bioihbjkbjnl/mcl2 huggingface dataset:
Proprioception and Meditation
Condition: Parkinson Disease; Proprioceptive Disorders; Movement Disorders
MeSH terms: Parkinson Disease; Movement Disorders; Somatosensory Disorders
Study type: Interventional

Summary: 
      In past work is has been shown that yoga can be as effective as a standard balance or Tai Chi
      protocol; however, there is an inability to distinguish between the mind and body
      contributions of yoga training. This study will compare an accepted proprioceptive training
      program to a meditation program which concentrates on body awareness in individuals with
      Parkinson's disease.
    


Intervention name(s): Yoga Meditation; Proprioceptive Drills
Intervention type(s): Other; Other
Intervention description(s): Yoga meditation using motor imagery to perceive movement patterns; Active balance and proprioception drills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers
Condition: Drug Drug Interactions; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This Study evaluates the possible drug interaction between FosD and verapamil when taken
      together.
    

Detailed description: 
      An Open-label, Single-Centre Study to Assess the Pharmacokinetics of R406 in Healthy
      Volunteers when Fostamatinib Disodium 150 mg is Administered Alone and in Combination with
      Verapamil.
    

Intervention name(s): FOSTAMATIN; Verapamil
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets - single dose; Oral tablets - administered 3 times daily over 4 days
Intervention MeSH terms: Verapamil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; FosD; fostamatinib disodium; verapamil; healthy volunteers
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)
Condition: Hypertriglyceridemia; Familial Chylomicronemia
MeSH terms: Hyperlipoproteinemia Type I; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and
      in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS).
    


Intervention name(s): ARO-APOC3; sterile normal saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): single or multiple doses of ARO-APOC3 by subcutaneous (sc) injections; calculated volume to match active treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acceptability and Feasibility of Apollo in Veterans With a History of PTSD
Condition: PTSD
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed investigation is an open label pilot study intended to establish the
      acceptability and feasibility of the Apollo in a population of Veterans. Exploratory data
      regarding biological signatures will also be collected.
    

Detailed description: 
      Evaluation of Apollo requires a stepwise process in which initial aims are geared towards
      identifying biological signatures versus diagnosing, treating, mitigating or curing any
      conditions. Towards the end of identifying potential biological signatures, we hypothesize
      the following. 1) Participants who use the Apollo will have an attenuated physiological
      stress response as measured by improved heart rate variability (HRV) compared to baseline. 2)
      Participants who use Apollo will have attenuated perceived psychological stress measured by
      lower scores on psychological correlates of acute stress when compared to baseline
    

Intervention name(s): Apollo Wearable System
Intervention type(s): Device
Intervention description(s): Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phone. Participants will use the Apollo for at least 30 minutes after waking up in the morning and at least 30 minutes before bed on the corresponding settings for those times of day. They will be given the Apollo Device TVS (10-200 Hz) to borrow which they will be instructed to wear for 6 +/- 2 weeks. They will be asked to continue to wear the device until all study data is collected.
Intervention model: Single Group Assignment
Intervention model description: Apollo Wearable System
Masking: None (Open Label)
Primary purpose: Other
Keywords: Stress; Heart Rate Variability; Microbiome
A Coaching Intervention to Young Adults With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The treatment burden for patients with cystic fibrosis (CF) is significant and poor adherence
      has been well-documented. The investigators hypothesize that a coaching intervention will
      empower young adults with CF to manage their lives with CF and improve health-related quality
      of life (HRQoL). The main aim of the study is to establish the feasibility and acceptability
      of a life-coaching intervention.
    


Intervention name(s): Coaching
Intervention type(s): Behavioral
Intervention description(s): Coaching is based on the principles of the Co-active coaching model and performed by a certified coach. At the first coaching session the coach and client will make an agreement about the format for subsequent coaching sessions. The first and the last coaching session will always be "face to face" at the hospital and last 1- 1½ hours. Intervening coaching sessions will be approximately 60 minutes by phone or face to face. In total, ten coaching sessions will be offered, one every 1-2 weeks early in the program and one every 2-4 weeks later in the process. The duration of the coaching intervention will be between 6 and 9 months.
Other intervention name(s): Life coaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Feasibility study; Coaching; Health related quality of life; Adherence
An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain
Condition: Cancer Pain
MeSH terms: Cancer Pain
Study type: Observational

Summary: 
      An open-label, single arm, observation study, to assess the efficacy and safety of
      proportional doses of Painkyl® in patients with breakthrough cancer pain.
    


Intervention name(s): Fentanyl Buccal Soluble Film
Intervention type(s): Drug
Intervention description(s): Eligible patients will receive Painkyl® for dose of 200, 400, 600, 800, 1000 or 1200 mcg for the treatment of breakthrough pain according to around-the-clock morphine daily dose.
Intervention MeSH terms: Fentanyl
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult cancer patients experienced breakthrough pain even under around-the-clock narcotic
        drug treatment.
Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement
Condition: Pain, Postoperative; Arthropathy of Knee Joint
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25%
      bupivacaine for controlling pain after total knee replacement to improve the quality of
      post-operative care.
    

Detailed description: 
      Compare post operative pain control after total knee replacement by periarticular injection
      with 0.25% bupivacaine compare with 0.9% normal saline.
    

Intervention name(s): 0.25% Bupivacaine; 0.9% normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.; Periarticular injection with 20 ml of 0.9% normal saline before wound closure.
Other intervention name(s): Marcaine; Isotonic saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post operative pain; Total knee replacement; Total knee arthroplasty; Bupivacaine; Periarticular injection; Placebo; Morphine consumption
Comparison of Three Combination Chemotherapy Regimens in Treating Women With Stage I or Stage II Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

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.

      PURPOSE: This randomized phase II trial is studying three regimens of combination
      chemotherapy to compare how well they work in treating women with stage I or stage II breast
      cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of vinorelbine/epirubicin and vinorelbine/mitoxantrone in terms
           of clinical objective tumor response, clinical complete remission, and pathological
           complete remission in women with early stage breast cancer.

        -  Compare the efficacy of these 2 new regimens with an established regimen of
           cyclophosphamide/doxorubicin in a randomly selected control group of patients.

        -  Compare the toxicity and side effects of these 2 new regimens in these patients.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to center and age (under 50 vs 50 and over). Patients are randomized to one of
      three treatment arms.

        -  Arm I: Patients receive vinorelbine IV on days 1 and 8 and epirubicin IV on day 1.

        -  Arm II: Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 1.

        -  Arm III: Patients receive doxorubicin IV and cyclophosphamide IV on day 1. Treatment
           continues every 3 weeks for 6 courses in the absence of unacceptable toxicity or disease
           progression. All patients except those who are under 50 and whose tumors are estrogen
           receptor negative receive oral adjuvant tamoxifen daily in addition to chemotherapy.

      All patients are offered surgery following completion of chemotherapy. Radiotherapy begins
      within 4 weeks of completion of chemotherapy or surgery, whichever is the immediately
      preceding treatment.

      Patients are followed every 3 months for the first 2 years, every 6 months for the next 3
      years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 62-125 patients will be accrued for this study within 12-18
      months.
    

Intervention name(s): cyclophosphamide; doxorubicin hydrochloride; epirubicin hydrochloride; mitoxantrone hydrochloride; vinorelbine tartrate; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Vinorelbine; Epirubicin; Mitoxantrone
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I breast cancer; stage II breast cancer
Intensive Outpatient Services for Teens
Condition: Depression; Suicide
MeSH terms: Suicide
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will identify the effectiveness of an intensive treatment program for teens who
      are at high risk for harming themselves.
    

Detailed description: 
      Suicidal ideation and behavior are the primary reasons for emergency psychiatric care and
      inpatient psychiatric hospitalization in this country. These expensive contacts with the
      health care system effectively address acute suicidality for many adolescents but there is a
      significant subset of suicidal patients that have continued suicidality. This study will
      target teens that are at risk for re-hospitalization based on continued suicidal ideation,
      their mood and another risk factor such as self-harm or substance use. These risk factors
      have been shown to increase risk for continued suicidal behavior and expensive contacts with
      the health care system. This protocol has been designed to determine whether Intensive
      Cognitive Behavioral Therapy (CBT), which was designed to treat adolescents with a mood
      disorder, suicidal ideation, and substance use, will result in better treatment outcomes
      compared to standard care in the community. The Intensive CBT condition will be delivered by
      a team of two licensed mental health therapists over the course of one year and will work
      with both the teen and parent. The standard care condition will receive treatment in the
      community. One hundred-and fifty adolescents (38 a year) will be recruited from several
      inpatient and partial hospital locations. Each adolescent will receive a thorough baseline
      assessment to determine whether they are appropriate for the study and will be assigned to
      either the Intensive CBT condition or treatment within the community. Both groups of teens
      will receive follow-up assessments at 6, 12, and 18 months to identify how they are doing
      over time.
    

Intervention name(s): Intensive Outpatient CBT; Standard Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year.; Treatment at step-down facilities
Other intervention name(s): Intensive CBT for High Risk Teens with a mood disorder; Treatment as Usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Suicide Attempt; Suicidal Ideation; NSSI; Substance Use
Cognition in Breast Cancer Patients: The Impact of Cancer-related Stress
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The study will investigate the impact of cancer-related stress and its consequences (acute
      and posttraumatic stress symptoms, altered cortisol secretion) on cognitive function in
      breast cancer patients. The hypothesis that stress associated with the cancer diagnosis and
      the cancer treatment is a major cause of cognitive dysfunction in breast cancer patients
      shall be evaluated.
    

Detailed description: 
      Primary hypothesis:

      *The adverse effects of cancer and cancer therapy on cognitive function in breast cancer
      patients are entirely or partly mediated by stress and the ensuing dysfunction of the
      HPA-axis.

      Secondary objectives:

        -  Determining the effect of cancer diagnosis, chemotherapy, disease-related stress, acute
           stress response, posttraumatic stress disorder, posttraumatic stress symptoms, anxiety,
           and depression on the HPA-axis in breast cancer patients

        -  Determining the effect of cognitive dysfunction assessed with neuropsychological tests,
           cancer diagnosis, chemotherapy, disease-related stress, acute stress response,
           posttraumatic stress disorder, posttraumatic stress symptoms, anxiety, and depression on
           subjective cognitive function in breast cancer patients

        -  Prevalence of acute stress response, posttraumatic stress disorder and posttraumatic
           stress symptoms, and extent of cancer-specific stress in breast cancer patients treated
           with or without chemotherapy
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of the Ludwig Maximilian University of Munich Breast Cancer Center; Klinikum
        Landshut Department of Obstetrics and Gynecology and Breast Cancer Services; Kreisklinik
        Ebersberg Department of Gynecology and Obstetrics; Klinikum Dritter Orden Department of
        Gynecology and Obstetrics; Rotkreuzklinikum Muenchen Department of Gynecology and
        Obstetrics, Helios Amper Hospital Dachau, Department of Gynecology and Obstetrics
      
Biospecimen description: 
      Saliva
    
Keywords: chemotherapy, adjuvant; adverse effects; breast neoplasms; cognition disorders; Stress Disorders, post-traumatic; cortisol
VR for Pediatric Burn Dressing Changes
Condition: Pain; Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing
      pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR
      participants played the game, passive VR group were immersed in the same VR without
      interactions, and a standard care group served as the control. One researcher administered VR
      and observed pain while another researcher administered post-trial survey that measured
      child's perceived pain and VR experience. Nurses were asked to report the clinical utility.
    


Intervention name(s): Virtual reality game as adjunctive pain management tool
Intervention type(s): Other
Intervention description(s): A smart phone virtual reality-based pain alleviation tool (VR-PAT).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective, three-group between subject randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Burns; Pain; Virtual Reality
Effect of PDRN in Post-operative Scars
Condition: Scar
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aimed to evaluate the efficacy of PDRN administration in early wound
      healing phase on prevention of post-operative scars after open thyroidectomy.
    


Intervention name(s): Polydeoxyribonucleotide (PDRN)
Intervention type(s): Procedure
Intervention description(s): A total 1mL of PDRN was injected along the suture line at distance of 1cm in one day and two days after the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety and Efficacy Study of RT001 to Treat Moderate to Severe Lateral Canthal Lines
Condition: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a single administration
      of RT001 compared to placebo gel for the treatment of moderate to severe lateral canthal
      lines.
    

Detailed description: 
      This is a double-blind, randomized, parallel-group, controlled, multi-center study to
      evaluate the efficacy and safety of a single administration of RT001 compared to placebo
      applied as a bilateral application in at least 72 subjects with moderate to severe Lateral
      Canthal Lines. Subjects will be randomized within each site to 1 of 2 treatment groups in a
      1:1 ratio. The efficacy and safety of RT001 compared to placebo will be evaluated. Study
      follow-up visits will occur at Weeks 2, 4 and 6.
    

Intervention name(s): Botulinum Toxin Type A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RT001 (Botulinum Toxin Type A Topical Gel) Dose D applied topically at Baseline (Day 0) to the lateral canthal lines; Placebo (Dose E) applied topically at Baseline (Day 0) to the lateral canthal lines
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lateral Canthal Lines; Crow's Feet; Facial Wrinkles
A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI)
      and compared to the combination of AZT and ddI as determined by survival and disease
      progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus
      ddI in symptomatic HIV infected children; to compare the virological and immunological
      parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS
      in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect.
      Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment,
      but later have progression of the disease. Thus, new drug treatments are needed. Studies of
      ddI in adults and children indicate some effectiveness of the drug. A direct comparison of
      AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT
      plus ddI) may give added therapeutic benefit to children.
    

Detailed description: 
      AZT has been shown to delay the progression of AIDS in HIV infected individuals. However,
      bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes
      occurs in patients who initially respond to treatment, but later have progression of the
      disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate
      some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has
      not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic
      benefit to children.

      Patients are placed by random selection into one of three groups to receive either AZT alone,
      ddI alone, or AZT and ddI. This is a double-blind study: neither patient nor treating
      physician knows which group patient is in. If patients are receiving either AZT or ddI alone
      and they develop drug toxicity (after dose reduction), or if HIV disease progresses, the
      alternative single drug is offered. If patients receiving both drugs develop drug toxicity
      (despite dose reduction) or if HIV disease progresses, they discontinue study drug and are
      offered the best alternative therapy. PER AMENDMENT 6/26/95: Initial monotherapy AZT arm is
      unblinded and no further crossover therapy for any arm is permitted. Patients who reach
      crossover criteria on initial blinded ddI or AZT+ddI will be unblinded and permanently
      discontinued from study drugs.
    

Intervention name(s): Zidovudine; Didanosine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Zidovudine; Didanosine
Masking: Double
Primary purpose: Treatment
Keywords: Didanosine; Drug Evaluation; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine