bioihbjkbjnl/mcl2 huggingface dataset:
Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      It is common practice to carry out the therapy of periodontal diseases in two phases. In a
      first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are
      removed using a cleaning method called "scaling and root planing" (SRP). After three to six
      months the case is evaluated and, if necessary, further treatment is provided, usually taking
      a more aggressive, surgical approach. Beneficial effects of adjunctive systemic antibiotics
      on clinical outcomes have been shown repeatedly but specific indications for antibiotics in
      subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to
      be issues of a long lasting controversy.This study assessed the differential outcomes of
      periodontal therapy supplemented with amoxicillin-metronidazole during either the
      non-surgical or the surgical treatment phase.
    

Detailed description: 
      Single center, randomized placebo controlled crossover clinical trial with a one-year
      follow-up. Eighty participants with Aggregatibacter actinomycetemcomitans-associated chronic
      or aggressive periodontitis were randomized into two treatment groups. A: Antibiotics (3/d
      500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase
      of periodontal therapy (T1), and placebo during the second, surgical phase (T2). B: Placebo
      during T1, and antibiotics during T2. Persistence of sites with a probing depth (PD) >4 mm
      and bleeding on probing (BOP) was the primary outcome. Evaluations were made three months
      after T1, as well as 6 and 12 months after T2.
    

Intervention name(s): 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days
Intervention type(s): Drug
Intervention description(s): Systemic antibiotics after sub gingival mechanical debridement
Intervention MeSH terms: Amoxicillin; Metronidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Periodontitis; amoxicillin; metronidazole; case management
Study to Learn About the Effect of Elevit (a Food Supplement Containing Several Vitamins, Minerals, Lutein and DHA) on the Nutrient Content in the Breast Milk and Blood of Women During Breastfeeding Period and on Babies' Physical Growth Parameters
Condition: Healthy Lactating Mother
Study type: Interventional

Summary: 
      The aim of the study is to learn about the effect of multi-micronutrient, lutein and DHA
      supplementation (Elevit Breastfeeding & Postnatal Care) on the breast milk nutrient
      composition and babies physical growth parameters.

      Mothers participating in this study received either Elevit or placebo orally once a day for
      12 weeks starting from 4 to 6 weeks after delivery. Blood, urine and milk samples were
      collected from the mothers and physical parameters like size and weight were collected from
      the babies to assess the effect of the supplementation.
    


Intervention name(s): Elevit Breastfeeding & Postnatal Care; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral; No active ingredients except of 225 μg iodine; One capsule daily, oral
Other intervention name(s): BAY987816 - Multi-micronutrients, lutein & DHA
Intervention MeSH terms: Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness
Condition: Influenza; Influenza -Like Illness
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled,
      parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute
      uncomplicated ILI due to influenza or other respiratory viruses in a community setting.
    


Intervention name(s): Norketotifen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Prucalopride on Gastric Emptying in Intensive Care Unit Patients
Condition: Enteral Feeding Intolerance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      to compare the effectiveness as well as the safety of prucalopride against metoclopramide as
      the first line treatment for feeding intolerance in critically ill patients.
    

Detailed description: 
      Provision of nutrition support to the critically ill is now established as an essential part
      of patient care where aiming toward 100% of the predicted target may have resulted in reduced
      mortality and increased ventilator-free days in those who are premorbidly malnourished.
      Despite these reported benefits, clinicians continue to deliver little more than half of the
      enteral nutrition (EN) they plan to provide, due to gastric motility disorders, patient
      intolerance and clinical interruptions. Also despite the availability of numerous clinical
      practice guidelines (CPGs) focused on feeding critically ill patients, observational studies
      have consistently demonstrated persistent and significant gaps between guideline
      recommendations and actual nutrition practice. Consequently, underfeeding is prevalent in the
      intensive care unit (ICU), with patients on average receiving only 60 % of the calories that
      are prescribed. Moreover, Among the barriers to adequate nutritional supply in the ICU which
      contributes to nutritional status deterioration, gastrointestinal disorders causing enteral
      feed intolerance are the most important and the most often mentioned in the literature. when
      gastric emptying was measured in critically ill patients, 46 % of them had evidence of
      delayed gastric emptying. Untreated slow gastric emptying has a plethora of clinical
      consequences such as vomiting, aspiration of gastric contents, pneumonia, and contributes
      significantly to the frequent interruptions and cessation of EN in the ICU, which results in
      inadequate nutritional delivery. Studies have shown an association between feeding
      intolerance, prolonged intensive care unit (ICU) stay, and increased risk of death.
    

Intervention name(s): Prucalopride; Metoclopramide
Intervention type(s): Drug; Drug
Intervention description(s): Prokinetic; Prokinetic
Other intervention name(s): Resolor; Primperan
Intervention MeSH terms: Metoclopramide; Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Does Tourniquet Use in Total Knee Replacement Improve Fixation
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby
      improve fixation, it might also cause complications. Migration as measured by
      RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use
      of a tourniquet influences fixation measured with RSA.
    

Detailed description: 
      The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine
      at many departments. It is thought to facilitate dissection and reduce peroperative bleeding,
      but the main argument for its use is that bleeding bone surfaces might impair the fixation of
      cemented prostheses, because of less cement penetration.

      We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to
      a tourniquet during the hole operation and 25 are not.

      Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.

      Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self
      assesed knee score (KOOS) Total follow up time 2 years
    

Intervention name(s): No use of tourniquet; Tourniquet
Intervention type(s): Procedure; Procedure
Intervention description(s): Tourniquet is not applied i 25 pts; Use of tourniquet
Other intervention name(s): No Tourniquet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Total knee; Tourniquet; Blood loss; pain; range of motion
Chronic Effects of DBS in Parkinson's Disease and Dystonia
Condition: Parkinson's Disease; Isolated Dystonia
MeSH terms: Parkinson Disease; Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to use an investigational device to record brain activity for
      12-24 months following surgical implantation of deep brain stimulation (DBS) systems. The
      goal of the study is better understanding of brain activity in movement disorders and how
      they relate to DBS, not to bring new devices to market.
    


Intervention name(s): Activa PC+S
Intervention type(s): Device
Intervention description(s): Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: deep brain stimulation; cortical recording; neuroprosthesis
A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 4

Summary: 
      Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous
      disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for
      the treatment of oral lichen planus. Half of participants (total number of participants was
      twenty eight) were received lycopene and the other half were received prednisolone.
    

Detailed description: 
      Prednisolone and lycopene were produced remission of lesions in oral lichen planus patients,
      but they do so by different mechanisms.

      The main cause of oral lichen planus is still unknown. Some authors advocate the disease
      appears to be a result of T-cell-mediated autoimmune responses in oral epithelial tissues.
      But, recent study suggests that increased reactive oxygen species (ROS) and lipid
      peroxidation together with an imbalance in the antioxidant defense system may play a part in
      the generation of disease.

      Lycopene exerts its antioxidant activity by physical and chemical quenching of free radicals
      and decreases free radicals-initiated oxidative reactions, particularly lipid peroxidation
      and DNA oxidative damage, thereby preventing tissue damage.

      Prednisone have both anti-inflammatory and immunosuppressant effects.It suppresses the
      inflammatory response by limiting the recruitment of inflammatory cells and inhibiting
      synthesis of pro-inflammatory products such as prostaglandins (PGs), leukotrienes (LTs) and
      platelet activating factors (PAF) by indirectly inhibiting phospholipase A2 and negative
      regulating cyclooxygenase (COX-2).
    

Intervention name(s): lycopene; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.; Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
Other intervention name(s): lycored; wysolone
Intervention MeSH terms: Prednisolone; Lycopene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antioxidant; Lycopene; Prednisolone
A Phase I Study to Assess the Safety and Tolerability of Topical CRx-197 Formulations in Healthy Volunteers
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a phase I, single center, randomized, vehicle-controlled, blinded study
      comparing two dosage strengths of CRx-197 cream, nortriptyline, an active comparator (0.1%
      mometasone) and placebo (the active ingredient free vehicle cream of CRx-197)in healthy
      volunteers.
    


Intervention name(s): nortriptyline HCl + loratadine; nortriptyline HCl + loratadine; nortriptyline HCl; mometasone furoate; Active ingredient free vehicle cream of CRx-197
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Topical; Topical; Topical; Topical; Topical
Intervention MeSH terms: Mometasone Furoate; Loratadine; Nortriptyline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CombinatoRx; Atopic; Dermatitis; Topical; CRx-197; Normal Healthy Volunteers
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Healthy Humans.
Condition: Healthy Humans
Study type: Interventional

Summary: 
      The aim of the study is to test the hypothesis that the function and/or regulation of
      aquaporin 2 and/or endothelial sodium channels in the principal cells of healthy humans is
      abnormal at high and low sodium intake
    


Intervention name(s): High Sodium Diet; Low Sodium Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 250-350 mmol; 25-35 mmol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Urinary Aquaporin 2; High/low Sodium Diet; Fractional Sodium Excretion
Performance Evaluation of Different Daily Disposable Silicone Hydrogel Contact Lenses.
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The goal of this study is to compare the performance of two daily disposable silicone
      hydrogel contact lenses.
    

Detailed description: 
      This study is a prospective, bilateral eye, double masked, randomized, 1-week crossover,
      daily wear design involving two different daily disposable lens types. Each lens type will be
      worn for approximately one week.
    

Intervention name(s): Control Contact Lens (stenfilcon A); Test Contact Lens (senofilcon A)
Intervention type(s): Device; Device
Intervention description(s): one week wear; one week of wear
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus; Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of TAK-079 in comparison
      with matching placebo, administered once every 3 weeks over a 12-week dosing period in
      participants with active SLE who are receiving stable background therapy for SLE.
    

Detailed description: 
      TAK-079 is being tested in a study population with moderate to severe SLE. This study will
      evaluate the safety and biologic activity of TAK-079 or matching placebo in combination with
      stable SLE background therapy.

      The study will enroll approximately 24 participants across 3 sequentially enrolling cohorts.
      Each cohort will enroll 8 participants, where 6 participants will be assigned to TAK-079
      injection, and 2 participants will be assigned to Placebo. Participants will receive TAK-079
      or matching placebo in combination with principal investigator directed background therapy
      for SLE.

      This multi-center trial will be conducted in the United States. Participants will make
      multiple visits to the clinic, and will be followed up for the safety assessment for the
      additional 12 weeks up to Week 24 after receiving their last dose of study drug. Based on the
      clinical assessments, participants may complete or may advance to long-term safety follow up
      period for an additional 12-week safety monitoring period up to Week 36.
    

Intervention name(s): TAK-079; TAK-079 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-079 Subcutaneous injection.; TAK-079 placebo-matching subcutaneous injection.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug therapy
High Definition White-Light Colonoscopy vs. Chromoendoscopy for Surveillance of Lynch Syndrome.
Condition: Lynch Syndrome
MeSH terms: Colorectal Neoplasms, Hereditary Nonpolyposis; Syndrome
Study type: Interventional

Summary: 
      Adenomas in Lynch syndrome have an accelerated progression to colorectal cancer (CRC) which
      might occur despite a regular follow-up. Despite low evidence, high-definition technology
      (HD) and indigo-carmine chromoendoscopy (CE) are recommended for surveillance in Lynch
      syndrome.The investigators will conduct a prospective multicenter randomized non-inferiority
      study. The principal aim is to compare the adenoma detection rate with WLE vs CE. Our
      hypothesis is that HD-white-light endoscopy (WLE) is not inferior to CE. Therefore - under
      expert hands - HD-CE does not add any significant advantage over HD-WLE on adenoma detection
      rate in patients with Lynch syndrome.
    

Detailed description: 
      The investigators will conduct a prospective multicenter randomized non-inferiority study.
      Eligible patients will be those with Lynch syndrome (known germline mutation in mismatch
      repair genes) who undergo surveillance colonoscopies. Patients will be sequentially assigned
      in a 1:1 ratio to HD-WLE or HD-CE. The method of stratified randomization based on partial
      colectomy history will be used to avoid proportion imbalance between groups. Participant
      centers must have an organized high-risk of CRC clinic and endoscopic unit provided with HD
      technology. Endoscopists must have a documented high adenoma detection rate and experience in
      performing CE in patients with high-risk conditions of CRC.

      The principal aim is to compare the adenoma detection rate with WLE vs CE. Principal outcome
      measures will be: 1) adenoma detection rate, defined as the proportion of patients with at
      least one adenoma in each arm; 2) number of adenomas per patient, defined as the total number
      of detected adenomas in each arm (HD-WLE or HD-CE) divided by the number of colonoscopies in
      each arm.

      The sample size calculation was determined for a non-inferiority study. Assuming an ADR of
      28% with conventional chromoendoscopy in patients with Lynch syndrome, a 15% non-inferiority
      margin, a one-sided significance level of 0.05 powered at 80% and a 10% of drop-off. Based on
      these assumptions, it was determined that 122 patients were required for each arm (a total of
      244).
    

Intervention name(s): High-definition white-light endoscopy
Intervention type(s): Other
Intervention description(s): The intervention is do not perform chromoendoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Surveillance; Colorectal cancer; Colonoscopy; Adenoma; Chromoendoscopy
CoQ10 in Geriatric Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      We propose to study and compare measures of brain energy metabolism in geriatric bipolar
      individuals and healthy older adults. We would also like to investigate changes in brain
      energy metabolites and in vivo creatine kinase (CK) enzymatic activity associated with CoQ10
      administration in older bipolar individuals.
    

Detailed description: 
      Hypotheses

        1. At baseline, the forward rate constant (kfor) of CK enzymatic activity in the frontal
           lobe of older subjects with bipolar depression will be significantly decreased relative
           to that of age-matched healthy controls.

        2. After 8 weeks of treatment, bipolar depression subjects will demonstrate an increase in
           the kfor of CK after 8 weeks of CoQ 10 treatment.

        3. Increases in the CK forward rate constant (kfor) will correlate with improvement in
           subjects' mood state as assessed by the Montgomery Asberg Depression Rating Scale
           (MADRS).

        4. Baseline measures of executive functioning and information processing speed (measured by
           performance on the Wisconsin Card Sorting Test (WCST), Trails A and B and Stroop tests)
           will be impaired in subjects with geriatric bipolar depression compared with healthy
           controls. These measures will improve with successful treatment with CoQ10 and correlate
           with increases in the CK forward rate constant (kfor).

      Summary:

      A review of literature suggests a distinct pattern of bioenergetic changes, possibly related
      to mitochondrial dysfunction and abnormal CK function, in older adults and in individuals
      with bipolar disorder. As opposed to rudimentary measurements of static metabolite
      concentrations, the novel use of MT-MRS in such individuals will offer insight into the
      enzyme kinetics of CK, specifically examining the rate at which ATP is formed from PCr. From
      previous investigations it would seem that the dietary-supplement, CoQ10, is able to improve
      the efficiency of mitochondrial function in subjects with altered bioenergetics. We propose
      to measure CK activity and PCr turnover rate before and after CoQ10 treatment, with the
      overall aim of understanding metabolic relationships between brain bioenergetic alterations
      and treatment with CoQ10 in geriatric bipolar depression.
    

Intervention name(s): CoEnzyme Q10
Intervention type(s): Drug
Intervention description(s): CoEnzyme Q10 with dosage range from 400 mg to 1200 mg per day
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bipolar depression; elderly; Coenzyme Q10; Magnetic resonance spectroscopy