bioihbjkbjnl/mcl2 huggingface dataset:
PROM Collected Via a WebApp Versus a Touch Screen Solution Among Patients With SLE
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional

Summary: 
      A randomised, within-participants cross-over design trial including 34 patients with systemic
      lupus erythematosus. The participants will be randomised to data registration of patient
      reported outcome measures (PROM) through the DANBIO webapp and thereafter via the outpatient
      touchscreen or vice versa.
    

Detailed description: 
      The aim of this trial is to evaluate whether electronic reporting of PROMs through the DANBIO
      web application (webapp) is comparable to the outpatient touchscreen among patients with SLE.

      The trial is a randomised, crossover, agreement study where 34 patients with SLE from the
      Department of Rheumatology at Aalborg University Hospital will be included and randomised in
      ratio 1:1 to:

        -  Group 1: PROMs are reported through the DANBIO webapp; thereafter, the touchscreen.

        -  Group 2: PROMs are reported through the touchscreen; thereafter, the DANBIO webapp.

      There will be a wash-out period of 1-2 day between the two registrations to minimise
      carryover bias.
    

Intervention name(s): PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
Intervention type(s): Device
Intervention description(s): PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomised, within-participants, open, cross-over trial
Masking: None (Open Label)
Primary purpose: Other
Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD)
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      To confirm the safety and efficacy of the NCP System in treating patients in a nmajor
      depressive episode.
    


Intervention name(s): vagus nerve stimulation (VNS)
Intervention type(s): Device
Intervention description(s): intermittent vagus nerve stimulation
Placebo group were implanted, but did not receive vagus nerve stimulation during the acute phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; vagus nerve stimulation
Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT
Condition: Graft Vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical
      cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute
      graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell
      transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for
      steroid-resistant aGVHD.
    

Detailed description: 
      A total of 130 patients with steroid-resistant aGVHD after allo-HSCT are enrolled in this
      multicenter, randomized, controlled trial. Patients were randomized to UC-MSC + anti-CD25
      monoclonal antibodies (mAb) group and anti-CD25 mAb group. The complete response (CR) rate
      after 4 weeks of treatment in the two groups will be compared. Adverse events are also
      recorded throughout the study.
    

Intervention name(s): UC-MSC; Anti-CD25 mAb
Intervention type(s): Drug; Drug
Intervention description(s): UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks.; Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
Other intervention name(s): Umbilical cord-derived mesenchymal stem cells; Basiliximab
Intervention MeSH terms: Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rapid Non-Invasive Brain Stimulation for OCD (oTMS)
Condition: OCD
Study type: Interventional

Summary: 
      The purpose of this study is to understand how cortical stimulation affects
      Obsessive-Compulsive Disorder (OCD) symptoms.
    

Detailed description: 
      Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the
      economy over $2 billion annually and represents a significant public health problem. This
      study aims to understand how cortical stimulation affects Obsessive-Compulsive Disorder
    

Intervention name(s): MagPro X100 by MagVenture
Intervention type(s): Device
Intervention description(s): Participants received 5 consecutive days of accelerated cTBSmod to the right frontal pole. Each cTBSmod session was comprised of 1800 pulses, delivered in a continuous train of 600 bursts. Each burst contained 3 pulses at 30 Hz, repeated at 6 Hz. Ten sessions were applied per day (18,000 pulses/day, hourly) (90,000 total pulses) using a Magventure Magpro X100. Stimulation was delivered at 90% resting motor threshold (depth corrected). Localite Neuronavigation System was used to position the TMS coil over the individualized stimulation target.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
Condition: Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Adolescent subjects hospitalized for the treatment of bacterial infections will be given 1
      gram of dalbavancin through their veins and levels of dalbavancin in blood and urine will be
      measured at different time points. Safety labs will also be checked on a regular basis to
      assess the safety of dalbavancin.
    


Intervention name(s): Dalbavancin
Intervention type(s): Drug
Intervention description(s): Subjects weighing > 60 Kg: 1 gram IV single dose Subjects weighing < 60 Kg: 15 mg/Kg IV
Intervention MeSH terms: Dalbavancin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: dalbavancin adolescent subjects
Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the tolerability of bifeprunox with the progressive elimination of
      titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in
      either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an
      optional open-label 26-week extension study.
    


Intervention name(s): Bifeprunox
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Decreasing Titration Study; Schizophrenia; Bipolar; Pharmacokinetic
Study of Multiple Oral Doses of Odanacatib (MK0822) in Healthy Adults (0822-002)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      once-daily multiple-dose administration of odanacatib (MK0822).
    


Intervention name(s): odanacatib; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.
Panel A: odanacatib tablets 2.5 mg qd for 14 days.
Panel B: odanacatib tablets 5 mg qd for 14 days.
Panel C: odanacatib tablets 10 mg qd for 14 days.
Panel D: odanacatib tablets 25 mg qd for 14 days.
Panel E: odanacatib tablets 0.5 mg qd for 21 days.
Panel F: odanacatib tablets 2.5 mg qd for 21 days.
Panel G: odanacatib tablets 10 mg qd for 21 days.; Panels A, B, C, and D will enroll males only; Panels E, F, and G will enroll females only.
Panel A: placebo to odanacatib tablets 2.5 mg qd for 14 days.
Panel B: placebo to odanacatib tablets 5 mg qd for 14 days.
Panel C: placebo to odanacatib tablets 10 mg qd for 14 days.
Panel D: placebo to odanacatib tablets 25 mg qd for 14 days.
Panel E: placebo to odanacatib tablets 0.5 mg qd for 21 days.
Panel F: placebo to odanacatib tablets 2.5 mg qd for 21 days.
Panel G: placebo to odanacatib tablets 10 mg qd for 21 days.
Other intervention name(s): MK0822
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Bioequivalence Study Of A New Alprazolam Dropped Formulation Versus Alprazolam Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      A Phase IV, Open Label, Randomized, Two-way Crossover, Single Dose Study to Determine
      Relative Bioavailability of Alprazolam 0,75mg/ml (laboratórios Pfizer Ltda) in the Oral
      Solution-drops Form, Versus Frontal® 0,25mg (laboratórios Pfizer Ltda), in the Tablets Form,
      Under Fasted Conditions in Healthy Volunteers.
    


Intervention name(s): alprazolam tablet; alprazolam oral solution
Intervention type(s): Drug; Drug
Intervention description(s): 0,25 mg oral tablets given once; 0,75 mg/ml Oral Solution (Drops) given once
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence study; alprazolam; frontal
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Condition: Colon Cleansing
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus
      HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.
    


Intervention name(s): Polyethylene glycol; Oral sodium phosphate solution
Intervention type(s): Drug; Drug
Intervention description(s): HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L; OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colon Cleansing; Bowel Prep; Colonoscopy
Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer
Condition: Healthy Subject
Study type: Interventional

Summary: 
      This trial studies how fiber and fish oil supplements affect the metabolism and activities of
      colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer,
      and several dietary components important in colorectal cancer prevention are modified by gut
      microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut
      cells and ultimately reduce risk of colorectal cancer.
    

Detailed description: 
      Participants are randomized to receive two dietary interventions in assigned random order.
      They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or
      they receive a fiber control and corn oil supplement daily for 30 days during the first
      intervention period. Then they enter a washout period for 60 days when they do not receive
      any treatment. After that they complete the second intervention period during which they
      receive the other intervention.
    

Intervention name(s): Dietary Fiber; Fish Oil; Comparator; Comparator
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): Given fiber supplement; Given fish oil supplement; Given fiber supplement placebo; Given fish oil supplement placebo (corn oil)
Other intervention name(s): Fiber; Oil, Fish; Seafood Oil; placebo therapy; PLCB; sham therapy; placebo therapy; PLCB; sham therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Colon; Rectum
Acidophilus Pearls Fecal Recovery Study
Condition: Survival of Probiotics During GI Transit; GI Symptoms
Study type: Interventional

Summary: 
      Commercial probiotics can be delivered in numerous forms. The two most common delivery forms
      are similar to the two product formats to be tested. It has been demonstrated using in vitro
      testing that probiotic organisms that are unprotected from gastric exposure may not survive
      that exposure and therefore may not remain viable throughout the rest of the GIT.
      (Unpublished studies conducted at SNA research facility, February, 2010.) Similar in vitro
      testing of Acidophilus Pearls has demonstrated the probiotic organisms in an enteric capsule
      will survive gastric exposure. It is anticipated that this difference in in vitro gastric
      survivability will translate to improved digestive tract survivability that can be
      demonstrated using fecal recovery techniques.

      The commercial product to be tested in this clinical trial has been in the market for over 17
      years. However, it is not known what effect this commercial product has on the commensal
      probiotic population in the gut and particularly in the lower bowel where much of probiotic
      benefits are believed to be largely realized. Also, it is not known what effect the
      commercial product has on the total commensal microbiota or fecal pH. While commercial
      probiotic products have been largely aimed at benefits related to improved health, they also
      have the potential to change overall gut microbiota (probiotics as well as all others)
      composition and activities. Learning what happens to the overall gut microbiota can be a
      helpful step in establishing the potential health benefits of the probiotic class of
      organisms in the test products.
    


Intervention name(s): Acidophilus pearls; Hard shell gelatin capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acidophilus pearls are encapsulated using patented process
Subjects take one capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days; Hard-shelled gelatin capsule with same microbial formulation as pearl supplement
Subjects consume one capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: microbiota; probiotics; fecal markers
The Study of Molecular Risk Panels (70-gene Assay) in Chinese Breast Cancer Patients
Condition: Chinese
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study is experimental and will prospectively assess the proportion of patients in the
      two (2) MammaPrint Risk categories in patients of Chinese descent.
    

Detailed description: 
      The incidence of breast cancer in Chinese women is lower than that of a Western population.
      Breast cancer is the most common cancer in Chinese women and the incidence is rising.
      Moreover there are more premenopausal women with breast cancer where the breast cancer
      incidence peaks in the forties and the postmenopausal rise in incidence is less commonly
      seen. As the genetic predisposition to breast cancer is increasingly understood, it has been
      suggested that the differences in breast cancer incidence in different ethnic populations is
      potentially due to interactions between lifestyle and genetic characteristics. To date, the
      use of Agendia's gene expression assays in Chinese women has not been studied. In this study,
      the feasibility of the gene-expression prognostic assays for risk assessment in this specific
      group will be assessed. Moreover, the specific molecular characteristics and potential
      biomarkers will be studied, focusing especially on the large group of premenopausal breast
      cancer patients.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women of Chinese Descent with Stage I or Stage II Breast Cancer
      
Keywords: Chinese women; Breast cancer
BCI for Hemiparetic Upper Extremities in Patients Due to Stroke
Condition: Stroke; Brain Computer Interface
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Non-invasive brain-computer interface (BCI) technology is one of the new training approaches
      to achieve motor restoration through a closed-loop system from brain activity through
      event-related desynchronization (ERD) after motor imagery (MI) or movement attempt to
      peripheral feedback triggered by an external hepatic device. Often, it is unclear whether the
      BCI intervention itself or the assistance of the external device leads to neural responses
      and functional gains.

      This study adopts a closed-loop BCI system involving ERD induced by MI. Functional electrical
      stimulation (FES) and virtual reality (VR) are simultaneously delivered as feedback. The aim
      is to investigate the efficacy of closed-loop BCI training combined with FES and VR on the
      recovery of the hemiparetic upper extremity of individuals with chronic stroke.

      Chronic stroke survivors are being recruited and randomly allocated into 3 groups: (1)
      BCI-FES-VR - participants look at an external screen displaying the VR avatar participant's
      arms while performing wrist dorsiflexion MI in random order (left or right). The BCI system
      detects the ERD of the motor area corresponding to correct MI. Then, visual feedback with the
      VR and motor-tactile feedback with the discharge of the FES is delivered; (2) BCI-FES - same
      procedure as group 1, but the difference is that the participant's hands replace the VR
      system; (3) BCI-VR - same procedure as group 1, but the FES is removed. Each session requires
      240 MI trials with a training duration of 10 sessions in a 3-week interval.

      Motor and MI assessments are being conducted at post-assessment and at a 3-week follow-up.

      The findings of this study will provide significant new information regarding
      neurophysiological motor relearning mechanisms, which could inform the development and
      evaluation of BCI-based treatment for individuals with stroke and impact the field of
      translational neuroscience.
    


Intervention name(s): Brain Computer Interface/ Functional Electrical Stimulation/ Virtual Reality
Intervention type(s): Device
Intervention description(s): A BCI system involves 3 main components - (1) brain activity collection, (2) external devices triggered by specific features of brain activity, and (3) a processor which decodes the brain activity signal and then translates it into computerized commands to control external devices such as virtual games and functional electrical stimulation (FES).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Brain Computer Interface; Neurorehabilitation; Event Related Desynchronization
Simple Preparation of Endotracheal Tube
Condition: Endotracheal Tube
Study type: Interventional

Summary: 
      To observe the effect of additional E-tube angulation on intubation time and success rate.
    

Detailed description: 
      The hypothesis of this study is that shaping endotracheal tube by end-to-end connection
      before induction will provide more optimal angulation for endotracheal intubation.
    

Intervention name(s): Curved-tube
Intervention type(s): Other
Intervention description(s): Connecting both ends of the endotracheal tube ("O" shape) for 5-min and releasing it provides additional anterior angle temporarily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Adherence Intervention to Promote Optimal Use of Insulin Pumps in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The overall objective of this study is to address the critical need of improving insulin pump
      adherence in adolescents with Type 1 Diabetes (T1D) by providing personalized intervention
      using evidence-based techniques during routine diabetes clinic visits at point of care.
    

Detailed description: 
      To achieve optimal use of the insulin pump, patients must engage in frequent Blood Glucose
      Monitoring (BGM) and insulin bolusing, and have an understanding of their relationship. BGM
      must occur and then it must be followed by a decision about what to do (or not do) regarding
      insulin bolusing. If insulin bolusing occurs in the absence of BGM, hypoglycemia and less
      than ideal glycemic control can occur. Of the few insulin pump adherence studies, only very
      basic adherence behaviors such as BGM and insulin bolusing frequency or number of
      hypoglycemic events have been reported.

      The overall objective of this study is to address the critical need of improving insulin pump
      adherence in adolescents with T1D by providing personalized intervention using evidence-based
      techniques during routine diabetes clinic visits at point of care.
    

Intervention name(s): Adherence behaviors and recommendations for improvement.; Adherence behavior that needs improvement is targeted
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized, Single-blind, Parallel Group and Multiple - Dose Design Study
Condition: Acetaminophen Toxicity
Study type: Interventional

Summary: 
      To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in
      healthy volunteers.
    

Detailed description: 
      Acetaminophen (AAP) is the most popular used analgesic/ antipyretic drug with serious
      hepatotoxic adverse effects; suicidal or unintentional overdose of AAP-induced
      hepatotoxicity. Cytochrome P450 2E1 (CYP2E1) is thought contribute to the responsible
      reactive metabolite N-acetyl-p-benzoquinone (NAPQI) of AAP overdose-induced hepatotoxicity.
      Pharmaceutical excipients are inactive ingredients that are added to a pharmaceutical
      compound. The objective of this study was to investigate the possible response of Panadol®
      (AAP alone) and SafeTynadol® (AAP with various selected excipients combination) formulations,
      while observing the AAP toxic metabolites (AAP-Cys) circumstances change in healthy
      volunteers. According to the current safety data, could be potentially develop
      hepatotoxicity-free AAP new formulation drug.
    

Intervention name(s): Panadol®; SafeTynadol®
Intervention type(s): Drug; Drug
Intervention description(s): Acetaminophen 500mg Tablet; Acetaminophen 500mg Tablet
Other intervention name(s): Acetaminophen; SNP-810
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Blindie
Masking: Single (Participant)
Primary purpose: Other
Keywords: acetaminophen; acute liver failure