bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response of Vasomera (PB1046) Injection Following a Single Subcutaneous Dose in Subjects With Stage 1 or 2 Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of single
      ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage
      1 or Stage 2 essential hypertension.

      The secondary objectives of the study are to characterize the pharmacokinetic profile of
      single ascending doses of Vasomera and the relationship between serum concentrations of
      Vasomera and change in systolic and diastolic blood pressure as measured by:

        -  Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by
           ambulatory blood pressure monitoring (ABPM) as compared to placebo.

        -  Identification of the minimum and maximum decrease in systolic and diastolic blood
           pressure as measured by ABPM.

        -  Mean change from baseline in cuff systolic and diastolic blood pressure as compared to
           placebo.

        -  Effect of Vasomera on pulse pressure and heart rate.

      An additional secondary objective of this study will be to characterize the immunogenicity
      profile of Vasomera following a single subcutaneous dose.
    


Intervention name(s): Vasomera (PB1046); 0.9% Sodium Chloride
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of Vasomera; Placebo injection
Intervention MeSH terms: VIP-ELP fusion molecule PB1046
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Vasomera; PB1046; Hypertension
Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates
Condition: Staphylococcus Aureus; Community-Acquired Infections; Staphylococcal Skin Infections
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Community-Acquired Infections
Study type: Interventional

Summary: 
      Outbreaks of skin and soft tissue infections (SSTI) related to community associated
      Methicillin-resistant Staphylococcus aureus (MRSA) have become increasingly common in
      military training units. Risk factors for MRSA related SSTI such as crowding, poor hygiene
      and shared equipment are often hard to avoid in a military training environment, often
      designed to simulate battlefield conditions.

      It has recently been demonstrated that military recruits colonized with MRSA may be at
      increased risk of developing SSTI. Studies in the hospital environment have shown that
      decolonizing inpatients known to carry MRSA decreases the rates of MRSA related infections in
      the treated individuals and also in their inpatient unit as a whole.

      The investigators propose a randomized, double blind, placebo controlled trial to:

        1. Evaluate the effectiveness, feasibility, and safety of chlorhexidine body cloths,
           self-administered three times weekly, in preventing SSTI among recruits in military
           training facilities; and

        2. Evaluate the effectiveness of chlorhexidine body cloths in decreasing rates of
           Staphylococcus aureus colonization among military recruits.
    


Intervention name(s): 2% chlorhexidine gluconate (CHG) impregnated cloths; Comfort Bath cloths (placebo cloths)
Intervention type(s): Drug; Drug
Intervention description(s): self applied three times per week; self applied three times weekly
Other intervention name(s): Sage Products Inc.; Sage Products Inc.
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: MRSA; Staphylococcus aureus
Effect of Daily Stair Walking on Cardiovascular Health
Condition: Cardiovascular Health
Study type: Interventional

Summary: 
      Many adults find it difficult to perform physical exercise during leisure. The workplace may
      provide an optimal setting to encourage a healthier lifestyle. This study investigates the
      effect of daily stair walking at the workplace on cardiovascular health.

      The main hypothesis is that daily stair walking for 10 weeks compared with a control group
      results in increased aerobic fitness.
    


Intervention name(s): Stair walking
Intervention type(s): Behavioral
Intervention description(s): Participants of the stair group is encouraged to use the stairs for 10 minutes a day at the workplace. Participants of the control group receive a health examination before and after the intervention period, and are advised to stay active
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect
      of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy
      volunteers. Subjects will be randomized to one of two treatment sequences to receive a single
      oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single
      oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.
    


Intervention name(s): cyclosporine; danoprevir; ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose; Single oral dose; Single oral dose
Intervention MeSH terms: Cyclosporine; Ritonavir; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Fuzeon Viral Decay Pilot Study
Condition: HIV-1
Study type: Interventional

Summary: 
      In order to better understand the source(s) and the mechanism(s) of HIV persistence and to
      potentially lead to further suppression of HIV from viral reservoirs, we propose to examine
      the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of
      the size of the viral reservoir in infected individuals who are receiving effective antiviral
      therapy for extended periods of time (> 5 years).
    


Intervention name(s): enfuvirtide
Intervention type(s): Drug
Intervention description(s): 1ml BID
Intervention MeSH terms: Enfuvirtide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fuzeon; Viral Decay
Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males
Condition: Healthy Males
Study type: Interventional

Summary: 
      There is no evidence that beetroot extract (Beta vulgaris L.) is advantageous for the
      recovery of cardiovascular parameters and the autonomic nervous system (ANS) after submaximal
      aerobic exercise. The objective of this study is to evaluate the effect of beetroot extract
      supplementation on the recovery of cardiorespiratory and autonomic parameters after a
      submaximal aerobic exercise session. Healthy male adults will perform a cross-over,
      randomized, double-blind, and placebo-controlled trial. Beetroot extract (600mg) or placebo
      (600mg) will be ingested 90 minutes before evaluation in randomized days. Systolic blood
      pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), mean arterial pressure
      (MAP), heart rate (HR), and HR variability (HRV) indexes will be recorded at Rest and during
      60 minutes of recovery from exercise.
    


Intervention name(s): Beetroot extract
Intervention type(s): Dietary Supplement
Intervention description(s): Beetroot extract capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Kinesio Taping in Subjects With Myofascial Pain Syndrome: a Randomized Controlled Trial
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      Musculoskeletal dysfunction is considered as a major public health problem affecting about
      one third of the adult population. Myofascial pain syndrome (MPS) characterized by myofacial
      trigger points as well as fascia tenderness are thought to be the main cause of
      musculoskeletal dysfunction. The aim of the treatment for musculoskeletal dysfunction is to
      reduce pain and restore normal function. Clinically, some evidence supports the application
      of kinesio tape in these patients. The underlying mechanism, however, is not clear. The
      investigators goal was to validate proposed mechanism of kinesio tape in these patients. The
      primary outcome are muscle stiffness, pain intensity and sensitivity.
    


Intervention name(s): Manual pressure release; Kinesio tape
Intervention type(s): Other; Other
Intervention description(s): Therapist applied non-painful pressure with slowly increase over the myofascial trigger point until he felts a tissue resistance barrier.; Kinesio tape was adhered from insertion to origin of the upper trapezius muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myofascial pain syndrome; taping; manual therapies
The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to further validate and extend our previous findings insofar that the effect
      of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating
      processes and its relationship to cognitive performance shall be explored.
    


Intervention name(s): Sertindole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral 3 x 4mg; 3 x 4mg Placebo
Intervention MeSH terms: Sertindole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Sertindole; sensory gating; PPI; P50 suppression; CANTAB; Effect of Sertindole on sensory gating (P50 suppression); on sensorimotor gating (PPI); and cognition (CANTAB)
Sarilumab Effect on the Pharmacokinetics of Simvastatin
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To evaluate the effect of a single 200 mg subcutaneous injection of sarilumab on the
      pharmacokinetics of simvastatin in patients with rheumatoid arthritis

      Secondary Objective:

      To describe the safety and efficacy (exploratory) of sarilumab
    

Detailed description: 
      The duration of the entire study per patient completing both Parts A and B is expected to be
      approximately 58 weeks (not including Screening).
    

Intervention name(s): sarilumab SAR153191 (REGN88); simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Prefilled syringe of sarilumab solution Route of administration: Subcutaneous injection; Pharmaceutical form:Film-coated 20 mg Tablet Route of administration: oral
Intervention MeSH terms: Simvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Phase 1 Clinical Trial to Investigate the Effect on the Pharmacokinetics of YH14755 Compared to Co-administration of Rosuvastatin and Metformin SR in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to Compare the Safety and the Pharmacokinetic Characteristics
      of the Co-administration of Rosuvastatin and Metformin SR and YH14755 and to Investigate the
      Effect of Food on the Pharmacokinetics of YH14755 in healthy volunteers.
    


Intervention name(s): Rosuvastatin, Metformin, YH14755; YH14755
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Other intervention name(s): Crestor, GlucodaunOR, YH14755
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Meal Composition and the Influence on Pre-prandial Blood Glucose Values
Condition: Diabetes in Pregnancy
MeSH terms: Pregnancy in Diabetics; Diabetes, Gestational
Study type: Observational

Summary: 
      The purpose of the proposed study is to assess the distribution of carbohydrates and fat in
      the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at
      the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The
      carbohydrate distribution and fat content of the meal will be compared to maternal glucose
      control, preprandial glucose levels, and the percentile for weight of the infant at birth. In
      addition, each meal and snack will be classified as low-moderate fat or high fat.
    

Detailed description: 
      This is a retrospective chart review. Data will be collected on all patients seen whose blood
      sugar and food logs were at least 75% complete. By calculating carbohydrate amounts at meals
      and snacks, as well as classifying meals and snacks as high fat, we will examine the
      correlation to higher preprandial blood glucose values and large for gestational age infants.
      Preprandial glucose levels will be reviewed, questioning whether the biggest contributor is
      the composition of the previous meal or additional snacks between meals.
    

Intervention name(s): Carbohydrate intake
Intervention type(s): Other
Intervention description(s): By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, the investigators will examine the correlation to higher preprandial blood glucose values and large for gestational age infants.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant, all ethnic groups
Nilotinib in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and tolerability of daily oral administration of nilotinib
      (150-300mg once daily) in Parkinson's Disease.
    

Detailed description: 
      The purpose of this study is to determine if nilotinib is safe, if it can be tolerated by
      patients with Parkinson's disease (PD) and to learn if nilotinib has the possibility of
      effectively treating PD symptoms. Nilotinib has been approved by the Food and Drug
      Administration (FDA) to treat certain types of cancer (leukemia) but is considered
      investigational in this study because it has not been approved for treating PD. Twenty-five
      sites will enroll participants into 2 cohorts,approximately 75 in Cohort 1 and 60 in Cohort
      2. Participants with moderate to advanced PD symptoms will be enrolled in Cohort 1, randomly
      assigned to take nilotinib (150 mg or 300mg) or placebo, and will complete 13 in-person study
      visits over 8.5 months.

      The results from Cohort 1 will determine if either dose of nilotinib (150mg or 300 mg) is
      safe and tolerable enough to move forward and evaluate in Cohort 2. If either dose is found
      to be safe and tolerable, participants with early PD will be enrolled into Cohort 2.

      Participants in Cohort 2 will be randomly assigned to either nilotinib (dose to be determined
      from Cohort 1 results) or placebo and will complete 17 in-person visits over 14.5 months. For
      both cohorts, the study visits will include clinical assessment of motor, neuropsychiatric
      and cognitive testing as well as collection of blood and cerebral spinal fluid, collected by
      lumbar puncture.

      This study will also evaluate if nilotinib can help improve motor symptoms associated with
      PD. All participants in Cohort 1 and participants in Cohort 2 who have started PD medications
      will have an assessment of the motor exam (Part III) in a practically defined OFF state (12
      hours post dose) and ON state (at least one-hour post dose).
    

Intervention name(s): Cohort 1:Nilotinib Oral Capsules (150mg or 300mg); Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 capsules taken once daily; 2 capsules taken once daily; 2 capsules taken once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Northwestern; Nilotinib; USA; NILO-PD; Parkinson Disease
Furosemide and Coarctation Surgery Lung Complications
Condition: Pulmonary Complication
MeSH terms: Aortic Coarctation
Study type: Interventional
Phase: Phase 2

Summary: 
      in our study the investigators give furosemide during surgery for repair of aortic
      coarctation via lateral thoracotomy and evaluated lung complications in comparison to control
      group
    


Intervention name(s): Furosemide
Intervention type(s): Drug
Intervention description(s): Administering furosemide
Intervention MeSH terms: Furosemide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
VelaShape III & UltraShape Power for Thigh Circumference Reduction
Condition: Circumference Reduction
Study type: Interventional

Summary: 
      Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III
      combined with UltraShape Power treatment for non-invasive circumference reduction to the
      thighs.
    

Detailed description: 
      Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with
      the VelaShape III and UltraShape Power devices according to the study protocol.

      Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12
      weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16
      weeks.
    

Intervention name(s): VelaShape III; UltraShape Power
Intervention type(s): Device; Device
Intervention description(s): The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.; The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Circumference reduction
Assessment of Liver Cancer Response to TACE Using MultiHance-Enhanced MRI.
Condition: Hepatocellular Carcinoma
MeSH terms: Liver Neoplasms
Study type: Interventional

Summary: 
      This research is being done to find out if using the contrast agent MultiHance can be used to
      show how a liver tumor responds to the chemotherapy given during Transcatheter Arterial
      Chemoembolization (TACE).
    

Detailed description: 
      MultiHance is approved by the Food and Drug Administration (FDA) for use as a contrast
      material for Magnetic Resonance Imaging (MRI) scans of the central nervous system. It is
      believed that using MultiHance may be able to help doctors tell normal liver cells apart from
      active tumor and from tumor affected by the chemotherapy. In this way, MultiHance may improve
      the way patients with hepatocellular carcinoma are managed clinically.

      We hypothesize that the Multi-Hance contrast material will provide better image definition of
      treated liver tumor(s) on MRI imaging in comparison to other commercially available contrast
      agents.
    

Intervention name(s): gadobenate dimeglumine (MultiHance)
Intervention type(s): Drug
Intervention description(s): The contrast agent, gadobenate dimeglumine, will be used during MR imaging for both the baseline and 1 month f/u studies.
Other intervention name(s): MultiHance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: liver cancer; transarterial chemoembolization
Effects of Anaesthesia on Inflammatory Markers
Condition: Inflammatory Response
Study type: Interventional

Summary: 
      undertake confidently both open and laparoscopic cholecystectomy. Major types of body
      injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory
      response caused by hormonal, immunological and metabolic mediators. This inflammatory
      response is essential for tissue repair and has evolved to maximize the organisms' healing
      potential. In healthy individuals the inflammatory response to major surgery is well balanced
      consisting of pro- and anti-inflammatory mediators. The severity of injury, the occurrence of
      surgical complications and its accompanying level of stress may hinder the balance of the
      inflammatory response6.
    


Intervention name(s): Morphine Sulfate; morphine+lidocaine; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intrathecal morphine will be added to anaesthetics; local anesthetic will be infused intravenously; intravenous saline infusion
Intervention MeSH terms: Lidocaine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention