bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)
Condition: Attention Deficit Disorder With Hyperactivity; Methylphenidate; Pharmacogenetics
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The noradrenergic system plays a known role in attentional systems and suspected causal role
      in attention deficit/hyperactivity disorder(ADHD).Methylphenidate also has been suspected as
      a inhibitor of norepinephrine transporter(SLC6A2). The investigators hypothesis is that
      norepinephrine transporter polymorphism is associated with responses and adverse effects of
      OROS-methylphenidate in treatment of ADHD.
    


Intervention name(s): norepinephrine transporter polymorphism,
Intervention type(s): Genetic
Intervention description(s): OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism
Other intervention name(s): OROS methylphenidate (Concerta) monopharmacotherapy; dose : 18-54mg; duration : 8 weeks; genotyping : norepinephrine transporter (SLC6A2) polymorphism
Intervention MeSH terms: Norepinephrine; Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD,; norepinephrine transporter; pharmacogenetics
Fluid ORiented Therapy for yoUNg Asa 1patients
Condition: Hemodynamics
Study type: Interventional

Summary: 
      In this retrospective analysis investigators will study the effects of using a minimally
      invasive hemodynamic monitoring (FloTrac-Edwards) on postoperative outcomes. Participants
      will compare a control group to a case group; in both groups ASA 1 patients suffering from
      advanced ovarian cancer underwent radical cytoreductive surgery. In case group hemodynamic
      was managed by using the FloTrac system; in the control group a standard hemodynamic
      monitoring was used.
    


Intervention name(s): FloTrac
Intervention type(s): Device
Intervention description(s): For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Goal Directed Fluid Therapy
A Single-Center Open-Label Study of 1064 nm for Nonablative Skin Rejuvenation
Condition: Skin Pigment; Photoaging
MeSH terms: Pigmentation Disorders
Study type: Interventional

Summary: 
      The purpose of this investigation is to evaluate the safety and efficacy of the Cutera excel
      V Laser Genesis procedure utilizing the 1064nm laser for skin rejuvenation.
    

Detailed description: 
      This is a single-center prospective, open-label uncontrolled study in 15 male or female
      subjects, age 35 to 55 years who desire non-ablative laser treatment for facial
      photo-rejuvenation, specifically improvement of rhytides, lentigines, erythema,
      telangiectasia and skin texture. Subjects will receive laser treatments and complete a follow
      up visit 12 weeks post-final treatment.
    

Intervention name(s): excel V Laser
Intervention type(s): Device
Intervention description(s): excel V Laser Genesis procedure utilizing 1064 nm laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
European Project on Nutrition in Elderly People
Condition: Aging
Study type: Interventional

Summary: 
      NU-AGE is a large multidisciplinary consortium (31 partners, from 17 EU countries) involving
      nutritionists, bio-gerontologists, immunologists and molecular biologists from the most
      prestigious institutions in Europe, 5 large food industries, 8 traditional food companies and
      1 biotech SME, SPES GEIE and CIAA, covering the SME Food Industrial Associations of 13
      European countries and the European Confederation the food and drink industry. NU-AGE aims
      are: 1. to counteract the physical/cognitive decline occurring in the elderly as a
      consequence of the progressive alteration of different organs/systems (immune and
      cardiovascular systems, bone, brain, muscle and intestine) by one year elderly-tailored whole
      diet intervention on 1250 healthy elderly men and women aged 65-79 years (half diet, half
      control) from 5 different EU regions; 2. to assess the effect of the newly designed food
      pyramid specific for 65+ EU citizens on the different organs/systems using a large set of
      biomarkers related to nutrition and aging, with particular attention to the low grade,
      chronic, systemic inflammatory status named inflammageing, a major risk factor for common
      age-related diseases; 3. to perform in a subgroup of 120 subjects in depth studies and high
      throughput "omics" to identify cellular/molecular targets/mechanisms responsible for whole
      diet effect; 4. to perform genetic and epigenetic studies to assess the role of individual
      variability on the response to diet; 5. to adopt an integrative comprehensive approach
      (systems biology) to analyze the whole set of data. The results of dietary intervention will
      be used to develop elderly-tailored prototypes of functional foods and to improve traditional
      foods. The research activity will be accompanied and followed by a strong activity of
      dissemination and industrial exploitation to support EU strategies on nutritional
      recommendations, thus contributing to the implementation of legislation related to
      nutritional and health claims for elderly in Europe.
    


Intervention name(s): Dietary Intervention
Intervention type(s): Dietary Supplement
Intervention description(s): nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth
Other intervention name(s): NU-AGE diet; NU-AGE whole diet approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition; Dietary intervention; Aging; Inflammation; Elderly; Europe
Is Analgesic Effect of Low Dose Ketamine-midazolam the Same as Morphine
Condition: Closed Multiple Fractures of Upper and Lower Limbs
MeSH terms: Fractures, Multiple
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on
      pain control in trauma patients with closed limb fracture(s); and also compared the incidence
      of adverse events (mainly cardio pulmonary ) between two groups.
    

Detailed description: 
      this prospective, single blind, noninferiority trial randomized consecutive ED patients aged
      18 to 60 years to two groups: receiving either 300-500 mcg ketamine plus 0.03 mg midazolam,
      or 0.05 to 0.1 mg morphine. Visual analogue score and adverse events were carefully verified
      during an interval of 30 minutes.

      Two hundreds, thirty six patients were selected, among whom were 207 males (87.3%), and 29
      females (12.2%). The average age was 29±2, with extremes of 60 years and 18 years.the
      patients were divided into two groups: G1: 116 patients receiving ketamine-midazolam and G2:
      120 patients receiving morphine alone.
    

Intervention name(s): Ketamine-midazolam; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.; morphine 0.05 mg/kg
Other intervention name(s): Ketaral; Avinza
Intervention MeSH terms: Midazolam; Ketamine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ketamine,; Midazolam,; Morphine,; visual analogue score
Radiotherapy With Cisplatin Versus Radiotherapy With Cetuximab After Induction Chemotherapy for Larynx Preservation
Condition: Larynx Cancer; Hypopharynx Cancer
MeSH terms: Laryngeal Neoplasms; Laryngeal Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Larynx preservation remains a very challenging approach in patients with larynx/pharynx
      cancer. A first attempt consisted of induction chemotherapy followed in good responders by
      irradiation. This approach allowed to preserve 60 % of the larynx without any significant
      difference in survival. The second attempt consisted of concurrent chemo-irradiation. This
      approach provided a higher larynx preservation rate but survival remained unchanged and
      mucosal toxicity was also higher. A third approach is currently under evaluation: induction
      chemotherapy followed by concurrent chemo-irradiation in good responders.
    

Detailed description: 
      At ASCO 2004 there were 3 major presentations issuing an increasing in survival:

        -  the update of the MACH-NC meta-analysis showed that actually only concurrent
           chemo-irradiation trials found a significantly improved survival (in particular the
           addition of cisplatinum alone to radiotherapy)

        -  the addition of docetaxel to the cisplatinum-5FU regimen (TPF) when compared with
           cisplatinum--5FU (PF)

        -  the addition of cetuximab to irradiation

      On this basis we decided to carry-out a randomized phase II for previously untreated patients
      requiring a total laryngectomy:

      All patients after a complete work-up including a CTscan will receive 3 cycles of TPF(T: 75
      mg/m², P: 75 mg/m² and 5FU 750 mg/m²).

      Patients with response over 50 % (endoscopy and CTscan) will be randomized to receive either
      irradiation (70 Gy) and cisplatinum (100 mg/m² on D1, D22 and D43) or irradiation (70 Gy)
      with cetuximab (loading dose of 400 mg followed by weekly 250 mg for a total of 8 cycles.

      Patients with less than 50% decease in tumour volume after TPF, patients with residual or
      recurrent disease after either RT-CDDP or RT-cetuximab will get salvage total laryngectomy.
    

Intervention name(s): cetuximab; Cisplatin; Radiotherapy 70 Gy, 35 fractions
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: larynx cancer; hypopharynx cancer; larynx preservation; concomitant radiochemotherapy; cisplatin; cetuximab; randomized trial
A Comparative Study of Effects of Berry and Grain Products on Postprandial Glycemic Response in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to determine the 2 hour glycemic responses of two bread products and one
      dried lingonberry product. The average postprandial response of each product is compared with
      glycemic response after ingestion of control solution with a similar carbohydrate content
      (glucose, glucose-fructose) as the provided by the respective test product.
    


