bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK),
      efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without
      dasabuvir (DSV) and with or without ribavirin (RBV) in Hepatitis C virus (HCV) genotype 1 or
      4 (GT1 or GT4)-infected pediatric participants of ≥ 3 to 17 years of age.
    

Detailed description: 
      The study population for Part 1, the PK study, included GT1-infected participants who were
      noncirrhotic and treatment-naïve (TN). Part 2, the safety and efficacy study, included GT1 or
      GT4-infected participants who were TN or interferon ([IFN] or Pegylated-interferon alfa-2a or
      2b [pegIFN] with or without RBV) treatment-experienced (TE) without cirrhosis or with
      compensated cirrhosis. In Part 1 and Part 2, the treatment regimen and duration were
      dependent on HCV GT, GT1 subtype, and cirrhosis status.
    

Intervention name(s): Ombitasvir/paritaprevir/ritonavir; Dasabuvir; Ribavirin; Ombitasvir mini tablet; Paritaprevir mini tablet; Ritonavir mini tablet; Dasabuvir mini tablet; Ribavirin solution
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Film-coated tablet for oral use; Film-coated tablet for oral use; Film-coated tablet for oral use; Film-coated tablet for oral use; Film-coated tablet for oral use; Film-coated tablet for oral use; Film-coated tablet for oral use; Oral solution
Other intervention name(s): Ombitasvir also known as ABT-267; Paritaprevir also known as ABT-450; Ombitsvir/paritaprevir/ritonavir also known as Viekirax; Exviera; ABT-333; ABT-267; ABT-450; Exviera; ABT-333
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Virus; Hepatitis C Genotype 1; Hepatitis C Genotype 4; Pediatric
Immunotherapy Administered Under the Tongue to Treat Dust Mite Allergy
Condition: Asthma
MeSH terms: Dust Mite Allergy; Hypersensitivity
Study type: Interventional

Summary: 
      This study will investigate sublingual immunotherapy (SLIT), a treatment involving antigens
      placement under the tongue to help asthma sufferers build a tolerance to the allergy-causing
      substances. Specifically, this study will determine the effectiveness of SLIT at two
      different dosing regimens for patients with intermittent mild asthma caused by dust mites.
    

Detailed description: 
      Asthma is a serious lung condition that is the leading cause of long-term illness in
      children. Many common household substances can trigger or worsen an asthma attack. It is
      important for people to reduce household allergens and learn effective treatments for
      specific types of asthma. Inhaled short-acting beta agonist such as albuterol is the standard
      treatment for mild, intermittent asthma. However, recent studies have shown that adding
      allergen-specific immunotherapy to your current asthma therapy can help to control asthma
      symptoms. This study will determine the safety and effectiveness of SLIT in two different
      dosing regimens in treating patients with house dust mite-induced allergic rhinitis/mild
      intermittent asthma.

      Participants will be randomly assigned to receive low dose SLIT, high dose SLIT, or placebo
      for at least 12 months. House dsut mite-induced allergy skin tests will be performed at study
      entry, at selected timepoints throughout the study, and at the end of the study. The tests
      will determine whether SLIT creates an immune tolerance state as well as whether SLIT acts
      via local or systemic immunological systems.
    

Intervention name(s): House Dust Mite SLIT; High dose SLIT; Placebo SLIT
Intervention type(s): Biological; Biological; Biological
Intervention description(s): low dose SLIT 143 Allergen Units(AU)/ml daily; House Dust Mite SLIT- 10,000 Allergen units(AU)/ml daily; Placebo SLIT daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breathing; Allergy; Mites, House Dust
Effects of Micro-Interventions on Stress Reactivity
Condition: Psychological Stress; Physiological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      This study aims to investigate the effects of short, psychological interventions on
      bio-psychological stress responses after an acute stressor. The efficacy of two different
      approaches (expectation-bases vs. acceptance-based) will be compared to a control-group.
    


Intervention name(s): Expectation; Acceptance
Intervention type(s): Behavioral; Behavioral
Intervention description(s): writing task; listening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Safety Study of Mesenchymal Stem Cells and Spinal Fusion
Condition: Lumbar Spondylolisthesis Involving L4-L5, and/or; Degenerative Discopathy Involving L4-L5
MeSH terms: Spondylolisthesis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The present prospective, randomized study, compares the spinal fusion obtained after
      instrumentation and the use of a biologic product (patient's mesenchymal cells obtained from
      his/her own bone marrow which will be fixed in human bone tissue form a donor), with the
      current procedure that consists in instrumented spinal fusion and the use of each patient's
      bone obtained from his/her iliac crest.

      The working hypothesis proposes that the tissue engineering is a valid and useful technique
      to achieve bone regeneration, avoiding the need for obtaining patient's iliac crest and its
      associated morbidity.
    

Detailed description: 
      Prospective, open-label, randomized, parallel, single-dose phase I-II clinical trial in which
      62 patients affected with L4-L5 degenerative spondylolisthesis grade I-II according to
      Meyerding and/or with L4-L5 degenerative discopathy needing spinal fusion will enter the
      trial with the primary objective of assessing the feasibility and safety of "ex-vivo"
      expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion.
      Secondary objectives are to assess the efficacy of the implantation by imaging (computerized
      helicoidal tomography and X-ray) and clinical questionnaires (pain by visual analogue scale,
      quality of life by SF-36 and Oswestry Disability Index).

      Patients will be randomized to one of the two treatment arms (instrumented spinal fusion and
      the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem
      cells fixed in allogenic bone tissue in spinal fusion or the standard treatment of
      instrumented spinal fusion and patient's bone iliac crest). Thereafter, patients will be
      followed for 12 months.

      Imaging assessment will be done by an independent blinded radiologist.
    

Intervention name(s): XCEL-MT-OSTEO-ALPHA; Standard treatment
Intervention type(s): Biological; Procedure
Intervention description(s): Isolation and "ex-vivo" expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, División de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion.; Instrumented spinal fusion together with patient's bone iliac crest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spondylolisthesis; Degenerative discopathy; Mesenchymal Stem Cells; Bone marrow; Tissue engineering; Spinal fusion
Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
Condition: Acute Pain; Nursing Caries
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Aim:This study was conducted to investigate the effects of music, kaleidoscope and video
      watching methods on children's pain perception and anxiety level during the blood collection
      procedures.

      Methods: This randomized controlled experimental study was carried out with 134 children in
      the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital
      between August and November 2018. In the study, nonpharmacological methods were applied to
      the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video
      Group (n=31). The routine blood collection procedure was used for the children in the control
      group (n=34). The data were collected using the "Introductory Information Form", "Children's
      Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".
    


Intervention name(s): music group; kaleidoscope group; video group
Intervention type(s): Other; Other; Other
Intervention description(s): The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over; The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over; The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: acute pain; anxiety; children; blood collection; nursing
The Efficacy and Tolerability of Acarbose in Healthy Individuals
Condition: Tolerance; Side Effect; Glucose Response
Study type: Interventional
Phase: Phase 4

Summary: 
      A Prospective Trial for Acarbose in Healthy Individuals Assessing Safety and Efficacy in
      Reducing Glucose Spikes After Carbohydrate Consumption.
    


Intervention name(s): Acarbose Tablets 50mg
Intervention type(s): Drug
Intervention description(s): Acarbose is an Alpha-glucosidase inhibitor. It is a compound also known under the names Glucobay, Precose, and Prandase. Acarbose is used (with diet and other medications) to treat type 2 diabetes (condition in which the body does not use
insulin normally and therefore cannot control the amount of sugar in the blood). Acarbose works by blocking α- glucosidase, which breaks down starch (aka amylose) into glucose (sugar) into your blood. Slowing food digestion
helps keep blood glucose from rising very high after meals.
Intervention MeSH terms: Acarbose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Muscle Fatigue in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Observational [Patient Registry]

Summary: 
      It is stated that 85% of patients with Multiple Sclerosis (MS) complain of gait disorders and
      35-90% of them have fatigue. Many factors play a role in the fatigue mechanism in MS
      patients. Fatigue can increase the symptoms that already exist in MS patients. It is thought
      that fatigue caused a decrease in muscle strength, making walking worse. There are not enough
      studies investigating whether fatigue affects gait parameters in MS patients.

