bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Single Doses of Oral Dexanabinol in Healthy Subjects
Condition: Safety; Tolerability; Pharmacokinetics; Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and observe the pharmacokinetics
      (distribution and elimination of the drug) of the compound dexanabinol (ETS2101) in healthy
      male subjects following a single oral dose.
    


Intervention name(s): Dexanabinol Dose Level 1; Dexanabinol Dose Level 2; Dexanabinol Dose Level 3; Dexanabinol Dose Level 4; Dexanabinol Dose Level 5; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral formulation of dexanabinol; Oral formulation of dexanabinol; Oral formulation of dexanabinol; Oral formulation of dexanabinol; Oral formulation of dexanabinol
Other intervention name(s): ETS2101; ETS2101; ETS2101; ETS2101; ETS2101
Intervention MeSH terms: HU 211; Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Dexanabinol; Oral; Safety; Tolerability; Pharmacokinetics
Serum A.Actinomycetemcomitans Antibodies and Periodontitis
Condition: Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Observational

Summary: 
      The aim of this study was to analyze the association between serum A.actinomycetemcomitans
      antibodies in patients with periodontitis. Furthermore, the objective was to determine if the
      periodontitis influenced serum IgG A.actinomycetemcomitans antibodies levels
    

Detailed description: 
      53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present
      study. Enrolled patients were examined and characterized for clinical and blood samples
      analysis and A.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked
      immunosorbent assay (ELISA) units (EU). The Spearman Correlation Test and Jonckheere-Terpstra
      Test were applied in order to assess the interdependence between serum IgG
      A.actinomycetemcomitans antibodies and clinical periodontal parameters.
    

Intervention name(s): observation of serum A.actinomycetemcomitans levels
Intervention type(s): Other
Intervention description(s): Analysis of serum A.actinomycetemcomitans levels
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        53 patients with periodontitis and 48 healthy subjects (HS) were enrolled in the present
        study. Enrolled patients were examined and characterized for clinical and blood samples
        analysis, andA.actinomycetemcomitans antibodies were expressed and evaluated enzyme-linked
        immunosorbent assay (ELISA) units (EU).
Study of Octanorm Subcutaneous IG in Patients With PID
Condition: Primary Immune Deficiency Disorder
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label phase III study with a 12-week wash-in/wash-out period followed by a
      12-month efficacy period. The main goals of the study are to assess the efficacy of octanorm
      in preventing serious bacterial infections (SBI) compared with historical control data and to
      evaluate the pharmacokinetic (PK) characteristics of octanorm.
    


Intervention name(s): octanorm 16.5%
Intervention type(s): Biological
Intervention description(s): octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PID
Real World Experience in Heart Failure With Reduced Ejection Fraction (HFrEF) Patients Treated With sAc/vaL.
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The study is a cohort observational, retrospective, non-interventional study.
    

Detailed description: 
      Study period:

      Index date: The index date were defined as the first date of the first prescription of
      Sacubitril/Valsartan during inclusion period and this were used to establish the beginning of
      the follow-up period.

      Characterization period: 6 months period before the index date were used to characterize
      patients.

      Follow-up period: Any patients has at least 1 year of follow-up. Follow-up period went from
      index date to June 2020.
    

Intervention name(s): Sacubitril/Valsartan
Intervention type(s): Drug
Intervention description(s): HF patients treated with Sac/Val
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Heart Failure with reduced Ejection Fraction (HfrEF) patients treated with
        Sacubitril/Valsartan.
      
Keywords: Drug utilization,; Heart failure,; Real-world,; Sacubitril/Valsartan
Effects of Muscle Energy Techniques Versus Core Stability Exercises in Pelvic Girdle Pain
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Study type: Interventional

Summary: 
      PGP is referred to as a specific form of LBP which occurs isolatedly as well as in
      combination with lumbar back pain. PGP localized to the anterior or posterior pelvis, most
      commonly located between the posterior iliac crest and gluteal folds especially around the SI
      joint. Pelvic girdle pain radiated to the posterior thigh
    

Detailed description: 
      Pelvic girdle pain (PGP) is known to be a musculoskeletal disorders which affects the pelvic
      bone. PGP is referred to as a specific form of LBP which occurs isolatedly as well as in
      combination with lumbar back pain. PGP localized to the anterior or posterior pelvis, most
      commonly located between the posterior iliac crest and gluteal folds especially around the SI
      joint. Pelvic girdle pain radiated to the posterior thigh. Moreover, it can also cause pain
      in the symphysis (1). Compared to lower back pain, PGP is substantially more painful and
      linked with functional limitations as standing, walking, sitting and changing positions are
      less tolerable in such patients (2). PGP is musculoskeletal in nature and is not caused by
      gynecological or urological conditions (3). Despite the fact that the cause of PGP is
      unknown, it is considered that it occurs due to many reasons such as trauma, arthritis,
      anatomical fault or it can be associated with pregnancy (4
    

Intervention name(s): Muscle energy techniques
Intervention type(s): Other
Intervention description(s): Group A: 20 patients were included in this group. This studygroup was assigned with basic treatment protocol with 15 minutes of TENS and thermal therapy for 10 minutes followed by muscle energy technique (Post facilitation stretching exercises). The intervention was given three days per weekfor six weeks. Each total session lasted for 45minutes. METs were applied for the weakened muscles. (21). Group B: 20 Patients of this group were given core stability exercises by the female physical therapist in three different levels. Each level continued for a duration of two weeks in which the patients were trained for the exercises. The patients were provided sessions thrice per week with 2 sets of 10 repetitions and a hold of 10 second after TENS for 15 minutes and thermal therapy for 10 minutes
Other intervention name(s): core stability exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate 3 Dosages of Estetrol After 28 Days Administration in Healthy Postmenopausal Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Estetrol is a natural compound that is produced by the fetus during fetal life and circulates
      in the unborn child and the mother. It is an estrogenic compound. In this study the safety
      and tolerability of 28 days of the oral administration of estetrol in healthy postmenopausal
      women are investigated. In addition, the pharmacokinetics and some pharmacodynamic parameters
      are studied. The lowest dose of 2 mg estetrol is directly compared with 2 mg estradiol.
    

Detailed description: 
      This is a partly randomized open-label study in healthy postmenopausal women. Groups are
      treated in the following sequence: first a 2 mg estetrol group together with a 2 mg estradiol
      group. When the dose of 2 mg estetrol is safe and the tolerability is good, a next higher
      dose group of estetrol will start, possibly followed by two next higher dose groups if the
      previous dose group is safe and the tolerability is good.

      The primary objective of this study is to investigate the safety and tolerability of estetrol
      during multiple dosing for 28 days. Furthermore steady state pharmacokinetics and some
      pharmacodynamic parameters of estetrol will be investigated. In addition, the
      pharmacokinetics and pharmacodynamic effects of the 2 mg estetrol group will be compared with
      those of the 2 mg estradiol group.

      In each group 5 postmenopausal women will be included with > 50 hot flushes per week and 5
      postmenopausal women with < 10 hot flushes per week. These criteria are set to get a more
      homologous composition in each group.
    

Intervention name(s): estetrol
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phase I study
Intranasal Fentanyl for the Treatment of Breakthrough Pain in Cancer Patients (FT-017-IM)
Condition: Cancer; Pain
MeSH terms: Breakthrough Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To demonstrate the efficacy of intranasal fentanyl in the treatment of breakthrough pain
      (BTP) in cancer patients.

      Secondary Objective:

      To explore the relationship between the response to the fentanyl dose and the stable
      background pain opioid dose.
    


Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cancer pain with breakthrough pain episodes
Effects of Different Exercise Programs for People With Chronic Whiplash Associated Disorders
Condition: Whiplash
MeSH terms: Whiplash Injuries
Study type: Interventional

Summary: 
      Background:

      Costs of health care consumption and sick leave 2006 in Sweden for Whiplash Associated
      Disorders (WAD) was estimated to be 4 billion Swedish crowns. Despite tremendous costs and
      personal sufferings there are only a few prospective randomized studies (RCT) in patients
      with chronic WAD, and none of them evaluating return to work, or the role of neck specific
      exercises with or without a combination of a behavioral approach compared with prescribed
      physical activity.

