bioihbjkbjnl/mcl2 huggingface dataset:
Japanese Pharmacokinetic Bridging Study for CC-93538
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, parallel design study to evaluate the PK, safety,
      tolerability and immunogenicity of single SC doses of CC-93538 in healthy Japanese and
      Caucasian adult subjects.

      A total of approximately 48 subjects, 24 Japanese and 24 Caucasians, will be enrolled.
      Japanese subjects will be enrolled first and randomized 1:1 to receive a single SC dose of
      either 180 mg or 360 mg CC-93538. Caucasian subjects will then be enrolled and matched to
      Japanese subjects (1:1) by weight (± 20%) and receive the same single SC dose of either 180
      mg or 360 mg CC-93538.
    


Intervention name(s): CC-93538
Intervention type(s): Drug
Intervention description(s): a single dose CC-93538 SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy subjects; CC-93538; Japanese PK bridging
Respiratory Morbidity Among Children Who Were Born by Elective Cesarean Section After 37-38 Weeks vs. 39 Weeks and More
Condition: Respiratory Complications
Study type: Observational

Summary: 
      Background: It is known that after Cesarean section is correlated with respiratory
      complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.

      Goal: The aim of the current study is to find out if these respiratory complications extend
      to later life.

      Methode: Reviewing the patients' medical file, and collecting data about respiratory
      complication.
    

Detailed description: 
      Background: It is known that after Cesarean section is correlated with respiratory
      complication more, if done after 37-38 week of gestation than if done after 39 weeks or more.
      We have already conducted a study about this topic, and published our results.

      Goal: The aim of the current study is to find out if these respiratory complications extend
      to later life.

      Method: Reviewing the patients' medical file, and collecting data about respiratory
      complication. We will use the same patients we used at the first study. Respiratory
      complications are defined as diagnosis of asthma, treatment by inhalations or systemic
      steroids, or consultation by pulmonologist.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children born in 2007-2009 in "Hillel Yaffe" medical center by elective Cesarean section
        according to a list of IDs we have.
Efficacy of Ubiquinone and Combined Antioxidant Therapy in Non-proliferative Diabetic Retinopathy
Condition: Non-proliferative Diabetic Retinopathy; Diabetes Mellitus Type 2
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of ubiquinone and combined antioxidant
      therapy on progression, clinical regression, oxidative stress markers and mitochondrial
      dysfunction in non-proliferative diabetic retinopathy.
    

Detailed description: 
      The investigators are interested in demonstrating the efficacy of Ubiquinone and combined
      antioxidant therapy in the pharmacological management of diabetic retinopathy since early
      stages.
    

Intervention name(s): Ubiquinone; Combined antioxidant therapy; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400mg daily of oral ubiquinone for 24 weeks; (1 mg copper, 20 mg zinc, 180 mg vitamin C, 30 mg vitamin E, 1 mg zeaxanthin, 4 mg astaxanthin, 10 mg lutein) daily of oral, all of them in one Tablet for 24 weeks; 100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
Other intervention name(s): coenzyme Q10; lutein; zeaxanthin; astaxanthin; vitamin C; vitamin E; zinc; copper; Inactive drug
Intervention MeSH terms: Vitamins; Vitamin E; Coenzyme Q10; Ubiquinone; Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oxidative stress; Mitochondrial dysfunction; Ubiquinone; Antioxidant combined therapy; Diabetic retinopathy
SMS: Substrate Modification Study in Patients Getting an Implantable Cardioverter Defibrillator (ICD)
Condition: Tachycardia, Ventricular
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional
Phase: Phase 4

Summary: 
      The present standard of care for the management of unstable ventricular tachycardia (VT) in
      the setting of chronic coronary artery disease is the placement of an implantable
      cardioverter defibrillator (ICD) after the initial episode, and radiofrequency ablation
      and/or antiarrhythmic medication in the event of recurrences causing frequent ICD
      interventions.

