bioihbjkbjnl/mcl2 huggingface dataset:
Transfusion of Biotinylated Red Blood Cells
Condition: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research is to study how red blood cells (RBCs) survive in a person's
      circulation, and how that survival may be different in red blood cells that are donated and
      stored prior to being transfused. Investigators will study this by collecting blood samples
      from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will
      then be re-infused back into the participant and blood samples will be taken weekly for 10
      weeks to assess the number of labeled cells in the samples.
    

Detailed description: 
      The purpose of this research is to study how red blood cells (RBCs) survive in a person's
      circulation, and how that survival may be different in red blood cells that are donated and
      stored prior to being transfused.

      In this study, blood is collected from healthy subjects, processed into packed red blood cell
      units, and either immediately afterwards or 40-42 days later the packed red blood cells are
      labeled with biotin. The biotin-labeled red blood cells are then re-infused back to the donor
      (autologous transfusion). Blood samples are then taken from the subject every week for up to
      70 days (10 weeks) to track survival of the labeled red blood cells.

      This study also seeks to demonstrate that biotin-labeled RBCs can be safely transfused back
      to autologous subjects without any adverse reactions. All participants will be followed to
      watch for the development of antibodies against biotin-labeled RBCs.
    

Intervention name(s): Biotin-Labeled Red Blood Cells (RBCs)
Intervention type(s): Drug
Intervention description(s): 500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit.
For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection.
For participants 3 through 8, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant.
Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs.
Intervention MeSH terms: Biotin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Red Blood Cell (RBC) transfusion; Biotin labeled red blood cells
Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
Condition: Drug-refractory Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to assess whether left atrial roof ablation adds any benefit
      in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.
    


Intervention name(s): Pulmonary vein encircling; Pulmonary vein encircling plus roof ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum; Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physical Activity and Glycemic Control
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This study will test the effects of daily physical activity on variations in blood glucose
      control.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): walking/running/cycling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy Study of Mix Vaccine in Prostate Carcinoma Patient
Condition: Prostatic Neoplasms
MeSH terms: Carcinoma; Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).
      Enrolled patients will receive standard treatment according to National Comprehensive Cancer
      Network (NCCN) guide line with or without combining MV injection. The efficacy and side
      effect will be compared between the two groups.
    

Detailed description: 
      In the study, after evaluation of the general and physical status, eligible patients will be
      enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients
      will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN)
      guide line (control group) and in experimental arm, patients will be receiving simultaneous
      standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease
      progression.

      Blood sample will be obtained at baseline and every week before MV injection for the
      assessment of clinical hematology, biochemistry measurements and immunology index (including
      immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout
      the study. Side effect, progression free survival, immunology index and general status will
      be recorded.
    

Intervention name(s): MV; standard treatment
Intervention type(s): Biological; Other
Intervention description(s): MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for; Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mix vaccine, prostate carcinoma, immunotherapy
Effectiveness of Self-Help for Dually-Diagnosed Persons - 1
Condition: Dual Diagnosis; Substance-Related Disorders; Mental Disorders
MeSH terms: Substance-Related Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of adding dual focus 12-step
      self-help groups to standard treatment to improve behavioral outcomes for patients dually
      diagnosed with substance abuse and psychiatric disorders.
    


Intervention name(s): Double Trouble in Recovery; Standard psychiatric day treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Dual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment; Individual counseling, groups, medication
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 12 step groups; self help; psychiatric day treatment; co-occurring disorders; dual diagnosis
A Study to Determine the Bioequivalence of Two Doses of Tafamidis
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to characterize the bioequivalence of a 12.2 mg free acid tablets compared to
      commercial supply (tafamidis meglumine soft gelatin 20 mg capsule) in healthy participants
      under fasted conditions.
    


Intervention name(s): Tafamidis free acid tablet; Tafamidis meglumine capsule
Intervention type(s): Drug; Drug
Intervention description(s): 12.2 mg tafamidis free acid tablet; 20 mg tafamidis meglumine soft gelatin capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Tablet Size on Cognitive Performance Caffeine
Condition: Placebo Effect
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to assess if tablet size, due to placebo effect, alters participants'
      performance on cognitive tests after consuming caffeine. Participants will be randomly
      assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no
      caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no
      caffeine with the large sucrose pillule.
    

Detailed description: 
      Background: A capsule's physical design (e.g. shape, size, and color) affects individuals'
      perception of drug efficacy; that is, how well a drug is likely to work. The goal of this
      study is to assess the effects tablet size may have on participant's performance on cognitive
      testing since research has found differences between preparation methods. Method: 120
      participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm
      diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine
      with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule. Participants will
      consume the designated placebo tablet with water (caffeinated or non-caffeinated); then,
      participants will provide weekly caffeine intake and complete the neutral portion of Velten's
      Mood Induction Procedure until 30 minutes have passed to allow for caffeine activation.
      Participants will complete the Stroop test, Trial Making Tests A and B, and the Rey Auditory
      Verbal Learning Test. Previous literature, as far as the author knows, relied on evaluating
      drug efficacy based on appearance alone. This study aims to assess if tablet size, due to
      placebo effect, alters participants' performance on cognitive tests after consuming caffeine.
    

Intervention name(s): Caffeine Anhydrous with small sucrose pill; Placebo - large sucrose pill; Caffeine Anhydrous with large sucrose pill; Placebo - small sucrose pill
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 1 mm sucrose pillule; sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups; caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 5 mm sucrose pillule; sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups
Other intervention name(s): pure caffeine powder; sugar pill; pure caffeine powder; sugar pill
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of four groups:
1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule.
Masking: Single (Participant)
Primary purpose: Basic Science
Flu Vaccination in Congestive Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      We evaluated the preventive impact of vaccination on subsequent death events in 117 severe
      congestive heart patients requiring ventilator support without endotracheal intubations and
      aggressive medical therapy.

      They were randomly allocated in a single-blind manner as a unique intramuscular influenza
      vaccination or as controls.

      The first primary outcome evaluated at 6 months follow-up - cardiovascular death - occurred
      in 3% of the patients in the vaccine group Vs 17% in controls (p=0.022). The composite end
      point occurred in 33% of the patients in the vaccine group Vs 74% in control group, p =
      <0.001.
    

Detailed description: 
      Background: Recent reports detected that one of the barriers that vaccination against
      influenza infection is that, physicians do not strongly recommend its applications to
      cardiovascular patients at risk. We evaluated the preventive impact of vaccination against
      death in severe congestive heart failure hospitalized patients.

      Methods and Results: A total of 117 severe congestive heart failure patients (New York Heart
      Association class III and IV) admitted in the first 12 hours who required ventilator support
      without endotracheal intubations and high doses of loop-diuretics, were included in a
      prospective, multicenter log, during the winter season. Congestive heart patients received
      intravenous vasodilators and loop-diuretics plus standard therapies, and then were randomly
      allocated in a single-blind manner as a unique intramuscular influenza vaccination or as
      controls. Death, and combined end points (death, and re-hospitalization for any reason) were
      assessed at 6 months follow-up.

      The first primary outcome - cardiovascular death - occurred in 3% of the patients in the
      vaccine group Vs 17% in controls (odds ratio with vaccine as compared with controls: 0.16; 95
      percent confidence interval, 0.33 to 0.79; p=0.022). The composite end point occurred in 33%
      of the patients in the vaccine group Vs 74% in controls, p = <0.001. The need of adding
      inotropic drugs occurred in 8% of patients receiving vaccination, and in 12.5% in the control
      group.
    

Intervention name(s): Flu Vaccine; Conventional medical therapy for heart failure
Intervention type(s): Biological; Other
Intervention description(s): Single dose of Flu vaccine by year (1); According with the international guidelines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Heart failure,; infection,; immune system,; atherosclerosis
Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of MT-5199 administered once
      daily for the treatment of Tardive Dyskinesia (TD) symptoms.
    


Intervention name(s): MT-5199; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MT-5199 40 mg capsules; MT-5199 placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
18615 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987704)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number: X71-109)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adductor Canal Block In Anterior Cruciate Ligament (ACL) Repair
Condition: Neuromuscular Block
Study type: Interventional

Summary: 
      Adductor canal block will provide adequate analgesia to patients undergoing arthroscopic ACL
      reconstruction surgery, yet result in less motor blockade than a femoral block.
    

Detailed description: 
      This study is designed to demonstrate that postoperative analgesia produced by the adductor
      canal block is not inferior to that produced by femoral nerve block in patients undergoing
      arthroscopic ACL reconstruction surgery. The study will also compare the degree of motor
      blockade of the adductor canal block to that of the femoral nerve block.
    

Intervention name(s): Adductor Canal Block; Femoral Nerve Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Examination of the adductor canal using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin in the medial upper-thigh region. The ultrasound probe will be moved either cephalad or caudad from its initial position in order to visualize the femoral artery immediately deep to the middle of the sartorius muscle. This point will then be selected as the appropriate level for needle insertion. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.; Examination of the femoral nerve using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin at the level of the femoral crease. The femoral artery will be identified and the femoral nerve will then be located immediately lateral to the artery, deep to the fascia iliaca and superficial to the iliopsoas muscle. The needle will be positioned next to the femoral nerve. Following this 20 ml of 0.25% bupivacaine with epinephrine will be injected incrementally over a 1 to 2 minute period. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor canal block; Femoral Nerve Block
Relationship Between Analgesia Techniques and Post-cesarean Recovery Quality
Condition: Quality of Recovery; Cesarean Section
Study type: Observational

Summary: 
      The question remains whether the patients in whom USG-guided regional anesthesia and
      analgesia techniques are applied have a better recovery score than subarachnoid morphine
      administration, which is considered the gold standard. The primary aim of this study is to
      evaluate the quality of recovery score using the Obstetric Recovery Quality Score-ObsQoR-10
      questionnaire experienced by the patients who underwent elective cesarean section and compare
      the results of different regional anesthesia techniques with subarachnoid morphine.
    

Detailed description: 
      National and international guidelines, hospital protocols, the anesthesiologist's experience,
      and the patient's decision play a role in selecting the technique used for postoperative
      analgesia after cesarean section. The quality of recovery score experienced following
      elective cesarean section in a total of 180 patients over one year (December 31, 2021-2022)
      who applied subarachnoid morphine, lateral TAP block, posterior-TAP block, QL block, ESP
      block, and TFD block (30 patients for each technique) will be evaluated with the ObsQoR-10
      questionnaire 24 hours after delivery. The regional anesthesia techniques information applied
      to the patients will be obtained from the patient file. Researchers will not perform any
      interventional procedure, and any randomization will not be applied. After the data
      collection process for the study is completed, ObsQoR-10 will be compared statistically. The
      secondary aims of this study are to compare the cases in terms of postoperative analgesia and
      antiemetic requirements, first food intake and standing up without support, and patient
      satisfaction.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Term obstetric patients who underwent elective cesarean section under spinal anesthesia
      
Keywords: Quality of recovery; ObsQoR-10; regional analgesia
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to look at how best to start and then gradually intensify (as needed)
      the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.
    


Intervention name(s): Insulin Glargine; Insulin Lispro Premix (mid-mixture and low-mixture)
Intervention type(s): Drug; Drug
Intervention description(s): patient glucose-level dependent, injection, as needed per patient glucose level, 48 weeks; patient glucose level dependent, injection, as needed per patient glucose level, 48 weeks
Other intervention name(s): LY275585
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Analysis of Long Term Risk of Coronavirus Disease-19 Emergency
Condition: Lifestyle; Dietary Habits; Psychosocial Problem
Study type: Observational

Summary: 
      The aim of this study is to investigate dietary, lifestyle and psychosocial changes possibly
      occurred during Italy's lockdown, that is in the period of time between March 9 2020 and May
      3 2020 (hereafter referred to as the Phase 1 lockdown) in two different populations: the
      Moli-sani Study cohort and the Italian general population.
    

Detailed description: 
      The containment measures released by the Italian Government for the period between March 9-
      May 3 2020 have been aimed to reduce the movement of people from their homes, which was only
      allowed in cases of special need, and the use of smart work (working from home) wherever
      possible .As a consequence, the lockdown period is likely to have lasting effects on people
      and their lifestyles, especially nutrition, and psychosocial well-being.

      A web-based questionnaire was developed to retrospectively investigate dietary, lifestyle and
      psychosocial changes possibly occurred during Italy's lockdown, that is in the period of time
      between March 9 2020 and May 3 2020 (hereafter referred to as the Phase 1 lockdown).

      The potential impact of Phase 1 lockdown on lifestyles will be tested in two distinct
      population cohorts, that is the Moli-sani Study cohort (established among residents in the
      Molise region in the period 2005-2010) and a sample of the general Italian population, aged ≥
      18 years.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Moli-sani Study sub-cohort A sample of 2,500 men and women from the Moli-sani Study cohort
        (2005-2010) who were re-examined in 2017-2020. Participants will be contacted by telephone
        by researchers of the Moli-sani Study recruitment team in order to collect dietary,
        lifestyle and psychosocial information and assess potential changes possibly occurred
        during Phase 1 lockdown. This project will be hereafter referred to as Moli-LOCK Study.

        Italian general population The project will retrospectively collect data through a
        web-based survey using Google form. The questionnaire consists of the same items used in
        the Moli-LOCK Study. The investigators aim at including as many subjects' records as
        possible. This project will be hereafter referred to as ALT RISCOVID-19.
      
Keywords: pandemic; lockdown; lifestyles; dietary habits; psychosocial factors