bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Examine the Progression of Attention-Deficit Hyperactivity Disorder (ADHD) Drug Treatment and to Analyze Associated Factors
Condition: Attention-deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The purpose of this observational study is to explore the efficacy of methylphenidate
      hydrochloride in children and adolescents diagnosed with attention-deficit hyperactivity
      disorder (ADHD) by Kiddie-scheduled for affective disorders (SADS)-present and life time
      version (K-SADS-PL).
    

Detailed description: 
      This is a 1-year open-label (all people involved know the identity of the assigned drug),
      multicenter, single arm, prospective, observational study to explore under natural setting
      the efficacy of drug treatment in children and adolescents diagnosed with ADHD by K-SADS-PL
      (K-SADS-PL is a tool used for ADHD diagnosis. Patient may be diagnosed with ADHD by using
      K-SADS-PL to check if he or she meets the criteria according to Diagnostic and Statistical
      Manual of Mental Disorders & edition (DSM-IV). After obtaining informed consent, investigator
      will prescribe stimulant or non-stimulant ADHD treatment medications (ie, Immediate release
      [IR]/extended release [ER]/osmotic release oral system (OROS) methylphenidate, atomoxetine).
      Efficacy and safety assessments will be performed at 4, 12, 24, 36, and 52 weeks after the
      first day of giving study drug. Progression of symptom improvement and adherence will be
      investigated and associated variables (ie, demographic, clinical, familial and treatment
      factors) will be analyzed.
    

Intervention name(s): Methylphenidate hydrochloride; Atomoxetine
Intervention type(s): Drug; Drug
Intervention description(s): Form = tablet, route = oral, administered as a flexible dosage; Form = tablet, route = oral;
Intervention MeSH terms: Methylphenidate; Atomoxetine Hydrochloride
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents of age between 6 and 15 years (in Korean age) who are dianosed
        with ADHD by K-SADS-PL but have never received any of methylphenidate or atomoxetine within
        3 months prior to screening.
      
Keywords: Attention-deficit hyperactivity disorder; Developmental disorder; Atomoxetine; Methylphenidate; Psychiatric disorder
Rhizarthrosis Study
Condition: Rhizarthrosis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Rhizarthrosis is the wear of the thumb saddle joint. It is a very common disease affecting up
      to 25% of postmenopausal women. There are currently various conservative and surgical methods
      available for treatment. If conservative treatment does not lead to freedom from pain, one of
      the surgical methods can be used, such as metacarpal extension osteotomy, trapeziectomy with
      or without ligamentoplasty, trapeziometacarpal arthrodesis, prosthesis implantation and
      various forms of interposition arthroplasty . Despite the high satisfaction rate of up to 95%
      after surgical treatment, the anatomy of the carpus is irreversibly destroyed . Apart from
      that, these operations are also associated with corresponding complications and
      post-operative immobilization of several weeks. Thus, a minimally invasive treatment method
      with a corresponding success rate would be of great advantage.

      Hypothesis:

      By infiltrating and filling the joint with Platelet-Rich Plasma (PRP), fat or a combination
      of both, the pain of rhizarthrosis can be reduced.

      Aim of the study:

      The aim of the announced doctoral thesis is to investigate the effect of PRP, lipofilling and
      its combination on arthroses of the thumb saddle joint after a single joint injection and to
      compare it with a control group.It is to be proven that PRP, fat and their combination lead
      to a different degree of pain relief compared to the control group due to the expansion of
      the joint space and the associated filling effect.
    


Intervention name(s): Infiltration with PRP; Infiltration with Fat; Infiltration with PRP and Fat; Infiltration with NaCl
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Infiltration with 1.5 ml PRP; Infiltration with 1.5 ml Fat; Infiltration with 0.75 ml PRP and 0.75 ml Fat; Infiltration with 1.5 ml NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rhizarthrosis
Investigation of Correlation Between Concentrations of Glucose in Blood and Interstitial Fluid in Type 1 Diabetics
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This is a mono-centre trial performed at the Center for Clinical Research at the Medical
      University Graz. There will be a screening information and a study visit.In the study visit
      arterialized venous blood glucose values will be monitored and subcutaneous sampling of
      interstitial fluid (ISF) with microdialysis for glucose determination will be performed.
      Additionally to the laboratory analysis of the subcutaneous glucose samples, the glucose will
      be measured with extracorporeal on-line sensors and two marketed devices (Guardian RT and
      Glucoday S).The study visit will last 30 hours starting with the insertion of microdialysis
      catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the
      Glucoday S system and Guardian RT system. The primary hypothesis of the study is:
      Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood
      glucose concentration profile in type 1 diabetic subjects.
    


Intervention name(s): Microdialysis; Guardian RT; Glucoday S
Intervention type(s): Procedure; Device; Device
Observational model: Defined Population
Time perspective: Other
Keywords: microdialysis; subcutaneous adipose tissue; glucose sensor; glucose monitoring; type 1 diabetes; Guardian RT; Glucoday S
Thorough QT (TQT) Study of TD-4208 in Healthy Subjects
Condition: Cardiac Repolarization in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate if TD-4208, an investigational drug being developed
      to treat people with chronic obstructive pulmonary disease (COPD), has any effect on the
      electrical activity of the heart.
    


Intervention name(s): TD-4208 175 mcg; TD-4208 700 mcg; Placebo for TD-4208; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): via nebulizer; via nebulizer; via nebulizer; oral
Other intervention name(s): revefenacin; revefenacin; Avelox
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Thorough QT (TQT); cardiac safety
A Study to Evaluate the Effect of Lycomato on Skin Attributes in Healthy Participants.
Condition: Skin
Study type: Interventional

Summary: 
      The study will be performed with oral gels, with up to 55 study subjects who meet the
      inclusion and non-inclusion criteria required. Study subjects will be instructed to use the
      products during 12 weeks and they will be assessed and supervised throughout the study by
      clinic technicians, in order to check for possible adverse events. Efficacy documentation
      through digital photography, instrumental measurements with the devices Cutometer® MPA 580
      and Tewameter®, image acquisition with Visia-CA® as well as self-assessment through
      questionnaires will be carried out.
    


Intervention name(s): Lycomato
Intervention type(s): Dietary Supplement
Intervention description(s): Lycomato sof gels
Intervention MeSH terms: Lycopene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Persistence of Airway Inflammation and Remodeling in Subjects With Symptomatic or Complete Asthma Remission
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study aims at determining the patterns of asthma remission, the prevalence of these
      different patterns, the various factors associated with such remissions and possible
      recurrences of asthma, in order to determine the mechanisms involved in these processes.

      The investigators therefore want to document these specificities in subjects in complete
      remission of their asthma, and those in only symptomatic remission of their asthma, in
      comparison with mildly symptomatic asthmatic subjects and healthy controls.
    

Detailed description: 
      Primary Outcome Measures :

        -  Airway inflammation (% induced sputum eosinophils)

      Secondary Outcome Measures:

        -  Perception of induced respiratory symptoms

        -  Airway response to methacholine and AMP, and perception scores

        -  Diurnal variation in Peak Expiratory Flows

        -  Profile of regulatory T cells in the peripheral blood

        -  Changes in these parameters over time (baseline, 6 months, 1 and 2 years)
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects wiil be offered to volunteer from advertisements in newspaper. Subjects with
        asthma or in remission of asthma from primary care clinics will be offered to participate.
      
Biospecimen description: 
      Serum
    
Keywords: remission of asthma
A Study of JNJ-64565111 After Single Subcutaneous Administration at Different Injection Sites in Otherwise Healthy Overweight/Obese Adult Participants and a Study of JNJ-6456511 in Otherwise Healthy Obese Adult Participants After Multiple Dose
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of JNJ-64565111 between
      subcutaneous (SC) administrations in the upper arm versus the abdomen, and between SC
      administrations in the thigh versus the abdomen in otherwise healthy overweight/obese
      participants (Part A) and to assess the gastrointestinal tolerability of JNJ-64565111
      following a dose titration in otherwise healthy obese participants at 6 weeks (Part B).
    


Intervention name(s): JNJ-64565111
Intervention type(s): Drug
Intervention description(s): JNJ-64565111 SC will be administered on Day 1 of Treatment Periods 1, 2 and 3 as per the assigned treatment sequence in Part A and as ascending doses on Days 1, 8, 15, 22, 29 and 36 in Part B.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of 6 Week Hamstring Exercise Programs on Hamstring Muscle Strength
Condition: Hamstring Injury
Study type: Interventional

Summary: 
      This study aims to compare the effect of two hamstring strengthening programs on hamstring
      muscle strength in university students. 60 participants will be recruited for this study.
      They will be randomly assigned to one of two 6-week hamstring strengthening programs, namely
      the single leg bridge exercise and the Nordic hamstring exercise protocol, and one control
      group. Eccentric and isometric hamstring strength, gluteal strength and will sprint speed
      will be measured before and after the intervention.
    

Detailed description: 
      Participants will be recruited from the local university sports clubs. Club chairpersons will
      be asked to send an email to club players. Players interested in participating in the study
      will be asked to attend a meeting where the study will be explained to them. Those who were
      interested will then be assessed for inclusion and exclusion criteria.

      Group allocation:

      A four block randomization method will be used to allocate participants to the Nordic
      hamstring exercise protocol or the single leg bridge protocol.

      Interventions:

      The Nordic hamstring exercise program or the single leg bridge program.

      Testing procedure:

      The eccentric strength of the participants' hamstrings will be recorded before and after the
      exercise intervention.

      A 10 point visual analogue scale will be used to record the level of muscle soreness
      experienced after each training session.
    

Intervention name(s): Nordic hamstring exercise program; Assisted nordic hamstring exercise program
Intervention type(s): Other; Other
Intervention description(s): Week 1 - 1 session per week consisting of 2 sets of 5 reps of the exercise Week 2 - 2 sessions per week consisting of 2 sets of 6 reps of the exercise Week 3 - 3 sessions per week consisting of 3 sets of 6 reps of the exercise Week 4 - 3 sessions per week consisting of 3 sets of 8 reps of the exercise Weeks 5 and 6 - 3 sessions per week consisting of 3 sets of the exercise. Set 1 with 12 reps, set 2 with 10 reps and set 3 with 8 reps.; Week 1 - 1 session per week consisting of 2 sets of 5 reps of the exercise Week 2 - 2 sessions per week consisting of 2 sets of 6 reps of the exercise Week 3 - 3 sessions per week consisting of 3 sets of 6 reps of the exercise Week 4 - 3 sessions per week consisting of 3 sets of 8 reps of the exercise Weeks 5 and 6 - 3 sessions per week consisting of 3 sets of the exercise. Set 1 with 12 reps, set 2 with 10 reps and set 3 with 8 reps.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Eccentric hamstring strength; Nordic hamstring exercise
WEB Clinical Assessment of IntraSaccular Aneurysm Therapy
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      The objective of this clinical study is to evaluate clinical utility of the WEB Aneurysm
      Embolization System used to embolize intracranial aneurysms
    

Detailed description: 
      The following parameters will be evaluated as part of this study:

        -  Aneurysm morphology

        -  Aneurysm size

        -  For ruptured aneurysms: Hunt and Hess Classification of Subarachnoid Hemorrhage (SAH)

        -  Size of the embolization device(s) used in the procedure

        -  Intra-procedural assessment of aneurysm occlusion and flow stasis

        -  Degree of aneurysm occlusion post-procedure (percentage occlusion, Raymond Scale and
           other scores as appropriate)

        -  Aneurysm occlusion durability

        -  Recanalization rate

        -  Device-related changes in Modified Rankin Scale from baseline

        -  Complications/adverse events

        -  Rebleed/new bleed
    

Intervention name(s): Intracranial aneurysm embolization
Intervention type(s): Procedure
Intervention description(s): Treatment of intracranial aneurysms
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with:

        - Diameter and width of the aneurysm is appropriate size for treatment with the WEB
        Aneurysm Embolization System per device Instructions for Use
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
Condition: Enuresis; Nocturnal Enuresis; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Nocturnal Enuresis
Study type: Interventional

Summary: 
      This is a randomized, double blind, placebo controlled study of the effect of Sacral
      Transcutaneous Electric Nerve Stimulation (TENS) in fifty-two children with monosymptomatic
      nocturnal enuresis (MNE).
    

Detailed description: 
      Objectives:

      Nighttime urinary incontinence (enuresis) is seen by 5-10% of children from six to fifteen
      years. Enuresis is a socially and psychologically stressful condition that can lead to
      bullying and low self esteem. Today the condition is treated with desmopressin or bells, that
      awake children at nighttime urination. One third of children suffering from enuresis are
      refractory to first line of treatment. Transcutaneous Electric Nerve Stimulation (TENS) has
      been documented efficacious on symptoms in children with daytime incontinence. Little is
      known regarding the effect of TENS on monosymptomatic nocturnal enuresis (MNE). The aim of
      our study is to investigate the effect of TENS on children diagnosed with MNE.

      Methods:

      This is a randomized, double blind, placebo controlled study of the effect of TENS in
      fifty-two children with MNE. The study period is from September 2015 to September 2016. The
      children recruited will receive TENS one hour during daytime and one hour during sleep for a
      total treatment period of ten weeks. The surface electrodes will be placed on the skin over
      s2-s3. TENS is safe and not associated with adverse effects.

