bioihbjkbjnl/mcl2 huggingface dataset:
Cluster Headache Cortivazol Injection (CHCI)
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      the aim of tis study is to demonstrate the efficacy of cortivazol injections at the level of
      the greater occipital nerve to diminish the frequency of cluster headache (episodic or
      chronic) attacks during an active period. Injections will be used in adjunct with oral
      verapamil.
    

Detailed description: 
      Cluster headache is characterized by unilateral attacks of severe periorbital pain
      accompanied by autonomic symptoms and restlessness. Though patients may respond to the
      standard prophylactic treatment of verapamil, some are refractory and continue to suffer from
      numerous attacks, with a limit of two doses of subcutaneous sumatriptan per day. Some
      patients also have contra-indications to standard prophylactic or acute treatments. Other
      preventive treatments like systemic steroids, lithium and methysergide may cause significant
      side effects. We intend to show the efficacy of occipital nerve injections with cortivazol,
      in adjunct to verapamil, in cluster headache patients. We expect a diminution of attack
      frequency over two weeks, with a protocol of three injections separated by two or three days
      each. Tolerance and safety will be examined.
    

Intervention name(s): ALTIM, cortivazol injections; PROAMP, subcutaneous serum physiological saline; Verapamil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ALTIM, cortivazol in greater occipital nerve injection separated by 2 or 3 days each.; Three injections will be performed at the level of the greater occipital nerve with a suboccipital approach. Injection will be separated by two or three days each.; standard prophylactic treatment
Other intervention name(s): ALTIM, cortivazol injections greater occipital
Intervention MeSH terms: Cortivazol; Verapamil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cluster headache; greater occipital nerve block; cortivazol
Study to Evaluate the Safety and Efficacy of GABITRIL Treatment in Adults With Generalized Anxiety Disorder.
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      A 12-Month, Open-Label, Flexible-Dosage Study to Evaluate the Safety and Efficacy of GABITRIL
      Treatment in Adults with Generalized Anxiety Disorder.
    


Intervention name(s): Gabitril
Intervention type(s): Drug
Intervention MeSH terms: Tiagabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outreach Visits to Optimize Chronic Care Management in General Practice: A Cluster Randomized Trial
Condition: Chronic Disease
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      The aim of this project is to motivate and support general practice clinics in implementing
      the visions and recommendations presented in two of the disease specific programmes for
      chronic care management (for chronic obstructive lung disease and Type 2 diabetes). These
      programmes describe evidence based treatment and division of tasks between the
      municipalities, the hospitals and general practice.

      The Facilitator Project is funded by The Danish Ministry of Interior and Health.
    

Detailed description: 
      In a cluster randomized trial the investigators will explore the efficacy of up to three
      outreach visits by specially trained GPs. Efficacy data are obtained by means of
      questionnaires at regional databases.
    

Intervention name(s): Outreach visits
Intervention type(s): Behavioral
Intervention description(s): The 16 facilitators in the project attend an educational programme designed to provide them with the necessary skills and tools for the task. The facilitators visit general practice clinics from March 2011 until the end of 2012. Each clinic is offered three visits. The facilitator is to act as a change agent who motivates and helps the clinic team in the process of defining common goals, and choosing the appropriate means for achieving them.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Health Services Research; Chronic Care; Outreach Visits; Primary care; chronic disease management
Effects of Delayed Muscle Pain on Respiratory Muscle Function
Condition: Muscle Soreness; Exercise; Respiratory Muscles; Respiratory Function Tests
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The aim of the study was to determine whether delayed-onset muscle soreness (DOMS) in trunk
      muscles has an effect on respiratory function parameters, respiratory muscle strength,
      respiratory muscle endurance, and exercise capacity.
    

Detailed description: 
      In 24 healthy university students was induced for the trunk muscles with a load equals to 80%
      of the maximum repetitive voluntary contraction. Pulmonary function parameters, respiratory
      muscle strength and endurance, exercise capacity, pain, fatigue, and dyspnea perception
      severity were recorded before DOMS and at the 24th and 48th hours after DOMS.

      After DOMS, there is a decrease in respiratory performance values and exercise capacity of
      healthy individuals and athletes. Therefore, it should be taken into account that delayed
      muscle soreness before the competition may affect performance. It may be beneficial to take
      precautions for delayed muscle pain while creating training and exercise programs, and to
      create treatment programs in case of the emergence of DOMS.
    

Intervention name(s): DOMS protocol
Intervention type(s): Other
Intervention description(s): For a maximum repetition of the trunk muscles, two measurements were made with a 45-second rest interval.The values were recorded in Newtons by taking the maximum value of the two repetitions measured. DOMS was formed by eccentric contraction with 80% of this determined value.To generate DOMS in the trunk, participants were seated on the bench with the knees flexed at 90° and the soles of the feet in full contact with the floor, keeping the weight at 80% of the predetermined maximum repetition.The participants were asked to perform trunk extension with eccentric contraction of the trunk in 5 seconds, and trunk flexion with concentric contraction in 3 seconds.Two-minute rests between sets and 45-second rests between repetitions were given.The date and time of the created DOMS were recorded and the measurements were repeated at the 24th and 48th hours.
Intervention model: Single Group Assignment
Intervention model description: 24 healthy university students (n=11 female, n=13 male) with a mean age of 21±2 years included the study.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Muscle Soreness; Exercise; Respiratory Muscles; Respiratory Function Tests
Nebulized vs. Oral Midazolam Sedation in Pediatric Anesthesia: A Randomized Comparative Study
Condition: Preoperative Sedation
Study type: Interventional

Summary: 
      This study is to be carried out to compare nebulized and oral midazolam in achievement of a
      satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30 mins of midazolam
      administration in pediatrics.
    

Detailed description: 
      This study is to be carried out to compare nebulized midazolam and oral midazolam in
      achievement of a satisfactory level of sedation, Ramsey Sedation Score (RSS) of 4, within 30
      mins of midazolam administration in pediatric surgical patients.

      In Pediatric Specialized Hospital, Cairo University 72 pediatric patients scheduled for
      undergoing general or uro-surgical operations under general anesthesia will be included in
      this double-blinded study. Patients will be randomly assigned into two equal groups, each
      group including 36 patients. In one group 36 children will receive nebulized midazolam 0.2
      mg/kg in 3 ml normal saline plus 5 ml clear juice (orally) 30 min before undergoing general
      anesthesia. In the other group 36 children will receive oral midazolam 0.5 mg/kg in 5 ml
      clear juice plus nebulizer of 3 ml normal saline 30 min before undergoing GA.

      level of sedation will be compared between both groups
    

Intervention name(s): Midazolam nebulized; Midazolam oral solution
Intervention type(s): Drug; Drug
Intervention description(s): midazolam nebulized; midazolam given oral
Other intervention name(s): nebulizer; oral
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Straberi Epistamp Device for Postinflammatory Hyperpigmentation
Condition: Postinflammatory Hyperpigmentation
MeSH terms: Hyperpigmentation
Study type: Interventional

Summary: 
      This pilot study will expand knowledge and application needling using the Straberi device for
      the improvement of Postinflammatory Hyperpigmentation (PIH) caused by acne.
    

Detailed description: 
      This pilot study will expand the knowledge and application of needling using the Straberi
      Epistamp device and its safety and benefits for improving the appearance of Postinflammatory
      Hyperpigmentation. Postinflammatory Hyperpigmentation (PIH) caused by acne is a common
      inflammatory disease that can adversely affect facial appearance. Facial acne can have a
      serious negative impact on psychosocial functioning leaving deep emotional scars. Severe acne
      can also lead to physical scars and disfigurement. Among patients with severe acne, facial
      scarring affects both genders equally and occurs to some degree in 95% of cases.
    

Intervention name(s): Straberi Epistamp
Intervention type(s): Device
Intervention description(s): The patient's entire face will be treated. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm
Other intervention name(s): Microneedling
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants in the Straberi by Epistamp device trial, are those who are seeking improvement for Postinflammatory Hyperpigmentation (PIH) caused by acne.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: needling; postinflammatory hyperpigmentation; Epistamp; Universal Skincare Institute
Follow-up at School-age of Children Who Participated in the Efficacy Study of Nitric Oxide for Premature Infants
Condition: Prematurity, Respiratory Distress Syndrome,Hypoxemia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hypoxia
Study type: Interventional
Phase: Phase 3

Summary: 
      Our previous data demonstrated that premature infants treated with inhaled nitric oxide at
      birth had improved neurodevelopmental outcomes at two years corrected age. We now wish to
      determine whether this benefit continues through school age.
    

Detailed description: 
      Two questionnaires (truncated versions of previously validated surveys), one for parent and
      another for teacher, for which written consent was previously obtained are being sent to
      parents. The teacher questionnaires will be delivered via parents. A clinic visit will
      accompany age appropriate neurodevelopmental examination, administration of the Functional
      Independence Measure for Children (WeeFIM) survey, and hearing and visual screening exams (if
      appropriate).
    

Intervention name(s): Inhaled nitric oxide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 day of iNO at 10 ppm, then 5 ppm of iNO for days 2-7; No iNO given for days 1-7
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inhaled nitric oxide,; Lung recruitment,; Ventilatory approach,; Neurodevelopmental outcomes,; School age children
EFFECT OF SELECTIVE COX-2 INHIBITOR (ETORICOXIB) ALONG WITH SCALING AND ROOT PLANING (SRP) ON CLINICAL PARAMETERS AND SALIVARY LEVEL OF SUPEROXIDE DISMUTASE IN CHRONIC GENERALIZED PERIODONTITIS A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOUBLE-MASKED RANDOMIZED CONTROLLED TRIAL (RCT).
Condition: Cyclooxygenase Two Inhibitors; Etoricoxib; Periodontitis; Superoxide Dismutase; Saliva
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis is that Etoricoxib act as an adjuvant to SRP in alleviating periodontal
      inflammation by:

        1. improving clinical periodontal parameters and,

        2. improving the salivary SOD levels.
    


Intervention name(s): Etoricoxib
Intervention type(s): Drug
Other intervention name(s): Nucoxia; Arcoxia
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cyclooxygenase two inhibitors; Etoricoxib; Periodontitis; Superoxide dismutase; Saliva
Prevalence and Reversibility of Lung Hyperinflation in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The aim of this observational study is to evaluate the pulmonary hyperinflation and its
      immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent
      asthmatic patients with dyspnea.
    

Detailed description: 
      The other objectives are :

        -  the evaluation of the hyperinflation defined by an increase of the residual volume (RV),

        -  the observation of the relationship between the hyperinflation and the asthma
           characteristics,

        -  the study of the improvement of the functional parameters after a reversibility test

        -  the evaluation of the correlation between hyperinflation parameters evolution, chest
           tightness and dyspnea
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults
      
Keywords: Distal Airways; Hyperinflation; Reversibility
ACE Stapler Sub Study
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Obesity and its associated conditions have reached epidemic proportions. Estimates are that
      about one third of the adults in the United States have obesity. At this moment there are
      many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment
      options are limited and so far surgical intervention has been proven to be the only strategy
      to overcome severe obesity. However, bariatric surgery has limitations and risks, which might
      be minimized by non-incisional endoscopic procedures.

      BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM)
      Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which
      intends to reduce the ability of the stomach to expand by creating plications in the region
      of the fundus and greater curvature. In contrast with other bariatric surgery it is
      endoscopically performed, reversible and if it fails most future surgical options are still
      open.

      The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness
      of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study (MUMC+, AMC
      and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this
      plicating system for patients with severe obesity.

      In this sub-study the investogators want to unravel the exact mechanism and provide more
      information about the efficacy of the BaroSense ACE™ Stapler. Therefore the authors will
      measure changes in various parameters that are known to affect weight loss and metabolism,
      before and after gastric plication (by using the BaroSense ACE™ Stapler) in overweight
      subjects (these parameters will only be measured in patients at MUMC+). These parameters are
      post-prandial satiety, food-reward and related brain signalling, gastric emptying, behaviour
      towards food, food intake, satiety hormone release, microbiota composition and inflammatory
      markers.

      Objectives:

      Aim of the present study will be to assess the effect of the BaroSense ACE™ stapler on
      postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour
      towards food, food intake, hormone release, microbiota composition and inflammatory markers.
    


Intervention name(s): ACE stapling procedure
Intervention type(s): Device
Intervention description(s): Endoscopic trans-oral gastroplication
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients that will undergo an ACE stapling procedure for the treatment of obesity.
      
Biospecimen description: 
      plasma samples, faeces
    
Keywords: Obesity; Bariatric surgery; Gastric plication; Minimal invasive surgery; gastrointestinal hormones; food-reward; satiety; microbiota
Influence of Aerobic Exercise on Inhibitory Control of Excutive Function in Spastic Hemiplegic C.P
Condition: Spastic Hemiplegic Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      The study was conducted to assess the influence of aerobic exercise on inhibitory control of
      executive functions in spastic hemiplegic cerebral palsy.
    

Detailed description: 
      Inhibitory control of executive functions (EF) is one of the main specific cognitive
      impairments that affect children with cerebral palsy, cognitive skills begin to develop in
      infancy and continuing through the pre-school years, childhood and into adolescence it
      changes across the lifespan of an individual and has great effect on their participation and
      quality of life. The aim of study was to assess the influence of aerobic exercise on
      inhibitory control of executive functions in spastic hemiplegic cerebral palsy. Sixty
      children with spastic hemiplegic cerebral palsy were enrolled in this study and were assessed
      for eligibility. Their aged ranged from seven and eleven years. They were assigned randomly
      into two equal groups. Group (A) the study group received aerobic exercise in addition to
      selected physical therapy program. And group (B) the control group received the same selected
      physical therapy program only. The treatment was conducted for one hour, three times / weak
      for three successful months. Eriksen flanker test and Stroop Color-Word test were used to
      assess inhibitory control of EF pre and post treatment.
    

Intervention name(s): Aerobic Exercises
Intervention type(s): Other
Intervention description(s): Aerobic exercise refers to exercise that involves or improves oxygen consumption by the body. It is the type of activity that uses large muscle groups. Its performance is in a continuous and rhythmic way with a main goal to make the heart and lungs work harder than they do when the person at rest
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: They were assigned randomly into two equal groups. Group (A) the study group received aerobic exercise in addition to selected physical therapy program. And group (B) the control group received the same selected physical therapy program only. The treatment was conducted for one hour, three times / weak for three successful months.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemiplegic cerebral palsy; inhibitory control of executive functions.; aerobic exercise.
Talotrexin in Treating Patients With Advanced or Recurrent Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as talotrexin, 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 I trial is studying side effects, best way to give, and best dose of
      talotrexin in treating patients with advanced or recurrent solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of talotrexin in patients in patients with advanced
           or recurrent solid tumors.

        -  Determine the safety of this drug in these patients.

        -  Determine the dose-limiting toxic effects of this drug in these patients.

      Secondary

        -  Determine the pharmacokinetics of this drug in these patients.

        -  Correlate pharmacokinetic parameters of this drug or patient characteristics with
           drug-related toxicity in these patients.

        -  Determine, preliminarily, the antitumor efficacy of this drug in these patients.

      OUTLINE: This is an open-label, dose-escalation, multicenter study.

      Patients receive talotrexin IV over 5 minutes on day 1 OR days 1 and 8 OR days 1, 8, and 15.
      Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

      Cohorts of 1-6 patients receive escalating doses of talotrexin until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at
      the MTD.

      Patients are followed at 1 month.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12
      months.
    

Intervention name(s): talotrexin ammonium
Intervention type(s): Drug
Intervention model: Single Group Assignment
Intervention model description: There were 7 potential PT523 single agent dose levels to be evaluated in this phase I study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific