bioihbjkbjnl/mcl2 huggingface dataset:
Dexmedetomidine for Prophylaxis Against PONV in Highly Susceptible Patients.
Condition: Postoperative Nausea and Vomiting; Head and Neck Surgeries
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The study aims to compare between two bolus doses of dexmedetomidine in preventing PONV in
      highly susceptible patients.
    

Detailed description: 
      Being A challenging complaint, many studies tried to find an effective preventive strategies
      for PONV. In this study protocol the investigators aim to compare between 0.5 mic/kg and 0.75
      mic/kg bolus doses of dexmedetomidine when given toward the end of head and neck surgeries in
      highly susceptible patients with a controlled group receiving ondansetron.

      The primary outcome is the 1st 24 hours incidence of PONV

      Other outcomes include:

        -  Time to 1st call for rescue antiemetic and the total amount of antiemetics

        -  Number of PONV attacks

        -  Post operative pain score with visual analogous scale (VAS) and time to 1st call for
           rescue analgesia

        -  Sedation Score using Observer's Assessment of Alertness and sedation (OAA/S)

        -  Patient satisfaction

        -  Vital signs in the 1st 24 hours
    

Intervention name(s): Dexmedetomidine Hydrochloride 0.5 mic/kg bolus; Dexmedetomidine Hydrochloride 0.75 mic/kg bolus; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): comparison between two bolus doses of dexmedetomidine with a placebo group; comparison between two bolus doses of dexmedetomidine with a conventional group receiving ondansetron.; equal volume of normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: comparative study between two doses and a 3rd control group
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Dexmedetomidine; PONV; ondansetron; post operative; nausea; vomiting
Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a
      reference capsule and an oral solution in healthy subjects.
    


Intervention name(s): SKI-606
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: healthy subjects
Identification of Potential Biomarkers of Peptide Immunotherapy. Part 1 - Proteomics Analysis
Condition: Cat Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      Cat allergy is an increasingly prevalent condition, affecting 10-15% of patients with
      allergic rhinoconjunctivitis. Cat-PAD is a novel synthetic, allergen derived peptide
      desensitizing vaccine currently being developed for the treatment of cat allergy.

      At present, the efficacy of immunotherapy (peptide or otherwise) can only be established at
      the conclusion of therapy. The aim of this study is to identify changes in potential
      biomarkers after peptide immunotherapy that may be subsequently developed as biomarkers that
      equate with clinical efficacy.
    


Intervention name(s): Cat-PAD
Intervention type(s): Biological
Intervention description(s): Intradermal injection 1 x 4 administrations 4 weeks apart.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cat allergy; Rhinoconjunctivitis; Immunotherapy; Cat-PAD
Application of Trans Cranial Direct Current Stimulation for Executive Dysfunction After Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Traumatic brain injury (TBI) particularly affects the frontal lobes and patients often suffer
      from executive dysfunction and behavioral disturbances. These types of injuries often involve
      axonal damage to pre frontal brain areas, which mediate various cognitive and behavioral
      functions. Dorsolateral prefrontal circuit lesions cause executive dysfunction, orbitofrontal
      circuit lesions lead to personality changes characterized by disinhibition and anterior
      cingulate circuit lesions present with apathy. Patients who suffered traumatic frontal lobe
      damage often demonstrate a lasting, profound disturbance of emotional regulation and social
      cognition.

      Weak transcranial direct current stimulation (tDCS) induces persisting excitability changes
      in the human motor cortex. this effect depends on the stimulation polarity and is specific to
      the site of stimulation. Interacting with cortical activity, by means of cortical
      stimulation, can positively affect the short-term cognitive performance and improve the
      rehabilitation potential of neurologic patients. In this respect, preliminary evidence
      suggests that cortical stimulation may play a role in treating aphasia, unilateral neglect,
      and other cognitive disorders.

      Several possible mechanisms can account for the effects of tDCS and other methods on
      cognitive performance. They all reflect the potential of these methods to improve the
      subject's ability to relearn or to acquire new strategies for carrying out behavioral tasks.
      It was also found that Activation of prefrontal cortex by tDCS reduces appetite for risk
      during ambiguous decision making.

      In this tDCS study the investigator uses one anode and one cathode electrode placed over the
      scalp to modulate a particular area of the central nervous system (CNS). The stimulation is
      administered via the neuroConn DC.Stimulator Serial number 0096. The DC-STIMULATOR is a
      micro-processor-controlled constant current source. The DC-STIMULATOR is a CE-certified
      medical device for conducting non-invasive transcranial direct current stimulation (tDCS) on
      people.Electrode positioning is determined according to the International EEG 10-20 System.
    


Intervention name(s): neuroConn_CE_DC-STIMULATOR; neuroConn_CE_DC-STIMULATOR; SHAM
Intervention type(s): Device; Device; Device
Intervention description(s): right frontal anodal stimulation; left frontal anodal stimulation; no meaningful stimulation will be given
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Executive function difficulties; Transcranial direct current stimulation
Post-Pregnancy Cardio Trial
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      Preeclampsia is a systemic pregnancy disorder and is associated with an increased
      cardiovascular risk later in life. This study will characterize myocardial tissue in patients
      after preeclampsia compared to controls and investigate potential functional and structural
      changes in the heart of preeclamptic women primarily with two methods: cardiovascular
      magnetic resonance imaging and echocardiography. A comparison between these two methods,
      where appropriate, is also envisaged.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women between 18 and 50 years of age, 0.5 - 20 years postpartum either with preeclampsia
        diagnosis during index pregnancy or without pathological findings. Controls are matched to
        cases based on age and BMI.
      
Keywords: magnetic resonance imaging; myocard; preeclampsia
Community-based Management of Hypertension in Nepal
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Hypertension contributes to significant burden of cardiovascular diseases (CVDs) in low and
      middle-income countries; however responses to CVDs are inadequate particularly due to lack of
      conclusive evidence on population based approach to hypertension control. This is a community
      based cluster randomized trial involving family based health education through female
      community health volunteers in Nepal. People ≥25 years of age and who are listed in the voter
      list 2006 of Electoral Commission of Nepal who were either hypertensive, pre-hypertensive or
      normotensive are eligible for eligible for participation in the study. A computer generated
      random codes will be used to divide clusters into treatment and control arm. FCHVs will
      conduct family based health education and blood pressure measurements in the treatment arm vs
      not any interventions in control arm. Independent assessors will conduct the baseline and end
      line assessment of the intervention. Intention to treat analysis and per protocol analysis
      will be used in analysis to detect significant differences between treatment and control
      group participants at baseline and follow up. Student t-tests for normally distributed
      variables and chi-squared tests for categorical variables will be used. In the event that
      randomization do not control for differences between the treatment and control groups on
      baseline characteristics, the investigators will statistically control for those differences
      in subsequent analysis of program effects. The final outcome will be modeled by using
      multiple linear regressions analysis. The investigators hope that if the intervention
      outcomes shows positive effects in treatment arm, this approach can be adopted into the
      existing health care delivery system in Nepal. Assessing the FCHVs' ability may further
      contribute to developing a policy that can be scaled-up to a national level. The lessons
      learned from this project may also be replicated in rural areas and similar settings
      elsewhere in the world.
    


Intervention name(s): FCHV visit
Intervention type(s): Behavioral
Intervention description(s): Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure
Other intervention name(s): FCHV Home Visit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      • To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the
      assessment of primary endpoint : Mean change in walking arthritis pain intensity score

      Secondary objectives:

        -  To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the
           assessment of secondary endpoints.

        -  To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on
           the nature and frequency of adverse events in treatment groups
    

Detailed description: 
      This trial is designed as an open-label, multicenter, randomized, clinical study for
      assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients
      with osteoarthritis
    

Intervention name(s): Ketoprofen topical; Diclofenac Topical
Intervention type(s): Drug; Drug
Intervention description(s): Ketoprofen topical for 21days; Diclofenac topical for 21days
Intervention MeSH terms: Diclofenac; Ketoprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ketoprofen; diclofenac; osteoarthritis
The Use of Diadynamic in Association With a Manual Therapy Program for Patients With Impingement Syndrome
Condition: Shoulder Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study will be to evaluate the effects of the use of manual therapy and
      diadynamic in muscle trigger points in the upper trapezius muscle in individuals diagnosed
      with shoulder impingement syndrome, unilateral shoulder as functional capacity, pain
      intensity and pain threshold the pressure.
    


Intervention name(s): manual therapy; diadynamic current
Intervention type(s): Other; Device
Intervention description(s): the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.; Through an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minute short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to assess the safety after
      multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2
      diabetes.
    


Intervention name(s): liraglutide; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mcg/kg daily for 14 days. Injected subcutaneously once daily; Initial dose of 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days. Injected subcutaneously once daily; Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Condition: Hematological Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this prospective study is to assess the overall mortality (whether related to
      relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell
      transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning
      regimen in patients with hematological malignancies.
    


Intervention name(s): Fludarabine, Busulfan, Thymoglobuline
Intervention type(s): Drug
Intervention MeSH terms: Fludarabine; Busulfan; Thymoglobulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic stem cell transplantation; Reduced-intensity conditioning; Reduced-toxicity conditioning; Hematological malignancies; IV Busulfan
RSV Challenge in Healthy Adults
Condition: Respiratory Infections, Acute; Respiratory Syncytial Virus
MeSH terms: Infections; Respiratory Tract Infections
Study type: Interventional

Summary: 
      The purpose of this study is to measure the immune response (how the body fights infection)
      to an experimental preparation of live Respiratory Syncytial Virus (RSV). A better
      understanding of this virus may be useful in development of vaccines and treatments.
      Participants will include 20 healthy adults age 21-40. Study procedures will include drawing
      blood, urine samples, respiratory exams, vital signs and temperature, diary cards, nasal
      mucus weight and nasal washes and swabs. All participants will receive vaccine via nose
      drops. Patients will participate in the study for about 2 months.
    

Detailed description: 
      Respiratory infections are a major cause of morbidity and mortality in the elderly. Recently,
      respiratory syncytial virus (RSV) has been shown to account for a significant portion of
      these illnesses. The causative factors associated with severe RSV disease in the elderly are
      not well understood. The contribution of viral load, host inflammatory responses and the
      cellular immune response to disease pathogenesis are unknown. A better understanding of these
      processes may be useful in the development of vaccines and therapeutics for RSV disease.
      Although the adult groups at highest risk for serious RSV disease are elderly and high-risk
      adults, we propose to use the challenge model in young healthy adults to determine optimal
      timing of specimen collection and the feasibility of performing certain tests before moving
      ahead to the target groups with natural infection. The purpose of this study is to measure
      the immune response (how the body fights infection) to an experimental preparation of live
      Respiratory Syncytial Virus (RSV. Participants will include 20 healthy adults age 21-40.
      Study procedures will include drawing blood, urine samples, respiratory exams, vital signs
      and temperature, diary cards, nasal mucus weight and nasal washes and swabs. All participants
      will receive vaccine via nose drops. Patients will participate in the study for about 2
      months.
    

Intervention name(s): RSV challenge material
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Respiratory Syncytial Virus Infections
Efficacy of Dialectical Behavior Therapy Versus CAMS-informed Supportive Psychotherapy on Self Harming Behavior
Condition: Borderline Personality Disorder; Suicide
MeSH terms: Suicide; Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      Purpose: The purpose of this study is to investigate the efficacy of Dialectical Behavior
      Therapy (DBT) versus CAMS (Collaborative Assessment and Management of Suicidality) -informed
      supportive psychotherapy on the risk of self-harm acts and suicide attempts in patients with
      self behavior and personality traits within the spectrum of borderline personality disorder.

      Hypothesis: The hypothesis is 16 weeks of treatment with Dialectical Behavior Therapy (DBT)
      after a defined manual has a higher efficacy than CAMS-informed supportive psychotherapy on
      self-harm acts, suicide attempts, suicidal ideation, depressive symptoms, impulsiveness and
      consumption of hospital services in patients with symptoms within the spectrum of borderline
      personality disorder (BDP).

      Method: The investigators will include 160 patients in the randomized trial to investigate
      whether 16 weeks of DBT-treatment as a higher efficacy than CAMS-informed supportive
      psychotherapy on the risk of self-harm acts and suicide attempts in patients with self-harm
      behavior and personality traits within the spectrum of borderline personality disorder. The
      trial will meet strict criteria for high quality randomized trials, and will hopefully help
      to establish evidence for the treatment of this patient group at higher risk of later
      suicide. There will be performed follow up interviews after 16 weeks, 28 weeks and 52 weeks.
    


Intervention name(s): DBT; CAMS
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 16 weeks DBT treatment; CAMS-informed psychotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Borderline Personality Disorder traits; Suicide prevention; Self-harm; Dialectical Behavior Therapy; DBT; Collaborative Assessment and Management of Suicidology; CAMS
Laparoscopic Internal Gastric Banding, New Simple and Costless Weight Loss Procedure
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to study the effectiveness of laparoscopic internal gastric
      banding as a treatment for morbid obesity in comparison to laparoscopic sleeve gastrectomy
    

Detailed description: 
      In this study 190 morbidly obese patients will be included and will randomly assign into 2
      groups, group 1 will be operated by laparoscopic internal gastric banding and group 2 by
      laparoscopic sleeve gastrectomy, the patients will be followed up for 1 year to evaluate the
      effectiveness and drawbacks of laparoscopic internal gastric banding in comparison to
      laparoscopic sleeve gastrectomy, the investigators preparing to submit our study protocol to
      our institution ethical committee for approval to start the study
    

Intervention name(s): Laparoscopic internal gastric banding; laparoscopic sleeve gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic internal gastric banding; laparoscopic sleeve gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Cognitive impairment is a known consequence of cerebral small-vessel disease. Moderate to
      severe cognitive impairment has been shown in up to 60% of certain individuals with COPD and
      is likely to profoundly influence an individual's ability to manage their disease.

      In addition to cerebral small vessel damage and cognitive dysfunction, other organs such as
      the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in COPD.
      Several large population studies have shown that COPD is a significant independent risk
      factor for myocardial infarction, with the effect most marked in early, mild disease.

      We propose to compare non-invasive MR brain imaging of white matter microstructure (diffusion
      tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral small vessel
      disease (cerebral microbleeds), in COPD patients to smokers without COPD. In addition we plan
      to explore mechanisms of cerebral small vessel disease in COPD by looking for associations
      between arterial stiffness, end organ vascular damage and cognitive function.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stable COPD
      
Biospecimen description: 
      Serum
    
Keywords: COPD; Cognitive Function; MRI Brain; Aortic Stiffness; Cerebrovascular disease