      Expected results:

      The investigators hypothesize a reduction in number of wet nights in the enuretic children
      receiving active TENS. If TENS proves effective in children with enuresis it will be
      implemented as part of enuresis treatment in the clinical practice.
    

Intervention name(s): Transcutaneous Electric Nerve Stimulation (TENS) - active; Transcutaneous Electric Nerve Stimulation (TENS) - placebo
Intervention type(s): Device; Device
Intervention description(s): TENS is a non-invasive method using surface electrodes. Except a few cases with local skin irritation in the area where the electrodes are applied, there is no evidence of side effects of TENS treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Laparoscopic Internal Retractor Device
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional

Summary: 
      The purpose of this study is to determine the safety and efficacy of the Endograb system
      which is an internal laparoscopic retractor device. This retractor device is inserted into
      the abdominal cavity through one of the 5 mm trocars and obviates the need for a separate
      dedicated trocar for retraction. Therefore enables the reduction of the number of abdominal
      incisions in a laparoscopic operation.
    


Intervention name(s): Gallbladder retraction
Intervention type(s): Device
Intervention description(s): The gallbladder will be retracted using the Endograb retractor
Other intervention name(s): Endograb
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholecystectomy; Cholecystectomy, Laparoscopic; Laparoscopy
Assessment of the Effect of Naltrexone on Lofexidine Single Dose Pharmacokinetics in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, open-label, single-arm study with two single doses of lofexidine and multiple
      doses of naltrexone in healthy adult subjects to determine the effect of naltrexone on the
      single dose pharmacokinetics of the oral lofexidine formulation.
    

Detailed description: 
      Subjects will be confined to an inpatient facility for a total of 14 nights and 15 days.
      Subjects who successfully complete screening will report to the inpatient facility (Day -1).
      At Day 1 all subjects will receive the first single, oral dose of 0.4 mg lofexidine HCl (two
      0.2 mg tablets) dosed with 240 mL of water (no food). The lofexidine dose will be followed by
      a 74-hour interval before beginning naltrexone daily dosing on Day 4 .The first naltrexone
      administration on Day 4 will be at a dose of approximately 25 mg QD, with subsequent doses on
      Days 5 to 13 at 50 mg QD. On Day 11, the second single dose of lofexidine (0.4 mg) will be
      administered and followed by the daily administration of the naltrexone dose (50 mg). The
      daily administration of naltrexone dose (50 mg) will continue on Day 12 and Day 13.After each
      administration of lofexidine on Day 1 and Day 11, fingerstick blood samples will be collected
      for lofexidine pharmacokinetic (PK) analysis before dosing and after dosing at multiple time
      points.Safety will be assessed by recording adverse events (AEs), measuring vital signs
      (blood pressure and pulse rate) and clinical laboratory tests (chemistry, hematology, and
      urinalysis), recording 12-lead safety and Holter electrocardiograms (ECGs), and performing
      physical exams.
    

Intervention name(s): Lofexidine + Naltrexone
Intervention type(s): Drug
Intervention description(s): Lofexidine HCl (two 0.2 mg tablets) will be administered as a single oral dose (0.4 mg) on Day 1 and on Day 11.Commercially available naltrexone HCL tablets will be administered as a single oral 25 mg dose on Day 4 and as a single oral 50 mg dose on Days 5 through 13. On Day 11 administration of both naltrexone and lofexidine will occur. Dose administration times for each drug are to be standardized for all treatment days. The scheduling of the naltrexone dose is to be standardized so that the naltrexone dose is administered 2 hours after the lofexidine dose on Day 11 when both drugs are administered.
Other intervention name(s): Lofexidine HCL; Naltrexone HCL
Intervention MeSH terms: Lofexidine; Clonidine; Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteer
A Comparison of the Effect of Warm and Cold Water Exercise Training on Vascular Function in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Warm water based cycling exercise training would more favorable than cold water based cycling
      exercise training and land based cycling exercise in vascular function in type 2 diabetic
      patients.
    


Intervention name(s): Warm water exercise; Cold water exercise; Land based cycling exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Warm water based cycling exercise training program will be based on cycling in warm water (temperature 34◦C ). Warm water exercise will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.; Cold water based cycling exercise training will be based on cycling in cold water (temperature 20◦C ). Cold water exercise will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.; Land based cycling exercise training will be based on ride a bicycle ergometer (Monark 894e, Sweden). Land based cycling exercise training will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Vascular Function; Water Exercise; Warm Water; Cold Water