bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Periodontal Therapy and Biofilm Management in Breast Cancer
Condition: Breast Cancer; Gingivitis; Periodontal
MeSH terms: Gingivitis; Breast Neoplasms
Study type: Interventional

Summary: 
      Objective: To evaluate the impact of chemotherapy on periodontal conditions, hematology, and
      salivary flow in patients with breast cancer and gingivitis, after basic periodontal therapy
      (BPT).

      Methods: They were divided into patients with breast cancer and gingivitis (BC/G =20); and
      patients without cancer with gingivitis (G=20). Clinical parameters [Plaque Index (PI),
      bleeding on probing (BOP), Probing Depth (PS), Clinical Attachment Level (CAL)],
      hematological parameters (complete blood count), and salivary flow were evaluated at
      baseline, 6, 12 and 24 weeks.
    

Detailed description: 
      Objective: To evaluate the impact of chemotherapy on periodontal conditions, hematology, and
      salivary flow in patients with breast cancer and gingivitis, after basic periodontal therapy
      (BPT).

      Methods: They were divided into patients with breast cancer and gingivitis (BC/G =20); and
      patients without cancer with gingivitis (G=20). Clinical parameters [Plaque Index (PI),
      bleeding on probing (BOP), Probing Depth (PS), Clinical Attachment Level (CAL)],
      hematological parameters (complete blood count), and salivary flow were evaluated at
      baseline, 6, 12 and 24 weeks.
    

Intervention name(s): Basic Periodontal Therapy
Intervention type(s): Other
Intervention description(s): All patients received oral hygiene instructions (interproximal cleaning with floss and interdental brushes, brushing instructions on the Bass technique). The patients were also encouraged to brush the back of the tongue once a day. Subsequently, all patients underwent supragingival scaling, prophylaxis, and polishing. Supragingival scaling was performed using manual instruments (Gracey curettes) and an ultrasonic device.
Other intervention name(s): Biofilm control
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast cancer; Gingivitis; Periodontal therapy
Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to

        -  compare the single dose bioavailability of Simvastatin 80 mg tablets with Zocor® 80 mg
           tablets of MercK & Co. Inc, USA in healthy subjects under fed conditions

        -  monitor adverse events and to ensure the safety of subjects.
    

Detailed description: 
      A randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence
      study of Simvastatin 80 mg tablets of Dr. Reddy's Laboratories Limited to be compared with
      Zocor® 80 mg tablets of Merck & Co. Inc., USA in healthy, adult, human subjects under fed
      conditions.
    

Intervention name(s): Simvastatin
Intervention type(s): Drug
Intervention description(s): Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
Other intervention name(s): Zocor® 80 mg tabletsof Merck & Co. Inc., USA
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Simvastatin
Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      A single-arm prospective, interventional clinical trial to evaluate the safety and
      performance of obtaining hemostasis with commercially approved catheters following prostate
      resection using the AquaBeam for treatment of LUTS resulting from BPH.
    

Detailed description: 
      PROCEPT BioRobotics has developed the AquaBeam, a personalized image-guided waterjet
      resection system that utilizes a high-velocity saline stream to resect and remove prostate
      tissue in males suffering from Lower Urinary Tract Symptoms (LUTS) due to BPH. The AquaBeam
      System is intended for the resection and removal of prostate tissue in patients experiencing
      LUTS. The primary objective of the study is to evaluate the safety and performance of
      obtaining hemostasis with commercially approved catheters following prostate resection using
      the AquaBeam. The time frame of the study is 7 days. Up to 30 participants will be included
      in this single-site clinical trial. The trial is a single-arm prospective, interventional
      clinical study. Results will be analyzed to determine the safety and efficacy of commercially
      approved catheters for the achievement of acute hemostasis without the need for
      cauterization.
    

Intervention name(s): AquaBeam System
Intervention type(s): Device
Intervention description(s): The AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Image-guided; BPH; Aquablation; AQUABEAM; LUTS; Tissue resection; Robotics
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a
      new formulation.
    

Detailed description: 
      A single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over
      study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single
      inhaled doses of GSK233705 (50, 100 and 200Âµg), formulated with the excipient magnesium
      stearate, in healthy volunteers.
    

Intervention name(s): GSK233705
Intervention type(s): Drug
Intervention description(s): investigational drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD; GSK233705,; Magnesium Stearate,
Student Anxiety & Stress Study
Condition: Anxiety; Somatic Symptom Disorder
MeSH terms: Medically Unexplained Symptoms; Anxiety Disorders
Study type: Interventional

Summary: 
      The present study is a randomized clinical trial of an emotional awareness and expression
      intervention (EAET) and a mindfulness meditation intervention (MMT) for Wayne State
      University students with anxiety and somatic symptoms. Each of these treatments will be
      compared to a wait list control condition and to one another to evaluate how well the
      treatments improve physical and psychological symptoms, stress, and interpersonal functioning
      of 120 Wayne State University students at 4-week and 8-weeks post-randomization. This
      research is intended to provide an evidence-based approach to working with emotions to
      improve both anxiety and somatic symptoms in young adults and will illuminate how EAET
      compares to the commonly used mindfulness training. It is hypothesized that both active
      interventions will be superior to no treatment, and differences between the two treatments
      will be explored.
    

