bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed as a randomized, double-blind, parallelity-controlled
      study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this
      study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between
      recombinant monoclonal antibody against human epidermal growth factor receptor injection
      (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.
    


Intervention name(s): recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627); Perjeta ®
Intervention type(s): Drug; Drug
Intervention description(s): A single intravenous infusion of HS627 420mg; A single intravenous infusion of Perjeta ®420mg
Intervention MeSH terms: Pertuzumab; Antibodies; Antibodies, Monoclonal; Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics
      after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian
      subjects.
    


Intervention name(s): Aprocitentan 25mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets in strength of 25 mg; Oral tablets matching aprocitentan tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of a Synergistic Food Basket on Metabolic Syndrome Risk
Condition: Metabolic Syndrome; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The study evaluates the effect of a diet combining two different functional concepts on
      markers associated to cardiometabolic risk. The functional concepts are selected on the basis
      of their reported ability to influence the inflammatory tonus. It is hypothesized that the
      medium-term consumption of a diet combining low GI-prebiotic foods may positively influence
      various biomarkers associated with the risk for developing metabolic syndrome and
      cardiometabolic disease. Also, the combination of functional mechanisms are expected to
      result in synergistic effects.
    

Detailed description: 
      The intervention is carried out in healthy women following a randomized crossover design in
      which an "active" (functional") diet is compared with a control diet formulated in agreement
      with the Nordic Dietary Recommendations but lacking the functional ingredients of the active
      regime.

      The active diet supplies important daily amounts of dried legumes and wholegrain cereal
      products.

      Each dietary treatment is applied for 4 weeks separated by a 4-6 week washout period.
      Subjects are encouraged to maintain a stable body weight under the whole trial.
    

Intervention name(s): Synergistic food basket
Intervention type(s): Other
Intervention description(s): A low glycemic index diet enriched in dried legumes and wholegrain cereals is compared with a control regime lacking these functional ingredients for their ability to ameliorate different markers associated with the risk for developing cardiometabolic disease
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cardiometabolic risk; Metabolic syndrome; Prebiotics; Legumes; Wholegrain cereal; Functional diet; Low glycemic index diet
Pharmacokinetic Profile of Two Formulations of PB1023 Following Single Subcutaneous Injection in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To compare the pharmacokinetic profile of PB1023 after a single dose administered by
      subcutaneous injection of two formulations (concentrations).

      Secondary objectives:

      To evaluate the safety and tolerability of two formulations of PB1023 Injection administered
      as a subcutaneous injection in adult subjects with T2DM.

      To evaluate the impact on the pharmacokinetic profile of PB1023 after a single 90 mg dose of
      formulation B (100 mg/mL) administered cold at 2 to 8°C by subcutaneous injection.
    


Intervention name(s): Single Dose PB1023; Single Dose PB1023; Single Dose PB1023
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single Dose PB1023 Formulation A; Single Dose PB1023 Formulation B; Single Dose PB1023 Formulation B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study will evaluate the clinica! and radiological results of a treatment for knee
      osteoarthritis with injections of autologous concentrated bone marrow aspirate at the
      bone-cartilage interface via percutaneous.
    

Detailed description: 
      This pilot study (N=30) patients will evaluate the clinica! and radiological results of a
      treatment for knee osteoarthritis with injections of bone marrow concentrate (BMC),obtained
      from the Bone Marrow Aspirate Concentration System (BioCUE) at the bone-cartilage interface
      via percutaneous injections. The PerFuse system will also be evaluated to determine if it can
      be used to deliver the BMC to the osseous sites. Follow-up is 1, 3, 6, 12, and 24 months.
    

Intervention name(s): Injection of autologous concentrated bone marrow aspirate
Intervention type(s): Biological
Intervention description(s): Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)
Intervention model: Single Group Assignment
Intervention model description: autologous concentrated bone marrow aspirate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee osteoarthritis ,; bone marrow aspirate; injections
Laser Assisted Sperm Selection of Viable Immotile Testicular Sperm in Azoospermic Infertile Men
Condition: Azoospermia; IVF
MeSH terms: Azoospermia
Study type: Interventional

Summary: 
      This study aims to investigate the outcome of ICSI after using LAISS for selection of viable
      immotile testicular sperm in azoospermic infertile men.

      Patients will be randomly assigned to 2 groups. In (LAISS) group, viable immotile testicular
      sperms will be selected before ICSI using laser assisted immotile sperm selection (study
      group). In (HOST) group, viable immotile testicular sperms will be selected before ICSI using
      hypo-osmotic swelling test (control group).
    


Intervention name(s): Laser Assisted Immotile Sperm Selection; Hypo-osmotic Swelling Test
Intervention type(s): Device; Procedure
Intervention description(s): LAISS will be performed using diode laser system at the lowest working power with a single laser shot at the lower one third of the sperm tail. If sperm tail curling occurred, the sperm is then viable and will be utilized for ICSI after immobilization in PVP.; HOST will be performed by transferring immotile sperms from incubation droplet into HOST droplet, with any sperm showing tail swelling will be identified as viable and will be utilized for ICSI after immediate transfer and immobilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: (LAISS) group: viable immotile testicular sperms will be selected before ICSI using laser assisted immotile sperm selection (study group).
(HOST) group: viable immotile testicular sperms will be selected before ICSI using hypo-osmotic swelling test (control group).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser Assisted Immotile Sperm Selection; Hypo-osmotic swelling test; ICSI; Testicular sperm
Combination of Motor Imagery Exercises and Brain Stimulation TMS Type PAS in Patients After Hemiplegic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Strokes represent, in industrialized countries the leading cause of acquired motor disability
      in adults older than 40. Stroke is responsible for France from 150 000 to 200 000 new cases
      of hemiplegia each year. These patients will see their deficit to improve during the first 6
      months after stroke. This recovery is largely based on brain plasticity mechanisms and the
      rehabilitation has as main objective to optimize these mechanisms. However, only 20% of
      patients hospitalized in a rehabilitation sector recover a functional upper limb. This lack
      of functionality is not only due to overall strength gap but also to the predominance of this
      gap on the extension movements of the wrist and fingers.

      Meanwhile, work on brain plasticity helped develop new techniques of non-invasive brain
      stimulation (Non-invasive Brain Stimulation, NIBS) as the model of coupled stimulations
      (Paired Associative Stimulation, PAS) for modulating way over effective brain plasticity. In
      previous studies, the investigators have shown over a 30 minutes session lasting facilitation
      (60mn) and specific motor evoked potential (MEP) of the Extensor Carpi Radialis (ECR).
      Several studies showed an adjuvant effect when GSIN were associated with learning of a motor
      task. For PAS, some studies have shown a greater facilitation when the latter is associated
      with muscle contraction.

      The motor imagery (MI) is imagining a movement without realizing it, it is based on
      mechanisms similar to those of the real movement. This technique also showed its effects as
      an adjuvant therapy in hemiplegic patients, however, they remain lower than those obtained
      after a motor drive. Its use in patients with no motor makes its uniqueness and strength.
    


Intervention name(s): Paired Associative Stimulation; Paired Associative Stimulation + Motor Imagery exercises; Placebo Paired Associative Stimulation + Motor Imagery exercises
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Patient with Paired Associative Stimulation only; Patient with Paired Associative Stimulation + Motor Imagery exercises; Patient with placebo Paired Associative Stimulation + Motor Imagery exercises
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Hemiplegia
Cerebral Oxymetry at Elective Coronary and Valve Surgery.
Condition: Coronary Artery Disease.; Aortic Valve Stenosis.; Aortic Valve Regurgitation.
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency
Study type: Observational

Summary: 
      Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to
      decreased cerebral flow and oxygenation in individual patients and this can be detected by
      means of cerebral oxymetry.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We want to include 50 patients, both women and men, undergo elective coronary bypass
        surgery or valve surgeon in CPB with moderate hypothermia.
      
Keywords: Cerebral Oximetry.; Aortic valve stenosis.; Aortic valve regurgitation.; Coronary artery disease.
Preemptive Low-dose Epidural Ketamine for Preventing Chronic Post-thoracotomy Pain
Condition: Chronic Post-thoracotomy Pain
Study type: Interventional

Summary: 
      Chronic post-thoracotomy pain is the most common long-term complication that occurs after a
      thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has
      become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic
      post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded,
      randomized, controlled trial was to assess the effect of preemptive low-dose epidural
      ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic
      post-thoracotomy pain.
    


Intervention name(s): Ketamine; ketamine free
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: preemptive epidural ketamine; prevention of chronic post-thoracotomy pain
A SAD/MAD Study to Evaluate the Safety, Tolerability, PK and PD of MT2004
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the
      safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of
      MT2004 following oral single and multiple ascending dose administration.
    

Detailed description: 
      A total of 48 subjects will be evaluated with 36 subjects randomized to receive active drug
      and 12 subjects randomized to receive placebo in a double-blind fashion (eight subjects per
      each dose cohort, six subjects randomized to active drug and two subjects randomized to
      placebo). A separate open panel of 8 subjects will receive a single dose of MT2004 under fed
      conditions following the last of the SAD dose escalation cohorts. The dose level will be
      selected by the sponsor based upon the safety and PK data generated in each dose escalation
      cohort of the SAD part of the trial. A total of 24 subjects will receive MT2004 (8 subjects
      in each dose cohort for a total of 3 cohorts, 6 subjects randomized to active drug and 2
      subjects randomized to placebo per cohort). MT2004 dosing regimens (dose levels and duration
      of administration) will be determined based on the collective SAD PK and safety data from
      Part 1 and nonclinical data of MT2004 (pharmacology and toxicology). Tentative dosing regimen
      is once daily for a consecutive 14 days.
    

Intervention name(s): MT2004; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MT2004 oral capsules; Placebo oral capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, sequential parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of alogliptin, once daily
      (QD), taken in combination with insulin for the treatment of Type 2 Diabetes.
    

Detailed description: 
      There are approximately 19 million people in the United States who have been diagnosed with
      diabetes mellitus, of which 90% to 95% are type 2. The prevalence of type 2 diabetes varies
      among racial and ethnic populations and has been shown to correlate with age, obesity, family
      history, history of gestational diabetes, and physical inactivity. Over the next decade, a
      marked increase in the number of adults with diabetes mellitus is expected.

      Takeda is developing alogliptin (SYR-322) for patients with type 2 diabetes mellitus.
      Alogliptin is an inhibitor of the dipeptidyl peptidase IV enzyme. Dipeptidyl peptidase IV is
      thought to be primarily responsible for the degradation of 2 peptide hormones released in
      response to nutrient ingestion. It is expected that inhibition of dipeptidyl peptidase IV
      will improve glycemic (glucose) control in patients with type 2 diabetes.

      The aim of the current study is to evaluate the efficacy of alogliptin in combination with
      insulin in subjects who are inadequately controlled on insulin alone (with or without
      metformin). Individuals who participate in this study will be required to commit to a
      screening visit and up to 14 additional visits at the study center. Study participation is
      anticipated to be about 34 weeks (or 8.5 months).
    

Intervention name(s): Alogliptin and insulin; Alogliptin and insulin; Insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.; Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.; Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
Other intervention name(s): alogliptin; SYR110322; alogliptin; SYR110322
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus; Lipoatrophic; Dyslipidemia; Drug Therapy
Sensory Integration Disorders in Patients With MS Including Disease Advancement and Relapses in the Last Year
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      the aim of the study was to assess the occurrence of sensory integration disorders in people
      with SI depending on the stage of the disease and relapses in the last year;analysis of
      sensory integration disorders in patients with Ms and healthy people
    

Detailed description: 
      141 patients diagnosed with RRSM were enrolled in the study. The control group consisted of
      72 healthy people. The Sensory Integration Assessment Scale in Adults (SPD) was used to test
      sensory integration, and an original questionnaire was carried out containing information on
      age, gender, frequency of relapses in the last year, and duration of the disease.
    

Intervention name(s): Scale for the Assessment of Sensory Integration in Adults
Intervention type(s): Diagnostic Test
Intervention description(s): In people with MS and people with health of similar age, a test was performed to assess sensory integration in adults
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with relapsing-remitting MS were qualified for the study; aged 30 to 45
      
Keywords: multiple sclerosis;; Sensory integration; relapses; the advancement of the disease
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label, single dose, randomized, two-way cross-over study will
      evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese
      volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20
      mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be
      re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.
    


Intervention name(s): RO4917838; RO4917838
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg single oral dose; 20 mg single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A New Therapeutic Approach for Root Coverage
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      Different surgical techniques have been proposed for root coverage, showing varying results
      especially in areas of deep recessions. The aim of this study is to evaluate the
      effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller
      class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample
      should be comprised of patients aged 18-45 years, both genders, presenting at least one site
      with marginal tissue recession >4mm. Patients will be randomly assigned to either one of the
      groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective
      tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at
      baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one
      way analysis of variance for repeated measures. Inter-group analysis will be performed by
      unpaired t-test for each of evaluation periods.
    

Detailed description: 
      Both gender patients presenting Miller class I or II recession defects >4mm were selected.
      Patients were randomly assigned to treatment groups: newly forming bone graft (NFBG) or
      subepithelial connective tissue graft (SCT). Patients were treated in the period of February
      2008 and March 2008 and monitored during 9 months.
    

Intervention name(s): Newly forming bone technique for root coverage; Subepithelial connective tissue graft for root coverage.
Intervention type(s): Procedure; Other
Intervention description(s): A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.; A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.
Other intervention name(s): Bone granulation; NFBG; SCTG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Root coverage; Graft; Soft tissue; Periodontal regeneration
The Treatment of the Median Nerve for the Elimination of the Symptoms Associated With the Carpal Tunnel Syndrome
Condition: Compression Neuropathy, Carpal Tunnel
MeSH terms: Carpal Tunnel Syndrome; Charcot-Marie-Tooth Disease; Nerve Compression Syndromes; Hereditary Sensory and Motor Neuropathy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the
      aponeurosis of the biceps and in the pronator teres muscle.

      We hypothesise that by eliminating these trigger points,using ischemic compressions, may
      diminish the symptoms.
    

Detailed description: 
      Using one thumb on the other,the pressure is applied 10 seconds on each TrPs.The treatment is
      done on each visit for a total of 15(without Charge).
    

Intervention name(s): Ischemic Compression (thumb Pressure)
Intervention type(s): Procedure
Intervention description(s): Pressure, one thumb on the other, applied on the trigger points
Other intervention name(s): Pressure point therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ischemic compression;carpal tunnel syndrome