bioihbjkbjnl/mcl2 huggingface dataset:
Effects of ASA on Prostate Tissue
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Aspirin affects many physiological processes through its anti-inflammatory actions. Various
      cancers, including prostate cancer, appear to utilize inflammatory signals to facilitate
      their growth and progression.

      We hypothesize that oral aspirin acts directly on prostate epithelial cells to alter
      COX-2-related metabolism and inhibit prostate cell growth.
    

Detailed description: 
      Prostate cancer is the most common non-cutaneous malignancy in men and is the second leading
      cause of cancer death among U.S. men. 221,000 new cases and 29,000 deaths are expected in
      2003. The incidence of prostate cancer diagnosis is increasing at 3% per year. Prostate
      specific antigen (PSA) screening has resulted in improvements in early diagnosis of prostate
      cancer. However, available treatments all may have a significant negative effect on quality
      of life.

      Studies have implicated a beneficial association between ASA use and a lower risk of other
      types of malignancies, including stomach, esophageal, breast, ovarian, and prostate cancer.
      There is significant evidence to suggest that aspirin has a protective effect against
      prostate cancer.
    

Intervention name(s): Aspirin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 325mg, one tablet orally, six months; 325mg, one tablet orally every day, 6 months
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cancer; Prostate; Preventive Therapy
First in Human Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1214784
Condition: Clinical Trials, Phase I as Topic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first in human study that will investigate the safety, tolerability and
      pharmacokinetics of ascending single doses of BAY1214784 using a placebo controlled,
      randomized, single center design. In addition the bioavailability of two different liquid
      formulations will be compared.
    


Intervention name(s): BAY1214784; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form; Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Ultherapy® for the Treatment of Acne Scars
Condition: Acne Scars; Atrophic Acne Scars
MeSH terms: Acne Vulgaris; Atrophy
Study type: Interventional

Summary: 
      This is a prospective, multi-site trial to be conducted at 2 clinical sites. Up to 20
      subjects will receive study treatments. Following study treatments, follow-up visits will
      occur at 60, 90 and 180 days from each subject's last study treatment.
    

Detailed description: 
      Subjects with moderate to severe atrophic acne scars will be enrolled. Subjects will receive
      up to three dual-depth treatments to the cheek and temple areas impacted by acne scars,
      treating the number of treatment squares necessary to cover the area of scarring. Each
      treatment square will receive 30 lines per transducer depth for a total of 60 lines per
      treatment square. Three treatments 30 days apart will be required.
    

Intervention name(s): Ultherapy® treatment
Intervention type(s): Device
Intervention description(s): Microfocused ultrasound treatment
Other intervention name(s): Ulthera System®
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera System®; Ultherapy®; Ulthera, Inc.
Assessing Ovarian Function During Prolonged Implant Use
Condition: Contraception
Study type: Observational

Summary: 
      The study will evaluate how the ovaries may be functioning while using the the
      Implanon®/Nexplanon® during the three years beyond the FDA approved duration. Ovarian
      function will be assessed with weekly serum progesterone levels. Participants will undergo
      weekly venipuncture for a total of four draws. Participants will be followed for 30 days.
    

Detailed description: 
      This prospective cohort will evaluate the ovarian function of 210 ENG users during the three
      years beyond the FDA approved duration. Participants enrolled in the current study, EPIC
      (Evaluating the Prolonged Use of IUD and Implant for Contraception, NCT02267616), will be
      contacted via telephone, screened and scheduled to enroll in person. After the signed consent
      is obtained participants will be asked to complete a brief questionnaire on demographic
      information and bleeding patterns. Participants will undergo a blood draw to assess serum
      etonogestrel and serum progesterone levels.

      Follow up visits will include a weekly blood draw for three weeks to assess serum
      progesterone levels. Participants will also complete a bleeding diary to assess daily
      bleeding patterns for the 30 day study period.

      The investigators will enroll participants at seven time points; at method expiration (3
      years of use), and in six-month intervals through six years of use.
    

Intervention name(s): Etonogestrel Implant
Intervention type(s): Device
Intervention description(s): Ovarian function will be assessed with weekly serum progesterone levels. Participants will undergo weekly venipuncture for a total of four draws over a 30 day period. Participants will also complete a bleeding diary to assess daily bleeding patterns for the 30 day study period.
Other intervention name(s): Subdermal arm implant
Intervention MeSH terms: Etonogestrel
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ENG implants users who are at expiration or beyond the end of the FDA-approved duration of
        use of the etonogestrel-releasing subdermal implant (ENG implant =3 years)
Effects of Exten(d) Supplementation on Training Ability in Recreational Runners
Condition: Joint Pain; Knee Inflammation; Biomechanical; Lesion
MeSH terms: Arthralgia; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will assess running biomechanics and joint inflammation of physically active males
      between 40 and 60 years of age, mainly runners, suffering from knee joint inflammation and
      pain after training. Participants were split into two groups, intervention and placebo, to
      evaluate the safety and efficacy of Exten(d) supplementation during 4 weeks.
    

Detailed description: 
      Triple-blind, randomized, placebo-controlled, parallel group, pilot safety, and efficacy
      study.

      30 healthy physically active males (40 to 60 years old) suffering from knee joint
      inflammation and pain after training were randomly assigned to the Exten(d) or Placebo group.
      During the first visit and after 4 weeks supplementation (either 2 g daily of Exten(d)
      capsules or placebo capsules) the participants were subjected to a three-stage exercise
      session: (i) running biomechanical assessment, (ii) exercise physiology maximal effort test
      and (iii) running biomechanical assessment after the incremental exercise to exhaustion. The
      volunteers have been assessed to determine: (1) inflammation by I-R thermography and pain
      perception, (2) running technics though biomechanic analysis and (3) performance.
    

Intervention name(s): Polyherbal Exten(d) vs Placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Supplementation during 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single dose, Randomized, triple Blinded, Placebo-controlled Study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Harpagophytum; Zingiber officinae; Bixa orellana; Joint pain; Inflammation; Biomechanics
A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison
      study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to
      patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day for
      8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total
      score, and to evaluate the safety based on adverse events, clinical laboratory tests and
      vital signs.
    


Intervention name(s): 323U66 SR 150 mg tablet; 323U66 SR 150 mg placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): 323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase.; 323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bupropion; 323U66 Sustained Release (SR); MDD (Major Depressive Disorder); IVRS HAM-D; IDS-SR; MADRS
Inhaled Furosemide Versus Placebo for Acute Viral Bronchiolitis in Hospitalized Infants
Condition: Bronchiolitis
MeSH terms: Bronchiolitis; Bronchiolitis, Viral
Study type: Interventional
Phase: Phase 1

Summary: 
      We hypothesize that inhaled Furosemide will be an effective treatment in infants with acute
      bronchiolitis.
    


Intervention name(s): Inhaled Furosemide vs Placebo (Normal Saline)
Intervention type(s): Drug
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Evaluation of the Nutritional Supplement Lycoderm on Its Impact on Skin Parameters
Condition: Skin Care
Study type: Interventional

Summary: 
      Carotenoids and polyphenols are assumed to have an active role in skin health. Sources for
      these phytonutrient are fruits and vegetables. They are widely applied as skin protectants,
      and supplementation with carotenoids have shown to protect against erythema caused by
      UV-radiation. UV radiation generates reactive oxygen species in the skin, which induces
      cellular signaling that may impair cell cycle, cell growth, and regeneration or repair
      processes.
    

Detailed description: 
      The face holds an integral role in human social communication and how humans are perceived as
      attractive. In addition to structural facial features, studies have shown that skin
      appearance is highly weighed in the perception of beauty and is determined primarily by its
      coloration and surface topography. Aging is caused by two processes, intrinsic and extrinsic.
      The sun is the primary cause of extrinsic aging and has also been shown to alter the normal
      course of intrinsic or natural aging. On the molecular level, various hypotheses have been
      proposed to explain aging, with free radical theory being prominent. The free radical theory
      addresses the concept of intrinsic biological instability of living systems, in which free
      radicals and other reactive oxygen species (ROS) damage biomolecules, and this damage results
      in aging of the skin (as well as other systems).

      The aim of this study is to examine the effects of an oral antioxidant supplement on skin
      aging and skin condition.
    

Intervention name(s): Lycoderm; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): soft gel contains nutritional supplement; soft gel without active ingredients
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind, Randomized, Placebo-Controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates
Condition: Infant, Newborn; Infant, Premature; Pain Perception; Pain Measurement; Pain Management; Electroencephalography
Study type: Interventional

Summary: 
      The assessment and treatment of pain in neonates remains a challenge. In an effort to improve
      the quality of care while limiting opioid-related adverse effects, this study aims to
      determine the efficacy of a non-pharmacological intervention on the mitigation of
      nociception-specific responses to a skin breaking procedure in term and preterm neonates.
      Such responses will be measured using behavioral measures as well as with
      electroencephalography-based methods.
    

Detailed description: 
      Eligible neonates who are 36-56 weeks post-menstrual age and who are scheduled to undergo a
      clinically required heel lance will be studied after obtaining appropriate verbal and written
      consent from the respective parents. Subjects will be monitored during a baseline resting
      state, during vibratory stimuli alone, and during a heel lance that is randomized to be
      preceded or not preceded by the vibratory stimulus. The sessions will include time-locked
      video recordings and electroencephalography using a specialized net of 128 electrodes
      (Electrical Geodesics Inc., EGI; Eugene, OR). Behavioral and cortical responses will be then
      be analyzed in a blinded fashion to determine the efficacy of the vibratory intervention, as
      well as to validate what behavioral responses are most correlated with nociception-specific
      cortical activity.
    

Intervention name(s): Baby GentleStick
Intervention type(s): Device
Intervention description(s): The Baby GentleStick is a handheld device that fits and provides vibration to an Owen Mumford Unistik3 Dual lancet. The gentle vibration occurs at 178 Hertz with a free-hanging 0.24 mm range of motion. The device may provide vibration alone and also allow for simultaneous vibration and deployment of the lancet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
High Speed Circuit Training and Cognition
Condition: Educational Control; Resistance Training
Study type: Interventional

Summary: 
      The purpose of this research study is to see if a weight training program can make a positive
      change in participant fitness as measured by the ability to use oxygen and help the
      participant remember things.
    

Detailed description: 
      The purpose of this research study is to see if a weight training program can make a positive
      change in cardiac fitness, that is a person's ability to use oxygen; and, if the program can
      help a person's memory, as measured by some standard tests. The researchers will also ask the
      participant to attend two sessions with researchers at the Bascom-Palmer Eye Institute so
      they can take pictures of the participants' eyes to see how training changes the number of
      blood vessels. This can be used by doctors and other clinicians to evaluate improvements
      blood flow to the brain due to training.
    

Intervention name(s): High-speed circuit resistance training; Educational control
Intervention type(s): Other; Other
Intervention description(s): The program will include three circuits of 11 exercises that target the upper and lower body. Training will gradually increase over the first three week from 1 to 3 circuits.; Lectures on health and fitness
Other intervention name(s): High-velocity circuit training; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of High-Speed Resistance training and educational control
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elderly; Circuit training; Cognitive ability; Cardiovascular condition
Study of Muraglitazar Versus Pioglitazone in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare Muraglitazar and Pioglitazone in patients with Type 2
      Diabetes. Both the safety and blood sugar lowering effects of these treatments will be
      studied.
    


Intervention name(s): Muraglitazar; Pioglitazone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 Diabetes
Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of AV650 in healthy
      subjects given single and multi-doses under fasted and fed conditions.
    


Intervention name(s): AV650
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the antibody response to each of the three influenza
      vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by
      hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart,
      in infants between 6 and 12 months of age.
    


Intervention name(s): AdimFlu-S
Intervention type(s): Biological
Intervention description(s): 0.25mL per injection 2 injections at 4 weeks apart
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Vaccine; Immunogenicity
COVID-19 Pandemic and Academic Performance of Veterinary Students
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The study aims to analyze the effect of COVID-19 pandemic on the academic performance of
      veterinary students, veterinarians, and researchers during the lockdown.
    


Intervention name(s): survey
Intervention type(s): Other
Intervention description(s): online survey
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Veterinary students and researchers
Measles, Mumps, and Rubella (MMR) Immunity in College Students
Condition: Measles; Mumps; Rubella
MeSH terms: Measles; Rubella; Mumps
Study type: Observational

Summary: 
      This study will lay the foundation for determining the underlying reasons for lack of
      immunity to mumps that led to the 2006 mumps outbreak on college campuses in the Mid West,
      and it will assess the potential for similar outbreaks of measles and rubella. A total of 70
      to 80 college students (age 18 to 22) on the Emory campus (or nearby college campuses or the
      community) will be assessed for antibodies to measles, mumps or rubella by drawing a one-time
      blood sample. Their medical records will be verified for documentation of immunization with
      MMR vaccine prior to enrollment in the study. If a study volunteer is found to not have MMR
      immunity, they will be offered an MMR-II vaccine. For this group, additional blood specimens
      will be obtained.
    

Detailed description: 
      No additional description needed.
    

Intervention name(s): MMR vaccine
Intervention type(s): Biological
Intervention description(s): People with no antibodies to either mumps, measles and rubella will be offered the MMR vaccine (they may choose to or choose not to receive the MMR vaccine)
Other intervention name(s): No other names
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects for this study will be 18-22 year olds recruited from Emory University's student
        population who have received two age-appropriate doses of the MMR-II vaccine.
      
Biospecimen description: 
      Whole blood
    
Keywords: Mumps; Immunity; Vaccine; Mumps antibodies; Mumps immunity
Passive Leg Raising - an Important Diagnostic Manoeuvre
Condition: Cardiovascular Insufficiency
Study type: Interventional

Summary: 
      The aim is to describe the physiological background for PLR and the interpretation of a PLR
      manoeuvre.

      The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient
      position), during PLR and after returning to semirecumbent position. Simultaneously blood
      pressure (BP), pulse rate (PR), pulse oximetric saturation (SpO2) and ECG are recorded. The
      procedure is performed in ten normal subjects, ten patients recruited in the cardiology
      outpatient department and ten critically ill patients under analgosedation in the ICU.

      Analysis includes changes in measured variables and heart rate variability in the frequency
      domain during the three phases of the experiment.
    

Detailed description: 
      See above
    

Intervention name(s): Passive Leg Raising
Intervention type(s): Diagnostic Test
Intervention description(s): See above
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Basic Science