Intervention name(s): Berry product; Bread product; Bread product; Glucose control solution; Glucose-fructose control solution
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Sugar infused dried lingonberry; Brown bread; Whole grain bread; Glucose solution with a corresponding amount of carbohydrates as provided by the bread test products; Control solution with a similar carbohydrate content as provided by the dried lingonberry test product
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease
Condition: Uremic Pruritus
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Pruritus
Study type: Interventional

Summary: 
      The purpose of this study was to confirm the efficacy of NB UVB phototherapy in alleviating
      uremic pruritus and investigate the association between improvement of pruritus and change of
      serum parameters, including routine biochemical data, immune profile and dialysis adequacy.
    

Detailed description: 
      We would conduct a randomized study to evaluate the effect of NB UVB therapy on uremic
      pruritus. The intensity of pruritus will be evaluated using visual analog scale (VAS) score
      (0 [no pruritus]-10 most severe pruritus]) and a detailed questionnaire assessing various
      characteristics of pruritus at baseline . The patients with the intensity of pruritus VAS
      score more than 5 will be randomized to narrow band UVB and control group. Phototherapy was
      administered to the whole body surface 2-3 sessions per week for total 18 sessions in a UV
      irradiation cubicle. The dose increased from 210mJ/cm2 .Doses were increased by 10 % at every
      session. The control group received time-matched exposures to long-wave ultraviolet light.
      The investigator will determine the pruritic intensity at baseline every 3 sessions by VAS
      score and by detailed questionnaire at baseline and after 18 sessions. The blood sample will
      also be collected at baseline and after treatment to determine factors associated with
      improvement.
    

Intervention name(s): Narrow band UVB phototherapy , long wave UVA phototherapy
Intervention type(s): Device
Intervention description(s): A UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. ) and 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Continuous Positive Airway Pressure (CPAP) Promotion And Prognosis - the Army Sleep Apnea Program (ASAP)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of Eszopiclone in improving short and
      intermediate-term compliance with continuous positive airway pressure (CPAP) in patients
      newly diagnosed with obstructive sleep apnea (OSA).
    

Detailed description: 
      CPAP is the treatment of choice for patients with OSA. However, patients are frequently
      intolerant of this therapy initially. After continued use, tolerance is achieved. However,
      this initial discomfort or intolerance frequently leads to a patient-initiated
      discontinuation of therapy. It has been shown that CPAP use at 1 month predicts use at 6
      months and 1 year. Patients who initially struggle with or are intolerant of CPAP frequently
      abandon therapy and are unlikely to use it long term. To prevent this, sleep physicians often
      prescribe short courses of sedatives to help improve initial tolerance and promote better
      compliance with therapy. However, the effectiveness of this practice has not been validated
      in a clinical trial. Compliance, in reference to this study is the willingness of the
      patients to follow the prescribed course of treatment.
    

Intervention name(s): Eszopiclone; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): Eszopiclone 3mg orally at bedtime for 14 nights; Matching placebo
Other intervention name(s): Lunesta
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Obstructive Sleep Apnea; Continuous Positive Airway Pressure; CPAP Compliance; Non-benzodiazepine hypnotics
Study to Define the Electrocardiogram Effects of a Single Dose of LX4211 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is to investigate the effects of higher doses of LX4211 (800 mg and 2000
      mg) do not differ from placebo in the mean change in QTcI from Baseline in healthy subjects.
    


Intervention name(s): LX4211 800 mg; LX4211 2000 mg; moxifloxacin 400 mg; LX4211 Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
Condition: Renal Impairment; Renal Insufficiency; Kidney Disease; Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, parallel-group study to compare the pharmacokinetics and
      pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with
      severe renal impairment and matched healthy volunteers with normal renal function.
    


Intervention name(s): IDN-6556
Intervention type(s): Drug
Other intervention name(s): emricasan; PF-03491390
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; pharmacodynamics; renal impairment
The Influence of a High Intensity Physical Activity Intervention on a Selection of Health Related Outcomes: An Ecological Approach
Condition: To Assess the Impact of the HIT Intervention on Physiological Responses; To Assess the Role of a Secondary High School as a Setting for Promoting Healthy Eating and PA Behaviours; To Determine the Associations Between CVD Risk Factors at Baseline in 15 - 18 Year Old Youth
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a High Intensity exercise intervention can
      elicit cardiovascular disease protection in adolescents.
    


Intervention name(s): High Intensity Exercise
Intervention type(s): Behavioral
Intervention description(s): In this study, participants will be instructed to sprint maximally for a period of 30 seconds. Following 30s rest, the participants will be instructed to repeat this procedure a further 3 times. This equates to 2 minutes of maximal effort sprinting interspersed with 2 minutes recovery. Participants will be requested to perform this protocol 3 times weekly. Training progression will be implemented by increasing the number of repeats from four repetitions during weeks 1 and 2, to five repetitions during weeks 3 and 4, to six repetitions during weeks 5 and 6. Finally, during week 7 participants will still perform six repetitions but interspersed by only 20 s recovery.
Primary purpose: Prevention
Keywords: Public Health; Biochemistry; Ecological
Vitamin D and Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Stroke remains one of the most devastating neurological diseases, often causing death, or
      gross physical impairment. It is the second most common cause of death worldwide and a major
      cause of acquired disability in adults.Vitamin D deficiency has been reported to contribute
      to the risk of cardiovascular disease especially stroke.
    

Detailed description: 
      This case -control observational prospective study will conducted on fifty patients with
      first -ever acute onset stroke within seven days (25 patients with hemorrhagic stroke and 25
      patients with ischemic stroke )
    

Intervention name(s): Vit D
Intervention type(s): Dietary Supplement
Intervention description(s): It is to examine the relationship between serum 25 (OH) D levels and Stroke either ischemic or hemorrhagic types
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with first -ever acute onset stroke within seven days
      
Keywords: Vitamin D; Stroke; Parathormone
Which is More Effective in Management of Bruxism: Botox or Occlusal Splints
Condition: Bruxism
MeSH terms: Bruxism
Study type: Interventional

Summary: 
      The aim of this study is to compare the efficacy of Botulinum toxin (Botox) and traditional
      occlusal splints for the management of bruxism in edentulous patients rehabilitated with MIOD
    

Detailed description: 
      42 edentulous patients having implant retained mandibular overdenture suffering from bruxism
      with clinical manifestation, will be randomly divided into three groups, group 1 control
      group (traditional approach of removing denture at night) ,group 2 will be managed by
      occlusal splints whereas group 3 will be managed with botulinum toxin injection (Botox). New
      maxillary dentures and mandibular over dentures will be constructed for both groups. Muscle
      activity will be measured at time of denture insertion (T0), 3(T3) 6(T6), 9(T9) and 12(T12)
      month of treatment. Patients satisfaction will be evaluated at the time of denture insertion
      (T0), 6(T6), and 12(T12) month of treatment using TMD/ NS numeric scales 10 cm questionnaire
      which include: headache, face pain, face tension, limitation of mouth opening and complaints
      during mastication.
    

Intervention name(s): overdenture; occlusal splint; Botox
Intervention type(s): Device; Device; Drug
Intervention description(s): removal of overdenture at night; occlusal splint on overdenture; Botox injection i masseter in temporalis
Other intervention name(s): Bolitinum Toxins
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fed Condition
Condition: Fasting
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study in normal, healthy adult human subjects under fed
      condition.
    

Detailed description: 
      Objective of the study is to compare and evaluate the single-dose oral bioavailability of
      Metformin Hydrochloride Extended-Release Tablets USP 750 mg of Ipca Laboratories Ltd, India
      and GLUCOPHAGE®XR (Metformin HCl extended-release tablets) 750 mg of Bristol-Myers Squibb
      Company, USA in normal, healthy, adult, human subjects under fed condition.

      Total duration of the study was of 17 days from the day of admission of first period till the
      end of second period.

      Upon entering into the study, subjects were housed in clinical facility of Veeda Clinical
      Research Pvt. Ltd. to ensure 10 hours overnight fasting before dosing and continued to be
      housed in the facility till 36.00 hours post-dose blood sample collection in each of the two
      periods.

      A gap of 14 days was kept as wash out between each consecutive dosing period.
    

Intervention name(s): Metformin Hydrochloride Extended-Release Tablets USP 750; GLUCOPHAGE®XR tablet 750 mg
Intervention type(s): Drug; Drug
Intervention description(s): Metformin Hydrochloride Extended-Release Tablets 750 mg once a day; GLUCOPHAGE®XR 750 mg once a day
Other intervention name(s): Test product; Reference product
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment