bioihbjkbjnl/mcl2 huggingface dataset:
Semi-quantitative Cough Strength Score (SCSS)
Condition: Mechanical Ventilation
Study type: Observational

Summary: 
      Cough strength score will give true prediction of Extubation outcome
    

Detailed description: 
      Head trauma patients were evaluated for readiness to be weaned off mechanical ventilation. If
      they had completed an Spontaneous Breathing Trial (SBT) before extubation. To measure
      Semiquantitative Cough Strength Score (SCSS), the investigator will put the patients at 30°
      to 45°, measure SCSS, first. The investigator enhance the patient to cough with as much
      effort as, when the investigator disconnect the ventilator. The cough strength was scored
      from 0 to 5 as follows: 0 = no cough on command, 1 = audible movement of air through the
      endotracheal tube but no audible cough, 2 = weakly (barely) audible cough, 3 = clearly
      audible cough, 4 = stronger cough and 5 = multiple sequential strong coughs.
    

Intervention name(s): Semiquantitative Cough Strength Score
Intervention type(s): Other
Intervention description(s): Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score
Other intervention name(s): (SCSS)
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The sample of this study include 80 head trauma patients from both sex of critically ill
        mechanically ventilated patient admitted to trauma Intensive Care Unit (ICU).
A Repeated Instruction by Telephone on the Day Before Colonoscopy to Patients Undergoing Colonoscopy
Condition: Ottawa Score; Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Cell phone retell the instruction of bowel preparation on the day before colonoscopy would
      help patient to prepare for colonoscopy and improve the quality of the bowel preparation.
    

Detailed description: 
      Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of
      colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing
      reduces the speed, the cecal intubation rate, and the number of polyps detected. It also
      increases costs, mostly due to repeated procedures. The quality of bowel cleansing has
      remained suboptimal even though numerous different products and regimens have been tested and
      compared in no fewer than six meta-analyses. Therefore, a completely different approach to
      improve precolonoscopy bowel cleansing is welcome.

      There are many factors effect the bowel preparation such as age, cirrhosis diabetes, drug
      compliance, cerebral infarction, dementia, history of major surgery. 20% of patients with
      poor bowel preparation were due to bad compliance. Studies found that addressing patient
      perceptions with an inexpensive and simple booklet based on the Health Belief Model improved
      preparation quality. We assume that doctor retelling the instruction of bowel preparation by
      cell phone on the day before colonoscopy would help patient to prepare for colonoscopy and
      improve the quality of the bowel preparation.
    

Intervention name(s): telephone education
Intervention type(s): Other
Intervention description(s): A repeated instruction by telephone on the day before colonoscopy was conducted
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: colonoscopy; bowel preparation; education
Feasibility Study: Heavy Water Tissue Labeling Protocol
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Enrolled subjects undergo tissue labeling to evaluate the rate of collagen synthesis in
      tissue treated with the Ulthera® System compared to control tissue.
    

Detailed description: 
      This study is a prospective, single-center, blinded, non-randomized clinical trial. Two
      subjects who have chosen to have a surgical facelift procedure and agree to drink heavy water
      for tissue labeling, will be enrolled. Subjects will consume heavy water and collect saliva
      specimens over the course of the study period, following a specific heavy water labeling
      protocol. Two weeks after starting the heavy water protocol, subjects will return to the
      study site to receive one Ultherapy® treatment to the pre-auricular region on one side of the
      face. The contra-lateral pre-auricular region will serve as a control. Following Ultherapy®
      treatment, subjects will continue to follow the heavy water protocol for 4 more weeks.
      Subjects will then return to the study site to undergo resection of the treated and control
      tissue for analysis during their planned rhytidectomy procedure. Subjects will send in saliva
      samples on a weekly basis to allow for confirmation that they are drinking the heavy water.
    

Intervention name(s): Ulthera® System Treatment; Heavy Water
Intervention type(s): Device; Other
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin; A tissue labeling model via the consumption of the stable isotope, deuterated water (heavy water). Heavy water consumed over the course of the 6-week study period for a direct kinetic measure of in vivo collagen synthesis. 60 ml (about 12 teaspoons) of heavy water (also called deuterated water or 2H2O), was consumed three times a day for the first five days. Starting on Day 6, two 60 ml doses of heavy water were consumed per day for the remaining 37 days.
Other intervention name(s): Ultherapy®; Deuterated Water
Intervention MeSH terms: Deuterium Oxide
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy® Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
Testosterone Therapy in Hypogonadal Men Treated With Opioids
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of testosterone replacement therapy in
      men with low testosterone due to opioid treatment on body composition, the haemostatic
      system, glucose metabolism, muscle function, pain sensitivity, pain modulation, lipids,
      sexual function and quality of life.

      Male patients on opioids for non-malignant diseases aged 18-59 years diagnosed with
      hypogonadotrophic hypogonadism, referred from day hospitals and outpatient populations. 40
      patients are randomized to either testosterone undecanoate i.m. or placebo i.m., i.e. 20
      patients per arm

      A double blinded randomized placebo controlled trial
    

Detailed description: 
      The study duration is 24 weeks. Patients are treated with Testosterone Undecanoate 1000 mg/4
      ml, intramuscular (i.m.) or placebo at 0, 6 and 18 weeks.

      Outcome measures will be evaluated at 0 and 14 weeks.
    

Intervention name(s): Testosterone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): intramuscular injection; intramuscular injection
Other intervention name(s): nebido
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Reinforcing Mechanisms of Smoking in Adult ADHD
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Whereas the smoking prevalence rates in the general population are declining, rates among
      people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be
      elevated. Smoking may be a form of self-medication in people with ADHD, which has specific
      reinforcing mechanisms such as improvement of ADHD core symptoms, enhancement of moods and
      arousal, or a combination of both. In addition, the reinforcing effects of smoking may be
      potentiated by stimulant medication.

      The study examined the reinforcing effects of ad libitum smoking with and without ADHD
      medication in adult smokers with clinically diagnosed ADHD. Participants were adults with
      ADHD. The effects of two day of ADHD medication compared to two days on placebo for were
      studied on nicotine intake (i.e., cotinine levels). In addition, task performance on the
      Continuous Performance Task and nicotine withdrawal symptoms were examined in response to
      ADHD medication + smoking a cigarette versus ADHD medication + abstinence versus placebo
      medication + smoking versus placebo medication + abstinence.

      The study identified the reinforcing mechanisms of smoking in interaction with ADHD
      medication. The findings will contribute to a better understanding of nicotine addiction and
      facilitate the development of targeted smoking cessation and prevention programs for
      individuals with ADHD and other people with deficiencies in impulse control and excessive
      risk taking.
    


Intervention name(s): ADHD medication; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days.; For the placebo condition, participants received placebo pills for two consecutive days.
Other intervention name(s): Dextroamphetamine; Amphetamine mixed salts; Atomoxetine; O-Methylphenidate; Lisdexamfetamine
Intervention MeSH terms: Methylphenidate; Amphetamine; Lisdexamfetamine Dimesylate; Dextroamphetamine; Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Smoking; ADHD; Stimulant medication
The Treatment of Clavicular Fractures
Condition: Displaced, Midshaft Clavicular Fractures
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two
      groups: conservative or operative treatment. The conservative arm is treated with a sling for
      6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.

      Patients are clinically and radiologically evaluated during 1 year. A economical analysis is
      also done.
    


Intervention name(s): osteosynthesis; sling
Intervention type(s): Procedure; Other
Intervention description(s): operative treatment; conservative treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV).
      Enrolled patients will receive standard treatment according to National Comprehensive Cancer
      Network (NCCN) guide line with or without combining MV injection. The efficacy and side
      effect will be compared between the two groups.
    

Detailed description: 
      In the study, after evaluation of the general and physical status, eligible patients will be
      enrolled and randomly assigned into two arms at an 1:1 ratio. In the control arm patients
      will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN)
      guide line (control group) and in experimental arm, patients will be receiving simultaneous
      standard therapy and injection of mix vaccine (MV). MV will be injected weekly till disease
      progression.

      Blood sample will be obtained at baseline and every week before MV injection for the
      assessment of clinical hematology, biochemistry measurements and immunology index (including
      immunoglobin, interleukin and interferon). Patients will be evaluated for toxicity throughout
      the study. Side effect, progression free survival, immunology index and general status will
      be recorded.
    

Intervention name(s): MV; standard treatment
Intervention type(s): Biological; Other
Intervention description(s): MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.; Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mix vaccine, breast neoplasms, immunotherapy
Iron Deficiency and TTG Normalization
Condition: Celiac Disease in Children
MeSH terms: Celiac Disease; Iron Deficiencies
Study type: Observational

Summary: 
      The investigators conducted a retrospective, observational cohort study which enrolled CD
      subjects aged 2-18y, diagnosed between Jan 2016 and Dec 2020. Demographic and laboratory data
      were collected at diagnosis and 1y after adherence to GFD. ID was determined according to
      hemoglobin and ferritin levels. The investigators compared CD subjects with and without ID at
      CD diagnosis in relation to TTG normalization at 1y.
    


Intervention name(s): Gluten free diet
Intervention type(s): Other
Intervention description(s): All subjects initiated a gluten free diet as mandated by their diagnosis of Celiac disease, regardless of the study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric patients diagnosed with Celiac disease
Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial
Condition: PONV
Study type: Interventional

Summary: 
      The aim of this study is to test the hypothesis that addition of dexmedetomidine to
      fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl
      bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing
      lumbar spine surgery.
    


Intervention name(s): dexmedetomidine; normal saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: PONV; IV PCA; dexmedetomidine; Female; non-smoking; lumbar spine surgery
Network Connectivity and Inhibitory Control Under Atomoxetin Challenge- A Pharmacological 'Resting State' and 'Inhibiton Task' Study in Patients With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 4

Summary: 
      Attention deficit /hyperactivity disorder (ADHD) is a disorder which manifests in childhood
      but often persists through adulthood. The most prominent symptoms in adults are inattention,
      emotional instability, disorganized behavior, impulsivity and restlessness, which cause
      several restrictions in different areas of life. It is suggested that those symptoms can be
      attributed to a general deficit in inhibitory control. This hypothesis is supported by
      several studies revealing that patients with ADHD show poor performance completing inhibitory
      control tasks.

      Furthermore, studies showed that a unique administration of atomoxetin (ATX) significantly
      improves inhibitory control in patients with ADHD as well as in healthy participtants. In
      contrast to other medication authorized for the treatment of patients with ADHD, does ATX has
      no risk for potential addiction. Due its indirect mode of action, ATX has a delayed effect
      occurence taking up to 2 weeks. However, this apects was unconsidered in those studies.

      Although we directly often associate failures in cognitive control with disruptions at
      prefrontal areas of the brain, there exists a specific brain network which is called the
      default mode network (DMN), which is suggested to be at least partly responsibe for the ADHD
      symptomatic.

      The following study is interested in which way a 2- week intake of ATX affects the DMN and
      surrounding networks in their connectivity during a inhibitory control task and during rest
      in patients with ADHD vs controls.
    


Intervention name(s): Atomoxetine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): 14-day treatment interval: first week 40 mg atomoxetine (one pill), second week 80mg atomoxetine (two pills); 14-day treatment interval: first week one placebo pill, second week two placebo pills
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Health Services Research
Keywords: Atomoxetin; fMRT
Evaluation of the Performance of the Motus Cleansing System (MCS)
Condition: CRC
Study type: Interventional

Summary: 
      The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the
      performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly
      prepared colons.
    

Detailed description: 
      Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in
      the Netherlands).

      Subjects who meet the eligibility criteria will be screened for study participation at a
      baseline visit(visit 1). Subject who is eligible to the study will required to follow a
      specific reduced preparation instruction starting 2 days prior to the colonoscopy with the
      Motus Cleansing System (MCS) procedure.

      Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and
      14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse
      Events (AE).
    

Intervention name(s): Motus Cleansing System (MCS)
Intervention type(s): Device
Intervention description(s): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Randomized, Open, Parallel, Controlled, Multi-center, Interventional, Cross-sectional Study to Evaluate the Detection Rate of Psoriatic Arthritis in Korean Moderate-to-severe Psoriasis Patients, With or Without Active Screening for Arthritis in Psoriasis (ASAP Study)
Condition: Psoriasis
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Study type: Interventional

Summary: 
      Primary objective To compare the detection rate of PsA with EARP screening versus detection
      rate of PsA without EARP screening in routine clinical practice in dermatological clinics
      amongst moderate to severe Korean Psoriasis (PsO) patients

      Endpoint:

      • Detection rate of PsA

      Secondary Objective To compare the sensitivity, specificity, positive predictive value (PPV)
      and negative predictive value (NPV) between EARP questionnaire (EARP group) and the
      investigator's judgement (Routine practice group) To describe the patient characteristics and
      disease severity between PsA and non-PsA patients

      Endpoint:

        -  Sensitivity, specificity, PPV and NPV

        -  Description of demographic characteristics, medications and PsO related characteristics
    


Intervention name(s): Routine practice groups; EARP group
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Routine practice groups; EARP group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To compare the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) between EARP questionnaire (EARP group) and the investigator's judgement (Routine practice group) To describe the patient characteristics and disease severity between PsA and non-PsA patients
Endpoint:
Sensitivity, specificity, PPV and NPV
Description of demographic characteristics, medications and PsO related characteristics
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PsA; EARP; Psoriasis; PsO; psoriatic arthritis
Vitamin Deficiency in Immigrants, a Treatment Study
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the efficacy of different doses of vitamin D in
      persons, immigrated to Sweden from Middle East or Africa, with decreased S vitamin D.
    

Detailed description: 
      The participants in the study have taken part in a previous screening study. They are now
      asked to participate in this treatment study. At a screening visit blood samples for vitamin
      D3 and PTH are collected. Data regarding previous fractures, life style, exposure for sun,
      clothes, diet, smoking and physical activities are collected. The Vitamin D value predict the
      treatment dose.
    

Intervention name(s): Cholecalciferol; Cholecalciferol; Cholecalciferol; Cholecalciferol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 000 IU daily i.e. 15 drops orally once daily for 12 weeks; 2000 IU daily i.e. 3 drops orally once a day for 12 weeks,; 2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,; 2000 IU daily i.e. 3 drops orally once daily for 12 weeks
Other intervention name(s): Vigantol Oil 20 000 IU/ml, drops for oral use, solution; Vigantol Oil 20 000 IU/ml, drops for oral use, solution; Vigantol Oil 20 000 IU/ml, drops for oral use, solution; Vigantol Oil 20 000 IU/ml, drops for oral use, solution
Intervention MeSH terms: Cholecalciferol; Vitamin D; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitamin D insufficiency; Cholecalciferol; D3; Parathyroid Hormone; 25-hydroxyvitamin D3; RDA, recommended daily intake (nutrition policy); Vitamin D; Hypovitaminosis-D; Pharmacologic treatment