bioihbjkbjnl/mcl2 huggingface dataset:
Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the use of Deep Brain Stimulation (DBS) to reduce symptom severity
      and enhance the quality of life for patients with treatment-resistant obsessive compulsive
      disorder (OCD).
    

Detailed description: 
      Despite advances in pharmacological and behavioral therapies for OCD, a substantial number of
      patients fail to improve significantly following years of conventional and experimental
      interventions. For some patients, stereotactic neurosurgery is the only promising option
      available. Although this procedure has relatively few side effects in the majority of OCD
      patients and may lead to enduring benefits, its effects on brain tissue and function are
      irreversible. Bilateral deep brain stimulation (DBS) is an adjustable and partially
      reversible procedure that may be a more effective treatment for patients with OCD. This study
      will determine the effectiveness, safety, and tolerability of DBS in patients with
      treatment-refractory OCD.

      Participants receive DBS treatment for 30 months. Obsessive Compulsive scales, depression
      scales, neuropsychological evaluations, and surveys are used to assess participants.

      Participants are monitored for 2 years after DBS treatment.
    

Intervention name(s): Deep Brain Stimulation
Intervention type(s): Procedure
Intervention description(s): Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating CVD Medication Adherence Program in Low SES
Condition: Cardiovascular Disease; Hypertension; Diabetes
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The investigators propose to evaluate the implementation of an efficacious medication
      adherence program in a group at high risk for CVD. The program involves patients
      receiving/responding to e-reminders to take CVD medications via patient-selected technology
      [mobile/web-based applications, short message service (SMS; text messaging), interactive
      voice response (IVR), or e-mail] supported by a tailored, monthly, self-management program
      administered by either research staff or a case manager staff member from the Duke Outpatient
      Clinic via the telephone. This is a hybrid type II implementation science study.
    

Detailed description: 
      The investigators propose to evaluate the implementation of a medication adherence program
      among patients who attend Duke Outpatient Clinic (DOC). It is anticipated that, among the
      providers' patient panels, at least 100 and up to 300 with CVD risk and poor CVD medication
      adherence (<0.08 medication possession ratio) will consent to the program.

      Using procedures from the investigators previous studies, the investigators will identify
      potential patients from the EHR, and will identify a pool of potential patients using
      electronic health records, with the goal of administering the program to at least 100
      patients. Patients will be mailed letters, signed by their own provider or medical director
      of DOC, requesting their participation in the programs. The RA will contact patients via
      telephone to explain the study, screen for eligibility, and determine what mode of
      administration individuals prefer to receive the program (SMS, IVR, or email).

      The primary outcome will be that the effectiveness/impact of the proposed adherence program
      will be a 10% improvement in MPR and CVD outcomes (anticipate reducing SBP by 5 mmHg, Hgb a1c
      by 0.5%, LDL-C by 20 mg/dl).
    

Intervention name(s): m-health
Intervention type(s): Behavioral
Intervention description(s): Patients will receive e-reminders via text message and email. A message library that allows us to disseminate constant and reliable information has been created. Messages will contain not only medication reminders, but information about issues related to self-management and medication adherence for CVD risk including messages on side-effects, risks/benefits of medication treatment, and barriers to medication adherence. In addition to these messages, patients will also receive tailored information via telephone by trained research staff.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is undertaken to provide the regulatory authorities in Japan with immunogenicity,
      efficacy, safety and reactogenicity data of GSK Biologicals' Human Rotavirus [HRV] vaccine,
      given as a 2-dose primary vaccination, in healthy Japanese infants aged approximately 2
      months at the time of the first dose and previously uninfected with HRV. The Protocol Posting
      has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      Combined diphtheria and tetanus toxoids and acellular pertussis (DTPa) and Hepatitis B (HBV)
      vaccines are allowed to be co-administered along with Rotarix vaccine/Placebo.
    

Intervention name(s): Rotarix; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Two-dose oral vaccination.; Two-dose oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of PF-06700841 in participants with moderate to severe active, generalized
      Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
    


Intervention name(s): Placebo; PF-06700841 15 mg; PF-06700841 30 mg; PF-06700841 45 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo; PF-06700841 15 mg; PF-06700841 30 mg; PF-06700841 45 mg
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Role of Affect Regulation and Self-presentation in the Expressive Writing Intervention
Condition: Posttraumatic Stress Disorders
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of the present study is twofold. First, we will attempt to examine the role that
      emotion regulation and self-presentation play as potential moderators in the expressive
      writing paradigm. We hypothesize that expressive writing participants who demonstrate greater
      abilities to regulate their emotions at baseline will improve more on our outcome measures.
      We also hypothesize that those expressive writing participants who demonstrate higher levels
      of self-presentation at baseline will improve less on our outcome measures.

      The second aim of the study has two related objectives. First, we will attempt to investigate
      whether the expressive writing intervention can increase and enhance an individual's emotion
      regulation abilities. Related to this, we will then go on to examine whether emotion
      regulation can be looked at as a potential mechanism of action in the expressive writing
      procedure. Related to these two objectives, we hypothesize that in comparison to the control
      group, participants in the expressive writing condition will show increases in their ability
      to regulate their emotions from baseline to four week follow up. Moreover, we predict that
      greater gains in emotion regulation abilities for the expressive writing participants will be
      significantly related to greater gains in outcome measures.
    


Intervention name(s): Expressive Writing; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will write about their experienced trauma for 20 minutes on each of three consecutive days using techniques associated with expressive writing; Participants will write as factually as possible about an assigned trivial topic for 20 minutes on each of three consecutive days
Other intervention name(s): Emotional writing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: expressive writing; trauma; intervention; posttraumatic stress
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers
Condition: Cystic Fibrosis; Mucociliary Clearance; Airway Hydration
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of repeated doses of
      GS-9411 in healthy volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway
      hydration and mucociliary clearance in the lung.
    

Detailed description: 
      GS-9411 is being evaluated as a potential therapy to improve airway hydration and mucociliary
      clearance in patients with cystic fibrosis. This study is evaluating the safety and
      tolerability of 3 dose levels of GS-9411 as an inhaled product, compared to a matched
      placebo, administered twice daily for 14 days.
    

Intervention name(s): GS-9411; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled GS-9411 dissolved in sterile saline; Inhaled Placebo, sterile saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; CF; Mucociliary Clearance; Epithelial Sodium Channel Inhibitor; ENaC Inhibitor; Airway Hydration; Amiloride
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
Condition: NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an investigational study to evaluate the experimental medication BMS-986036 in
      participants with different levels of kidney function.
    


Intervention name(s): BMS-986036
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Omega-3 Fatty Acid on Vitamin D Activation
Condition: Hemodialysis Patients; Vitamin D Insufficiency; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1,
      25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high
      dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D
      concentrations were significantly increased after 3 months of omega-3 FA supplementation
      compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients.
      In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D
      supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to
      25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or
      deficient 25-hydroxyvitamin D levels.
    


Intervention name(s): Omega-3 fatty acid ethylester 90; Olive oil; cholecalciferol
Intervention type(s): Drug; Other; Other
Intervention description(s): Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks; Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks; if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
Other intervention name(s): Omacor®
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Omega-3 fatty acid; vitamin D; ergocalciferol; hemodialysis
Postprandial Response After Intake of Meals With Different Fatty Acid Composition
Condition: Healthy; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional

Summary: 
      The aim of the study is to understand more about how different fatty acids modulate
      postprandial lipid metabolism and inflammatory response.
    


Intervention name(s): SFA muffin; PUFA muffin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Muffin rich in saturated fat.; Muffin rich in polyunsaturated fat.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC
Condition: Metastatic Colorectal Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Observational

Summary: 
      Fruquintinib with PD-1 inhibitors (FP) and TAS-102 with bevacizumab (TB) are two common
      therapies for patients with previous-treated metastatic colorectal cancer (mCRC). However,
      it's still not clear that which therapy can bring better prognosis. Our study sought to
      investigate the efficacy and safety of fruquintinib with PD-1 Inhibitors versus TAS-102 with
      bevacizumab in Late-Line mCRC between July 2019 to October 2022July 2019 and June 2021 at the
      Hunan Cancer Hospital.
    

Detailed description: 
      This is a retrospective cohort study conducted in Hunan Cancer Hospital. Patients (pts) with
      mCRC who had received at least the 2nd line treatment were eligible. Propensity score (PS)
      would be calculated to balance the baseline characteristics of two arms. Overall survival
      (OS) was set as the primary endpoint. From July 2019 to October 2022, 106 eligible pts in
      total were enrolled. According to the treatment received, 72 and 34 pts were respectively
      allocated into FP cohort and TB cohort.
    

Intervention name(s): Fruquintinib; PD-1 inhibitors; Trifluridine/Tipiracil; Bevacizumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5mg once daily for 14 days on/7 days off, over a 21-day cycle; The anti-PD-1 antibody was administered intravenously on day 1, and its recommended dosage was as follows: nivolumab: 240 mg, every 2 weeks; pembrolizumab, camrelizumab, and sintilimab: 200 mg every 3 weeks; and toripalimab: 240 mg every 3 weeks.; TAS-102 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days; Bevacizumab 5 mg /kg, intravenously on days 1,15,every 28 days
Other intervention name(s): anti-PD-1 antibodies; TAS-102; Lonsurf; S 95005; Avastin
Intervention MeSH terms: Trifluridine; Bevacizumab; Immune Checkpoint Inhibitors
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study population were the patients treated with at least 2 cycle of fruquintinib plus PD-1
        Inhibitors or TAS-102 plus BEV in patients suffering refractory mCRC from July 2019 to
        October 2022 at the Hunan Cancer Hospital.
      
Keywords: Colorectal cancer; Fruquintinib;PD-1;TAS-102; bevacizumab
First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
Condition: Colic
MeSH terms: Colic
Study type: Interventional

Summary: 
      This randomized, open label, dose-response study will be realized at the first line with
      Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of
      infantile colics.

      The patients will be randomized into two arms, A and B, in function of the intervention dose.
      The quality of life of te parents as well as the daily median crying time and the number of
      daily crying will be assessed.
    


Intervention name(s): Bactecal® D Liquid
Intervention type(s): Dietary Supplement
Intervention description(s): The patients will be randomized into two arms, A and B, in function of the intervention dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
Condition: Urinary Incontinence; Bladder Control
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training
      (PFMT) and Bladder Training (BT) in women aged 55 and older.
    

Detailed description: 
      The study was designed to determine the capacity of self-efficacy to predict maintenance of
      the practices of PFMT and BT. Women in the treatment arm of the RCT attended a Bladder Health
      Class (PFMT & BT) to prevent UI. The class content emphasized self-efficacy. At 3-months post
      intervention the self-efficacy of participants was measured; these results were collected to
      analyze for predictive capacity of training adherence. For four years participants in both
      the treatment and control (no class) arms were followed with both questionnaires and 3-day
      bladder diaries (2/year) and clinic evaluations of (1/year). In addition, qualitative
      analyses of the narratives of Bladder Health Class participants identified individual
      attitudes and strategies that either facilitated or deterred adherence.
    

Intervention name(s): Bladder Health Class consisting of 6 weekly group sessions; Practice PFMT and BT; Clinic examination for pelvic muscle function; Record keeping in 3-day voiding diary
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 1 time; As needed for 4 years; 1/year for 4 years; Every 6 months for 4 years
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Urinary Incontinence; Self efficacy; Pelvic floor muscle training; Bladder training
Study to Compare Pharmacokinetics & Pharmacodynamics of Warfarin & Esmolol in the Absence & Presence of MEDI0382
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 study to evaluate the effect of MEDI0382 on PK and PD of warfarin and esmolol in
      healthy subjects.
    

Detailed description: 
      This is a Phase 1 open label, one-sequence, crossover study to evaluate the effect of
      MEDI0382 on PK and PD of warfarin and esmolol in healthy subjects. The safety and
      tolerability of MEDI0382 in combination with warfarin and esmolol will also be evaluated.
      Following screening, the study consists of 2 5-day inpatient stays followed by outpatient
      visits.
    

Intervention name(s): MEDI0382; Warfarin; Esmolol
Intervention type(s): Biological; Drug; Drug
Intervention description(s): All participants will receive MEDI0382; All participants will receive Warfarin; All participants will receive Esmolol
Intervention MeSH terms: Warfarin; Esmolol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 Diabetes Mellitus, MEDI0382
A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial is a multi-center, open-label, dose-escalation study designed to evaluate the
      safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury
      patients: those with a complete cervical injury or a complete thoracic injury. Dose levels
      from 0.3 mg - 9 mg of Cethrin will be administered.
    


Intervention name(s): Cethrin
Intervention type(s): Drug
Other intervention name(s): (BA-210)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biologic drug; transport sequence; rho; spinal cord injury; paralysis; paraplegia; tetraplegia; quadraplegia; trauma; nervous system; fibrin sealant; neurosurgery
IVAC MUTANOME Phase I Clinical Trial
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of
      intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or
      without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma
    

Detailed description: 
      IVAC MUTANOME is a poly-neo-epitopic coding RNA vaccine targeting the unique mutation
      signature of an individual patient. It is engineered on demand, provided as two
      patient-specific RNA drug products and administered as an individual treatment.

      RBL001/RBL002 and IVAC MUTANOME are naked ribonucleic acid (RNA) based recombinant vaccines
      optimized to induce antigen-specific CD8+ and CD4+ T cell responses against melanoma
      associated target antigens.

      The two antigens are well characterized antigens in melanoma that have been previously
      utilized with excellent safety and proven immunogenicity as vaccine targets in a number of
      independent clinical trials.

      The overall rationale of the study is to determine safety of the novel RNA-based vaccine
      strategy and determine the number and function of vaccine-induced antigen-specific
      immune-responses as early biomarkers for the clinical mode of action.

      The IVAC MUTANOME vaccine approach is based on targeting multiple immunogenic tumour
      mutations unique to a given patient's tumour using a poly-epitopic RNA-based vaccine
      manufactured for use in a single patient only. Parallel to the target discovery process and
      on demand manufacturing of IVAC MUTANOME vaccine patients with RBL001 and/ or RBL002
      positive-tumours will receive the RBL001/RBL002 vaccine. Patients which tumours that are
      RBL001 and RBL002 negative can also be included into the clinical study but will not receive
      RBL001/RBL002 prior to IVAC MUTANOME. Applying this approach the RBL001/RBL002 vaccine and
      the IVAC MUTANOME vaccine administration is expected to lead to several effects contributing
      to their immunological (therapeutic) effects.
    

Intervention name(s): IVAC MUTANOME, RBL001/RBL002
Intervention type(s): Biological
Intervention description(s): Each patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002.
Other intervention name(s): cancer vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVAC MUTANOME; IVAC; personalized therapy; personalized immuno therapy; RB_0004-01; Ribological; Melanoma; cancer vaccine