bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Biofreeze® on Shoulder Pain and In-office Exercise Performance
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Biofreeze® is a topical analgesic, frequently used in the office or given to a patient for
      home use as a way to mitigate pain during the course of treatment. Rehabilitative exercises
      are considered an important component of care for shoulder pain patients, although pain can
      be a limiting factor in the advancement of rehabilitation. The purpose of this study is to
      evaluate the addition of Biofreeze® to an in-office group of shoulder pain patients to
      determine its impact on pain reduction. Methods: Patients 18-64 years old with mechanical
      shoulder pain who are candidates for standard shoulder therapy will be randomized into two
      groups (N=20). The Control group (N=10) will receive standard shoulder therapy alone while
      the Intervention group (N=10) will receive standard shoulder therapy plus Biofreeze® just
      prior to initiating the in-office exercise program. Values of pain (NPRS) and disability
      (ASES) will be recorded at baseline, 2 weeks, and 4 weeks. Hypotheses will be addressed by
      repeated measures ANOVAs within and between group, time, and interaction main effects.
      Clinical Relevance: Progression of therapeutic exercises can be limited by pain and the
      associated disability. The ability to decrease shoulder pain and disability with a topical
      analgesic will allow health care professionals to advance patients through a therapeutic
      exercise program without the restriction of pain. In turn, patients will correct the
      underlying condition of their shoulder pain at a faster rate.
    


Intervention name(s): Biofreeze
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploration of microRNA and Metabolomics Biomarkers Predicting Drug Induced Liver Injury in Elderly People
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, one-sequence, multiple administration study for exploration of microRNA and
      metabolomics biomarkers to predict drug induced liver injury in healthy elderly Korean
      people.
    


Intervention name(s): Augmentin tab
Intervention type(s): Drug
Intervention MeSH terms: Amoxicillin-Potassium Clavulanate Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Elderly
A Single Dose Study of SHR4640 in Healthy Male Volunteers
Condition: Gout
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose
      Phase I trial.
    

Detailed description: 
      This study includes screening (Days -16 to -3), check-in (Day -2), enrollment (Day -1),
      dosing (Day 1), observational period (Days 2 to 3), discharge day (Day 4), and safety
      follow-up visit (Day 8). Forty eligible subjects will be enrolled into 4 dose cohorts (10 for
      each cohort), and every 10 subjects will be randomized in a 4:1 ratio to receive a single
      dose of either SHR4640 (n=8) or placebo (n=2).
    

Intervention name(s): SHR4640; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): a single dose of SHR4640 (n=8) for each dose cohort; a single dose of placebo (n=2) for each dose cohort .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age
Condition: Invasive Group B Streptococcus (GBS) Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity
      of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect
      humans from infection.
    


Intervention name(s): Monovalent GBS-CRM glycoconjugate vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose of GBS conjugate vaccine; 1 dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: GBS; GBS prevention
Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+
Condition: HIV Seropositivity
MeSH terms: HIV Seropositivity
Study type: Interventional
Phase: Phase 2

Summary: 
      In the vast majority of those infected with HIV virus who are untreated, there is
      deterioration in immune health over a period of months or years inevitably leading to
      full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if
      started before a certain degree of progression occurs and has saved millions of lives. The
      investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved
      medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to
      ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.
    

Detailed description: 
      The LDN (low-dose naltrexone) vs ARV (anti-retroviral drugs) Effectiveness Study in Mali
      sponsored by The Ojai Foundation in California-USA is a clinical research study endorsed and
      approved by the Malian Government. Naltrexone hydrochloride is a generic, FDA-approved since
      1998 drug, an opioid antagonist that has clinically shown immune enhancing/modulating
      qualities in very low dosage and may offer an alternative to ARV drugs that is effective,
      non-toxic, easily available, inexpensive, with simple once-daily at bedtime administration.
      LDN capsules must be created by compounding pharmacists to get these ultra-small doses. Due
      to toxicity of current ARV drugs and need for special medical management young HIV infected
      children are largely neglected particularly in developing countries; LDN can also be made
      available in a transdermal cream for infants and children who are HIV infected.
    

