bioihbjkbjnl/mcl2 huggingface dataset:
Short-term Changes on C-Reactive Protein (CRP) Levels After Non-surgical Periodontal Treatment
Condition: Chronic Periodontitis; Atherosclerotic Cardiovascular Disease
MeSH terms: Periodontitis; Chronic Periodontitis; Cardiovascular Diseases; Atherosclerosis
Study type: Interventional

Summary: 
      The hypotheses tested were that levels of C-Reactive Protein (CRP) would be higher in
      patients with chronic periodontitis in comparison with those without periodontal disease and
      that the non-surgical periodontal treatment would decrease levels of CRP in patients with
      chronic periodontitis.
    


Intervention name(s): Non-surgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): Patients included in the test group were submitted to a non-surgical periodontal treatment protocol, which consisted of oral hygiene orientation and motivation followed by mechanical plaque control involving scaling and root planning using Gracey curets (Hu-Friedy Manufacturing, Chicago, IL, USA) and ultrasonic instrumentation (Cavitron Ultrasonics, Long Island City, NY, USA), under local anesthesia (Mepivacaine 2% with epinephrine 1:100000). The treatment was performed in one or two sessions depending on the extension of the patient's periodontal condition. Patients that presented teeth unreasonable to treat due to advanced periodontitis, or any other condition were extracted under local anesthesia.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: C-Reactive protein; risk
Pertussis and Meningitis C Concomitant Vaccination in Adolescents
Condition: Pertussis; Meningitis; Preventive Immunization; Meningitis; Immunization
MeSH terms: Whooping Cough; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The trial includes groups receiving various combinations of meningitis C and pertussis
      containing vaccines, to be administered concomitantly in adolescents due their school leaving
      booster vaccinations (as per UK routine immunisation schedule at 13-17 years of age).
      Immunogenicity and reactogenicity will be assessed.
    

Detailed description: 
      Recent numbers of cases of infection with meningococcal C and pertussis (whooping cough), and
      the characteristics of the people who are these cases, makes it clear that UK adolescents
      will require booster doses of vaccination for both in the near future. These are increasingly
      important priorities for the national immunisation policy advisers to the Department of
      Health, the Joint Committee on Vaccination and Immunisation (JCVI).

      There are good indications that the likely target agegroup for these booster vaccinations
      will be at 14-17 years. Therefore this study seeks primarily to measure antibody responses to
      the meningitis C and whooping cough vaccines when given at the same time in this agegroup,
      and see how well the vaccines are tolerated.

      Up to 800 adolescents will be recruited across eight study groups. The eight groups arise as
      a result of combinations of four meningococcal and two whooping cough vaccines each
      participant will receive a single dose of each of the two types of vaccine (i.e. two
      injections). Two blood samples will be collected of 10ml each, one prior to vaccination and
      the second at 35 weeks later. These samples will allow assessment of how the immune system
      responds to the vaccinations in terms of the antibodies that are present in the blood.

      The study will also be assessing how well the vaccines are tolerated in this age group when
      given together, as described above. Each participant will therefor be asked to complete a
      health diary for the week following vaccination. This will record any redness/ swelling/ pain
      at the injection site as well as any illnesses or visits to a GP or hospital.
    

Intervention name(s): Meningococcal vaccine; Pertussis containing vaccine
Intervention type(s): Biological; Drug
Intervention description(s): Meningococcal vaccination; Pertussis containing vaccination
Other intervention name(s): Meningitec, NeisVacC, Menitorix, Menveo, Nimenrix; Boostrix, Repevax
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of the Copenhagen Plank on Aductional Strenght and Vertical Jump in Female Football Players
Condition: Groin Injury; Muscle Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      There is enough evidence to know the high incidence of groin injuries in soccer. Despite
      this, there is not enough about these in women's football. The researchers perform the
      Copenhagen plank to obtain an improvement in the improvement of adductor strength and the
      reduction of groin injuries
    

Detailed description: 
      At present, there is enough evidence to know the high incidence of groin injuries in soccer.
      Despite this, there is not enough about them in women's football. Strengthening the adductor
      muscles is beneficial in preventing these injuries. The Copenhagen plank is beneficial in
      programs for the prevention and treatment of groin injuries. A randomized controlled trial
      was carried out. The sample was made up of 26 players between 18 and 31 years of age from the
      CAP Ciudad de Murcia soccer team. The experimental group (n=12) performed the Copenhagen
      plank protocol for 4 weeks, the control group continued their training as normal. Performance
      was assessed using the CMJ jump and the hip adduction strength test using manual dynamometry.
      3 measurements were made.
    

Intervention name(s): Copenhagen plank
Intervention type(s): Procedure
Intervention description(s): Performing Copenhagen adduction as prevention for adductor injury.
Other intervention name(s): Copenhagen Adduction
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Groin pain; Adductors; Copenhagen plank; Strength
Avandamet Bioequivalence Study Brazil - Fed Administration
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is prospective, open-label, randomized, crossover, with 02 treatments, 02
      sequences, and 02 periods. The volunteers received, in each period, the reference or the test
      formulation after standardized meals.
    

Detailed description: 
      This is an open-label, randomized, crossover study with 02 treatments, 02 sequences, and 02
      periods, in which the healthy volunteers received, in each period, the test or the reference
      formulation after standardized meals. Test product is Rosiglitazone Maleate + Metformin -
      Avandamet 4 mg + 1000 mg (GlaxoSmithKline Brasil Ltda) in the form of film coated tablets.
      Reference product is Rosiglitazone Maleate + Metformin - Avandamet 2 mg + 500 mg (Glaxo Smith
      Kline Brasil Ltda) in the form of film coated tablets. The population is composed by 26
      healthy volunteers, adults, of both genders and their ages varied between 18 and 50 years.
      Their body mass index (BMI) varied between 18,5 and 25. There are no restrictions regarding
      the ethnic group. The relative bioavailability of the two formulations, after oral
      administration, will be evaluated based on statistical comparisons of relevant
      pharmacokinetic parameters obtained from data of drug concentration in blood.
    

Intervention name(s): Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg; Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg
Intervention type(s): Drug; Drug
Intervention description(s): Avandamet reference product; Avandamet test product
Intervention MeSH terms: Metformin; Rosiglitazone; Maleic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Metformin; Rosiglitazone; Healthy volunteers; Avandamet; Fed conditions; Bioequivalence
A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are:

      Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic
      (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects
      over 7 days of repeated dosing

      Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets
      administered orally to healthy subjects, in fed and fasted states, in an open-label,
      single-dose, 2-period, 2-sequence crossover study.
    


Intervention name(s): IW-1701; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IW-1701 Tablet; Matching Placebo Tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CBPR Strategies to Increase Colorectal Cancer Screening in Ohio Appalachia
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this project is to implement and evaluate an intervention to increase and
      sustain rates of use of colorectal cancer (CRC) screening among men and women aged 50 and
      older in 6 intervention counties in Appalachia Ohio. Researchers will employ community-based
      participatory research (CBPR) in combination with two CRC interventions that have been
      developed and piloted with community partners to improve CRC screening
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Utilize CBPR methods to develop specific county-level media campaigns and a clinic-based
      chart reminder for 12 Ohio Appalachia counties focused on CRC screening or an attention
      control message.

      II. Implement and test, using a group-randomized design, a staggered county-wide intervention
      program that consists of county-specific media campaigns, clinic-specific chart reminder
      systems, and a combination of both strategies in 6 randomly selected intervention counties
      vs. an attention control condition in 6 randomly selected control counties.

      III. Utilize process and outcome evaluation strategies to assess the efficacy of each
      strategy.

      IV. Utilize the results to plan the dissemination of the intervention into 36 Appalachian
      counties in 6 additional states of the Appalachia Community Cancer Network (ACCN) in a
      subsequent study.

      OUTLINE: Participants are randomized to 1 of 2 arms.

      Arm I: Participants are exposed to the "Get Behind Your Health!" media campaign intervention
      comprising 3 phases: the media campaign, the medical chart reminder, and a combination of
      media campaign and chart reminder. Participants also undergo telephone interviews during
      years 2-4.

      Arm II: Participants are exposed to a media campaign, patient education material in clinics,
      and a combination related to healthy eating, "PEACHES" (Promoting Education in Appalachia on
      Cancer and Healthy Eating Styles). Participants also undergo telephone interviews during
      years 2-4.
    

Intervention name(s): "Get Behind your health"; Peaches
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are exposed to the "Get Behind Your Health!" media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4.; Participants are exposed to a "Healthy Eating!" media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Colorectal Cancer Screening; Ohio Appalachia
Renal Denervation in Diabetic Nephropathy
Condition: Diabetic Nephropathy; Persistent Proteinuria With Type II Diabetes
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Proteinuria; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The DERENEDIAB study is a proof-of-concept, multi-center, prospective, open, randomized,
      controlled study of the effectiveness of renal denervation in addition to standardized
      medical treatment compared to medical treatment alone in diabetic subjects with diabetic
      nephropathy and resistant proteinuria. Bilateral renal denervation will be performed using
      the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy
      through the luminal surface of the renal artery.
    

Detailed description: 
      The DERENEDIAB study is a proof-of-concept multi-center, prospective, open, randomized,
      controlled study of the effectiveness of renal denervation in addition to standardized
      medical treatment compared to medical treatment alone in diabetic subjects with diabetic
      nephropathy and resistant proteinuria. Bilateral renal denervation will be performed using
      the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy
      through the luminal surface of the renal artery.
    

Intervention name(s): Percutaneous renal denervation and TMNS; Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin
Intervention type(s): Procedure; Drug
Intervention description(s): Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications; Patients are maintained on Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker (irbesartan 300mg), a diuretic (furosemide 40mg or indapamide LP 1.5mg according to the eGFR), 25OH vitamin D3 and a statin (atorvastatin 20mg)
Intervention MeSH terms: Vitamin D; Cholecalciferol; Diuretics; Angiotensin Receptor Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic nephropathy; renal denervation; nephroprotection; Renal failure; Renal injury; End stage renal disease
Randomized Study of Acetylcysteine in Patients With Acute Liver Failure Not Caused by Acetaminophen
Condition: Acute Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES:

      I. Determine the safety and efficacy of a short course (72 hours) of intravenous
      acetylcysteine in patients with acute liver failure for whom no antidote or specific
      treatment is available.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to receive
      intravenous acetylcysteine or placebo for 72 hours. Treatment must begin within 12 hours of
      hospitalization. Patients who advance to grade III or IV encephalopathy are eligible for
      liver transplantation.

      Patients are followed at 3 weeks.
    

Intervention name(s): N-acetylcysteine (NAC); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of 5% dextrose with N-acetylcysteine with an initial loading dose of 150 mg/kg/h of NAC over 1 hour, followed by 12.5 mg/kg/h for 4 hours, then continuous infusions of 6.25 mg/kg/h for the remaining 67 hours.; Infusion of 5% dextrose
Other intervention name(s): Acetadote
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute liver failure; gastrointestinal disorders; rare disease
Pharmacokinetic Interactions of Valsartan and Hydrochlorothiazide (Double Doses)
Condition: Healthy Normotensive Participants
Study type: Interventional

Summary: 
      This study was conducted to compare the rate and extent of absorption of valsartan and
      hydrochlorothiazide. To maximize the possibility of finding drug-drug interactions, the dose
      of valsartan and hydrochlorothiazide was doubled (320 mg of VAL and 25 mg of HCT).
    


Intervention name(s): Valsartan/Hydrochlorothiazide; Valsartan; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Co-administration or fixed dose combination; Valsartan alone; Hydrochlorothiazide alone
Intervention MeSH terms: Valsartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fixed dose combination; Pharmacokinetics; Valsartan; Hydrochlorothiazide
The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The main aim of this study is to determine whether there is a difference in the physiological
      effects of theobromine when provided via a single serving compared to multiple servings
      adding up to the same amount of theobromine provided on a day.

      This study also aims to study the pharmacokinetics of theobromine after administration once
      per day versus administration 4 times per day.

      Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is
      given in 4 smaller doses.
    


Intervention name(s): Theobromine; Theobromine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Single dose of theobromine; Multiple doses of theobromine; Placebo capsules
Intervention MeSH terms: Theobromine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: theobromine; heart rate; blood lipids
Effects of Garlic Supplements on Opioids in Healthy Volunteers
Condition: Healthy, No Evidence of Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting
      its effectiveness as an opioid analgesic for the relief of moderate or severe pain.

      PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the
      pharmacokinetics of oxycodone and its analgesic and side effects in healthy volunteers.
    

Detailed description: 
      OBJECTIVES:

        -  To determine whether CYP3A (Cytochrome P450 3A) and/or P-glycoprotein mediated
           interactions exist between garlic supplements and oxycodone (a commonly used oral opioid
           analgesic) in healthy volunteers.

      OUTLINE:

      This is a single-blind, randomized, crossover study. Participants are randomized to 1 of 2
      arms. Each arm entails two 30-day treatment periods, with a washout of at least 4 weeks in
      between.

        -  Arm I: In Period 1, participants receive oral garlic powder twice daily on days 1-28 and
           oral oxycodone on day 28. In Period 2, participants receive oral placebo twice daily on
           days 1-28 and oral oxycodone on day 28.

        -  Arm II: In Period 1, participants receive oral placebo twice daily on days 1-28 and oral
           oxycodone on days 28. In Period 2, participants receive oral garlic powder twice daily
           on days 1-28 and oral oxycodone on day 28.

      In both periods of each arm, participants receive a combination of oral midazolam and oral
      digoxin for CYP3A and P-glycoprotein phenotyping on day 29. Blood samples are collected
      periodically and analyzed by liquid chromatography-mass spectrometry (LC-MS).

      Blood and urine samples are collected after receiving oxycodone for pharmacokinetic
      characterization. Plasma concentrations of oxycodone and its metabolites are measured by
      LC-MS.

      Response to experimentally induced pain by the Cold Pressor Test (CPT) is assessed at
      baseline and periodically after oxycodone treatment. Subjective ratings of opioid side
      effects are assessed by validated questionnaires for somatic side effects and cognitive
      function impairments.
    

Intervention name(s): garlic powder tablets; oxycodone
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Each Garlicin tablet has a claimed allicin content of 3,200 microgram per tablet; Single administration of three 5-mg oxycodone tablets or a 15-mg dose
Other intervention name(s): Nature's Way Garlicin; oxycodone hydrochoride, Roxicodone
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Healthy, No Evidence of Disease
Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase III, multicenter, randomized, double-blind, active-controlled,
      non-inferiority trial designed to assess the efficacy and safety of Brexpiprazole in the
      Treatment of Adults With Acute Schizophrenia. A total of approximately 370 subjects will be
      included in the study, and randomized to Brexpiprazole (2~4 mg/d) or Aripiprazole (10~20
      mg/d) in a 1:1 ratio.
    

Detailed description: 
      Screening Phase: It will begin when informed consent form (ICF) is signed and be a maximum of
      14 days, to evaluate the inclusion/exclusion criteria, collect information such as
      demographic data, medical history, wash out previous antipsychotic agents and other
      prohibited concomitant medications.

      Double-blind Treatment Phase: It lasts 6 weeks; the purpose is to compare the efficacy and
      safety of Brexpiprazole with Aripiprazole in the treatment of adults with acute
      schizophrenia.

      Follow-up Phase: All subjects will be followed up for safety reasons via telephone contact or
      clinic visit 30 (+ 2) days after the last dose of investigational medicinal product,
      collecting safety information (adverse events and concomitant medication).
    

Intervention name(s): Brexpiprazole; Aripiprazole
Intervention type(s): Drug; Drug
Intervention description(s): Brexpiprazole 2-4 mg/day; Aripiprazole 10-20 mg/day
Other intervention name(s): Brexpiprazole Tablets; Aripiprazole Tablets
Intervention MeSH terms: Aripiprazole; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Brexpiprazole; Non-inferiority