bioihbjkbjnl/mcl2 huggingface dataset:
P Wave and QT Dispersion in Psoriasis
Condition: Arrhytmia in Psoriasis
MeSH terms: Psoriasis
Study type: Observational [Patient Registry]

Summary: 
      Background:

      Several reports have demonstrated an association between psoriasis and cardiovascular
      diseases. P wave dispersion (PWD) is the most important electrocardiographic (ECG) markers
      used to evaluate the risk of atrial arrhythmias. QT dispersion (QTD) can be used to assess
      homogeneity of cardiac repolarization and may be a risk for ventricular arrhythmias.

      Aim: To search PWD and QTD in patients with psoriasis. Methods: Ninety-four outpatient
      psoriasis patients and 51 healthy people were evaluated by physical examination, 12-lead ECG
      and transthoracic echocardiography. Severity of the psoriasis was evaluated by psoriasis Area
      and Severity Index (PASI).
    

Detailed description: 
      Ninety-four outpatient psoriasis patients and 51 healthy people were included in the study.
      Patients having systemic hypertension, diabetes mellitus, history of ischemic heart disease,
      significant valvular heart disease, chronic obstructive pulmonary disease, hypo or
      hyper-thyroidism, renal failure or any associated systemic disease were excluded. Diagnosis
      of psoriasis was confirmed by dermatological examination and/or punch biopsy. Severity of the
      psoriasis was evaluated by psoriasis area and severity index (PASI). Patients were evaluated
      by physical examination, 12-lead electrocardiography and transthoracic echocardiography.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diagnosis of psoriasis was confirmed by dermatological examination and/or punch biopsy.
Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to investigate the efficacy, safety and tolerability of SB-742457
      versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an
      experimental treatment which increases the levels of certain chemicals in the brain that are
      often decreased in patients with Alzheimer's disease.
    


Intervention name(s): SB-742457; Donepezil; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): investigational drug; comparator; comparator
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer's disease; Cognition; SB-742457
First-in-Human Single Ascending and Multiple Dose of GLPG0259
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)
      and multiple (MD) oral dose of GLPG0259 compared to placebo.

      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple
      oral administration will be evaluated, and, if applicable, the maximum tolerated dose
      determined.
    


Intervention name(s): GLPG0259; placebo; GLPG0259; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single ascending doses, oral solution; single dose, oral solution; multiple dose, oral solution, 5 days; oral solution, 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics
ALBI and PALBI Scores and HCC Prognosis
Condition: Hepatocellular Carcinoma (HCC) Prognosis
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      To compare the predictive ability of ALBI and PALBI grades with CTP and MELD scores.

      To investigate the efficacy of ALBI and PALBI grades for predicting the prognosis of HCC and
      overall survival among different modalities of treatment.
    


Intervention name(s): ALBI
Intervention type(s): Diagnostic Test
Intervention description(s): Albumin-Bilirubin and Platelet-Albumin-Bilirubin Grades for prognosis of HCC
Other intervention name(s): PALBI
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will include all patients diagnosed with HCC both males and females equal to or
        above 18 years old, attending the outpatient clinic or admitted at the inpatient section of
        Tropical Medicine and Gastroenterology Department, Sohag University Hospital
Evaluation of the BOKS Before-school Physical Activity Program
Condition: Overweight and Obesity; Affect; Physical Activity; Fitness
MeSH terms: Overweight
Study type: Interventional

Summary: 
      BOKS, Build Our Kids' Success, is a before-school physical activity program that has been
      implemented in over 2,000 elementary and middle schools. Students participate in the program
      for 12 weeks, two or three mornings per week for about 1 hour per session. This study if a
      non-randomized control trial seeking to 1) examine the extent to which participation in the
      before-school BOKS program improves, health, well-being, and performance, and 2) compare the
      results of a two-day-per-week versus a three-day-per-week program.
    


Intervention name(s): BOKS: 2 day a week before-school physical activity program; BOKS: 3 day a week before-school physical activity program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.; Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Overweight; Obesity; School; Physical Activity
Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe COPD.
Condition: COPD
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg
      Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with
      placebo once daily in patients with stable moderate to severe COPD.
    

Detailed description: 
      The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg
      Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with
      placebo once daily in patients with stable moderate to severe COPD.

      Patients who met all inclusion criteria will be randomized to receive double-blind treatment
      with Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily (n = 35) or
      placebo (n = 35) once daily for 4 weeks.

      Patients will be evaluated at 2 consecutive visits: screening & treatment visit (first visit)
      and after treatment visit (second visit).

      Spirometric measurements will be performed at pre-treatment during the first visit and
      post-treatment at two different time points (23 hr + 15 min and 23 hr + 45 min) during the
      second visit. The average of the values at 23 hr 15 min and 23 hr 45 min during the second
      visit will be defined as trough value.
    

Intervention name(s): Acetylcysteine/Doxofylline; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.; Placebo once daily for four weeks.
Other intervention name(s): Mucofix 1200/400 mg Effervescent Tablet
Intervention MeSH terms: Acetylcysteine; Doxofylline; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acetylcysteine/Doxofylline; Acetylcysteine; Doxofylline; Effervescent Tablet; COPD
A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the safety and efficacy of various doses of
      VI-0521 compared to both placebo, and the single-agent components that comprise each
      combination dose. This study will provide confirmatory data to demonstrate that doses of
      VI-0521 have efficacy that is greater than placebo and each of the single-agent components
      that comprise the combination dose.
    


Intervention name(s): VI-0521; VI-0521; topiramate; topiramate; phentermine; phentermine; VI-0521
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): phentermine 15 mg and topiramate 92 mg, po once daily; phentermine 7.5 mg and topiramate 46 mg, po once daily; topiramate 46 mg, po once daily; topiramate 92 mg, po once daily; phentermine 7.5 mg, po once daily; phentermine 15 mg, po once daily; placebo, po once daily
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
Condition: Obesity; Pre-Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The natural history of type 2 diabetes commonly follows a pattern of postprandial
      dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes.
      Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous
      study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical
      Western meal, investigators demonstrated that a food order in which protein and vegetables
      are consumed first, before carbohydrate, results in significant lowering of incremental
      glucose peaks compared to the reverse order. In the present study, investigators seek to
      expand on the previous findings to gain further insight into the impact of food order in
      individuals with pre-diabetes, using a meal with different macronutrient composition, in the
      setting of three meal patterns. The study is designed to be a simple, practical intervention
      that may have very significant clinical implications for prevention of diabetes in a large
      population at increased metabolic risk.
    


Intervention name(s): Food Order; Carbohydrate Last; Vegetables first
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables; protein and vegetables first, followed 10 minutes later by carbohydrate; vegetables first, followed 10 mins later by protein and carbohydrate.
Other intervention name(s): Carbohydrate First
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents
Condition: Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate in boys and girls the improvement in body composition under GH treatment in
      adolescents with CO-GHD who remain partially GHD after GH discontinuation.
    


Intervention name(s): Blood sample; Radiography
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Shock Waves on Tooth Movement and Miniscrew Stability
Condition: Mesial Movement of Teeth; Miniscrew Stability
MeSH terms: Mesial Movement of Teeth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The low-energy extracorporal shockwave is a scientifically approved method to activate
      respectively increase bone-turnover processes especially in orthopedic medicine. The aim of
      this clinical study is to apply this effect in orthodontic dentistry and evaluate the
      orthodontic tooth movement respectively miniscrew stability clinically.

      This randomized clinical study is carried out in orthodontic patients undergoing space
      closure therapy at the university clinic of dentistry. During this period the tooth movement
      rate as well as the miniscrew stability are evaluated consecutively chairside.
    


Intervention name(s): Extracorporeal shockwave therapy; ESWT placebo
Intervention type(s): Device; Device
Intervention description(s): 1000 impulses; 0 impulses, acoustic effect
Other intervention name(s): Orthogold 100 MTS; Orthogold 100 MTS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Velocity; Location; Periodontal status
Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System
Condition: Stroke
Study type: Interventional

Summary: 
      The use of virtual reality technology in a telerehabilitation service is not well established
      in Singapore. This feasibility trial aims to evaluate the benefits of using Jintronix to
      deliver a clinic-to-home, caregiver-supervised and individualised exercise telerehabilitation
      program to complement outpatient services and improve clinical outcomes for post-stroke
      users.
    


Intervention name(s): Jintronix Virtual Reality Telerehabilitation System
Intervention type(s): Device
Intervention description(s): System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.
Study team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.
Telemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training.
Other intervention name(s): Jintronix
Intervention model: Single Group Assignment
Intervention model description: Prospective open label study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation, Telerehabilitation, Virtual Reality
Preoperative Progression of Macular Holes
Condition: Macular Holes
MeSH terms: Retinal Perforations; Disease Progression
Study type: Observational

Summary: 
      Knowledge of the natural history and progression of macular holes is mainly limited to the
      studies from the pre-optical coherence tomography era. By observing macular holes
      preoperatively we are able to determine the extent of the preoperative macular hole
      progression.

      At our institution macular holes are treated in an elective setting. The majority of macular
      holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation
      followed by vitrectomy.

      We wish to observe the effect of time and cataract surgery on the progression of macular
      holes prior to vitrectomy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tertiary Ophthalmic University Center
      
Keywords: Macular Holes; Progression
A Comparison of Methylphenidate and Cognitive Behavioural Therapy for the Treatment of Binge Eating Disorder
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether methylphenidate is effective in the
      treatment of binge eating disorder, in a randomized controlled trial extended release
      methylphenidate versus cognitive behavioral therapy for binge eating disorder in overweight
      or obese adult females.
    

Detailed description: 
      Fifty-six adult female outpatients with binge eating disorder will receive 12 weeks of
      methylphenidate (dosage 18-72 mg) or 12 sessions of manualized cognitive behavioral therapy.
      Participants will complete interviewer-rated and self-report measures of eating, mood,
      attention, and personality features before treatment, after 6 weeks of treatment, immediately
      after treatment is completed, and 3 months after treatment is completed.
    

