bioihbjkbjnl/mcl2 huggingface dataset:
Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Healthy Men
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial is studying the side effects and best dose of Bowman-Birk
      inhibitor concentrate in preventing cancer in healthy men. Chemoprevention is the use of
      certain drugs to keep cancer from forming, growing, or coming back. The use of Bowman-Birk
      inhibitor concentrate may prevent cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the toxic effects of Bowman-Birk inhibitor concentrate, administered as an
      orange juice suspension, in healthy male participants.

      II. Determine a safe dose range of this drug in these participants. III. Determine a
      recommended phase II dose of this drug in these participants.

      SECONDARY OBJECTIVES:

      I. Determine the pharmacokinetics of this drug in these participants.

      OUTLINE: This is a randomized, placebo-controlled, double-blind, dose-escalation study.

      Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each
      dose level cohort is randomized to receive placebo. Participants receive 1 of 4 escalating
      doses of oral Bowman-Birk inhibitor concentrate or placebo, as an orange juice suspension, on
      day 1.

      After completion of study treatment, participants are followed periodically for 4 weeks.
    

Intervention name(s): placebo; Bowman-Birk inhibitor concentrate
Intervention type(s): Other; Drug
Intervention description(s): Given orally; Given orally
Other intervention name(s): PLCB; BBIC
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effects of Whole-Body Vibration Training Versus Balance Training in Patients With Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Aim of this study is to compare the effects of whole-body Vibration Training versus
      conventional Balance Training on Balance performance, gait quality and exercise capacity in
      patients with severe chronic obstructive pulmonary disease. Patients will be recruited during
      a 3-week inpatient pulmonary rehabilitation program and will be randomized into one of two
      intervention groups. On top of a standardized endurance and strength Training program (5 days
      per week) patients in both groups will perform an additional Balance Training (on 3 days per
      week). Patients in both Groups will perform the same 4 different Balance exercises (2x1
      Minute each): dynamic squats with closed eyes, heel raise, semi-Tandem stance and single leg
      stance but on a different surface. The Vibration Training Group will perform the exercises on
      a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz and the
      control Group will perform exercises on instable objects like Balance pads. The degree of
      difficulty in both Groups will be individually adjusted and will be progressively increased,
      if possible.
    


Intervention name(s): Balance Training on a vibration platform; Conventional Balance training
Intervention type(s): Other; Other
Intervention description(s): n=24 patients with severe chronic obstructive pulmonary disease. Exercises will be performed on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz.; n=24 patients with COPD, Exercises will be performed on a Balance pad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; Balance; Whole Body Vibration Training; pulmonary rehabilitation; exercise
Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis
Condition: Other Haemostasis Disorder; Haemorrhagic Cystitis
MeSH terms: Cystitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      assess the efficacy of activated recombinant human factor VII in the treatment of refractory
      haemorrhagic cystitis (HC) following chemotherapy.
    


Intervention name(s): activated recombinant human factor VII
Intervention type(s): Drug
Intervention description(s): If non-responding haemorrhagic cystitis to 24-hour trial of conventional therapy, 80 mcg/kg is administered i.v. for the first dose. If necessary, two additional doses of 120 mcg/kg can be administered i.v.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimization of Hip-exoskeleton Weight Attributes
Condition: Healthy; Gait, Frontal
MeSH terms: Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      The investigators are examining how weight distribution affects the way people walk, in terms
      of joint kinematics, kinetics, and muscle activity. The investigators are measuring these
      quantities while people walk while wearing a weighted belt. The investigators distribute the
      weights and walk for specified periods. They hypothesize that greater weight will have a
      greater effect on walking.
    

Detailed description: 
      The purpose of this study is to examine how the amount and distribution of weight on the
      pelvis affects how people walk. The investigators two factors, weight and placement. They are
      examining how these factors affect muscle activation, joint motions and foot forces. The
      investigators plan to recruit 40 healthy adult individuals. Each of the 20 experimental
      conditions (3x3 factorial and one control condition with no weight) will be recorded
      immediately in a single session. The investigators hypothesize that weight amount, gait speed
      and weight distribution will all affect how people walk, which will lead towards optimized
      design of hip exoskeletons.
    

Intervention name(s): Weight belt
Intervention type(s): Other
Intervention description(s): Wearing belt around waist with various weights attached.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this placebo-controlled, double-blind study is to assess the effect of several
      doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of
      high-intensity statin, and to evaluate the safety and tolerability of different doses of
      CAT-2054 for 4 weeks.
    


Intervention name(s): CAT-2054; Placebo; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of BOS161721 in Healthy Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      Study BOS161721-01 is a randomized, single center, double-blind, placebo-controlled trial
      conducted to study the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single
      ascending intravenous (IV) and subcutaneous (SC) doses of BOS161721 or placebo in healthy
      adult male and female participants.
    

Detailed description: 
      Study BOS161721-01 will consist of 7 single ascending dose (SAD) cohorts, each with 8
      participants (6 active:2 placebo), and an eighth SAD cohort with 5 participants (all active).
      Participants will be randomized in a 3:1 ratio (BOS161721:placebo) and will either receive a
      single dose of BOS161721 (1, 3, 10, 22, 30, 60, 120, or 240 milligrams [mg]) or placebo.
      Participants in Cohort 1 will receive the lowest dose, administered IV (1 mg), followed by
      Cohort 2, in which participants will receive the second lowest dose, administered SC (3 mg).
      BOS161721 or placebo will also be administered SC in Cohorts 3, 4, 5, 7, and 8. Participants
      in Cohort 6 will be administered an IV dose of 22 mg (5 active) in parallel to the 60 mg
      SC-dosed fifth cohort. This dose has been selected to generate a similar exposure to that
      following the 30 mg SC dose. The actual Cohort 6 IV dose may be adjusted upon available PK
      data.

      Participants will be in this study for up to 56 weeks, which includes a Screening Period of
      up to 28 days, a single-dose treatment day (during the in-subject treatment period), and a
      52-week post-treatment Follow-up Period, which is required due to the potential half-life of
      BOS161721.
    

Intervention name(s): BOS161721; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose administered IV or SC; Single dose administered IV or SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy participants; BOS161721; Pharmacokinetics; Pharmacodynamics
A Study of the Efficacy and Safety of NVA237 in Patients With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a post-authorization commitment to the European Medicines Agency (EMA). The
      study serves to determine whether the treatment of patients with stable, symptomatic Chronic
      Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and
      safe. The efficacy and safety of the drug was tested for twice daily dosing against once
      daily dosing.
    


Intervention name(s): NVA237; Placebo; Salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1; Placebo to NVA237; All patients received salbutamol (100 μg) as only rescue medication
Other intervention name(s): glycopyrronioum bromide
Intervention MeSH terms: Glycopyrrolate; Bromides; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anticholinergic; Antimuscarinic; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease; Chronic Obstructive Pulmonary Disease; COPD; LAMA; Lung Disease; Lung Diseases, Obstructive; Lung Function; Muscarinic receptor antagonist; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases
HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Versus Non Smokers
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Observational

Summary: 
      Smoking is a major risk factor for developing peri-implantitis so the current study is
      comparing inflammatory markers in smokers versus non smokers to know if they have a potential
      role in pathogenesis of peri-implantitis
    

Detailed description: 
      Peri -implant crevicular fluid was obtained from seven smoker patients and then compared to
      peri-implant crevicular fluid from seven non smoker individuals.

      The peri-implant crevicular fluid was obtained using periopaper strips then analyzed using
      ELISA kits of these markers; HIF-1 Alpha, VEGF and MMP-8
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Smoker patients with restored implants
      
Biospecimen description: 
      Peri-implant crevicular fluid samples collected using periopaper strips
    
Keywords: gingival crevicular fluid; Smoking; inflammation
PET Study in Parkinson's Disease Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or
      female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a
      clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20
      patients to complete this study.The study will evaluate the effect of 8 weeks treatment with
      AZD3241 on microglia activation as measured via PET examinations.
    

Detailed description: 
      A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study
      to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as
      Measured by Positron Emission Tomography (PET), in Patients with Parkinson's Disease
    

Intervention name(s): ER tablet 25 mg AZD3241; ER tablet 100 mg AZD3241; Placebo for AZD3241 25 mg; Placebo for AZD3241 100 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 tablets twice daily for Day 1; 1-6 tablets twice daily from Day 2 until Day 56±3 days; 2 tablets twice daily for Day 1; 1-6 tablets twice daily from Day 2 until Day 56±3 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase IIa; AZD3241; microglia activation; safety; Pharmacodynamics and pharmacokinetics analyses; Parkinson patients
Randomized Trial of Dietary Intervention Therapy in Obese Hypertensives (DITOH)
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effects on blood pressure of dietary intervention, restricting caloric
      intake to 600 calories per day for 16 weeks compared to a control diet of 1200 calories per
      day in obese hypertensives. Secondary aims included a study of psychological characteristics
      at baseline and during the weight loss and maintenance phases of the study.
    

Detailed description: 
      BACKGROUND:

      Hypertension is a highly prevalent disorder contributing to a large proportion of
      cardiovascular morbidity and mortality in the United States. Although drug therapy of
      elevated blood pressure can reduce the risks of cardiovascular morbidity and mortality, such
      therapy constitutes significant expense for individuals over long periods of time as well as
      large national expenditures. In addition, the side effects of drug therapy may be
      significant. DITOH would provide much needed information concerning the effects of various
      means of weight reduction on blood pressure as possible definitive therapy for hypertension
      or as an approach which could be combined with reduced drug dosages.

      DESIGN NARRATIVE:

      Randomized. After three weeks on a control diet, subjects were randomized to the Protein
      Sparing Modified Fast Diet which provided 600 calories per day (1.5 grams per kilogram of
      ideal body weight of high quality protein plus 19 grams of fat) or to a 1200 calorie per day
      Balanced Deficit Diet. After 16 weeks in the weight-loss phase, subjects entered the
      maintenance program for 20 weeks. Both diets were supplemented with vitamins, minerals, and
      fluids. The Protein Sparing Modified Fast Diet was supplemented with 5 grams of salt given as
      bouillon to equal the salt intake of the Balanced Deficit Diet. Patients were followed for 24
      months after the end of the weight loss phase. The primary endpoint was change in diastolic
      blood pressure. Individuals who continued to have diastolic pressures above 104 mm Hg
      following the initial 16 week treatment period were treated with antihypertensive drugs.

      The study completion date listed in this record was obtained from the Query/View/Report (QVR)
      System.
    

Intervention name(s): diet, reducing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
DL6049 Versus Cosmoplast in the Treatment of Nasolabial Fold Wrinkles, Long Term Follow-up
Condition: Nasolabial Fold Wrinkles
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being undertaken to:

        -  evaluate the degree of correction attainable with DL6049 (injectable poly-L-lactic
           acid)compared to a commercially available CosmoPlast™ Collagen Implant in the treatment
           of dermal nasolabial fold wrinkles at 13 months following the last application of study
           treatment.

        -  Document the types and incidence of adverse events reported with DL6049 (injectable
           poly-L-lactic acid)compared with CosmoPlast™ Collagen Implant. Long term adverse events
           will be assessed for an additional 12 months following discharge from the main study in
           subjects treated with DL6049.
    


Intervention name(s): DL6049 (injectable poly-L-lactic acid)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Effects of Dapagliflozin on Hormonal Glucose Homeostasis in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Inhibitors of sodium-dependent glucose-transporter 2 (including dapagliflozin) represent
      intensively investigated drugs in the field of diabetes. SGLT-2 inhibition limits glucose
      reabsorption in renal tubular cells, hereby increasing the amount of glucose excreted via
      urine in the hyperglycemic state. Its mechanisms of action are independent of insulin, the
      indispensable standard of care in Type 1 Diabetes (T1D). Several international diabetes
      experts highlighted the need for adjunct therapies in T1D.

      Subcutaneous application of insulin is non-physiological. Most significant, subcutaneous
      insulin substitution does not address the bi-hormonal character of T1D. The loss of
      pancreatic beta cells and subsequent endogenous insulin production uncouples alpha cell
      derived glucagon secretion from its paracrine suppressor. Consequently, excess glucagon
      concentrations occur in the fasting and the postprandial state, which promotes hyperglycemia,
      requires higher doses of subcutaneous insulin, and promotes glycaemic variability.

      Recent studies on SGLT-2 inhibition in T1D showed better glycemic control compared to
      placebo, whereas a higher risk for the development of diabetic ketoacidosis was observed.
      Knowledge about the underlying mechanisms is scarce. Studies showed that SGLT-inhibition
      increased Glucagon-like-peptide 1 (GLP-1) in T1D, an incretin hormone capable of suppressing
      glucagon. On the other side, total concentrations of ketone bodies were higher following
      SGLT-2 inhibition, irrespective of ongoing subcutaneous or intravenous insulin substitution.
      The present study aims to investigate the effect of SGLT-2 inhibitor dapagliflozin on
      hormonal regulators of glucose homeostasis and ketogenesis in T1D. The primary endpoint is
      the difference of GLP-1 during oral glucose tolerance test clamps (OGGTc). Secondary
      endpoints comprise total ketone body concentrations, free fatty acids, glucagon, and
      somatostatin during OGTTc and hyperinsulinemic, euglycemic clamps (HEC) following
      dapagliflozin and placebo. The study recruits male and female patients with T1DM in a
      randomized, open label, cross-over intervention study.
    


Intervention name(s): Forxiga 10mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Forxiga™ 10mg, dapagliflozin 10mg, oral, once daily for 7 days (70 mg total); Placebo tablets, starch, oral, once daily for 7 days (7 tablets total)
Other intervention name(s): Dapagliflozin
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, placebo-controlled, open-label, cross over intervention study
Masking: None (Open Label)
Primary purpose: Other
Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients
Condition: Multiple Sclerosis; Relapsing Multiple Sclerosis; Advancing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess safety and tolerability of patients converting from approved Relapsing Multiple
      Sclerosis (RMS) Disease Modifying Therapies (DMTs) to siponimod.
    

Detailed description: 
      This is a 6-month, open-label, multi-center, single arm design, including advancing RMS
      patients, evaluating the overall safety and tolerability profile of converting from oral,
      injectable or infusion RMS DMTs to oral siponimod.
    

Intervention name(s): Siponimod
Intervention type(s): Drug
Intervention description(s): Siponimod 2mg tablets taken once daily
Other intervention name(s): BAF312
Intervention MeSH terms: Siponimod
Intervention model: Single Group Assignment
Intervention model description: Open-label single arm study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Relapsing multiple sclerosis; Advancing multiple sclerosis; conversion; siponimod; adult; BAF312; disease modifying therapies; cognitive assessment; open-label
A Multiple Ascending Dose Study of BPN14770 in Healthy Young and Elderly Male or Female Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled,
      multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic
      profile of BPN14770 in healthy young and elderly male and female subjects and to provide a
      preliminary assessment of the cognitive effects of BPN14770 in healthy elderly subjects.
    

Detailed description: 
      Objectives:

        1. To evaluate the safety and tolerability profile of multiple oral ascending dose levels
           of BPN14770 in healthy young and elderly subjects.

        2. To characterize the plasma pharmacokinetic profile of BPN14770 following oral
           administration in healthy young and elderly subjects.

        3. To provide preliminary assessment of the cognitive effect of BPN14770 in healthy elderly
           subjects.
    

Intervention name(s): BPN14770; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BPN14770 is an investigational new drug being developed for the treatment of Alzheimer's disease and other cognitive disorders. BPN14770 is a small molecule, subtype selective, negative allosteric modulator of phosphodiesterase 4D.
Intervention MeSH terms: BPN14770
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: cognition; dementia; phosphodiesterase type 4D; PDE4D