bioihbjkbjnl/mcl2 huggingface dataset:
Manual Therapy Treatment for Myofascial Pain
Condition: Myofascial Pain Syndromes
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome
Study type: Interventional

Summary: 
      This study is a pain intensity evaluation in patients with myofascial pain submitted
      kinesitherapy after trigger point injection.
    

Detailed description: 
      Randomized prospective study conducted on 30 patients of both genders ranging in age from 18
      to 60 years, with neck and shoulder girdle Myofascial Pain Syndrome (MFS), with a duration of
      ≥ 4 months and pain intensity ≥ 4.

      Trigger point injection of 1 mL 0.25% bupivacaine at each point, once a week for 8 weeks (T1
      to T8).

      Group 1: kinesiotherapy once a week for 8 weeks Group 2: not submitted to kinesiotherapy
      Evaluation of pain intensity on the first assessment (T0) and after 1, 2, 3, 4, 5, 6, 7, 8,
      and 9 weeks
    

Intervention name(s): Manual therapy
Intervention type(s): Procedure
Intervention description(s): Manual therapy, once a week for 8 weeks
Other intervention name(s): massage; finger pressure; myofascial release; mobilization
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myofascial pain; trigger point injection; manual therapy
Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke; Paresis
Study type: Interventional

Summary: 
      This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment
      of stroke and will help understand if DBS improves motor recovery for patients who continue
      to have significant impairment.
    

Detailed description: 
      The proposed study is a safety and feasibility study intended to provide preliminary data to
      design a future pilot study. The objective of this study is to document the safety and
      patient outcomes of electrical stimulation of the dentate nucleus area for the management of
      chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Device
Intervention description(s): Electrical stimulation of the dentate nucleus area of the cerebellum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic Stroke; Deep Brain Stimulation; DBS; Physical Therapy; Rehab; Brain Stimulation
rPMS Compared With Pelvic Floor Exercises for Treatment of Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      This study will compare the clinical efficacy and safety between rPMS device and pelvic floor
      exercises for the treatment of urinary incontinence. The subjects will be enrolled and
      assigned into two study groups - active and control group. Subjects will be required to
      complete six (6) treatment visits and five follow-up visits - 1, 3, 6, 9 and 12 months after
      the final treatment.
    


Intervention name(s): rPMS device; Pelvic floor muscle training
Intervention type(s): Device; Procedure
Intervention description(s): Pelvic floor muscle contractions will be induced by the rPMS device.; Control group will undergo a pelvic floor muscle training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Intranasal Ketamine for Social Impairment in Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine if intranasal ketamine shows initial evidence of
      safety, tolerability and efficacy for the treatment of social impairment in individuals with
      Autism Spectrum Disorder.
    

Detailed description: 
      To address the significant need for effective treatment of core symptoms of Autism Spectrum
      Disorder (ASD), this trial is designed as a double-blind, placebo-controlled crossover pilot
      study of intranasal ketamine in 24 individuals with ASD ages 12- 30 years using a novel
      quantitative eye-tracking outcome measure to assess impact of the drug on social impairment.
      Additionally, to develop a ketamine-focused personalized medicine approach in ASD, the
      investigators will include pharmacokinetic, molecular pharmacodynamic, and
      electrophysiological assessments into initial systematic study.
    

Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine will be compounded into a mucosal atomization device and self-administered or administered with assistance of a caregiver/study coordinator; Placebo will delivered as an atomized saline spray which will be self-administered or administered with assistance of a caregiver/study coordinator
Other intervention name(s): Ketalar; Saline
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine; Social Impairment; Autism; Autistic Disorder
Comparison of Fluid Requirements in Pancreatectomy: Laparotomy vs. Laparoscopy
Condition: Pancreatectomy; Fluid Therapy; Laparoscopy
Study type: Observational

Summary: 
      In this retrospective cohort study, the investigators reviewed and analyzed the electronic
      medical records of consecutive patients who underwent distal pancreatectomy either via
      laparotomy or laparoscopy. Intraoperative fluid administration amount, postoperative
      complications, length of hospital stay, and readmission rate were evaluated. The total fluid
      amounts were calculated using the sum of colloids multiplied by 1.5 or 2.0 and crystalloids.
    

Detailed description: 
      There has been recent progress in intraoperative fluid therapy. However, little is known
      about intraoperative fluid therapy in laparoscopic surgery. The purpose of this study is to
      determine whether there are differences in the basal fluid requirements during surgery
      between laparotomy and laparoscopic distal pancreatectomy. This study analyzed the records
      between June 2006 and March 2016. And 253 patients who underwent distal pancreatectomy via
      either laparotomy (73 patients) or laparoscopy (180 patients). This study was based on a
      retrospective review and analysis of the electronic medical records. The volume of
      intraoperative fluid administered, postoperative complications, length of hospital stay, and
      readmission rate were evaluated. The total volume of fluids was calculated as the sum of the
      volume of crystalloid plus the volume of colloid multiplied by 1.5 or 2.0.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        indication of distal pancreatectomy
      
Keywords: Fluid Therapy; Laparoscopy
In Vivo Investigation of Initial Stages of Enamel Erosion
Condition: Tooth Erosion
MeSH terms: Tooth Erosion
Study type: Interventional

Summary: 
      This exploratory study is designed to help develop a clinical model to measure the earlier
      stages of dietary acid medicated enamel loss. The study will use fluoride as positive control
      to explore the validity of this design.
    


Intervention name(s): Sodium fluoride + potassium nitrate; Potassium nitrate
Intervention type(s): Other; Other
Intervention description(s): Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate; Experimental toothpaste containing 5% potassium nitrate
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV
      activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a
      daily basis for 2 weeks to HIV-infected patients.
    

Detailed description: 
      Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo
      daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients
      receive placebo.
    

Intervention name(s): Adefovir dipivoxil
Intervention type(s): Drug
Intervention MeSH terms: Adefovir; Adefovir dipivoxil
Masking: Double
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents; Adenine
A Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of 2-Week Treatment With Inhaled AZD7594 in Adolescents (12 to 17 Years) With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week
      treatment with inhaled AZD7594 in adolescent patients with asthma.

      The study is planned to be conducted at 4-10 study sites in the United States. The study
      intends to include 24 patients (12 to 17-year-old patients). For each patient, the duration
      of participation in the study will be approximately 5 to 7 weeks (37 to 52 days).
    

Detailed description: 
      This is an open-label, multi-centre, Phase I study to assess the PK, PD and safety of 2 week
      treatment with inhaled AZD7594 in adolescent patients with asthma.

      The study is planned to be conducted at 4-10 study sites in the United States. Eligible 12 to
      17-year-old patients with asthma controlled on Global Initiative for Asthma (GINA) step 2
      medication (ie, low dose inhaled corticosteroid [ICS] or leukotriene receptor antagonist
      [LTRA]), as evidenced by an asthma control questionnaire (ACQ-5) score ≤1.5, will be asked to
      stop their ongoing asthma maintenance treatment. After a washout period (14 to 21 days), all
      patients with confirmed reversibility will start study treatment, consisting of inhalations
      of AZD7594 (360 µg, delivered dose, via dry powder inhaler [DPI]) once daily for 15 to 16
      days.

      The study intends to include 24 patients in order to have 18 evaluable patients, enrolled in
      equal proportion in the age group of 12 to 14 years (inclusive), and the age group of 15 to
      17 years (inclusive), with at least 7 patients in each subgroup.

      For each patient, the duration of participation in the study will be approximately 5 to 7
      weeks (37 to 52 days)
    

Intervention name(s): AZD7594
Intervention type(s): Drug
Intervention description(s): During treatment period, AZD7594 (360 µg per day) will be administered as oral inhalation via dry powder inhaler or DPI (SD3FL inhaler).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glucocorticoid receptor (GR) modulator (SGRM); non-steroidal; Asthma; Adolescents
Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This is a randomized clinical trial, aimed to analyse the effects of a potentially
      anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory
      markers, and quality of life of Fibromyalgia patients. Patients in the intervention group
      will adopt an anti-inflammatory diet and a diet with a low ingestion of fermentable oligo-,
      di- and monosaccharides, and polyols (FODMAPs), for a 3 months period. Group control will
      adopt a diet based on general recommendations for healthy eating in accordance with the World
      Health Organization.
    

