bioihbjkbjnl/mcl2 huggingface dataset:
LiveWell: A Mobile Intervention for Bipolar Disorder
Condition: Bipolar Disorder; Bipolar I Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      LiveWell is a study evaluating the use of smartphones to better understand and improve the
      treatment of bipolar disorder. Our goal is to increase access to psychosocial interventions
      and improve their effectiveness in reducing symptoms and preventing mood episodes.
    

Detailed description: 
      A single blind, randomized controlled trial (N = 200, 2:3 ratio of usual care vs usual care
      and intervention) will be conducted in clinical practices around Chicago and Minneapolis.
      Eligible participants are adult bipolar 1 disorder patients not experiencing a current mood
      episode with a history of at least one acute episode in the last two years who are in
      treatment with a psychiatrist.

      The primary clinical outcome will be time to relapse, and the secondary outcomes will be
      percent time symptomatic, symptom severity, and quality of life.

      Participation in the study lasts for 12 months. Participants are asked to carry a smartphone
      with them whenever they leave home and wear a wristwatch for measuring activity all day every
      day. Participants are also asked to complete a series of telephone assessments and may be
      asked to complete daily check-ins on a smartphone and work with a health coach.

      Participants will need to attend two in-person clinic visits at 680 N Lake Shore Drive,
      Chicago IL 60611 Suite 1520 or at 3311 E Old Shakopee Rd, Bloomington, MN 55425.
    

Intervention name(s): Psychiatric management; Psychosocial treatment; LiveWell Program
Intervention type(s): Other; Behavioral; Behavioral
Intervention description(s): Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy.; Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups.; Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Smartphone; Behavior Therapy
Dose Escalation Study of Valortim® (MDX-1303) Administered Intravenously (IV) in Healthy, Normal Subjects
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      Valortim is the name of the experimental drug that volunteers will receive in this study.
      Valortim may also be called MDX-1303. Experimental means that the drug is not yet approved by
      the Food and Drug Administration (FDA). Valortim is a monoclonal antibody (laboratory-made
      immune system molecule) for the treatment of inhalation anthrax (when the infection starts in
      the lungs). Valortim works by attaching itself to part of the anthrax toxin preventing the
      toxin from doing damage to cells. This study is being conducted to see if Valortim given over
      120 minutes is safe and tolerable. This study will take place in five parts: Screening Phase,
      Check-in Phase (the day you arrive at Quintiles to start the study), Treatment Phase (the
      time when you receive the study medication), Follow-up Phase (the time after you receive the
      study medication) and Final Visit.
    

Detailed description: 
      Twenty-eight subjects will be recruited and entered into one of three dose groups 1mg/kg,
      5mg/kg, 10mg/kg or placebo. Subjects will be stagger dosed into one of the three groups and
      randomly assigned to receive Valortim or saline. Subjects will reside in the clinical trial
      Phase I Unit from Day -1 through Day 2. After discharge on Day 2, all subjects will return to
      the Phase I unit 7 times at specified time points over an additional 130 days post-dosing
      (133 days total participation from check-in on Day -1)or placebo.
    

Intervention name(s): Normal Saline for Injection; MDX1303
Intervention type(s): Drug; Biological
Intervention description(s): Equivalent amounts to subjects weight, once over 120 minutes; a sterile solution at a protein concentration of 25 mg/mL: 20 mM sodium citrate, 50 mM sodium chloride, 3.0% mannitol, 50 µM diethylenetriamine pentacetic acid and 0.06% polysorbate 80 at pH 6.5. A tubular, clear glass vial, filled with a 5 mL dose of colorless to pale yellow solution. The vial is sealed with a 20 mm stopper and white flip-off seal.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Phase I
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets
Condition: Anesthesia; Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, randomized, two-stage, two-way crossover study
      evaluating the effect of voriconazole on the PK, PD, and safety of HSK3486 in healthy
      subjects.
    

Detailed description: 
      After the recruited healthy subjects passed the screening of inclusion and exclusion
      criteria, a seed number was set in the PLAN program of the SAS 9.4 software by the
      statistician before the formal enrollment, and the subject screening numbers were randomly
      assigned to the two groups by using a 1:1 block randomization method. The enrolled subjects
      were assigned a subject number according to the results of randomization and received stage I
      dosing of HSK3486 injectable emulsion (sequence 1) or HSK3486 injectable emulsion +
      voriconazole (sequence 2). After a 7-day (sequence 1) or 14-day washout period (sequence 2),
      the stage II dosing of HSK3486 injectable emulsion + voriconazole (sequence 2) or HSK3486
      injectable emulsion (sequence 1) was carried out in a crossover fashion.
    

Intervention name(s): HSK3486; voriconazole +HSK3486
Intervention type(s): Drug; Drug
Intervention description(s): Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.; Sequence 2: voriconazole：Day 1,400mg，BID；Day 2--Day 6,200mg，BID；200 mg of voriconazole were taken orally in the morning on an empty stomach of Day 7; followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later.
Intervention MeSH terms: Voriconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age
Condition: Preterm Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The investigators plan to use a new process to shorten the time of attaining full oral
      feeding in preterm infants less than 30 weeks gestational age.
    

Detailed description: 
      In the neonatal intensive care unit, the attention of oral feeding of premature infants is
      far less than that of mechanical ventilation, antibiotics and other medical treatment, the
      use of parenteral nutrition, etc., and it is often not until the premature infants are enough
      mature and stable, or even before discharge that the caregivers pay attention to the problem
      of oral feeding. At this time, the corrected gestational age of premature infants is almost
      36 weeks, but in fact the study shows that preterm infants have the ability of self feeding
      when they are about 32 weeks old. And oral feeding is very helpful to improve their
      nutritional status, reduce the use of parenteral nutrition and other forms of enteral
      nutrition, prevent complications and shorten the length of stay. Therefore, this study plans
      to use a new process to promote oral feeding and to verify whether it is feasible to earlier
      attainment of full oral feeding in premature infants.
    

Intervention name(s): New Oral feeding process
Intervention type(s): Behavioral
Intervention description(s): From the beginning of 32 weeks, try oral feeding once a day, suck pacifier for 10 minutes before feeding. When she/he can finish 50% of the amount of one meal in consecutive two days, and there is no adverse events happened, then we will try oral feeding twice a day. In the same way, in the oral feeding she/he can finish 50% of this meal in consecutive two days, there is no adverse events happened, then we will try three oral feedings three times a day. We wil continue the process until the infant can be fully oral fed by herself/himself.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled study. Standard group: old protocol. Intervention group: New protocol.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Study of Pyrotinib in Patients With Human Epidermalgrowth Factor Receptor 2 (HER2) Positive Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This
      study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2
      positive advanced breast cancer:

        -  To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose
           (MTD)

        -  To determine the dose-limiting toxicity (DLT)

        -  To determine the pharmacokinetic profile of Pyrotinib and its metabolites

        -  To assess preliminary antitumor activity

        -  To determine preliminary regimen dose for phase II study

        -  To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
    


Intervention name(s): Pyrotinib
Intervention type(s): Drug
Intervention description(s): Pyrotinib either at 80, 160, 240, 320, 400, 480 mg ....., p.o. once daily.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer; advanced; Pyrotinib; Phase I; HER2 positive advanced breast cancer
The Effectiveness of Kinesio Taping in Violin Players
Condition: Pain, Neck; Pain, Joint; Pain, Shoulder; Occupational Diseases; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Arthralgia; Shoulder Pain; Neck Pain; Occupational Diseases
Study type: Interventional

Summary: 
      This study aimed to investigate the effectiveness of Kinesio taping (KT) on playing-related
      pain, upper extremity and hand function, grip and pinch strength in violin players. One
      hundred seventeen participants who were professional violinists for at least two years were
      randomized to receive either therapeutic tape application (KT group), a sham tape application
      (placebo group) or no application (control group) for one week. The primary outcome was the
      Disabilities of the Arm, Shoulder and Hand (DASH) in one week. The secondary outcomes were
      the Visual Analogue Scale (VAS), the Purdue Pegboard Test, grip and pinch strength. Outcome
      measures were performed at baseline, immediately after the intervention, and one week later
      (follow-up). Participants were asked to play the "Violin Concerto No.2, Op.35", and pre-and
      post-performance pain and grip and pinch strength were assessed.
    

Detailed description: 
      Kinesio tape (KT), an alternative taping technique, is a method consisting of a tape with
      elastic properties and stretching capabilities used to treat pain or prevent injuries in
      conjunction with exercise.It has been concluded that KT intervention might not be helpful to
      reduce dystonic patterns or improve playing ability in musicians with focal hand dystonia.
      However, there is no enough study to conclude the effectiveness of KT application in
      Playing-related musculoskeletal disorders. Therefore, this study aimed to investigate the
      effect of KT on playing-related pain, upper extremity and hand function, grip and pinch
      strength in violin players compared to placebo KT application and control. As a secondary
      outcome, the investigators explored whether the pre-and post-performance effect of the KT on
      playing-related pain and grip and pinch strength.
    

Intervention name(s): Therapeutic tape; Placebo tape
Intervention type(s): Other; Other
Intervention description(s): Tape was applied to sternocleidomastoid, upper trapezius, deltoid, flexor palmaris longus muscles as suggested by Kase et al. (Kase, Wallis, Kase, & Association, 2003). The tape was applied to the left side of the participants while sitting position because the violin is traditionally played by placing it on the left shoulder, balancing the neck using the left hand, and bowing with the right arm.; The placebo tape was applied transverse to the muscle groups in two levels (a point of 10 cm above to wrist and elbow) with no tension when the participants were sitting position with the shoulder flexed at 90°, and the elbow flexed at 90°.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Prospective Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia
Condition: Post Laparotomy Pain Treatment
Study type: Interventional

Summary: 
      The current study aim is to compare between the opioids morphine, fentanyl and methadone in
      terms of efficacy and side effects profile when administered epidurally for pain management
      after laparotomies. Intravenous morphine will also be used. The outcomes of that method will
      be compared to those obtained using epidurally administered opioids, as this is another
      commonly used postoperative pain relief method.
    


Intervention name(s): epidural morphine via PCEA; epidural fentanyl via PCEA; epidural methadone via PCEA; intravenous morphine via PCA
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Fentanyl; Morphine; Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: morphine; fentanyl; methadone; epidural; intravenous; pain; analgesia
Alveolar Ridge Augmentation Following Tooth Extraction Using Bovine Xenograft With Platelet Rich Fibrin Membrane
Condition: Bone Regeneration
Study type: Interventional

Summary: 
      fourteen patients requiring extraction of one posterior tooth with lost buccal bone (>50%)
      confirmed preoperatively by Cone-beam computed tomography (CBCT) scans. Extraction sockets
      were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF
      membranes to seal the extraction sockets. (CBCT) scans, performed before tooth extraction and
      after 6 months, were used to assess vertical and horizontal bone changes.
    


Intervention name(s): a bone graft mixed with PRF & covered by PRF membrane in fresh extraction socket
Intervention type(s): Procedure
Intervention description(s): Extraction sockets were filled with minced PRF clots mixed with the bovine xenograft and covered by PRF membranes to seal the extraction sockets.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe
      Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.
    

Detailed description: 
      A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3
      Clinical Trial
    

Intervention name(s): Livalo, Ezetrol
Intervention type(s): Drug
Intervention description(s): Pitavastatin+Ezetimibe Pitavastatin
Other intervention name(s): Pitavastatin, Ezetimibe
Intervention MeSH terms: Ezetimibe; Pitavastatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating Cognitive and Functional Impairment in Alzheimer's Dementia With a Ketogenic Diet.
Condition: Cognitive Function 1, Social
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional

Summary: 
      The present study is being done in a scientifically rigorous manner, using readily available
      MCT oil (refined from coconut oil) versus a placebo oil to assess any cognitive and
      functional benefits for AD patients.
    

Detailed description: 
      The proposed study, is a randomized placebo controlled cross-over study for 6 months, with an
      open label extension for another 6 months designed to test the benefits and safety of MCT oil
      in patients with established AD. It will be the first study on MCT oil ever done with this
      design, and for this duration in AD.
    

Intervention name(s): Bulletproof Brain Octane; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Medium chain triglyceride oil (MCT); Placebo (olive) oil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, placebo control cross-over study, with an open label extension
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neuromas as the Cause of Pain
Condition: Neuropathic Pain; Neuroma
MeSH terms: Neuroma; Neuralgia
Study type: Interventional

Summary: 
      Neuromas are frequent after trauma and surgery, including amputation and can be identified by
      high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is
      uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be
      relieved by injection of local anesthetics near painful neuromas in subjects with peripheral
      nerve injury.
    


Intervention name(s): Lidocaine; Isotonic Saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Safety, Tolerability, and Immunogenicity Study of Investigational Recombinant Botulinum Vaccine A/B (rBV A/B) in Volunteers Previously Immunized With Investigational Pentavalent Botulinum Toxoid
Condition: Botulism
MeSH terms: Botulism
Study type: Interventional
Phase: Phase 2

Summary: 
      Study rBV A/B-CL-001 is a Phase 2b, 2-part, open-label, uncontrolled study to evaluate
      safety, tolerability, and immunogenicity of a single dose of recombinant botulinum vaccine
      A/B (rBV A/B) for the production of BabyBIG in volunteers previously immunized with the
      pentavalent botulinum (PBT) toxoid. This study is designed to determine neutralizing antibody
      levels for botulinum toxin types A and B in healthy subjects who were previously immunized
      with the PBT for occupational protection and who receive the rBV A/B. Subjects with titers of
      the neutralizing antibodies against the toxins would be candidates for plasma donation for
      BabyBIG production.
    


Intervention name(s): rBV A/B
Intervention type(s): Biological
Intervention description(s): rBV A/B injections will consist of a single 40 µg injection of total antigen (20 µg of Antigen A and 20 µg of Antigen B) adsorbed to 0.2% (wt/vol) Alhydrogel™, in a total dose volume of 0.5 mL. The vaccine will be administered by intramuscular injection in the deltoid muscle, preferably in the nondominant arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Botulism Vaccine
Electrolysis Technique vs Manual Therapy in Pelvic Pain
Condition: Dyspareunia; Pelvic Pain; Pelvic Floor Disorders; Musculoskeletal Pain; Perineal Tear
MeSH terms: Musculoskeletal Pain; Pelvic Floor Disorders; Dyspareunia; Pelvic Pain
Study type: Interventional

Summary: 
      Pelvic floor muscle physical therapy is recommended in clinical guidelines for women
      dyspareunia and pelvic pain. This study compare pelvic floor manual therapy and intratissue
      percutaneous electrolysis (EPI) technique in the treatment of pelvic pain in women with
      dyspareunia. Half of participants will receive pelvic floor manual therapy while the other
      half will receive intratissue percutaneous electrolysis technique.
    

Detailed description: 
      Dyspareunia is painful sexual intercourse and causes could be related to musculoskeletal
      pelvic floor muscles disorders (tenderness, trigger points, scars). There is evidence that
      manual therapy and intratissue percutaneous electrolysis can be effective for musculoskeletal
      pain disorders affecting muscles, tendons and fascias of the extremities but they have not
      been evaluated in pelvic floor muscle pain syndrome. The aim of this study is to compare
      manual therapy and EPI in the treatment of pelvic pain in women with dyspareunia.

      Pelvic floor manual therapy is a clinical approach utilizing specifics hands-on mobilizing
      techniques to treat soft tissues. Pelvic floor mobilization is a slow controlled process of
      soft-tissue (myofascial) stretching intended to improve bio-mechanical elasticity.

      EPI technique consists in an ultrasound-guided application of a galvanic electrolytic current
      that causes a controlled local inflammatory process in the target tissue. This allows for
      phagocytosis and the subsequent regeneration of the affected tissue.
    

Intervention name(s): Pelvic floor manual therapy group; Pelvic floor electrolysis group
Intervention type(s): Procedure; Procedure
Intervention description(s): Soft-tissue (myofascial) stretching techniques on pelvic floor muscles through external and internal (intra-vaginal) mobilizations. One weekly session for four weeks.; An ultrasound-guided application of a galvanic electrolytic current with an acupuncture needle in the soft tissue of pelvic floor. EPI technique was applied using a specifically device (EPI-X Omega Advanced Medicine, Barcelona, Spain) which produces modulated galvanic electricity. This is applied using a modified electrosurgical scalpel that incorporates acupuncture needles (0.3 mm in diameter) of different lengths. The intensity can be adjusted by changing either the duration of stimulation or the output current (mA) of the device.
One weekly session for four weeks.
Other intervention name(s): Man Ther Group; EPI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pelvic floor muscles; pelvic floor myalgia; manual therapy; electrolysis; galvanic