bioihbjkbjnl/mcl2 huggingface dataset:
Supra High-intensity Interval Training for Police Officers
Condition: Physical Fitness
Study type: Interventional

Summary: 
      Police work is extreme in terms of the physical activity and physical exertion spectrum as it
      is composed of a mixture of enforced sitting and sudden physical exertion. Police officers
      remain sitting for the majority of their working hours. In theory, regular physical activity
      exerts a number of health and fitness benefits that could act on most issues that police
      officers suffer from. Supra high-intensity interval training (supra HIIT) appears to be a
      perfect solution for police officers as the training modality can be accomplished in less
      than 5 minutes. The primary purpose of this proposal is to create and assess supra HIIT
      program that is suitable for police officers and then to assess feasibility of such exercise
      program in a small pilot study.
    


Intervention name(s): Supra high intensity interval training
Intervention type(s): Behavioral
Intervention description(s): The exercise program will consist of eight 20-second all-out exercise bouts followed by 10 seconds of rest for a total of 4 minutes of total exercise duration. The intensity of exercise is all out. The exercise will be conducted 3 times a week for 8 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This research study of subjects with inadequately controlled type 2 diabetes mellitus (T2DM)
      will compare the glycemic control (measured by HbA1c) in subjects co-administered saxagliptin
      and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects
      receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a
      treatment period of 52 weeks.
    

Detailed description: 
      CV181-369; A 24 Week International, Open-Label Trial With a 28 Week Extension to Evaluate the
      Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in
      Subjects With Type 2 Diabetes on Metformin With or Without Sulfonylurea Therapy
    

Intervention name(s): Saxagliptin, Onglyza; Dapagliflozin, Farxiga; Glargine insulin; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 5mg , Once daily, 24 weeks; Tablets, Oral, 10mg , Once daily, 24 weeks; 100 Units/ml solution for injection in a prefilled SoloStar pen; Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks
Other intervention name(s): Onglyza; BMS-512148; Lantus; Glucophage
Intervention MeSH terms: Metformin; Insulin Glargine; Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
P38 Mitogen-activated Protein (Map) Kinase Inhibitor (SB-681323)Study In Patients With Neuropathic Pain
Condition: Pain, Neuropathic
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a double-blind, placebo controlled cross-over study. After enrolment and initial
      assessments, subjects will receive oral SB681323 or matching placebo for 14 days. SB681323
      will be administered twice daily at a total daily dose of 7.5mg. Sufficient numbers of
      patients will be recruited to obtain 40 evaluable patients
    


Intervention name(s): SB681323; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 15 milligrams (mg)/day
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: MAP kinase; SB681323; neuropathic pain; patients; P38; nerve trauma
Investigating Stress-related Mechanisms in the Laboratory and Real World in Individuals With Cannabis Use Disorder
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Study type: Observational

Summary: 
      This research project proposes a novel approach to elucidate the biological adaptations
      associated with Cannabis Use Disorder and to assess whether such adaptations are predictive
      of higher drug craving in response to both drug cues and stressors in both the laboratory and
      real-world, and higher relapse risk and drug use in the real world.
    

Detailed description: 
      The intent of this study is to recruit 25 treatment-seeking individuals with Cannabis Use
      Disorder (CUD) and 25 light users (<1 joint/week) to complete three guided imagery conditions
      (stress, cannabis, neutral) in inpatient research units. During the guided imagery, repeated
      measurements of subjective (i.e., craving, negative affect), neuroendocrine (i.e., cortisol),
      and physiological variables (i.e., heart rate variability [HRV]) will be collected.
      Thereafter, individuals with CUD will begin one-month of drug counseling treatment coupled
      with surveys delivered via smartphones daily in the morning, evening, and at four random
      times during the day.
    

Intervention name(s): Guided Imagery Laboratory Session
Intervention type(s): Other
Intervention description(s): On days 1, 2 and 3 of the study, subjects will come to the research testing rooms and be provided with lunch before beginning the laboratory session. After a 40-minute adaptation period, two blood samples will be drawn before imagery (BASELINE). After the second blood draw, a 5-minute baseline period will follow to assess continuous pulse rate, BP, and HRV assessments. The subject and research staff conducting the sessions will be blinded to the order and content of the imagery condition. In each recording, the subjects will listen to the scripts over headphones and will vividly imagine the described situation, 'as if' it were happening right now," for 5 minutes. The research nurse will take a blood draw immediately after the imagery (IMAGERY). After that, three recovery blood draws will be performed at 15-minute intervals (RECOVERY). We will analyze the total of six blood samples for levels of cortisol.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with Cannabis Use Disorder and individuals who use cannabis <1/week and do not
        meet criteria for Cannabis Use Disorder
      
Biospecimen description: 
      Saliva samples
Effectiveness of Primary Care Physicians in Delivering Weight Control Counseling
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This randomized clinical trial will determine the efficacy of physicians providing weight
      control advice to their overweight and obese patients in primary care practice.
    

Detailed description: 
      Enrolled physicians are randomly assigned to receive brief training in either: 1) behavioral
      weight control intervention or 2) obesity education. Enrolled patients are asked to see their
      physician for 2 weight control consultations during the year to discuss their weight and
      physical activity. Regardless of the training the physician receives, the weight control
      advice is tailored to the individual patient. Patients include men and women between the ages
      of 21 - 70 years, with a Body-Mass Index of 27 or greater, and they have met medical and
      other study eligibility criteria in order to safely participate. As a participant in the
      trial, all patients are asked to attend an initial baseline assessment, and two follow-up
      assessments; 3 and 12 months after their first weight control consultation visit with their
      physician in order to evaluate any changes in their weight, waist circumference, physical
      activity, eating patterns, and mood. The findings of this important study will shed light
      upon the role physician advice may have in helping overweight and obese patients lose weight
      and become more physically active.
    

Intervention name(s): physician-delivered weight control
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
Keywords: physician education; behavioral weight control; physician intervention; obesity counseling
Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate which changes in immunological biomarkers under
      treatment with fingolimod in patients with relapsing-remitting multiple sclerosis can be
      detected.
    


Intervention name(s): Fingolimod
Intervention type(s): Drug
Intervention MeSH terms: Fingolimod Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Multiple sclerosis; RRMS; relapsing-remitting; fingolimod; biomarkers
Bioequivalence Study of Two Formulations of 10 mg Lisinopril Tablet Under Fasting Condition
Condition: Healthy
Study type: Interventional

Summary: 
      The present study was conducted to find out whether the bioavailability of 10 mg lisinopril
      tablets produced by PT Dexa Medica was equivalent to the tablets produced by the innovator
      (Zestril® 10 mg, PT Boehringer Ingelheim Indonesia, Indonesia, under license from Astra
      Zeneca UK Ltd.)
    

Detailed description: 
      This was a randomized, single-blind, two-period, two-sequence, cross-over study under fasting
      condition. The participating subjects were required to have an overnight fast and in the next
      morning were given orally one tablet of the test drug (Lisinopril 10 mg, produced by PT Dexa
      Medica) or one tablet of the reference drug (Zestril® 10 mg, PT Boehringer Ingelheim
      Indonesia, Indonesia, under license from Astra Zeneca UK Ltd.).

      Blood samples were drawn immediately before taking the drug (control), and at 1, 2, 3, 4, 5,
      6, 7, 8, 9, 10, 12, 16, 24, 36, and 48 hours after drug administration. Seven days after the
      first drug administration (washout period), the procedure was repeated using the alternate
      drug.

      The pharmacokinetic parameters, including AUCt, AUCinf, Cmax, t max, and t1/2, were
      determined from plasma concentrations of lisinopril, using liquid chromatography with tandem
      mass spectrometry detection (LC-MS/MS) method.
    

Intervention name(s): Lisinopril 10 mg tablets of PT Dexa Medica; Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia
Intervention type(s): Drug; Drug
Intervention description(s): Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.; Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Other intervention name(s): Test Product: Lisinopril 10 mg tablets of PT Dexa Medica; Reference product: Zestril® 10 mg, produced by PT Boehringer Ingelheim Indonesia, under license from Astra Zeneca UK Ltd..
Intervention MeSH terms: Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Lisinopril; Bioequivalence; Bioavailability; Pharmacokinetic; Angiotensin-converting enzyme inhibitor
Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of alogliptin, once daily
      (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of
      sulfonylurea and metformin for treating subjects with type 2 diabetes.
    

Detailed description: 
      Of the approximately 19 million people in the United States who have been diagnosed with
      diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2
      diabetes mellitus varies among racial and ethnic populations and has been shown to increase
      with age, obesity, family history, history of gestational diabetes, and physical inactivity.
      Over the next decade, a disproportionate increase in the elderly population will result in a
      marked increase in diabetic patients, placing an ever-increasing burden on families and the
      health care system.

      In response to this problem, Takeda Global Research & Development Center, Inc. is developing
      SYR-322 (alogliptin), a selective, orally available inhibitor of the enzyme dipeptidyl
      peptidase IV. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo
      degradation of 2 peptide hormones released in response to nutrient ingestion, namely
      glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

      Individuals who want to participate in this study will be required to provide written
      informed consent. Study participation is anticipated to be about 14 Weeks. Multiple
      procedures will occur at each visit which may include blood collection, urine collection,
      vital signs including sitting and standing blood pressure and pulse, body height and weight,
      physical examinations and electrocardiograms.
    

Intervention name(s): Alogliptin; Alogliptin; Alogliptin; Alogliptin; Alogliptin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks; Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.; Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
Other intervention name(s): SYR-322; SYR110322; SYR-322; SYR110322; SYR-322; SYR110322; SYR-322; SYR110322; SYR-322; SYR110322
Intervention MeSH terms: Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Drug Therapy; Diabetes Mellitus, Type II; Type 2 Diabetes Mellitus; Hyperinsulinism; Insulin Resistance
PK Study of Liquid Formulation of BIO89-100 in Subjects With NASH With Compensation Cirrhosis
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose study to evaluate the PK profile of the liquid SC
      formulation of BIO89-100 in approximately 8 male and female subjects with NASH with
      compensated cirrhosis.
    


Intervention name(s): BIO89-100
Intervention type(s): Drug
Intervention description(s): Subcutaneous Injections
Intervention model: Single Group Assignment
Intervention model description: Open label, single dose, PK study
Masking: None (Open Label)
Primary purpose: Other
A Study of the Feasibility of Using the Dietary Supplement "ARTNEO" in Patients With Osteoathritis
Condition: Osteoarthritis, Knee; Osteoarthritis; Knee Osteoarthritis; Knee Arthritis; Knee Discomfort; Knee Pain Swelling; Knee Pain Chronic
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The goal of this clinical study is to evaluate the effectiveness of the properties that
      support the functional state of the joints and the safety of the dietary supplement for food
      ARTNEO®, oral capsules, in patients with stage II-III primary osteoarthritis of the knee
      joint.

      The main questions it aims to answer are:

        1. To evaluate the effectiveness of the joint functional state-supporting properties of
           dietary supplement ARTNEO®, capsules for oral administration, in patients with stage
           II-III primary osteoarthritis of the knee joint;

        2. To evaluate the safety of dietary supplement ARTNEO®, capsules for oral administration,
           in patients with stage II-III primary osteoarthritis of the knee joint.

      Participants will be randomly distributed equally among two groups:

        -  Group 1 "ARTNEO" (106 people): patients take the study dietary supplement ARTNEO®, 1
           capsule 1 time per day for 6 months;

        -  Group 2 "Placebo" (106 people): patients take placebo 1 capsule 1 time per day for 6
           months.
    


Intervention name(s): undenaturated collagen type II, methylsulfonylmethane, boswellia serrata, vitamin D3 (cholecalciferol), vitamin C (ARTNEO); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Release form: capsules with an average weight of 585 mg. Active ingredients: MCM (methylsulfonylmethane) 300 mg, vitamin C (ascorbic acid) 80 mg, boswellia extract (65% boswellic acids) 50.05 mg, undenatured (native) type II collagen 40 mg, vitamin D3 (cholecalciferol) 400 IU.
Suggested Use: Adults, 1 capsule daily with meals.; Release form: capsules with an average weight of 585 mg. No active ingredients.
Intervention MeSH terms: Vitamin D; Cholecalciferol; Vitamins; Dimethyl sulfone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: undenatured type ii collagen; collagen; Boswellia serrata; methylsulfonylmethane; osteoarthritis; knee pain
Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Sleep Apnea Syndromes; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The current research program aims to study how sleep disordered breathing, age and genetics
      affect memory in older adult veterans with Posttraumatic Stress Disorder (PTSD).

      The study will help researchers and clinicians better understand the relationship among PTSD,
      sleep disordered breathing, genetics and memory function.
    

Detailed description: 
      The research project will clarify how sleep disordered breathing and Apolipoprotein (APOE)
      status affect cognitive decline in a population already at risk for accelerated
      decline-veterans with PTSD.

      To fill this knowledge gap properly, we will conduct a longitudinal study and data include
      analytic techniques designed specifically to identify moderators and mediators of clinical
      change.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        US war Veterans with PTSD and possible sleep problems
      
Biospecimen description: 
      blood or saliva
A Phase III Open-Label, Multi-Center, Long-Term Extension Study of Depakote ER in Subjects Who Either Completed or Prematurely Discontinued Due to Ineffectiveness From Study M02-488.
Condition: Migraines
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if long-term treatment, up to 1 year, with Depakote
      ER is safe in the reduction of occurrence of migraine headaches in adolescents.
    


Intervention name(s): divalproex sodium
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraines; Depakote ER; divalproex sodium
Safety, Tolerability, PK and PD of LGT209 in Healthy Volunteers and Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to measure the effects of LGT209 when given intravenously to patients
      with high cholesterol who are on stable doses of statin medications, and to healthy subjects
      with elevated cholesterol
    


Intervention name(s): LGT209; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg lyophilized powder in glass vial; Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypercholesterolemia,; LGT209,; PCSK9,; LDL-C
A Study of Tislelizumab in Combination With Chemotherapy Versus Chemotherapy in Advanced Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      An open-label, randomized, multicenter Phase 3 study designed to compare the efficacy and
      safety of tislelizumab combined with chemotherapy versus chemotherapy only as first-line
      treatment in advanced squamous non-small cell lung cancer (NSCLC).
    


Intervention name(s): Tislelizumab; Paclitaxel; Nab-paclitaxel; Carboplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered intravenously as described; Administered intravenously as described; Administered intravenously as described; Administered intravenously as described
Other intervention name(s): BGB-A317
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Tislelizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Adjunctive Systemic Administration of Moxifloxacin in the Treatment of Aggressive Periodontitis
Condition: Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Interventional
Phase: Phase 4

Summary: 
      The adjunctive use of systemically administered antibiotics has been shown to provide a
      better clinical outcome, particularly in terms of probing depth (PD) reduction and
      attachment-level gain than SRP in subjects with Aggressive Periodontitis.

      The overall objective of this study is to evaluate the clinical and microbiological efficacy
      of moxifloxacin as an adjunct to scaling and root planing versus scaling and root planing
      over placebo in the treatment of aggressive periodontitis.
    


Intervention name(s): scaling and systemic moxifloxacin; scaling and root planing
Intervention type(s): Other; Other
Intervention description(s): scaling and root planing (SRP) combined with systemic moxifloxacin; scaling and root planing
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aggressive Periodontitis; antimicrobial(s); microbiology