bioihbjkbjnl/mcl2 huggingface dataset:
Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation
Condition: Stress Related Disorder; Anxiety
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of transcranial electrical stimulation on
      processes associated with fear extinction in healthy humans.
    

Detailed description: 
      Research links the processes of fear conditioning and extinction to the treatment of anxiety
      and stress-related disorders. Moreover, considerable translational research examines the
      neural correlates of these processes. However, virtually no research in humans manipulates
      neural correlates of these processes, which limits basic-clinical integration. The present
      study aimed to use transcranial electrical stimulation (tES) to modulate processes associated
      with fear extinction in order to assess the potential utility of tES in enhancing
      exposure-based treatment. To this end, healthy participants underwent a three-day fear
      conditioning and extinction paradigm. Participants were randomly assigned into 3 groups,
      differing in terms of tES applied during the extinction learning phase (Day 2) and targeting
      the medial prefrontal cortex: 1) direct current (DC) stimulation, aimed at enhancing
      extinction learning; 2) alternate current (AC) stimulation, aimed at interfering with
      reconsolidation of the fear memory activated during the extinction phase; and 3) sham
      stimulation. The outcome measures (outlined next) involve the assessment of extinction recall
      during a test phase (Day 3). Successful modulation of extinction learning by tES would be
      reflected in enhanced extinction recall.
    

Intervention name(s): Sham stimulation (1.5 milliampere,30 seconds); DC stimulation (1.5 milliampere, 20 minutes); AC stimulation (1.5 milliampere,1.5 Hertz frequency)
Intervention type(s): Device; Device; Device
Other intervention name(s): DC Stimulator Plus (neuroConn, Germany), serial 0118; DC Stimulator Plus (neuroConn, Germany), serial 0118; DC Stimulator Plus (neuroConn, Germany), serial 0118
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effects of Exercise in Parkinson's Disease
Condition: Parkinson Disease 10
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Parkinson's disease is caused by a reduction of dopamine causing motor deficits. The
      investigators are studying how exercise can help PD patients by increasing dopamine release
      in an area of the brain that coordinates movement, the striatum. The investigators will
      enroll PD patients into two groups; one group will complete a 12-week aerobic exercise
      program and the other will complete a 12-week control program including yoga and stretching
      only. The investigators will measure changes in dopamine release before and after either
      12-week intervention. Subjects will complete motor and cognitive questionnaires in addition
      to functional magnetic resonance imaging and positron emission tomography neuroimaging.
    

Detailed description: 
      The purpose of this study is to determine the basis for symptomatic and disease modifying
      benefits of exercise in Parkinson's disease (PD).

      Although the benefits of exercise in PD have been purported for several decades, only
      recently have there been controlled reports of symptomatic benefits in Parkinson's disease in
      terms of bradykinesia, postural balance and quality of life. There have been unsubstantiated
      suggestions that exercise may improve cognition and mood in PD.

      The mechanisms underlying such benefits are poorly understood. Exercise may induce dopamine
      release, thereby contributing to improved motor function in the dorsal striatum, and to
      enhanced mood and reduced apathy in the ventral striatum.

      We will test the hypotheses that exercise results in altered synaptic plasticity in the form
      of altered connectivity in response to aerobic exercise and reward-induced dopamine release.
      We will assess networks of functional connectivity using functional magnetic resonance
      imaging and measure dopamine release with positron emission tomography (PET).
    

Intervention name(s): Active Exercise; Passive Exercise
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Exercise; Parkinson's Disease; Positron Emission Tomography; fMRI
L-carnitine and Coenzyme Q10 in Relation to the Oxidative Stress, Antioxidant Enzymes Activities, Inflammation, and the Risk of Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Cardiovascular disease (CVD) is the leading cause of Taiwan. L-carnitine (LC) and coenzyme
      Q10 is recognized as lipid soluble antioxidants. The purposes of this study are going to
      investigate the relation of LC and coenzyme Q10 with the markers of lipid peroxidation,
      antioxidant enzymes activities, and the inflammatory markers in coronary artery disease (CAD)
      patients. The study is designed as a three-year study. The first year is an observation
      study. We will recruit CAD patients who are identified by cardiac catheterization as having
      at least 50% stenosis of one major coronary artery, and age-gender matched healthy subjects.
      The concentrations of LC, coenzyme Q10, lipid peroxidation markers (TBARS and ox-LDL),
      antioxidant enzymes activities (catalase, glutathione peroxidase, glutathione reductase, and
      superoxide dismutase), and inflammatory markers are going to analysis. The second year is a
      single-blind, single dose intervention study. CAD subjects are recruit form the first year
      and randomly assigned to placebo, coenzyme Q10-150 (150 mg/d), coenzyme Q10-300 (300 mg/d),
      LC-1000 (1000 mg/d) or LC-2000 (2000 mg/d) groups. Intervention is going to administration
      for three months. Fasting blood will be obtained in each month and determine the
      concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes
      activities, and inflammatory markers after intervention. The third year is a single-blind,
      multiple doses intervention study. We are going to measure the CAD subjects from the second
      year intervention study. After three months washout period, the subjects are assigned to
      placebo, coenzyme Q10-150 plus LC-1000, coenzyme Q10-150 plus LC-2000, coenzyme Q10-300 plus
      LC-1000, and coenzyme Q10-300 plus LC-2000 groups. Intervention is going to administration
      for three months. Fasting blood will be obtained in each month and determine the
      concentration of LC, coenzyme Q10, lipid peroxidation markers, antioxidant enzymes
      activities, and inflammatory markers after intervention. Hopefully, the results of this study
      could provide information of LC and coenzyme Q10 supplementation for clinical dietitian in
      advising CAD patients.
    


Intervention name(s): LC-1000; LC-2000; Q10-150; Q10-300; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): L-carnitine 1000 mg /d; L-carnitine: 2000 mg/d; Coenzyme Q10: 150 mg/d; Coenzyme Q10: 300 mg/d
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon
      subcutaneously at a constant rate for 90 days.

      This study is being performed to evaluate the safety and antiviral effects of omega
      interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects
      with chronic Hepatitis C genotype 1.
    


Intervention name(s): Omega DUROS device
Intervention type(s): Drug
Intervention description(s): Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapse; HCV; Hepatitis C; Interferon; Ribavirin
Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246
Condition: Orthopoxviral Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two
      clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral
      dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose
      will be used in expanded pivotal safety trials.
    

Detailed description: 
      This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3
      sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg
      Form I ST-246 when administered as a single daily oral dose for 14 days to 107 healthy, fed
      volunteers between 18 and 74 years of age. Safety parameters included adverse events, vital
      signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis)
      and electrocardiograms.
    

Intervention name(s): ST-246 400 mg; ST-246 600 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules, 400 mg daily for 14 days; Capsules, 600 mg daily for 14 days; Capsules, once daily for 14 days
Other intervention name(s): Tecovirimat; Tecovirimat
Intervention MeSH terms: Tecovirimat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Orthopoxvirus; Smallpox; This is a safety study only; ST-246 is being studied for treatment of Orthopoxviruses
DBS of the MLR for Gait and Balance Disorders in PD Patients
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Gait and balance disorders represent the main motor disability in advanced Parkinson's
      disease. These symptoms are less or unresponsive to levodopa treatment and are considered to
      be a contraindication for deep brain stimulation of the subthalamic nucleus. Falls and
      freezing of gait are responsible for high morbidity (fractures, residential health care) and
      increased significantly mortality. The pathophysiology of gait and balance disorders is still
      poorly understood, but recent data obtained in animals and humans suggest that a degeneration
      of cholinergic neurons of the pedunculopontine nucleus (PPN), within the mesencephalic
      locomotor region, could play a crucial role. In line with this hypothesis, low-frequency
      stimulation of the pedunculopontine area, thought to increase the activity of the remaining
      cholinergic PPN neurons, has been proposed to alleviate gait and balance disorders in
      advanced PD patients. Here, the efficacy of deep brain stimulation of the mesencephalic
      locomotor region will be tested in 12 PD patients in a randomized, double-blind, cross-over,
      controlled study.
    


Intervention name(s): Deep brain stimulation; Sham stimulation
Intervention type(s): Device; Device
Intervention description(s): Stimulating deep brain electrodes and pulse generator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease; Deep brain stimulation; Mesencephalic locomotor region
A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the efficacy and safety of LY3502970 in
      participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on
      diet and exercise alone or on a stable dose of metformin. This study will last about 30
      weeks.
    


Intervention name(s): LY3502970; Dulaglutide; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered subcutaneously; Administered orally; Administered subcutaneously
Intervention MeSH terms: Dulaglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Supracondylar Femur Fracture After DDH
Condition: DDH
MeSH terms: Fractures, Stress
Study type: Interventional

Summary: 
      incidence of ipsilateral Supracondylar femoral fractures after cast removal for Developmental
      dysplasia of the hip (DDH) surgery
    


Intervention name(s): DDH surgery and casting
Intervention type(s): Procedure
Intervention description(s): DDH surgery and casting
Intervention model: Single Group Assignment
Intervention model description: incidence of ipsilateral Supracondylar femoral fractures after cast removal for Developmental dysplasia of the hip (DDH) surgery
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DDH; insufficiency fractures
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder
Condition: Delayed Sleep Phase Syndrome
MeSH terms: Sleep Disorders, Circadian Rhythm
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test whether measuring the circadian clock during treatment of delayed
      sleep-wake phase disorder results in greater improvements in sleep compared to estimating the
      circadian clock.
    

Detailed description: 
      The study is a randomized, controlled, parallel double-blind 4-week trial of 0.5 mgs of
      exogenous melatonin timed to either 3 h before actual dim light melatonin onset (DLMO) based
      on in-home measurement (M-DLMO, n = 25) or 3 h before DLMO estimated at 2 h before average
      sleep onset time based on actigraphy and sleep diary (E-DLMO, n = 25) in adult participants
      with delayed sleep-wake phase disorder. All participants will receive melatonin 0.5 mgs.
      Outcomes include change in DLMO, subjective and objective sleep parameters, and daytime
      symptoms.

      As of January 7, 2020, the Insomnia Severity Index was removed from the IRB-approved
      protocol. No data were collected for this measure.
    

Intervention name(s): Melatonin 0.5 MG; Dim Light Melatonin Onset (salivary)
Intervention type(s): Drug; Other
Intervention description(s): Melatonin tablet; Test to determine the time of melatonin onset in saliva under dim light conditions
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to evaluate the effect of propolis or metformin on glycemic control
      in patients with type 2 diabetes mellitus without pharmacological treatment.

      All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h
      serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic
      profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index,
      and Matsuda index were measured.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial of three pharmacological groups
      was carried out, with the participation of 36 patients with type 2 Diabetes Mellitus without
      pharmacological treatment.

      At the beginning and end of the study, fasting serum glucose, 2-h serum glucose after oral
      glucose tolerance test, glycated hemoglobin A1c, and a metabolic profile were measured. Areas
      under the curve of glucose and insulin, total insulin secretion insulinogenic index), the
      first phase of insulin secretion (Stumvoll index), and insulin sensitivity (Matsuda index)
      were calculated.

      All patients received for 12 weeks two capsules a day, one before the first bite of breakfast
      and another before the first bite of dinner. 12 of them took propolis (300 mg), another 12
      received metformin (850 mg), and 12 more placebo in the same pharmacological presentation.

      This protocol was approved by a local ethics committee and written informed consent was
      obtained from all volunteers.

      Results are presented as mean and standard deviation. Intra-group differences were evaluated
      using Kruskal-Wallis and Mann-Whitney U-tests, while inter-group differences were calculated
      with the Wilcoxon test; p≤0.05 was considered significant.
    

Intervention name(s): Propolis; Metformin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.; Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.; Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.
Other intervention name(s): Metformin hydrochloride; Calcined magnesium
Intervention MeSH terms: Metformin; Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus type 2; Glycemic control; Propolis; Metformin; Pharmacological treatment-naïve patients
A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease
Condition: Multiple Myeloma; Non-hodgkin's Lymphoma; Hodgkin's Disease
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell
      Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma,
      Non-Hodgkin Lymphoma or Hodgkin Disease.
    


Intervention name(s): TG-0054
Intervention type(s): Drug
Intervention description(s): 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
Other intervention name(s): burixafor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patellofemoral Pain After Unicondylar Knee Arthroplasty
Condition: Mobile-bearing Unicondylar Knee Arthroplasty
MeSH terms: Patellofemoral Pain Syndrome
Study type: Observational

Summary: 
      Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from
      unicompartmental knee osteoarthritis. Two different types of UKA design are available - both
      with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an
      additional amount of cartilage and bone close to the implantat. It is unclear whether this is
      of clinical relevance.

      We speculate that the amount of cartilage/bone removal is related to the clinical outcome of
      the UKA-surgery.

      In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured
      during the surgery. The clinical success of the procedure will be determined with certain
      knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months
      postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling
      around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.

      The three variables (removed amount of cartilage/bone; clinical success with regard to the
      questionnaires; bone remodelling) are then analyzed with statistical methods to find out
      potential assoziations among them.
    


Intervention name(s): mobile-bearing unicondylar knee arthroplasty
Intervention type(s): Procedure
Intervention description(s): mobile-bearing unicondylar knee arthroplasty
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        consecutive patients scheduled for unicondylar knee arthroplasty at the Dept. for
        orthopaedic surgery of our medical university
      
Keywords: unicondylar knee arthroplasty; mobile-bearing; patellofemoral pain