bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Clinical Trial of Ceramic Bearing Primary Total Hip Arthroplasty
Condition: Total Hip Replacement
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary total hip arthroplasty (THA) has been a very successful surgical intervention in the
      geriatric population. Numerous studies have reported good mid and long term results of THA in
      patients over the age of 60 years. With the reported high success rate of this surgical
      intervention, the THA surgery is being performed in younger patients who have significant
      joint disease.

      A clinical trial, using a randomized blinded design, was undertaken to compare the functional
      outcome of 1) alumina heads/alumina liners, and 2) alumina head/Crossfire polyethylene liners
      in patients 60 years of age or younger with non-inflammatory arthritis of the hip.

      Subjects were assessed preoperatively and at one and five years postoperatively. Ten-year
      follow-up is currently underway.

      The primary outcome measure is the WOMAC Osteoarthritis Index. Secondary measures were the
      RAND-12, as well as measurement of complication and revision rates. The patient's demand on
      the implant as calculated by the patient's age, weight, health status and activity level was
      also measured.
    


Intervention name(s): Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head; Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Joint Replacement; Health Related Quality of Life; Functional Outcomes; Revision Rate
Platelet Rich Plasma for Knee Osteoarthritis
Condition: Osteo Arthritis Knee; Platelet-rich Plasma
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study aimed to analyze the effect of platelet-rich plasma (PRP) on knee osteoarthritis.
      Eligible patients will undertake arthroscopic knee surgery plus intraoperative PRP and also
      receive second look surgery and intraoperative biopsy.
    

Detailed description: 
      Osteoarthritis is a chronic disease defined by progressive degradation of the joint as well
      as loss of cartilage on joint surfaces. The degeneration that occurs in the joint leads to
      changes in the catabolic and anabolic activity of chondrocytes. Osteoarthritis may induce
      pain, stiffness and limitation in range of motion of the joint and also may impact the
      quality of life. Platelet-rich plasma (PRP) is a fraction of plasma that contains platelets
      and multiple growth factors concentrated at high level. Because activated platelets have the
      potential to release growth factors, PRP has been clinically used to accelerate wound healing
      and tissue regeneration in orthopedic and oral surgery. Although several studies have
      assessed the effects of PRP on knee osteoarthritis, a higher level of evidence has not been
      provided. This study aimed to analyze the effect of PRP on knee osteoarthritis. After
      performing arthroscopic knee surgery plus intraoperative PRP in eligible patients, a second
      look arthroscopic surgery with intraoperative biopsy will be arranged 6 months later. Pre-
      and post-operative imaging and clinical outcomes will also be compared.
    

Intervention name(s): Platelet-rich plasma
Intervention type(s): Other
Intervention description(s): Intraoperative platelet-rich plasma injection during arthroscopic knee surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet-rich plasma; Osteoarthritis Knee
Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease; Cognitive Impairment
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is
      effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine
      the best therapeutic dose of sodium oligo-mannurarate capsule.
    

Detailed description: 
      Alzheimer's disease is known for placing a great burden on caregivers which includes social,
      psychological, physical or economic aspects. Research indicates that the disease is
      associated with plaques and tangles in the brain. Currently used treatments offer a small
      symptomatic benefit. No treatments to delay or halt the progression of the disease are, as of
      yet, available. The investigators suppose sodium oligo-mannurarate capsule to be effective to
      halt the progression of the disease.
    

Intervention name(s): Sodium oligo-mannurarate 600mg; Sodium oligo-mannurarate 900mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks; sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks; simulant of sodium oligo-mannurarate capsule
Other intervention name(s): Sodium oligo-mannurarate low dose; Sodium oligo-mannurarate high dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of Two Formulations of Ixekizumab in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare two different formulations of ixekizumab. One
      formulation (Reference) is approved by the Food and Drug Administration (FDA) and one
      formulation (Test) is not approved. This study will compare how much of each formulation gets
      into the blood stream. Information about any side effects that may occur will also be
      collected. The study will last up to about four months for each participant.
    


Intervention name(s): Ixekizumab
Intervention type(s): Drug
Intervention description(s): Administered SC.
Other intervention name(s): LY2439821
Intervention MeSH terms: Ixekizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy of Fluoride Varnish Containing Xylitol Coated Calcium Phosphate Versus Conventional Fluoride Varnish in Management of Hypersensitivity of Exposed Root Surfaces in Adult Patients
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial will be conducted to compare the efficacy of fluoride varnish containing
      xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride
      varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult
      patients over a 12 months period.
    


Intervention name(s): Fluoride varnish with xylitol coated calcium and phosphate
Intervention type(s): Drug
Intervention description(s): Fluoride varnish with xylitol coated calcium and phosphate
Intervention MeSH terms: Calcium; Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dentin Hypersensitivity
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Gait Asymmetry Assessed Using Portable Gait Analysis System
Condition: Ankle Osteoarthritis; Knee Osteoarthritis; Hip Osteoarthritis; Lumbar Spine Stenosis; Muscle Contracture
MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Contracture
Study type: Observational

Summary: 
      To date, detailed analysis of movement patterns in orthopaedic conditions are mainly
      performed in research projects. Because these tests are time consuming, they are not feasible
      in clinical routine or in standard examinations. Novel technologies allow capturing detailed
      movement patters within a few minutes. The aim of this regional study is to compare aspects
      of movement tasks measured using a mobile gait analysis system to those measured using
      laboratory based systems and to determine aspects of gait patterns relevant for different
      orthopaedic conditions. Moreover, the researchers will investigate if these relevant aspects
      can be altered using surgical treatment or manual therapy.
    

Detailed description: 
      This is a cross-sectional study. Pre- and post-treatment data will only be collected in
      patients undergoing routine orthopaedic treatment.
    

Intervention name(s): arthroplasty; manual therapy; lumbar spinal stenosis decompression
Intervention type(s): Procedure; Other; Procedure
Intervention description(s): patients, who are scheduled for arthroplasty, will be measured before and on average 6 months after surgery; patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment; patients, who are scheduled for lumbar spinal stenosis decompression, will be measured before and on average 6 months after surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from patients visiting the outpatient clinic or are scheduled
        for arthroplasty or LSS decompression at the University Hospital Basel and from the
        surrounding community.
      
Keywords: gait asymmetry; joint angles
Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary Plaque
Condition: Hypercholesteremia; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of intensive lipid-lowering therapy with Lipitor on the changes of
      characteristics of yellow coronary plaque in subjects with hypercholesteremia accompanying
      coronary artery disease
    


Intervention name(s): atorvastatin, Lipitor
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lipitor; atorvastatin; Hypercholesteremia; yellow coronary plaque
Effect of AXOS on the Colon Metabolism in Healthy Volunteers
Condition: Gut Health
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism
      and gut health
    


Intervention name(s): Arabinoxylanoligosaccharides; Maltodextrine
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Cholesterol Effects of Kori-tofu Proteins
Condition: Lipid Metabolism Disorders
MeSH terms: Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The study is a randomized, cross-over, double-blind, controlled trial in which participants
      with mildly elevated levels of cholesterol will receive two 4-week interventions (e.g.
      kori-tofu or control), with a wash-out period of 4 weeks in between. During the intervention
      periods, subjects will eat 3 slices of bread per day, representing a Kori-tofu dose of 34.5
      grams or a matched reference. Fasting total and LDL cholesterol will be determined at the
      start and end of each of the two intervention periods.
    

Detailed description: 
      There are several types of tofu, an example of a specific type of tofu is called Kori-tofu.
      Kori-tofu literally means frozen tofu. The production process of Kori-tofu leads to the
      formation of a higher high molecular weight fraction (HMF) content of the soy proteins.
      Several studies describe the effects of Kofi-tofu on health. In this study the aim is to
      investigate the effect of repetitive consumption of Kori-tofu on blood cholesterol levels and
      other lipid metabolism related measures, in research subjects with mildly elevated levels of
      cholesterol.

      The primary objective is to assess the effect of repetitive consumption of Kori-tofu on blood
      total and LDL cholesterol levels. The secondary objective is to assess the effect of
      repetitive consumption of Kori-tofu on other markers of lipid metabolism, glucose metabolism
      and blood pressure.

      The study is a randomized, cross-over, double-blind, controlled trial in which participants
      will receive two 4-week interventions (e.g. kori-tofu or control), with a wash-out period of
      4 weeks in between. During the intervention periods, subjects will eat 3 slices of bread per
      day, representing a Kori-tofu dose of 34.5 grams or a matched reference (whey protein, soy
      oil and maltodextrin/cellulose). Research subjects will visit our research unit before and
      after each intervention period for a test day. During these test days fasting blood samples
      will be collected and blood pressure measurements will be performed.
    

Intervention name(s): Kori tofu bread; Whey protein bread
Intervention type(s): Other; Other
Intervention description(s): 34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.; Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kori tofu; Cholesterol
Long Term Follow-Up of Traumatic Fracture Patients Treated With Integrated Complementary and Alternative Medicine: Observational Study
Condition: Fractures, Bone; Medicine, Korean Traditional
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      The purpose of this study is to reveal the effectiveness of integrative Korean medicine for
      trauma fracture by observation inpatients treated with integrative Korean medicine.

      This study is a prospective observational study. The subjects for study are patients
      diagnosed with fracture and who have been admitted to five Jaseng Hospital of Korean medicine
      (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) for 2017.03-2020.08.

      Medical records of selected patients will be analyzed, and online google surveys(or
      telephone) will be conducted for each patient. The survey questions are Numeric rating scale
      (NRS), quality of life, and Patient Global Impression of Change (PGIC), etc.
    


Intervention name(s): online survey(or phone survey)
Intervention type(s): Other
Intervention description(s): A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over google survey(or the phone survey) for patients.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects for study are patients diagnosed with fracture and who have been admitted to
        five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae)
        for 2017.03-2020.08.
      
Keywords: acupuncture therapy; herbal medicine
Cognitive Remediation and Social Skills Training in Schizophrenia
Condition: Schizophrenia; Schizoaffective
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether patients who participate in cognitive
      remediation prior to a skills training program learn and perform the skills better than
      patients who do not participate in cognitive remediation.
    

Detailed description: 
      Subjects are 40 stable outpatients with schizophrenia or schizoaffective disorder who are
      receiving medication and routine follow-up care at community clinics in San Antonio, Texas.

      Patients receive baseline assessments and then are randomly assigned to either Cognitive
      Remediation (CR) or Keyboarding Skills (KS) for a period of 8 weeks. Following 8 weeks of
      treatment in either CR or KS, all patients participated in Social Skills Training (SST) for a
      period of 8 weeks. Assessments conducted by raters blinded to treatment condition are
      repeated following either remediation or control treatment, and again following SST.

      Treatment groups Cognitive Remediation (CR) -- The CR program is based upon teaching
      techniques developed within educational psychology that promote intrinsic motivation and task
      engagement. The program uses existing computer software packages (e.g., Oregon Trail) with
      engaging story lines or activities, and built-in reinforcement of correct responses to help
      patients with schizophrenia develop attention, memory, planning, and problem-solving skills.
      CR is delivered in a computer lab setting with a facilitator present to assist patients.

      Keyboarding Skills (KS) -- Control Treatment: The control treatment is an engaging self-paced
      software program designed to teach typing skills. KS is delivered in a computer lab setting
      with a facilitator present.

      Both the KS and CR are administered in small groups of three to five patients each.

      Social Skills Training (SST) -- SST is a manual-driven, behavioral rehabilitation program
      teaching basic conversation and social problem-solving skills (Bellack et al., 1997). SST
      runs for 8 weeks and is conducted in small groups that meet twice weekly.
    

Intervention name(s): Cognitive Remediation; Social Skills Training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Schizophrenia; Cognitive Remediation; Social Skills Training; Psychosocial
Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation
      of induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of
      participants will receive ColdZyme® mouth spray while the other half will receive placebo.
    

Detailed description: 
      Common colds can be caused by a number of viruses, e.g. rhinoviruses, coronaviruses,
      influenza viruses and others. The majority of colds are however caused by rhinovirus
      infection, which is responsible for up to 80% of all common colds. This study evaluates the
      effect of creating a physical barrier on the pharyngeal mucosal membrane to prevent or reduce
      virus cell entry during common cold infection to reduce total virus load and common cold
      symptoms in vivo in relation to placebo.
    

Intervention name(s): ColdZyme® mouth spray; Placebo
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
LUPS-Lipids and Glucose Under Prospective Surveillance
Condition: Metabolic Syndrome; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Metabolic Syndrome
Study type: Observational

Summary: 
      Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns,
      perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic
      syndrome and type 2 diabetes
    

Detailed description: 
      The LUPS-study is a collaboration between Asklepios Clinics Hamburg GmbH and University
      Clinic Hamburg Eppendorf, Germany. This study is assessing a multitude of serum biomarkers,
      anthropometrics, dietary habits, physical activity, perceived stress along with genetic
      information from "healthy workers" (25-60years) to better understand phenotype-genotype
      associations leading to MetS and type 2 diabetes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        so-called "Healthy-Workers", aged 25-60years, of Lufthansa-Technik, Hamburg, Germany, who
        voluntarily aggreed to participate in the study.
      
Keywords: Metabolic Syndrome, Syndrome X, MetS,; Type 2 Diabetes
Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The study is planned to evaluate the cognitive functions in subjects with RRMS treated with
      interferon beta-1a, and its relationship to the fatigue and neurological dysfunction status.
    

Detailed description: 
      Besides the motor and sensory dysfunctions, the progression of cognitive decline is a
      frequent manifestation of RRMS. Fatigue is another important symptom of MS, and can
      negatively affect subject's Quality of life (QoL) and socio-economic functioning, including
      the ability to work, independent of the direct effects of disability. This is a phase IV
      observational, non-interventional, prospective, multicentric study to evaluate cognition in
      RRMS subjects treated with Rebif and its relationship to the fatigue and neurological
      dysfunction status. The study plans to enroll 300 subjects, across 14 centres in Czech
      Republic, who will be prescribed with Rebif according to its summary of product
      characteristics (SmPC). Assessment of cognitive and fatigue status will be done at baseline
      and follow-up visits at Months 3, 6, 12, 24. Subjects will be selected using the convenience
      method following the non-probability sampling.

      OBJECTIVES

      Primary Objective:

        -  To assess changes of cognition [measured by Paced Auditory Serial Addition Test (PASAT)]
           in RRMS subjects treated with Rebif

      Secondary Objectives:

        -  To assess changes of fatigue [measured by Fatigue Descriptive Scale (FDS)] in RRMS
           subjects treated with Rebif

        -  To assess a correlation between cognition, fatigue and neurological status in RRMS
           subjects treated with Rebif

        -  To assess a relationship between Rebif dosage [22 mcg vs 44 mcg thrice a week (tiw)] and
           cognition (PASAT)

        -  To assess a relationship between Rebif dosage (22 mcg vs 44 mcg tiw) and fatigue (FDS)

        -  To assess adherence to Rebif treatment

        -  To explore the use of antidepressive and antifatigue medicaments
    

Intervention name(s): Rebif (Interferon beta-1a)
Intervention type(s): Drug
Intervention description(s): The treatment to be administered is interferon beta-1a on prescription, used as per SmPC, i.e. both doses 22 and 44 mcg s.c. tiw, and the titration pack 8.8 mcg and 22 mcg s.c. tiw when initiating the therapy.
Other intervention name(s): Rebif
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with RRMS prescribed with Rebif across 14 centres in Czech Republic.
      
Keywords: Multiple Sclerosis, Relapsing-Remitting; Rebif; Interferon beta-1a