Intervention name(s): ARV's + Placebo; Naltrexone; Naltrexone + ARV's
Intervention type(s): Other; Drug; Drug
Intervention description(s): Patients continued ARV's plus a placebo nightly for 9 months; Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months; Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.
Other intervention name(s): Azidothimidine + lamivudine + nevirapine Or; Stavudine + lamivudine + nevirapine (TRIOMUNE)Or; Azidothimidine + lamivudine + efavirenz Or; Azidothimidine + lamivudine + lopinavir/r Or; Emtricitabine + tenofovir + efavirenz; Azidothimidine + lamivudine + nevirapine Or; Stavudine + lamivudine + nevirapine (TRIOMUNE)Or; Azidothimidine + lamivudine + efavirenz Or; Azidothimidine + lamivudine + lopinavir/r Or; Emtricitabine + tenofovir + efavirenz
Intervention MeSH terms: Tenofovir; Lamivudine; Emtricitabine; Efavirenz; Lopinavir; Nevirapine; Stavudine; Stavudine, lamivudine, nevirapine drug combination; Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the
      growth of abnormal cells by stopping them from dividing or killing them. Giving
      colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the
      bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal
      antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The
      stem cells are then returned to the patient to replace the blood-forming cells that were
      destroyed by the chemotherapy.

      PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib
      followed by stem cell transplant works in treating patients with primary systemic
      amyloidosis.
    

Detailed description: 
      OBJECTIVES:

        -  To determine if hematologic responses to high-dose melphalan and autologous stem cell
           transplantation increase with addition of bortezomib in the conditioning regimen in
           patients with primary systemic amyloidosis.

      OUTLINE:

        -  Autologous stem cell mobilization and collection: Patients receive filgrastim to
           mobilize stem cells, which are then collected.

        -  Conditioning regimen: Patients receive bortezomib intravenously on days -6, -3, 1, and 4
           and oral high-dose melphalan on days -2 and -1.

        -  Stem cell transplantation: Patients undergo autologous stem cell transplantation on day
           0.

      After completion of study therapy, patients are followed every 6 months for 1 year and
      annually thereafter.
    

Intervention name(s): filgrastim; bortezomib; melphalan; Stem Cell Infusion
Intervention type(s): Biological; Drug; Drug; Procedure
Intervention description(s): 16 mcg/kg daily beginning 3 days before stem cell collection through day before final stem cell collection; 1.0 mg/m2/dose D -6, D-3, D +1, D + 4; 100 mg/m2/dose D -2, D -1; infusion of previously collected autologous stem cells
Other intervention name(s): Growth-Colony Stimulating Factor, neupogen; velcade; alkeran
Intervention MeSH terms: Bortezomib; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary systemic amyloidosis
Convalescent Plasma for Patients With COVID-19: A Randomized, Single Blinded, Parallel, Controlled Clinical Study
Condition: Coronavirus; Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy
      when there is no vaccine or treatment available for infectious diseases. In the latest viral
      epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization
      issued a document outlining a protocol for the use of whole blood or plasma collected from
      patients who have recovered from the Ebola virus disease by transfusion to empirically treat
      local infectious outbreaks
    

Detailed description: 
      The process is based on obtaining plasma from patients recovered from COVID-19 in Colombia,
      and through a donation of plasma from the recovered, the subsequent transfusion of this to
      patients infected with coronavirus disease (COVID-19). Our group has reviewed the scientific
      evidence regarding the application of convalescent plasma for emergency viral outbreaks and
      has recommended the following protocol
    

Intervention name(s): Plasma; Standard Therapy
Intervention type(s): Drug; Drug
Intervention description(s): Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.; Standard therapy defined by institutional protocol.
Other intervention name(s): Convalescent Plasma COVID-19
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19; Coronavirus Disease 2019
Safety and Effectiveness of Giving Two Nucleoside Reverse Transcriptase Inhibitors Alone or in Combination With 141W94 to HIV-Infected Children Who Have Never Received Protease Inhibitors
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 a new protease
      inhibitor (PI), 141W94, to an anti-HIV regimen that includes 2 nucleoside reverse
      transcriptase inhibitors (NRTIs).
    

Detailed description: 
      In this double-blind, placebo-controlled, pediatric study, 210 patients are randomized to
      receive 2 NRTIs plus either 141W94 or placebo. Enrollment of patients is sequential: patients
      13 to 18 years of age are enrolled first, followed by children < 13 when the appropriate
      pediatric dose has been determined. Patients who are unable to swallow capsules will be
      accrued when a liquid formulation becomes available.
    

Intervention name(s): Amprenavir
Intervention type(s): Drug
Intervention MeSH terms: Amprenavir
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: HIV-1; Drug Therapy, Combination; HIV Protease Inhibitors; RNA, Viral; VX 478; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load
Application of 3D Scanner to Measure Physical Size in Patients With Severe Cerebral Palsy
Condition: Cerebral Palsy, Spastic
MeSH terms: Hip Dislocation; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study is to improve the manufacturing techniques of hip brace in preventing
      progressive hip displacement in patients with severe cerebral palsy, through the measurement
      of patient's physical size using a 3D scanner.
    

Detailed description: 
      1. Design : Prospective Study

        2. Setting: Hospital rehabilitation department and Home

        3. Intervention: Before starting the study, radiologic and clinical evaluation were
           performed. After measuring the patient's exact physical size by applying a 3D scanner,
           we manufacture hip brace in preventing progressive hip displacement in patients with
           severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical
           evaluation were performed.

        4. Main outcome measure 1) Primary outcome: right, left, both hip MI 2) Secondary outcomes:
           the hip and knee joint range of motion (ROM), pain intensity, satisfaction and
           discomfort score for the hip brace, quality of life (QOL) of the patients and their
           caregivers, and the wearability test.
    

Intervention name(s): Application of 3D scanner to measure physical size in patients with severe cerebral palsy
Intervention type(s): Device
Intervention description(s): Before starting the study, radiologic and clinical evaluation were performed. After measuring the patient's exact physical size by applying a 3D scanner, we manufacture hip brace in preventing progressive hip displacement in patients with severe cerebral palsy. After wearing for a week, follow-up radiologic and clinical evaluation were performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: 3D Scanner; Cerebral palsy; Hip dislocation; Orthotic devices; Protective devices
Quantification of Posterior Capsule Opacification in Pediatric Cataract
Condition: Posterior Capsule Opacification
MeSH terms: Cataract; Capsule Opacification
Study type: Interventional

Summary: 
      The purpose of this study is to quantify the opacity of posterior capsule in pediatric
      cataract comparing two intraocular lens materials.
    

Detailed description: 
      The eye exam at the first appointment will consist of anamnesis, external motor, evaluating
      strabismus and nystagmus, visual acuity with and without correction, biomicroscopy,
      fundoscopy, binocular ultrasound biometry, pachymetry and specular microscopy. The surgery
      will be performed by a single surgeon under general anesthesia. All participants will receive
      primary intraocular lens implantation as the randomization process, or hydrophobic acrylic
      material or hydrophilic acrylic. The implanted intraocular lens differ primarily in the
      material. The lens of hydrophobic acrylic materials (AcrySof SA60AT, Alcon Lab) single,
      folding part, material acrylate / methacrylate with UV protection AcrySof filter, optical
      diameter of 6.0 mm, total length of 13.0 mm, haptic angle of 0 degree with 360 degree double
      square edge, spherical convex earlier. The lens hydrophilic acrylic material (Akreos ADAPT,
      Bausch and Lomb) single, folding piece with optical diameter 6.00 mm and length de10.7 mm
      aspheric convex in anterior and posterior with absorbent UV, haptic angle 0 degree angulation
      . It has 4 attachment points (haptics) with 360 degree square double edge.
    

Intervention name(s): Cataract Surgery; Alcon AcrySof SA60AT; Bausch Lomb AkreosA
Intervention type(s): Procedure; Device; Device
Intervention description(s): Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device); Implant of intraocular lens hydrophobic; Implant of intraocular lens hydrophilic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human (FIH), single-centre, double blind, randomised, cross-over, SAD
      followed by a MAD study of Inzomelid. The study is designed to evaluate the safety,
      tolerability, PK, PD, and food effect of Inzomelid in healthy adult participants and to
      evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of Inzomelid in
      adult patients with CAPS. Oversight will be provided by a safety monitoring committee (SMC)
      comprised of the Investigator, the Sponsor's Medical Monitor and an Independent Medical
      Monitor.
    


Intervention name(s): Inzomelid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Drug; Placebo to Match
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
Condition: Renal Function; Liver Transplant
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to assess the evolution of renal function and to collect efficacy,
      safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric
      liver transplant recipients.
    

Detailed description: 
      Study is completed (was active and ongoing but no longer recruiting since December 2014). The
      study Data Monitoring Committee meeting communicated to Novartis the following safety
      findings in the study population: high rate of premature discontinuation of study medication,
      high rate of post-transplant lymphoproliferative disease and high rate of related serious
      infections leading to hospitalization. In light of the safety findings, Novartis followed the
      DMC recommendation to discontinue the study medication in this age group and to stop
      enrolling new patients in this study (regardless of age).
    

Intervention name(s): Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
Intervention type(s): Drug
Intervention description(s): Immunosuppression after liver transplantation. Pediatric transplant recipients received a starting dose of 0.8 mg/m^2/dose in combination wit Cyclosporine A or 2.0 mg/m^2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/ml.
Intervention MeSH terms: Cyclosporine; Everolimus; Tacrolimus; Cyclosporins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paediatric liver transplantation; Everolimus; Reduced calcineurin inhibitor; Cyclosporine, tacrolimus; Renal function; Composite efficacy endpoint (treated biopsy proven acute rejection death, graft loss); Liver transplant
Abdominal Symptom Phenotype Study in Children
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome
Study type: Observational

Summary: 
      Children and adults commonly suffer from recurrent abdominal (stomach) pain. One type is
      called irritable bowel syndrome (IBS). IBS in adults and children is one of the most common
      and costly health care problems in the US. Some children have pain frequently (recurrent
      pain) while others rarely have pain. The investigators are conducting this study to help us
      answer questions about the causes and treatments, and management of IBS in children.

      The purpose of this study is to find out if there is more than one type of IBS in children.
      If there is, this will be important in deciding the best treatments. The investigators also
      want to learn how children with IBS differ from those who do not have recurrent abdominal
      (stomach) pain.
    

Detailed description: 
      Functional gastrointestinal (GI) disorders (FGIDs), in particular irritable bowel syndrome
      (IBS) in adults and children, are among the most common and costly health care problems in
      the US. IBS disproportionately affects adult women (10-15% in western nations) and adolescent
      girls. Yet, health care providers remain challenged to provide effective clinical management.
      The etiology of IBS is not well defined and likely multi-factorial.

      A Need to Define Subgroups of IBS:

      This study emerges from the claim that identification of patient subgroups will advance our
      understanding of IBS and ultimately help develop treatment approaches. Most studies have
      lumped together patients with IBS into 2 groups (constipation-, diarrhea-predominant) and
      tested whether they differ from healthy controls. We propose that a paradigm shift is in
      order. We should recognize that IBS likely has multiple causes and therefore, multiple
      expressions. We speculate that by understanding better defined patient subgroups and linking
      them to newer biomarkers or tests, ultimately will further the understanding of the origins
      and create effective treatments.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We are studying only girls in this exploratory study because IBS is more common in girls
        than boys and the results of these studies can be compared with the results from studies of
        IBS in adults where the overwhelming number of patients are women.

        Girls who meet the Rome III criteria for IBS or healthy girls with no complaints of stomach
        pain.
      
Biospecimen description: 
      We will be banking DNA for future analysis. The samples will be retained according to the
      legal and ethical laws.
    
Keywords: IBS; irritable bowel syndrome; abdominal pain; urgency; bloating; diarrhea; constipation