bioihbjkbjnl/mcl2 huggingface dataset:
Dynamic Scaffold Versus Lichtenstein Open Hernioplasty.
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Evaluating the outcomes of patients undergoing open anterior inguinal hernioplasty comparing
      two different techniques: Lichtenstein/plug and mesh and ProFlor. The outcomes of these two
      groups of patients, respectively the Lichtenstein inguinal hernia repair with static flat
      mesh and the defect obliteration with 3D dynamic scaffold Proflor, are compared in respect to
      defined variables along stages: intraoperative, early and long term postoperative.
    


Intervention name(s): inguinal hernia repair with mesh
Intervention type(s): Procedure
Intervention description(s): inguinal hernia repair with mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inguinal hernia repair; ProFlor technique; lichtenstein hernia repair
Pharmacokinetic and Safety Comparison of Two Capecitabine Tablets in Patients With Colorectal or Breast Cancer
Condition: Patient Participation
Study type: Interventional
Phase: Phase 1

Summary: 
      A multicenter, randomized, open-label, three-period, and reference-replicated crossover study
      was conducted in 48 patients with colorectal or breast cancer under fed conditions to assess
      the bioequivalence between two formulations of capecitabine.
    

Detailed description: 
      This was a multicenter, open, random, balanced, three-period, three-sequence and
      semi-repetitive cross study with 48 subjects. Eligible subjects were randomly assigned in a
      1:1:1 ratio to receive one period of test formulation or two period of reference formulation,
      followed by a 1-day washout period and administration of the alternate formulation. Serial
      blood samples for pharmacokinetic assessment were collected at 0 hours (predose) up to 8
      hours postdose. The plasma concentrations of capecitabine were analyzed by LC/MS-MS.
      Pharmacokinetic parameters (non-compartmental model) were assessed with WinNonlin software.
      The pharmacokinetic parameters assessed were area under the plasma concentration-time curve
      from time 0 to the time of last measurable concentration (AUC0-t), AUC from time zero to
      infinity (AUC0-∞), the peak plasma concentration of the drug (C max ), time needed to reach
      maximum concentration (Tmax), the elimination half-life (t1/2), and terminal elimination rate
      (λz). All were analyzed using an ANOVA model after logarithmic transformation of the data.
      For establishing bioequivalence (BE) for capecitabine， reference-scaled average
      bioequivalence (RSABE) acceptance criteria and average bioequivalence (ABE) acceptance
      criteria were used. Safety and tolerability was assessed during the entire study period.
    

Intervention name(s): 150 mg of Xeloda®; 150 mg of capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects were allocated to one of three groups randomly and equally with a 1-day wash time period. 150 mg of Xeloda® produced by Genentech USA, Inc., a subsidiary of the company, was used as the reference intervention in this study.The subjects randomly received single oral administration of 150 mg of Xeloda®.; Subjects were allocated to one of three groups randomly and equally with a 1-day wash time period.The tablet of 150 mg of capecitabine from Qilu Pharmaceutical Co., Ltd. (17H0053DE4, Jinan, Shandong Province, China) was used as the test formulation.The subjects randomly received single oral administration of 150 mg of capecitabine.
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A multicenter, randomized, open-label, three-period, and reference-replicated crossover study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Capecitabine; Bioequivalence; Pharmacokinetics
Efficacy and Safety of Pediatric Drugs in Nasal Congestion
Condition: Nasal Congestion
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of the Naridrin in improving nasal
      congestion.
    

Detailed description: 
      Open label, randomized, multicenter clinical study. Maximal experiment duration: 2 days; 2
      visits. Safety and efficacy evaluation
    

Intervention name(s): Naridrin; Afrin
Intervention type(s): Drug; Drug
Intervention description(s): Naridrin® : 2 drops in each nostril once daily as prescription; 2 pumps in each nostril every 12 hours.
Other intervention name(s): Naphazoline Hydrochloride; Mepyramine Maleate; Dexpanthenol; oxymetazoline hydrochloride
Intervention MeSH terms: Pyrilamine; Phenylephrine; Oxymetazoline; Naphazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasal congestion
A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, three-period, crossover, single-dose study to evaluate the
      effects of a low-fat meal and a standard meal on the pharmacokinetics of DBPR108 and the
      safety and tolerability of DBPR108 under different fed states in healthy adult subjects.
    

Detailed description: 
      The objective of the study is to evaluate the effect of different meal types on the
      pharmacokinetics of DBPR108, a potent dipeptidylpeptidase-4 inhibitor. In this open-label,
      randomized, three-period, crossover study, healthy subjects will receive a single dose of
      DBPR108 100 mg under fasted conditions and following a low-fat meal or a standard meal.
      Twenty-one healthy subjects will be randomized 1:1:1 to Sequence A, Sequence B, or Sequence
      C. This study will consist of a screening and baseline period, a treatment period, and a
      follow-up period. Blood samples for pharmacokinetic assessments will be taken pre-dose and up
      to 48 h post-dose.
    

Intervention name(s): DBPR108 tablets
Intervention type(s): Drug
Intervention description(s): Drug: DBPR108, tablets, oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SurePulse Oximeter - a Targeted Oxygenation Observation
Condition: Healthy
Study type: Interventional

Summary: 
      This clinical investigation will investigate how accurate the SurePulse VS and SurePulse VS
      Patch (VSP) are for measuring blood oxygen levels (oxygen saturation). If the results are
      accurate, the VSP will be ready to apply for regulatory approval, meaning it could then be
      available for use on newborn babies in the National Health Service (NHS).
    

Detailed description: 
      Healthy volunteers who express an interest in the study and meet the eligibility criteria
      will be invited to participate in the study. This study will investigate the accuracy and
      safety of the SurePulse VS and SurePulse VS Patch (VSP) in measuring blood oxygen levels.
      This is done by measuring blood oxygen levels across a range of values in healthy adults. The
      measurements from the VS and VSP will be compared to the known correct value. The study
      follows the internationally agreed standard for pulse oximeter approval.

      Agreeing participants will have their name, contact details, medical history, height, weight,
      date of birth, skin colour, emergency contact details and address recorded, as necessary to
      conduct the study. After completion of the eligibility and consent process, participants will
      be enrolled in the study. Healthy volunteers will have their blood oxygen levels temporarily
      reduced in a controlled and stepwise manner. Oxygen levels will not be low for the entire
      duration of the session. Oxygen levels will be reduced to a specific target for a few minutes
      at a time. Volunteers will have a small tube inserted into an artery (blood vessel) in their
      wrist; this will be used to take blood samples throughout the session. The blood samples will
      be taken, analysed and destroyed in the same room. The session should take approximately 1.5
      - 2 hours in total.

      The output from the study will be compared to the primary and secondary outcomes to evaluate
      the performance and safety of the device. This study is required for the SurePulse VSP to be
      regulatory approved, meaning it could then become available in the NHS.
    

Intervention name(s): SurePulse VSP; SurePulse VS
Intervention type(s): Device; Device
Intervention description(s): A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VSP placed on the volunteer.; A controlled and stepwise reduction in oxygen blood levels in healthy volunteers, with the SurePulse VS placed on the volunteer.
Intervention model: Single Group Assignment
Intervention model description: A controlled and stepwise reduction in oxygen blood levels, with both the SurePulse VS and SurePulse VSP placed on the volunteer.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Hypoxia; Oxygen Saturation; Pulse Oximetry
Rediscovering Hydroxychloroquine as a Novel Insulin Sensitizer
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      Current options to treat insulin resistance in diabetes are fairly limited. For this reason,
      novel treatments would represent a major progress. The generic drug hydroxychloroquine (HCQ)
      has poorly understood effects on blood sugar metabolism. In this study, the investigators
      will examine the mechanisms by which this drug affects glucose metabolism and which cells are
      affected. Findings emanating from this project will help establish whether HCQ may be a
      viable treatment for disorders of glucose metabolism.
    


Intervention name(s): Hydroxychloroquine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Hydroxychloroquine sulfate 400mg/d PO for 13±1 weeks; Placebo PO for 13±1 weeks
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
The Effects of Trancranial Magnetic Stimulation Multichannel Stimulator on Motor Excitation
Condition: Healthy
Study type: Interventional

Summary: 
      Our aim is to Test the influence of a new multichanel Transcranial Magnetic Stimulation
      stimulator (Multiway) on motor excitation, in comparision to a wildly used Magstim Super
      Rapid 2 single channel stimulator.

