bioihbjkbjnl/mcl2 huggingface dataset:
VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis
Condition: Deep-Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional

Summary: 
      The VITRO (Vitamins and Thrombosis) study investigated the effect of homocysteine lowering by
      daily supplementation of B-vitamins on the risk reduction of deep-vein thrombosis and
      pulmonary embolism. Patients between 20 to 80 years old with a first objectively confirmed
      proximal deep-vein thrombosis or pulmonary embolism in the absence of major risk factors and
      a homocysteine concentration above the 75th percentile of a reference group were asked to
      participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of
      patients with a homocysteine below the 75th percentile of the reference group
      (normohomocysteinemic group). After informed consent patients were randomized to daily
      multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin) or
      placebo and were followed for 2.5 years. End-points were objectively diagnosed recurrent
      deep-vein thrombosis or pulmonary embolism.
    


Intervention name(s): 5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin
Intervention type(s): Drug
Intervention MeSH terms: Folic Acid; Pyridoxine; Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Venous thrombosis; Deep-vein thrombosis; Pulmonary embolism; Homocysteine; B-vitamins; Folate; Vitamin B12; Vitamin B6
Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, non-randomised, single-period, single-dose study in
      healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile
      and metabolite identification of [14C]-BLU-5937.
    


Intervention name(s): [14C]-BLU-5937
Intervention type(s): Drug
Intervention description(s): Each subject will receive a single oral administration of [14C]-BLU-5937 capsule, in the fasted state.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validity of Neck Extensor Muscles Endurance Test in Non-specific Chronic Neck Pain and Asymptomatic Subjects
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's
      societies. Cervical muscles endurance has been commonly associated with the development of
      NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical
      therapists to evaluate muscle structure, function and activation patterns. The aim of this
      study is if change in muscle thickness can correlate with the results of the endurance
      testing.
    


Intervention name(s): Assessment
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with and without neck pain
Absolute Oral Bioavailability of Remimazolam
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single-dose, 2-way crossover study to compare the relative
      bioavailability of orally administered remimazolam to an intravenous formulation in healthy
      volunteers
    


Intervention name(s): Remimazolam
Intervention type(s): Drug
Other intervention name(s): CNS7056
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the tolerability and safety of SAR113244 in male and female lupus patients after
      every 4 (Q4) weeks repeated ascending subcutaneous doses of SAR113244.

      Secondary Objectives:

      To assess in male and female lupus patients:

        -  The pharmacokinetics of SAR113244.

        -  The pharmacodynamics of SAR113244 for the following disease-related parameters:

             -  Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus
                Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus
                Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus
                Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index
                (SRI) (if applicable), Lupus-quality of life (QoL) and Functional Assessment of
                Chronic Illness Therapy (FACIT)-Fatigue, anti-double stranded deoxyribonucleic acid
                antibody (anti-dsDNA Ab) and anti-nuclear antibody levels (ANA) and plasma
                complement levels (C3, C4), erythrocyte sedimentation (SED) rate and C-reactive
                protein.

             -  Peripheral blood B and T cells subsets.
    

Detailed description: 
      The total duration of screening to end of study per subject is 20 weeks with post-study
      observation on Day 226 for anti-drug antibody assessment (for patients with positive
      anti-drug antibody at end of study only).
    

Intervention name(s): SAR113244; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solution for injection Route of administration: subcutaneous; Pharmaceutical form:solution for injection Route of administration: subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Exergame Program Structured Via Analytic Hierarchy Process on Trunk Control and Upper Extremity Functionality
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of the study is to investigate effects of structured exergame program on upper
      extremity functions and trunk control in children with Cerebral Palsy (SP). A 3 phase
      randomized controlled trial has planned to conduct. In the first phase, baseline assessments
      will be completed for all participants who are eligible to participate. After the baseline
      assessments, randomisation will be completed for Exergame and Activity Based Exercise groups.
      During this phase suitable video games for exergame program will be selected. Analytical
      Hierarchy Process (AHP) will be used to collect expert opinion for most effective video games
      for upper extremity functionality, postural control, GMFCS I-II-III levels. Second phase of
      the study will be started afterwards. Upon completing second assessments, interventions for
      both groups will be conducted. Third assessments will be completed after interventions and
      outcomes will be analyzed for primary results. The third phase of the study planned as
      follow-up period. All participant will continue their routine NDT trainings and follow-up
      assessments will be completed after 3 moths of the second assessments. Final results will be
      analysed for all participants.
    


Intervention name(s): Video-game based exercise - Exergame; Activity Based Exercise Group (AG)
Intervention type(s): Other; Other
Intervention description(s): Selected Kinect compatible video games from Microsoft Xbox one will be applied in this group. Four video games will be selected for a session (each game will last 10 mins). Video games are active video games which participants have to use their body parts in order to control games.; Task-oriented exercises to be performed in standing and sitting positions, including upper extremity and trunk, will be applied to the activity-based exercise group in addition to routine NDT training. Examples for activities; stepping and putting stickers on the wall, treading the play dough placed on a step board within one leg stance; reach-grasp activities progressively from sitting to standing, throwing and catching balls on a balance board.
Other intervention name(s): Microsoft Xbox One Kinect based exergame program; Goal Directed Upper Limb and Postural Control Exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Anti-calculus Efficacy of a Dentrifice Containing Sodium Pyrophosphate and Potassium Pyrophosphate in Heavy Calculus Formers
Condition: ANTICALCULUS EFFICACY OF PYROPHOSPHATE IN HEAVY CALCULUS FORMERS
MeSH terms: Calculi
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine the anti-calculus effect of dentrifice containing
      5% sodium pyrophosphate and potassium pyrophosphate in a triple-mask placebo controlled
      randomized clinical trial.
    


Intervention name(s): DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE; PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE
Intervention type(s): Drug; Drug
Intervention description(s): DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS; PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS
Other intervention name(s): XTAR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Investigating the Clinical Utility of the MDS
Condition: Skin Lesion; Melanoma; Moles
MeSH terms: Melanoma
Study type: Observational

Summary: 
      The purpose of this study is to establish the clinical utility of the Melanoma Detection
      System (MDS).
    

Detailed description: 
      The purpose of this study is to establish the clinical utility of the MDS while continuing to
      evaluate the safety and performance of the MDS in patients with skin lesions who are referred
      to secondary care clinics for evaluation, whose lesions (moles) are suspicious for melanoma.
    

Intervention name(s): Melanoma Detection System -MDS
Intervention type(s): Diagnostic Test
Intervention description(s): Imaging of lesion using the MDS test.
Other intervention name(s): MDS
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects referred to a specialist for possible presence of melanoma in skin lesions.
Respiratory Muscles and Inspiratory Muscle Training
Condition: Respiratory Muscles; Breathing Exercises
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      The effects of inspiratory muscle training (IMT) remain controversial. Many studies have
      examined the effect IMT has on exercise performance, but any changes to the body that come
      from IMT have yet to be looked at.

      This study will look at how someone breathes can change after IMT. Understanding how IMT
      changes the body can help us use IMT in different treatments.
    


Intervention name(s): Inspiratory Muscle Training; Sham Inspiratory Muscle Training
Intervention type(s): Other; Other
Intervention description(s): 6-weeks of inspiratory muscle training; A sham training procedure that is meant to elicit no physiologic changes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Exercise
High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the
      tumor without affecting the surrounding tissue.

      PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in
      treating patients with locally recurrent prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the ability of Sonablate to focus ultrasound waves for the purpose of
           selectively destroying prostate cancer tissue, with resultant drop in PSA levels to
           below 0.5 ng/mL and negative biopsy for cancer cells, in patients with locally recurrent
           prostate cancer.

      OUTLINE: Patients are stratified according to prior treatment failure (brachytherapy vs
      post-external beam radiotherapy).

      A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using
      the Sonablate system is delivered to the prostate tissue over approximately 2 hours. Patients
      with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels
      taken 2 months apart, visible prostate tissue on ultrasound, and no local or distant
      metastases after day 90 undergo retreatment with HIFU.

      Patients are followed at 2, 14, 30, 90, and 180 days.

      PROJECTED ACCRUAL: A total of 20 patients (10 per stratum) will be accrued for this study.
    

Intervention name(s): high-intensity focused ultrasound ablation
Intervention type(s): Procedure
Primary purpose: Treatment
Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; recurrent prostate cancer
Mass Balance and Biotransformation Study of [14C]LXI-15028 in Humans
Condition: Healthy Subjects; Pharmacokinetics of 14C-labeled of LXI-15028
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess absorption, metabolism and excretion of [14C]-LXI-15028 in Chinese healthy male
      Subjects following a single oral dose of [14C]LXI-15028 suspension.
    


Intervention name(s): [14C]LXI-15028
Intervention type(s): Drug
Intervention description(s): [14C]LXI-15028
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-D4010 in Healthy Subjects
Condition: Cognitive Disorder
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effect of food, gender, and age on the
      single-dose pharmacokinetics (PK) of SUVN-D4010.
    

Detailed description: 
      The main objective of the study is to evaluate the safety and tolerability of orally
      administered SUVN-D4010 under single-dose conditions in healthy adult male and female
      subjects and healthy elderly male subjects.
    

Intervention name(s): SUVN-D4010
Intervention type(s): Drug
Intervention description(s): Tablets
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Serotonin 4 (5-HT4) receptor; Phase 1
Probiotics for Weight Loss
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      This study will investigate a compound of probiotics and prebiotics in females and males with
      overweight with the aim to evaluate the effect on weight and metabolic markers.

      The design is a three month randomized doubled-blinded, three-armed placebo-controlled trial
      of probiotics for weight loss. Normal dose (2 capsules á 0.4g per day) doubled dose (4
      capsules á 0.4g per day), or placebo.

      A second, non-blinded, phase with only the compound of probiotics and prebiotics, with
      tripple dose (6 capsuled á 0.4g per day), will be performed for individuals who had the
      compound in the first phase.
    

Detailed description: 
      Participants Total number of study participants will be 75-90, consisting of overweight men
      and women, 18-45 years of age.

      Treatment Dietary supplement consisting of probiotic capsules called LB001. It contains
      strains of pediococcus (Bacterial family of Lactobacillaceae) and saccharomycetes (kingdom of
      Fungi and the division Ascomycota) with a concentration of 13 millions cfu/g. Other
      ingredients (including stabilization) include rice bran, vegetable L-Cystein, magnesium salts
      from vegetable fatty acids. The capsule shell is made of vegetable
      HydroxyPropylMetylCellulosa (HPMC). Each capsule has a weight of 0.4 gram. The placebo is
      made of rice flour.

      Since one of the inclusion criteria is "willingness to lose weight", all study participants,
      regardless of randomized treatment, will receive general advice regarding healthy lifestyle
      habits.
    

Intervention name(s): LB001
Intervention type(s): Dietary Supplement
Intervention description(s): Probiotics
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Intravenous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to investigate the safety and tolerability of CM-101 for the treatment
      of medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic
      steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).
    

Detailed description: 
      A total of 32 male subjects were enrolled into the study and randomized to 4 treatment
      groups. The study was comprised of a screening period, a treatment day, a follow-up (FU)
      period of 42 days and an end of study (EOS) FU visit. In each Dose Group subjects was
      randomized to receive a single IV infusion of CM-101.
    

Intervention name(s): Anti-human CCL24 monoclonal antibody (CM-101); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous Infusion of Anti-human CCL24 monoclonal antibody (CM-101); Placebo Comparator
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cognitive Behavioral Therapy for Insomnia to Address Insomnia Symptoms in People With Multiple Sclerosis
Condition: Insomnia
MeSH terms: Multiple Sclerosis; Sleep Initiation and Maintenance Disorders; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to learn if cognitive behavioral therapy for insomnia (CBT-I)
      will improve sleep quality, fatigue, and quality of life in individuals with multiple
      sclerosis (MS) with symptoms of insomnia.
    


Intervention name(s): Cognitive Behavioral Therapy for Insomnia; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.; Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis
Intraoperative Different Concentrations Oxygen And Oxidatıve Stress Markers
Condition: Stress; Hyperoxia
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      The aim of the study was to assess the effect of intraoperative oxygen (O2), which was
      applied at 30% and 50% concentrations on patients who had undergone septoplasty surgery, on
      Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Oxidative Stress Index (OSI).
    


Intervention name(s): taking arterial blood sample through the injector
Intervention type(s): Procedure
Intervention description(s): taking blood samples from patients applied with different oxygen concentrations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: oxidative stress markers; general anesthesia
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This clinical investigation is a prospective, multicenter, single arm clinical evaluation
      utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode
      circular diagnostic catheter.
    

Detailed description: 
      The objective of this clinical investigation is to assess the safety and acute effectiveness
      of the multi-electrode radiofrequency balloon catheter and multi-electrode circular
      diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of
      Paroxysmal Atrial Fibrillation (PAF).
    

Intervention name(s): Radiofrequency Ablation
Intervention type(s): Device
Intervention description(s): RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiofrequency Ablation; Paroxysmal Atrial Fibrillation
Neurocognitive Benefits of a Weight Management Program
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether weight loss induced through diet and physical activity can
      change neural responses to high- and low-calorie food images. In addition, it will evaluate
      whether weight loss can improve neural function when performing the N-back task, a measure of
      working memory. Findings will address notable gaps in the literature by testing whether a
      scalable weight loss intervention can help protect and improve neurocognitive functioning and
      brain health in individuals with obesity. This study will also provide important information
      about the effects of weight loss on neuroplasticity in brain regions crucial for memory and
      cognitive functioning, which will help to inform future interventions aimed at promoting
      brain health.
    

Detailed description: 
      The purpose of the present study is to conduct a randomized controlled trial (RCT) to assess
      the effects of a commercially available weight loss program (WW; formerly Weight Watchers) on
      neural response to food cues and memory tasks, as well as on structural brain morphology.
      Participants with obesity will be randomized to either 16 weeks of an in-person, group-based
      WW program (n=30) or a wait-list control (WLC; n=30). Both groups will have structural and
      blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) scans at
      baseline and after the 16-week intervention. Participants will complete the following fMRI
      tasks: 1) structural scan; 2) food cue task to measure reactivity to high and low-calorie
      food images and 3) N-back task to measure working memory (i.e., the ability to temporarily
      hold information available for processing). In addition, participants will complete
      self-report and behavioral measures of eating behaviors, appetite, physical activity, mood,
      quality of life, attention and memory at baseline, and weeks 8 and 16.
    

Intervention name(s): WW (formerly Weight Watchers); Waitlist
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.; The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; weight loss; neuroimaging; fMRI; behavioral obesity treatment