bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Implanon in Obese Women
Condition: Contraception; Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Prior studies examining the pharmacokinetics, safety, and efficacy of the new
      etonogestrel-containing single rod implantable contraceptive device, Implanon, did not
      include women who exceeded 130% of ideal body weight. Yet, as these women comprise a
      significant portion of the U.S. population, studies of Implanon in obese women are essential.
      The proposed study represents an important first step in addressing the lack of data on
      Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women
      during the first 6 months of use and to provide data on the acceptability, side effect
      profile, and ease of insertion, palpation, and removal in these women. We also aim to collect
      samples for future validation studies of the use of the blood spot (finger-stick blood sample
      on filter paper) as a method of determining plasma etonogestrel.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from resident and faculty practices at the University of
        Chicago outpatient facilities and from the University of Chicago clinical trails database
        of past study participants.
      
Biospecimen description: 
      whole blood, serum, plasma
    
Keywords: Contraception; Implanon; Obesity; Blood spots; Implant; Pharmacokinetics
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional

Summary: 
      This study is being conducted to evaluate if a written action plan for hidradenitis
      suppurativa (HS) will help patients with hidradenitis suppurativa gain a better understanding
      of the condition and how to manage the condition on a daily basis compared to a routine
      verbal consultation.
    


Intervention name(s): Verbal consultation; Written Action Plan
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Verbal consultation only without written information before receiving written action plan; Written handout of treatment plan and disease management strategies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
Condition: End-Stage Kidney Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to identify subjects who are highly sensitized with antibodies.
      It is difficult for these patients to find suitable kidneys. We propose to treat such
      patients to decrease the antibodies in such a way, that it may become possible to safely
      transplant kidneys into them.
    

Detailed description: 
      Kidney transplantation is the desired treatment of choice in subjects with end-stage kidney
      disease (ESRD). The average waiting time for subjects to receive a "deceased donor" kidney
      transplant is 3-5 years. Currently, there are about 60,000 subjects on the national waiting
      list, and about 13,000-14,000 kidney transplants are performed each year. Approximately, 25%
      of subjects on the waiting list are "highly sensitized", meaning that they have natural
      proteins (antibodies) that aggressively protect their bodies from the invasion of foreign
      proteins. These individuals often have a difficult time accepting transplanted kidneys. The
      purpose of this study is to identify subjects who are highly sensitized with these
      antibodies, and treat them in such a way, that it may become possible to transplant kidneys
      into them. Drugs like atorvastatin (Lipitor) may decrease the levels of these anti-bodies and
      increase the possibility of these subjects to receive a kidney transplant. This research
      study is being done because currently, there are very limited and cumbersome treatment
      options to address this issue, subjects who are highly sensitized with antibodies, may
      unfortunately wait for a very long time or may never get transplanted.
    

Intervention name(s): Atorvastatin (Lipitor)
Intervention type(s): Drug
Intervention description(s): 20mg every day, taken by mouth. Dose could be increased up to 60mg every day during the course of the trial if tests indicate this is needed.
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney Disease, Lipitor, Atorvastatin, Allosensitization
Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering
Condition: Healing Surgical Wounds
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      This study represents a prospective, controlled and randomized clinical trial assessing the
      effects of L-PRF on the healing time of the donor area and on the patient's postoperative
      morbidity in the 4 weeks following the Apically Positioned Flap (APF) procedure in the
      uncovering phase of two-stage implants.

      A total of 40 patients were recruited and divided into two groups. The implant uncovering
      procedure in the test group was performed with APF and application of L-PRF on the donor
      area. Patients in the control group, on the other hand, were treated with APF alone, leaving
      the donor area to heal by secondary intention.
    


Intervention name(s): Application of L-PRF on the donor area; Secondary intention healing of the donor area
Intervention type(s): Procedure; Procedure
Intervention description(s): After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF; After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Platelet Rich Fibrin; Wound Healing; Implant Uncovering
The Effect of In Vitro Fertilization on Coagulation Parameters as Measured by Thromboelastogram
Condition: Fertilization in Vitro and Blood Coagulation Factors
Study type: Observational

Summary: 
      Since its introduction in 1978, over 3.75 million babies have been born using in vitro
      fertilization (IVF). Maturing ovarian follicles lead to a large rise in estrogen to
      supra-physiological levels . This increase in estrogen has been shown to cause a
      hypercoagulable state, leading at times to arterial and venous thrombosis.(Thromboelastogram
      (TEG) is a point of care whole blood hemostatsis analyzer mimicking in vivo conditions and
      measuring visco elastic properties of the clot. The TEG shows effect of most of the
      components of hemostatsis: coagulation factors, fibrinogen, platelets and fibrinolysis.
      Components of TEG include R, reflecting coagulation factor cascade, alpha angle and K
      measurements reflecting fibrin function, MA reflecting mostly thrombocyte function,
      coagulation index (CI) measuring global hemostatic statis and LY30 measuring fibrinolysis.

      In this study the investigators would like to measure serum estrogen levels and (TEG) in
      parturients at the beginning and conclusion of an IVF simulation cycle and evaluate how it's
      influnence on coagulation parameters, and wheather or not a large sample size will effect
      primary outcomes.

      Secondarily the investigators would like to see if estrogen levels are predictors of
      coagulation parameters and see if age influences TEG parameters
    


Intervention name(s): Blood coagulation anyalsis by Thromboelastogram
Intervention type(s): Other
Intervention description(s): Two blood tests will be taken during routine tests from all parturient s undergoing IVF treatment before starting gonadotropins treatment (the first few days of menstruation) and at the height of hormone therapy prior to egg retrieval Coagulation parameters will be measured by the use of Thromboelastogram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parturients undergoing in-vitro fertilization treatment
Mycoprotein Consumption and Glucose Absorption
Condition: Healthy
Study type: Interventional

Summary: 
      Previous research has demonstrated that the food found in Quorn 'Mycoprotein' can lower the
      blood glucose response to a meal, which may be an important finding for the management of
      type 2 diabetes. However, it has never been investigated how this lower response occurs, and
      whether there is dose-dependent response with mycoprotein. The present study will include 12
      healthy young adults, who will visit the laboratory for 3 test days, with each day lasting 9
      hours. On each visit, separated by a washout period of at least 2 weeks, participants will
      ingest either a control drink with no mycoprotein, a drink containing 20g mycoprotein or a
      drink containing 40g mycoprotein. By intravenously infusing labelled glucose during each
      visit in combination with repeated blood sampling, investigators will determine if the lower
      blood glucose after mycoprotein ingestion is due to reduced glucose absorption from the gut
      or increased uptake into body tissues.
    


Intervention name(s): Mycoprotein Ingestion
Intervention type(s): Dietary Supplement
Intervention description(s): Ingestion of various doses of mycoprotein compared to placebo control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on
      treatment for children affected by allergic rhinoconjunctivitis.
    

Detailed description: 
      Allergic rhinoconjunctivitis (AR) is a common chronic disorder in children, especially in
      developed countries. It is not characterized by nasal symptoms only (such as congestion and
      sneezing), but may also cause general complaints such as fatigue and cough. AR can also have
      detrimental effects on mood, sleep, social activities and scholastic performance.

      Lertal® is a novel nutraceutical containing seed extracts from Perilla Frutescens, Quercetin
      extracted from Sophora japonica and Vitamin D3, all compounds that have demonstrated their
      ability to reduce allergy symptoms and the use of anti-allergy drugs in adults.

      The aim of this randomized, double-blinded, parallel-group, placebo-controlled study is to
      evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by
      allergic rhinoconjunctivitis.
    

Intervention name(s): Lertal® + standard therapy; Placebo + standard therapy
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Lertal® is a novel food supplement. Each tablet contains the following active ingredients:
Quercetin 150 mg: a natural flavonoid that inhibits the release of histamine, leukotrienes, PGD2, IL (IL-6, IL-8, TNF-alpha).
Perilla frutescens 80 mg: A dry extract of the seeds containing rosmarinic acid, luteolin, apigenin and crysoeriol that inhibits the release of histamine and expression of interleukins (IL-6, TNF-alpha).
Vitamin D3 5 mcg (200 IU), which contributes to the normal function of the immune system.
Standard therapy: antihistamine.; Placebo tablet identical in appearance, size and taste to Lertal® tablets. Standard therapy: antihistamine.
Standard therapy: antihistamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blinded, parallel-group, placebo-controlled clinical study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vorapaxar in the Human Endotoxemia Model
Condition: Healthy Volunteers
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet
      inhibition may also exert positive results on coagulation activation and may beneficially
      influence the inflammatory response. Since vorapaxar is the first available substance of a
      new class of platelet inhibitors its effects on the human coagulation system and the
      inflammatory response will be assessed in the well-established human endotoxemia model.
    

Detailed description: 
      Vorapaxar is a novel platelet inhibitor inhibiting PAR-1. It is the first available substance
      of a new class of platelet inhibitors blocking the activation of platelets via thrombin or
      thrombin receptor activating peptides via PAR-1. As platelets contribute to the coagulation
      activation, i.e. by providing the surface for the assembly of the Tenase complex, and
      furthermore to the inflammatory response by releasing their stored granula containing
      promotors of both, inflammation and coagulation, we want to assess the effects of vorapaxar
      on these in the human endotoxemia model. Sixteen healthy volunteers will be included in this
      randomized, double-blind, placebo-controlled, single center, crossover trial with a washout
      period of 8 weeks. This wash out period was chosen based on the long elimination half-life of
      vorapaxar and to prevent any carry-over effects. After intake of 10mg vorapaxar (-24h) the
      degree of platelet inhibition will be assessed by whole bood aggregometry and, in case of
      insufficient platelet inhibition, subjects may receive another 10mg of vorapaxar. A bolus of
      2ng/kg bodyweight lipopolysaccharide (LPS) will be infused and blood sampling will be
      performed at pre-defined time-points. After the washout-period the respective other treatment
      will be given to subjects.
    

Intervention name(s): Vorapaxar; Placebo; LPS
Intervention type(s): Drug; Drug; Other
Intervention description(s): 10mg-20mg vorapaxar to achieve >80% thrombin-receptor activated peptide-6 (TRAP) induced platelet inhibition; 2ng/kg Lipopolysaccharide as a bolus infusion
Other intervention name(s): capsules consisting of lactose-starch; Lipopolysaccharide
Intervention MeSH terms: Vorapaxar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coagulations; Platelets; Inflammation; endotoxemia; vorapaxar
Intake Duration Effects of Blackcurrant on Cardiovascular and Metabolic Responses
Condition: no Conditions
Study type: Interventional

Summary: 
      Study will examine the metabolic, physiological and cardiovascular changes by intake of New
      Zealand blackcurrant extract at rest and during moderate-intensity treadmill walking in
      healthy males.
    

Detailed description: 
      The investigators will examine effects of acute intake, intermittent intake and chronic
      intake of New Zealand blackcurrant extract using indirect calorimetry and hemodynamic
      measurements.
    

Intervention name(s): New Zealand blackcurrant extract
Intervention type(s): Dietary Supplement
Intervention description(s): Capsules taken daily or intermittent
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis
Condition: Menopause; Postmenopausal Vaginal Atrophy
MeSH terms: Vaginitis; Atrophic Vaginitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial was conducted in the United States of America (USA). This trial aimed for a
      comparison between the effect of two different doses of estradiol on parameters related to
      efficacy and safety.
    


Intervention name(s): estradiol, 10 mcg; estradiol, 25 mcg; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection
Condition: Fluid Management
MeSH terms: Liver Neoplasms
Study type: Interventional

Summary: 
      Studies have demonstrated that the rate of change in stroke volume variation (SVV) can be
      used to determine the volume of body fluids during major abdominal surgery.
      Anaesthesiologists can use SVV as a guide for the appropriate administration of
      intraoperative fluids to improve postoperative prognoses. Liver surgery is a major abdominal
      operation, and the amount of blood lost is typically higher than that during other general
      abdominal surgeries. Blood loss is positively correlated with the intraoperative fluid
      infusion volume, and greater blood loss is associated with more postoperative complications.
      Additionally, comorbid liver disease or cirrhosis can increase the complexity of liver tumour
      resection, causing difficulty in assessing intravascular volume and determining the
      appropriate intraoperative infusion volume.
    


Intervention name(s): SVV-guided fluid management
Intervention type(s): Procedure
Intervention description(s): fluid will be guided by value of stroke volume variation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial had a randomised study design with simple randomisation and a fixed allocation ratio (1:1 to the low-SVV group or high-SVV group). The patients were blinded to the randomisation and allocation.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stroke volume variation; Fluid therapy; Hepatectomy; Alanine aminotransferase; Estimated glomerular filtration rate
Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
Condition: Primary Immune Deficiency Disorder
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients
      with primary immunodeficiency.
    


Intervention name(s): Vigantol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vigantol 4000IU/day; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Breastfeeding Study
Condition: Infant Term Birth
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the stool consistency and microbiota composition of
      healthy breastfed infants.
    

Detailed description: 
      This is a prospective, observational, non-interventional study. The purpose of this study is
      to evaluate the stool consistency and variability in fecal microbiota composition, diversity,
      and abundance of defined taxa in 75 healthy, term, exclusively breastfed infants. All
      enrolled infants will participate in the trial for approximately 169 days.
    

Intervention name(s): Breastfed infants
Intervention type(s): Other
Intervention description(s): Breastmilk
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        75 healthy term exclusively breastfed infants
The Neural Basis of Lumbosacral Proprioceptive Impairment in Recurrent Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Low back pain (LBP) is a well known health problem in Western society that is significantly
      responsible for socio-economic problems like absenteeism and disability. The lifetime
      prevalence of LBP is 60-80% and approximately 85% of this LBP has a "non-specific" character
      whereby the underlying causes and risk factors cannot be demonstrated. While many people
      recover within a month, most individuals will have recurrence within a year with more severe
      symptoms. This might be due to insufficient knowledge of the underlying mechanisms. Impaired
      proprioception, the ability to discern body/limb positions and movements, may cause and
      maintain LBP shown by an altered postural control strategy. Specifically, patients with LBP
      rely more on proprioceptive signals from the ankles due to less reliable proprioceptive input
      of proximal segments. Moreover, they show a decreased variability in postural control and
      less postural robustness, while variability is a prerequisite for optimal functioning of
      biological systems. However, further clarification of the neural correlates is necessary.
      Deficits in proprioception, as found in a subgroup of patient with LBP, are associated with a
      decreased ability of the brain to process proprioceptive inputs.

      The aim of this project is to clarify the central changes in individuals with recurrent
      non-specific low back pain and healthy controls. To evaluate these central changes MRI
      techniques (3DTFE, DTI and RS-fMRI) will be used. In addition, the association between
      central changes and postural control tasks will be evaluated.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Leuven and surrounding area
      
Keywords: Low back pain; Proprioception; Postural control; Spine; Variability; MRI; Vibration; Brain
A Single Oral Dose Study to Compare the Bioavailability Between Two Different Tablet Formulations and Assess if There is a Food Effect With the New Formulation
Condition: Pharmacokinetics of ASP015K; Bioavailability of ASP015K; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioavailability and pharmacokinetics between
      two different formulations of ASP015K tablets and determine the food effect on the absorption
      of the new formulation.
    

Detailed description: 
      Eligible subjects will be admitted on Day -2 and remain confined on the unit for 20 days.
      Each subject will receive a single dose of study drug per the defined treatment periods on
      the morning of Day 1, Day 8 and Day 15. There will be a minimum of 7 days between each
      consecutive dose group.

      For Treatment A, Formulation 1 tablets will be administered within 30 minutes after the start
      of a standard FDA moderate-fat breakfast. Treatment B, Formulation 2 tablets will be
      administered in a fasted state. For Treatment C, Formulation 2 tablets will be administered
      within 30 minutes after the start of a standard FDA moderate-fat breakfast.

      Any subject discontinuing the study prior to completion should have all end of study
      evaluations completed
    

Intervention name(s): ASP015K
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP015K; healthy subjects; bioavailability; food effect; rheumatoid arthritis; psoriasis; transplantation