bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Vaccine Component P3C541b in HIV-1 Seronegative Human Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate an HIV synthetic lipopeptide candidate vaccine component, P3C541b, at two dose
      levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled
      study.
    

Detailed description: 
      The prospective volunteers will be screened and HLA typed for Class I MHC haplotypes. Only
      volunteers possessing HLA alleles A33, B8, B27, B35 or Bw62 or any combination thereof will
      be enrolled in the study. Subjects will be allocated to 1 of 2 study groups. Group 1 will
      receive 70 mcg of P3C541b or the placebo and Group II will receive 350 mcg of P3C541b or the
      placebo. NOTE: Enrollment for Group II wil not begin until at least 5 Group I participants
      have reached day 14 without serious adverse events.
    

Intervention name(s): P3C541b Lipopeptide
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Effects of Whole-Body Electromyostimulation on Golf Performance
Condition: Golf Specific Performance; Muscle Strength; Trunk Stability
Study type: Interventional

Summary: 
      Golf is becoming increasingly popular in Germany. However, the biomechanical and motor
      challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers
      carry out serious preparation and conditioning as part of a strength/stabilization program.
      The main argument for this limitation is the aspect of "limited time resources". A solution
      to this problem could therefore be the time-effective and highly individualizable whole-body
      electromyostimulation (WB-EMS) technology. The aim of the present study is to evaluate the
      effectiveness of 16 weeks of WB-EMSapplication on maximum strength of the lower extremities,
      trunk stability and (golf) handicap in male amateur golfers in a (randomized) controlled
      setting.
    


Intervention name(s): WB-EMS
Intervention type(s): Device
Intervention description(s): 16 weeks of WB-EMS
Other intervention name(s): Whole Body Electromyostimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Self-Determination Theory and Motivational Interviewing
Condition: Schizophrenia; Diabetes
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Self-Determination Theory and motivational interviewing would be integrated to enhance the
      efficacy of diabetic self-management for patients with schizophrenia and Type 2 Diabetes.
    

Detailed description: 
      Participants would be randomly allocated into either the intervention group or the usual care
      group from baseline to 3 months follow-up. The intervention is based on integrated
      self-determination theory and motivational interviewing.
    

Intervention name(s): Interviewing
Intervention type(s): Behavioral
Intervention description(s): Self-Determination Theory within motivational interviewing
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety
      and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).
    


Intervention name(s): MIV-711
Intervention type(s): Drug
Intervention description(s): MIV-711 administered orally once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the combination of panitumumab and
      Triflridine/Tipiracil (FTD/TPI; TAS-102) in patients with RAS wild-type metastatic colorectal
      cancer (CRC) refractory to standard chemotherapy (oxaliplatin, fluoropyrimidines, irinotecan
      and angiogenesis inhibitors).
    

Detailed description: 
      The purpose of this study is to evaluate the combination of panitumumab and TAS-102 in
      patients with RAS wild-type metastatic colorectal cancer (CRC) refractory to standard
      chemotherapy (oxaliplatin, fluoropyrimidines, irinotecan and angiogenesis inhibitors).

      Patients who are judged eligible for the study based on the inclusion and exclusion criteria
      will be received panitumumab (6 mg/kg) every 2 weeks and TAS-102 (35 mg/m² given orally twice
      a day in a 28-day) in 2-week cycle of 5 days of treatment followed by a 2-day rest period,
      and then a 14-day rest period.

      A maximum of 58 participants will be enrolled.
    

Intervention name(s): Panitumumab + TAS-102
Intervention type(s): Drug
Intervention description(s): panitumumab + TAS-102 combination therapy
Other intervention name(s): Panitumumab + Triflridine/Tipiracil (FTD/TPI)
Intervention MeSH terms: Panitumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer, Panitumumab, TAS-102
Retrospective Analysis of the Incidence of Complications From Transvaginal Oocyte Retrieval (TVOR).
Condition: In Vitro Fertilization
Study type: Observational

Summary: 
      The investigators retrospectively analysed the complication rate of ultrasound guided
      transvaginal oocyte retrieval (TVOR) from all the procedures performed between 1996 and
      October 2016 in a tertiary level university based fertility clinic.
    

Detailed description: 
      Ultrasound guided transvaginal oocyte retrieval (TVOR) is nowadays gold standard techniques
      to collect oocyte after ovulation induction in Assisted Reproductive techniques (ART). It is
      a very safe technique with infectious complications of any kind occurring in just 1% (Bennett
      et al.) of all procedures, vaginal bleeding in 0 to 1.3% of the procedures (Ludwig et al.,
      Bodri et al., Aragona et al.) and vascular, gastrointestinal and genitourinary (Grynberg et
      al. and Catanzarite and al.), injuries being extremely rare (Bennett et al.). Case reports
      account also for rarer complications such as ovarian abscess formation (Kelada & Ghan and
      Sharp et al.) pseudoanerysm formation (Bozdag et al. and Jayakrishnan et al.),
      uroretroperitoneum (Fiori et al.).

      The rational of thestudy is to provide the percentages of complication from TVOR of the
      Fertility Center of Humanitas Research Hospital, also considering the development in time of
      technologies and techniques in Assisted Reproduction. Another rational is inquire whether
      there is any risk factor for such complications in order to try to prevent them in future
      procedures. The investigators performed a retrospective observational study including all the
      transvaginal oocyte retrieval procedures performed between 1996 and October 2016.

      The data have been collected from the Humanitas Fertility Center' Department database
      (ART.it). Because of the retrospective nature of this study, a specific informed consent was
      not necessary.
    

Intervention name(s): TVOR
Intervention type(s): Procedure
Intervention description(s): Ultrasound guided transvaginal oocyte retrieval (TVOR) in deep sedation for IVF.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All the patients that patients that underwent ultrasound guided transvaginal oocyte
        retrieval during the study period were including in the analysis.

        No case was excluded.
      
Keywords: oocyte retrieval; surgical complications
C Reactive Protein (CRP) Intervention to Reduce Inappropriate Antibiotic Prescriptions in the Primary Healthcare Setting
Condition: Acute Respiratory Infections
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional

Summary: 
      Many studies have showed that rapid point-of-care (POC) c-reactive protein (CRP) test can
      reduce inappropriate use of antibiotic at primary health care level. In Vietnam, prevalence
      of antibiotic abuse for community acute respiratory infection has been reported. This study
      will test the hypothesis that CRP POC testing for patients with non-severe acute respiratory
      illness at primary healthcare stations reduces inappropriate antibiotic use safely.

      The study will be conducted at ten district health care facilities in Hanoi, Viet Nam.
      Investigators intend to enroll 2,000 participants aged 6-65 years with non-severe acute
      respiratory infection. Patients will be randomly allocated to the control or the intervention
      arm. Participants in the control group will be treated according to routine care.
      Participants in the intervention arm will have a CRP test, the results of which will be
      available to the health care practitioner to contribute to their diagnosis and treatment
      decisions.

      All patients will be followed-up via telephone call after 14 days. The study will compare the
      proportion of patients in each arm receiving any antibiotics within 2 weeks of study
      enrollment.
    


Intervention name(s): Patients will be tested by rapid POC CRP test
Intervention type(s): Procedure
Intervention description(s): Patient will be tested with CRP test. Treatment decisions including any antibiotics prescribed will be based on test results and clinical judgement. Treatment choices are not recommended/prescribed by the study protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Lifestyle On-line Intervention in Patients With Obesity and Hypertension
Condition: Obesity; Hypertension
MeSH terms: Hypertension; Obesity
Study type: Interventional

Summary: 
      This study aims to describe a totally self-applied online program to promote healthy
      lifestyles (nutritional education and exercise practice) for obese participants with
      hypertension. Participants will be recruited from users of a hypertension unit of a public
      hospital and will be randomized into two groups: experimental group and control group
      (treatment as usual). The experimental program (3 months) will be composed by 8 modules aimed
      for promoting healthy eating habits and increase physical activity. Assessment will include:
      body composition (BMI), blood pressure, glucose metabolism variables, and physical activity
      level (measured with accelerometers).

      Design: Randomized Controlled Trial.
    

Detailed description: 
      Healthy eating and regular exercise play an important role to maintain health while ageing.
      Nutritional education and exercise practice could be monitored by different means, such as
      Internet, face to face and/or through exercise diaries. Information and Communication
      Technologies (ICTs) could be a useful tool to promote health, and could be used to work on
      barriers, such as low motivation and difficulties to maintain exercise or diet. ICTs also
      have other important advantages, especially their good cost-benefit relationship and the
      possibility of increasing the efficiency of interventions, allowing them to reach a wider
      audience at a lower cost. This study aims to describe a totally self-applied online program
      to promote healthy lifestyles (nutritional education and exercise practice) for obese
      participants with hypertension. Participants will be recruited from users of a hypertension
      unit of a public hospital and will be randomized into two groups: experimental group and
      control group (treatment as usual). The experimental program (3 months) will be composed by 8
      modules aimed for promoting healthy eating habits and increase physical activity. Assessment
      will include: body composition (BMI), blood pressure, glucose metabolism variables, and
      physical activity level (measured with accelerometers).
    

Intervention name(s): Educational intervention
Intervention type(s): Other
Intervention description(s): The self-applied on-line intervention will comprise a three months behavioural intervention composed by 8 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits.
Other intervention name(s): ICT intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Nutrition; Internet; Obesity; Hypertension
Therapeutic Riding and Neuromuscular Disease
Condition: Neuromuscular Disease
MeSH terms: Neuromuscular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this current prospective study is to assess the effects of a Therapeutic
      Riding exercise program conducted in patients suffering from neuromuscular disease. The
      exercise intervention aims at improving gross motor function, gross motor performance,
      balance, spasticity, posture and quality of life. Patients were randomized according to age,
      sex, mental ability and gross motor function. Furthermore, patients will be subdivided into
      categories of central nervous system (brain/ spinal cord) and peripheral (peripheral nerve or
      muscle) diseases. The exercise program duration will be 12 weeks, once a week with 30-40
      minutes sessions. Six measurements will be conducted: the Gross Motor Function Measure, the
      Gross Motor Performance Measure, the Quality of life Questionnaire for Children, the
      Pediatric Balance Scale, the dynamic plate in combination with x-ray for posture control, the
      Modified Ashworth Scale for spasticity and the Wisc 3 for mental ability. The results will be
      collected and evaluated using the statistical programme SPSS.
    


Intervention name(s): Therapeutic Riding/ Hippotherapy Intervention
Intervention type(s): Other
Intervention description(s): The Therapeutic Riding exercise intervention consisted exercises for warm up,transitions on the horseback, stretching exercises and exercises to strengthen muscles of trunk and four limps, games with balls and rings and walking of the horse to change directions as diagonal / lateral changes, cycles with open and closed eyes.
Other intervention name(s): therapeutic riding/hippotherapy
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral palsy; brain injury; spinal cord injuries; muscular disease
Nitrite Supplementation for Improving Physiological Function in Older Adults
Condition: Ageing
Study type: Interventional

Summary: 
      Nitric oxide (NO) is an essential molecule in the body that decreases with aging and causes
      reductions in vascular, movement ("motor") and cognitive functions. This study will determine
      if daily oral supplementation (3 months) with a compound that increases NO in the body, i.e.,
      sodium nitrite, improves vascular, motor and cognitive function in older adults. The project
      also seeks to provide insight into the biological reasons (mechanisms) by which
      supplementation with sodium nitrite improves physiological function in older adults. Overall,
      this research will provide scientific evidence supporting the use of sodium nitrite for
      preserving physiological function and preventing clinical disease and disability with aging.
    


Intervention name(s): Sodium nitrite; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Bioequivalence And Lack Of Food Effects Of 300mg Lamotrigine XR
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study intends to demonstrate bioequivalence and lack of food effect on 300mg lamotrigine
      XR in healthy male and female volunteers
    


Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): In treatment regimen A lamotrigine XR tablets will be available 100 and 200mg tablets, for regimen B and C of lamotrigine tablets 300 mg will be available.
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy volunteers; bioequivalence; food effects
Safety, Tolerability, and Pharmacokinetics of AZD7268 After Single Ascending Oral Doses in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Single Ascending Dose Study
    


Intervention name(s): AZD7268; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution/Capsule, Oral, once daily
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Phase 1
A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the body's immune response when vaccines are given
      alone versus when vaccines are given along with the study drug called ixekizumab. The
      vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with
      follow-up at 12 weeks.
    


Intervention name(s): Ixekizumab; Boostrix®; Pneumovax®23
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered by SQ injection; Administered by IM injection; Administered by IM injection
Other intervention name(s): LY2439821; Tetanus, diphtheria, acellular pertussis vaccine (Tdap); Pneumococcal polysaccharide vaccine
Intervention MeSH terms: Ixekizumab; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of abrilumab as measured by
      the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission
      (CDAI < 150) after treatment for 8 weeks.
    

Detailed description: 
      The study consisted of a 24-week double-blind treatment period, a 108-week open-label
      treatment period, and a 2-year safety follow-up period.

      Participants who did not reach minimal improvement, or experienced disease worsening after
      initial response, had the option to receive open-label abrilumab 210 mg every 3 months (Q3M)
      beginning at double-blind period week 12 or after. Not reaching minimal improvement was
      defined as not having an improvement in CDAI score of ≥ 70 points from baseline on 2
      consecutive visits (at or after week 8) at least 2 weeks apart. Disease worsening after week
      8 (or week 12) response was defined as having an increase in CDAI score of ≥ 70 points from
      the week 8 (or week 12) CDAI score on 2 consecutive visits at least 2 weeks apart, and a CDAI
      score of > 150.

      Participants were planned to be randomized in a 2:1:2:1 ratio to SC placebo or abrilumab at
      21 mg, 70 mg (on day 1, week 2, week 4, and every 4 weeks thereafter until week 24), or 210
      mg (on day 1 followed by placebo in weeks 2 and 4 and every 4 weeks thereafter until week
      24), respectively. Due to a consistent discrepancy between the investigational product (IP)
      instruction manual (IPIM) description of vial positions and the actual vial positions in the
      IP package participants were initially randomized to 3 arms (placebo, 70 mg, and 210 mg) with
      a randomization ratio of 3:2:1. The study was temporarily paused while this issue was
      investigated. Once the discrepancy was corrected, Protocol Amendment 3 implemented, and
      affected participants completed their double-blind treatment period, the study resumed
      enrollment and randomization per protocol. Neither the randomization nor study blind was
      compromised and therefore the intent-to-treat principle was maintained.
    

Intervention name(s): Abrilumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection.; Placebo matching to abrilumab administered by subcutaneous injection
Other intervention name(s): AMG 181
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: IBD, Crohn's Disease
Dose-related Effect of Aspirin on Laboratory-defined Acetylsalicylic Acid Resistance and Clinical Outcome After Coronary Stenting
Condition: Coronary Stenting
Study type: Interventional

Summary: 
      The investigators prospectively studied the effect of aspirin on platelet function in 106
      stable outpatients 6 months after successful percutaneous coronary angioplasty. Participants
      were randomized in a double-blind, double-crossover study (80 or 500 mg per day for 6
      months).T
    

Detailed description: 
      Background:

      Acetylsalicylic acid (aspirin) is widely used in the secondary prevention of coronary artery
      disease. There is controversy regarding the prevalence of aspirin resistance in patients with
      coronary artery disease and the effect of dose on resistance. Our primary aims were to
      determine the degree of platelet responsiveness to aspirin, and to study the influence of
      dose on platelet inhibition and clinical outcomes after coronary stenting.
    

Intervention name(s): 80 mg ASA dosing; 500 mg ASA dosing
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASA resistance; coronary stenting; platelet function; laboratory ASA resistance; MACE; Positive SPECT