bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 50 mg
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,
      balanced, single dose pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fasting
      condition in healthy adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Metoprolol Succinate 50 mg Ipca Laboratories Limited, India and the corresponding Reference
      Product: TOPROL-XL® (Metoprolol Succinate) extended release Tablets 50 mg of Astrazenica LP,
      USA under fasting condition in healthy adult human subjects in a randomized crossover study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single 50 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Metoprolol Succinate ER Tablets 50 mg; 'TOPROL-XL®' ER Tablets 50 mg
Intervention type(s): Drug; Drug
Intervention description(s): 1* 50 mg tablet once a day; 1 * 50 mg tablet per day
Other intervention name(s): Test Product; Reference Product
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess bone mineral density in patients switching from an
      oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.
    


Intervention name(s): zoledronic acid
Intervention type(s): Drug
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: osteoporosis, osteopenia, post-menopausal, zoledronic acid
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
Condition: Non-alcoholic Fatty Liver Disease (NAFLD); Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 study with 4 treatment groups of two differing doses and matched placebos designed
      to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects
      of two dose levels of MEDI0382 in obese subjects with non-alcoholic fatty liver disease
      (NAFLD)/non-alcoholic steatohepatitis (NASH). The subjects will have biopsy-confirmed
      NAFLD/NASH with liver fibrosis stage F1, F2 or F3. Approximately 72 subjects will be
      randomized
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, study to evaluate the safety
      (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of
      MEDI0382 in obese subjects with non-alcoholic fatty liver disease (NAFLD)/non-alcoholic
      steatohepatitis (NASH). The subjects will have biopsy-confirmed NAFLD/NASH with liver
      fibrosis stage F1, F2 or F3. Approximately 72 subjects will be randomized across multiple
      study sites.
    

Intervention name(s): MEDI0382 high dose; Placebo for MEDI0382 high dose; MEDI0382 low dose; Placebo for MEDI0382 low dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): MEDI0382 high dose administered subcutaneously; Placebo for MEDI0382 high dose administered subcutaneously; MEDI0382 low dose administered subcutaneously; Placebo for MEDI0382 low dose administered subcutaneously
Other intervention name(s): Cotadutide high dose; Placebo high dose; Cotadutide low dose; Placebo low dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-alcoholic fatty liver disease; NAFLD; Non-alcoholic steatohepatitis; NASH; 0382
Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine
Condition: Pandemic Influenza Vaccine; Prevention; Pandemic Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate
      the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1)
      vaccine (whole-virion, aluminium-adjuvanted).
    


Intervention name(s): pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection; pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection; pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection; pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single
      dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared
      to healthy participants.
    


Intervention name(s): Ipatasertib
Intervention type(s): Drug
Intervention description(s): A single oral dose of 100 mg ipatasertib will be administered.
Other intervention name(s): GDC-0068
Intervention MeSH terms: Ipatasertib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Families Defeating Diabetes
Condition: Diabetes Prevention
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      No evidence-based, evaluated, population-appropriate resources exist to translate Type 2
      diabetes (T2DM) primary prevention messages to Canadians. Significant barriers to such
      large-scale interventions include:

        -  the need to identify, then target specific at-risk populations

        -  significant time-delays before any program effects on T2DM incidence may manifest.

      However, women with gestational diabetes (GDM) are a readily identifiable study cohort at
      significant risk for recurrent GDM and T2DM-hence GDM women provide important opportunities
      for rigorous, timely diabetes prevention intervention studies. The investigators propose FDD
      (Families Defeating Diabetes), a Canadian diabetes prevention intervention uniquely targeting
      women with recent GDM in the context of their families.

      FDD is a 12 month, randomized, controlled T2DM prevention intervention targeting women with
      recent GDM, within their family context. Five Canadian sites and 177 women will participate.
      Multifaceted information and behavioural change support will be provided for diet, weight
      loss, and activity through: seminar, walking groups, electronic updates, password-protected
      social networking site.

      Subjects and controls will be compared for: DM prevention knowledge; diet/activity choices;
      HbA1C; body habitus at study onset/during study/12 months/24 months.

      Consenting immediate family members will have protective knowledge/diet/exercise choices/body
      habitus measures documented at study onset/12 and 24 months.
    


Intervention name(s): FDD program
Intervention type(s): Other
Intervention description(s): FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: gestational diabetes; GDM; prevention
Study to Explore the Efficacy and Safety of BIO89-100 in Subjects With Severe Hypertriglyceridemia
Condition: Severe Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the efficacy, safety, and tolerability of different doses
      and dose regimens (QW or every 2 weeks [Q2W]), subcutaneous (SC) dosing of BIO89-100 compared
      to placebo in subjects with Severe Hypertriglyceridemia (SHTG).
    


Intervention name(s): BIO89-100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BIO89-100; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertriglyceridemia; Dyslipidemia; Lipid disorder; FGF21
IASTM Versus PRT in Patients With Chronic PF
Condition: Chronic Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      The goal of this clinical trial] is to compare between the effect of instrument assisted soft
      tissue mobilization and positional release technique in patients with chronic plantar
      fasciitis

      The main question[s] it aims to answer are:

        1. Is there a difference between the effect of instrument assisted soft tissue mobilization
           and positional release technique on pain pressure threshold in patients with chronic
           plantar fasciitis?

        2. Is there a difference between the effect of instrument assisted soft tissue mobilization
           and positional release technique on foot function level in patients with chronic plantar
           fasciitis?
    

Detailed description: 
      Design of the study:

      Pretest - posttest randomized controlled trial.

      Subjects selection:

      Sixty patients their age range from 30-50 years of both genders with chronic plantar
      fasciitis will participate in this study according to sample size calculation.
    

Intervention name(s): Instrument assisted soft tissue mobilization in addition to traditional treatment; Positional release technique in addition to traditional treatment; Traditional treatment
Intervention type(s): Other; Other; Other
Intervention description(s): The treatment protocol will be two sessions will be given per week for 4 weeks.; The treatment protocol will be two sessions will be given per week for 4 weeks.; The treatment protocol will be two sessions will be given per week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Positional release technique; Instrument assisted soft tissue mobilization
Effects of Resistance Training on Pain, Function and Work Ability in Patients With Moderate to Severe Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if high-intensity resistance training can induce
      additional beneficial effects, for patients with moderate to severe long term pain in the
      neck, when added to a multidisciplinary treatment program.
    


Intervention name(s): High-intensity resistance training; General physical activity; Multidisciplinary rehabilitation program
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Exercise therapy; Resistance training; Multidisciplinary treatment
Relative Bioavailability, Transdermally Administered EE and GSD, 3 Applications Sites
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      Influence of different application sites on the blood levels after administration of a
      fertility control patch
    


Intervention name(s): Gestodene/EE Patch (BAY86-5016); Gestodene/EE Patch (BAY86-5016); Gestodene/EE Patch (BAY86-5016)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks; Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm; Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen
Intervention MeSH terms: Gestodene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
Validity of an AI-based Program to Identify Foods and Estimate Food Portion Size
Condition: Nutrition Assessment
Study type: Interventional

Summary: 
      The purpose of this study is to test the accuracy of the Nutrition Artificial Intelligence in
      the Openfit app during meals in a controlled laboratory setting
    

Detailed description: 
      For this pilot study, using a convenience sample, the investigators will recruit up to 25
      adults to use the Nutrition AI technology in Openfit to identify and estimate portion size of
      foods plated in a laboratory setting at Pennington Biomedical Research Center (PBRC) and/or
      Louisiana State University (LSU). Laboratory members within the Ingestive Behavioral
      Laboratory will also test the ability of Nutrition AI to identify foods and to quantify foods
      provided in the laboratory. Meals will be simulated, and participants will not consume the
      foods provided.
    

Intervention name(s): PortionSize AI
Intervention type(s): Device
Intervention description(s): For this pilot study, using a convenience sample, the investigators will recruit up to 25 adults to use the Nutrition AI technology in Openfit to identify and estimate portion size of foods provided in a laboratory setting at Pennington Biomedical Research Center (PBRC) and/or Louisiana State University (LSU). Laboratory members within the Ingestive Behavioral Laboratory will also test the ability of Nutrition AI to identify foods and to quantify foods provided in the laboratory. Meals will be simulated, and participants will not consume the foods provided.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nutrition Assessment
Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks
Condition: Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators aim to compare the use of a suprainguinal fascia iliaca compartment block
      vs lumbar plexus block as an adjunct to general anesthesia in pediatric patients undergoing
      orthopedic procedures involving the hip or upper femur. This study will help determine the
      efficacy of the two techniques and their advantages when compared to each other including
      time to perform the block, opioid consumption reduction, effects on postoperative pain, and
      the length of stay.
    


Intervention name(s): Ropivacaine Hcl 0.5% Inj Vil 20Ml
Intervention type(s): Drug
Intervention description(s): Anesthetic agent used in peripheral nerve block
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A 26-Week Extension Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy
Condition: Schizophrenia; Impaired Cognition
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to further investigate the safety of prolonged exposure to
      EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic
      who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.
    


Intervention name(s): EVP-6124
Intervention type(s): Drug
Intervention description(s): Arm 1, 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; Cognition Impairment; Alpha-7 nAChR
Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This exploratory study is designed to evaluate various pharmacodynamic effects of
      subcutaneously (SC) infused or injected pramlintide in obese, nondiabetic male and
      postmenopausal female (not on hormone replacement therapy) subjects. The study will also
      assess the safety and tolerability of pramlintide administered by SC infusion or injection.
    


Intervention name(s): pramlintide acetate
Intervention type(s): Drug
Intervention description(s): Clear, colorless, sterile solution for SC administration
Intervention MeSH terms: Pramlintide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pramlintide; Symlin; Amylin
A Randomized Controlled Trial of the Effects of Reactive Neuromuscular Training on Balance
Condition: Balance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Falls are a major concern for the geriatric population and represent a significant public
      health problem. Various interventions are being explored to improve balance and decrease
      falls in the elderly. Success has been shown in some programs; various exercise interventions
      place emphasis on strength, balance, or endurance exercises. Results reported in the
      literature are still equivocal. Controversy exists as to optimal types of exercise, and the
      optimum frequency, duration, and intensity of exercise. It is believed that the SpineForce
      device, which places a unique combination of strength and balance demands upon the user, can
      result in rapid increases in balance as compared to other rehabilitation programs. Gains in
      balance have implications for geriatric populations as well as those seeking enhanced sports
      performance and injury prevention. The Purpose of this study is to assess the SpineForce
      device as a novel intervention in the treatment of balance disorders.
    


Intervention name(s): SpineForce Reactive Neuromuscular Trainer
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for
      certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly
      subcutaneous injections for 12 weeks.
    

Detailed description: 
      This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440
      for injectable suspension). It is to be tested for its ability to reduce weight in obese
      subjects. The study will provide information on how much ZGN-440 gets into the blood, how
      long it stays in the body, and how it affects other biological markers.
    

Intervention name(s): Beloranib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.; Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses.
Other intervention name(s): ZGN-440 for injectable suspension; ZGN-440; ZGN-433; ZGN-440 sterile diluent
Intervention MeSH terms: CKD732
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obese; Obesity; Overweight; Weight loss; Weight reduction; Beloranib