Detailed description: 
      The presence of low grade intestinal inflammation has been reported in Fibromyalgia (FM)
      patients. Other studies associate the persistence of symptoms described in FM to possible
      alterations of the intestinal microbiota composition, i.e. dysbiosis, with consequent
      existence of Small Intestinal Bacterial Overgrowth (SIBO). A sample of 100 female patients
      diagnosed with FM, followed-up at Portuguese Rheumathology Institute in Lisbon, will be
      distributed randomly in two groups. Group 1 will adopt an anti-inflammatory diet, which is
      characterized by the exemption of the intake of potentially inflammatory foods, namely
      gluten, dairy and ultra-processed foods, over a consecutive period of 3 months. During the
      first month, a low FODMAPs diet will be implemented, along with the anti-inflammatory diet,
      followed by the reintroduction of all fruits and vegetables over a consecutive period of 2
      months, for a total of 3 months of intervention. Group 2 will adopt a diet based on general
      recommendations for healthy eating in accordance with the World Health Organization. The
      Ethics Committee of the Portuguese Institute of Rheumathology approved this intervention
      study.

      The results of this study are expected to determine whether a change in patient nutrition
      helps to alleviate symptoms, which would optimize medical intervention.
    

Intervention name(s): Anti-inflammatory and low FODMAPs diet; General healthy eating
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exemption of the intake of potentially inflammatory foods, namely gluten, dairy and processed foods, over a consecutive period of 3 months. During the first month, a low FODMAPs diet will be implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months.; Healthy eating counseling according to the World Health Organization
Intervention MeSH terms: Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Antiinflammatory diet; Low FODMAPs diet; Gluten, casein, sugar and processed-foods free diet; Nutrition
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine if oxycodone and naltrexone combination
      capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
    

Detailed description: 
      Abuse Liability Study
    

Intervention name(s): ALO-02 weight-matched placebo; crushed ALO-02 30 mg/3.6 mg; oxycodone weight-matched placebo; crushed oxycodone IR 30 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): crushed sugar spheres (powder) x 1 dose; crushed ALO-02 30 mg/3.6 mg capsule x 1 dose; crushed lactose tablets (powder) x 1 dose; Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Relative abuse potential study; Chronic pain; oxycodone; naltrexone; opioid-related disorders; drug abusers
Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is evaluating the safety and immunogenicity of GSK Biologicals' Hib-MenCY-TT
      vaccine compared to a control group receiving licensed Hib conjugate vaccine, each
      administered at 2, 4, and 6 months of age, and compared to licensed meningococcal serogroups
      A, C, Y, and W-135 polysaccharide vaccine administered at 3 to 5 years of age.

      The safety and immunogenicity of a booster dose of Hib-MenCY-TT vaccine will be compared to a
      booster dose of licensed Hib conjugate vaccine, each administered at 12 to 15 months of age.
      The group primed with the Hib conjugate vaccine will re-randomized at 12-15 months of age to
      receive a booster dose of Hib-MenCY-TT or a booster dose of the Hib conjugate vaccine.
    

Detailed description: 
      The non-inferiority of the immunogenicity, safety, and antibody persistence of Hib-MenCY-TT
      vaccine will be compared to ActHIB®, a monovalent Hib conjugate vaccine licensed in the US.

      All subjects will be vaccinated at 2, 4, 6, and 12 to 15 months. The immunogenicity of the
      MenC and MenY antigens will be summarized.

      MenC and MenY immunogenicity will be compared to Menomune® (a quadrivalent meningococcal A,
      C, Y, and W-135 plain polysaccharide vaccine licensed in the US) administered to children 3
      to 5 years of age.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): GSK Biologicals' Haemophilus influenza type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine 792014 vaccine; ActHIB; Pediarix; Prevnar; Menomune
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Primary phase: 3 IM doses Booster phase: 1 IM dose; Primary phase: 3 IM doses Booster phase: 1 IM dose; Primary phase: 3 IM doses; Primary phase: 3 IM doses Booster phase: 1 IM dose; Primary phase: 1 SC dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Immunogenicity; Primary & booster vaccination; Infants; Meningococcal vaccine; Safety; Children; Hib disease; Meningococcal disease
Effects of COVID-19 Induced Deconditioning After Long-term High Intensity Resistance Exercise
Condition: Osteoporosis; Sarcopenia
MeSH terms: Osteoporosis; Sarcopenia
Study type: Observational

Summary: 
      Osteosarcopenia designates the simultaneous presence of sarcopenia and osteopenia; both
      chronic conditions of advanced age. Dynamic-resistance exercise (DRT) might be the most
      powerful agent to fight osteosarcopenia. Indeed, in the present FrOST study, we clearly
      determine the positive effect of slightly adapted 18 month high-intensity (HIT)-DRT on bone
      mineral density (BMD), sarcopenia and other health related parameters in osteosarcopenic men.
      However, after a short training break, COVID-19 induced lock down prevented a re-start of the
      HIT resistance exercise training in the FrOST cohort.

      The aim of the present observational study is thus to determine the effects of 6 months of
      deconditioning on health related parameters under special regard of osteosarcopenia in this
      cohort of older men with osteosarcopenia.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants of the FrOST study (men 72 years and older with osteosarcopenia)
Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to find out the effects of adding B lymphocyte
      modulating agents in patients at risk for rejection receiving an anti-rejection
      (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and
      corticosteroid therapy.
    

Detailed description: 
      Optimal induction regimens for patients at high risk for antibody and/or cell-mediated
      rejection have not been established. This pilot, prospective, randomized study evaluated
      addition of B cell/plasma cell-targeting agents to T cell-based induction with rabbit
      antithymocyte globulin (rATG) in high immunologic risk renal transplant recipients. Patients
      were randomized to induction with rATG, rATGþrituximab, rATGþbortezomib or
      rATGþrituximabþbortezomib.
    

Intervention name(s): Rabbit Antithymocyte Globulin; Velcade; Rituxan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): rATG will be given 1.5mg/kg intravenous (IV) per dose.; Velcade will be given 1.3mg/m2 via intravenous push (IVP) per dose.; Given via IV per group assignment.
Other intervention name(s): Thymoglobulin; rATG; bortezomib; Rituximab
Intervention MeSH terms: Rituximab; Bortezomib; Thymoglobulin; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney; Renal; Rejection; High risk; Induction; Immunology; Transplantation; B Cell; Allograft; Desensitization
The Impact of Carbon Monoxide and Altitude on Vascular Function
Condition: Vasodilation; Vasoconstriction
Study type: Interventional

Summary: 
      The CarMA (Carbon Monoxide and Altitude) Study aims to observe the vascular effects of carbon
      monoxide exposure at low and high altitudes.
    

Detailed description: 
      Each year, millions of people make journeys from low altitude regions to high altitude for
      recreation, travel, and religious pilgrimage. Carbon monoxide (CO) is commonly associated
      with cigarette smoke, exhaust fumes, and is viewed as a life-threatening toxic gas. Exposure
      to CO occurs during travel to and during activities common in high-altitude travel and
      pilgrimage including vehicle fumes, incense, and second-hand smoke exposure. High altitude
      exposure and CO exposure have been observed independently to have complex and opposing
      effects on vascular endothelial function. Observation of these stimuli together in a
      controlled environment may allow for further understanding of the underlying mechanisms of
      vascular physiology and adaptations to both high-altitude and CO exposure. The CarMA (Carbon
      Monoxide and Altitude) Study aims to observe the vascular effects of carbon monoxide exposure
      at low and high altitudes. Recently, other studies have showed a significant improvement in
      flow mediated dilation (FMD) with acute exposure to low levels of CO To date, no research has
      been presented concerning the effect of CO on vascular function at altitude. The present
      study aims to observe the effect of acute carbon monoxide exposure on 1) flow mediated
      dilation, 2) conduit artery flow in exercise induced reactive hyperemia at sea level and at
      altitude, and 3) the effect of CO on vascular function in a high altitude dwelling (sherpa)
      population.
    

Intervention name(s): Carbon monoxide rebreathe; Sodium Nitroprusside; Phenylephrine Hydrochloride
Intervention type(s): Other; Drug; Drug
Intervention description(s): Carbon monoxide exposure to increase blood (Carboxyhemoglobin) COHb safely to ~10%; Bolus Sodium Nitroprusside (SNP) injection for endothelium-independent vasodilation measure; Bolus Phenylephrine injection for observe α1-mediated vasoconstriction during mild exercise
Other intervention name(s): Schmidt-Prommer blood volume test; Nipride
Intervention MeSH terms: Nitroprusside; Phenylephrine; Oxymetazoline; Carbon Monoxide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will partake in both room air and CO exposure on 2 separate visits.
Masking: Single (Participant)
Primary purpose: Basic Science