      The primary purpose of this randomized study is the assessment of recurrences of unstable VT
      in patients who undergo ICD implantation plus substrate ablation after the initial episode
      compared to patients who only undergo ICD implantation. Thus the primary purpose is an
      improvement in the quality of life. A decrease in mortality is not a primary purpose of this
      study.
    


Intervention name(s): ICD Ablation plus VT-ablation; ICD Therapy
Intervention type(s): Procedure; Device
Intervention description(s): ICD-Therapy for the treatment of unstable VT´s plus catheter ablation for substrate modification; ICD Therapy for the Treatment of unstable VT´s
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unstable Ventricular Tachycardia
Pulse Shortwave Therapy in Cervical Osteoarthritis
Condition: Cervical Osteoarthritis
MeSH terms: Osteoarthritis; Spondylarthritis; Spondylosis
Study type: Interventional

Summary: 
      The ActiPatch is an FDA cleared pain therapy device that uses pulsed shortwaves to interrupt
      pain signals at the nerve. 200 patients will be randomized and divided into an ActiPatch
      treatment group and comparison analgesic drug therapy group . Subjects will be assessed with
      the Neck Disability Index (NDI) at baseline and at four weeks and VAS scores will be recorded
      in order to determine the efficacy of the ActiPatch device compared to Etoricoxib. Cervical
      osteoarthritis causes chronic neck pain which could potentially be alleviated by the
      ActiPatch without the use of medication.
    

Detailed description: 
      Cervical Osteoarthritis causes chronic pain in the neck due to the discs of the spine
      breaking down, losing fluid, and becoming stiffer over time. As obesity and age increase, the
      likelihood of cervical osteoarthritis increases as well. When the pain caused by the broken
      down discs becomes severe, it may result in a loss of mobility in the neck region. Chronic
      neck pain has a serious impact on not only quality of life, but can also negatively affect a
      persons ability to lead a healthy active lifestyle. Standard analgesic therapy it limited in
      efficacy and can result in serious adverse effects specially with long term use.
    

Intervention name(s): ActiPatch; Etoricoxib 60 mg
Intervention type(s): Device; Drug
Intervention description(s): A Pulsed Shortwave Therapy Device; nonsteroidal anti-inflammatory drug used as standard therapy
Other intervention name(s): pulsed shortwave therapy; analgesic
Intervention MeSH terms: Etoricoxib; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Skin Prick Test for the Diagnosis of Food Allergy- a Comparison of Different Commercial Extracts and Raw Food
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      Immediate food allergy is , sometimes , a life threatening situation . Diagnosis is done by
      skin prick test with commercial extracts. Nevertheless, some of the extracts are not optimal
      and reproduce false negative results (no allergy) in patients with history highly suggestive
      of allergic reaction. The aim of this study is to compare the reproducibility of different
      commercial extracts and raw food in patients with convincing history of acute allergic
      symptoms related to food .
    


Intervention name(s): skin test
Intervention type(s): Procedure
Intervention description(s): skin test with the Suspected raw food
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: skin test; raw food; commercial extract
Study Evaluating The Coadministration of Begacestat And Donepezil
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the cardiac effects (effects on the heart) of administering donepezil and
      begacestat together to healthy subjects.
    


Intervention name(s): Donepezil plus placebo; Donepezil; Begacestat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5- and 10-mg tablets, single dose; 5- and 10-mg tablets, single dose; 6 x 50-mg capsules, single dose
Other intervention name(s): Aricept; Aricept; GSI-953, WAY-210953, PF-05212362
Intervention MeSH terms: Donepezil; Begacestat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Alzheimer Disease
Study Evaluating Changes In Bone Mineral Density (BMD), And Safety Of Rhbmp-2/CPM In Subjects With Decreased BMD
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to assess whether a locally-administered rhBMP-2/CPM
      injection can rapidly increase bone mass in subjects at high risk for osteoporotic fractures
      of the hip. All subjects will receive standard treatment for low bone mass, consisting of
      bisphosphonates, calcium, and vitamin D (all taken by mouth). Subjects that are randomly
      selected to receive treatment with rhBMP-2 will receive an injection directly into the hip.
      The injection is given in a surgery room using a light anesthesia.
    


Intervention name(s): rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy); rhBMP-2/CPM injection and bisphosphonates, calcium, and vitamin D (oral bisphosphonate therapy); bisphosphonates, calcium, and vitamin D
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 1.0 mg/mL.; Single, unilateral intraosseous injection of 6mL of rhBMP-2/CPM , 2.0 mg/mL.; Oral bisphosphonate therapy
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Ergocalciferols; Cholecalciferol; Diphosphonates; Vitamins; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bone mineral density; bone morphogenetic protein; osteoporosis
Determining Lipid Content in Stool After Alpha-cyclodextrin
Condition: Healthy Participants
Study type: Interventional

Summary: 
      The Investigator hypothesizes that the currently used dose of dietary ingredient
      alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared
      with placebo. The proposed studies will address the degree to which α-CD increases dietary
      fat loss.

      The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester,
      Minnesota.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo controlled, two-way crossover
      trial in healthy volunteers. The primary objective is to determine the fat losses in stool
      associated with alpha-cyclodextrin use as compared to placebo using a radiotracer. The study
      design will include two treatment periods, assigned in random order:

        -  Treatment 1 consists of subjects receiving α-CD and a meal containing the fatty acid
           radiotracers

        -  Treatment 2 consists of subjects receiving placebo and a meal containing the fatty acid
           radiotracers

      All subjects randomized to receive α-CD will orally ingest two tablets containing α-CD, or
      placebo, with a standardized liquid breakfast (100 µ Ci of [3H]triolein and 20 µ Ci of [14C]
      tripalmitin). The tablets will be consumed with 150 ml of still (uncarbonated) water
      immediately prior to consuming each meal.

      Subjects will be observed for a period of 48 hours as an in-patient, and then an additional
      24 hours as an out-patient following the breakfast meal containing the radiotracers. During
      this time the participants will undergo a meal fatty acid metabolism study, through hourly
      blood and fecal sampling, to assess meal fatty acid oxidation and storage.

      The participants will then undergo a further ≥ 14 day washout period before crossing over to
      the alternate treatment, where all evaluations will be repeated.
    

Intervention name(s): Alpha-cyclodextrin; Placebo; Triolein radiolabeled with 100 microcuries of 3^Hydrogen; Tripalmitin radiolabeled with 20 microcuries of 14^Carbon
Intervention type(s): Dietary Supplement; Dietary Supplement; Radiation; Radiation
Intervention description(s): Alpha-cyclodextrin is approved by the Food and Drug Administration as a dietary ingredient.; Placebo tablets identical in appearance to the active comparator; A MicroCurie (µCi) is a measure of radioactivity.; A MicroCurie (µCi) is a measure of radioactivity.
Other intervention name(s): FBCx; Calorease
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effect of Positive Expiratory Pressure on the Management of Chest Trauma
Condition: Thoracic Fracture
MeSH terms: Thoracic Injuries
Study type: Interventional

Summary: 
      Chest trauma (CT) are a common problem in our environment caused mainly by traffic accidents
      and causal and domestic accidents among the elderly population. CTs, in some situations, can
      lead to sequelae such as fibrothorax secondary to hemothorax and / or empyema and residual
      chronic pain. Clinical regulations and guidelines recommend a guideline for chest
      physiotherapy (CP) for all patients with rib fractures, but there is little scientific
      evidence. It would be interesting to establish CP treatment protocols and describe the most
      appropriate techniques according to the type and stages of thoracic trauma consolidation.

      Objective: To evaluate the effect of Positive Expiratory Pressure (PEP) breathing added to
      conventional CP in terms of aid secretion clearance, pain control, pleuropulmonary
      radiological abnormalities, restoration of lung function, and admission days in the immediate
      phase of the CT.
    

Detailed description: 
      After acceptance to participate in the study, patients will be computerized randomized into 2
      groups:

        -  PEP group: positive expiratory pressure breathing.

        -  CONTROL group: conventional CP treatment without positive pressure brething. The period
           between day 0 and 20 days post-trauma is considered an immediate phase of CT.

      Once admitted, an initial evaluation by the doctor will be performed, and pleuro-pulmonary
      complications, the presence of respiratory failure, and pain control will be evaluated. The
      chest physiotherapist will perform a clinical and secretion assessment using the Seva test
      and a dynamic costal examination. The medical treatment of pain control will begin, and the
      treatment of CP will begin, where it will be randomized in 2 groups: 1- PEP group: positive
      expiratory pressure breathing with the help of a PEP bottle device. 2-CONTROL group:
      conventional CP treatment without positive pressure breathing will be daily FR sessions, on
      weekdays. Upon admission, hospital discharge and post-discharge, radiological checks (simple
      radiography) will be performed and forced vital capacity will be measured with forced
      spirometry.
    

Intervention name(s): PEP bottle
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Test How Food Influences the Amount of BI 1291583 in the Blood of Healthy Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of food on the pharmacokinetics of an oral tablet formulation of BI
      1291583, by investigating the relative bioavailability following single dose administration
      under fed and fasted conditions.
    


Intervention name(s): BI 1291583
Intervention type(s): Drug
Intervention description(s): Tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this study is to determine the effectiveness and safety of an annual intravenous
      treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will
      receive calcium and vitamin D supplements.
    


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: Male Osteoporosis
Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on
      techniques for the treatment of neck pain is an intervention commonly implemented in clinical
      practice. Recently researchers and clinicians have implemented manual therapy techniques to
      the thoracic spine (midback) to treat patients with neck pain. To date no studies have
      examined the short-term combined effects of thoracic spine manual therapy and cervical spine
      manual therapy in the treatment of patients with mechanical neck pain. The purpose this study
      is to assess the combined effects of thoracic spine thrust manipulation with cervical spine
      non-thrust manipulation in patients with neck pain.
    


Intervention name(s): Manual Therapy
Intervention type(s): Other
Intervention description(s): Thrust manipulation is a type of manual therapy that clinicians apply using a high-velocity, low-amplitude thrust directed at a joint(s)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Neck Pain; Thrust Manipulation; Non-Thrust Manipulation
Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)
Condition: Hospital-Acquired Bacterial Pneumonia; Ventilator-Associated Bacterial Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and
      relebactam (REL) [IMI/REL, MK-7655A] compared to piperacillin/tazobactam (PIP/TAZ) in the
      treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or
      Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is
      non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day
      28 post-randomization.
    


Intervention name(s): IMI/REL FDC; PIP/TAZ FDC; Linezolid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial; 4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial; Open-label 600 mg Linezolid
Other intervention name(s): MK-7655A
Intervention MeSH terms: Linezolid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Switching From Generic Selective Serotonin Reuptake Inhibitors (SSRIs) and Selective Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) to Three Different Dose Initiation Strategies With Vilazodone
Condition: Major Depressive Disorder (MDD)
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an 8-week, randomized, double blind, parallel group, 3-arm trial to compare 10
      mg/day, 20 mg/day and 40 mg/day as starting doses of vilazodone following a switch from
      generic SSRIs and SNRIs. Vilazodone HCl under the trade name Viibryd™ is approved by the U.S.
      FDA for the treatment of major depressive disorder in adults. The purpose of this study is to
      evaluate the efficacy (how well the drug works), safety (the side effects), and tolerability
      (how well tolerated) of Vilazodone in preventing relapse or recurrence of depression. As
      vilazodone is not approved by the United States Food and Drug Administration (FDA) to prevent
      the recurrence of depression, for the purposes of this study it is considered
      investigational. The word "investigational" means that the study drug is still being tested
      in research studies and has not been approved for this use by the FDA.
    


Intervention name(s): Vilazodone
Intervention type(s): Drug
Intervention description(s): All subjects will receive Vilazodone at 10, 20 or 40mg.
Other intervention name(s): Viibryd
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Vilazodone
A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacodynamic effect of single doses of
      MT-8554 in healthy subjects.
    


Intervention name(s): MT-8554 low dose; MT-8554 high dose; Oxycodone hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double