bioihbjkbjnl/mcl2 huggingface dataset:
Carotid Stenting in Patients With High Risk Carotid Stenosis ("Soft Plaque")
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The
      intra and/or postprocedural cerebral embolization remains the most frequent complication.
      Thanks to the systematic use of cerebral protection systems, these complications have
      reduced.A debate concerning which cerebral protective device should be more effective is
      still ongoing.
    


Intervention name(s): carotid stenting with MOMA; Carotid stenting with filter wire EZ
Intervention type(s): Device; Device
Intervention description(s): The MOMA system is an endovascular catheter for proximal protection during carotid stenting. The system allows a concomitant balloon occlusion of both external and common carotid arteries leading to blood flow reversal within the internal carotid artery.; The filter wire EZ a distal protection system that is placed in he distal internal carotid artery before carotid stenting. The filter should entrap almost all the debries that are generated during endovascular procedure. At the end of the procedure the filter is retrieved throught a dedicated retrieval catheter.
Other intervention name(s): MOMA device (INVATEC RONCADELLE, BRESCIA - ITALY); Filterwire EZ - Boston Scientific
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: stenting; carotid plaque; stenosis; angioplasty
Recorded Maternal Voice on the Emergence of General Anesthesia on Pediatric Patients
Condition: Anesthesia, General
Study type: Interventional

Summary: 
      Mother spend a large amount of time with their children. It is assumed that mother
      contributes to their neurological development not only with visual stimuli, but also with
      auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response
      to the self-name being spoken by the mother than by a stranger. Therefore, investigators
      suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten
      the emergence from general anesthesia.
    


Intervention name(s): recorded maternal voice; recorded stranger's voice
Intervention type(s): Procedure; Procedure
Intervention description(s): A voice recording will be performed before the operation. At a preoperative visit or preoperative clinic, informed consent was obtained before the recording. On a calm environment, the mother was asked to speak following sentences.
" OO (first name of child), wake up~. Let's go home with mommy. OO, wake up~. Open your eyes. Take a deep breath. " At the end of surgery, the recorded maternal voice was delivered to the child every 15 seconds until he/she wakes up.; A voice recording will be performed before the operation. On a calm environment, a blinded female investigator was asked to speak following sentences.
" OO (first name of child), wake up~. Let's go home with mommy. OO, wake up~. Open your eyes. Take a deep breath. "
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: emergence delirium; emergence time; bispectral index
Does Meal Timing Affect Energy Expenditure
Condition: Meal Timing
Study type: Interventional

Summary: 
      The purpose of this study is to find out if meal timing affects calories burned and blood
      sugar levels.
    

Detailed description: 
      10 overweight adult men and women will eat according to two different eating schedules:
      grazing and time-restricting feeding ("early eating"). While on each eating schedule,
      metabolism (calories burned) will be measured during a 24-hour stay in a respiratory chamber.
      Glucose levels-as well as key diurnal rhythms such in heart rate-will also be measured
      continuously. This study requires two 1-week periods of participation.
    

Intervention name(s): Grazing; Time-restricted feeding (early eating)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Couples Therapy to Enhance Intimacy Between Patients With Advanced or Recurrent Prostate Cancer and Their Partners
Condition: Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment; Sexual Dysfunction; Sexuality and Reproductive Issues
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: A couples therapy program may enhance intimacy and reduce psychological distress
      in patients with prostate cancer and in their partners.

      PURPOSE: This randomized clinical trial is studying how well couples therapy enhances
      intimacy and reduces psychological distress in patients with advanced or recurrent prostate
      cancer and in their partners.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients with
           advanced or recurrent prostate cancer and their partners.

        -  Compare the effect of IECT vs usual care on patients' and their partners' level of
           global psychological distress.

        -  Compare the effect of IECT vs usual care on relationship intimacy in these participants.

      OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified
      according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment
      Scale (high [< 21] vs low [≥ 21]). Patients and their partners are randomized to 1 of 2 arms.

        -  Arm I: Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6
           weeks comprising the following four 90-minute sessions: the Story of Cancer;
           Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping,
           Support, and Adaptation. Patients and their partners complete treatment satisfaction
           questionnaires after completion of study intervention.

        -  Arm II: Patients and their partners receive standard psychosocial care. All participants
           complete questionnaires assessing psychological distress, intimacy, communication
           patterns, and overall relationship adjustment/satisfaction at baseline and at 1 month
           after completion of study intervention.
    

Intervention name(s): counseling intervention; questionnaire administration; psychosocial assessment and care
Intervention type(s): Other; Other; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: psychosocial effects of cancer and its treatment; sexual dysfunction; sexuality and reproductive issues; recurrent prostate cancer; stage III prostate cancer; stage IV prostate cancer
A Study of the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With Non-erosive Reflux Disease
Condition: GERD
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      A random controlled study to investigate the effect of a new drug, ONO-8539, on oesophageal
      pain hypersensitivity in patients with gastric reflux disease
    

Detailed description: 
      This is a Randomised, Double-blind, Placebo-controlled, Two-period Crossover Study to
      Investigate the Effect of ONO-8539 on Oesophageal Pain Hypersensitivity in Patients With
      Non-erosive Reflux Disease
    

Intervention name(s): ONO-8539; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Treatment; Placebo
Other intervention name(s): Experimental
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GERD
Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients
Condition: Mechanical Ventilation; Lung Infection
Study type: Interventional

Summary: 
      The researchers hypothesized that the aid of the resuscitator by the technique Air Stacking
      increase lung volume, promoting increased lung compliance and improvement of the ventilatory
      pattern. In addition, Air Stacking does not depend on patient collaboration. The objective of
      this study was to compare the effects of breath stacking and air stacking techniques on
      respiratory mechanics and ventilatory pattern in patients admitted to the ICU
    


Intervention name(s): Breath Stacking; Air Stacking
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients were connected to a unidirectional valve coupled to artificial airway (tracheostomy), with bacteriological filter. The ventilator was coupled to the unidirectional valve to measure inspiratory volume mobilized in each cycle and a connection to adapt a manometer. The patient performed successive inspirations for a maximum period of 30 seconds or until unidirectional valve opening or volume increase was observed for 2 consecutive efforts. Ten cycles of the technique were performed, with an interval of 30 seconds.; The same system of monitoring and adaptation of the ventilometer and manometer was carried out. A manual resuscitator coupled to a unidirectional valve was used, both connected to the tracheostomy, with a filter interface. Slow and successive inspirations were performed through slow compression of the resuscitator until the maximum inspiratory pressure reached 40 cmH2O. Ten cycles of the technique were performed, with an interval of 30 seconds.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Physical Therapy Modalities; Respiratory Care Units; Respiratory Mechanics
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Condition: Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 3

Summary: 
      Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and
      may cause discomfort. In this study, patients with varicose veins in the legs will be
      participating. The purpose of this research study is to evaluate the safety and effectiveness
      of three different concentrations of an investigational drug, polidocanol injectable foam
      compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose
      veins.
    


Intervention name(s): Polidocanol injectable foam (PEM); Placebo Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Injection of Polidocanol injectable foam; Placebo vehicle
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Varicose Veins
Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system
      commercially available in Germany & Holland.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Up to 480 subjects with type 1 or 2 diabetes mellitus
      
Keywords: diabetes, SMBG, glucose testing systems, accuracy
Prevention of Post-Traumatic Stress Disorder in Soldiers
Condition: Post-traumatic Stress Disorder (PTSD); Aggressive Behavior
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      Soldiers in conflict or former conflict regions deployed in peace-keeping missions were and
      are often exposed to multiple traumatic events and situations in which they are forced to
      engage in violent behavior. The Preventive Narrative Exposure Therapy (Pre-NET) aims to
      reinforce resilience thereby reducing the risk of developing or aggravating PTSD or other
      mental disorders as a result of traumatic experiences. The effective prevention of mental
      disorders as a result of war deployment is expected to facilitate reintegration in civil life
      after deployment and reduce uncontrolled violence.
    


Intervention name(s): Preventive Narrative Exposure Therapy
Intervention type(s): Behavioral
Intervention description(s): During Pre-NET the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. During two sessions a chronological overview of the whole life with a focus on traumatic events is developed and the most important traumatic experiences are processed.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Post-traumatic Stress disorder (PTSD); Aggressive Behavior; Appetitive Aggression; Resilience; Preventive Narrative Exposure Therapy
Study to Investigate the Long Term Survivorship of Coflex
Condition: Spinal Fractures
MeSH terms: Spinal Fractures
Study type: Interventional

Summary: 
      Examine the long-term survivorship via CT Scan of the coflex in patients who presented with
      spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.
    

Detailed description: 
      This is a prospective, multi-center, single-arm, radiographic evaluation of all coflex IDE
      patients who presented with a spinous process fracture at 24 months as identified by
      independent radiographic review (using X-ray or CT). All patients were enrolled and followed
      through 60 months under the IDE and extended follow-up protocol.

      The specific objective of this CT Study is to perform a sub-analysis of the patients with 24
      month spinous process fracture(s) via a CT scan at post-60 months. A CT Scan will be
      performed and analyzed by an independent radiographic review lab for evidence of fracture or
      healing at the long term timepoint.
    

Intervention name(s): CT Scan
Intervention type(s): Radiation
Intervention description(s): Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months.
There are no other interventions. It is just a onetime CT post 60 month time point.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Escitalopram in Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of escitalopram after 8 weeks of
      treatment in patients with Generalized Anxiety Disorder (GAD), to evaluate proportion of
      patients who respond to escitalopram during the treatment period, and to evaluate safety of
      escitalopram.
    

Detailed description: 
      The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The
      patients will receive escitalopram for 8 weeks. Start and maintenance dosages as well as dose
      titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with
      the national Summary of Products Characteristics (SPC).
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Flexible-dosed (5 to 20 mg Oral Tablets Daily)
Other intervention name(s): Cipralex, Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder; GAD; Antidepressant; Anxiolytic
Assessment of Tramadol as a Treatment for Opioid Addiction
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Opioids are one of the most commonly abused drugs among individuals who seek treatment for
      drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose
      of this trial is determine whether tramadol is effective in treating opioid dependent
      individuals.
    

Detailed description: 
      This human laboratory study will test the effects of tramadol as a step in its development as
      a new treatment for opioid dependence. Tramadol is a moderate mu agonist opioid that may
      produce low levels of opioid physical dependence. Tramadol's capacity for producing physical
      dependence has not been systematically studied in humans. It is important to quantify
      tramadol, as it provides a measure of its opioid agonist effects. This would also be
      informative in regards to the abuse liability of tramadol when used as an analgesic (as
      currently marketed), or when used in the treatment of opioid addiction (as proposed in this
      study). The purpose of this trial is to evaluate the level of physical dependence as well as
      blockade efficacy produced by chronic maintenance on oral tramadol in opioid dependent
      individuals.

      Participants will be randomly assigned to receive different doses of tramadol or placebo for
      up to six weeks. Experimental sessions will take place up to three times per week during the
      treatment period. During challenge sessions, participants will receive an injection; four
      different kinds of effects may occur in a session following this injection. First, no effect
      may occur (a placebo). Second, an opioid agonist effect may occur (opioid agonists include
      heroin, morphine, hydromorphone, tramadol, and methadone), which may cause the participant to
      feel "high." Third, an opioid antagonist effect may occur (e.g., naloxone, naltrexone), which
      may cause the participant to feel a sense of opioid withdrawal.
    

Intervention name(s): Tramadol
Intervention type(s): Drug
Intervention description(s): oral doses four times per day
Other intervention name(s): Ultram
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic
      (PK) parameters between macitentan and tadalafil administered as a fixed dose combination
      (FDC) (test) of macitentan/tadalafil and the co- administered free combination (reference) of
      macitentan (Opsumit) and tadalafil (Adcirca) in fasted conditions in healthy adult
      participants; and to evaluate the effect of food on the primary PK parameters of macitentan
      and tadalafil administered as an FDC of macitentan/tadalafil in fed versus fasted conditions
      in healthy adult participants.
    


Intervention name(s): Macitentan 10 mg; Tadalafil 20 mg; Macitentan 10 mg/Tadalafil 20mg FDC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Macitentan 10mg tablet will be administered orally as per assigned treatment sequence.; Tadalafil 20mg tablet will be administered orally as per assigned treatment sequence.; FDC of Macitentan 10 mg/Tadalafil 20 mg will be administered orally as single dose tablets.
Other intervention name(s): Opsumit; JNJ-67896062; Adcirca; JNJ-10291697; ACT-064992D
Intervention MeSH terms: Tadalafil; Macitentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
International Registry for Intraductal Papillary Mucinous Neoplasma
Condition: Pancreatic Cysts
MeSH terms: Pancreatic Cyst
Study type: Observational

Summary: 
      A centralized web-based database will be used to track patients with IPMN lesions of the
      pancreas to study natural history and risk factors for malignant transformation in this
      multi-center study.
    

Detailed description: 
      Intraductal papillary mucinous neoplasms of the pancreas (IPMN) are increasingly recognized
      in clinical practice. They represent a unique clinicopathologic entity that is characterized
      by mucin production, cystic dilation of the pancreatic ducts, and intraductal papillary
      growth. The World Health Organization recognized IPMN as a distinct clinical entity in 1996.
      Recent literature suggests that up to 45% of IPMN are malignant and should be resected;
      however these data are based on larger, primarily symptomatic lesions. Several studies have
      been published in the recent literature reporting single-center experience with IPMN
      resections and observations with small numbers of patients. The natural history of these
      lesions and risk of malignancy is still vague. Consensus guidelines for management of IPMN
      were published in 2006, but noted the limited knowledge available in six areas: definition
      and classification, preoperative evaluation, indication for resection, method of resection,
      histological data on frozen section/positive margins and specimen processing, and finally,
      method of follow-up. Speaking to this need, we propose an international registry for
      multi-center collaboration in the above areas of need in IPMN research and clinical
      management. This will be through a centralized, web-based registry with data entered by each
      center in a de-identified way to protect confidentiality.

      The data collected from the IRB approved retrospective chart review IRB# 07-007202 will be
      incorporated into this data base. Any patients that participate in the prospective study will
      be consented with HIPPA consent prior to collection of data.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care