      Aim:

      The general aim of this RCT is to examine what neck-specific training with or without a
      combination with behavioral approach adds to prescribed physical activity of persons with
      chronic WAD with regard to pain intensity, physical and psychological function, health care
      consumption and return to work. Another aim is to study predictive factors of importance for
      a good outcome of rehabilitation.

      Method:

      After informed consent patients in age 18-63 years of age with WAD II-III with more than 6
      months duration will be randomized to one out of the three alternatives of physiotherapy,
      treatment with medical exercise therapy with neck specific exercises (A),treatment with a
      behavioral approach combined with neck specific exercises (B), prescribed physical activity
      (C). Randomisation will be done by the central project leader. 200 patients will be included
      in the study. All physiotherapists engaged in the structured and well described treatment
      will be introduced in the program by the project leader. The measurements with good
      clinometric properties will be performed before treatment, after 12 weeks, 6, 12 and 24
      months after inclusion into the study. Clinical measurements will be performed by a blinded
      investigator. Background data, disease-specific and generic data will be measured by
      self-evaluated answered questionnaires by the patients. Days of sick-leave will be collected
      from the Social Insurance Agency. Main outcomes of the measurements are pain intensity, neck
      specific disability and return to work. Cost-effectiveness will be calculated.
    


Intervention name(s): Neck Specific Exercises; Behavioral approach combined with neck specific exercises; Prescribed Physical activity
Intervention type(s): Other; Behavioral; Other
Intervention description(s): 2 times a week for 3 months followed by encourages to continue on their own; Behavioral physiotherapeutic approach combined with neck specific exercises 2 times a week for 3 months. Exercises will be chosen from a well defined and structured frame of exercises.; Physical activity without neck specific exercises for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Whiplash; Rehabilitation; Physiotherapy; Exercises
Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access
Condition: Dialysis Access Malfunction
Study type: Observational [Patient Registry]

Summary: 
      This is a multicenter, prospective study investigating a new concept of intra-procedural
      percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the
      quantification and optimization of endovascular treatment outcomes of dysfunctional
      autologous arteriovenous fistulae (AVF).
    

Detailed description: 
      This is a prospective, multi-center, single-arm observational clinical trial investigating a
      new functional index of success of endovascular treatment of dysfunctional AVF assessed with
      intraprocedural percutaneous DUS. The study will include 100 consecutive patients undergoing
      fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Exclusion
      criteria will be (i) patients with arteriovenous synthetic grafts. (ii) Immature AFVs not
      previously used for hemodialysis (at least once). Patients' demographical data, dialysis
      access history, and procedural details will be recorded. Intraprocedural volume flow
      measurements will be obtained just prior to the procedure and after final balloon dilation,
      before sheath removal. Clinical follow-up will be set at 6 months after the index procedure.
      All DUS measurements will be performed using the same imaging protocol. The study's primary
      endpoints will be (i) the quantification of angioplasty outcome using DUS volume flow
      analysis before sheath insertion and at the end of the procedure before sheath removal and
      (ii) to assess the correlation between volume flow at the end of the procedure and clinically
      driven re-intervention-free rate at defined as the rate of reintervention due to dysfunction
      recurrence of the treated AVF. Secondary endpoints will be (i) to assess the correlation
      between volume flow and clinical success defined as high-quality dialysis for a period of at
      least one month and (ii) identification of independent predictors of re-intervention-free
      rate.
    

Intervention name(s): Percutaneous DUS volume flow measurements
Intervention type(s): Diagnostic Test
Intervention description(s): Volume flow measurements of the AFV will be obtained using intraprocedural DUS just prior to sheath insertion and at the end of the final balloon dilation, before sheath removal.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty
        due to dysfunctional AVF and assessed with pre-and post-procedural volume flow measurements
        using percutaneous DUS
      
Keywords: Percutaneous transluminal angioplasty; Volume-flow measurement; Autologous arteriovenous fistula; Dialysis access; Interventional Radiology
RI-AME Study OF [ISOTHIAZOLYL-3-14C]-LURASIDONE
Condition: Pharmacokinetics; Metabolism
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, non-randomized, absorption, metabolism, and excretion study of
      Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a
      postprandial state
    

Detailed description: 
      A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of
      [Isothiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in
      Healthy Male Subjects.
    

