bioihbjkbjnl/mcl2 huggingface dataset:
Seroprevalence Study of Hepatitis A, Varicella-Zoster, Cytomegalovirus, Herpes Simplex and Bordetella Pertussis
Condition: Viral Hepatitis Vaccines; Hepatitis A; Cytomegalovirus; Varicella-Zoster Virus; Bordetella Pertussis Infection; Herpes Simplex (1 and 2)
MeSH terms: Hepatitis A; Herpes Simplex; Whooping Cough; Herpes Zoster; Chickenpox; Varicella Zoster Virus Infection; Hepatitis
Study type: Observational

Summary: 
      The purpose of this study is to determine the seroprevalence of Hepatitis A Virus (HAV),
      Varicella-Zoster virus (VZV), Cytomegalovirus (CMV), Herpes Simplex (HSV) and Bordetella
      pertussis (BP)infections in Mexico.
    

Detailed description: 
      In order to document the epidemiological changes in the sero-prevalence of Hepatitis A, Human
      simplex virus (1 and 2), Varicella-Zoster virus and Cytomegalovirus infections, we propose to
      conduct a population based, seroprevalence, cross-sectional study, in Mexico. This will allow
      the identification of susceptible populations, which in turn, will serve as evidence for the
      elaboration of recommendations for the prevention of Hepatitis A, Human simplex virus,
      Varicella-Zoster virus and Cytomegalovirus infection in the region.

      This study was conducted using data and serum samples from a random sample of subjects that
      participated in the 2006 National Health and Nutrition Survey.
    

Intervention name(s): Serum sample
Intervention type(s): Other
Intervention description(s): Serum samples collected
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will include a random sample of 4000 subjects of subjects who
        participated in the 2006 National Health and Nutrition Survey (ENSANUT).
      
Biospecimen description: 
      Serum samples
Comparison of Different Oral Rehydration Solutions
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Compliance is the biggest challenge in patients with Short Bowel Syndrome (SBS) on Home
      Parenteral Nutrition. These patients need to hydrate themselves to meet the excess fluid loss
      due to their anatomy. Oral Rehydration Solution (ORS) is prescribed to all these patients.
      The investigators believe that taste of the standard ORS is the biggest reason why these
      patients are not complaint. The new ORS in the market has been prepared with this in mind.
      The investigators want to study if this new ORS will improve the compliance in this patient
      cohort.
    


Intervention name(s): WHO ORS; Commercial ORS
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will be randomized into one of the two groups. They will be provided with one of the two ORS solutions. Then, they will be followed for 6 months.; Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
Other intervention name(s): World Health Organization ORS; Dripdrop
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Home Parenteral Nutrition; Compliance; Short Bowel Syndrome; Oral Rehydration Solution
Palliation: the Effect of Education on Pain
Condition: Bone Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale: Although radiotherapy is an effective palliative treatment for patients with
      painful bone metastases with over 70% responders, pain intensity is not always sufficiently
      controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients
      show that during weekly follow up, 35% of the patients remain above a pain intensity level of
      4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO
      criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline
      'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain
      control. However, the effect of a nurse-led education of patients undergoing palliative
      radiotherapy for painful bone metastases has not been investigated yet.

      Objective: This project investigates whether nurse-led pain education in addition to standard
      care results in better control of pain in patients referred for palliative radiotherapy.

      Study design: A national multicenter phase 3 study (n=450).

      Study population: Patients with painful bone metastases referred for short schedule
      radiotherapy.

      Intervention: Patients will be randomized between standard care or standard care with the
      Pain Education Program, a nurse-led pain education. The pain Education Program will be
      provided on the same day the radiotherapeutic treatment will start. The nurse will first
      assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will
      be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses
      will telephone patients at regular intervals during follow-up to monitor their needs.

      Main study parameters/endpoints: The primary outcome of this randomized multicenter study is
      a decrement of the number of patients whose worst pain intensity remains above 4 at any time
      during the 12 weeks of follow up with regard to the control group. The secondary outcome is
      improvement of quality of life.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and
      the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.
    


Intervention name(s): Pain education
Intervention type(s): Behavioral
Intervention description(s): Patients receiving pain education
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: palliation; pain education
Safety of Bilateral HTO: One-Stage vs.Two-Stage: A Randomized Controlled Study
Condition: Gonarthrosis; Primary; Varus Gonarthrosis
MeSH terms: Osteoarthritis, Knee; Osteoarthritis
Study type: Observational

Summary: 
      In this study, bilateral simultaneous high tibial osteotomy (HTO) was compared with staged
      bilateral HTO in terms of complications. We did not use any grafts to support the osteotomy
      line and the patients were mobilized immediately with a full load on a postoperative day 1.
      And our hypothesis is that bilateral simultaneous applications are safe in comparison to the
      staged ones in terms of complications.
    

Detailed description: 
      Knee osteoarthritis is the most common orthopedic chronic disease, and varus knee
      abnormalities can often be related. The load from the medial tibiofemoral joint increases
      significantly in varus alignment disorder and it plays an important role in the structural
      progression of knee osteoarthritis. Varus malalignment and patients with medial tibiofemoral
      disease comprise a common patient subset. The probability of progressing to severe disease is
      3 to 4 times higher in these patients compared to those with a neutral knee alignment.
      Although the long-term results of high tibial osteotomy are well documented, but data on
      bilateral simultaneous HTO are insufficient. In general, staged surgery is preferred in
      bilateral cases due to the difficult rehabilitation, healing of the osteotomy line, and
      complications related to surgery. Advances in post-surgical rehabilitation have been made due
      to increased confidence in stability due to improvements in the technology of plates.The
      advantages of an bilateral simulatneous HTO is single administration of anesthesia, total
      shortening of the hospitalization periof and reduced costs.
    

Intervention name(s): simultaneous bilateral high tibial osteotomy; Staged bilateral high tibial osteotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): One-stage simultaneous bilateral high tibial osteotomy; Two-stage bilateral high tibial osteotomy
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with bilateral genu varus gonarthrosis operated by the tertiary step hospital
        high-volume knee surgeons
Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study
Condition: Smoking Cessation
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to develop strategies to maintain smoking abstinence initiated
      in pregnancy and prevent relapse in the postpartum period.
    

Detailed description: 
      Many women quit smoking during pregnancy, but postpartum relapse rates are high,
      approximately, 50-80% (Van't Hof, et al). The majority of women who quit smoking during
      pregnancy resume smoking within the first 3 months postpartum (McBride, et al). The
      environmental risks of tobacco smoke on the newborn child can lead to acute respiratory
      infections, bronchitis, pneumonia, and SIDS. Several studies have tried to identify reasons
      for the high rates of relapse. Postpartum relapse has been attributed to decreased
      self-efficacy, the lack of effective coping strategies to resist temptation to smoke, and
      weight concerns (McBride, et al). Addictive behaviors such as smoking are learned behavioral
      means of coping. By learning new rules for dealing with problems, a behavior can be modified
      or unlearned. Physical exercise, when combined with cognitive behavioral therapy (CBT) as a
      smoking cessation treatment, is useful in the maintenance of smoking cessation in women.
      Yoga, as a form of exercise, has been shown to promote the desire to stop smoking and enhance
      subjective well-being and mood. Though untested in postpartum relapse prevention, yoga
      practice, when coupled with CBT, may address both mood and physiologic postpartum sensations
      that may be associated with the prevention of smoking relapse. Women are more apt to decrease
      or even stop smoking during pregnancy, and if successful in sustaining cessation, are likely
      to live longer.

      This randomized exploratory pilot study will use a controlled parallel group design using
      smoking cessation yoga intervention and cognitive behavioral therapy. The study will include
      a total of 30 participants aged 18-45 years. Smoking status will be identified by self-report
      and carbon monoxide testing at enrollment. At randomization and following time points,
      smoking status will be identified by self-report and confirmed by carbon monoxide testing.
    

Intervention name(s): Yoga; Yoga and Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Smoking abstinence
Wearable Sensor for Responsive DBS for ET
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      The purpose of this study is evaluate the effectiveness and safety of a possible new
      treatment for Essential Tremor (ET) using external wearable sensors, which have the
      capability of recording acceleration and Electromyography (EMG). This therapy is called
      Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer,
      and apply stimulation when the computer detects patterns associated with tremor. This
      detection will suppress pathological activity and improve or alleviate the tremor.

      Currently, DBS is approved for the treatment of ET; however, stimulation is delivered
      continuously even when tremor or other symptoms are absent. Continuous DBS can lead to
      unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS
      will turn on only if activity associated with ET from the external sensors is detected.
    

Detailed description: 
      The overall purpose of this application is to capture pathological activity related to
      essential tremor using external wearable sensors to responsively initiate or terminate DBS.
      To this end, the researchers propose to use the Nexus-D system, which requires a firm ware
      update to an Activa Implantable Neurostimulator (INS), and it will in a smart way turn DBS
      on/off in patients. The study team will recruit subjects with Activa SC or PC neurostimulator
      implants during 6 post-operative programming visits. The research group is already familiar
      with and is in possession of the Nexus-D system, and the investigators have successfully
      performed responsive DBS in two patients with Tourette syndrome (TS) and in four patients
      with Parkinson's disease in acute settings. The lab is also equipped with wireless wearable
      sensor and amplifier systems, such as a 16-unit wireless EMG+ acceleration+inertia Trigno
      Wireless Bio Acquisition System (Delsys Inc, Natick, MA). The study team aims to combine
      these signal modalities to capture pathological symptoms and generate commands to initiate or
      terminate DBS (also record adverse side effects, if any). The project goal is to characterize
      the clinical efficacy, side effect profile, and battery life of closed-loop DBS in acute
      settings using wearable sensors in essential tremor patients.
    

Intervention name(s): Responsive deep brain stimulation
Intervention type(s): Device
Intervention description(s): Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Effect of Cognitive Behavioral Approach-Based Psychoeducation
Condition: Substance Use Disorders; Self Efficacy; Addiction
MeSH terms: Substance-Related Disorders; Behavior, Addictive
Study type: Interventional

Summary: 
      This study, which was planned to examine the effects of cognitive behavioral approach-based
      psychoeducation on addiction profiles, self-efficacy levels and addiction courses in patients
      with substance use disorders, was carried out as a randomized controlled experimental study.
    

Detailed description: 
      It can be said that alcohol/substance nurses, by applying cognitive behavioral approach-based
      psychoeducation to patients with substance use disorders, can have a positive effect on
      reducing the severity of addiction, increasing their self-efficacy levels, and providing the
      care, education and counseling support that patients need.

      The aim of this study is to examine the effects of cognitive behavioral approach-based
      psychoeducation applied to patients with substance use disorder on addiction profiles,
      self-efficacy levels and addiction courses.
    

Intervention name(s): Psychoeducation
Intervention type(s): Other
Intervention description(s): In the cognitive behavioral approach based psychoeducation given to the experimental group patients; "Addiction and Its Effects", "Increasing and Maintaining Motivation", "The Cognitive Model and the Cognitive Model of Addiction", "Automatic Thoughts That Increase Impulse to Substance Use", "Dysfunctional Beliefs Regarding Substance Use", "High Risk Situations and Coping Skills", " The topics of "Prevention of Slippage and Recurrence" and "Problem Solving" are included.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following recruitment, person who the substance use disorder were divided into a study and a control group by randomization (1:1 randomization)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Substance Use Disorder; Psychosocial Intervention; Self Efficacy; Psychiatric Nursing
Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma
Condition: Hodgkin´s Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2)
      toxicity, overall response and FFTF.
    


Intervention name(s): Cyclophosphamide; Adramycin; Procarbacine; Prednisone; Vincristine; Bleomycin; Erythropoietin beta
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Prednisone; Cyclophosphamide; Vincristine; Bleomycin; Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin´s Lymphoma; eldery patients; primary diagnosis
First Time in Human Study of Intravenous Interleukin-18 Antibody
Condition: Inflammatory Bowel Diseases
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1070806 is a humanised monoclonal antibody that blocks a protein present in the body
      called Interleukin-18. The main purpose of this study is to test GSK1070806 in healthy and
      obese male subjects with normal immune systems to find out how safe this drug is and how long
      the body takes to get rid of it. The study consists of 2 parts. Part 1 will consist of 6
      groups of healthy male subjects and Part 2 will consist of 3 groups of obese male subjects. A
      total of 89 subjects is planned for this study. Subjects in each group will receive one dose
      of the study drug or placebo. Dosing in Part 2 will not start until dosing of the first 4
      groups is completed in Part 1 and the preliminary safety and pharmacokinetic data from these
      4 groups in Part 1 has been reviewed. Both parts will be conducted single-blind and with a
      placebo control. Within each group, allocation of subjects to placebo or active treatment
      (GSK1070806) will be randomised.
    


Intervention name(s): GSK1070806
Intervention type(s): Drug
Intervention description(s): The study drug, GSK1070806, is a humanised monoclonal antibody. Antibodies are proteins that are made by white blood cells during an immune reaction. They circulate in the blood and attach to foreign proteins called antigens in order to destroy or neutralise them.
Humanised monoclonal antibodies are a type of protein that is genetically engineered to resemble a human protein (humanised). GSK1070806 is designed to block a specific protein that exists in the body called Interleukin-18. Interleukin-18 works within the immune system, i.e. the body's defence system, which helps protect it from disease, bacteria and viruses. Interleukin-18 activates the immune system to fight infections and may also occasionally cause inflammation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: First time in human; Interleukin-18; Healthy male subjects; Obese male subjects; Monoclonal antibody; Pharmacokinetics; Tolerability; Safety; Pharmacodynamics
A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the
      Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in
      Combination with Hydrochlorothiazide in Patients with Mild to Moderate Hypertension
    


Intervention name(s): Fimasartan; Hydrochlorothiazide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Patients; with mild; moderate; essential
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Condition: Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
    

Detailed description: 
      To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule
      formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed
      conditions.
    

Intervention name(s): fesoterodine; fesoterodine; fesoterodine; fesoterodine; fesoterodine; fesoterodine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose of beads in capsule; single dose of beads in capsule; single dose of beads in capsule; single dose of beads in capsule; single dose of tablet; single dose of beads in capsule
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: BIOAVAILABILITY; FOOD EFFECT
The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation
Condition: Awake Tracheal Intubation
Study type: Interventional
Phase: Phase 4

Summary: 
      Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to
      find a safe and effective method for intubation. Awake tracheal intubation which is used to
      retain spontaneous breathing is one of the important measures to ensure the safety of the
      patients with difficult airway in anesthesia.

      Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of
      awake tracheal intubation, however, the outstanding problem is serious respiratory depression
      after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid
      antagonist related to mild respiratory depression and can prevents sufentanil-induced cough
      during general anesthesia induction.It is necessary to carry out large-scale, multi-center,
      randomized, controlled clinical study to determine whether dezocine prevents
      sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe
      and effective method for awake tracheal intubation.
    


Intervention name(s): Docozine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): dezocine（Dez A：0.05 mg/kg，Dez B：0.1 mg/kg and Dez C：0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia; The same amount of saline is given for 10 seconds after surface anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: docozine