bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Pharmacodynamic and Pharmacokinetic Interactions of Tasimelteon and Ethanol
Condition: Pharmacodyamics and Pharmacokinetics of Tasimelteon Alone and in Combination With Ethanol
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to understand if there is any difference in the effects
      of tasimelteon when it is taken alone or in combination with alcohol. This research study is
      also being done to understand if there is any difference in the amount of tasimelteon (and
      its breakdown products) or alcohol in the blood when taken alone or together. Finally, the
      study will also look at the safety and tolerability (how acceptable it is) of tasimelteon.
    

Detailed description: 
      Alcohol is a drug that gets absorbed into the bloodstream quickly. The blood carries the
      alcohol to the brain where it slows down the messages in the brain (alcohol is a depressant).
      Alcohol affects a person's memory, behaviour, concentration, alertness (your thought process
      is slower), and coordination (your movements become clumsy). The intended effect of
      tasimelteon is to cause sleepiness. Sleepiness may result in similar effects on memory,
      concentration, alertness, and coordination as alcohol. There is the possibility taking
      tasimelteon and alcohol together can make these effects stronger or worse.
    

Intervention name(s): tasimelteon; Ethanol; Placebo tasimelteon; Placebo ethanol
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): 20mg, once; 0.6 g/kg ethanol (women) or 0.7 g/kg ethanol (men) in a total volume of 300 mL as a light cranberry juice cocktail, (consumed within 15 minutes).; once; A total volume of 300 mL as a light cranberry cocktail (consumed within 15 minutes) with about 1 mL of supernatant of ethanol in the top
Other intervention name(s): VEC-162; BMS-214778; vodka
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: alcohol
Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Dose Regimens of BIA 5-453
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to characterise the plasma and urine pharmacokinetic profile of
      Etamicastat (BIA 5-453) and its metabolites after three multiple rising dose regimens of
      Etamicastat (BIA 5-453).
    

Detailed description: 
      Single centre, double-blind, randomised, placebo-controlled study of three dosage regimens of
      Etamicastat (BIA 5-453) in 3 groups of 8 hypertensive patients.

      In each group, the study consisted of a 10-day multiple-dose period. Progression to the next
      dose level only occurred if the previous dose level was considered to be safe and well
      tolerated. An appropriate interval separated the investigation of doses to permit a timely
      review and evaluation of safety data prior to proceeding to a higher dose level.
    

Intervention name(s): Placebo; BIA 5-453
Intervention type(s): Drug; Drug
Intervention description(s): Placebo blue hard gelatine capsules; Etamicastat (BIA 5-453) blue hard gelatine capsules - 50 Strength (mg)
Other intervention name(s): Etamicastat
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Autologous Platelet Rich Plasma (PRP) for the Treatment of Chronic Non-Healing Ulcers
Condition: Chronic Ulcer
MeSH terms: Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of autologous PRP injection
      in combination with topical application of PRP gel in treating chronic or non-healing ulcers
      on lower extremity using a rapid, intra-operative, point-of-care technology at the patient's
      bedside.
    

Detailed description: 
      Platelet Rich Plasma (PRP) therapy is an innovative treatment that uses body's own cells to
      relieve pain and promote accelerated healing of Non-healing Foot Ulcer /Wound. The body's
      response to any tissue injury is to deliver platelets, which play an instrumental role in the
      normal healing process by secreting growth factors and attracting stem cells-critical
      components of the healing cascade.

      Any wound or ulcer on skin that has been present for 4-5 weeks duration, without healing is
      called a non-healing ulcer. Non-healing ulcers include venous, arterial, diabetic, pressure
      and traumatic ulcers. Cellular therapies using Autologous Platelet Rich Plasma provides new
      options for wound healing. The efficacy of the treatment has been proven in surgical
      applications, in the treatment of severe burns and in transplantation of cells and tissues.

      Local application of a solution of plasma enriched in platelets derived from the patient's
      blood intends to trigger the healing process in non-responsive chronic wound, increase the
      wound repair rate and reduce pain. PRP is a good option for non-healing wounds because it
      utilizes the body's natural healing processes to jump-start wound healing. Plasma which
      contains very valuable growth factors is separated from other blood components utilizing a
      point of care technology based on density gradient centrifugation. The platelet rich plasma
      is harvested and then activated by a mixture of human thrombin and calcium chloride for
      initiating the healing cascade followed by PRP injection directly into the ulcer/wound
      periphery or spread over a wound in the form of a PRP gel.
    

Intervention name(s): Autologous PRP Gel and PRP Injection
Intervention type(s): Biological
Intervention description(s): Autologous PRP prepared using the Res-Q™ 60 PRP system from patient's whole blood, will be injected subcutaneously around the periphery of the wound/ulcer.
Based on the wound size and area, autologous platelet gel obtained by spraying simultaneously equal volumes of PRP and activator solution (thrombin with calcium chloride) will be applied topically over the ulcer or wound.
Single dose of PRP injections and application of PRP gel will be administered, only on the day of treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Autologous PRP; Non-healing ulcer; Point-of-care
A Safety Study of Tocilizumab to Improve Transplant Rates in Highly Sensitized Patients Awaiting Kidney Transplantation
Condition: End Stage Renal Disease (ESRD)
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this Phase I/II trial, 10 highly sensitized patients will be entered after informed
      consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg x
      5 doses on days 15, 45, 75, 105, 119, 135, and 149. If robust reductions in anti-HLA antibody
      are seen, patients will progress to kidney transplantation when an "acceptable" crossmatch is
      achieved with a living donor (LD) or deceased donor (DD). Those receiving transplants will
      also receive Tocilizumab infusion monthly X7 doses post-transplant. All subjects will have
      intensive monitoring of Donor Specific Antibodies (DSA), viral PCRs, and routine
      post-transplant labs. At 6 months post-transplant, those who have retained their transplanted
      kidney will have a protocol biopsy.
    


Intervention name(s): Tocilizumab; Intravenous Immunoglobulin
Intervention type(s): Drug; Drug
Intervention description(s): Tocilizumab 8mg/kg on Days 0, 15, 30, 45, 75, 105, 119, 135, 149, and 180; All HS who meet criteria for desensitization will receive IVIG 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30).
Other intervention name(s): Actemra®; IVIG
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Donor-Specific Anti-HLA Antibodies; Kidney Transplantation
A Brief Study To Evaluate The Safety, Tolerability, And Blood Levels Of Multiple Doses Of PF-044467943 Or Placebo In Combination With Donepezil In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety of PF-04447943 when given in combination
      with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the
      absorption and distribution of both PF-04447943 and donepezil.
    


Intervention name(s): PF-04447943; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg of PF-04447943 orally every 12 hours for 7 days; 25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: phase 1 Alzheimer's disease donepezil
PENG-block Versus FIB-block in Emergency Room
Condition: Pain Relief in Proximal Femoral Fracture
MeSH terms: Emergencies; Femoral Fractures
Study type: Interventional

Summary: 
      The trial aims to verify a possible greater analgesic efficacy of PENG (Pericapsular Nerve
      Group) block compared to iliac fascia block (FIB block) in elderly patients (age > 65 years)
      suffering from traumatic fracture of proximal femur in emergency room.
    

Detailed description: 
      Prospective randomized double-blind single-center preliminary study aimed to demonstrate a
      possible greater analgesic efficacy of the PENG block compared to the iliac fascia block (FIB
      block) in elderly patients (age > 65 years) suffering from traumatic fracture of the proximal
      femur in emergency room.

      The study will cover patients aged > 65 years suffering from a proximal traumatic fracture of
      the femur who access the emergency room of Santo Spirito Hospital in Rome (ASL Roma 1).
    

Intervention name(s): Regional Anesthesia - Nerve Blocks
Intervention type(s): Procedure
Intervention description(s): Regional Anesthesia and ultrasound-guided nerve blocks
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      The main objective of the study is to examine the relationship between anxiety disorders and
      neurodevelopmental disorder/delay in children aged 7- 13 years.
    

Detailed description: 
      Project summary Anxiety disorders (AD's) in childhood are common and may cause great
      suffering.Childhood AD's may persist into adulthood and knowledge of important risk factors
      for development and maintenance of these disorders is essential.The development of AD's is
      due to a complex interaction between biological and environmental factors.This study will
      examine the relationship between AD's and two biological risk factors:1.Neurodevelopmental
      delays/disorders (NDD'S) in motor and cognitive function and 2.Temperament/personality.To
      date a few studies have consistently found that motor impairment is associated with childhood
      anxiety and predicts persistent anxiety in adolescence.The association between AD's and NDD's
      in cognitive functions such as language and attention is far less studied. In contrast, there
      is a huge research literature on temperament as a risk factor for AD's.The temperamental
      trait "behavioural inhibition" has been shown to be particularly associated with
      AD's.However, very few studies have examined the interplay between NDD's, temperament and
      anxiety.The study is a clinical case-control study of children aged 7-13 years with AD's
      referred to three different out-patient clinics.The participants will be assessed by
      diagnostic interviews, neuropsychological tests and temperament/personality
      instruments.Comparison groups are:1.children with ADHD (to compare AD's with another mental
      disorder related to NDD's) and 2.Non-referred children without a mental disorder. Follow-up
      at 6 months,1 and 5 years.A pilot study at two of the three out-patient clinics to be
      included,showed a sufficient sample size.Anticipated implications of the study include
      increased knowledge of biological risk factors and of latent neurological brain correlates,as
      well as treatment implications.Children with NDD's are often met with demands they cannot
      cope with due to their neurodevelopmental immaturity.To adjust the demands to the child's
      actual level of functioning is important.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Consecutive patient sampling
      
Biospecimen description: 
      Saliva for measuring Cortisol
    
Keywords: anxiety disorders; children; neurodevelopmental disorder; neurodevelopmental delay; temperament
A Multisite Trial of ACQUIREc Therapy
Condition: Hemiparetic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      A multisite trial to testing different dosage levels of a systematic form of Pediatric
      Constraint-Induced (CI) Therapy called ACQUIREc Therapy. The high dosage treatment involved 6
      hours of daily therapy services for 21 days. This was compared to a moderate dosage level of
      3 hours of daily therapy services for 21 days. It was hypothesized that children receiving
      the higher therapy dosage would have greater and more clinically significant benefits from
      ACQUIREc Therapy but that both groups of children would benefit from the therapy services.
    


Intervention name(s): Therapy services (ACQUIREc Therapy)
Intervention type(s): Other
Intervention description(s): Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.
Other intervention name(s): Occupational Therapy; Physical Therapy; Pediatric CI Therapy; ACQUIREc Therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric CI Therapy; ACQUIREc Therapy; Dosage; Occupational Therapy; Physical Therapy; Cerebral Palsy; Hemiparesis
Role of Active Valvular Calcification and Inflammation in Patients With Aortic Stenosis
Condition: Aortic Stenosis
MeSH terms: Aortic Valve Stenosis; Calcinosis; Inflammation; Constriction, Pathologic
Study type: Observational

Summary: 
      The aortic valve is the main outlet valve from the heart. This valve can become diseased and
      narrowed when it needs to be replaced with an artificial valve. Currently, this is the
      commonest reason for someone to undergo a heart valve operation in the UK. Unfortunately,
      there are no medical treatments that can prevent or delay the progression of this disease
      process. Here, the investigators propose to use new state-of-the-art imaging techniques to
      better understand the disease process so that the investigators can effectively design and
      assess potential new treatments. The ultimate aim is to stop this disease before patients
      need to have surgery. In addition the investigators believe this technique will allow us to
      predict the rate of progression of the disease
    

