bioihbjkbjnl/mcl2 huggingface dataset:
Anterior Insula Regulation and Pain Empathy
Condition: Anterior Insula Activity During Regulation; Empathic Responses After Anterior Insula Regulation
Study type: Interventional

Summary: 
      The aim is to test whether rtfMRI-based neurofeedback training on anterior insula impacts
      pain empathy.
    

Detailed description: 
      In the present study, investigators plan to use the real-time fMRI neurofeedback to train
      healthy subjects to learn volitional control over their own anterior insula (AI) activity.
      Then the effect of AI regulation will assessed by examining subjects' empathic responses and
      functional connectivity changes. Subjects were separated into two groups randomly. While the
      experimental group received specific neurofeedback from their own AI, the control group
      received sham NF from an unspecific region.
    

Intervention name(s): real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
Condition: Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult
      Chinese Volunteers.
    


Intervention name(s): T0001，10mg; T0001，20mg; T0001，35mg; T0001，50mg; T0001，65mg; T0001，75mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: T0001; Immunoglobulin Fc Fragments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Framing of Numerical Information in Cochrane Summaries
Condition: Health Literacy
Study type: Interventional

Summary: 
      The aim of the study was to conduct three different parallel randomized controlled trials to
      assess how the different framing of Cochrane summary information (positive vs negative
      framing of health information) affects affect the perception of the efficacy and intention
      for use of the described treatment.
    

Detailed description: 
      The aim of the study was to conduct three different parallel randomized controlled trials to
      assess how the different framing of Cochrane summary information (positive vs negative
      framing of health information) affects affect the perception of the efficacy and intention
      for use of the described treatment.
    

Intervention name(s): Frame of numerical information
Intervention type(s): Other
Intervention description(s): Each group received only one frame of information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Efficacy and Safety of Fluvastatin in Different Doses in Adults With Mixed Dyslipidemia or Primary Hypercholesterolemia
Condition: Mixed Dyslipidemia; Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of fluvastatin 80 mg in a
      Chinese population. This study is not recruiting patients in the US.
    


Intervention name(s): Fluvastatin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Mixed Dyslipidemia; high cholesterol; adults; fluvastatin
Ulimorelin Study of Efficacy and Safety (ULISES 008)
Condition: Gastrointestinal Dysmotility
Study type: Interventional
Phase: Phase 3

Summary: 
      Post-operative administration of ulimorelin is expected to reduce time to recovery of
      Gastrointestinal (GI) function in patients who have undergone partial large bowel resection
    


Intervention name(s): Ulimorelin Intravenously (IV); Ulimorelin Invtravenously (IV); 5% dextrose in water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 160 µg/kg daily (QD); 480 µg/kg daily (QD); Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparisons Between Low Thoracic and Lumbar Epidural Analgesia on Postoperative Pain Low Thoracic v.s. Lumbar Epidural for Post-cesarean Pain
Condition: Post-cesarean Pain Control Quality
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Whether low thoracic epidural analgesia improves postoperative cesarean pain qualities than
      conventional lumbar epidural analgesia?
    

Detailed description: 
      Postoperative pain remains the leading cause of concern in women faced with undergoing a
      cesarean delivery. Inadequate acute pain management is associated with numerous negative
      effects, including delayed postpartum recovery, interference with mother-child bonding
      because postoperative pain limits breastfeeding, and a high risk of postpartum depression and
      persistent pain.

      Epidural analgesia (EA) is being increasingly preferred to systemic opioid because of better
      analgesic effect. Although EA is widely used for cesarean delivery, the effect of the site of
      epidural catheter insertion on the quality of postoperative pain management remains
      inadequately investigated. For example, placement of the epidural catheter in the low
      thoracic intervertebral spaces may be more suitable for catheter-incision-congruent analgesia
      during caesarean delivery than in the lumbar intervertebral space; however, epidural catheter
      insertion is conventionally recommended at the lumbar intervertebral space. Therefore, in
      this study, we aim to investigate the difference in post-cesarean pain control quality
      between low thoracic EA and lumbar EA.
    

Intervention name(s): low thoracic epidural; lumbar epidural
Intervention type(s): Procedure; Procedure
Intervention description(s): obstetric epidural catheters inserted at low thoracic intervertebral spaces; obstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Patient controlled epidural analgesia ,Cesarean delivery,pain management,epidural opioid
Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly
Condition: Low-grade Inflammation; Increased Intestinal Permeability
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the ability of a blend of berries and probiotics in
      reducing low-grade inflammation and intestinal permeability in the elderly. The intervention
      period is one month. Blood and fecal samples will be collected for analysis at baseline and
      at the end of the intervention with the aim to analyse possible changes in different
      parameters at the two timepoints. The participants will also be asked to keep a study diary
      throughout the study period for the documentation of their intestinal health and as a means
      for checking compliance.
    


Intervention name(s): Placebo; Active, only probiotics; Active, blend of berries and probiotics
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Powder; Powder; Powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of Structure and Function of Radial Artery After Transradial Coronary Intervention
Condition: Intervention; Transradial
Study type: Interventional

Summary: 
      Several approaches have been proposed to reduce the risk of RAO, including anticoagulation,
      immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler
      ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal
      end rather than distal part of the artery,which was ignored by a majority of interventional
      cardiologists. Different insights into occlusion location may lead to different options of
      sheath materials, models, catheters and puncture access. Thus, the investigators designed
      this present study to explore the reason of radial artery endothelial dysfuction and damage
      and occlusion location by ﬂow-mediated dilation (FMD) to determine the suitable method to
      reduce occlusion risk during TRI.
    


Intervention name(s): Percutaneous coronary intervention
Intervention type(s): Procedure
Intervention description(s): Percutaneous coronary intervention was a nonsurgical technique for treating obstructive coronary artery disease
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Transradial; ﬂow-mediated vasodilation
Efficacy and Safety Study of Neramexane to Treat Congenital and Acquired Nystagmus
Condition: Nystagmus, Congenital Idiopathic; Nystagmus, Acquired
MeSH terms: Nystagmus, Pathologic; Nystagmus, Congenital
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in
      the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition,
      a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be
      included; this subgroup will be analyzed in an exploratory manner only.
    


Intervention name(s): Neramexane mesylate
Intervention type(s): Drug
Intervention description(s): 2 double-blind, cross-over treatment periods of 7 weeks separated by a wash-out phase, up to 75 mg Neramexane mesylate per day
Other intervention name(s): - verum, placebo; - placebo, verum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prospective Randomized Evaluation of a Two and Three Piece Total Ankle Replacement
Condition: Ankle Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This is a randomized study to prospectively compare and evaluate the functional outcome and
      patient satisfaction of total ankle replacements for tibio-talar osteoarthritis using either
      the STAR or Salto-Talaris prothesis.
    


Intervention name(s): Salto-Talaris Total Ankle Replacement; STAR Total Ankle Replacement
Intervention type(s): Device; Device
Intervention description(s): Salto-Talaris Total ankle replacement surgery; STAR Total Ankle Replacement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      food interaction, pharmacokinetics, safety and tolerability
    


Intervention name(s): Itasetron tablet; Itasetron infusion; high fat breakfast
Intervention type(s): Drug; Drug; Other
Intervention MeSH terms: Itasetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of a Single Dose of Intravenous TD-8954 Compared With Metoclopramide in Critically Ill Patients With Enteral Feeding Intolerance
Condition: Enteral Feeding Intolerance
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is being conducted to evaluate the safety, tolerability and early efficacy of IV
      TD 8954 compared to metoclopramide in critically ill subjects, aged 18 to 85 years, who are
      admitted to the intensive care require mechanical ventilation, and are intolerant to enteral
      feeding.
    


Intervention name(s): TD-8954; Metoclopramide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Enteral feeding
ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain
Condition: Bone Metastases; Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasm Metastasis
Study type: Interventional

Summary: 
      A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic
      Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not
      Candidates for Radiation Therapy
    


Intervention name(s): ExAblate MRfFUS; Sham
Intervention type(s): Device; Device
Intervention description(s): MR guided focused ultrasound.; sham comparator
Other intervention name(s): MRgFUS; FUS; Focused Ultrasound; MR guided Focused Ultrasound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bone Cancer; Pain Palliation; Metastasis; Multiple Myeloma; Breast Cancer; Lung Cancer; Prostate Cancer; cancer related Pain; Tumors
Impact of the Chikungunya Outbreak in Reunion Island on the Quality of Life After 10 Years
Condition: Chikungunya Fever; Quality of Life
MeSH terms: Chikungunya Fever
Study type: Observational

Summary: 
      QoLCHIK study aims at evaluating impact of chikungunya infection on the quality of life of
      infected people during the 2005-2006 outbreak in Reunion Island and followed in the TELECHIK
      cohort by comparing scores of SF-36 health survey.
    

Detailed description: 
      QoLCHIK is a prospective cohort telephone study on the quality of life of people from the
      TELECHIK cohort, measured by the SF-36 health survey. TELECHIK was a telephone survey
      conducted 2 years after the 2005-2006 outbreak in Reunion Island and drawn from the SEROCHIK
      study which aimed at assessing the seroprevalence of chinkungunya over the island between
      august and october 2006.

      A sample of 440 people (220 per group) was calculated and to be drawn from TELECHIK cohort,
      220 with a serodiagnosis of chikungunya and 220 with negative serology.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        TELECHIK cohort population drawn for telephone survey
      
Keywords: Chikungunya; Quality of Life
The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluate the safety of UB-421 in combination with standard antiretroviral therapy
      (ART) and the efficacy of HIV reservoir reduction as compared with ART alone in ART
      stabilized HIV-1 patients
    


Intervention name(s): UB-421(25 mg/kg) Q2W; UB-421(25 mg/kg) Q4W
Intervention type(s): Biological; Biological
Intervention description(s): Monoclonal antibody by IV infusion plus standard ART; Monoclonal antibody by IV infusion plus standard ART
Intervention MeSH terms: UB-421
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users
Condition: Depression; Dual Diagnosis; Drug Addiction
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Methamphetamine (MA) addiction is a public health concern that causes substantial harm to
      individual users, and imposes an economic burden in the U.S. totaling up to $48.3 billion
      annually. This study proposes to address a critical aspect of this problem: the lack of any
      proven, FDA-approved pharmacological treatments for MA users. The proposal combines an
      intervention designed to improve energy metabolism in the brain, and a neuroimaging technique
      capable of measuring the neurochemicals that represent cerebral bioenergetic function. The
      study will replicate and extend a key neuroimaging finding from the investigators recent MA
      studies: that MA users have decreased phosphocreatine (PCr) levels in the brain, compared to
      healthy volunteers. Phosphocreatine is the substrate reservoir for the creatine kinase
      reaction, which reversibly converts PCr into adenosine triphosphate (ATP), the brain's major
      energy supply, and creatine. Neuronal energy demands are met through a shift in reaction
      equilibrium, which is designed to maintain the concentration of ATP constant. Research
      results from the investigators recent study also showed that female MA users have lower brain
      PCr levels compared to male users. These findings join the converging lines of evidence that
      MA use is associated with mitochondrial dysfunction, i.e. deficient energy metabolism, in the
      brain. Frequently, MA users also experience depression, as well as cognitive deficits.
      Interestingly, both of these entities are also linked to mitochondrial dysfunction in the
      brain.

      The long-term goal of this research program is to define the alterations in brain chemistry
      that underlie MA use disorders, and to utilize translational magnetic resonance spectroscopy
      (MRS) neuroimaging to identify rational brain-based treatment targets. Once a
      hypothesis-driven intervention is identified, MRS can then be further employed in treatment
      studies, to verify that "target engagement" is achieved. The specific aims of this proposal
      are an example of this stepwise scientific process: the nutritional supplement creatine will
      be tested in a randomized, placebo-controlled study of women with MA use disorders, to
      investigate creatine's effect on cerebral PCr levels, depressive symptoms, and MA usage.
    


Intervention name(s): Creatine monohydrate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers
Condition: Leishmaniasis
MeSH terms: Leishmaniasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and immunogenicity in
      healthy adult subjects of an investigational vaccine being developed for the prophylaxis of
      visceral leishmaniasis. The vaccine, identified as LEISH-F3 + GLA-SE, consists of the
      recombinant two-antigen Leishmania recombinant protein LEISH-F3 together with the adjuvant
      GLA-SE.
    


Intervention name(s): LEISH-F3 + GLA-SE; LEISH-F3 + GLA-SE; LEISH-F3 alone
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 20 ug of LEISH-F3 and 2 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.; 20 ug of LEISH-F3 and 5 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.; 20 ug of LEISH-F3 antigen alone. 3 injections at Days 0, 28, and 56.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Pretreatment With Mifepristone Prior to Mirena Insertion
Condition: Women in Need of Long Acting Reversibel Cntraception With the Intrauterine Levonorgestrel Releasing System, Mirena
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypothesis: Pretreatment with mifeprsitone prior to Mirena placement will induce amenorrhea
      and reduce bleeding irrregularities during the initial months of Mirena use.
    

Detailed description: 
      The levonorgestrel releasing intrauterine system (IUS), Mirena, represents a highly effective
      contraceptive method that is cost-effective and requires limited patient effort. Furthermore
      Mirena offers numerous noncontraceptive benefits and addresses different medical needs for
      women in reproductive and non reproductive age. Side effects such as menstrual abnormalities
      are important reasons for early discontinuation of a contraceptive method. Irregular bleeding
      pattern and spotting represents a well known adverse effect during the first months of use
      with Mirena and corresponds to the most important factor that negatively influences the
      acceptability of the IUS. Up to today no standard treatment has been suggested to resolve
      this issue.

      By inducing amenorrhea within a short period of treatment with an anti-progesterone,
      mifepristone, prior to insertion of Mirena, the bleeding irregularities during the first
      months of use might be reduced and could therefore represent an important strategy for
      increasing acceptability of this contraceptive system.

      The purpose of the present study is to evaluate the bleeding pattern during the first months
      of use of Mirena in patients treated with mifepristone compared to placebo in women using
      Mirena for contraception. The study will also address the effect of mifepristone on
      endometrial morphology and breast tissue.
    

Intervention name(s): Mifepristone prior to Mirena; Placebo prior to Mirena insertion
Intervention type(s): Drug; Drug
Other intervention name(s): Mifepristone
Intervention MeSH terms: Mifepristone; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: LNG-IUS; Mirena; Contraception; Bleeding; Hormonal effects in the breast
Blood Pressure Telemonitoring and Goal Blood Pressure in Diabetes
Condition: Diabetes; Hypertension
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Does home telemonitoring increase the number of diabetes patients at goal blood pressure in a
      primary care practice?
    

Detailed description: 
      This is a randomized control trial, two arms with block randomization. Primary care patients
      with diabetes and elevated blood pressure randomized to intervention or control. Intervention
      arm: home telemonitoring using the Ideal Life blood pressure cuff and telephone or internet
      transmission device to transmit blood pressure information to the Primary care manager team
      with otherwise normal care manager care. Control arm: Omron (off the shelf) home blood
      pressure monitor (no transmission of data) and usual care. We will be comparing blood
      pressure control between groups and provider contacts.
    

Intervention name(s): Blood pressure monitor with telemetry; Home blood pressure monitor without telemetry
Intervention type(s): Device; Device
Intervention description(s): Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager; Self monitor of blood pressure without telemetry
Other intervention name(s): Ideal Life Blood Pressure Monitor; Omron blood pressure monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes