bioihbjkbjnl/mcl2 huggingface dataset:
Acupuncture for Low-Dose Opioid for TKA Replacement
Condition: Knee Osteoarthritis; Pain, Postoperative; Acupuncture
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The majority of patients undergoing total knee replacement(TKR) rely on opioids for
      postoperative analgesia. These medications have undesirable side effects and potential for
      abuse and addiction. The aim of this cohort study is to determine the incidence rate of
      patients who are able to maintain a low dose opioid regimen after TKR with the use of a
      multimodal approach that includes intraoperative auricular acupuncture protocol.
    

Detailed description: 
      This is a prospective cohort study to assess the feasibility of patients to undergo TKR while
      adhering to a low-dose opioid regimen by using a multimodal analgesic approach that includes
      intraoperativeauricular acupuncture. We hypothesize that it will be feasible to maintain a
      low-dose opioid regimen during TKR while followingthe intraoperative auricular acupuncture
      protocol, and that patients will be satisfied with their pain control with a low incidence of
      adverse events.
    

Intervention name(s): Acupuncture; Peripheral Nerve Stimulator
Intervention type(s): Other; Device
Intervention description(s): Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed; Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupuncture, Total Knee Replacement
Behavioral Interventions for Active Duty Service Members and Veterans With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The central aim of this proposed study is to test a multimodal, mindfulness-oriented
      intervention designed to disrupt the risk chain leading to prescription opioid dose
      escalation, opioid misuse and opioid addiction, which are mounting threats to active duty
      service members and Veterans with chronic pain conditions, who may develop disordered opioid
      use as a consequence of long-term opioid pharmacotherapy.
    


Intervention name(s): Mindfulness-Oriented Recovery Enhancement (MORE); Support Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.; A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat
Condition: Submental Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, double-blind, placebo-controlled, dose-ranging, parallel,
      multi-center, phase II study to evaluate the efficacy and safety of MT921 in subjects with
      moderate to severe submental fat.
    


Intervention name(s): MT921; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.; Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome
Condition: Major Depressive Disorder; Soft Tissue Discomfort Syndrome; Pain
MeSH terms: Syndrome; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine the time course of duloxetine efficacy on the
      symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort
      Syndrome(STDS) via use of 24-hour Actigraph™ measures.

      We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients
      with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement
      in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS
      symptoms which may occur even before the antidepressant effect is observed.
    


Intervention name(s): Duloxetine
Intervention type(s): Drug
Intervention description(s): 30-60 mg daily for 8 weeks
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Maturity and Motor Fitness
Condition: Physical Fitness
Study type: Observational

Summary: 
      The current study examined the effect of maturity on the sprint and jump performances in a
      single year age group of 13 year old boys.
    

Detailed description: 
      The investigators examined the issue in adolescent boys (n = 107) aged from 13.0 to 13.9
      years. The maturity status was assessed using a self-assessment of stage of pubic hair based
      on the criteria of Tanner. Body composition and maximal voluntary knee extension torque (KET)
      were determined using a bioelectrical impedance analyzer and a static myometer, respectively.
      Sprint velocity was measured by a non-motorized treadmill. Jump height was calculated from
      the following equation; g × (flight time)2 × 8 × 10-1. The flight time during jumping was
      measured by a matswitch system.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Junior high school students
      
Keywords: pubic hair; sprint velocity; vertical jump height; body composition; maximal voluntary torque
Combination Chemotherapy in Treating Patients With Bladder Cancer
Condition: Bladder Cancer; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known whether four-drug combination chemotherapy is more effective than two-drug
      combination chemotherapy in treating bladder cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two combination
      chemotherapy regimens in treating patients who have bladder cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the recurrence rates and overall survival of patients treated with
      postoperative adjuvant methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) to those
      treated with combination paclitaxel and carboplatin for muscle invasive bladder cancer at
      particularly high risk of relapse. II. Compare the relative toxicities of postoperative M-VAC
      versus those encountered with postoperative paclitaxel and carboplatin. III. Compare the
      quality of life scores during and following completion of treatment of patients in these two
      treatment arms.

      OUTLINE: This is a randomized study. Patients are stratified by N stage (N0 vs N+) and
      performance status (0-1 vs 2). Patients are randomized to receive methotrexate, vinblastine,
      doxorubicin, and cisplatin (arm I) or paclitaxel and carboplatin (arm II). Arm I: Patients
      receive methotrexate IV push on days 1, 15, and 22; vinblastine IV push on days 2, 15, and
      22; doxorubicin IV push on day 2; and cisplatin IV over 2 hours on day 2. Treatment repeats
      every 28 days for 4 courses. Arm II: Patients receive paclitaxel IV over 3 hours on days 1
      followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4
      courses. Quality of life assessments are completed pretreatment, prior to course 3, 6 weeks
      after the last dose of chemotherapy, and at 6, 12, and 24 months from the end of therapy.
      Patients are followed every 3 months until year 2, every 6 months for years 2-5, and then
      annually thereafter.

      PROJECTED ACCRUAL: There will be 490 patients accrued into this study within 2.6 years.
    

Intervention name(s): carboplatin; cisplatin; doxorubicin hydrochloride; methotrexate; paclitaxel; vinblastine sulfate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Vinblastine; Carboplatin; Doxorubicin; Liposomal doxorubicin; Methotrexate
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III bladder cancer; transitional cell carcinoma of the bladder; urethral cancer associated with invasive bladder cancer
Randomized Trial for Mixed Acute Rejection
Condition: Graft Rejection
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to determine how safe and effective using an immune cell (b
      cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are
      experiencing certain types of rejection.
    

Detailed description: 
      The purpose of the study is to determine safety and efficacy of treatment if mixed (cellular
      and antibody) mediated acute rejection with addition of B-cell depleting therapy to
      Thymoglobulin in kidney and simultaneous kidney pancreas allograft recipients.
    

Intervention name(s): Rabbit Antithymocyte Globulin (RATG); Rituximab; Bortezomib; Acetaminophen; Antihistamine; Methylprednisolone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.; Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.; Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.; Patients will be premedicated with acetaminophen prior to dosing per institution standard of care.; Patients will be premedicated with an antihistamine prior to dosing per institution standard of care.; Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose.
Other intervention name(s): thymoglobulin; rituxan; Velcade; Tylenol; diphenhydramine; Medrol
Intervention MeSH terms: Acetaminophen; Diphenhydramine; Methylprednisolone; Rituximab; Bortezomib; Thymoglobulin; Antilymphocyte Serum; Histamine H1 Antagonists; Histamine Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy
Condition: ATTR-CM; TTR-CM
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label Safety and Efficacy Evaluation of Fx-1006a in Patients with V122i Or Wild-type
      Transthyretin (ttr) Amyloid Cardiomyopathy.

      Patients who successfully complete Fx1B-201 will report to the clinical unit on Day 0 to sign
      the informed consent form and determine eligibility for Protocol Fx1B-303. In addition, on
      Day 0, patients will have their entrance criteria reviewed, and medical histories and
      demographic characteristics obtained.

      The physical examination (including weight and vital signs) and the relevant end of study
      clinical laboratory tests (alkaline phosphatase, alanine aminotransferase, aspartate
      aminotransferase, blood urea nitrogen, gamma glutamyl transferase, creatinine, total
      bilirubin, international normalized ratio, troponin I, troponin T, and amino-terminal B-type
      natriuretic peptide) from Protocol Fx1B-201 will be used for Protocol Fx1B-303. If more than
      30 days has elapsed between the final study visit of Protocol Fx1B-201 and Day 0 of Protocol
      Fx1B-303, an abbreviated physical examination (including weight and vital signs) and clinical
      laboratory assessments must be performed on Day 0.

      Eligible patients will begin once-daily dosing with 20 mg Fx-1006A at home on Day 1 (i.e.,
      first dose) and will return to the clinical unit for study visits every 6 months.

      Adverse events (AEs) and concomitant medication use will be collected at each 6-month visit
      to the clinical unit. Blood draws for clinical safety laboratory tests and abbreviated
      physical examinations (including weight and vital signs) will also be performed at each
      6-month clinic visit. ECGs will be performed every 12 months on an annual basis. A telephone
      call will be made at 3-month intervals between clinic visits to assess safety and use of
      concomitant medications.

      For the evaluation of efficacy, the Patient Global Assessment, NYHA classification, KCCQ,
      6-minute walk test, and efficacy-related clinical laboratory tests (serum levels of troponin
      T, troponin I, and NT-pro-BNP) will be determined every 6 months. In addition,
      echocardiograms will be performed every 12 months on an annual basis.

      An end of study visit including all safety and efficacy assessments will occur upon patient
      completion of the study, premature withdrawal (for any reason), or in the event of program
      discontinuation by the Sponsor.
    


Intervention name(s): tafamidis
Intervention type(s): Drug
Intervention description(s): Once daily 20 mg oral tafamidis (soft gelatin capsule)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TTR, ATTR, cardiomyopathy, amyloidosis, tafamidis
Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      Central South University in collaboration with Tianjin University developed the first
      domestically produced Chinese minimally invasive surgical (MIS) robot system which named
      "Micro Hand S" in 2013. This new MIS robot had been authorized to enter the clinical trial
      stage by the Ethics Committee of the Third Xiangya Hospital at Central South University. The
      Micro Hand S robot is safe and feasible in the preliminary study. However, compared with
      minimally invasive approaches (da Vici, laparoscope), the merits and demrits of rectectomy
      for rectal cancer are unclear. Therefore, the investigators conduct this retrospective study
      to focus on this concern.
    


Intervention name(s): Micro Hand S robot; Laparoscope
Intervention type(s): Device; Device
Intervention description(s): The surgeries are performed with the Micro Hand S robot; The surgeries are performed with the laparoscope
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Incorporating teleCBIT Into a Hospital-Based Tic Program
Condition: Tic Disorders; Tourette Syndrome
MeSH terms: Tourette Syndrome; Tic Disorders
Study type: Interventional

Summary: 
      This is a single-arm open trial of Comprehensive Behavioral Intervention for Tics (CBIT)
      delivered to pediatric and adult patients with persistent tic disorders in their homes via
      videoconferencing (i.e., teleCBIT). All participants who enroll will receive teleCBIT.
    

Detailed description: 
      Comprehensive Behavioral Intervention for Tics (CBIT) is a behavioral therapy with proven
      efficacy for treating persistent tic disorders (e.g., Tourette Syndrome) in youth and adults.
      Lack of access to a local CBIT provider prevents treatment access for many patients who could
      benefit from CBIT. Providing CBIT to patients in their homes via videoconferencing technology
      (i.e., teleCBIT) is a promising approach to increasing CBIT access. This study investigates
      treatment uptake, acceptability, feasibility, and clinical effectiveness of teleCBIT among
      pediatric and adult patients enrolled as patients in a state-of-the-art medical tic program.
    

Intervention name(s): teleCBIT
Intervention type(s): Behavioral
Intervention description(s): Eight sessions of individual behavior therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Light Therapy for Depression During Pregnancy
Condition: Major Depressive Disorder; Pregnancy
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether morning bright light therapy is an
      effective treatment for major depression during pregnancy compared with low-intensity placebo
      light therapy, when administered 60 minutes daily for 5 weeks.
    

Detailed description: 
      Affective disorder during pregnancy is a common and severe condition, associated with a
      higher risk for prenatal complications, preterm delivery, a higher rate of surgical birth and
      vaginal operative delivery. Depressed pregnant women are at risk for inadequate nutrition,
      poor weight gain, increased use of nicotine, drugs and alcohol, and failure to obtain
      adequate prenatal care, as well as poor mother-child attachment. Their infants have a higher
      risk for low birth weight, a higher rate of admission to neonatal intensive care, and
      cognitive, emotional and behavioural disturbances.Treatment of antepartum depression requires
      careful judgement to minimise risk to the foetus. Pharmacological treatment is an option, but
      all antidepressants cross the placenta, and both practitioners and patients are concerned
      about possible teratogenicity, pre- and perinatal adverse effects for the infant, as well as
      negative effects on long-term development. Thus, psychiatric medication use for depression in
      pregnancy may also pose an excess risk of preterm delivery and withdrawal symptoms in the
      newborn. Treatment of depression during pregnancy that is efficacious, reliable, safe, and
      with minor side effects is an urgent unmet clinical need. Light therapy may provide this
      somatic, non-pharmaceutical alternative. It is well established as the treatment of choice
      for Seasonal Affective Disorder (SAD), and there is a growing data base for response in
      nonseasonal major depression. Two promising pilot studies led to the present randomised,
      double-blind, placebo-controlled trial of 5 weeks daily morning bright light therapy (1h,
      7000 lux white) compared with low-intensity placebo light therapy (1h, 70 lux red).
    

Intervention name(s): Light therapy
Intervention type(s): Other
Intervention description(s): During the 5-week treatment period, subjects sit in front of a light box for 60 minutes daily after awakening, at a specified distance that provides the required light intensity.
Other intervention name(s): Phototherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: light therapy; antepartum depression; controlled trial
Efficacy and Safety Study of Topical Rapamycin Associated With Pulsed Dye Laser in Patients With Sturge-Weber Syndrome
Condition: Sturge- Weber Syndrome
MeSH terms: Sturge-Weber Syndrome; Brain Stem Infarctions; Klippel-Trenaunay-Weber Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Sturge-Weber syndrome (SWS) is a rare congenital neuro-cutaneous disorder considered as a
      rare or orphan disease. SWS is characterized by a capillary vascular malformation (CM)
      localized on the skin of the face, eyes and central nervous system. Given the localization
      and the extent of the CM, children with SWS are particularly prone to developing severe
      psychological problems. The standard treatment for CM is pulsed dye laser (PDL) although in
      these cases whitening of the lesion is rarely achieved. Combining topical rapamycin, a
      specific inhibitor of the mammalian target of rapamycin, with PDL is hypothesised to be a
      good therapeutic option in these patients.
    

Detailed description: 
      Patients with SWS will be treated with 2 sessions of PDL in the lateral part of the CM
      separated by an interval of 6 weeks and with 1% topical rapamycin or placebo in the superior
      or inferior half, both applied once a day for 12 weeks. The clinical response will be
      analyzed using a morphologic and chromatographic computerised system and with spectrometry.
      Histological response will be evaluated also. For that purpose, we will make 4 biopsies, one
      in each quadrant (quadrant treated with PDL and placebo, quadrant treated with PDL and
      rapamycin, quadrant treated only with rapamycin and quadrant treated only with placebo)
    

Intervention name(s): Drug: Topical Rapamycin
Intervention type(s): Drug
Intervention description(s): After signing this consent form, you will be asked to undergo some screening tests or procedures to find out if you can be in the research study.
A medical history, which involves questions about your health history, any medications you are taking or plan to take, any allergies and the treatments you received for your CM.
A physical exam, during which you will be asked about any problems that you might be having. Additionally, your clinician will check your vital signs (blood pressure, heart rate, weight and height). The doctor will also evaluate your performance status, which indicates how much your illness affects your activity level.
Blood tests, which will be done to make sure your hemogram, triglyceride and cholesterol levels are normal.
A pregnancy test for females will be done to check that you are not pregnant. If theses tests show that you are eligible to participate in the research study, you will begin the study treatment.
Other intervention name(s): topical rapamycin 1%
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)