bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease
Condition: HIV Infections; Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Several studies have shown that there is an increased risk of heart disease in people with
      HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid)
      on improving endothelial function and decreasing inflammation which may contribute to this
      increased risk. The investigators will also be doing studies to analyze coagulation and
      inflammation markers.
    


Intervention name(s): Lovaza; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lovaza one gram twice a day for 24 weeks; Placebo
Other intervention name(s): Omega-3 fatty acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: Omega-3 Fatty Acids; HIV; Heart Disease; Treatment experienced
Flagyl Microbiome in Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the types of bacteria in the colon before and after colon resection
      surgery. The investigator will also compare standard post-operative antibiotic treatment to
      flagyl (metronidazole) treatment post-operatively to see if giving the antibiotic, decreases
      the incidence of return of Crohn's disease.
    

Detailed description: 
      Participants who are scheduled for colon resection for Crohn's disease will be invited to
      take part in this randomized study. Participants will be randomized 1:1 to either
      Metronidazole 250 mg three times a day, starting after surgery, for three months, or the
      local usual standard of care after surgery, which may be a different antibiotic prescribed by
      the physician.

      Participants will also provide a stool sample at the following time points: prior to surgery,
      the day of discharge, at their follow-up appointment (usually about two weeks after surgery),
      three months, and six months.

      Participants will also be followed to determine their clinical outcome.
    

Intervention name(s): Metronidazole Oral
Intervention type(s): Drug
Intervention description(s): 250 mg Three times a day
Other intervention name(s): Flagyl
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized 1:1 study groups
Masking: None (Open Label)
Primary purpose: Basic Science
Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica
Condition: Polymyalgia Rheumatica
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis
Study type: Observational

Summary: 
      Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at
      characterizing immunological abnormalities in PMR patients, and to assess the effects of
      tocilizumab therapy on this abnormalities.
    

Detailed description: 
      Comparison of PMR patients and matched control subjects.
    

Intervention name(s): tocilizumab
Intervention type(s): Drug
Intervention description(s): 3 monthly IV infusions in PMR patients
Other intervention name(s): anti-IL-6 receptor monoclonal antibody
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        PMR patients included in the TENOR study (NCT01713842).
      
Biospecimen description: 
      Serum
Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine.
      Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is
      unpleasant for the patients and sometimes keeps them at bed longer time than needed. We
      investigate in new combinations of analgesics for postoperative pain, hoping to minimize the
      need for morphine.
    

Detailed description: 
      Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin +
      dexamethasone is investigated. Primary outcome is 24 hours morphine usage.
    

Intervention name(s): Pregabalin; Dexamethasone
Intervention type(s): Drug
Intervention description(s): Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
Intervention MeSH terms: Dexamethasone; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Abdominal hysterectomy; Pregabalin; Dexamethasone; Multimodal postoperative analgesia
Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART
      regimen with persistent HIV-1 viral suppression could increase the slope of decay of the
      HIV-1 latent reservoir.
    

Detailed description: 
      While highly active antiretroviral therapy (HAART) reduces plasma HIV-1 levels to below the
      limits of detection with standard assays, replication-competent virus persist in a stable,
      latent reservoir in resting CD4+ T cells. So, there is a rapid resumption in plasma viremia
      when therapy is interrupted.

      In addition to cellular reservoir, other pharmacologically privileged areas such as the
      central nervous system and the genital tract might act as additional sources of residual
      virus in patients with undetectable levels of plasma HIV-1 RNA. There is great current
      interest in strategies for depleting and eliminating this reservoir.

      The antiviral potency of current regimens emerges as an important determinant of complete
      viral control. In certain patients, the latent reservoir decay can be hastened with treatment
      intensification.

      An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART
      regimen with persistent HIV-1 viral suppression could increase the slope of decay of the
      HIV-1 latent reservoir. This could provide further insight into this area, decrease the size
      of latent reservoir, and translate into clinical benefits for patients being simplified to
      maintenance monotherapy with RAL or in the HIV-1 rebound kinetics and slope after a
      programmed treatment interruption.
    

Intervention name(s): MK-0518 400mg twice a day
Intervention type(s): Drug
Intervention description(s): Raltegravir, MK-0518
Other intervention name(s): Raltegravir
Intervention MeSH terms: Raltegravir Potassium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Raltegravir; MK-0518; Treatment intensification; HIV-1 latency; HIV eradication; treatment experienced
Efficacy of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces in Children
Condition: Fissure Sealants; Oral Hygiene Orientation
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy of oral hygiene orientation singly,
      compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary
      and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal
      surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion
      will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups:
      oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and
      12 months regarding clinical and radiographic lesions progression. The costs and
      cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction
      and impact on quality of life will also be investigated. Poisson regression analysis will be
      performed in order to compare the groups, through clinical and radiographic criteria. This
      test will also be used to assess the association between the group and patient discomfort and
      parents' satisfaction. Time, costs and impact on quality of life of the treatments will be
      compared by Student's t test. For all analyses, the significance level will be set at 5%.
    


Intervention name(s): fissure sealant; oral hygiene orientation
Intervention type(s): Other; Other
Intervention description(s): Surfaces allocated to this group will be treated with resin-based sealant (FluroShield®, Dentsply, United States of America) according to the manufacturer's instructions.
Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 30 seconds, followed by spray of water/air for at least 15 seconds. The sealant will be dispensed on the occlusal surface and light cured for 20 seconds (Optilight Max, Gnatus, Brazil).; Surfaces allocated to this group will be treated with sterile water application, as a placebo, without anesthesia and rubber dam. The active treatment in this group will be only oral hygiene orientations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental caries; primary tooth; resin-based sealants
Lactulose Supplementation in Premature Infants
Condition: Necrotizing Enterocolitis; Sepsis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      A pilot study to test the safety of use of lactulose in preterm infants and to preliminary
      assess the hypothesis that lactulose would support the early growth of Lactobacilli in the
      stools of premature infants and possibly would also improve nutritional status and decrease
      NEC and late-onset sepsis.
    

Detailed description: 
      Prospective, double-blind, placebo-controlled single center pilot study in 23-34 weeks
      gestation premature infants. Study group will receive 1% lactulose, while control group will
      receive 1% dextrose placebo in all their feeds (human milk or preterm formula). Clinical
      parameters will be followed. Stool samples will be sent for culture.
    

Intervention name(s): Lactulose; Dextrose
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Babies in the study group received lactulose in a dose of 1% in their entire mother's breast milk or preterm formula feeds (1 gram per 100 ml feeds, based on the daily volume of feeds, and evenly distributed between all the feeds for the entire duration of their hospital stay). 67% lactulose in the original preparation (Laevolac, Fresenius Kabi, Austria) was diluted by distilled water to 33.5% preparation in the pharmacy in strict sterile conditions under hood. Just before feeding the nurses added the required volume of this 33.5% lactulose solution to the ordered volume of feed to generate a final concentration of 1% lactulose in each feed.; Babies in the control groups were given equal volumes of the comparable placebo in all their preterm formula feeds at final concentration of 1% dextrose. The 33.5% dextrose placebo solution was prepared by dissolving dextrose (Dextrose Pulv. USP.24/BP, Roquette Frores 6280, Lestrem, France) in distilled water under heat to the point of near boiling under the same strict sterile conditions in the pharmacy. This gave a placebo solution that looked similar in color, odor and liquidity to the study solution of 33.5% lactulose. Dark bottles were used to further blind the medical team as to what solution was the baby given.
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: lactulose; prebiotic; premature infant; enteral feeding; stools; lactobacillus; nutrition; growth
Comparison of Two Formulations of Androxal
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine and compare the pharmacokinetics (PK) of a single dose of each of two
      formulations Androxal
    

Detailed description: 
      To determine and compare the pharmacokinetics (PK) of a single dose of each of two
      formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to
      determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25
      mg Androxal administered to healthy male volunteers.
    

Intervention name(s): 12.5 mg Androxal Formulation A; 12.5 mg Androxal Formulation B; 25 mg Androxal Formulation A; 25 mg Androxal Formulation B
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 12.5 mg Androxal formulation A; Single dose of 12.5 mg Androxal Formulation B; Single dose of 25 mg Androxal formulation A; Single dose of 25 mg Androxal formulation B
Other intervention name(s): enclomiphene citrate; enclomiphene citrate; enclomiphene citrate; enclomiphene citrate
Intervention MeSH terms: Citric Acid; Sodium Citrate; Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacological Intervention for Symptomatic Snoring
Condition: Snoring
MeSH terms: Snoring
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Currently, there is no pharmacological intervention capable of maintaining airway patency for
      the treatment of snoring and airflow limitation during sleep. Here we study the effect of
      pharmacological stimulation of the pharyngeal muscles on snoring severity, in a randomized
      quadruple-blind, crossover study.
    

Detailed description: 
      Two active interventions are being studied and compared against placebo. Participants will
      therefore be randomized to one of six possible sequences. Washout periods will be 1 week.

      Effects of interventions on outcomes will be assessed using mixed effect model analyses: we
      will quantify the effect of active treatment 1 (referenced to placebo), the effect of active
      treatment 2 (referenced to placebo), adjusting for effects of time (period number), carryover
      effects, and baseline values (fixed effects). Participants are considered random effects.

      Primary outcome is based on significance of active intervention 1 versus placebo.
    

Intervention name(s): SAS2094AH and SAS2094BH; SAS2094AL and SAS2094BL; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SAS2094AH and SAS2094BH for 7 days, preceded by SAS2094AL and SAS2094BH for 3 days.; SAS2094AL and SAS2094BL for 10 days; Placebo for 10 days. Capsules will mimic active treatments.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in
      participants with type 1 diabetes who are using an insulin pump and have high blood sugar
      after eating. For each participant, the study will last about two to nine weeks.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered by CSII; Administered by CSII
Other intervention name(s): Humalog; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Aesthetic Performance of "Profhilo®" Injective Intradermal Treatment for the Neck
Condition: Skin Manifestations
MeSH terms: Skin Manifestations
Study type: Interventional

Summary: 
      The objective of this study is to investigate the aesthetic performance of the Hyaluronic
      acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique
      ("BAP" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.
    


Intervention name(s): Profhilo®
Intervention type(s): Device
Intervention description(s): Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment With Peginterferon Alfa-2a (40 KD) of Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to investigate the HBV DNA suppression (and HBeAg seroconversion among HBeAg
      positive patients) pegylated interferon treatment at 24 weeks after end of treatment among
      patients who have failed anti-viral treatment in the past.
    

Detailed description: 
      Chronic hepatitis B is the commonest cause of liver cirrhosis and hepatocellular carcinoma in
      Hong Kong. Persistent high viraemia and necro-inflammation is associated with higher risk of
      liver-related complications.

      Lamivudine and adefovir dipivoxil are the two anti-viral agents that can suppress the
      replication of the virus. However, these drugs using either alone or in combination only
      induce HBeAg seroconversion in less than 20% of patients. Most patients therefore required
      long-term treatment, which has a risk of development of drug resistance. Premature cessation
      of these anti-viral agents is usually accompanied by relapse of viraemia and hepatitis.

      Pegylated interferon-alfa-2a is modified form of interferon with a 40 kDa polyethylene glycol
      strand attached to a recombinant interferon. This formulation increases the product's
      half-life from 7-10 hours to 77 hours. Therefore it can be administered on a more convenient
      once weekly basis. Pegylated interferon-alfa-2a monotherapy for 24 weeks has been shown to
      induce sustained HBeAg seroconversion in 35% of patients at the optimal dose of 180 mcg
      weekly. This drug has been found to be more effective than conventional interferon-alfa in
      the treatment of chronic hepatitis B as well as chronic hepatitis C.

      Data on interferon-based treatment among chronic hepatitis B patients who have failed
      previous anti-viral treatment is scanty. It is uncertain whether pegylated interferon-alfa-2a
      treatment will be effective in this group of patients. This is a single-center, pilot study
      on the virological response of chronic HBV infection to pegylated interferon-alfa-2a among
      patients who have failed anti-viral treatment in the past. This study will investigate the
      HBV DNA suppression (and HBeAg seroconversion among HBeAg positive patients) pegylated
      interferon treatment at 24 weeks after end of treatment.
    

Intervention name(s): Pegylated Interferon-alfa-2a
Intervention type(s): Drug
Intervention description(s): Pegasys once weekly
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; Pegylated Interferon-alfa-2a; Pegasys
Laser Intervention in Early Age-Related Macular Degeneration Study
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether 2RT nanosecond laser therapy slows the
      progression to advanced age-related macular degeneration.
    

Detailed description: 
      LEAD is a patient and assessor masked, multi-centre randomized controlled exploratory medical
      device clinical investigation of 240 participants (1:1 active to shame laser procedure)
      designed to assess the effectiveness of nanosecond laser treatment of patients with early
      high-risk AMD.

      No less than 240 participants will be randomized into either active laser treatment or sham
      laser procedure groups at a ratio of 1:1. Patient eligibility based on ocular inclusion
      criteria will be evaluated using measures of vision, fundus photography, OCT imaging, and
      macular integrity (MAIA) performed during the qualifying period. Fundus images and MAIA
      results will be sent to a coordinating centre where these will be reviewed to confirm
      eligibility based on lesion attributes and the criteria specified in the protocol. Following
      confirmation of eligibility by the coordinating centre, participants whom satisfy all the
      inclusion and exclusion criteria can be randomized. Allocation to treatment group will be
      stratified by smoking status. All participants will receive either active laser treatment or
      sham laser procedure at the treatment visit and be assessed for retreatment on a semi-annual
      basis. All participants will be contacted by telephone at 1 week and present for clinical
      examination visits at 1, 6, 12, 18, 24, 30 and 36 months.
    

Intervention name(s): 2RT nanosecond laser
Intervention type(s): Device
Intervention description(s): active laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: laser treatment, high risk, early AMD
Towards an Objectivation of the Therapeutic Effect of a Rocking Movement
Condition: Rocking Movement
Study type: Interventional

Summary: 
      The study evaluates the benefits of a rocking movement on well-being and attention, through
      high-density electroencephalography recordings. The effect of the rocking movement is
      compared to a seated position and a lying position.
    


Intervention name(s): high-density electroencephalography
Intervention type(s): Device
Intervention description(s): Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment