bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Spice Consumption on Postprandial Vascular Function
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      A 3-period randomized cross-over, controlled feeding study will be conducted to determine the
      effect of chronic spice consumption on postprandial vascular function. Participants will
      consume three test diets containing different amounts of spice. Each treatment period will
      last for 4 weeks. After each diet period a meal test will be conducted. Participants will
      consume a meal with a spice content corresponding to the diet period they have just
      completed. Endothelial function will be measured at 2 and 4 hours after meal consumption.
      Blood samples will also be taken during the 4 hours after meal consumption for measurement of
      lipids, immune and inflammatory markers.
    

Detailed description: 
      A 3-period randomized cross-over, controlled feeding study will be conducted to determine the
      effect of chronic spice consumption on postprandial vascular function, lipid levels, immune
      and inflammatory markers. Participants will consume three test diets containing different
      amounts of spice. Each treatment period will last for 4 weeks. At baseline and after each
      diet period a postprandial test will be conducted. Flow mediated dilation (FMD) will
      conducted in the fasting state and a catheter will be inserted for blood sampling.
      Participants will consume a control test meal containing low spice at baseline and after each
      diet period the test meal will contain a level of spice that corresponds to the amount of
      spice consumed during the diet period. Blood samples will be taken at 30, 60, 120, 180 and
      240 minutes after meal consumption, and FMD will be performed at 120 and 240 minutes.
    

Intervention name(s): Spice blend
Intervention type(s): Other
Intervention description(s): Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3 period randomized cross over
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Evaluation of Mineralized Plasmatic Matrix With and Without Collagen Membrane in Peri-implant Bone Regeneration
Condition: Horizontal Alveolar Bone Defect; Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      This study focuses on comparing the effect of MPM with or without collagen membrane on
      delayed implant placement in anterior maxillary aesthetic zone.
    


Intervention name(s): mineralized plasmatic matrix with collagen membrane; mineralized plasmatic matrix (MPM) without collagen membrane
Intervention type(s): Biological; Biological
Intervention description(s): Two tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers:
A yellow plasma liquid on the top of the tube.
Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM.
After implant placement, the buccal bone defect was grafted with MPM and covered by collagen membrane; Two tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers:
A yellow plasma liquid on the top of the tube.
Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM.
After implant placement, the buccal bone defect was grafted with MPM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Research Study of How a New Medicine NNC0365-3769 (Mim8) Works in the Body of Healthy People
Condition: Healthy Volunteers - Haemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in
      people with haemophilia A (an inherited disorder in which blood does not coagulate properly).

      This study will investigate if different doses of Mim8 are safe, and also check how Mim8
      behaves in the body.

      Twelve different doses will be tested. Participants will only get one of the doses. Which
      dose participants get is decided by chance. Participants will get a single injection under
      the skin of the belly by means of a syringe and a needle.

      The study will last for about 17 - 21 weeks.
    


Intervention name(s): Mim8 B, 10 mg/mL; Mim8 B, 100 mg/mL; Mim8 B, placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; All participants will receive a single dose of Mim8 subcutaneously (s.c- under the skin) and will stay in-house at the site until 3 days after dosing.; Placebo will be used to dilute the IMP to different Mim8 concentrations
Other intervention name(s): NN0365-3769; NN0365-3769
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals
Condition: HIV
Study type: Interventional

Summary: 
      The project will have two tracks, one for participants who are currently taking
      elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or E/C/F/tenofovir
      alafenamide (E/C/F/TDF or E/C/F/TAF) single-tablet regimen* (STR) (Track A) and one for
      participants who will begin therapy with E/C/F/TDF or E/C/F/TAF STR during the study (Track
      B).

      Participants will take E/C/F/TDF and/or E/C/F/tenofovir alafenamide fumarate (E/C/F/TAF)
      STR** (if available) for 24 weeks.

      *Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and
      300 mg of tenofovir disoproxil fumarate.

      **Co-formulation of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine,
      and 10 mg of tenofovir alafenamide fumarate.
    

Detailed description: 
      The proposed project will be a prospective, open-label treatment trial of 14 HIV-infected
      adults. Participants will be enrolled in two tracks. Track A will enroll participants who
      have been taking E/C/F/TDF to E/C/F/TAF for at least 12 weeks. Track B will enroll
      participants who are not taking ART and no prior exposure to elvitegravir and no genotypic
      drug resistance to any component of E/C/F/TDF to E/C/F/TAF. CSF and blood will be collected
      twice in Track A (two on-treatment assessments) and three times in Track B (one
      pre-treatment, two on-treatment assessments). If possible, we plan to time assessments to
      bridge the transition from E/C/F/TDF to E/C/F/TAF so that all participants will ideally have
      one CSF collection on each regimen, enabling a paired comparison of tenofovir concentrations
      between the two tenofovir formulations. We estimate that 28 on-treatment CSF collections will
      be sufficient to provide a small-sample estimate of the distribution of elvitegravir,
      tenofovir and TAF into CSF.
    

Intervention name(s): Stribild; Genvoya
Intervention type(s): Drug; Drug
Intervention description(s): To be administered orally, once daily with food.; To be administered orally, once daily with food.
Other intervention name(s): Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate; Co-formulated elvitegravir/ cobicistat/ emtricitabine/ tenofovir alafenamide
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Cobicistat; Emtricitabine tenofovir alafenamide; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stribild; Genvoya; elvitegravir; Cerebrospinal Fluid; HIV
A 24 Hour Occlusive Single Patch Test to Assess Acute Tolerance of Pre Lubricated Condom on a Panel of Healthy Adult Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      This is a 24 hour patch test to determine the acute tolerance of 3 variants of condom on a
      panel of healthy adult subjects. The patches will be affixed to the back and remain under
      occlusion for 24 hours. They will then be assessed at 30 minutes and 24 hours post patch
      removal.
    

Detailed description: 
      Three test products (plus positive and negative control) will be applied to the back using
      occlusive tape and will remain on the skin for 24 hours. The patches will be removed after 24
      hours and assessed as 30 minutes post patch removal and again at 24 hours post patch removal.
      Each test site will be scored for erythema and oedema by a dermatologist.

      The primary endpoint for this Clinical Investigation is the irritation of the test products
      according to the Cutaneous Irritancy Index value. The test products success criteria is to be
      graded as 'non-irritant' and this should be confirmed by the study dermatologist.
    

Intervention name(s): Condom
Intervention type(s): Device
Intervention description(s): This study involves testing a condom, however the device will not be used as intended. The device will be destroyed to make the test patches required for this safety study.
Other intervention name(s): Durex
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Safety study; new product; normal healthy skin.
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal
Condition: Opioid-use Disorder; Opioid Withdrawal
MeSH terms: Opioid-Related Disorders; Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to evaluate whether tAN via the tragus (vagal) and
      auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in
      opioid withdrawal symptoms.
    

Detailed description: 
      This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical
      trial in which subjects will be consented, receive a baseline assessment, and receive tAN
      treatment and assessment every day during their 3 to 5-day detox treatment. Use of
      opioid-based medication assisted therapy (MAT) will not be permitted at any point during the
      study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be
      permitted until after the subject has completed the 60 minute COWS assessment to ensure
      changes in COWS score at 60 minutes are only the result of tAN therapy.
    

Intervention name(s): Sparrow Therapy System
Intervention type(s): Device
Intervention description(s): Transcutaneous auricular neurostimulation
Intervention model: Single Group Assignment
Intervention model description: This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: auricular neurostimulation; vagus nerve stimulation; transcutaneous; withdrawal symptoms
Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic
      management in non-critically ill patients with type 2 diabetes at the general ward
    


Intervention name(s): GlucoTab System
Intervention type(s): Device
Intervention description(s): Tablet based workflow and decision support system with incorporated software algorithm (GlucoTab) used for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Visual Performance of Bilateral AcrySof ReSTOR Aspheric +4
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      Determine the clinical visual outcomes following bilateral implantation of the AcrySof ReSTOR
      Aspheric Intraocular Lens (IOL) and to demonstrate what percentage of the subjects obtain
      spectacle freedom.
    


Intervention name(s): AcrySof ReSTOR Aspheric +4
Intervention type(s): Device
Intervention description(s): Implantation with the AcrySof ReSTOR Aspheric +4 Multifocal Intraocular Lens (IOL)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants taken from physician's patient pool implanted with the AcrySof ReSTOR +4
        Intraocular Lens (IOL)
      
Keywords: AcrySof ReSTOR Aspheric +4
Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum Malaria
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied
      in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to
      correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria
      for each regimen.
    

Detailed description: 
      We propose to conduct an amodiaquine-artesunate efficacy trial at Bondo District Hospital in
      Kenya. The results will enable us to better interpret the results of the main IPTi trial. We
      will assess the efficacy of a three day course of amodiaquine plus three days of artesunate
      (AQ3/AS3) for the treatment of symptomatic, uncomplicated P. falciparum infections. Study
      subjects are febrile children, 6-59 months old, with laboratory-confirmed uncomplicated P.
      falciparum infections. Clinical and parasitological parameters will be monitored over a
      28-day follow-up period to evaluate drug efficacy. Children will be followed closely for
      signs of drug failure or recrudescence, and any children failing therapy will be treated with
      Coartem or, if severe, with quinine. We will also perform drug resistance testing on parasite
      samples from children with treatment failure. The results of this efficacy trial will allow
      us to assist policymakers in deciding what drugs should be used for IPTi, should it be
      adopted into national policy.
    

Intervention name(s): AQAS
Intervention type(s): Drug
Intervention description(s): AQAS dosed by body weight, on days 0, 1, 2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: malaria; efficacy; intermittent preventive therapy in infants; drug resistance
Devel. and Eval. of an Active Surveillance Decision Aid for Men With Low or Intermediate Grade Prostate Cancer
Condition: Adenocarcinoma of Prostate
MeSH terms: Adenocarcinoma
Study type: Interventional

Summary: 
      The overall goal of this project is to test an interactive, multi-media decision aid in the
      form of an electronic clinical decision dashboard designed to improve the quality of clinical
      decision making for initial treatment of patients with newly diagnosed, low or intermediate
      risk prostate cancer.
    

Detailed description: 
      The overall goal of this project is to test an interactive, multi-media decision aid in the
      form of an electronic clinical decision dashboard designed to improve the quality of clinical
      decision making for initial treatment of patients with newly diagnosed, low or intermediate
      risk prostate cancer.

      Specifically, we propose to conduct a clinical trial to compare the effects of a prostate
      decision dashboard versus usual care on:

        1. patient knowledge regarding the treatment options available for low or intermediate risk
           prostate cancer,

        2. measures of the decision making process including decisional conflict and the extent to
           which decisions were made via a shared decision making process,

        3. the treatments selected, and

        4. 3-6 and 9-12 month outcome assessments of clinical status, decision regret,
           cancer-related quality of life including worry, functional status, and treatment side
           effects.
    

Intervention name(s): Dashboard
Intervention type(s): Behavioral
Intervention description(s): With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostate; Cancer; Adenocarcinoma
Efficacy of γ-linolenic Acid and Thioctic Acid in Patients With Diabetic Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was a 12-week, multi-center, randomized, double-blind, double dummy, parallel
      clinical trial to compare the efficacy of γ-linolenic acid and Thioctic acid in patients with
      diabetic neuropathy.
    

Detailed description: 
      This study evaluated non-inferiority about the efficacy and safety of γ-linolenic acid
      (Evoprim soft capsule) through patients with diabetic neuropathy were compared γ-linolenic
      acid (Evoprim soft capsule) and Thioctic acid(LipoA HR Tab. 600mg) using double-blind, double
      dummy clinical trials. First outcome measures are Visual Analog Scale(VAS) and Total Symptom
      Score(TSS), secondary outcome measures are Michigan Neuropathy Screening Instrument(MNSI),
      Current perception Threshold(CPT), Modified Brief Pain Inventory-diabetic
      polyneuropathy(Modified BPI-DPN) and EuroQol-5 Dimensions(EQ 5D).
    

Intervention name(s): γ-linoleic acid and placebo(Thioctic Acid); Thioctic Acid and placebo(γ-linoleic acid)
Intervention type(s): Drug; Drug
Intervention description(s): γ-linoleic acid (Evoprim soft capsule) twice a day and 4 capsules at a time.
Thioctic Acid(LipoA HR Tab. 600mg) placebo once a day and 1 tablet at a time.; Thioctic Acid(LipoA HR Tab. 600mg) once a day and 1 tablet at a time.
γ-linoleic acid (Evoprim soft capsule) placebo twice a day and 4 capsules at a time.
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Hypoglycemia and Autonomic Nervous System Function
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      The goals of this proposal are to determine the effects of hypoglycemia on the autonomic
      nervous system.
    


Intervention name(s): Hypoglycemic hyperinsulinemic clamp; Euglycemic hyperinsulinemic clamp
Intervention type(s): Other; Other
Intervention MeSH terms: Hypoglycemic Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Hypoglycemia; Autonomic Nervous System; baroreflex sensitivity; muscle sympathetic nerve activity; lower body negative pressure
Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational

Summary: 
      The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb)
      compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart
      disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to
      acyanotic children.
    

Detailed description: 
      Blood hemoglobin is measured daily in clinical practice. Laboratory measurement (Lab-Hb) of
      is the gold standard for assessment of blood hemoglobin. Recently, non-invasive monitors had
      been introduced. Non-invasive measurement of hemoglobin (Sp-Hb) would save time and minimize
      the risk of infection. Blood sampling in children is usually more difficult and stressful;
      moreover, it also carries the risk of iatrogenic anemia.

      Radical-7 (Masimo corporation, Irvine, CA) is a device that operates using the principle of
      co-oximetry . Radical-7 had been validated in various clinical purposes. Measurement of blood
      hemoglobin is an important application for Radical-7 device. Non-invasive hemoglobin (Sp-Hb)
      measurement has been frequently validated in adults; as well as in pediatric patients;
      however, its accuracy in children with congenital heart disease was not investigated.
      Congenital heart disease infants usually undergo major operations and frequently need
      transfusion of blood. Moreover, these patients have special circulatory physiology that might
      impact the device accuracy. It had been recently reported that the performance of co-oximetry
      in congenital heart disease children is poor in measurement of oxygen saturation specially at
      oxygen saturation under 75%; however, its accuracy in measurement of hemoglobin was not
      investigated yet. In this study, the investigators will evaluate the accuracy of Sp-Hb
      compared to traditional Lab-Hb in children with congenital heart disease. the investigators
      will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.
    

Intervention name(s): radical-7 pulse co-oximeter
Intervention type(s): Device
Intervention description(s): Radical-7 pulse co-oximter will be applied to the patient through a special probe attached the the patient digit to measure blood hemoglobin
Other intervention name(s): Masimo pulse co-oximeter
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include children less than 8 years with congenital hear diseases scheduled
        for surgery or endo-vascular iintervention
Gravitas Feeding Tube System Placement in Neonates
Condition: Nasogastric Tube
Study type: Observational

Summary: 
      The purpose of this study is to optimize the Gravitas Feeding Tube System Placement Algorithm
      for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube
      in the neonate population for the administration of nutrition, fluids and medications.
    


Intervention name(s): Nasogastric Tube
Intervention type(s): Device
Intervention description(s): Temperature and impedance data will be collected from sensors embedded within the feeding tube wall.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates in NICU