      The aim of this study is to examine the effects of muscle fatigue on muscle strength, joint
      position sensation, and gait in MS patients.
    

Detailed description: 
      Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)
      and healthy individuals of similar age and sex to patients will be included in the study. The
      muscle strength, joint position sensation, gait, and fatigue will be evaluated once.

      The investigators will use descriptive statistics and t-tests to compare demographic
      characteristics between groups and for the categorical variables chi-square. Effect of the
      group (MS patients or healthy controls), condition (Single task and dual-task conditions),
      and group × condition interaction will be compared using two-way repeated-measures ANOVA.
    

Intervention name(s): Muscles Fatigue
Intervention type(s): Other
Intervention description(s): An exhaustion protocol that reduces knee joint flexor and extensor torque will be applied.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ambulatory sample
      
Keywords: Multiple Sclerosis; gait; sensation; fatigue
A Multicentre Clinical Investigation to Assess Efficacy and Safety of Intra-articular Injections of Hyaluronic Acid Combined With Chondroitin Sulfate in Knee Osteoarthritis
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This is a multicentre, prospective, sponsor initiated clinical investigation that aims to
      evaluate safety and efficacy of Hyaluronic Acid Combined With Chondroitin Sulfate in
      symptomatic patients with OA of the knee.
    


Intervention name(s): Hyaluronic Acid Combined With Chondroitin Sulfate
Intervention type(s): Device
Intervention description(s): Subjects' participation in the study will last 26 weeks. The study includes 7 visits that consist of a Screening visit, three treatment visits and three follow-up visits.
Eligible subjects will undergo a Baseline visit (V1 at week 0) during which, after the confirmation of eligibility, assessments and ultrasound evaluation, the study subjects will be treated with the 1st injection of 2%Hyaluronic Acid and 2% chondroitin sulfate Subsequent treatments will be administered at weekly intervals during Visit 2 (V2 at week 1) and Visit 3 (Visit 3 at week 2) after the effectiveness assessments.
Study subjects will return for Follow-up visits 1 month (Visit 4 at week 6), 3 months (Visit 5 at week 14) and 6 months (Visit 6 at week 26) after the last injection
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyaluronic Acid; Chondroitin sulfate
Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab
Condition: Hairy Cell Leukemia (HCL)
MeSH terms: Leukemia; Leukemia, Hairy Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will test the effectiveness (rate of complete remissions, total remission rate and
      duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous
      cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for
      relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous
      therapy.

      CD20* = cluster of differentiation antigen 20
    

Detailed description: 
      The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell
      leukaemia variant or with relapsed hairy cell leukaemia.
    

Intervention name(s): 2CdA +/- Rituximab
Intervention type(s): Drug
Intervention description(s): Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion
Other intervention name(s): Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg; Rituximab (Mabthera®; Rituxan®) 375 mg/m²
Intervention MeSH terms: Rituximab; Cladribine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCL variant; HCL relapse; Risk stratified
Study for Comparing The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to:

        1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to
           immediate release capsule(150mg * 2).

        2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained
           release tablet.
    


Intervention name(s): Lyrica; Experimental drug; High fat meal; fasted
Intervention type(s): Drug; Drug; Dietary Supplement; Dietary Supplement
Intervention description(s): sustained release formulation of pregabalin
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuropathic pain; pregabalin
Efficacy and Safety of Qinggongshoutao Bolus in aMnestic Mild Cognitive Impairment
Condition: Mild Cognitive Impairment; Herbal Medicine Allergy
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a 52-weeks, multicenter, randomized, double-blind, double- placebo, parallel
      controlled phase VI trial being carried out in 20 centers around China. The study population
      includes amnestic mild cognitive impairment patients (planned a total of 360) aged 55-85 in
      both gender. Participants will be randomly allocated to Qinggongshoutao bolus (7g per time,2
      times per day) and placebo identified to Ginkgo biloba (Ginaton), Ginkgo biloba (Ginaton)
      (80mg per time, 2 times per day) and placebo identified to Qinggongshoutao bolus, or placebo
      identified to Qinggongshoutao bolus and placebo identified to Ginkgo biloba (Ginaton) for a
      52-weeks double-blind treatment period. The primary outcome measure is change from baseline
      in the Alzheimer's Disease Assessment Scale- Cognition Subscale (ADAS-cog) and rate of
      conversion to dementia. The secondary outcomes are changes from baseline in the Mini-Mental
      State Examination(MMSE), Delayed Story Recall(DSR), Alzheimer's Disease Cooperative
      Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24). Safety is
      being assessed by observing side effects and adverse reaction during the entire treatment
      period. Statistical analysis will be conducted according to per-protocol population and
      intend-to-treat population and the safety will be analyzed in safety set.
    


Intervention name(s): Qinggongshoutao Bolus; Ginkgo Biloba Extract 761; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761; Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761; Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba
Other intervention name(s): Ginkgo biloba also named Egb761 or Ginaton; Ginkgo biloba also named Egb761 or Ginaton
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Real Versus Sham Manual Therapy for RCRSP
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita
      Universidad Autonoma de Puebla will be treated with an exercise program with sham or real
      manual therapy for 5 weeks.

      The hypothesis of the present study is that the addition of manual therapy to a therapeutic
      exercise program produces better benefits in comparison to the same exercise program with
      sham manual therapy procedures in the management of patients with RCRSP.
    

Detailed description: 
      The objective of this study is to demonstrate that the combination of manual therapy and
      therapeutic exercise achieves better results in the management of the patient with shoulder
      pain.

      For this, manual therapy techniques in the thoracic region and in the shoulder together with
      a therapeutic exercise program will be applied.

      The investigators will compare this intervention protocol with placebo manual therapy
      techniques and the same therapeutic exercise protocol.
    

Intervention name(s): Manual therapy thoracic spine; Manual therapy glenohumeral joint; Sham thoracic manual therapy; Sham glenohumeral manual therapy; Therapeutic exercise
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Manual therapy mobilization directed to the costovertebral joint.; Manual therapy mobilization directed to the glenohumeral joint.; Sham manual therapy directed to the costovertebral joint.; Sham manual therapy directed to the glenohumeral joint.; Therapeutic exercise program consisting on isometric exercise with progressive load.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigation of Single Rising Doses of BI 685509
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single
      rising oral doses of BI 685509
    


Intervention name(s): BI 685509; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Sensory-Motor Blocks and Postoperative Pain in Lumbar Disk Herniation Surgery
Condition: Lumbar Spine Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Pain, Postoperative; Hernia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to Compare three methods of intrathecal bupivacaine;
      bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and
      postoperative pain in patients undergoing lumbar disk herniation surgery.
    

Detailed description: 
      -  Comparison three methods of intrathecal
           bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on sensory-motor
           blocks in patients undergoing lumbar disk herniation surgery

        -  Comparison three methods of intrathecal
           bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative
           pain in patients undergoing lumbar disk herniation surgery

        -  Comparison three methods of intrathecal
           bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative
           side effects in patients undergoing lumbar disk herniation surgery
    

Intervention name(s): Magnesium Sulfate; Spinal Anesthesia; Bupivacaine; Fentanyl
Intervention type(s): Drug; Procedure; Drug; Drug
Intervention description(s): Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.; Lumbar puncture was performed in sitting position,at the one level above iliac crest. Using a median approach, a 25-G Quincke needle was introduced with the needle aperture directed laterally.
Other intervention name(s): Magnesium sulfate 50%; Marcaine; Sublimaze
Intervention MeSH terms: Magnesium Sulfate; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Spinal Anesthesia; Bupivacaine; Fentanyl; Magnesium sulfate; Postoperative Pain