bioihbjkbjnl/mcl2 huggingface dataset:
Zinc and Iron in Children With Short Stature
Condition: Zinc; Deficiency With Anemia
MeSH terms: Dwarfism
Study type: Observational [Patient Registry]

Summary: 
      Short stature is defined as height below 3rd centile or less than two standard deviations
      below the median height for that age and sex according to the population standard zinc and
      iron have important role in growth for children
    

Detailed description: 
      Short stature is defined as height below 3rd centile or less than two standard deviations
      below the median height for that age and sex according to the population standard.

      Approximately 3% children in any population will be short, amongst which half will be
      physiological (familial or constitutional) and half will be pathological.

      It is estimated that approximately 60%-80% of all short children at or below 2standerd
      deviation fit the definition of idiopathic short stature.

      The growth and development of human require an adequate supply of many different nutritional
      factors. Nutritional deficiencies causing short stature include: those associated with
      stunting as: protein and zinc, nutrient associated with rickts as :vitamin D, and those with
      bone abnormalities as: cupper,zin,and vitamin c Insufficient nutrition tends to lead to short
      stature with a delayed pattern of growth. Under-nutrition can be isolated (eg, caused by
      inadequate food supply or self-imposed restriction, such as fear of obesity), or it may be a
      component of an underlying systemic disease that interferes with food intake or absorption,
      or increases energy needs. The hallmark of under-nutrition is low weight-for-height .

      Trace elements are dietary mineral that are present in very minute quantities (less than
      0.01%),they divided into three groups (WHO classification): Essential elements such as iodine
      and zinc ,Probably essential elements such as manganese and silicon , Potentially toxic
      elements such as fluoride,lead,cadmium, mercury, & Lithium.

      Trace elements play significant functions as growth,oregulation of gene expression,
      immunity,the endocrine system, brain development, and the cell protection system. An adequate
      micronutrient intake is crucial for health, particularly in infants, children and adolescents
      ,deficiency in micronutrients can affect growth and development, particularly during periods
      of rapid growth.
    

Intervention name(s): serum zinc and iron
Intervention type(s): Diagnostic Test
Intervention description(s): history ,examination,investigations
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        50 cases will be included :35 child with idiopathic short stature and 25 as controls aging
        from4-18 years old coming to endocrinology clinic at Assuit University Children Hospital
        will be investigated for serum of zinc and iron
Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this clinical research study is to learn whether BMS-562086 is both safe and
      effective in treating outpatients with major depressive disorder.
    


Intervention name(s): Pexacerfont; Escitalopram; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation; Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.; Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
Other intervention name(s): BMS-562086
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Neo-adjuvant Treatment With Temozolomide and Bevacizumab Previous to Temozolomide Plus Radiation Plus Bevacizumab Therapy in Unresectable Glioblastoma
Condition: Glioblastomas
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      In the last 20 years, only temozolomide has obtained indication for the treatment of
      High-grade glioma (HGG). Temozolomide during and later radiation therapy has doubled one year
      survival and is the standard treatment for glioblastoma. But 30% of glioblastomas receive
      only a biopsy as they can't be resected and don't get benefit from this treatment. They and
      should be treated immediately after the biopsy to prevent neurological deterioration but in
      spite of this approach they often deteriorate neurologically during radiotherapy. . An
      effective pre-radiation treatment should improve their prognosis and allow them to complete
      concomitant radiotherapy and temozolomide treatment. Bevacizumab in recurrent HGG displays
      63% of objective responses when combined with irinotecan. But irinotecan is not the most
      active treatment in this disease.

      We propose a phase II, two arms, open label, randomized, multicentric study with 2 cycles of
      temozolomide before radiation therapy and concomitant temozolomide, in patients with
      glioblastoma and 'biopsy-only'. Bevacizumab will be added to one arm.
    


Intervention name(s): Temozolomide; Bevacizumab; Standard radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Temozolomide 85 mg/m2/d x 21 days every 28 days for 2 cycles.
Temozolomide 75 mg/m2/d x 42-49 days
Temozolomide 150 - 200 mg/m2 d1-d5 q 28d for 6 cycles.; 2 cycles + bevacizumab 10 mg/kg every 15 days each two cycles.
Bevacizumab 10 mg/kg every 15 days, three dosis.; 42-49 days with standard radiation therapy (60 Gy): 2 Gy per day.
Intervention MeSH terms: Bevacizumab; Temozolomide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Unresectable/inoperable glioblastomas
Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response
Condition: Pain; Tachycardia; Hypertension
MeSH terms: Tachycardia
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate the influence of a standardized noxious
      stimulus on the ANI, SPI and hemodynamic parameters during standard propofol and sufentanil
      TCI and to see if the ANI and SPI are predictive of a hemodynamic reaction.

      In addition the investigators compare the performance of ANI and SPI against one another as
      well as investigate if ANI or SPI can be used to find the ideal CeSUF for a given patient.
    

Detailed description: 
      During general anesthesia hypnosis can be monitored routinely using EEG derivates like
      Bispectral index (BIS), entropy,.… However, monitoring analgesia or more precisely the
      nociceptive-antinociceptive (analgetic) balance during anesthesia proved more difficult.
      Clinical signs such as heart rate (tachycardia) or blood pressure (hypertension) are usually
      observed and used to assess nociception and a patient's autonomic unbalance. During general
      anesthesia administration of opioids like sufentanil and remifentanil decrease the ANS
      reactivity to noxious stimulation. Recently two variables based on standard anesthesia
      monitor equipment have been introduced into clinical practice: the Analgesia Nociception
      Index (ANI), derived from analysis of the small beat-to-beat oscillations of the heart rate
      during respiration, the heart rate variability (HRV), and the Surgical Pleth Index (SPI),
      calculated from the plethysmographic amplitude and heart beat interval.
    

Intervention name(s): Metrodoloris Medical System; Aisys® care station, Acertys
Intervention type(s): Device; Device
Intervention description(s): Application of a skin electrode; Standard photoplethysmography
Other intervention name(s): ANI monitor; SPI monitor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ANI; SPI; Autonomic balance; Nociception measurement
Safety and Tolerability of Lithium in Spinocerebellar Ataxia 2 (SCA2)
Condition: SPINOCEREBELLAR ATAXIA 2
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine safety and tolerability of the treatment with
      lithium in Spinocerebellar Ataxia 2. Moreover, clinical symptoms, neuronal loss, quality of
      life and depressive symptoms, will be considered to further investigate the effect of lithium
      therapy.
    

Detailed description: 
      Patients will be progressively enrolled in the study and undergo a screening visit to test
      for inclusion/exclusion criteria. Patients will then be randomized to receive either Lithium
      carbonate or placebo. Patients will visit study center at 2, 4, 8, 12, 24, 36 and 48 weeks,
      for endpoint and laboratory assessments.
    

Intervention name(s): LITHIUM CARBONATE
Intervention type(s): Drug
Intervention description(s): Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
Intervention MeSH terms: Lithium Carbonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SCA2; Lithium
Effect of Violent First-Person Shooter (FPS) Video Games on Shooting Accuracy
Condition: Gun Shot Wound
MeSH terms: Wounds, Gunshot
Study type: Interventional

Summary: 
      The present research tests the effects of violent shooting games on behavior within the game
      (Pilot Study) and on behavior after the game is turned off (Experiment Proper). The
      Experiment Proper is an exact replication of a previous study conducted in our lab that was
      retracted (see citation), but with a larger sample to get more reliable results (N=287 rather
      than N=151).
    

Detailed description: 
      Violent shooting games are used to train soldiers and police officers. This research tests
      whether violent shooting can train people to shoot targets in the head, both during gameplay
      (Pilot Study) and after the game is turned off (Experiment Proper). Participants in both
      studies played a violent shooting game with humanoid targets that rewarded headshots, or a
      nonviolent shooting game that punished shots to bull's-eye targets with faces. Afterward,
      participants shot at a mannequin with a realistic CO2 gun. We anticipate that participants
      who play the violent game which rewards headshots to hit the mannequin's head more often than
      those who play the non-violent game.
    

Intervention name(s): Video game; Controller
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants played either a violent shooting game or nonviolent shooting game in the pilot study, and either either a violent shooting game, nonviolent shooting game, or nonviolent non-shooting game in the experiment proper.; Participants used either a gun-shaped or regular controller to play the violent and nonviolent shooting video games.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 (controller type) x 3 (video game type) factorial design. Participants used either a regular or gun shaped controller while playing a non-shooting, non-humanoid shooting, or humanoid shooting game.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: First-person shooter (FPS); Violent video game; Headshot; Gun; Operant conditioning theory
A Behavioral Intervention for Reducing Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This study will examine a contingency management (CM) intervention designed to provide
      incentives for losing weight versus participating in a manual-guided behavioral weight loss
      intervention alone. Participants in the CM condition will earn the opportunity to win prizes
      by losing weight and completing activities that contribute to weight loss, such as keeping
      daily food and physical activity diaries, choosing healthy foods, exercising, and using other
      weight loss strategies. The investigators will determine if the CM improves weight loss
      relative to the usual care manual-guided intervention alone.
    


Intervention name(s): contingency management; weight loss manual-guided individual therapy sessions
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Prize-based contingency management for weight loss; once weekly counseling sessions with research staff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Contingency Management
A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds
Condition: Healthy Volunteers; Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      People with type 2 diabetes have too much sugar in their blood and need treatment to control
      their sugar level. The 3 study compounds in this study are similar to an approved
      antidiabetic medicine that helps to lower blood sugar levels in people with type 2 diabetes.
      This approved antidiabetic medicine is generally safe and well tolerated. The study compounds
      are expected to have the same antidiabetic effect as the approved medicine. The purpose of
      this study is to investigate how quickly and to what extent each of the 3 study compounds are
      broken down in the body (this is called pharmacokinetics). The dose of each study compound
      will be very low (this is called a microdose), and will be labelled with a small amount of
      carbon-14. This is radioactive, and it makes it possible to track the study compound in the
      blood. The 3 study compounds in this study have not been given to humans before. The study
      will be performed in up to 18 healthy male volunteers. The study will consist of 3 groups of
      6 volunteers each. Each participant will receive only one dose of study medicine.
    


Intervention name(s): NNC0113-6861; NNC0113-6860; NNC0113-6891
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study compound 1 - Each participant will receive a single intravenous (i.v) dose of [14C]-NNC0113-6861; Study compound 2 - Each participant will receive a single i.v dose of [14C]-NNC0113-6860; Study compound 3 - Each participant will receive a single i.v dose of [14C]-NNC0113-6891
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Menorrhagia Study in Women With Treatment-resistant Menorrhagia
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to explore effects of the investigational product for the treatment
      of treatment-resistant menorrhagia without organic cause.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Asoprisnil (BAY86-5294); Asoprisnil (BAY86-5294); Asoprisnil (BAY86-5294); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5mg/day; 10mg/day; 25mg/day; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment-resistant menorrhagia
Role of Lung Ultrasound in Weaning From Mechanical Ventilation in Postoperative Neurosurgical ICU Patients
Condition: Intensive Care (ICU)
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate the role of lung ultrasound in weaning from
      mechanical ventilation in neurosurgical ICU patients compared to the ordinary tools as chest
      X-ray , ABG, rapid shallow breathing index, ventilator parameters.
    


Intervention name(s): lung ultrasound; routine tools
Intervention type(s): Device; Other
Intervention description(s): bedside lung ultrasound will be done for patients; chest X-ray , ABG, RSBI, Ventilator parameters will be done for all patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Determine the Effects of MK0557 in Obese Subjects (0557-006)(COMPLETED)
Condition: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of MK0557 on body weight in obese
      subjects.
    


Intervention name(s): MK0557
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Serotonin and oxytocin play a role in fear conditioning and fear extinction learning,
      psychological processes that are critically involved in psychiatric disorders such as
      posttraumatic stress disorder (PTSD). Specifically, administration of oxytocin has been shown
      to facilitate fear extinction in humans. Similarly, substances that release serotonin and
      oxytocin such as MDMA have been shown to enhance the extinction of fear memory in animals.
      However, there are no data on the effects of MDMA on fear extinction in humans. Therefore,
      the primary aim of this study is to investigate the role of acute serotonin release in the
      effects of fear extinction. MDMA will be used as pharmacological tool to induce serotonin
      release in this study.
    


Intervention name(s): MDMA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 125 mg MDMA per os, single dose; Capsules containing mannitol looking identical to the other drugs.
Other intervention name(s): 3,4-Methylenedioxymethamphetamine
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to proof
      the feasibility of a specific individual training at home aimed to increase pulse pressure
      above a predefined threshold which might attenuate the loss of arterial wall thickness.

      Hypothesis:

      Increasing daily physical activity near to normal (> 10.000 steps per day) with a pre-defined
      level of pulse pressure (intensity) is a realizable and feasible approach to investigate
      changes in arterial wall thickness and cardio-respiratory capacity in cfLVAD patients.
    

Detailed description: 
      The investigators will study 3 cfLVAD patients with low pulse pressure during work package 1
      using two different exercises, treadmill and bicycle. Walking and cycling present the most
      commonly used physical activities which are applicable to most individuals on a daily basis.
      The investigators aim to demonstrate that individual changes of pulse pressure during these
      types of exercise can be assessed in cfLVAD patients.

      In a feasibility study (work package 2) the investigator will enroll 6 cfLVAD patients to
      perform home-based physical activity programs including walking a defined number of steps per
      day with a predefined speed and cycling with a predefined power [watt] on a bicycle
      ergometer. The performance of the patients will be monitored over seven days using a wearable
      activity device.
    

Intervention name(s): Daily physical activity
Intervention type(s): Behavioral
Intervention description(s): A combination of walking (> 10.000 steps per day) and cycling on a stationary bicycle at home at an individual intensity. For the activity walking patients need to walk at a certain speed (e.g. 3 km/h) in order to be in the range of pulsatility as obtained from their pre-training treadmill test. For cycling a defined power in watt and duration will be given to each patient as defined from the pre-training cycling test.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LVAD
Pharmacokinetics and Safety in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate the pharmacokinetics, safety and tolerability of SCT630 and to establish
      pharmacokinetic similarity of SCT630 to adalimumab.
    


Intervention name(s): SCT630; adalimumab-EU source
Intervention type(s): Drug; Drug
Intervention description(s): SCT630 single s.c. injection; adalimumab-EU source single s.c. injection
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Evaluation of Two Daily Disposable Toric Soft Contact Lenses Over One Week of Wear
Condition: Ocular Physiology
Study type: Interventional

Summary: 
      This is a bilateral wear, dispensing, randomized, controlled, double-masked, 2-sequence
      ×2-period crossover study to evaluate ocular physiology following contact lens wear.
    


Intervention name(s): PRECISION1® for Astigmatism Contact Lenses; MyDay® Toric Soft Contact Lenses
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Probiotics for Irritable Bowel Syndrome
Condition: Functional Gastrointestinal Disorders; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Syndrome
Study type: Interventional

Summary: 
      This randomised, double blind, cross-over study compares the effect (symptoms, fecal
      bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF
      1298 with placebo in patients with irritable bowel syndrome. The results are related to
      dietary habits, food intolerance and food allergy.
    


Intervention name(s): placebo followed by Lactobacillus plantarum MF 1298; Lactobacillus plantarum MF1298 followed by placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks; Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks
Other intervention name(s): probiotic; probiotic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Probiotics