bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Deep Brain Stimulation on Depression and Quality of Life in Parkinson's Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Depression
Study type: Observational

Summary: 
      We will evaluate the effect of deep brain stimulation on the depression and quality of life
      in Parkinson's disease. We aim to compare depression pre-operatively and post-operatively in
      Parkinson's patients with deep brain stimulation to Parkinson's patients evaluated and
      approved for deep brain stimulation but who did not complete surgery. We will also compare
      quality of life measures between patients with and without deep brain stimulation.
    

Detailed description: 
      Deep brain stimulation is an approved therapy for Parkinson's patients, and this procedure is
      actively performed at Vanderbilt University Hospital. Questions have been raised concerning
      the effect of deep brain stimulation on the depression commonly seen in Parkinson's patients.
      Through this study, we plan to evaluate and compare the incidence and severity of depression
      in Parkinson's patients with deep brain stimulation to those who did not complete the
      surgery. Primary literature has indicated a general increase in quality of life of those
      patients receiving DBS, but no studies have compared these two specific patient populations.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Procedure
Observational model: Defined Population
Time perspective: Other
Keywords: Parkinson's Disease; Depression; Quality of Life; Deep Brain Stimulation
Comparison of PSMA-based 18F-DCFPyL PET/CT to Conventional Imaging in the Evaluation of Patients With Castration-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      We intend to validate 18F-DCFPyL for imaging patients with metastatic, castrate-resistant PCa
      (CRPC), so that it may be used to full advantage in supporting existing and emerging
      therapies for a spectrum of patients suffering from PCa. In this study we will image patients
      with CRPC undergoing second-line anti-androgen therapy (enzalutamide or abiraterone) using
      18F-DCFPyL-PET/CT for detection of metastases and therapeutic monitoring, with correlation to
      standard-of-care conventional imaging modalities (CIM) (CT, bone scan) and clinical
      follow-up.
    


Intervention name(s): 18F DCFPyL- Radiopharmaceutical
Intervention type(s): Drug
Intervention MeSH terms: Radiopharmaceuticals
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with CRPC and planned treatment with evidence of metastases on conventional
        imaging modality (CIM) (CT and/or bone scan)
Pharmacokinetics/Bioavailability of BIBF 1120 Administered to Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess pharmacokinetics and the extend of absorption of a single dose of BIBF 1120
      soft gelatine capsule with food effect (BA) in healthy subjects respectively.
    


Intervention name(s): BIBF 1120
Intervention type(s): Drug
Intervention description(s): 150 mg of BIBF 1120 ES soft gelatine capsules
Intervention MeSH terms: Nintedanib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate whether concurrent administration of rabeprazole, an antacid
      known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as
      one of six experimental formulations.
    

Detailed description: 
      This will be a 6 cohort study investigating one experimental formulation of palbociclib in
      each of the six cohorts of 10 healthy subjects. Each cohort will receive two treatments in a
      fixed-sequence. In Period 1, all subjects will receive a single 125mg dose of palbociclib
      alone and undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. In
      Period 2, all subjects will receive daily 40mg doses of Rabeprazole for 7 consecutive days,
      and approximately 4 hours after the Day 7 rabeprazole dose each subject will receive a single
      125mg dose of palbociclib. Subjects will undergo serial pharmacokinetic blood sampling up to
      120 hours post-dose.
    

Intervention name(s): Palbociclib Alone; Palbociclib + Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): In Period 1 of each Cohort, a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.; In Period 2 of each Cohort, subjects will receive daily 40 mg oral doses of the proton pump inhibitor rabeprazole on 7 consecutive days. Approximately 4 hours after the last rabeprazole dose a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
Other intervention name(s): Palbociclib, PD-0332991; Palbociclib, PD-0332991, Rabeprazole, Aciphex, Proton Pump Inhibitor, PPI
Intervention MeSH terms: Palbociclib; Rabeprazole; Proton Pump Inhibitors
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Palbociclib, Rabeprazole, Proton Pump Inhibitor, Drug Interaction Study, DDI
Dosing Obese With Noxafil® Under a Trial (DONUT)
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 4

Summary: 
      Although posaconazole is approved for the prophylaxes and treatment of invasive fungal
      infections, specific dosing guidelines for posaconazole in (morbidly) obese patients are not
      specified. There is clear evidence indicating that heavier patients are receiving a
      sub-optimal dose if the current guidelines are used. Specifically in the setting of augmented
      prevalence of species with intermediate susceptible to posaconazole, adequate dosing is
      needed at start of treatment.

