bioihbjkbjnl/mcl2 huggingface dataset:
To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new,
      different extended release formulations of tablets of AZD3241 (300 mg), in relation to the
      100 mg extended release tablet used in a previous study and potential food interaction. The
      safety and tolerability of AZD 3241 will also be investigated as a secondary objective. In
      addition to these a number of exploratory objectives will be investigated with blood
      sampling.
    

Detailed description: 
      A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study
      to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release
      Formulations of Tablets of AZD3241 (300 mg) after Administration of Multiple Doses in Healthy
      Male and Female Volunteers
    

Intervention name(s): AZD3241 ER formulation 1; Placebo; AZD3241 Alternative titration scheme with formulation 1 or 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast; Placebo will be administered with the same intervention scheme as intervention 1 and 2; 50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8
Other intervention name(s): This titration scheme will only be used if ER formulations 1 or 2 are not well tolerated
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Phase 1; Parkinson's disease; pharmacodynamic; biomarkers; pharmacokinetics; extended release formulation
Pain in Sickle Cell Epidemiologic Study
Condition: Blood Disease; Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell; Hematologic Diseases
Study type: Observational

Summary: 
      To measure the variability in pain and response to pain in sickle cell disease, and to build
      multivariate models to explain both patients' pain and their response to pain, especially,
      utilization of health care.
    

Detailed description: 
      BACKGROUND:

      Pain in sickle cell disease is poorly recognized, measured, and treated. Although painful
      episodes are the most common reason sickle cell patients seek care, studies have seldom
      directly measured pain in detail. In studies to date, biological and demographic variables
      alone only partly explain the observed variance in painful episode frequency. Further, little
      is known about differences in pain responses including home management versus health care
      utilization.

      DESIGN NARRATIVE:

      This cohort study is measuring the variability in pain and response to pain in sickle cell
      disease, and building multivariate models to explain both patients' pain and their response
      to pain, especially, utilization of health care. The models' outcome variables include mean
      pain, painful episodes, and various types of utilization episodes, including non-narcotic
      analgesic use, narcotic use, office visits, emergency department (ED visits, and
      hospitalization. An additional outcome is the percentage of each patient's painful episodes
      that result in various types of utilization. Outcomes will be operationalized using daily
      pain diaries collected over six months. Reflecting on the prior 24 hours, patients will
      recall on an ordinal (0-9) scale maximum pain, distress, and disability, judge whether they
      were in a "crisis," and note pain locations and their various types of utilization. Daily
      pain intensity ratings will be transformed into pain episode counts using a formulaic
      threshold for a painful episode. The formula calculates each patient's threshold
      individually, based on his/her pain ratings. The models will measure the effect of several
      classes of explanatory variables (demographic, disease-related, psycho social, and readiness
      to utilize care), operationalized using primary data and validated instruments.

      Patients will be recruited from the central and Tidewater regions of Virginia, will undergo
      an initial survey battery, chart review, and a brief final survey, venipuncture and urine
      sampling, and complete pain diaries daily for six months. This study will advance knowledge
      of the etiology and influences on pain and pain response in sickle cell disease. By revealing
      potentially mutable explanatory variables, the study's results will suggest targets of
      biobehavioral treatment interventions.
Standard Root Planing vs. Periodontal Structure Repair Device for Treatment of Pockets Caused by Periodontal Disease
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      This study evaluates the efficacy and safety of Periodontal Structure Repair device (PSR)
      compared to conventional periodontal therapy (scaling and root planing) for the treatment of
      periodontal pockets caused by periodontal disease.
    

Detailed description: 
      This is a multicenter, prospective, randomized, open, active comparator-controlled study with
      a parallel group, subject-paired design (i.e. the effect of both treatments can be observed
      in the same subject).

      Subjects must have two quadrants of their mouth that each have at least two teeth with one or
      more pockets per tooth that are 5-8 mm in depth. Subjects having more than 2 quadrants will
      have the first 2 quadrants randomized to receive two different treatments (one quadrant root
      planing and one quadrant PSR procedure) from the group of available quadrants.

      Investigators will assess the efficacy of the Periodontal Structure Repair device (PSR) as
      measured by a reduction in pocket depth.
    

Intervention name(s): Periodontal Structure Repair (PSR); Standard Root Planing
Intervention type(s): Device; Device
Intervention description(s): Following local anesthesia, initial pocket preparation will be done by bur abrasion utilizing specially designed burs to plane the root surface and remove the inner lining of the pocket. Following bur abrasion, thin strips of gauze sponge are placed into the created space. After removing the gauze strips, PSR is inserted to fill the spaces beginning at the pocket bottom. The final step is placing a layer of cyanoacrylate on both the gingival margin and tooth supragingivally.; Ultrasonics and hand instruments are used to remove any subgingival deposits on the roots. Standard instruments and standard application are used. Visual or instrument tactile inspection is used to verify the roots are hard-smooth and have been adequately cleaned.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For each subject, one quadrant will be randomized to PSR and the other quadrant will be randomized to conventional scaling and root planing.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT
Condition: Allogeneic Hematopoietic Stem Cell Transplantation; Busulfan; Total Body Irradiation; Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient
      tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice
      between BU-based or TBI-based conditioning regimens still remains controversial. In this
      study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in
      patients undergoing allo-HSCT for ALL in CR1 are evaluated.
    

Detailed description: 
      Allo-HSCT appears to be an efficient tool to cure standard-risk ALL in CR1. The conditioning
      regimen with BUCY or TBICY is considered as the standard myeloablative regimen for ALL in
      CR1, but the choice between BU-based or TBI-based conditioning regimen still remains
      controversial.In order to analyze the impact of conditioning regimen on long-term survival
      and relapse, in this study, the safety and efficacy of BUCY and TBICY myeloablative
      conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
    

Intervention name(s): Busulfan (BU); Cyclophosphamide (CY); Total Body Irradiation (TBI)
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.; Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.; Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.
Intervention MeSH terms: Cyclophosphamide; Busulfan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tissue Sample Collection From Patients With Fanconi Anemia
Condition: Fanconi Anemia; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Fanconi Syndrome; Anemia; Fanconi Anemia
Study type: Observational

Summary: 
      RATIONALE: Collecting and storing samples of tumor tissue from patients with Fanconi anemia
      to test in the laboratory may help the study of cancer in the future.

      PURPOSE: This laboratory study is collecting and storing tumor tissue samples from patients
      with Fanconi anemia.
    

Detailed description: 
      OBJECTIVES:

        -  Acquire rare solid tumor samples from patients with Fanconi anemia in order to create a
           Fanconi Anemia Cell Repository at the Oregon Health and Science University Cancer
           Institute.

        -  Study repository tissue using a variety of molecular methods, including gene
           microarrays.

        -  Develop cancer cell lines that are publicly available from tissue archived from patients
           with Fanconi anemia.

      OUTLINE: Tumor biopsies are collected from patients with Fanconi anemia and archived for
      future molecular studies, cell line generation, and general usage by the research community
      at large. Medical information about the patient's cancer is also archived.

      PROJECTED ACCRUAL: Not specified.
    

Intervention name(s): biologic sample preservation procedure; biopsy
Intervention type(s): Other; Procedure
Intervention description(s): Once the pathologist has taken the material needed to establish diagnosis of cancer, the anonymized snap-frozen and fresh samples will be either shipped to our laboratory for analysis or will be picked up by a member of the principal investigator's lab team. Samples will be stored indefinitely.; Once the pathologist has taken the material needed to establish diagnosis of cancer, 1-10 grams of the remaining tissue should be placed in phosphate buffered saline and shipped to the Bagby Lab.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        To recruit participants into this project, an announcement will be posted on the Fanconi
        Anemia Research Fund website (http://www.fanconi.org/) after IRB approval is obtained.
      
Keywords: Fanconi anemia; unspecified adult solid tumor, protocol specific; unspecified childhood solid tumor, protocol specific
Desarda Repair Compared to Lichtenstein Repair for the Treatment of Inguinal Hernias
Condition: Postoperative Pain; Recurrence; Wound Complication
MeSH terms: Recurrence; Hernia, Inguinal
Study type: Interventional

Summary: 
      The Lichtenstein technique for hernia repair is safe and simple, but the underlying mesh
      prosthesis has its setbacks, as it acts as a mechanical barrier5. The mesh does not provide
      mobile and the physiologically dynamic posterior wall. The most dangerous complication
      associated with the mesh prosthesis is its migration from the abdominal cavity's primary
      implantation site. The relatively knew technique developed by Dr. Desarda does not utilize
      the synthetic mesh rather it uses a strip of external oblique aponeurosis to strengthen the
      posterior wall. Our study has compared the two methods regarding various aspects.
    


Intervention name(s): Desarda repair
Intervention type(s): Procedure
Intervention description(s): Desarda is a new tissue-based technique developed from applying the externally oblique muscle aponeurosis in the form of an undetached strip making the posterior wall in the inguinal canal stiffer. This paper focuses on analyzing comparisons between mesh-free Desarda repair and the Lichtenstein technique for the treatment of hernia inguinalis
Other intervention name(s): Lichtenstein repair
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 82 patients with inguinal hernias were selected randomly to participate in this study. They were subjected to either Lichtenstein hernioplasty or Desarda herniorrhaphy. A follow-up was conducted to analyze the hospital stay, return to work, recurrence rate, chronic pain, postoperative complications, and cost-effectiveness.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Desarda Repair; Comparison; Lichtenstein Repair; Randomized Controlled Trial
A Study of the Effect of BIIB023 on Muscle Atrophy in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine whether muscle atrophy induced by
      immobilization of the lower limb can be attenuated by BIIB023 in healthy male volunteers. The
      secondary objectives of this study in this study population are:

        -  To determine whether muscle weakness induced by immobilization of the lower limb can be
           attenuated by BIIB023

        -  To assess the effect of BIIB023 on the recovery of muscle mass and strength after
           immobilization

        -  To assess the effect of BIIB023 on histological markers of muscle atrophy and
           regeneration

        -  To assess the effect of BIIB023 on muscle bioenergetics based on oxidative metabolism
           recovery kinetics

        -  To evaluate the safety and tolerability of BIIB023
    


Intervention name(s): BIIB023; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intravenous (IV) infusions; Matched placebo
Other intervention name(s): (anti-TWEAK [TNF-related Weak Inducer of Apoptosis] monoclonal antibody)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Muscle Disuse Atrophy
Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients
Condition: Pre-Eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate the effects of dexmedetomidine infusion on the
      stress response to intubation, postoperative analgesia, and renal functions (urinary output
      [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient.
    


Intervention name(s): placebo infusion; Dexmedetomidine infusion
Intervention type(s): Drug; Drug
Intervention description(s): Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.; Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®)
      injections into pericranial muscles compared to placebo to prevent migraine attacks.
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring
Condition: Gestational Diabetes Mellitus; Pregnancy
MeSH terms: Diabetes, Gestational
Study type: Interventional

Summary: 
      This study includes a behavioral educational intervention that focuses on healthy eating,
      physical activity and glucose management during pregnancy and post partum among women newly
      diagnosed with gestational diabetes mellitus (GDM).
    

Detailed description: 
      This is a pilot trial in which 50 women newly diagnosed with gestational diabetes are
      randomized to either one of two groups: 1) active internet intervention or 2)Usual Care
      (Self-directed) educational intervention. The primary pregnancy outcome is change in A1C. The
      primary postpartum outcome is weight.
    

Intervention name(s): Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): Participants receive lifestyle counseling on healthy eating and physical activity through an internet based program or self-directed educational program.
Other intervention name(s): Healthy Lifestyle; Glucose Control
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gestational diabetes
Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Condition: Type 1 Diabetes Mellitus
MeSH terms: Vascular System Injuries; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This project aimed to explore novel methods of detecting small blood vessel disease in a
      paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold
      capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory
      Blood Pressure Monitoring were used. Each of these techniques investigated different areas of
      small blood vessels around the body.

      It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel
      investigations would be associated with small blood vessel disease and that widespread
      changes to these blood vessels would be detected through associations between the different
      novel investigations.
    


Intervention name(s): Video Nailfold Capillaroscopy; Ambulatory 24 hr Blood Pressure Monitoring; Fundoscopy of eyes; Laser Doppler Flowmetry
Intervention type(s): Procedure; Device; Procedure; Procedure
Intervention description(s): Single session of video Nailfold Capillaroscopy wit KKK technology; 24 hr upper arm cuff measurement of Blood Pressure; examination of microvascular health of eye with the use of opthalmoscope; Examination of vascular flow
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants were recruited from the John Hunter Children's Hospital paediatric diabetes
        clinic. They were between the ages of 8-18 years old.
      
Keywords: paediatric and adolescent population; nailfold capillaroscopy; laser Doppler flowmetry; retinal vessel calibre; retinal vessel fractal analysis; 24 hour Ambulatory Blood Pressure Monitoring
Comparison of hhCG With hCG+ß in the Early Prediction of Ongoing Pregnancy.
Condition: Pregnancy Test
Study type: Interventional

Summary: 
      Proof of concept study for the prediction of ongoing pregnancy in women undergoing In-Vitro
      Fertilization (IVF), using hyperglycosylated human chorionic gonadotropin (hhCG), early after
      In-Vitro Fertilization and fresh Embryo Transfer (IVF-ET).
    


Intervention name(s): Pregnancy test
Intervention type(s): Diagnostic Test
Intervention description(s): Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.
Intervention model: Single Group Assignment
Intervention model description: All the patients will undergo 3 blood samples for analyses to determine pregnancy.
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Elite Soccer Training on Routine Laboratory Parameters
Condition: Stress
Study type: Observational

Summary: 
      Repeated blood sampling within a regular soccer season of German first league clubs shall
      serve to define soccer-specific reference values for routine parameters determined from
      venous blood. It was hypothesized that only for a minor number of parameters common reference
      values will have to be adapted for soccer players during their competitive season.
    

Detailed description: 
      It is often difficult to discern exercise-induced changes in laboratory parameters from
      pathological changes in elite athletes during the regular training process. This is
      particularly true in soccer players who compete more often than many other athletes.
      Therefore, soccer players of the first two German soccer leagues (all professional athletes)
      are recruited for repeated blood sampling during the season (4 sampling times, one of them
      immediately before training commences in the summer, the other ones in October/November,
      February/March, and April/May). Among other standardizing requirements, it is mandatory that
      precisely one training session (not zero, not two, no competition) takes place the day before
      sampling. Several confounders for the interpretation of laboratory results are verified by
      means of a questionnaire. Phases of high competitive stress are compared with those of low
      stress. The course of the parameters as well as confidence intervals for given times during
      the season are of main interest.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        soccer players of the first two German professional soccer leagues
      
Biospecimen description: 
      iced serum samples
    
Keywords: soccer; laboratory; reference; exercise; variability; season; elite athletes; Define reference blood parameters in elite athletes