bioihbjkbjnl/mcl2 huggingface dataset:
A Leukapheresis Study for Immune Responses in Healthy US Adults Who Receive BCG Vaccination Followed by Boosting With AERAS-402
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy adults received BCG on Study Day -84, followed by randomization on Study Day 0 to
      receive 2 booster doses in a blinded fashion of either AERAS-402 (N=9) or placebo (N=2) on
      Study Days 0 and 28. Subjects were followed for a total of 98 days.
    

Detailed description: 
      This was a double-blind, randomized, placebo-controlled study. At least 13, but no more than
      16, subjects who met all eligibility criteria were to receive a prime vaccination with BCG
      (1-8 x 105 colony forming units [CFU] intradermally [ID]) at Study Day -84. Thirteen of the
      BCG-vaccinated subjects who completed all protocol-specified procedures and continued to meet
      eligibility criteria were to be enrolled and randomized on Study Day 0 in a 10:3 ratio to
      receive study vaccine (either AERAS-402 3 x 1010 virus particles [vp] intramuscularly [IM] or
      placebo IM) at Study Days 0 and 28, based on time of completion of screening. Eleven subjects
      were randomized (N=9 AERAS-402; N=2 placebo) and analyzed. Enrollment was stopped when 11 of
      the planned 13 subjects had been randomized, as it was felt that this number of subjects was
      sufficient to address the objectives of the study.
    

Intervention name(s): AERAS-402; Placebo; BCG (1-8 x105 cfu ID)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4).; Identical buffer solution in which AERAS-402 is formulated.; BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of Posterior Capsule Opacification in Eyes With Diabetes Mellitus
Condition: Development of Posterior Capsule Opacification
MeSH terms: Capsule Opacification; Diabetes Mellitus
Study type: Observational

Summary: 
      To compare the development of posterior capsule opacification (PCO) between eyes with and
      without a history of diabetes mellitus (DM) after single-piece hydrophobic acrylic
      intraocular lens (IOL) implantation 4 years postoperatively.Diabetes mellitus would not
      increase the incidence of PCO at 4 years.
    

Detailed description: 
      There is a paucity of available literature that prospectively evaluates the development of
      PCO with the single-piece hydrophobic acrylic IOL implantation in diabetic versus
      non-diabetic eyes on a long-term basis. Therefore, this study was designed to compare the
      degree of PCO after cataract surgery between diabetic and age-matched non-diabetic patients.
      This prospective, observational case control study comprised patients who underwent
      phacoemulsification .The patients were asked to return for postoperative follow-up visits at
      1 month, 1 year and 4 years.

      the digital images were analyzed for PCO .
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients who underwent phacoemulsification for age-related cataract
      
Keywords: Diabetes,posterior capsule opacification,case control study
Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain
Condition: Exercise
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purposes of this study are to compare the effects of core stabilization exercises on pain
      intensity, functional disability and lumbar stability between using and not using the Swiss
      ball in patients with non-specific chronic low back pain.
    

Detailed description: 
      For Patient Registries:

      The participant was screened for inclusion criteria and was asked to sign the informed
      consent prior to participate. A randomized control trial was performed with participants
      randomly divided into one of the two treatment groups: core stabilization exercise with ball
      and core stabilization exercise without ball by using sealed envelopes.
    

Intervention name(s): exercise with ball; exercise without ball
Intervention type(s): Other; Other
Intervention description(s): exercise with ball; exercise without ball
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: exercise
A Study to Assess Safety and Efficacy in Participants Age 40 to 55 With Presbyopia (Old Eye) Who Receive AGN-190584 in Both Eyes Twice Daily
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      Currently available treatments for presbyopia (old eye) include nonsurgical options
      (spectacles or contact lenses) and surgical options, however, each has its own risks and
      limitations. The purpose of this study is to evaluate how effective AGN-190584 is in treating
      presbyopia compared to vehicle (placebo).

      AGN-190584 is an investigational drug being developed for the treatment of presbyopia.
      Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a
      different treatment. There is a 1 in 2 chance that participants will be assigned to vehicle.
      Around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in
      the study in approximately 20 sites in the United States.

      Participants will receive AGN-190584 or vehicle in each eye twice daily for 14 days.

      There may be additional procedures for participants in this trial compared to their standard
      of care. Participants will attend regular visits during the study at a doctor's office. The
      effect of the treatment will be checked by medical assessments, vision/eye tests, checking
      for side effects and completing questionnaires.
    


Intervention name(s): Pilocarpine HCl; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Pilocarpine HCl ophthalmic solution 1.25% ocular drops.; Oxymetazoline HCl and pilocarpine HCl placebo ocular drops.
Other intervention name(s): AGN-190584
Intervention MeSH terms: Pilocarpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Presbyopia; AGN-190584; Pilocarpine HCl 1.25%; Old Eye; Aged Eye
Dog-Assisted Therapy for Children and Adolescents With FASD
Condition: FASD
MeSH terms: Fetal Alcohol Spectrum Disorders
Study type: Interventional

Summary: 
      The rationale of the present study was to evaluate the efficacy of DAT in children and
      adolescents with FASD in relation to its effects on social skills, internalized and
      externalized symptomatology and on severity of FASD symptoms. This objective was accomplished
      through a randomized controlled pilot study of DAT for children and adolescents with FASD.
    

Detailed description: 
      The rationale of this study was to evaluate the efficacy of Dog Assisted Therapy in children
      and adolescents with FASD. The investigators conducted a randomized, rater-blinded,
      controlled pilot trial in a cohort of 33 children and adolescents with FASD. Participants
      were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group)
      (n=16). The investigators evaluated changes on social skills, internalized and externalized
      symptomatology and on severity of FASD symptoms at pre-treatment and post-treatment.
    

Intervention name(s): Dog-Assisted Therapy and pharmacological treatment
Intervention type(s): Behavioral
Intervention description(s): The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design was a randomized, rater-blinded, controlled pilot trial. Participants were randomly assigned either to DAT group (n=17) or Treatment as Usual (TAU control group) (n=16).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: FASD; animal-assisted therapy; dog-assisted therapy
Study of Oglemilast for the Prevention of Asthma.
Condition: Exercise-Induced Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether it is effective in the treatment of
      exercise-induced asthma and investigate the safety of oglemilast.
    


Intervention name(s): Oglemilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oglemilast, 15mg once per day, oral administration; Dose-marched placebo, once per day, oral administration
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: oglemilast; asthma; exercise; prevention; prophylaxis
Follow-up of Adult Phenylketonuria (PKU) Patients
Condition: Nutritional Deficiencies; Phenylketonuria
MeSH terms: Phenylketonurias; Malnutrition
Study type: Observational

Summary: 
      Adult patients with phenylketonuria (PKU) at the age around 40 years belong to the first
      patients generation with early treatment of the disease. PKU is caused by an inborn error of
      the amino acid metabolism and the so far best suitable therapy is an early and strict diet,
      which is low in phenylalanine.

      Besides an early and continuously treatment in childhood, the nutritional and medical support
      during adolescence and adulthood have been suggested to influence the long-term physical
      health of adult PKU patients. As many adult PKU patients tend to neglect the necessarily
      strict diet, they do not get a balanced diet. For PKU patients some nutrients, which may be
      rare in an unbalanced diet, might help to improve health status, physical and neurological
      performance and quality of life.

      Information about the longitudinal development of the patients status and the influence of
      the type of their medical care is not available. In this 5 year follow-up the investigators
      aim to study the quality of life and the medical, nutritional and psychological status of
      adult PKU patients, in whom corresponding information has already been collected previously.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult PKU patients who are or have been attending the Departements of Metabolic Diseases of
        the Klinikum der Universität München will be recruited for this study, if they had been
        participating already in the last study trial comparing adult PKU patients with healthy
        controls.

        It will be attempted to include the same control persons as in the last study trial.
      
Biospecimen description: 
      blood cheek cells
    
Keywords: PKU; phenylketonuria; adult; patient; development; nutritional deficiencies; neurological outcome; psychological and neurological development; comparison with healthy adults; longitudinal development; quality of life
Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following
      oral administration under fasting conditions or with a meal in healthy adult subjects
    


Intervention name(s): AT-527 fasted; Placebo Comparator fasted; AT-527 fed; Placebo Comparator fed; AT-527; AT-527 single dose
Intervention type(s): Drug; Other; Drug; Other; Drug; Drug
Intervention description(s): AT-527 administered twice daily (BID) for 5 days fasted; Matching placebo administered twice daily (BID) for 5 days fasted; AT-527 administered twice daily (BID) for 5 days fed; Matching placebo administered twice daily (BID) for 5 days fed; AT-527 administered twice daily (BID); AT-527 single dose fasted/fed cross-over
Other intervention name(s): Bemnifosbuvir; Bemnifosbuvir; Bemnifosbuvir; Bemnifosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate
      the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone
      30 mg after oral administration in healthy male subjects
    

Detailed description: 
      A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence,
      crossover study
    

Intervention name(s): Evogliptin, Pioglitazone, Evogliptin+Pioglitazone; Pioglitazone, Evogliptin, Evogliptin+Pioglitazone; Evogliptin, Evogliptin+Pioglitazone, Pioglitazone; Pioglitazone, Evogliptin+Pioglitazone, Evogliptin; Evogliptin+Pioglitazone, Evogliptin, Pioglitazone; Evogliptin+Pioglitazone, Pioglitazone, Evogliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD; Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD; Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD; Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD; Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD; Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD
Other intervention name(s): Suganon; Actos; Suganon; Actos; Suganon; Actos; Suganon; Actos; Suganon; Actos; Suganon; Actos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Effect of Increased Pain Tolerance on Exercise Performance
Condition: Opioid Use; Exercise
Study type: Interventional

Summary: 
      Clinical prescription and use of opioids is a clear problem in large parts of the world and
      has the recent years received an increasing publicity in sports. This is in particular due to
      the World Anti-Doping Agency monitoring list, which reveal that endurance athletes utilize
      the opioid Tramadol frequently with the aim to enhance performance according to anecdotal
      evidence.

      Studies investigating the effect of tramadol on exercise performance in healthy humans is
      limited to one study in moderate trained subjects. However, this effect may be different in
      highly trained subjects due to the effects of chronic exercise. Furthermore, ingestion of
      tramadol may impact motor-cognitive performance and it remains unknown whether tramadol can
      be detected in highly trained subjects following exercise.

      In the present study the investigators apply a randomized double-blind placebo-controlled
      counterbalanced cross-over design to investigate whether tramadol treatment improves a
      preloaded cycling time trial performance, whether it affects motor-cognitive performance and
      whether it is detectable following exercise.
    


Intervention name(s): Tramadol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The subjects will orally ingest 100 mg tramadol retard actavis; The subjects will orally ingest 100 mg calcium powder
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      High dose atorvastatin may worsen insulin sensitivity.
    


Intervention name(s): statin
Intervention type(s): Drug
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: insulin sensitivity
Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      Tramadol 37.5 mg/APAP 325 mg combination tablets (ULTRACET®) were effective and safe as addon
      therapy with COX-2 NSAID for treatment of osteoarthritis (5) and chronic low back pain
      (6).There is no clinical trial regarding tramadol usage in chronic inflammatory arthritis
      such as rheumatoid arthritis (RA) or ankylosing spondylitis. It would be important to do a
      pilot clinical trial on add-on effect of tramadol to NSAID in patients with AS or RA.
    

Detailed description: 
      Ankylosing spondylitis (AS) is a chronic inflammatory arthritis causing back pain, peripheral
      arthritis and enthesitis due to genetic background and autoimmunity. Patients with ankylosing
      spondylitis usually suffered from chronic pain over spine and peripheral joints since their
      second or third decades. It may also cause severe social and psychological burden to patients
      and their family.

      Exercise and non-steroid anti-inflammatory drugs (NSAID) are the standard first-line
      treatments for AS（1）. Only 50% of patients with AS reach the ASAS response criteria（2） in
      clinical trials. Patients with severe disease activity should be put on disease-modifying
      anti-rheumatic drugs (DMARD), such as sulfasalazine（3） and anti-TNF biological agents. Add-on
      of acetaminophen and low dose anti-depressant （4）can slightly improve the response rate.
      However, there is no data if tramadol or ultracet can benefit AS.
    

Intervention name(s): Ultracet
Intervention type(s): Drug
Intervention description(s): For the treatment arm: Tramadol 37.5 mg/APAP 325 mg combination tablets (Ultracet®) one tablet twice a day plus aceclofenac tablet per oral 100 mg twice a day.
For the control group: Placebo plus aceclofenac tablet per oral 100 mg twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Testosterone Replacement for Male Opioid Agonist Maintained Patients
Condition: Chronic Pain; Opioid Addiction; Symptomatic Hypogonadism
MeSH terms: Hypogonadism; Chronic Pain; Opioid-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to develop an effective treatment intervention for chronic pain,
      symptomatic hypogonadism, and opioid addiction
    

Detailed description: 
      This study aims to assess the initial efficacy of testosterone replacement in male opioid
      agonist patients with symptomatic hypogonadism and chronic pain.

      The study has two specific aims:

        1. To estimate, in male opioid agonist maintained patients, the prevalence of
           (a)symptomatic hypogonadism and (b) co-occurring symptomatic hypogonadism and chronic
           pain.

        2. To conduct a pilot randomized clinical trial to obtain data regarding the feasibility,
           acceptability, and efficacy (compared to waitlist control) of testosterone replacement
           for male patients with chronic pain and opioid dependence, and symptomatic hypogonadism
           treated with opioid agonist maintenance treatment (N=40).
    

Intervention name(s): Testosterone replacement; Waitlist control
Intervention type(s): Drug; Other
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic pain; Opioid addiction; Symptomatic hypogonadism; Testosterone replacement; Opioid agonist maintenance; Methadone; Buprenorphine
Caesarean Scar Revision With the UltraPulse
Condition: Scar Revision
Study type: Interventional

Summary: 
      Ten (10) adult female subjects that had a caesarean surgery performed.Study will be conducted
      in 1 site.

      Each subject will receive three treatments on one area that was randomly chosen. The other
      area will be left untreated and will serve as a control.

      The objective is to Evaluate the clinical impact of UltraPulse fractional carbon dioxide
      laser treatment on the appearance of a Caesarean Scar (CS) as compared to a similar untreated
      scar side.
    


Intervention name(s): Lumenis UltraPulse Encore.
Intervention type(s): Device
Intervention description(s): Treatment using Lumenis UltraPulse Encore.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous
      (SC) evolocumab compared with ezetimibe, on percent change from baseline in low-density
      lipoprotein cholesterol (LDL-C) in hypercholesterolemic adults unable to tolerate an
      effective dose of a statin.
    

Detailed description: 
      After screening participants who met all inclusion/exclusion criteria were randomized with an
      allocation ratio of 2:2:1:1 into 4 groups: evolocumab (AMG 145) 420 mg administered by
      subcutaneous injection monthly and placebo pill daily; evolocumab 140 mg administered by
      subcutaneous injection every two weeks and placebo pill by mouth daily; placebo 420 mg
      administered by subcutaneous injection monthly and ezetimibe 10 mg pill daily; placebo 140 mg
      administered subcutaneous injection every two weeks and ezetimibe 10 mg pill daily.
      Randomization was stratified by screening LDL-C level and baseline statin use. Participants
      on low or atypical statin dose therapy must have been on a stable dose for at least 4 weeks
      prior to screening and throughout the blinded portion of the study; the dose could not be
      adjusted during screening and for the duration of the study. After Week 12, ezetimibe was
      discontinued and participants moved to an open-label dose of evolocumab administered by
      subcutaneous injection either every two weeks or monthly and their standard of care.
    

Intervention name(s): Evolocumab; Ezetimibe; Placebo to Evolocumab; Placebo Ezetimibe
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Administered by subcutaneous injection; Tablet for oral administration; Administered by subcutaneous injection; Tablet for oral administration
Other intervention name(s): AMG 145; Repatha; Zetia
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Japanese; High cholesterol; Treatment of high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia; Statin intolerant