Intervention name(s): Methylphenidate; Cognitive Behavioral Therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): Weekly appointments with study psychiatrists for the first four weeks, and then biweekly appointments for the last eight weeks.
Intervention will consist of medication as well as components of "Med-Plus" treatment (e.g., medication management, general support, and compliance enhancement strategies).; Cognitive Behavior Therapy will include three phases:
Phase 1 undertakes to eliminate binge episodes and introduce a 'regular' pattern of eating;
Phase 2 aims to reduce food intake and restructure eating-related cognitions;
Phase 3 focuses upon relapse prevention
Other intervention name(s): TEVA-METHYLPHENIDATE ER-C
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation
Condition: Shoulder Dislocation
MeSH terms: Joint Dislocations; Shoulder Dislocation
Study type: Interventional

Summary: 
      Comparison of immobilization in internal versus external rotation after first time anterior
      shoulder dislocation.
    

Detailed description: 
      The purpose of this study is to compare immobilization in internal versus external rotation
      after first time anterior shoulder dislocation, and thereby increase our knowledge about the
      best standard of care.
    

Intervention name(s): External rotation shoulder sling; Internal rotation shoulder sling
Intervention type(s): Device; Device
Intervention description(s): The external rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 10 to 15 degrees of external rotation at the shoulder.; The internal rotation sling will be adjusted to position the injured upper extremity in 90 degrees of elbow flexion, 0 degrees of shoulder abduction and flexion, and 70 to 80 degrees of internal rotation at the shoulder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does the Use of a Videolaryngoscope Modifies Anesthetic Induction ?
Condition: Tracheal Intubation
Study type: Interventional

Summary: 
      Videolaryngoscopes become widely used. The aim of this study is to compare anesthetic
      induction when patients are tracheally intubated using a MacGraph Mac videolaryngoscope or a
      conventional MacIntosh laryngoscope.

      Tracheal intubation induces a nociceptive stimulation. Hypothesis is that the use of a
      videolaryngoscope induces a less pronounced nociceptive stimulation and, consequently, that
      it modifies the anesthetic drugs requirement. .
    

Detailed description: 
      All patients will received a standardized anesthetic procedure : combined closed-loop
      anesthesia system using bispectral index as control variable and two
      proportional-differential control algorithms, a propofol and a remifentanil target-controlled
      infusion system. The effectiveness of such a closed-loop anesthesia system has been
      demonstrated in a prospective, randomized study.

      Patients will be randomized in two groups : intubation using a conventional MacIntosh
      laryngoscope or intubation using a videolaryngoscope.

      If our hypothesis is confirmed, the required concentration of remifentanil, an opioid agent,
      will be reduced in the group using a videolaryngoscope.
    

Intervention name(s): Tracheal intubation; Propofol and remifentanil anesthesia
Intervention type(s): Procedure; Drug
Intervention description(s): Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope; The standardized anesthetic procedure used a closed-loop anesthesia system with bispectral index as control variable and with two proportional-differential control algorithms, one for propofol target-controlled infusion system and one for remifentanil target-controlled infusion system.
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Spinal Magnetic Stimulation in Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      It involves delivering a train of magnetic pulses, 5 at each time, to the brain. In the
      present study, we are using the same method to treat severe pain due to nerve conditions. You
      will be given up to 1000 pulses in total over the spine in the lower back (Spinal Magnetic
      Stimulation or SMS). Each train will be given in 10-second intervals. You will have SMS on a
      single day. You will be given SMS pulses at 1 or 10 per second. No stimulation will be given
      over the head.

      You will be assessed before and after the study for up to 1 week. Your usual medical
      treatment will be continued
    

Detailed description: 
      You must be aware of that this is a placebo-controlled trial. This means that you may either
      receive real SMS or sham SMS. The latter involves a harmless process of ineffective
      stimulation, designed for comparison with real SMS. Whether you receive either form of
      treatment will be assigned randomly, and there will be a 50% chance of being assigned to
      either.
    

Intervention name(s): magnetic stimulation; Magnetic Stimulation with tilted coil
Intervention type(s): Device; Device
Intervention description(s): SMS was delivered with a repetitive magnetic stimulator connected to a figure of eight coil capable of delivering a maximum output of 2 Tesla per pulse. The coil measured 90 mm in each wing and was centered over the surface landmark corresponding to the cauda equina region. SMS was performed with the patient lying comfortably in the prone position and a soft pillow supported the lower abdomen. The coil was placed flat over the back with the handle pointing cranially. Each patient on active treatment received 200 trains of 5 pulses delivered at 10 Hz, at an interval of 5 s between each train. As this was a pilot study, each only received 1000 pulses in a single session.; The placebo arm consisted of 'sham' SMS delivered with the coil angled vertically and one of the wing edges in contact with the stimulation point. As this coil type allows maximum magnetic flux at the center of the intersection, we believe minimum or no stimulation was effected at the edge of the coil in contact with the patient. Stimulation parameters and duration were unchanged in this arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: magnetic stimulation; neuropathic pain; spinal; lower limb; clinical trial