Detailed description: 
      Anxiety is an increasingly common condition among college students and is often accompanied
      by somatic symptoms. These conditions impair students' social, psychological, and academic
      functioning and outcomes. Although students are utilizing campus and community mental health
      centers at increasing rates, these resources are strained. The present study aims to test the
      efficacy of two brief treatment options for students.

      Integrating techniques from several emotion-focused therapies, the investigators have
      developed and tested an intervention encouraging the awareness and expression of habitually
      suppressed or avoided emotions. This Emotional Awareness and Expression Therapy (EAET) has
      been evaluated with various patient populations including fibromyalgia, irritable bowel
      syndrome, chronic pelvic pain, and medically unexplained symptoms. Results of these trials
      suggest that the intervention is efficacious in improving physical and psychological
      well-being, and is equal to or superior to other psychological interventions for somatic
      conditions. The present study seeks to advance the EAET literature by evaluating the efficacy
      of the intervention for a broader population and by employing a strong and conceptually
      different comparison condition: mindfulness meditation training.
    

Intervention name(s): Emotional Awareness & Expression Therapy; Mindfulness Meditation Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): emotion-focused; meditation training and practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: college students; anxiety; somatic symptoms
Smoking Cessation in Menthol Flavored Cigarette Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine if in smokers of menthol cigarettes, switching to
      non-menthol cigarettes prior to a cessation attempt results in greater cessation success than
      attempting to quit without first switching
    


Intervention name(s): switch to non-menthol cigarettes prior to cessation attempt; continue smoking menthol cigarettes prior to cessation attempt
Intervention type(s): Other; Other
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of three concentrations of a
      development drug compared to placebo in the treatment of atopic dermatitis.
    


Intervention name(s): ZK245186; Placebo (vehicle without active ingredient)
Intervention type(s): Drug; Drug
Intervention description(s): Daily topical application; Daily topical application
Other intervention name(s): Mapracorat (BAY86-5319)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise in Patients With Post-Concussion Symptoms
Condition: Craniocerebral Trauma; Head Injury, Minor; Postconcussion Syndrome; Posttraumatic Headache; Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Craniocerebral Trauma; Post-Concussion Syndrome; Post-Traumatic Headache; Headache; Wounds and Injuries
Study type: Interventional

Summary: 
      Physical activity and exercise have traditionally not been much of a focus in treatment of
      postconcussion symptoms and posttraumatic headache. On the contrary, patients have often got
      advice to rest until they were free from symptoms. This approach, however, is challenged, and
      complete rest should probably be discouraged after the first 24-72 hours. Moderate aerobic
      exercise has been found promising in the early phase after sports-related concussion, and in
      the treatment of patients with headache. This study is an open pilot-study of guided,
      home-based exercise in a clinical sample with postconcussion symptoms and posttraumatic
      headache after mixed-mechanism mild traumatic brain injury and minimal head injuries. The
      study will result in data about the feasibility and possible effects of exercise as treatment
      for prolonged postconcussion symptoms and posttraumatic headache.
    


Intervention name(s): aerobic exercise program
Intervention type(s): Behavioral
Intervention description(s): The intervention is exercise at home, 5-6 days per week during 12 weeks, guided by a schedule that the physiotherapist will design after initial treadmill testing. Exercise intensity is 80-90 % of the heart rate threshold that was identified by the treadmill test. During the 12 weeks program, intensity will be increased according to feedback from the participant.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; exercise therapy; treadmill; symptom threshold; Postconcussion symptoms
Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics
Condition: Pain; Fever; Hepatotoxicity
Study type: Interventional
Phase: Phase 4

Summary: 
      Although acetaminophen is the most commonly used nonprescription drug in the USA, little is
      known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The
      investigators long-term goal is to understand the causes of differences in acetaminophen
      disposition between people that are the result of genetic variation and ethnicity and may
      predispose individuals to a higher risk of acetaminophen hepatotoxicity. The aim of this
      particular study is to measure the rate of elimination of acetaminophen via the 3 main
      pathways (glucuronidation, sulfation and oxidation) in self-identified White-Americans
      (n=100) and African-Americans (n=100). These rates will then be correlated with selected
      genetic polymorphisms in genes encoding enzymes involved in acetaminophen metabolism. Two
      main hypotheses will be tested: 1. African-Americans eliminate acetaminophen more rapidly by
      glucuronidation than do White-Americans. 2. Elimination via glucuronidation, sulfation, and
      oxidation in subjects will be significantly correlated with the presence of polymorphisms in
      the UGT1A6, SULT1A1, and CYP2E1 genes, respectively.
    


Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention description(s): 2 x 500 mg by mouth once
Other intervention name(s): Tylenol
Intervention MeSH terms: Acetaminophen
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Condition: Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aims to demonstrate that intramuscular injection of botulinum toxin with a
      paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than
      corticoid injection only or toxin injection only for treating lateral epicondylitis in
      reducing pain at 6 months.

      As secondary objectives, the study aims to

        -  demonstrate improvement of quality of patient's life and positive effect on their
           resuming to professional activities or sportive activities.

        -  evaluate tolerance of treatment by grip strength measurement and adverse event
           collection.
    

Detailed description: 
      This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled
      study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis.

      All patients will be randomized in 3 following parallel treatment groups:

      Group A : botulinum toxin + corticoid

      Group C : placebo of toxin + corticoid

      Group T : botulinum toxin + placebo corticoid

      The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of
      each patient will last 6 months after treatment.
    

Intervention name(s): Injection, botulinum toxin + corticoid; Injection, placebo of toxin + corticoid; Injection, botulinum toxin + placebo corticoid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %); Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control
Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %); Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ratio 1:1:1
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epicondylitis; Botulinum toxin; Corticoid
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in
      patients with non-small cell lung cancer.
    

Detailed description: 
      Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy.
      Despite the significant importance of cancer-related cachexia, treatments are lacking and
      there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin
      agonist activity, may serve a role in the treatment of cancer cachexia. This placebo
      controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in
      patients with non-small cell lung cancer, a cancer associated with a high prevalence of
      cachexia.
    

Intervention name(s): anamorelin HCl; anamorelin HCl; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg tablet; 100 mg tablet; placebo tablet
Other intervention name(s): ST-1291; ST-1291
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NSCLC
Study to Evaluate the Safety, Tolerability, PK, and PD of PB2452 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled, single
      ascending dose, sequential group study to evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of PB2452 with and without ticagrelor pretreatment
      when administered to healthy male and female subjects.

      Up to 6 dose levels will be evaluated. This study will have up to 10 cohorts and up to a
      total of approximately 76 subjects with either 4 or 8 healthy young subjects in Cohorts 1
      through 9 or approximately 16 older subjects in Cohort 10. The starting dose of PB2452 will
      be 100 mg and the planned doses for subsequent cohorts are 300, 1000, 3000, 9000, and 18000
      mg.
    


Intervention name(s): PB2452 Infusion; Placebo - Sodium Chloride; Ticagrelor Oral Tablet - Pre-Treatment; Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 30 minute - 12 hour infusion; 30 minute - 12 hour infusion; Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo; Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo and Ticagerlor 180 mg 24 hours following MEDI2452 (PB2452) or Placebo
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial of a New Online Programme for Physical Activity and Healthy Eating.
Condition: Overweight/Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Many healthy lifestyle interventions have been developed to help people change their activity
      and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and
      cardiovascular disorders (CVD). However, these interventions often fail to engage their
      target audience, which undermines their effectiveness in changing behaviour and health
      outcomes.

      The purpose of this study is to investigate the effectiveness of a self-directed,
      website-based intervention to promote physical activity and healthy dietary behaviours. The
      intervention frames health information from a novel perspective, which our previous work has
      indicated can help to promote interest in the health information and improve attitudes,
      self-efficacy and motivation towards physical activity and healthy dietary behaviours.

      The intervention comprises a website of information resources and personal recording areas to
      set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim
      to see whether the intervention has any impact on people's physical activity and diet, as
      well as their risk of developing CVD and T2DM. The intervention will be compared with a
      control condition in which participants will be shown standard resources available on NHS
      websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be
      recruited from the community. The active intervention will last 6 weeks (during this period
      participants will receive weekly emails from the research team) and there will be a 6-week
      follow-up phase (in which participants will still have access to the website but contact from
      the research team). Activity, diet, disease risk markers and psychological antecedents of
      behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12-
      weeks).
    


Intervention name(s): Website and pedometer intervention; Control
Intervention type(s): Behavioral; Other
Intervention description(s): Self-directed, website-based intervention delivered with a pedometer to promote understanding of health and health behaviour change.; Standard, publicly available NHS resources for healthy lifestyles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Physical activity; Diet; Health Behavior
Study to Obtain Full Thickness Bladder Tissue From Subjects Undergoing Cystectomy Surgery
Condition: Cystectomy
Study type: Observational

Summary: 
      The objective of this study is to obtain bladder tissue specimens from patients otherwise
      undergoing cystectomy for use in research and training of personnel at Tengion, Inc.
    


Intervention name(s): tissue procurement
Intervention type(s): Other
Intervention description(s): No intervention. Tissue procurement study.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients otherwise undergoing cystectomy
      
Biospecimen description: 
      Tissue
    
Keywords: cystectomy