bioihbjkbjnl/mcl2 huggingface dataset:
Desidustat in the Treatment of Anemia in CKD on Dialysis Patients
Condition: Chronic Kidney Disease Stage 5 on Dialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase 3, multicenter, open-label, randomized, active-controlled study to evaluate the
      efficacy and safety of Desidustat Tablet versus Epoetin alfa Injection for the treatment of
      anemia in patients with CKD on dialysis. (DREAM-D)
    


Intervention name(s): Desidustat Oral Tablet; Epoetin Alfa
Intervention type(s): Drug; Drug
Intervention description(s): Desidustat tablet; Epoetin Injection
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and immune response to
      the DNA HIV vaccine, PENNVAX-B alone, in combination with IL-12, or with 2 different doses of
      IL-15.
    

Detailed description: 
      A vaccine that is effective against multiple strains of HIV remains the best option for
      preventing the spread of HIV. Plasmid DNA vaccines are inexpensive and easy to construct.
      When DNA vaccines are administered in combination with cytokines, such as IL-12 or IL-15, the
      immune response to the vaccine is increased. The purpose of this study is to determine the
      safety and tolerability of the DNA plasmid vaccine, PENNVAX-B when administered alone, or
      with IL-12 or IL-15 DNA adjuvants. The most effective and safe dose of IL-15 will also be
      determined during this study.

      This study will last approximately 12 months. Participants will be randomly assigned to one
      of four groups. Group 1 will receive an injection of PENNVAX-B combined with 0.8 mg IL-15 in
      each deltoid or placebo. Group 2 will receive an injection of PENNVAX-B alone or placebo.
      Group 3 will receive an injection of PENNVAX-B combined with IL-12 in each deltoid or
      placebo. Group 4 will receive PENNVAX-B combined with 2 mg IL-15 or placebo. Injections will
      occur at study entry, Months 1, 3, and 6. Additional study visits will occur on Days 14, 42,
      98, 182, 273, and 364. At these visits a brief physical, blood collection, interview, and
      risk reduction counseling will occur. At some visits HIV testing, urine collection, and
      pregnancy tests will also occur.

      As of 05/30/08, participants will be enrolled into Groups 3 and 4 at a limited pace to allow
      for additional safety reviews for the first few participants in these groups. Additionally,
      safety data will be reviewed for Groups 1 and 2 to determine whether the remainder of
      participants in Groups 2, 3, and 4 will be enrolled.
    

Intervention name(s): PennVax B; IL-12; IL-15
Intervention type(s): Biological; Biological; Biological
Intervention description(s): DNA vaccine containing the HIV genes Gag, Pol, and Env; Cytokine injection; Cytokine injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Seronegativity; DNA Plasmid Vaccine; HIV Preventive Vaccine
Descriptive Analysis: STarT Back Screening Tool: Cross-sectional Survey & Chart Review
Condition: Back Pain
MeSH terms: Back Pain
Study type: Observational

Summary: 
      Keele STarT Back SCreening Tool (KSB) is a practical and validated bio-psychosocial
      questionnaire that stratifies lower back pain patients into 3 risk groups (low, medium,
      high), with suggested treatment guidelines for each grouping. The 9-question KSB has been
      used in chiropractic practice to help guide medical decision making, but its use in
      chiropractic teaching environments has been limited.
    

Detailed description: 
      All new LBP patients between the ages of 18-65 years presenting to a chiropractic teaching
      clinic in Dallas, TX between March 05, 2018 and April 06, 2018 were asked to complete the KSB
      questionnaire. No introduction of the KSB was given to students or faculty. For all patients
      that completed the KSB, a chart review of the first 4 weeks of care was completed to retrieve
      patient follow-up information and treatment provided, including: self-reported LBP on a
      10-point numerical rating scale (NRS), region of spinal manipulation therapy (SMT), and
      active rehabilitation provided.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        New LBP patients presenting to a chiropractic teaching clinic in Dallas, TX
      
Keywords: Chiropractic; Screening tool; Teaching
One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF1 and rV Antigens)
Condition: Plague
MeSH terms: Plague
Study type: Interventional
Phase: Phase 1

Summary: 
      One hundred and five subjects will be recruited into three groups. Each subject will receive
      two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant
      antigen proteins).
    