      Therefore it seems prudent to conduct a trial in a cohort of obese patients who receive
      posaconazole (300mg or 400mg) and define the pharmacokinetics. These will then be compared to
      the pharmacokinetics in a normal-weight group receiving 300mg posaconazole.
    

Detailed description: 
      Obese patients with a BMI ≥ 35 kg/m2 undergoing endoscopic gastric bypass surgery will
      receive a 300 mg or 400mg dose of posaconazole. A PK curve will be determined after
      administration at t=0.45, 0.75, 1, 1.5, 2, 4, 8, 12, 24, and (if feasible) 48 hours post
      infusion. Blood samples (4 mL) on PK days will be taken to obtain at least 2.0 mL of plasma.
    

Intervention name(s): Posaconazole Injection [Noxafil] 300mg; Posaconazole Injection [Noxafil] 400mg
Intervention type(s): Drug; Drug
Intervention description(s): Single dose by intravenous infusion 300mg; Single dose by intravenous infusion 400mg
Intervention MeSH terms: Posaconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparing a 2 groups of obese subjects vs 1 group of non-obese subjects.
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain
Condition: Post Traumatic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      In the emergency department, 60% of patients have an acute pain. Appropriate management of
      acute pain is a public health priority according to who recommendations. Nebulized morphine
      has been extensively studied in children but less well in adults.

      It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than
      intravenous (IV) method.
    


Intervention name(s): nebulized morphine; Intravenous morphine
Intervention type(s): Drug; Drug
Intervention description(s): After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .; After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS >30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS >30%).
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nebulized morphine; Intravenous morphine; Post traumatic; Pain; Emergency department
Study to Assess Safety, Tolerability and Pharmacokinetics of APX001 Administered by Intravenous Infusion to Healthy Subjects
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      First In Human (FIH), randomized, double-blind, placebo-controlled single ascending dose
      (SAD) and multiple ascending dose (MAD) escalation study of approximately 80 subjects. The
      SAD portion of the study will enroll six cohorts of eight healthy subjects per cohort, for a
      total of approximately 48 healthy subjects. The MAD portion of the study will enroll four
      cohorts of eight healthy subjects per cohort, for a total of approximately 32 healthy
      subjects.
    


Intervention name(s): APX001 single dose 1; APX001 single dose 2; APX001 single dose 3; APX001 single dose 4; APX001 single dose 5; APX001 single dose 6; APX001 multiple dose 1; APX001 multiple dose 2; APX001 multiple dose 3; APX001 multiple dose 4; Matching Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Functional Power Training on Frail and Pre-frail Community - Dwelling Older Adults in Singapore
Condition: Frailty; Muscle Weakness
MeSH terms: Muscle Weakness; Frailty
Study type: Interventional

Summary: 
      To investigate the efficacy of a 12-week Functional Power Training (FPT) program in pre-frail
      and frail community-dwelling older adults in Singapore for the management of physical
      frailty. The proposed study will provide information on the benefits of FPT on physical
      performances of older adults and help to shape future exercise recommendations to slow or
      reverse the onset and severity of physical frailty.
    


Intervention name(s): Functional Power Training; Usual care
Intervention type(s): Other; Other
Intervention description(s): The exercise intervention encompassed high-velocity movement, balance, and mobility exercises with the use of body weight and resistance bands as resistance. Participants were instructed to move rapidly during the concentric phase and slowly during the eccentric phase when performing the dynamic exercises.; Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Effects of Exercise on Alignment and Muscle Parameters in Forward Head Posture
Condition: Forward Head Posture
Study type: Interventional

Summary: 
      It is aimed to investigate the effect of corrective exercise program on alignment, muscle
      activation and biomechanical properties of muscles in medical students with forward head
      posture.
    

Detailed description: 
      Forward head posture (FHP) is a common postural abnormality that can be seen in all age
      groups. It is characterized by the head position being forward relative to the neck in the
      sagittal plane. The anterior displacement of the head is mainly assessed through examination
      of the craniovertebral angle (CVA) and a CVA of ˂50° is described as a FHP. Therapeutic
      exercises have shown to be effective in FHP and related symptoms in many studies. One of the
      exercise programs applied is the corrective exercise program. Within the scope of this
      program, deep cervical flexor muscles and shoulder retractors are strengthened, cervical
      extensors and pectoral muscles are stretched. This exercise protocol has been reported to
      provide relief in neck pain, improvement in CVA and shoulder angle. However, the number of
      studies examining the effect of corrective exercise program for the affected muscle groups in
      FHP on muscle activation parameters is limited, and there is no study examining the effect on
      the biomechanical properties of the muscles.

      In this study, it is aimed to investigate the effect of corrective exercise program on
      alignment, muscle activation and biomechanical properties of muscles in medical students with
      forward head posture.
    

Intervention name(s): Corrective exercise program
Intervention type(s): Other
Intervention description(s): Strengthening exercises for deep cervical flexor muscles and shoulder retractors.
Stretching exercises for cervical extensors and pectoral muscles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Exercise; Craniovertebral angle; Muscle activation; Biomechanical properties; Surface electromyography
Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      This post-marketing investigation will evaluate the functional knee performance of Subjects
      who have undergone primary total knee arthroplasty (TKA). Data from Subjects who receive one
      of four contemporary knee configurations will be pooled to establish a contemporary dataset.

      The primary objective of this study is to evaluate the pre-operative (approximately -90 to -1
      day before surgery) to minimum one year (approximately 304 to 668 days) postoperative
      functional performance improvement for the Attune™ primary, cemented TKA system as measured
      by the activities of daily living (ADL)subscore of the Knee Osteoarthritis Outcomes Score
      (KOOS)questionnaire (KOOS-ADL sub-score). This will be carried out for all four implant
      configurations: cruciate retaining fixed bearing (Attune™ CR FB), cruciate retaining rotating
      platform (Attune™ CR RP), posterior stabilized fixed bearing (Attune™ PS FB), and posterior
      stabilized rotating platform (Attune™ PS RP).
    

Detailed description: 
      The study is designed as a prospective, single arm stratified, multi-center investigation.

      Approximately 20 study sites, worldwide, will enroll 1040 subjects (1040 knees). Each study
      is expected to enroll approximately 52 subjects (approximately 52 knees). An additional 10
      subjects per site may be recruited at sites which have Sub-Investigators participating in the
      study. Cohort reallocation is permitted. There will be no control group. One thousand and
      forty (1040)Subjects will be stratified into 4 subgroups of 260: cruciate retaining fixed
      bearing(CR FB), posterior stabilized fixed bearing (PS FB), cruciate retaining rotating
      platform (CR RP), and posterior stabilized rotating platform (PS RP). Treatment assignment in
      this study is not randomized.

      Each site will only enroll patients in one of the four knee configuration sub-groups most
      commonly used as their standard of care.
    

Intervention name(s): ATTUNE Primary Total Knee Arthroplasty
Intervention type(s): Device
Intervention description(s): Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, PS RP).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female Subjects, age 22-80 years, inclusive, with Non-inflammatory Degenerative
        Joint Disease (NIDJD) who are suitable candidates for primary TKA using the Attune system.
      
Keywords: Arthroplasty; Replacement; Knee
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Condition: Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet
      age-related macular degeneration (AMD).
    

Detailed description: 
      Phase 4 study to test the safety, tolerability and effectiveness of a higher doses (1.0 mg
      and 2.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age related
      macular degeneration who have never been treated with ranibizumab. An additional purpose is
      to determine if the higher doses (1.0 mg and 2.0 mg) of ranibizumab can increase the time
      between doses beyond that currently needed with the 0.5 mg dose.
    

Intervention name(s): ranibizumab
Intervention type(s): Drug
Intervention description(s): Arm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Third Arm 2.0mg Arm with retreatment based on defined criteria not to occur sooner than every 28 days
Other intervention name(s): rhuFab V2
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      Background:There are still many gaps in research concerning the effect of different physical
      training modalities on sleep quality in the population underwent coronary artery bypass graft
      surgeries(CABG).Purpose:The present study was conducted to compare the quality of sleep in
      subjects who underwent CABG, were submitted to two types of training (i.e, aerobic exercise
      alone or combined aerobic and resistance training
    

Detailed description: 
      OBJECTIVE/BACKGROUND:

      There are still many gaps in research concerning the effect of different physical training
      modalities on sleep quality in the cardiac population. Thus, the objective of the present
      study was to compare the quality of sleep in subjects who underwent coronary artery bypass
      surgery submitted to two types of training (ie, aerobic exercise alone or combined aerobic
      and resistance training).

      PATIENTS/METHODS:

      80 Participants aged 45-65 years were randomized to two groups: aerobic group (AG), combined
      aerobic and resistance group (ARG). Training lasted ten consecutive weeks with 30
      uninterrupted sessions. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) -
      Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored
      continuously while being recorded at one minute intervals. The participants kept the device
      for a period of 96 hours before the first and last training sessions.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks
Other intervention name(s): cardiac rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: sleep quality; aerobic and resisted exercises; CABG
Combined Vibrations, Passive Motion and Thermotherapy for Knee Osteoarthritis
Condition: Osteoarthritis; Knee Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluated the efficacy of combined mechanical vibrations, continuous passive motion
      and heat on the severity of pain in management of osteoarthritis of the knee
    


Intervention name(s): "Kineticure System" followed by sham; sham followed by "Kineticure System"
Intervention type(s): Device; Device
Intervention description(s): 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion) during the first 4 weeks followed by 2 weeks wash out and 4 weeks of sham device; sham device during the first 4 weeks then 2 weeks wash out period followed by 4 weeks for 20 minutes sessions with knee brace (integrated heating pad, a vibration unit and a foot pedal that delivers continuous passive motion)
Other intervention name(s): Kineticure System; kineticure system
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Asymptomatic Bacterial Vaginosis and Herpes Simplex Virus Type 2 (BV/HSV-2) Shedding Study
Condition: Bacterial Vaginosis
MeSH terms: Herpes Simplex; Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This investigation assessed the effects of asymptomatic BV on daily genital tract shedding of
      HSV-2 by determining shedding frequency before and after treatment of asymptomatic BV.
    

Detailed description: 
      An important contributor to the epidemic spread of herpes simplex virus type 2 (HSV-2) is its
      high frequency of asymptomatic shedding in the genital tract, as transmission usually occurs
      during these periods of subclinical reactivation of the virus. Therefore, an improved
      understanding of the risk factors associated with HSV-2 shedding is needed.

      Preliminary data suggests that bacterial vaginosis (BV) may be associated with increased
      genital tract shedding of HSV-2. As BV is the most common cause of vaginal symptoms in
      reproductive age women, even modest associations with genital tract shedding of HSV-2 would
      result in substantial attributable risks for transmission of the virus.

      This study assessed the effects of asymptomatic BV on daily genital tract shedding of HSV-2
      by determining shedding frequency before and after treatment of asymptomatic BV. Twelve HSV-2
      seropositive women with asymptomatic BV were enrolled. These women were instructed to
      self-collect daily swab specimens for HSV-2 deoxyribonucleic acid (DNA) polymerase chain
      reaction (PCR) analysis from the lower genital tract for one month. At the end of the one
      month follow-up visit, each participant completed a one week course of oral metronidazole for
      treatment of BV. This was followed by daily home collection of genital tract swab specimens
      for an additional one month.
    

Intervention name(s): Metronidazole
Intervention type(s): Drug
Intervention description(s): 500 mg, taken by mouth, two times a day, 7 days
Other intervention name(s): Flagyl
Intervention MeSH terms: Metronidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: herpes simplex virus