bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness of Expressive Writing on a Sample of New Mothers
Condition: Maternal Distress; Health Care Utilization
Study type: Interventional

Summary: 
      This pilot study aims to evaluate the effects of an expressive writing intervention on a
      sample of new mothers after the childbirth on the psychological health and on the healthcare
      costs. The mothers were evaluated also in a follow-up one month after the end of the
      expressive writing intervention.
    

Detailed description: 
      Women are recruited starting from the sixth month of pregnancy; forty-one eventually agreed
      to participate and they were randomly assigned to two groups: an Experimental group (treated
      with the expressive writing task, one weeks-three months after childbirth) and a Control
      group (no intervention).

      Psychological health is measured at three stages:

      before intervention, at 8-9 months pregnant (T0); after intervention, from 1 week to 3 months
      after delivery (T1); and a follow-up after 1 to 3 months (T2). The assessment protocol
      consists of the Attachment Style Questionnaire (ASQ), the Prenatal Attachment Inventory
      (PAI), the Toronto Alexythimia Scale-20 (TAS-20), the Beck Depression Inventory (BDI-13), the
      State-Trait Anxiety Inventory (STAI-Y), the Rating Scale For Rapid Stress Assessment (VRS)
      and the 12-Item Short Form Survey (SF-12). The healthcare costs are collected at baseline
      (T0) and follow-up (T2) with a survey created ad hoc, in which participants reported the
      number and the type of the medical examinations, hospitalisations, prescribed drugs etc.
      Social and personal data are collected from the first survey.
    

Intervention name(s): Expressive Writing tecnique; Neutral Writing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Expressive Writing (EW), is a simple, potentially inexpensive, therapeutic intervention which involves writing daily for 15-20 min over 3-4 consecutive days. EW can be completed at home without the need for facilitation, a specialist therapist or a dedicated facility.; Participants were asked to write on neutral objects or events.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Serum Folic Acid Levels in Preterm Infants
Condition: Very Low Birth Weight Baby
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      Therefore preterm infants must need folic acid replacement than term babies.
    

Detailed description: 
      All babies need to different vitamin supplementation. Especially preterm infants need some
      vitamin supplements. Folic acid is very important structure of part of cell growing.ın
      theorically; preterm infants have very rapid cell reproduction capacity than term infants.
      Therefore preterm infants must need folic acid replacement than term babies. The
      investigators want to determine preterm infants folic acid levels due to gestational age
      whether needs folic acid replacement.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Extremely low birth weight, Very low birth weight, Low birth weight
      
Keywords: Folic acid replacement; Folic acid; Preterm neonate
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
Condition: Surgical Wound
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva
      Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and
      providing reduced times to ambulation (TTA) compared with manual compression at the
      completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
    

Detailed description: 
      A prospective, randomized, controlled multi-center clinical trial designed to evaluate the
      safety and effectiveness of the study device in sealing multiple femoral venous access sites
      and providing reduced times to ambulation compared with manual compression at the completion
      of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.

      Only patients with multiple access sites will be enrolled in order to support the desired
      indication. Randomization will be stratified to account for patients with varying numbers of
      access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control
      arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4
      access sites/patient.
    

Intervention name(s): Cardiva Mid-Bore VVCS; Manual compression
Intervention type(s): Device; Other
Intervention description(s): The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.; Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomized in 1:1 fashion to either Cardiva Mid-Bore Venous Vascular Closure Device (VVCD) or manual compression for multiple venous access site hemostasis
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: vessel closure; venous access site; femoral venotomy; medium bore; multiple access sites
Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Kidney Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The Phase 1b study is a multi-center trial designed to test the safety, tolerability,
      biologic activity of escalating doses of FG-3019 in up to 20 patients with type 1 or type 2
      diabetes and microalbuminuria (early-stage kidney disease). Patients will receive either 3 or
      10 mg/kg of FG-3019 administered every two weeks as an infusion for a total of four doses.
      The ability of FG-3019 to reduce the excretion of protein in the urine is being measured as a
      secondary endpoint.
    


Intervention name(s): FG-3019
Intervention type(s): Drug
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Incipient Nephropathy; Type 1 or Type 2 Diabetes
Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the mass balance recovery and metabolite profile, and will identify
      metabolite structures following a single oral dose of [14C]-CORT113176 in healthy male
      participants.
    


Intervention name(s): [14C]-CORT113176
Intervention type(s): Drug
Intervention description(s): [14C]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Differences in Evoked Intracellular Interferon Signaling Pathways Using Single Cell Phosphoprotein Profiling
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose:

      The purpose of this exploratory study is to evaluate phosphoprotein profiling to determine
      differences in the intracellular actions of interferon or interferon stimulated genes among
      people with different treatment outcomes to interferon based therapy for hepatitis C (HCV).
      Participants: Patients with genotype 1 HCV who have had interferon based therapy at the
      University of North Carolina (UNC). Procedures: Thirty patients with varied responses to
      treatment will be given a single subcutaneous injection of interferon alpha 2b. Prior to the
      injection and at 30 minutes, 1,2,4,6,12 and 20 hours after injection, blood will be drawn for
      analysis of phosphoprotein profiling and changes in serum cytokines.
    


Intervention name(s): Interferon Alfa-2b
Intervention type(s): Drug
Intervention description(s): Patients will receive a single dose of interferon followed by serial blood draws to assess cellular responses to interferon
Other intervention name(s): Intron A
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Single-Dose Safety Study of APD791 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791
      when administered as a single oral dose to healthy adult subjects.
    


Intervention name(s): APD791
Intervention type(s): Drug
Intervention MeSH terms: APD791
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy adult volunteers
Elderly Patients With Acute Myeloid Leukemia (AML), Maintenance Phase After Complete Remission (CR)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of a
      Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit
      Patients With Poor Prognosis Acute Myeloid Leukemia (AML).

      The disease-free survival (DFS) of the patients included in this study will be compared to
      the ones of the two previously reported groups of patients treated with the same LIA
      induction therapy
    

Detailed description: 
      -  The primary objective of this study will be to improve the DFS with an alternate schema
           combining azacitidine and lenalidomide in elderly fit patients with previously untreated
           AML and with high risk cytogenetics or secondary AML, who achieved either a complete
           remission after an LIA induction therapy

        -  The secondary objectives will be to determine the relapse incidence, overall survival,
           event free survival at 1 and 2 years of follow-up, toxicities of the treatment,
           incidence of infectious events.

        -  To define a gene expression and promoter methylation signatures associated with CR and
           absence of relapse when patients received azacitidine and lenalidomide. Gene promoter
           methylation and gene expression profiling will be performed at diagnosis, at CR, and
           after 2 courses of azacitidine and lenalidomide in order to give insight within the
           mechanisms involved by the use of these 2 drugs and to identify new epigenetic
           prognostic markers.
    

Intervention name(s): azacitidine; Lenalidomide
Intervention type(s): Drug; Drug
Intervention description(s): azacitidine sc 75 mg/m²/d (d1- d7); lenalidomide 10mg/d (d1- d21)
Other intervention name(s): vidaza®; revlimid®
Intervention MeSH terms: Lenalidomide; Azacitidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maintenance treatment; Disease free survival
Open-Label Study to Evaluate the Safety and Efficacy of a Low-Dose 28-Day Oral Contraceptive
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, single treatment study. All subjects will receive 6 months of oral
      contraceptive therapy with DR-1021. Study participants will receive physical and
      gynecological exams, including Pap smear. During the study, all participants will be required
      to complete a diary.
    

Detailed description: 
      The overall study duration for each patient will be approximately 8 months, which includes a
      screening period of approximately 4 weeks; a treatment period of approximately six months
      (six,28-day cycles); and a follow-up visit approximately 4 weeks after completion of study
      drug.
    

Intervention name(s): DR-1021
Intervention type(s): Drug
Intervention description(s): 1 tablet daily
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy prevention; oral contraceptives
The Effects of Attentional Filter Training on Working Memory
Condition: Cognitive Decline; Healthy; Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The investigators are interested in how attentional filter training/ distractor inhibition
      training could influence cognitive functions like working memory, executive control, problem
      solving, decision making and attentional control.
    

Detailed description: 
      Two different computer based trainings were applied: an attentional filter training and a
      working memory training.
    

Intervention name(s): filter training; memory training; no training (control)
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): one-week filter training on the computer: computerized visual change detection experiment (selective attention ); one-week storage training on the computer: computerized visual change detection experiment (memory storage); no training applied
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: training intervention; filter training; distractor inhibition
Optimized Loading Response by JOURNEY II BCS Knee Increases Daily Physical Activity and Functions
Condition: Knee Injuries
MeSH terms: Knee Injuries
Study type: Observational

Summary: 
      Smith & Nephew's first edition of the Journey posterior stabilizing total knee arthroplasty
      was analyzed by the Center for Musculoskeletal Research in a past research study, and it was
      determined that subjects experienced more normal-like kinematic patterns. They also achieved
      excessive axial rotation and a decrease in weight-bearing knee flexion. Since Smith & Nephew
      has made modifications to the Journey bi-cruciate stabilizing (BCS) total knee arthroplasty
      (TKA) design, researchers will again evaluate the kinematics of subjects implanted with the
      revised design to determine if subjects experience normal-like kinematic patterns and if
      greater weight-bearing knee flexion is achieved. The objective for this study is to analyze
      the in vivo kinematics for subjects implanted with a 2nd generation Journey BCS TKA and
      compare those patterns to subjects having a normal knee and those having the 1st generation
      Journey posterior stabilizing (PS) TKA that were analyzed in the previous study.
    


Intervention name(s): Journey II BCS TKA
Intervention type(s): Device
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) implanted
        by Dr. Harold E. Cates or subjects with a healthy knee
Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
Condition: Gingival Inflammation
MeSH terms: Gingivitis; Inflammation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME,
      topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by
      the incidence of adverse events, including mucosal inflammation and irritancy and findings
      from safety labs. Subjects will be monitored for development of periodontitis, and oral flora
      will be analyzed to detect an increase in opportunistic organisms.

      The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring
      changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP)
      and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF).

      The study comprises three groups in a randomized, placebo-controlled double-blind clinical
      trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group
      will each include 50 subjects. The no-rinse control group will consist of 25 subjects.
      Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or
      placebo) to be applied once daily after morning teeth brushing. Safety parameters will be
      assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will be
      assessed before and after 14 and 28 days of treatment.
    


Intervention name(s): BLXA4; Placebo oral rinse
Intervention type(s): Drug; Drug
Intervention description(s): BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.; The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety and efficacy of BLXA4
Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation
      receiving multimodal analgesia in day-case surgery setting.

      Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom
      Cleft Lift operation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing Bascom Cleft Lift operation in a day-case surgery setting
      
Keywords: Postoperative pain; Multimodal analgesia; Bascom Cleft Lift; Day-case.
Titrated Quantitative Conjunctival Provocation Test (tqCPT)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      The clinical relevance of an allergen-specific sensitization is proven e.g., by allergen
      challenge tests in clinical routine. Several protocols for different challenge tests such as
      nasal (NPT), bronchial (BPT) or conjunctival provocation test (CPT) have been proposed.
      Beneath others, the CPT is broadly used in both clinical trials and routine because of its
      feasibility.

      However, there is no internationally harmonized standard regarding the clinical
      interpretation of CPT results as well as a lack of validation of a specific outcome score.
      Therefore, this trial aims to investigate and validate a new scoring system for CPT results
      in order to provide this test as a useful method in future clinical trials.
    

Detailed description: 
      Of 33 patients who had been initially screened, ten patients did not fulfill all of the
      inclusion criteria mentioned hereafter. Thus, 23 patients aged 18 to 67 years having a birch
      and/or grass pollen allergy were included in the analysis. The study is in line with the
      Declaration of Helsinki and is approved by the responsible ethics committee (FF 118/2012 (4
      December 2012); Landesärztekammer Hessen, Frankfurt, Germany). All participating patients are
      informed of the nature and objectives of the study and signed an informed consent document.

      The CPT is conducted using standardized and registered allergen extracts (ALK- Abelló,
      Hørsholm, Denmark). At the first visit, a titrated quantitative CPT (tqCPT) is performed
      according to a standardized protocol. In case of a positive test result, CPT-results are to
      be confirmed at a re-challenge one week later. The final CPT takes place 3 to 4 weeks after
      the 2nd (confirmatory) challenge for analyzing the primary objective of the trial:
      reproducibility of the CPT symptom score. Furthermore, objective evaluation of the clinical
      reactions after the tqCPT is documented using a MATLAB software program to calculate the
      degree of redness in percent. This is then correlated with the (subjective) main
      investigators' evaluations and with the external observer's evaluations.
    

Intervention name(s): (diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml
Intervention type(s): Other
Intervention description(s): see information in "arm/group descriptions"
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: titrated quantitative conjunctival provocation test
Safety and Efficacy of CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy to Treat Refractory Viral Keratitis
Condition: Viral Keratitis; Blindness Eye; Herpes Simplex Virus Infection; Cornea
MeSH terms: Herpes Simplex; Blindness; Keratitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and efficacy of a single
      escalating doses of BD111 CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy administered
      via corneal injection in participants with refractory herpetic viral keratitis.
    

Detailed description: 
      This is an open-label, single ascending dose study of BD111 in adult (ages 18 to 70)
      participants with refractory herpetic viral keratitis. Approximately 6 participants will be
      enrolled.BD111 is a novel gene editing product designed to clear Herpes simplex virus type I
      (HSV-1) that results in herpetic stromal keratitis in both acute and recurrent infection
      models which is the leading factor for infectious blindness.

      The follow-up period was 360 days, and the patients will be followed up 3±1 days, 7±2 days,
      30±7 days, 90±14 days, 180±21 days, and 360+31 days after treatment.
    

Intervention name(s): BD111 Adult single group Dose
Intervention type(s): Drug
Intervention description(s): 3-6 Participants will receive a single group dose administered via corneal injection in the study eye.
Intervention model: Single Group Assignment
Intervention model description: Single group target value: Since there is no similar products approved on the market and there is no similar comparative treatment methods, the single group target value method is adopted
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Herpes simplex virus type 1 (HSV-1); CRISPR/Cas9 mRNA; instantaneous gene editing