Detailed description: 
      Aortic stenosis is the commonest valvular heart disease in the western world and is the
      leading indication for valve surgery. Histological studies have suggested similarities with
      atherosclerosis including inflammation, lipid deposition, increased macrophage activity and
      calcification. However, recent randomised controlled trials have failed to demonstrate a
      reduction in the rate of disease progression with statin therapy and the investigators
      believe there is now a need to re-evaluate the underlying factors involved in the initiation
      and progression of aortic stenosis. The investigators propose to assess the role of
      inflammation and calcification in the pathogenesis and progression of aortic stenosis by
      using positron emission tomography with [18F]-fluorodeoxyglucose and [18F-]-fluoride in
      patients with a range of aortic valve disease. The investigators hypothesise that increasing
      severity of valvular inflammation and calcification will correlate with disease severity and
      rate of disease progression. This work will lay the foundation for the subsequent application
      of interventions targeted at inflammation and calcification.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators will recruit 168 patients: 24 control patients, 24 mild, 48 moderate and
        48 severe aortic stenosis
      
Biospecimen description: 
      In patients undergoing aortic valve replacement during the course of the trial we will retain
      samples of their aortic valve for histological studies.
    
Keywords: Positron Emission Tomography; Inflammation; Calcification
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
Condition: Chronic Hepatitis C Infection; Compensated Cirrhosis
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267
      (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and
      ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus
      (HCV) genotype 1-infected adults with compensated cirrhosis.
    

Detailed description: 
      During the treatment period of the study, participants received treatment with
      ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon
      completing the treatment period or premature discontinuation of the treatment period,
      participants entered a 48-week post-treatment period.
    

Intervention name(s): ABT-450/r/ABT-267, ABT-333; Ribavirin (RBV)
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet; Capsule
Other intervention name(s): Viekira Pak; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cirrhosis; Hepatitis C; Child Pugh A; Compensated Cirrhosis; Hepatitis C Genotype 1; Cirrhotic; Chronic Hepatitis C; Hepatitis C Virus; ombitasvir; paritaprevir; dasabuvir; Interferon-Free; Viekira Pak
Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear
Condition: Foot Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this prospective proof of concept study is to examine the effectiveness of a
      new pain relief footwear (Orthofeet) on function and daily activities. he investigators
      hypothesize that Orthofeet will reduce foot pain leading to an increase in daily physical
      activities, measured objectives using validated wearables (PAMSys and Garmin wristwatch), and
      functional performance (gait and balance). In addition, the investigators hypothesis that
      reduction in foot pain is associated with reduced physiological stress response (HRV) and
      better community engagement (assessed by life space questionnaire).
    

Detailed description: 
      A clinical study at the Baylor College of Medicine, to evaluate short and intermediate
      benefits and effectiveness of a novel pain relief footwear, called Orthofeet. This is a
      randomized crossed over trial. The duration of the study would be 12-week. The investigators
      will recruit 50 eligible ambulatory adults (age 50 years or older) with moderate to severe
      self-reported foot pain. Participants will be randomly assigned to Group A (25 subjects) and
      Group B (25 subjects). There is no difference in assessments or eligibility between Group A
      and Group B, the only difference is when they have the opportunity to try the shoes for 6
      weeks. Group A will receive a pair of Orthofeet shoes with adjustable insoles and will be
      asked to wear it every day activities of daily living for duration of six weeks. Participants
      will be also encourage to wear the shoes inside of home if possible. Group B will be followed
      for duration of six weeks. At six weeks the groups will be switched and group B will receive
      and a pair of Orthofeet shoes with adjustable insoles and Group B will follow-up for six week
      without Orthofeet shoes. Participants will be assessed at baseline, week-1, week-6, week 7,
      and week 12.
    

Intervention name(s): Orthofeet Shoes
Intervention type(s): Device
Intervention description(s): Participants will wear a pair of Orthofeet shoes to wear for 6 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: foot pain; falls; frailty; footwear; mobility