bioihbjkbjnl/mcl2 huggingface dataset:
Partial Pulpotomy on Caries Free Human Teeth
Condition: Dentin Bridge; Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare the human pulp response to partial pulpotomy using
      White ProRoot MTA or iRoot BP in the terms of dentinal bridge formation and inflammation.
    

Detailed description: 
      This will be a randomized single blind clinical trial. Setting and conduct: Twenty caries
      free premolar teeth from fifteen patients assigned for orthodontic extraction will be
      included. Participants including major eligibility criteria: Their parents need to sign an
      informed form, Patients shouldn't have any systematic complication, The teeth should be free
      of any symptom, caries and decalcification and should reveal a normal response to pulp
      sensitivity tests, No mobility or swelling in the surrounding soft tissues, sensitivity on
      palpation or percussion should be present. Intervention: A class one cavity will be prepared
      and the depth will be increased until the pulp exposure occurs. One millimeter of the coronal
      pulp will be removed. Then the exposure site will be covered using two pulpotomy agents:
      White ProRoot MTA as control group and iRoot BP. After six weeks (42 days) the teeth will be
      extracted after radiographic and clinical examination to find any sign of swelling, abscess
      or sinus tract. Main outcome measures (variables): The teeth will be sectioned and examined
      to compare the presence of dentinal bridge, its thickness and feature in the terms of tunnel
      defect formation. The underlying pulp will be assessed and graded according to the degree of
      inflammation as follows: grade 0 no inflammation, grade 1 mild inflammation, grade 2 moderate
      inflammations, grade 3 severe inflammation, grade 4 abscess formation or necrosis. Our
      criteria are based on ISO 7405.
    

Intervention name(s): MTA; iRoot BP
Intervention type(s): Drug; Drug
Intervention description(s): partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.; Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).
Other intervention name(s): White ProRoot MTA; Injectable Root Bioaggregate Paste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: partial pulpotomy; Cvek pulpotomy; MTA; iRootBP; dentin bridge
Acute Response Capsaicin Flare Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Prior to administering PF-04427429 to patients we wish to increase the understanding of
      functional effects associated with calcitonin gene related peptide (CGRP) pathways. This
      study will examine whether it is possible for a single dose of PF-04427429 to acutely
      attenuate a capsaicin induced flare response.
    

Detailed description: 
      Proof of mechanism in healthy volunteers
    

Intervention name(s): PF-04427429; Capsaicin challenge; Placebo; Capsaicin challenge; EMLA positive control
Intervention type(s): Drug; Other; Drug; Other; Other
Intervention description(s): Single dose IV infusion up to 300mg; Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period; Placebo IV infusion (saline) to be administered during two of the three treatment periods; Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period; 2g EMLA cream to be applied ONCE during study period 1
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy male volunteers; capsaicin challenge; safety; toleration
Epidemiology of H. Pylori Transmission
Condition: Communicable Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Observational

Summary: 
      This observational epidemiologic study with nested cross-sectional and longitudinal aims will
      evaluate host immune response to mixed chronic infections (Helicobacter pylori, latent
      tuberculosis, intestinal helminthiasis) in recent US immigrants.
    

Detailed description: 
      1750 clinically-well, adult (age 18-55 years), recent immigrants (<2 years U.S. residence),
      referred through cooperating public health clinics in the Santa Clara Valley area, CA will be
      screened for H. pylori, helminth, and latent tuberculosis infections ["Screening"
      population]. Of these 1750, 426 will be selected for more intensive study (Cohort
      population), 105 of whom will receive baseline endoscopy. Of those selected for the cohort,
      300 are expected to complete a 9-month follow-up assessment, 75 of whom are expected to
      undergo a second follow-up endoscopy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1750 clinically-well, adult (age 18-55 years), recent immigrants (<2 years U.S. residence),
        referred through cooperating public health clinics in the Santa Clara Valley area, CA will
        be screened for H. pylori, helminth, and latent tuberculosis infections ["Screening"
        population]. Of these 1750, 426 will be selected for more intensive study (Cohort
        population), 105 of whom will receive baseline endoscopy. Of those selected for the cohort,
        300 are expected to complete a 9-month follow-up assessment, 75 of whom are expected to
        undergo a second follow-up endoscopy.
      
Biospecimen description: 
      Serum and PBMC
    
Keywords: chronic coinfection
Influence of Physical Treatments of Human Milk on the Kinetics of Gastric Lipolysis in Preterm Newborns
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The optimization of newborns nutrition is a challenge especially for preterm newborns for
      whom nutrition plays a crucial part in cerebral and global development. Human milk is
      considered as the best food for newborns. Several short and long-term beneficial health
      effects were attributed to breastfeeding and have induced the increase of human milk in
      preterm newborns nutrition.

      Whereas the chemical composition of infant formula has been optimized to mimic human milk,
      there is still a major difference between the structure of human milk and commercial infant
      formulas. It is well known in adult nutrition that the structure of emulsions influences
      their susceptibility to hydrolysis, such results have been obtained either on in vitro or in
      vivo studies.

      Human milk is a natural emulsion (oil in water). Lipids droplets are dispersed under the form
      of entities called milk fat globules (average diameter 4 µm, span 0.1-20 μm). The globules
      are stabilized by a trilayered membrane composed mainly of polar lipids (phospholipids,
      sphingolipids and gangliosides), of proteins, neutral lipids and other minor compounds.

      The physical treatments apply to human milk or more generally to bovine milk to pasteurize or
      stabilize the milk modify the structure of the natural emulsion. Heat treatment for instance
      induces whey proteins denaturation and the adsorption of protein aggregates on the surface of
      the milk fat globules. Heat treatment also leads to the denaturation of bile salt stimulated
      lipase. These effects limit intragastric lipolysis in preterm newborns.

      Conversely, reduction of milk globules size, by homogenisation of milk, increases the
      specific surface available for lipase adsorption and limits the lost of fat during enteral
      administration of milk. Such treatment could thus enhance gastric lipolysis and improve fat
      absorption of preterm newborns.

      The objective of this trial is to evaluate the effects of physical treatments (pasteurization
      and homogenisation by ultrasonication) applied to human milk on gastric lipolysis and milk
      destructuration. This trial is conducted, in vivo, on preterm newborns.
    


Intervention name(s): Raw human milk; Pasteurized human milk; Pasteurized-homogenized human milk; Gastric samples
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Preterm newborns; Gastric lipolysis; Physical treatments; Human milk
Treatment of Opioid/Heroin Dependence: Comparison of Three Medication Dosing Regimens
Condition: Heroin Dependence; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      Heroin dependence remains a major addiction problem in the United States. The purpose of this
      study is to determine the effectiveness of levoacetyl methadol (ORLAAM) in treating heroin
      dependent individuals.
    

Detailed description: 
      Heroin is a highly addictive drug, and its abuse has both medical and social consequences.
      ORLAAM is approved to treat both opiate and narcotic dependence. The purpose of this study is
      to determine the efficacy of ORLAAM in treating heroin dependent individuals. In addition,
      this study will determine the most effective dosing regimen of ORLAAM.

      This study will last 20 weeks. Participants will be randomly assigned to receive one of three
      dosing conditions: 1) standard fixed dose, 2) dose-by-weight, and 3) dose effect. The dose
      effect condition will include a dose of ORLAAM dependent on opiate use and withdrawal
      symptoms associated with opiate use; doses may be adjusted throughout the study. All
      participants will receive cognitive behavioral therapy throughout the study.
    

Intervention name(s): Levoacetyl Methadol; Levoacetyl Methadol; Levoacetyl Methadol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): WtDosing up to 1.0 mg/kg Stable 1.0 mg/kg/day; MaxEffect+CBT evaluation to 48 mg Adjust to effect (+/-); LAAM Fixed Dose evaluation up to 48 mg 48 mg
Other intervention name(s): LAAM; LAAM; LAAM
Intervention MeSH terms: Methadyl Acetate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heroin dependence
Pharmacokinetic Study of Fentanyl 400 µg Sublingual Spray, Actiq® 400 µg Transmucosally, and Fentanyl Citrate Injection 100 µg Intravenously (iv)
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the rate of absorption and bioavailability of
      fentanyl 400 µg sublingual spray, Actiq® 400 µg transmucosally, and fentanyl citrate
      injection 100 µg intravenously.
    

Detailed description: 
      This was a Phase I, single-dose, open-label, randomized, 3-period, 3-treatment cross over
      study in which 21 healthy subjects received single doses of fentanyl 400 µg sublingual spray,
      Actiq® 400 µg transmucosally, and fentanyl citrate injection 100 µg intravenously following a
      10-hour overnight fast. There was a 7 day washout period between treatments.
    

Intervention name(s): Fentanyl 400 µg sublingual spray; Actiq® 400 µg transmucosally; Fentanyl citrate injection 100 µg intravenously; Naltrexone 50 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Actiq® 400 µg is a solid formulation of fentanyl citrate on a plastic stick that dissolves slowly in the mouth for absorption across the buccal mucosa.; Naltrexone hydrochloride was administered approximately 12 hours and 1 hour prior to and 12 hours after each dose of fentanyl to minimize the occurrence of unacceptable adverse effects (eg, decreased respiration, nausea) often associated with administration of fentanyl.
Other intervention name(s): fentanyl citrate
Intervention MeSH terms: Fentanyl; Naltrexone; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional

Summary: 
      The purpose of this study is to:

        -  To access the efficacy of TW compared to Aza in the maintenance therapy for lupus
           nephritis

        -  To investigate the safety and tolerability of TW versus Aza in the maintenance therapy
           for lupus nephritis
    

Detailed description: 
      Tripterygium (TW) is a Chinese traditional patent drugs in treating chronic
      glomerulonephritis. It has been used to treat lupus nephritis for many years with less side
      effects. We compare the efficacy and safety of TW vs Aza in the maintenance therapy of lupus
      nephritis.
    

Intervention name(s): Tripterygium
Intervention type(s): Drug
Intervention description(s): TW 90mg/d
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Allopurinol in Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The pathogenesis of coronary heart disease is closely related to inflammation. IL-1 beta is
      an effective target for anti-inflammatory treatment of coronary heart disease. Allopurinol is
      a drug used for treating hyperuricemia and gout for many years. Recently, allopurinol has
      been proved to inhibit the production of NLRP3 in monocytes and reduce the level of IL-1beta,
      resulting in the decrease of TNF-alpha, IL-6 and CRP. Thus, in this study, the investigators
      aim to evaluate the efficacy and safety of allopurinol sustained-release capsules on
      improving the stability of coronary plaque in patients with acute coronary syndrome treated
      by conventional standardized therapy by the single-center, prospective, randomized,
      double-blind and controlled methods, which would provide new strategies for the treatment of
      coronary heart disease.
    


Intervention name(s): allopurinol sustained-release capsules; placebo capsules
Intervention type(s): Drug; Drug
Intervention description(s): allopurinol sustained-release capsules (0.25g), once a day, one pill at a time; placebo sustained-release capsules, once a day, one pill at a time
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treating Pyelonephritis an Urosepsis With Pivmecillinam
Condition: Pyelonephritis; Urinary Tract Infections
MeSH terms: Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Febrile urinary tract infections and urosepsis are common and potentially serious infections
      that require effective antimicrobial treatment. The duration of parenteral treatment depends
      on oral alternatives. These alternatives are few and due to antimicrobial resistance,
      quinolones are "standard of care". The increased use of quinolones is concerning because of
      its negative ecological aspects and it is confirmed an increasing incidence of resistant
      E.coli to quinolones in Norwegian isolates.

      Pivmecillinam is an antibiotic with high susceptibility to E.coli but the evidence for
      treating febrile urinary tract infections is insufficient. This trial will investigate the
      efficacy and safety of pivmecillinam in treating pyelonephritis and urosepsis caused by
      E.coli.

      The hypothesis is that urosepsis can safely be treated with pivmecillinam when it is given
      after 2-3 days with empirical i.v. antibiotics.
    

Detailed description: 
      This trial will be conducted at Vestfold Hospital, Norway, and is a prospective observational
      study with intention to treat. Participants will be consecutively included among hospitalized
      patients suffering from urosepsis - see eligibility criteria. After 3 days with parenteral
      antibiotics, when clinical improvement and absence of fever/leukocytosis is confirmed, the
      participants will start on pivmecillinam 400mg four times daily and be discharged.
      Pivmecillinam is to be taken for one week. The participants will be contacted by phone on day
      4, 10 and 33 (days after admission). On day 17 (test of cure, TOC) they will meet for
      physical examination. They will report symptom score (standardized schema) on day 0, and 17.
      Urine samples will be collected on day 10 and 17. Blood samples on day 17. All data will be
      stored anonymously. The trial will be monitored by extern resources.
    

Intervention name(s): pivmecillinam
Intervention type(s): Drug
Intervention description(s): Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment
Other intervention name(s): Selexid, Penomax
Intervention MeSH terms: Amdinocillin Pivoxil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pivmecillinam
Effect of a Food Supplementation With a Combined Food Supplement on Lipid Pattern, Indexes of Non-alcoholic Fatty Liver Disease and Systemic Inflammation
Condition: Hypercholesterolemia
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Hypercholesterolemia; Inflammation
Study type: Interventional

Summary: 
      Several controlled interventional studies have shown that there is a close correlation
      between cholesterol reduction and cardiovascular risk; in fact, reductions in the plasma
      concentration of total cholesterol and LDL, obtained through lifestyle modification or
      specific drugs, result in reductions in the incidence of major coronary events. The
      effectiveness of these interventions has been demonstrated both in subjects in primary
      prevention and in subjects in secondary prevention.

      Based on this evidence, the National Cholesterol Education Program (NCEP) has defined in the
      ATP III report the target values of LDL cholesterol (C-LDL) to be reached with interventions
      on food and / or pharmacological habits to perform an effective cardiovascular prevention.

      Although the atherogenic action of hypercholesterolemia is largely attributable to a direct
      damage exerted on vascular endothelium, recent studies suggest that the activation of a
      low-grade systemic pro-inflammatory state, typical of the patient with cardiovascular risk
      factors, does also play a role in the determinism of endothelial damage and atheroma
      degeneration of the arteries. It is believed that this systemic inflammation, as documented
      by the determination of some humoral signs of inflammation (e.g. C-reactive protein,
      interleukin-6, tumor necrosis factor-α), may further contribute to an increase of
      cardiovascular risk.

      The inflammatory state can modulate the atherosclerotic process at various levels,
      determining endothelial activation, promoting leukocyte chemotaxis in the sub-intimal space
      of the arterial wall and therefore the formation of an atheromatous plaque rich in
      inflammatory cells; the latter represents the lesion responsible for the vast majority of the
      coronary and cerebrovascular events observed in subjects with cardiovascular risk factors.
    


Intervention name(s): Dietary Supplement; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dietary supplement formulated with components of natural origin: artichoke, bergamot, folic acid, astaxanthin, Chromium picolinate and excipients.
Oral administration: 1 tablet/day at evening meal; Placebo (microcrystalline cellulose, calcium carbonate, magnesium stearate, silica dioxide and iron oxides).
Oral administration: 1 tablet/day at evening meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Elders Preferences in Care Decisions
Condition: Early Detection of Cancer; Colon Cancer; Decision Making; Patient-Centered Care
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this research study is to explore ways to improve appropriate colorectal
      cancer (CRC) screening in the elderly by attempting to target screening in those most likely
      to benefit and avoiding screening in those least likely to benefit.
    

Detailed description: 
      The investigators propose a randomized controlled trial at the patient level to determine the
      efficacy of a colorectal cancer screening decision support intervention for patients ages 70
      to 84 within a clinical setting. The investigators hypothesize that the use of the
      intervention will prepare patients for individualized decision making with their providers
      and result in an improvement in appropriate CRC screening decisions and screening outcomes.
      To assess appropriate CRC screening decisions and screening, the investigators will use a
      classification scheme derived from the literature based on age and the Charlson Comorbidity
      Index. Using this scheme, appropriate screening will include screening for those in the best
      health because they are likely to benefit, no screening for those in the worst health because
      they are unlikely to benefit, and evidence of a discussion about CRC screening for those in
      the intermediate health group because the benefit is unclear.
    

Intervention name(s): Making A Decision About CRC Screening; Drivers 65 Plus
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Targeted by age and gender with 3 components.
Educational component
Values clarification exercise
Individualized decision making worksheet
The intervention or control condition is administered before the index visit with the patient's provider.; This text booklet is provided as an attention control for those in the control arm and like the intervention is administered prior to the index visit with the patient's provider.
Other intervention name(s): Making A Decision About Colon Cancer Screening Woman 70; Making A Decision About Colon Cancer Screening Woman 75; Making A Decision About Colon Cancer Screening Woman 80; Making A Decision About Colon Cancer Screening Men 70; Making A Decision About Colon Cancer Screening Men 75; Making A Decision About Colon Cancer Screening Men 80; Attention control; Control condition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Colon cancer screening; Decision support interventions; Health status; Patient-centered care; Age; Randomized controlled trial; Double blind; UNC