Intervention name(s): Lurasidone
Intervention type(s): Drug
Intervention description(s): 40 mg suspension, PO, for 7 days
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics, lurasidone
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
Condition: Human Immunodeficiency Virus 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (what the body does to the
      medication), safety and antiviral activity to support dose recommendations by body weight of
      darunavir with low-dose ritonavir (DRV/rtv), in combination with other antiretroviral drugs
      (ARVs), in treatment-experienced Human immunodeficiency virus 1 (HIV 1) infected children.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), study to evaluate
      the pharmacokinetics, safety and antiviral activity. Approximately 24 HIV-1 infected children
      will be enrolled in this study. The study consists of a 4-week screening period, a 48-week
      treatment period, and a 4-week follow-up period. Participants will receive DRV/rtv according
      to their body weight. Safety evaluations will include assessment of adverse events,
      laboratory tests, physical Examination, neurologic examination, vital signs, and
      electrocardiogram. The total duration of the study will be 56 weeks.
    

Intervention name(s): Darunavir; Ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): Darunavir oral suspension (100 mg/mL) will be administered as 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg before dose adjustment. Darunavir oral suspension will be administered 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg darunavir tablets twice daily if weight more than or equal to 15 kg after dose adjustment.; Ritonavir oral solution (80 mg/mL) will be administered as 3 mg per kg body weight twice daily before dose adjustment and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg.
Intervention MeSH terms: Ritonavir; Darunavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human immunodeficiency virus 1; HIV-1; Darunavir; Ritonavir; Norvir
Bacteriotherapy in Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; CD
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the investigators want to see if Bacteriotherapy (also referred to as stool
      transplantation) improves the symptoms and decreases inflammation in children with
      Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis.
      Additionally, researchers want to learn whether this experimental therapy delays the need for
      starting additional medications to treat pediatric IBD.
    


Intervention name(s): Bacteriotherapy
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohns Disease; Ulcerative Colitis; Inflammatory Bowel Disease; IBD
The Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel in Normal Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Background:

        -  The prevalence of arthritis which needs celecoxib prescription is high in patients with
           coronary artery disease.

        -  The main concern is that celecoxib would increase thrombogenicity by inhibiting the
           synthesis of prostacyclin in endothelial cells.

        -  It is not known whether the administration of celecoxib would deteriorate antiplatelet
           effects of aspirin and clopidogrel which are used after stenting.

      Methods:

        -  Healthy volunteers (n=40)

        -  Randomization into five subgroups

        -  aspirin, celecoxib, aspirin+celecoxib, aspirin+clopidogrel,
           aspirin+clopidogrel+celecoxib

        -  Medication schedule : medication of each drug for 6 days, blood samples at day 0 and day
           7

        -  Celecoxib 200mg twice a day, and/or aspirin 100mg daily, and/or clopidogrel 75 mg daily

        -  Platelet function test : light transmittance aggregometry and arachidonic acid
           metabolite assay among subgroups.

      Study hypothesis : The addition of celecoxib does not deteriorate antiplatelet function of
      aspirin and clopidogrel.
    


Intervention name(s): aspirin; celecoxib; aspirin + celecoxib; aspirin + clopidogrel; aspirin + clopidogrel + celecoxib
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): aspirin 100 mg qd for 7 days; celecoxib 200 mg bid * 7 days; aspirin 100 mg qd + celecoxib 200 mg bid for 7 days; asprin 100 mg qd + clopidogrel 75 mg qd for 7 days; aspirin 100 mg qd + clopidogrel 75 mg qd + celecoxib 200 mg bid
Other intervention name(s): aspirin : Keun-Hwa Phamaceutical; clopidogrel : sanofi-aventis; celecoxib : Pfizer; aspirin : Keun-Hwa Phamaceutical; clopidogrel : sanofi-aventis; celecoxib : Pfizer; aspirin : Keun-Hwa Phamaceutical; clopidogrel : sanofi-aventis; celecoxib : Pfizer; aspirin : Keun-Hwa Phamaceutical; clopidogrel : sanofi-aventis; celecoxib : Pfizer; aspirin : Keun-Hwa Phamaceutical; clopidogrel : sanofi-aventis; celecoxib : Pfizer
Intervention MeSH terms: Aspirin; Celecoxib; Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: celecoxib; platelet; thrombosis; Volunteers