      Each of the 20 Healthy subjects that are inticipated to inrole to the study wiil undergo 6
      simple procedures which are designed to compare the motor threshold obtained by diffrent
      combination of TMs coils (figure 8, double cone coil,H coil array) and stimulators (Multiway,
      Super Rapid 2).

      The entire length of the procedures is about 4 hours and all subjects will be paid for their
      participation in the study.

      Our main hypothesis is that the motor threshold obtained by the multichanel stimulator will
      be significtly lower then the single chanel stimulator.
    


Intervention name(s): Magstim Rapid2 Stimulator; Brainsway Multi-channel Stimulator
Intervention type(s): Device; Device
Intervention description(s): Duration: Time is takes to find motor thresholds obtained with figure-8 coil using Magstim Rapid2 Stimulator (Estimated at 15 minutes).
Total Duration of device: 15 minutes; Finding motor thresholds using the figure-8 coil and the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).
Finding motor threshold of leg obtained with Double Cone coil using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).
Finding motor threshold of leg obtained with circular coils using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).
Finding motor threshold of thumb obtained with circular coils on multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 15 minutes).
Finding motor thresholds of multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 1 hour).
Finding specificity of the motor thresholds of multiple channels using the Brainsway Multi-channel Stimulator (Estimated at 30 minutes).
Total Duration with Device: 2 hours and 30 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Transcranial Magnetic Stimulation; TMS; Motor Threashold; Multiway; Magstim Rapid 2; Abductor policis brevis; Figure 8 coil; Double cone coil; Circular coil; Brainsway; Healthy participants.
Retapamulin as a Decolonizing Agent for MRSA
Condition: MRSA
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of
      MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin
      among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The
      sample size will include 27 subjects in each of the two arms of the study (retapamulin versus
      placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal
      colonized with MRSA will be randomized to receive either retapamulin or placebo applied
      nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at
      pre-defined time points during study duration (screening swab, swab one week after completion
      of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA
      colonization status. The colonization rates of both groups will be assessed via Fisher's
      Exact Test.
    


Intervention name(s): Retapamulin; Placebo Ointment
Intervention type(s): Drug; Drug
Intervention description(s): Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).; The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.
Intervention MeSH terms: Retapamulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rectal MRSA; mupirocin-resistant nasal MRSA
Ultrasound Guided Intra-uterine Device Insertion
Condition: Contraception
Study type: Interventional

Summary: 
      Different studies have been made in an attempt to reduce the pain and the duration of the
      process of outpatient insertion of the intrauterine device. in this trial, the investigators
      aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain,
      decrease the process of insertion, in addition, it reduces the incidence of malposition of
      IUD as well as the risk of complications.
    


Intervention name(s): intrauterine device TCu 380A
Intervention type(s): Device
Other intervention name(s): TCu 380A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Chronic PDE5-Inhibition on Endothelial Function in Diabetics
Condition: Diabetes
Study type: Interventional
Phase: Phase 3

Summary: 
      chronic PDE5-Inhibition improves endothelial function in diabetics
    

Detailed description: 
      Evaluation of endothelial function at baseline and after chronic administration of sildenafil
      in male subjects with diabetes
    

Intervention name(s): sildenafil
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: function; inhibition
The Role of Stem Cells on Immune Cells in the Development of Cardiovascular Diseases
Condition: Atherosclerosis; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Observational [Patient Registry]

Summary: 
      An observational pilot proof-of-principle study. 15 patients with significant coronary artery
      disease and 15 matched controls. To investigate whether long-term activation of the innate
      immune system, named 'trained innate immunity', occurs at the level of the bone marrow
      progenitor cells in patients with significant coronary artery disease and whether this
      correlates with the proinflammatory phenotype of monocytes.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include 15 patients with significant coronary artery disease and 15
        patients without significant coronary artery disease. Patients who have been presented to
        the cardiology departments of the CWZ hospital or Radboud University Medical Centre and
        have undergone CCTA in the past two years are eligible to participate if they meet the in-
        and exclusion criteria.
      
Biospecimen description: 
      whole blood, serum, plasma and bone marrow
    
Keywords: Hematopoietic Stem Cells
Analysis of Revascularization in Ischemic Stroke With EmboTrap
Condition: Stroke; Ischemia
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      The study objective is to examine the recanalization efficacy of the EmboTrap device and its
      associated performance characteristics and to record associated clinical outcomes in a manner
      that facilitates relevant comparison of outputs with that of devices approved in the U.S. for
      clearing Large Vessel Occlusions.
    


Intervention name(s): EmboTrap® Revascularization Device
Intervention type(s): Device
Other intervention name(s): EmboTrap II
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain; Brain Clot; Brain Diseases; Brain Infarction; Cerebral Ischemia; Cerebrovascular Disorders; EmboTrap® Revascularization Device; EmboTrap; Ischemia; Ischemic; Ischemic Stroke; Mechanical Thrombectomy; Neurovascular Intervention; Revascularization; Stent Retriever; Stroke; Vascular Diseases; Neuravi
Safety of Different Forms of Creatine
Condition: Nutritional Supplements
Study type: Interventional

Summary: 
      This study will aim to determine whether ingesting creatine nitrate (CrN) at higher doses
      will differentially affect hemodynamic variables compared to a placebo.
    

Detailed description: 
      This study will examine the short-term (7 day) characteristics of ingesting creatine nitrate
      (CrN) compared to placebo on Chem-15 blood safety, heart rate, blood pressure, heart rate and
      blood pressure reactivity and self-reported side effects.
    

Intervention name(s): Creatine nitrate, low dose; Creatine nitrate, high dose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose); Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate); Placebo at 6.0 grams (6.0 grams dextrose)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Stereotactic Transplantation of hAESCs for Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of stereotactic
      transplantation of hAESCs for Parkinson's disease.
    

Detailed description: 
      The study plans to recruit 3 participants with Parkinson's disease . Using stereotactic
      technology, hAESCs will be accurately transplanted into the lateral ventricle. Therapeutic
      effectiveness and safety of hAESCs on PD will be evaluated. hAESCs are derived from placental
      amnion donated after cesarean section in healthy women. hAESCs is developed from the epiblast
      as early as 8 days after fertilization, recent reports indicate that hAESCs have some
      characteristics of neural stem cell. These cells are able to differentiate into dopaminergic
      neurons and secrete dopamine and various neurotrophic factors. These HAESCs could be seen as
      one of the best potential stem cell source for treating Parkinson's disease.
    

Intervention name(s): Human Amniotic Epithelial Stem Cells
Intervention type(s): Biological
Intervention description(s): Stereotactic transplantation of hAESCs for participants with PD.
Intervention model: Single Group Assignment
Intervention model description: The study plans to recruit 3 patients who meet the criteria. 50 millions HAESCs will be transplanted to participants with PD.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; stereotactic transplantation
Exercise, Arterial Cross-Talk Modulation and Inflammation in an Ageing Population
Condition: Cardiovascular Disease; Obesity; Atherosclerosis; Heart; Disease, Activity
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Inflammation
Study type: Interventional

Summary: 
      The aims of the study are twofold. In the cross-sectional approach (Part I), the study will
      be conducted in an older population to assess the association of physical fitness on
      different parts of the human vascular bed. In the interventional approach (Part II), it aims
      to investigate whether and to what extent advanced vascular ageing (AVA) in older subjects
      with increased cardiovascular risk can be reversed by regular walking- based high intensity
      interval training.
    

Detailed description: 
      In the cross-sectional part the investigators analyze physical fitness, vascular health and
      further outcomes in a healthy older active, a healthy older sedentary and a obese sedentary
      group with increased cardiovascular risk. The investigators will analyze large and small
      artery function, physical fitness and activity as well as inflammatory parameters in these
      three groups. Here the investigators will investigate the influence of physical activity and
      inflammatory parameters on the vascular health in different beds.

      In the intervention part the older sedentary group with increasing cardiovascular risk (OSR)
      will be randomized in a control and an intervention group. The intervention group will get a
      high intensity interval training which is walking based and individual adjusted. The control
      group will get general lifestyle recommendations. After 12 weeks of training OSR group will
      be tasted again. The aim of the second part is to assess the effect of high intensity
      interval training on vascular health and inflammatory parameters.
    

Intervention name(s): Training or control condition
Intervention type(s): Other
Intervention description(s): Participants get a 12 week high intensity and walking-based interval training which is adapted to their individual physical fitness level or a general recommendation on physical activity according to European Guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: arterial stiffness; retinal vessels; physical activity; ageing