or 2 reverse
      transcriptase inhibitors of their choice plus blinded therapy on Arm A or B as follows:

      Arm A: DMP 266 placebo plus indinavir. Arm B: DMP 266 plus indinavir. After 16 weeks,
      patients may switch the NRTI portion of their regimen if they meet a treatment failure
      criterion. After the completion of the 24-week period, patients have the option to continue
      on open-label DMP 266 and indinavir.
    

Intervention name(s): Indinavir sulfate; Efavirenz
Intervention type(s): Drug; Drug
Intervention MeSH terms: Efavirenz; Indinavir
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Placebos; Drug Therapy, Combination; HIV Protease Inhibitors; Indinavir; Reverse Transcriptase Inhibitors; efavirenz
Comparing Buccal Infiltration and Inferior Alveolar Nerve Block for Extraction of Mandibular Teeth
Condition: Buccal Infiltration Inferior Alveolar Nerve Block Articaine
Study type: Interventional

Summary: 
      This study compares the effectiveness of two techniques of local anesthesia in the extraction
      of mandibular teeth. One group received inferior alveolar nerve block and the other group
      received buccal infiltration of 4% Articaine
    

Detailed description: 
      Inferior alveolar nerve block is the commonly used local anesthetic injection technique for
      extraction of mandibular teeth. Buccal infiltration technique alone is considered to be
      ineffective in treating mandibular teeth due to the thickness of buccal cortical plate.
      However, buccal infiltration, if provided with an agent with higher penetration capability,
      may be used instead of Inferior alveolar nerve block. Articaine, due to its thiophene ring,
      has higher liposolubility and bony diffusion than any other agent.

      This study compares the effectiveness of inferior alveolar nerve block and buccal
      infiltration using 4% Articaine in the extraction of mandibular teeth
    

Intervention name(s): Buccal infiltration; Inferior alveolar nerve block
Intervention type(s): Procedure; Procedure
Intervention description(s): Injection of local anaesthetic parallel to the Long axis of the tooth in the depth of buccal sulcus; Standard technique of mandibular nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Buccal infiltration inferior alveolar nerve block Articaine
Pilot Trial of Opioid Taper Support
Condition: Chronic Non-cancer Pain
Study type: Interventional

Summary: 
      The proposed research will develop, demonstrate the feasibility of, and pilot test in a
      randomized controlled trial a prescription opioid taper support intervention. This
      intervention aims to prevent opioid misuse and adverse events among patients receiving
      chronic opioid therapy for chronic non-cancer pain without evidence of current substance
      abuse.

      The project will yield information essential to planning a future, larger-scale RCT designed
      to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse,
      misuse, overdose and other adverse events among patients receiving chronic opioid therapy for
      chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related
      activity interference, and mood. Participants in our pilot study will be limited to those
      without current opioid abuse or other substance abuse, but past substance abuse will be
      allowed. This will provide a sample of patients at risk for opioid abuse, misuse and
      overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients
      receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid
      taper support intervention, as compared with patients randomized to usual opioid prescribing
      care, will have lower opioid average daily doses at 22 and 34 weeks.
    


Intervention name(s): opioid taper support
Intervention type(s): Behavioral
Intervention description(s): Weekly visits with physician's assistant (supervised by pain physician/psychiatrist and pain psychologist) who provides pharmacological and psychological support for opioid taper at 10% per week
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic non-cancer pain; opioid taper; chronic pain self-management; motivational interviewing
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus Vaccine
Condition: Healthy Volunteers
MeSH terms: Dengue; Hepatitis A
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the immunogenicity and safety of the concomitant
      administration of TDV (subcutaneous [SC] injection) and of hepatitis A virus (HAV) vaccine
      (intramuscular [IM] injection) in healthy participants aged 18 to 60 years living in
      country(ies) non-endemic for both dengue and hepatitis.
    

Detailed description: 
      The vaccine tested in this study is TDV. TDV co-administered with HAV vaccine will be tested
      to assess immunogenicity and safety in healthy participants in non-endemic area(s) for dengue
      and HAV.

      The study will enroll approximately 900 patients. Participants will be randomly assigned to
      one of the three groups-which will remain undisclosed to the observer. Participants will be
      randomized in 1:1:1 ratio to receive:

        -  Group 1: HAV vaccine (IM) and TDV placebo-matching injection (SC), co-administered at
           Day 1 (Month 0 [M0]); TDV placebo-matching injection (SC) administered at Day 90 (Month
           3 [M3])

        -  Group 2: TDV (SC) and HAV placebo-matching injection (IM), co-administered at Day 1
           (Month 0 [M0]); TDV (SC) administered at Day 90(Month 3 [M3])

        -  Group 3: TDV (SC) and HAV vaccine (IM), co-administered at Day 1 (Month 0 [M0]); TDV
           (SC) administered at Day 90 (Month 3 [M3])

      This multi-center trial will be conducted in United Kingdom. The overall time to participate
      in this study is 270 days. Participants will have multiple visits to the clinic with a
      6-months follow up after the last study administration, including a final visit at Day 270.
    

Intervention name(s): TDV; HAV Vaccine; TDV Placebo; HAV Vaccine Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): TDV SC injection; HAV Vaccine IM injection.; Placebo-matching (normal saline (0.9% NaCl) SC injection.; Placebo-matching (normal saline (0.9% NaCl) IM injection.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine
Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy
Condition: Mite Allergy; Allergic Asthma
Study type: Observational

Summary: 
      One aim of this study was to find out if the bronchial allergen provocation (BAP) is an
      appropriate method to appraise the efficacy of a specific immunotherapy (SIT). The
      investigators had one group of children receiving SIT and one group of patients who denied a
      SIT although they had an indication for it. Retrospectively the investigators analysed the
      data of the first BAP and blood parameters specific IgE-mite, total IgE before SIT (November
      2008 till February 2010). Prospectively The investigators analysed the lung parameters and
      allergic labor parameters that we got in the course of the second BAP. The investigators mean
      parameter was PD20FEV1-mite. Another aim of The investigators study was to find specific
      immunological differences between children who improved because of SIT and those who showed
      no improvement. Thus, The investigators compared the levels of total IgE, cumulative IgE-mite
      and specific IgE-mite before and after SIT and the levels of specific IgG-mite and specific
      IgG4-mite after SIT.
    

Detailed description: 
      One aim of this study was to find out if the bronchial allergen provocation(BAP) is an
      appropriate method to appraise the efficacy of a specific immunotherapy (SIT). We had one
      group of children receiving SIT and one group of patients who denied a SIT although they had
      an indication for it. Retrospectively we analysed the data of the first BAP (PD20FEV1, VC,
      FEV1, FEV1/VC (%), eNO) and allergic blood parameters like specific IgE-mite, total IgE,
      cumulative IgE before SIT (November 2008 till February 2010). Prospectively we analysed the
      lung parameters and allergic labor parameters that we got in the course of the second BAP.
      Our mean parameter was PD20FEV1-mite. Another aim of our study was to find specific
      immunological differences between children who improved because of SIT and those who showed
      no improvement. Thus, we compared the levels of total IgE, cumulative IgE-mite and specific
      IgE-mite before and after SIT and the levels of specific IgG-mite and specific IgG4-mite
      after SIT. Additionally all patients answered a questionnaire according to ISAAC about their
      clinical symptoms, their quality of life and their medication score.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 6-17 years of age with house dust mite allergy
      
Biospecimen description: 
      serum
    
Keywords: specific immunotherapy; bronchial allergen provocation; specific IgE; specific IgG; specific IgG4; SIT
Ten-year Outcomes After AF Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational [Patient Registry]

Summary: 
      Ablation of atrial fibrillation (AF) using pulmonary vein isolation is employed when patients
      do not respond favorably to medical therapy. Successful procedures are accomplished in the
      majority of patients, but the outcome after many years of follow-up after ablation is
      unknown.
    

Detailed description: 
      A prospectively identified cohort of 445 patients who demonstrated freedom from AF for at
      least one year following ablation (single procedure in 391, 87.9%) was followed for 66.0 ±
      34.0 months. Patients were seen at least annually as outpatients, and underwent regular ECG
      monitoring, especially if there were symptoms suggestive of recurrent arrhythmia. Continued
      absence of arrhythmia was defined as freedom from AF or flutter > 30 secs.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent PVI ablation for drug refractory AF over a 10 year period and were
        free of AF for one year after last ablation procedure
Medicinal Nicotine for Preventing Cue Induced Craving
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine if changing the timeframe (relative to cue
      presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms
      of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In
      this cross-over study, all subjects attend three laboratory sessions at which either nicotine
      lozenge or placebo is given prior to presentation of smoking cues or after presentation of
      smoking cues. The order in which the three conditions will be presented are randomized.
    


Intervention name(s): Nicotine lozenge 4 mg; Placebo lozenge
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other