Detailed description: 
      Plague is an infection occurring in small rodents and mammals caused by the gram-negative
      bacterium Yersinia pestis (Y. pestis). Transmission from rodent to man is usually by a flea
      vector leading to the characteristic swelling of the lymph nodes draining the region of the
      bite, followed by a septicaemic illness (classic bubonic plague). Human-to-human transmission
      can occur via droplet nuclei spread by coughing of patients with bubonic or septicaemic
      plague who have developed pulmonary lesions (pneumonic plague). However, cases of pulmonary
      transmission have also been described from household pets. In pneumonic plague symptoms of a
      respiratory infection develop first followed by an acute onset septicaemic illness. In the
      military context, the likely exposure is via the inhalation route, as a Biological Warfare
      Agent (BWA), and therefore protection against pneumonic plague is the paramount requirement.
      This is a phase 1, parallel group, single-blind study of 105 healthy adult aged 18-55,
      randomly assigned to one of the three cohorts and will receive the same dose of vaccines (2x)
      and then re-randomized at 6 months to receive either a third dose or placebo, in order to
      determine the safety and tolerability associated with different primary immunization doses of
      recombinant IM plague vaccine (rF1 and rV) antigen proteins for optimum safe dose, assess
      responses (both antibody and cell-mediated) following immunization, investigate the
      correlation between cell-mediated and antibody titers and to assess the duration of the
      immune responses to antigens following a third dose.
    

Intervention name(s): Alhydrogel; rF1 and rV protein antigens
Intervention type(s): Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: plague
Effect of Stabilization Exercises in Individuals With Non-Specific Chronic Neck Pain.
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      In this study, the effects of an 8-week telerehabilitation-based stabilization training in
      persons with chronic non-specific neck pain will be investigated.
    

Detailed description: 
      The aim of the study is to investigate the effects of different telerehabilitation-based
      stabilization exercises on gait, balance, pain, functionality and depression in individuals
      with non-specific neck pain. The population of the study will consist of 40 individuals with
      chronic neck pain, who are followed up with the diagnosis of chronic non-specific neck pain
      in the Department of Neurosurgery of Dokuz Eylul University Faculty of Medicine. The
      socio-demographic characteristics of the participants will be recorded through mutual
      interviews, 'BTS G-Walk' device for walking, 'Biodex Balance' device for balance, Neck
      Disability Index for disability assessment, Visual Analog Scale (VAS) for pain severity, the
      Beck Depression Inventory will be used for depression. All participants will walk to the
      length of a 10 m walkway and back to the start point with the BTS G-Walk (BTS Bioengineering
      S.p.A., GarbagnateMilanese, Italy), a wearable sensor device to assess spatiotemporal gait
      parameters. Individuals will walk first in a normal walking pattern and then in a fast
      walking pattern. Biodex Stability System will be used for balance measurement. The exercises
      will be taught to the participants face-to-face once in the first session, within the
      framework of social distance and hygiene rules, and then they will have exercise sessions by
      mutual videoconference method via the Zoom program for 8 weeks. Patients will be randomly
      divided into two groups. Cervical stabilization and scapular stabilization training will be
      given to the first group, and cervical stabilization and core stabilization training will be
      given to the second group. The effects of these two different telerehabilitation-based
      exercise methods will be compared.
    

Intervention name(s): Telerehabilitation-based cervical and scapular stabilization exercises; Telerehabilitation-based cervical and core stabilization exercises
Intervention type(s): Other; Other
Intervention description(s): Telerehabilitation based cervical and scapular stabilization exercises will be applied via videoconference method for 8 weeks, one day a week , 45-60 minutes for each session.; Telerehabilitation based cervical and core stabilization exercises will be applied via videoconference method for 8 weeks, one day a week , 45-60 minutes for each session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Non-Spesific Neck Pain; Telerehabilitation; Gait; Balance
Effect of Calanus Oli on Intra-abdominal Fat, Glucose Tolerance and Lipids in Man
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Preliminary studies in rats and mice indicate that calanus oil reduce accumulation of
      intra-abdominal fat. Pilot studies in humans have shown no adverse effects. In the present
      study 120 subjects, males and females, 20-65 years old, BMI 25-30 kg/m2 will be included and
      given calanus oli 1 g twice daily versus placebo for 1 year. The hypothesis is that calanus
      oil will reduce intra-abdominal fat, improve glucose tolerance and lipid profile.
    


Intervention name(s): calanus oil; olive oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 gram twice daily; 1 gram twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Pregabalin on Pain of Propofol Injection
Condition: Pain
Study type: Interventional

Summary: 
      Pain is a common side effect of propofol injection. The purpose of this study was to compare
      the efficacy of pregabalin and lidocaine in reducing propofol injection pain.
    

Detailed description: 
      In a randomized, double blind, prospective trial, 120 patients were allocated to one of three
      groups (each n=40) receiving intravenous lidocaine 40mg (group L), oral pregabalin 75 mg
      (group LP), and oral pregabalin 150 mg (group HP) as pretreatment, followed by injection of
      25% of 2 mg/kg propofol. Pain was assessed by a four point scale (0=no, 1=mild, 2=moderate,
      3=severe pain).
    

Intervention name(s): Lidocaine; Pregabalin; propofol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Lidocaine; Pregabalin; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: propofol; lidocaine; pregabalin
Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy
Condition: Macular Dystrophy, Corneal
MeSH terms: Macular Degeneration; Stargardt Disease; Corneal Dystrophies, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP,
      fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if
      4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these
      processes, individuals with Stargardt disease may have better chances of saving their
      remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved
      for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by
      shutting down the body's ability to process alcohols. This medication has an excellent safety
      profile and has been reported to have no short-term or long-term side effects, as long as
      patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP
      remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your
      eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment
      to save Stargardt patients' vision, and may also have similar effects in other macular
      degenerative diseases.
    


Intervention name(s): 4-Methylpyrazole; saline
Intervention type(s): Drug; Other
Intervention description(s): 15 mg/kg dose
Intervention MeSH terms: Fomepizole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dark adaptation inhibition; Stargardt macular dystrophy; 4-Methylpyrazole (4-MP); Antizol; Fomepizole
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam
Condition: Prostate Cancer Screening
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      1. Does a one-page American College of Physicians educational flyer about the pros and cons
           of prostate cancer screening sent to men within two weeks of their scheduled annual
           health examinations in a general medicine clinic result in a different rate of prostate
           cancer screening than among men who were not sent the flyer?

        2. Do patients find the flyer useful and understandable?

      Context: The use of prostate specific antigen (PSA) screening for prostate cancer is
      controversial because of a lack of evidence that such screening saves lives when applied
      within a population and because such testing can lead to invasive downstream biopsies and
      aggressive treatment that is associated with a high risk of permanent side effects (e.g.
      impotence, incontinence). Almost all professional societies (American Cancer Society,
      American Urologic Association, American College of Physicians, United States Preventive
      Services Task Force) advocate that patients receive education and complete an informed
      decision-making discussion with their medical providers about the pros and cons of the PSA
      test, as well as their personal preferences, before proceeding with this test. Unfortunately,
      despite these recommendations, there is seldom sufficient time during clinic visits to
      achieve this goal.
    


Intervention name(s): PSA flyer
Intervention type(s): Other
Intervention description(s): A mailed low-literacy informational patient flyer about the PSA test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Prostate Cancer Screening; Pragmatic Trial; Health Literacy
N-3 PUFA and Rheumatoid Arthritis in Korea
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of this study is to see if supplementation of n-3 polyunsaturated fatty acid
      (PUFA) can be beneficial for the patients with rheumatoid arthritis.
    


Intervention name(s): Omega-3 fatty acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid; 5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
Other intervention name(s): Ropufa 75 n-3, DSM Nutritional products, Switzerland
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: n-3 PUFA; rheumatoid arthritis; inflammation; eicosanoids; bone turnover markers
Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
Condition: Miscarriage, Recurrent; Abortion, Habitual
MeSH terms: Abortion, Spontaneous; Abortion, Habitual; Recurrence
Study type: Interventional

Summary: 
      Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are
      trying to establish a family. This clinical study will evaluate the effectiveness of
      intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from
      secondary recurrent miscarriage. This study will help in providing an answer to the question
      of whether IVIG is helpful in secondary recurrent miscarriage.
    

Detailed description: 
      The purpose of this multi-center trial is to evaluate the efficacy of IVIG in improving the
      ongoing pregnancy (>20 weeks of gestation) rate in couples with unexplained secondary
      recurrent miscarriage, and; to characterize and compare pharmacokinetic and pharmacodynamic
      parameters for IVIG pre-conceptually and in the 1st and 2nd trimesters of pregnancy, so that
      an improved IVIG dosing strategy can be determined.
    

Intervention name(s): Gamimune N or Gamunex 10%; normal saline
Intervention type(s): Biological; Other
Intervention description(s): 500 mg/kg administered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.; equivalent volume of normal saline
Other intervention name(s): Immune Globulin Intravenous (Human), 10%, IGIV-C, 10%
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Recurrent miscarriage; Recurrent spontaneous abortion; Habitual abortion; IVIG; Randomized Controlled Trial
Pain Perception by the Chronic Renal Patient at the Time of Vascular Access Cannulation.
Condition: Renal Dialysis
Study type: Interventional

Summary: 
      Pain in patients under hemodialysis affects chronic renal patients' quality of life.
      Distraction has been effective in controlling pain induced by the insertion of needles. Once
      applied adequately, distraction promotes endorphins' release, with efficacy in acute pain.
      This study aims to evaluate pain perception while puncturing the hemodialysis device using an
      anti-stress ball as a distraction strategy.
    


Intervention name(s): Distraction technique
Intervention type(s): Behavioral
Intervention description(s): Distribution of an anti-stress ball before the moment of cannulation of the vascular access and instructing to place it in hand opposite the limb of the vascular access
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Arteriovenous Fistula; Renal Insufficiency Chronic; Quality of Life; Distraction
Study to Compare 2 Formulations of LY900014 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves a comparison of 2 formulations of LY900014, which is a type of fast acting
      insulin. Study participants will be administered LY900014 U-100 two times and LY900014 U-200
      two times, over 4 study periods, by injection under the skin. Blood samples will be taken to
      compare how the body handles the study drugs and how they affect the blood sugar levels. Side
      effects and tolerability will be documented. The study will last about 4 weeks, not including
      screening and follow up. Screening is required within 28 days prior to the start of the study
      and follow up is required at least 2 weeks after the last dose of study drug.
    


Intervention name(s): LY900014 U-200; LY900014 U-100
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; Ultra-Rapid Lispro
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Whole-body Vibration Versus Aerobic Exercise on the Inflammatory Status and Hormonal Parameters Premenstrual Syndrome
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate and compare the effect of whole-body vibration to
      aerobic exercise on inflammatory status in females with premenstrual syndrome.
    

Detailed description: 
      Premenstrual syndrome (PMS) is a complex disorder characterized by moderate to severe
      symptoms taking place during the luteal phase of the menstrual cycle. It has a negative
      impact on females' lives, which can affect their relationships, educational efficiency,
      social activities, and quality of life. Despite previous studies reported that physical
      exercise improves the symptoms of PMS, the effects of physical exercise on inflammatory
      status in females with PMS are not clear yet. sixty females allocated to three groups
      randomly to group (A) that will receive whole-body vibration+supplementation, group (B) that
      will receive aerobic exercises+supplementation, and group c that will receive supplementation
      only
    

Intervention name(s): whole body vibration; aerobic exercise; supplementation
Intervention type(s): Other; Other; Other
Intervention description(s): All participants in the WBV group will perform the WBV training on a vibrating device (Confidence Vibration Plate Power Plus, China), which produces a lateral peak-to-peak oscillation. They will stand on the WBV platform with a 150° knee angle during the exposure minute. They started the training with three sets of 1 min separated by a 1-min resting period and vibration amplitude of 1 mm. They will add one set every session until they performed 10 sets of WBV. The frequency started at 20 Hz, which will be increased gradually by 2 Hz every 2 weeks +magnesium (Mg) (250 g) and vitamin B6 supplementation; the subjects will receive aerobic exercises+ magnesium (Mg) (250 g) and vitamin B6 supplementation; the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: whole-body vibration and aerobic exercise
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: whole body vibration; aerobic exercises; premenstrual syndrome