bioihbjkbjnl/mcl2 huggingface dataset:
Phonosurgical Augmentation After Laser Resection of Early Glottic Carcinoma
Condition: Head and Neck Neoplasms; Head and Neck Squamous Cell Carcinoma; Voice Disorders; Laryngeal Cancer
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Laryngeal Neoplasms; Voice Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives: Transoral Laser Microsurgery (TLM) is widely used in for treating T1/T2 glottic
      cancers. Hyaluronic acid (HA) is a safe and commonly-used injectable in vocal cord
      augmentation. We report on the results of our single-blinded, randomized-controlled trial
      (RCT) investigating the impact of intra-operative HA injection on voice outcomes in early
      glottic cancer.

      Methods: Patients with T1/T2 glottic cancers were randomized to the treatment group (n=14)
      receiving HA injection to the unaffected cord during TLM; or the control group, receiving no
      injection (n=16). All patients had a Voice Handicap Index-10 (VHI-10) questionnaire and a
      Maximum Phonation Time (MPT) measurement preoperatively and at 3, 12 and 24 months
      post-operatively. Mean change in VHI-10 and MPT, between pre-operative and post-operative
      time points, and between the time points, were compared. Survival estimates were also
      calculated.
    


Intervention name(s): Hyaluronic acid; No Hyaluronic Acid Injection Injection
Intervention type(s): Drug; Other
Intervention description(s): Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.; Patients in the placebo group did not receive hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.
Other intervention name(s): Hyaluronic Acid Laryngoplasty
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Unstable Angina Pectoris Trial
Condition: Angina, Unstable; Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Angina, Unstable; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of medical or surgical (coronary artery bypass graft) therapy with
      regard to survival and quality of life in patients with unstable angina and requisite
      coronary anatomy as defined by angiography.
    

Detailed description: 
      BACKGROUND:

      Angina pectoris is a symptomatic condition of attacks of chest pain, often debilitating. It
      is caused by a decreased supply of blood to the heart, such as that which might occur in
      coronary artery disease. The usual treatment of angina pectoris is designed to relieve the
      symptoms. It includes avoidance of activities that produce the discomfort and the use of
      nitroglycerin and beta blocking drugs. Soon after the introduction of coronary bypass
      surgery, many doctors enthusiastically adopted this approach in treating patients with
      unstable angina.

      In 1972, emphasizing that there was no definitive evidence showing the superiority of
      intensive medical management or coronary bypass surgery in determining mortality and
      morbidity in patients hospitalized with unstable angina, some of the participating groups in
      the NHLBI Myocardial Infarction Research Units developed a cooperative clinical trial to
      compare these medical and surgical approaches to therapy.

      From 1972 through 1976, 288 patients were entered into this randomized clinical trial. One
      hundred forty-seven patients received intensive pharmacological medical therapy, and 141
      comparable patients underwent coronary artery bypass surgery. Careful follow-up studies were
      performed on patients in both groups, in-hospital and during the post-hospital phase. These
      studies included, apart from routine physical examinations, resting electrocardiograms, chest
      x-ray films, and grade exercise tolerance tests at six months and twelve months.

      DESIGN NARRATIVE:

      Randomized, non-blind, sequential design with a control group and an experimental group. The
      patients in the experimental group were treated with coronary bypass surgery. Patients in the
      control group received intensive medical management. Endpoints were mortality and morbidity
      measures, such as incidence of myocardial infarction and persistence of angina.
    

Intervention name(s): coronary artery bypass
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
Study Evaluating Biomarkers In Relapsed/Refractory Pediatric Solid Tumors
Condition: Adenocarcinoma; Neoplasms
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label, two-part study of temsirolimus given as a 60-minute intravenous (IV)
      infusion once weekly to pediatric subjects with advanced solid tumors.

      Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly
      to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or
      refractory to standard therapy or for whom standard therapy is not available. (enrollment
      completed) Part 2 will be conducted in three groups of children with refractory or relapsed
      pediatric solid tumors. Subjects with the following tumor types will be enrolled:
      neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV
      temsirolimus once weekly until disease progression or unacceptable toxicity. (recruiting)
    


Intervention name(s): Torisel
Intervention type(s): Drug
Intervention description(s): 60-minute intravenous (IV) infusion once weekly to pediatric subjects with advanced solid tumors. Part 1 is an ascending-dose study to evaluate the safety of IV temsirolimus given once weekly to subjects ages 1 to 21 years with advanced solid tumors disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. (enrollment completed) Part 2 will be conducted in three groups of children with refractory or relapsed pediatric solid tumors. Subjects with the following tumor types will be enrolled: neuroblastoma, rhabdomyosarcoma, and high-grade gliomas. Subjects will receive IV temsirolimus once weekly until disease progression or unacceptable toxicity.
Other intervention name(s): temsirolimus
Intervention MeSH terms: Temsirolimus
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Tumors
Reducing Teen Pregnancy in the Emergency Department
Condition: Reproductive Behavior; Sexual Behavior; Adolescent Behavior; Contraception
MeSH terms: Emergencies
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the feasibility, acceptability, and potential efficacy of an
      emergency department-based pregnancy prevention intervention targeting sexually active
      adolescent female emergency department patients.
    

Detailed description: 
      Emergency Departments (ED) care for 15 million adolescents each year. Adolescents who use the
      ED are at particularly high risk of unintended pregnancy. To date, no intervention has
      successfully increased contraception use among this high risk, hard-to-reach ED population.

      In this study, the investigators will conduct a pilot randomized controlled trial of a
      user-informed, theory-based, personalized, interactive, pregnancy prevention text messaging
      intervention (Dr. Erica) to determine its feasibility, acceptability and potential efficacy.
      The investigators hypothesize that high risk adolescent female ED patients who receive Dr.
      Erica will more often initiate contraceptives than those females who receive standard
      discharge instructions alone.

      At baseline and follow-up assessment at 3 months, participants will provide information
      regarding effective contraception initiation, any contraception at last intercourse, follow
      up with reproductive preventive health services, and contraception self-efficacy.
    

Intervention name(s): Dr. Erica
Intervention type(s): Behavioral
Intervention description(s): The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled trial with two arms
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: emergency medicine; reproductive health; sexual health; adolescent health; emergency department; text messaging; mobile health; digital health
Treatment Time-frame Guideline for Dry Needling in the Lower Limb
Condition: Trigger Points
Study type: Interventional

Summary: 
      This study evaluates the impact of treating myofascial trigger points with a single session
      of dry needling on maximal isometric strength in the short term. Two groups will receive dry
      needling in separate muscle groups and a third group will receive no dry needling.
    

Detailed description: 
      Dry needling is a effective treatment for myofascial trigger points. It is very common in a
      sporting environment. Strength is a key aspect of athletic performance. Despite the
      prevalence of dry needling within a sporting environment, the effects of dry needling on
      strength remains unknown.

      This study will investigate the effects of dry needling on maximal isometric strength with a
      view to informing clinical practice amongst clinicians working in the elite sport setting.
    

Intervention name(s): Dry needling
Intervention type(s): Procedure
Intervention description(s): Dry needling is an invasive procedure involving inserting acupuncture needles directly into trigger points within muscles. The needle is partially withdrawn and re-inserted repeatedly to maximally stimulate the muscle and it's fibers.
Other intervention name(s): Myofascial dry needling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants with latent trigger points in rectus femoris (RF) and gluteus maximus (GM) muscles will be stratified evenly into 3 groups (RF dry needling, GM dry needling or control) based on baseline strength. Treatment, data collection and data analysis of all participants will be conducted concurrently.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry needling; Strength; Latent trigger points
Study of LM11A-31-BHS in Mild-moderate AD Patients
Condition: Mild to Moderate Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety of 2 doses of LM11A-31-BHS in 180
      patients with Alzheimer's Disease versus placebo and to access biomarker and clinical
      exploratory endpoints of LM11A-31-BHS
    

Detailed description: 
      The goal of this AD Pilot is to conduct a prospective, double-blind, multicenter, phase IIa
      exploratory safety, feasibility and proof-of-concept trial in mild to moderate Alzheimer's
      disease patients with the orally bioavailable p75 neurotrophin receptor ligand LM11A-31-BHS
      dosed twice daily for 26 weeks. Successful completion of this trial will provide the safety,
      endpoint and statistical basis for the design and execution of a phase 2b/3 efficacy trial.
      It will also bring to the AD field a much-needed new set of target mechanisms and will help
      pioneer the strategy of the concomitant targeting of multiple fundamental AD-related
      pathological processes.

      During the 26 weeks study period the eligible patients will be invited to 5 visits.

      Safety monitoring will include the full extent of phase 2 clinical, electrophysiological and
      laboratory testing.
    

Intervention name(s): 400mg LM11A-31-BHS; 800mg LM11A-31-BHS; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 Oral Capsules (200mg of LM11A-31-BHS and 200mg of placebo) twice daily (morning & evening) for 26 weeks; 2 Oral Capsules (200mg of LM11A-31-BHS) twice daily (morning & evening) for 26 weeks; 2 Oral Capsules (200mg of Placebo) twice daily (morning & evening) for 26 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy of Transcranial Direct-Current Stimulation (tDCS) for Provoked Vestibulodynia : a Triple Blind Randomized Controlled Trial
Condition: Provoked Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      Provoked vestibulodynia (PVD) is the most common form of vulvodynia and despite its high
      prevalence and important sexual, conjugal and psychological deleterious repercussions,
      effective evidence-based interventions remain limited. For a high proportion of women,
      significant pain persists despite the currently available treatments. Transcranial
      direct-current stimulation (tDCS) was shown to be effective in various chronic pain
      conditions. So far, only one case report study has shown significant pain reduction in women
      with vulvodynia. The main goal of this randomized controlled trial is to evaluate the
      efficacy of tDCS in women with PVD compared to sham tDCS. Forty women diagnosed with PVD, by
      a gynecologist following a standardized protocol will be randomized to either active or sham
      tDCS for ten 20 minute sessions of 2 mA stimulation over a 2-week period. Outcome measures
      will be collected at baseline, after treatment and at 3-month follow-up. The primary outcome
      is pain during intercourse assessed with a numerical rating scale (NRS). Secondary
      measurements focus on sexual function, vestibular pain sensitivity, psychological distress,
      treatment satisfaction and Patient Global Impression of Change (PGIC). The investigators
      expect that active tDCS treatment will significantly reduce pain during intercourse
      (post-treatment and 3-month follow-up compared to pre-treatment assessment). This trial will
      provide important information for determining the efficacy of a novel and promising
      intervention for women with PVD.
    


Intervention name(s): Active tDCS or Sham tDCS
Intervention type(s): Device
Intervention description(s): tDCS is a painless technique which consists in applying low direct-current through electrodes (one electrode serving as an anode, the other as a cathode) placed on the scalp to target the cerebral cortex. In patients with chronic pain, the anode is commonly placed over the motor cortex (M1) (Valeriani et al., 1999).
Other intervention name(s): neuroConn; Model no: 0008; Serial no:0169
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS
Effective Maneuver for Post-laparoscopic Shoulder Pain
Condition: Gynecologic Diseases
MeSH terms: Shoulder Pain; Genital Diseases, Female
Study type: Interventional

Summary: 
      The aim of this clinical trial is to estimate the efficacy and safety of combined
      intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment
      maneuver for reducing post-laparoscopic shoulder pain.
    

Detailed description: 
      Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon
      dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary
      recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the
      efficacy and safety of combined intervention with normal saline instillation and pulmonary
      recruitment maneuver have not been investigated yet. The aim of this clinical trial is to
      estimate the effectiveness of combined intervention with the intra-peritoneal normal saline
      instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.
    

Intervention name(s): Passive Deflation; Normal Saline Instillation; Normal Saline Instillation + Pulmonary Recruitment
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): In the control group, residual carbon dioxide gas was evacuated by the routine method using passive exsufflation through the port site at the end of surgery.; In the normal saline instillation group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), isotonic normal saline (20 ml/kg of body weight) was infused in the sub-diaphragmatic region at the end of surgery.; In the combined intervention group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), and a pulmonary recruitment maneuver was performed after instillation of isotonic normal saline (20 ml/kg of body weight) in the sub-diaphragmatic region at the end of surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effects of Instrument-Applied Spinal Manipulative Therapy on Postureal Control and Autonomic Balance
Condition: Heart Rate
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of spinal manipulative therapy on
      autonomic balance and to determine if there exists a relationship between autonomic state and
      postural control.
    

Detailed description: 
      Previous studies have demonstrated that sensory and cognitive systems share some common
      neural substrate. The afferent neural impuleses of mechanoreception (also known as
      somatosensation) as produced by joint mechanoreceptors and adjacent muscle spindle cells may
      impact supraspinal centers. Few studies have been done to determine if the afferent impulses
      generated by spinal manipulative therapy (SMT) can impact the porcessing that occurs at
      supra-spinal centers. The relationship between postural control and cognition is studies
      using a dual-tak methodology, a primary (postural) task will often demonstrate degradation
      with the addition of a secondary, concurrent (cognitive) task. The current study seeks to
      determine the effects of SMT on postrual control using a dual-task paradigm, while monitoring
      autonomic state (using Heart Rate Variability analysis) during the course of therapy. It is
      thought that SMT can improve HRV status, and postural control within a dual-task situation,
      and that there will be differences in postural control related to a participant's HRV status.
      Activities of daily living often invole the coupling of a cognitive task with a complex
      postural task.
    

Intervention name(s): Instrument-applied spinal manipulative therapy
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
Condition: Asthma; Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a multi-center study to evaluate fractional exhaled nitric oxide (FeNO) measured with
      the Vivatmo pro in adult and pediatric subjects.
    

Detailed description: 
      Subjects will be screened, enrolled and tested at Study Visit #1 and then prescribed inhaled
      corticosteroid (ICS) treatment as per routine clinical care. Subjects will return for Study
      Visit #2 in two weeks and repeat fractional exhaled nitric oxide (FeNO) measured with the
      Vivatmo pro
    

Intervention name(s): Vivatmo pro FeNO Test
Intervention type(s): Diagnostic Test
Intervention description(s): Breath gas analysis
Other intervention name(s): Fractional exhaled nitric oxide (FeNo)
Intervention MeSH terms: Nitric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
: Intravascular Injection Rates During Cervical Medial Branch Block
Condition: Vascular Complications
Study type: Interventional

Summary: 
      The purpose of this study is to compare using Toughy needle has an advantage of reducing
      intravascular injection rates during cervical medial branch block.
    

Detailed description: 
      In previous reports, the use of Toughy needle was thought to reduce the incidence of
      intravascular injection as low as 2.9% during lumbar transforaminal injection.

      Blunt needles with a pencil point tip, such as Whitacre needles, are not as sharp at their
      tip as are Quincke needles, which have bevels. Toughy or blunt needles may therefore be less
      likely to penetrate a vessel during a procedure. Hence, we postulated the incidence of
      intravenous uptake would be significantly lower using a Toughy needle than using a Quincke
      needle for lumbar medial branch block. To confirm the intravascular injection rates, we used
      the real time fluoroscopy after injection of contrast medium.

      The goal of this study was to compare the incidence of intravascular injection rate betweeen
      Toughy and Quincke needles using real time fluoroscopy during cervical medial branch block
    

Intervention name(s): cervical spinal injection with 0.2% ropivacaine
Intervention type(s): Procedure
Intervention description(s): spinal injections performed in cervical pillar area to relieve chronic neck pain
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intravascular injection