bioihbjkbjnl/mcl2 huggingface dataset:
Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorders
MeSH terms: Dyssomnias; Parasomnias; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to obtain data investigating the safety and efficacy of
      eszopiclone for the treatment of post-traumatic stress disorder (PTSD)-related sleep
      disturbance and the impact of improved sleep with eszopiclone treatment on neuroendocrine
      correlates of PTSD. The investigators hypothesize that eszopiclone will be significantly more
      effective than placebo and well tolerated for PTSD-related sleep disturbance, improvement in
      sleep will be associated with improvement in overall PTSD symptoms, and patients with
      PTSD-related sleep disturbances will have abnormal levels of stress hormones.
    

Detailed description: 
      Post-traumatic stress disorder (PTSD) is characterized by three symptom groupings:
      re-experiencing symptoms including flashbacks, nightmares, and intrusive memories;
      physiological hyperarousal; and avoidance symptoms. Of the three major categories of symptoms
      in PTSD listed by the Diagnostic and Statistical Manual of Mental Disorders, sleep-related
      problems are listed in two of them: difficulty falling asleep is considered an aspect of
      hyperarousal symptoms, and nightmares are a type of re-experiencing symptom. Both are found
      commonly in PTSD. Little is known about the relationship of neuroendocrine dysregulation in
      PTSD and sleep disturbance. It is possible that successful treatment of sleep disturbance in
      PTSD may alter an abnormal stress hormone pattern. The novel cyclopyrrolone hypnotic
      eszopiclone thus presents an intriguing opportunity to examine the treatment of sleep
      disturbances and nightmares in PTSD. This study will determine the safety, efficacy and
      impact on neuroendocrine parameters of eszopiclone compared to placebo for sleep disturbance
      and overall PTSD symptoms in individuals with PTSD and reported sleep disturbance.
    

Intervention name(s): Eszopiclone
Intervention type(s): Drug
Intervention description(s): The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Sleep disturbance; Eszopiclone; Double-blind; Crossover
Tension-free-vaginal-tape-obturator (TVTO) Versus Tension-free-vaginal-tape-Secur (TVTS) for Treatment of SUI
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Observational

Summary: 
      Women with urinary stress incontinence who underwent surgical treatment by either TVTO or
      TVTS will be enrolled. The investigators will collect data from charts and use a telephone
      questionnaire to check the outcome of these women. Physical examination findings will also be
      incorporated.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with stress urinary incontinence who underwent surgery, by TVT methos, either TVTO or
        TVTS.
      
Keywords: Urinary stress incontinence; TVT
Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment
Condition: Sleep Apnea Syndrome; Malocclusion
MeSH terms: Malocclusion; Sleep Apnea Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The
      consequences of these features can include deviation of normal craniofacial growth such that
      this may result in a facial morphology more suitable to the development of sleep apnea later
      in life. The aim of this study was to compare the growth redirection, the evolution of
      respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils
      from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new
      protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and
      proper tongue positioning on swallowing , that together may be helpful on remodeling the
      upper airways.
    

Detailed description: 
      Methods-The study population included 40 children, ranging in age from 6 to 9 years old, who
      were on the waiting list for adenotonsillectomy at the ENT Department of FMUSP. The patients
      were randomly divided into two groups and were subsequently compared after a six month
      interval. The first group included 24 patients who where treated with the Bioajusta X
      appliance and the second group included 16 patients who served as controls, and,thus, did not
      received any treatment. Cephalometric analysis was used to assess the growth direction by
      comparing the relationship of the vertical jaw based upon the angle of the palatal plane with
      the mandibular plane (ANS-PNS/Go-M).Pharyngeal size was measured using acoustic
      pharyngometry. The parents filled out a questionnaire with respect to the respiratory
      symptoms of their children.
    

Intervention name(s): Bioajusta X Orthodontic treatment
Intervention type(s): Device
Intervention description(s): Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship
Other intervention name(s): Oral appliance; Orthodontic Treatment; Orofacial Orthopedics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Apnea Syndrome; Orthodontics; Tonsillectomy; Child
Temozolomide in Treating Patients With Low-Grade Glioma
Condition: CNS Tumor, Adult
MeSH terms: Glioma; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well temozolomide works in treating patients
      with supratentorial low-grade glioma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of temozolomide, defined as response rate (complete and partial
           response), in patients with supratentorial mixed low-grade glioma.

      Secondary

        -  Assess the safety profile of temozolomide in patients with supratentorial low-grade
           glioma.

        -  Assess the time to tumor progression in patients treated with temozolomide.

      OUTLINE: Patients receive oral temozolomide once daily on days 1-5. Treatment repeats every
      28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed every 3 months for 1 year, every 4
      months for 1 year, every 6 months for 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
    

Intervention name(s): temozolomide
Intervention type(s): Drug
Intervention description(s): Chemotherapy
Other intervention name(s): Temodar
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult oligodendroglioma; adult mixed glioma; adult diffuse astrocytoma; adult pilocytic astrocytoma; adult pineal gland astrocytoma
Study of Fibrinogen Metabolism During Severe Trauma and Burns
Condition: Burn Injury; Major Trauma
MeSH terms: Wounds and Injuries; Burns
Study type: Observational

Summary: 
      To study the fibrinogen metabolic changes in relation to coagulation disorder in patients
      with severe burns and trauma injuries. As a result of the burn or trauma injury breakdown of
      fibrinogen is accelerated.
    

Detailed description: 
      In this protocol, we will investigate fibrinogen metabolism in burn and trauma patients,
      using an 8h infusion of stable isotopes labeled amino acids (1-13C-phenylalanine,
      2H5-phenylalanine, and 2H3-ketoisocaporate). The increase of the labeled amino acids
      incorporating into fibrinogen during the infusion and the decay of labeled fibrinogen after
      stopping the isotopes infusion (as measured by GC-MS) will be used to calculate fibrinogen
      synthesis and degradation. Stable isotopes are non-radioactive.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Burn patients Trauma patients Healthy Volunteers
      
Keywords: fibrinogen; burns; trauma; metabolism
Safety and Efficacy Study of Fentanyl Buccal Tablet Use in the Emergency Department for Isolated Extremity Injury
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate fentanyl buccal tablet (FBT) for analgesia
      in comparison to standard analgesia, to determine if the FBT allows for faster achievement of
      "significant analgesia"
    

Detailed description: 
      The subjects/patients will be asked if they would desire a low dose or high dose pain
      medication regimen. The low dose (low-FBT) group will receive FBT at a dose of 100 mcg, as
      well as an oral (pill) placebo preparation. The low dose (low-control) group will receive an
      "inactive comparator" (lansoprazole rapidly-dissolving buccal 15mg, " FBT placebo") and a
      dose of 5/325 Percocet tablet (oxycodone/acetaminophen 5/325). The high dose (high-FBT) group
      will receive 200 mcg FBT plus 2 placebo tablets. The high dose (high-control) group will
      receive the "FBT placebo" and a dose of 2, 5/325 Percocet tablets.
    

Intervention name(s): Fentanyl; Fentanyl; Oxycodone/acetaminophen; oxycodone/acetaminophen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fentanyl buccal tablet 100 mcg once; Fentanyl buccal tablet 200 mcg once; Oxycodone/acetaminophen 5/325 mg once; Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time
Other intervention name(s): Fentora 100 mcg buccal tablet; Fentora buccal tablet 200 mcg; Percocet 5/325; Percocet 5/325
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Fentanyl; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Fentanyl buccal tablet
Better Memory With Literacy Acquisition Later in Life
Condition: Memory Impairment
Study type: Interventional

Summary: 
      This study aims to discover whether acquiring basic-literacy in adulthood can improve
      episodic memory and brain structural and functional connectivity. In a collaborative project
      between Brazil and USA, the investigators will use a randomized controlled trial approach to
      leverage the level of evidence of the benefits of basic adult-education as a possible
      cognitive reserve builder. If successful, the study's findings will be important in shaping
      policies targeting increasing access to late-life education to reduce dementia risk.
    


Intervention name(s): Literacy training; Non-Literacy training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Teaching adults how to read and write using the analytical and phonemic method; Attending classes in geography, history, sciences, without receiving the specific training in literacy
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Clinical Study Trial of Phenlarmide in China
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To evaluate the tolerance and safety of FLA tablets in healthy volunteers.

        2. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers.

        3. Provide basis for dosage setting for follow-up clinical research.
    


Intervention name(s): Phenlarmide Tablets; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.; Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.
Other intervention name(s): FLZ; FLZ-Placebos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Tolerance; Safety; Pharmacokinetic characteristics
Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective:

      To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with
      the combination chemotherapy of Eloxatin+5-FU/LV

      Secondary objective:

      To evaluate time to progression, 6month survival, overall survival, safety and tolerability
      of patients with hepatocellular carcinoma treated with the combination chemotherapy of
      Eloxatin+5-FU/LV
    


Intervention name(s): Oxaliplatin; Fluorouracil; Leucovorin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks; 400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks; 200mg/m², Day 1 and Day 2; Every 2 weeks
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intervention Study to Control High Blood Pressure for Korean American
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The primary objective of the proposed clinical trials is to compare the differential
      reduction in blood pressure in underserved hypertensive adult Korean American. The study is
      designed to test the effectiveness of a comprehensive self-help intervention program.
    

Detailed description: 
      CVD is the leading cause of mortality among KA. Recent statistics underscoring the high
      prevalence and impact of uncontrolled HBP upon this population warrant the development and
      implementation of effective intervention. KA experiences a great deal of social isolation,
      which makes it more difficult for them to make behavioral changes for health improvement.
      individual, family, and community behaviors are part of the HBP problem and also constitute
      major part of the solution. The proposed research is designed to investigate these issues in
      a KA population and to lay the groundwork for community-based self-help health education
      interventions to enhance appropriate care and BP control.

      Comparison(s):This community-based self-help intervention approach offers a more culturally
      appropriate approach to closing the health status gap for KA. Incorporating a partnership
      with community leaders and health and human service care providers, this approach will
      utilize state-of-the-art health education strategies and a well-trained bilingual nurse from
      the community.
    

Intervention name(s): Self-Help Intervention Program-High Blood Pressure
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Open Label Extension of LipoLat-CS202
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      This is an open-label, observational extension of patients who received POLAT-001 in
      LipoLat-CS202.
    


Intervention name(s): Observation only
Intervention type(s): Other
Intervention description(s): No intervention in this study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were randomized to received POLAT-001 and successfully completed LipoLat-CS202
Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the
      pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS)
      patients.
    

Detailed description: 
      This study will be performed in patients with shoulder pain due to excess of nociception
      associated with chronic Myofascial Pain Syndrome in asymmetrical unilateral trapezius muscle
      trigger points.

      Patients will be randomly assigned to two treatment arms: Active (A) (n=20) and Sham (S)
      (n=21). Group A will receive actual treatment with trigger point dry needling. Group S will
      receive a sham treatment, with the needle inserted superficially in the skin, without
      reaching the muscle underneath it.

      The duration and pain elicited during active and sham dry needling will be controlled for.
      Patients will be evaluated one week before needling (D-7), on the day of dry needling (D0)
      and seven days after the procedure (D+7).

      Patients will fill out the Brazilian version of the Douleur Neuropathique 4, Beck Depression
      Inventory, Brief Pain Inventory (BPI), McGill Pain Questionnaire-SF (SFMPQ), Hospital Anxiety
      and Depression Scale and Global Impression of Change, and also a 14-day Carnet to more
      accurately evaluate their daily pain before and after the treatment.

      For the evaluation of neurologic changes, we will evaluate local hyperalgesia, tactile,
      mechanical, static and thermal sensitivity with thermal quantitative sensorial testing (TQS),
      and also mapping of the painful area, before and after treatment in both D0 and D+7.
    

Intervention name(s): Dry needling; acupuncture needle 0,25 x 40mm
Intervention type(s): Procedure; Device
Intervention description(s): Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Myofascial Pain Syndrome; Dry needling; Clinical Trial
Study To Assess The Efficacy And Safety Of The Medical Device Iracross Versus Iraline Administered Intra-Articular To Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Comparison with a non-inferiority design at 12 and 24 weeks on a larger scale is real to
      objectively evaluate the composite measurement of ROM, pain and basic activities like walking
      or performing daily activities (QoL) in a population with a large coverage of age and levels
      of physical activity (from no physical activity history to athletes).
    

Detailed description: 
      After giving their consent, subjects will undergo a screening visit to determine eligibility
      for study entry. After randomization, subjects will have administered medical device Iracross
      or Iraline. For subjects allocated to Iracross, medical device will be administered only at
      first visit and for subjects allocated to Iraline, medical device will be administered at
      visit 1, visit,2, visit 3 and optional for visit 4 and visit 5.
    

Intervention name(s): Iracross; Iraline
Intervention type(s): Device; Device
Intervention description(s): Administration of max 2ml of Iracross at first visit; Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, controlled, open label, multicentre study with two parallel groups of patients and a non-inferiority hypothesis.
Masking: None (Open Label)
Primary purpose: Treatment
Autologous Bone Marrow Derived Stem Cells in Decompensate Cirrhotic Patients
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Liver cirrhosis (LC) is the final outcome for chronic liver diseases. The liver
      transplantation is the sole effective therapy available to these patients. However, limited
      number of donors, post surgical complications, immunological rejection, and financial
      consideration are it's crucial problems. The plasticity of stem cells in bone marrow (BM) to
      differentiate into Hepatocyte cells was recently confirmed, and several clinical studies have
      applied BMC injection to induce regeneration of myocardium and blood vessels. In this study,
      the investigators will study safety and feasibility of twice transplantation of Autologous
      bone derived marrow mono nuclear (BM-MNC) and enriched CD133+ hematopoietic stem cell through
      the portal vein in patients with decompensate cirrhosis.
    

Detailed description: 
      BM Aspiration will be done twice (3months interval) from the iliac crest according to
      standard procedures under general anesthesia and is collected (200ML) in plastic bags
      containing anti coagulant. After precipitation of red blood cells, mononuclear cells will be
      collected by centrifugation in Ficoll-Paque density gradient. For separation of CD133+ cells
      the CliniMACS instrument will be used. Cells are injected twice (3months interval) via portal
      vein under sonography monitoring. After cell therapy, patients are followed up every week for
      6 months, and laboratory data are analyzed for 6 months
    

Intervention name(s): MNC; CD133; Control
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2-3 X 109 cells in 20ML suspension IPV in 4 min; 5-15 X 106 cells in 20ML suspension IPV; Injection of 20 ml Normal saline via IPV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cirrhotic; Stem Cells; Bone marrow stem cells; Decompensate Cirrhotic Patients