bioihbjkbjnl/mcl2 huggingface dataset:
Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Subacromial pain catheters have been used with uncertain efficacy for many years after
      rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that
      postoperative subacromial continuous infusion bupivacaine catheters will provide no pain
      control benefits over placebo infusions or no catheter use.
    

Detailed description: 
      This will be a prospective, randomized, double-blinded placebo controlled study.
      Randomization will be performed by a random numbers table. Envelopes will be sealed with the
      accompanying randomization group.Patients will be eligible for inclusion in the study if they
      have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI.
      They will be included in the study if they are medically stable to undergo the surgery and
      consent to involvement in the study.

      Patients consenting to the study will undergo arthroscopic rotator cuff repair by one of the
      two senior authors. The surgery will be performed as an outpatient procedure under general
      anesthesia. The procedure will be performed utilizing the standard techniques of the senior
      authors. All concomitant pathology found at the time of arthroscopy will be treated in the
      usual appropriate fashion. At the completion of the rotator cuff repair, patients will be
      randomly allocated to one of three groups. This will be done by opening a sealed envelope
      with the randomization allocation. The patients will either be placed into the study group,
      the placebo group or the control group.
    

Intervention name(s): 0.5% bupivacaine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The bupivacaine will have an infusion rate of 4cc an hour.; The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.
Other intervention name(s): Marcaine; Saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of REMD-477 in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus; Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, placebo-controlled, double-blind, dose escalation study to evaluate
      safety, tolerability, PK and PD of single and repeated SC doses of REMD-477 in Type 2
      diabetic subjects. The study will be conducted at multiple sites in the United States and
      will enroll approximately 102 subjects with Type 2 diabetes who are either treatment-naïve,
      controlled with diet and exercise or treated with oral antidiabetic medications.
    

Detailed description: 
      The study will consist of three parts: Part A - Dose Escalation, Part B - Adaptive Dose
      Cohort, and Part C - REMD-477 in Combination with Metformin. Part A includes 5 cohorts that
      will be enrolled and dosed sequentially at escalating doses. Each cohort will consist of 12
      subjects randomized in a 3:1 (active: placebo) fashion. Part B includes a single dose cohort
      that will enroll 12 subjects (9 on active treatment and 3 on placebo) with dose level and
      frequency determined by a Dose Level Review Meeting (DLRM)Committee. Part C includes 2
      cohorts of T2DM patients currently treated with metformin alone, and each cohort will consist
      of 15 subjects (10 on active treatment and 3 on placebo).
    

Intervention name(s): REMD-477
Intervention type(s): Biological
Intervention MeSH terms: Volagidemab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Arterial Revascularization Therapies Study Part II.
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective is to compare the effectiveness of coronary stent implantation using the
      sirolimus-eluting Bx VELOCITY™ balloon expandable stent with that of surgery as observed in
      ARTS I. Effectiveness is measured in terms of Major Cardiac and Cerebrovascular Events
      (MACCE) free survival at 1 year.
    

Detailed description: 
      ARTS II is a multicenter, European, open-label, non-randomized, stratified trial in about
      45-50 centers which will include six hundred eligible patients with multivessel disease who
      should be equally treatable by surgery or stenting. In all patients the sirolimus-eluting Bx
      VELOCITY™ balloon expandable stent of Cordis will be used for treatment.The results of ARTS
      II will be compared with the by-pass arm of ARTS I as the historical control. It is
      hypothesized that a similar or higher number of lesions will be treated by stenting. We
      assume that the use of this eluting stent will not only reduce the rate of MACCE at 30 days,
      but that it will considerably reduce the need for re-intervention, which was historically
      21.0% in ARTS I.
    

Intervention name(s): drug-eluting stent
Intervention type(s): Device
Intervention description(s): Cypher Sirolimus-eluting Coronary stent
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Study to Evaluate Wound Healing
Condition: Wound Heal
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of
      the study medication compared with vehicle in subjects with incisional wounds
    

Detailed description: 
      This is primarily a safety study to evaluate the safety of AIV001 when administered near
      incisional wounds. Exploratory efficacy measures will also be collected as well as
      pharmacokinetic profiles.
    

Intervention name(s): AIV001
Intervention type(s): Drug
Intervention description(s): Intradermal injection
Other intervention name(s): AIV001 suspension
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Randomized, double-blind, vehicle-controlled, dose-escalation
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: wound healing
Effect of Loaded Functional Training on Hemiplegic Cerebral Palsy
Condition: Hemiplegic Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      weakness of lower limb is common in cp children
    


Intervention name(s): expermintal; CONTROL
Intervention type(s): Other; Other
Intervention description(s): progressive resistive functional strength training in the plantigrade foot position plus designed physical therapy program; Designed physical therapy program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Correlating Real and Virtual World Behavioral Fluctuations in Adolescence
Condition: Attention-Deficit and Hyperactivity Disorder; Anxiety; Disruptive Mood Dysregulation Disorder; Depression; Oppositional Defiant Disorder; Conduct
MeSH terms: Hyperkinesis; Depression; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders
Study type: Observational

Summary: 
      The present study will explore a new approach to ongoing evaluation and monitoring of
      fluctuations in personality traits via commercial video games. The aim of this longitudinal
      study is to examine the influence of everyday life event on video games performance as a
      function of individual differences in gaming behavioral patterns. focusing on the ongoing
      performance vacillations of the patient on commercial video games will offer insights in to
      possibly new generation of real time assessment medium of ongoing behavior.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male adolescents, 13-18, with and without psychopathology, evaluated and diagnosed by
        psychiatrists. Adolescents will be recruited from Shalvata MHC children and adolescents
        outpatient clinic and from convinience sample in the community.
      
Keywords: Attention-Deficit and Hyperactivity Disorder; Anxiety; Impulsivity; Computer Games; Depression
Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin
      and etoposide in participants with extensive disease small cell lung cancer (ED SCLC).
    

Detailed description: 
      This is a Phase 1, open-label, dose-escalation/Phase 2 randomized double-blind study of
      veliparib in combination with carboplatin and etoposide and maintenance veliparib
      monotherapy.

      Participants in Phase 1 will be sequentially assigned to ascending dose levels of veliparib
      in combination with standard carboplatin/etoposide regimen for up to four 21-day cycles based
      on the observed toxicities. The study design for Phase 1 will follow a traditional "3 + 3"
      dose-escalation protocol.

      Once the veliparib recommended Phase 2 dose (RPTD) and schedule is determined, enrollment
      into Phase 2 will begin. Participants from the Phase 1 dose-escalation portion of the study
      are not eligible for enrollment into the Phase 2 portion. Participants in Phase 2 will be
      randomized in a 1:1:1 ratio to carboplatin, etoposide, placebo followed by placebo
      maintenance (Arm C), or carboplatin, etoposide, veliparib followed by either veliparib (Arm
      A) or placebo (Arm B) maintenance. Randomization for Phase 2 will be stratified by baseline
      lactate dehydrogenase (LDH) level (> upper limit of normal [ULN] vs. ≤ ULN), and gender.
    

Intervention name(s): Veliparib; Carboplatin; Etoposide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules administered orally twice a day according to the dosing schedule.; Administered by intravenous infusion on Day 1 of each 21-day cycle over approximately 30 minutes at a target area under the curve (AUC) 5 mg/mL*minute.; Administered by intravenous infusion on Days 1 to 3 of every 21-day cycle over approximately 60 minutes at 100 mg/m².; Placebo to veliparib administered orally twice a day according to the dosing schedule.
Other intervention name(s): ABT-888; VP-16
Intervention MeSH terms: Carboplatin; Etoposide; Veliparib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Extensive Stage Smal Cell Lung Cancer; ABT-888; Veliparib; PARP - Poly (ADP) ribose polymerase
Substance Dependent Teens - Impact of Treating Depression Study 1 - 1
Condition: Alcohol-Related Disorders; Marijuana Abuse; Substance-Related Disorders
MeSH terms: Marijuana Abuse; Substance-Related Disorders; Alcohol-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the impact of treating depression on substance
      dependent teens.
    

Detailed description: 
      The primary study aim is to determine whether fluoxetine + CBT is a more effective treatment
      than placebo + CBT for substance outcomes, depression, and behavior problems. The current
      community standard of care often withholds pharmacotherapy for depression in substance
      abusing adolescents, since it is often assumed that their depressions may remit with SUD
      treatment alone. However, this is an untested hypothesis in adolescents and one that we
      propose to test in the current study.
    

Intervention name(s): Fluoxetine + outpatient cognitive behavioral therapy; fluoxetine; placebo + CBT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single fixed morning dose 20 mg X 15 weeks; 20mg, QD x 16 weeks; single fixed morning dose X 16 weeks
Other intervention name(s): Prozac; prozac
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol dependence; marijuana dependence
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to determine the safety and effectiveness of
      an experimental drug called rilonacept in subjects with gout who are on urate-lowering
      therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is
      being studied for use in preventing gout flares in subjects on urate-lowering therapy.
    


Intervention name(s): Rilonacept; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Rilonacept 160 mg subcutaneous injection once a week; Placebo subcutaneous injection once a week
Intervention MeSH terms: Rilonacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Metabolism, Inborn Errors; Allopurinol; Metabolic Disease; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Metabolic disorder; Purine Pyrimidine Metabolism, Inborn Errors; Gout; Intercritical Gout
Remote Simultaneous Medical Interpreting and Medical Outcomes
Condition: DIabetes
Study type: Interventional

Summary: 
      All new patients to the general medicine clinic who were not primarily English speaking were
      randomized, after consenting, to receieve either remote simultaneous medical interpreting or
      usual and customary interpreting services. Patient charts were followed for one year after
      enrollment to assess medical outcomes, including patient satisfaction, diabetes management,
      lipid management, depression screening and management, vaccine administration.

      All Spanish-speaking ER patients were similarly enrolled. They were followed for one ER visit
      and their knowledge of exit instructions was assessed, as well as their satisfaction with
      care.
    


Intervention name(s): remote simultaneous medical interpreting; usual and customary; ENglish speaking
Intervention type(s): Other; Other; Other
Intervention description(s): remote simultaneous medical interpretation; usual and customary interpreting; English speakers
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Immigrant; Interpreting
Sun Protection Factor - Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY 987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. formulation number SR15-39-Z12-002.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types
Condition: Ovarian Cysts
MeSH terms: Cysts; Ovarian Cysts
Study type: Interventional

Summary: 
      The aim of our study is to compare the effect of laparoscopic ovarian cystectomy on ovarian
      reserve in terms of different cyst types.
    

Detailed description: 
      Participants who will be treated surgically for ovarian cysts will be included in the study.
      Anti-Mullerian Hormone (AMH) levels of the participants will be investigated before the
      surgery and 6 months after the surgery. All surgeries will be performed under general
      anesthesia laparoscopically. After histopathological evaluation, the participants will be
      divided into three groups; Group 1: Endometrioma, Group 2: Mature cystic teratoma (Dermoid
      cyst) and Group 3: Serous or mucinous cystadenoma.

      A total of fifty-five women will be included in the study.
    

Intervention name(s): Laparoscopic cystectomy
Intervention type(s): Procedure
Intervention description(s): All surgeries will be performed under general anesthesia by laparoscopically.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian reserve; anti-mullerian hormone; ovarian cyst
Female LUTS and Quality of Life
Condition: Bladder Diary
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      Storage symptoms include frequency, urgency, nocturia and incontinence. Based on bladder
      diaries, we could get the objective data of the above symptoms. To the best of our knowledge,
      there is lack of correlation of quality of life with lower urinary tract symptoms based on
      bladder diaries. Thus, we aimed to perform the study.
    

Detailed description: 
      The bladder diaries and the King's Health Questionnaires of all consecutive women with lower
      urinary tract symptoms who visited urogynecologic clinics in a tertiary referral center, were
      reviewed. Based on bladder diaries, women with at least one episode of urgency and urinary
      incontinence (UI) were allocated to the overactive bladder syndrome (OAB) -wet group. Women
      with at least one episode of urgency but without incontinence were allocated to the OAB-dry
      group. Women with at least one episode of UI but without urgency were allocated to the UI
      group. Women with more or equal to 2 episodes of nocturia but without urgency and UI were
      allocated to the nocturia group. Women with more or equal to 8 episodes of daytime frequency
      but without urgency, UI and nocturia were allocated to the frequency group. Otherwise, normal
      group. Analysis of variance with Bonferroni correction was used to perform statistical
      analysis for between-group comparisons.
    

Intervention name(s): Bladder diary
Intervention type(s): Diagnostic Test
Intervention description(s): A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with lower urinary tract symptoms completed a 3-day bladder diary and King's Health
        Questionnaire.
      
Keywords: Lower urinary tract symptoms; Quality of life
Telemedicine Evaluation for Stem Cell Transplant Patients
Condition: Stem Cell Transplant Patients
Study type: Interventional

Summary: 
      Telemedicine is a new area of health care where medical information is transferred through
      audiovisual media, such as a computer or a video camera, for the purpose of remote doctor's
      visits or examinations. This new area of health care is important to test because it can
      potentially provide real-time interactions between the patient and their health care team,
      including phone conversations, online communication, and/or home visits. Many activities such
      as a history review or physical examination can be conducted virtually as compared to the
      traditional face-to face visits.

      The purpose of this study is to determine patient and health care team acceptance of a
      "virtual medical visit" as a substitute for a "face to face" visit for patients either
      preparing to receive a stem cell transplant or previously received a stem cell transplant.
    


Intervention name(s): virtual medical visit
Intervention type(s): Behavioral
Intervention description(s): At the pre-set time, the "Mobile Telehealth Cart" will be set up in the exam room or the clinic office, and a connection with the doctor will be made through their computer. The telemedicine visit will be conducted at the same time as the regular clinic visit. During the visit, the nurse will evaluate the physical symptoms, vital signs, past medical history, present medical history, and any side effects from the autologous or allogeneic transplant. The nurse will place a digital stethoscope on the chest to listen to the heart and lungs. The "virtual medical visit" will take about 25 minutes. At the end of the "Virtual Medical Visit," the patient will evaluate the event using a survey to assess the acceptance of the virtual visit. The surveys will be written and should take around 15 minutes to complete. The answers provided will be shared with the MD and nurses after the patient has completed all their "virtual medical visits."
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Telemedicine; Virtual Medical Visit; Quality of Life; 11-022
Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
Condition: Tonsillectomy
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 3

Summary: 
      To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of
      Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus
      Injection of Dexmedetomidine.
    


Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: tonsillectomy; emergence agitation
An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with
      Atopic Dermatitis
    

Detailed description: 
      This is an open-labeled exploratory study to evaluate safety and efficacy of FB825 in adults
      with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan.

      Approximately 12 subjects with atopic dermatitis (AD), who meet the criteria for study entry,
      will be enrolled to the one-arm-study.
    

Intervention name(s): FB825, FB825-15D11, Anti-CemX
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: 20mg/ml solution Route of administration: IV
Other intervention name(s): FB825-15D11, Lot # 16-2056
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment