bioihbjkbjnl/mcl2 huggingface dataset:
Nutritional Study in Spanish Pediatric Population
Condition: Child, Only; Metabolic Diseases; Child Development; Diet Habit; Healthy Diet; Feeding Behavior; Health Behavior; Sedentary Lifestyle; Food Habits; Nutritional Status; Diet, Food and Nutrition
MeSH terms: Metabolic Diseases
Study type: Observational

Summary: 
      This study investigates the aspects related to the intake of food and nutrients, physical
      activity and sedentary behavior of Spanish children from 1 to 9 years. Furthermore, the
      investigators will know if the consumption of dairy products is associated with a better
      dietary pattern.

      Hypothesis: The habitual consumption of dairy products as part of a regular diet is
      associated with a better dietary pattern and a higher global diet quality.
    

Detailed description: 
      A prospective cross-sectional observational study in 1500 Spanish children (1 to 9 years) in
      urban areas >50,0000 inhabitants, distributed in eight regions (according to Nielsen Spanish
      areas) aiming to evaluate the food habits, dietary patterns, and nutrient intake, as well as
      physical activity behaviors.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Apparently healthy children between 1 to 9 years who live in an urban area with more than
        50 000 inhabitants in Spain and that answer all the study recalls
      
Keywords: Nutrition; Pediatric age; Physical activity; Dairy products; Dairy consumption; Sedentary habits; Diet quality; Children
Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation
Condition: Mitral Valve Disease; Coronary Artery Disease; Tricuspid Valve Disease; Aortic Valve Disease; Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Coronary Artery Disease; Aortic Valve Disease
Study type: Interventional

Summary: 
      The aim of our study was to investigate, whether enhancement of left atrial cryoablation by
      ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of
      surgical treatment of atrial fibrillation in patients with structural heart disease
      undergoing open-heart surgery.
    

Detailed description: 
      The observed patient file consisted of 100 patients, who have undergone a combined open-heart
      surgery at our department between July 2012 and December 2014. The patients were indicated
      for the surgical procedure due to structural heart disease, and suffered from paroxysmal,
      persistent, or long-standing persistent atrial fibrillation. In all cases, left atrial
      cryoablation was performed in the extent of isolation of pulmonary veins, box lesion,
      connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting
      lesion of the appendage base with left pulmonary veins. Furthermore, thirty-five of the
      patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with
      decision and ablation of the ligament of Marshall.
    

Intervention name(s): Concomitant Mapping and Radiofrequency Ablation; No intervention
Intervention type(s): Procedure; Procedure
Intervention description(s): Mapping of GP around the orifice of pulmonary veins was performed, together with their radiofrequency ablation. In the area of right-side pulmonary veins, the procedure was performed prior to initiation of extracorporeal circulation. In case of the left-side PVs; the procedure was performed after initiation of extracorporeal circulation. Part of this procedure was also a decision and ablation of the ligament of Marshall.
GP mapping was performed using high-frequency stimulation (1000 beats min-¹, potential 18V, pulse width 1.5ms). The indication for GP ablation was a doubling in the R-R interval in the sinus rhythm, or ventricular rate slowing of more that 50% associated with a decrease of blood pressure>20mmHg in patients with AF. In case of a positive response, radiofrequency ablation of the ganglia was performed following switching of the pen at the console. This procedure was repeated until the activity of the ganglia has disappeared.; No intervention was performed in patients without ganglionated plexi.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of patients undergoing standard treatment have been compared retrospectively.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Left Atrial Cryoablation; Ganglionated Plexi; Open-Heart Surgery
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Condition: Deep Vein Thrombosis; Venous Thrombosis; Postphlebitic Syndrome; Venous Thromboembolism; Post Thrombotic Syndrome
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Postthrombotic Syndrome; Postphlebitic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the use of adjunctive Pharmacomechanical
      Catheter Directed Thrombolysis, which includes the intrathrombus administration of
      rt-PA--Activase (Alteplase),can prevent the post-thrombotic syndrome(PTS)in patients with
      symptomatic proximal deep vein thrombosis(DVT)as compared with optimal standard DVT therapy
      alone.
    

Detailed description: 
      Activase, the study drug, is a fibrinolytic drug that is indicated for use in acute
      myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism in adults.
      Previous studies have established the ability of rt-PA to lyse venous thrombus in patients
      with deep vein thrombosis (DVT), and suggest that successful rt-PA mediated thrombolysis can
      prevent the post-thrombotic syndrome (PTS), a morbid, late complication of DVT that occurs in
      nearly 50% of patients.

      rt-PA is delivered directly into venous thrombus using a catheter/device which is embedded
      within the thrombus by a physician under imaging guidance. This method of rt-PA delivery,
      pharmacomechanical catheter-directed intrathrombus thrombolysis (PCDT),is thought to be
      safer, more effective, and more efficient than previous methods. The question of whether PCDT
      using rt-PA improves long-term DVT patient outcomes with acceptable risk and cost has not yet
      been addressed.

      The rationale for performing the ATTRACT Trial is based upon:

        -  the major burden of PTS on DVT patients and the U.S. healthcare system

        -  the association between rapid clot lysis and prevention of PTS

        -  the proven ability of rt-PA to dissolve venous thrombus in proximal DVT

        -  recent advances in CDT methods which may lower bleeding risk

        -  the major clinical controversy on whether CDT should be routinely used for first-line
           DVT therapy
    

Intervention name(s): Recombinant tissue plasminogen activator (rt-PA)
Intervention type(s): Drug
Intervention description(s): Pharmacomechanical catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
Other intervention name(s): rt-PA; recombinant tissue plasminogen activator; Activase; Alteplase
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: deep vein thrombosis; deep venous thrombosis; post thrombotic syndrome; blood clot; thrombolysis; tissue plasminogen activator; rt-PA; Activase; mechanical thrombectomy; pharmacomechanical; ATTRACT
Trilogy Comparison Study - Pediatrics
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The objective of this study (Part II) will be to compare the performance of the Trilogy
      device and a conventional ventilator (participant's current device). Both devices will be set
      to the participants' current mode and prescription settings.
    

Detailed description: 
      A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared
      to conventional ventilators, the Trilogy device achieves comparable level of gas exchange
      (measured as partial pressure of carbon dioxide (CO2) in arterial, venous or capillary
      blood)and peripheral capillary oxygen saturation, (SpO2) levels during various modes of
      ventilation.

      B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when
      compared to conventional ventilators, the Trilogy device achieves comparable breathing
      pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and
      subjective measures of breathing comfort (measured by modified Borg dyspnea scale).
    

Intervention name(s): Trilogy Ventilator; Standard of Care
Intervention type(s): Device; Device
Intervention description(s): Exposure to one hour on the Trilog ventilator; Exposure of one hour on the Participants prescribed ventilator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics of MEDI9929 (AMG 157) in Adolescents With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the PK profile of a single-dose of 140 mg subcutaneous (SC) administration of
      MEDI9929 (AMG 157) in adolescent subjects with mild to moderate asthma.
    

Detailed description: 
      The primary objective is to evaluate the PK profile of a single-dose of 140 mg subcutaneous
      (SC) administration of MEDI9929 (AMG 157) in adolescent subjects with mild to moderate
      asthma. The secondary objective is to evaluate the safety and tolerability of MEDI9929 and to
      evaluate the immunogenicity of MEDI9929 (AMG 157). The exploratory objective is to evaluate
      the effect of MEDI9929 (AMG 157) on pulmonary function
    

Intervention name(s): MEDI9929, 140 mg
Intervention type(s): Drug
Intervention description(s): On Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age.
Other intervention name(s): Subcutaneous single-dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma
Activity at 25% Above the Ventilation Threshold on Appetite and Food Intake in Boys
Condition: Healthy Boys With no Emotional, Behavioral or Learning Problems Within a Normal Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The investigators hypothesize exercise increases short term appetite and food intake, and
      interferes with satiety and satiations to a preload in normal weight, boys.
    

Detailed description: 
      The effect of exercise (EXR) on short-term food intake (FI) and subjective appetite was
      investigated in normal weight (NW), boys were randomized into 4 treatments. Each boy consumed
      either a non-caloric sweetened control (CON) or GLU drink after either exercise (EXR) or
      sedentary activity. Subjects exercised at 25% above their ventilation threshold (VeT).
    

Intervention name(s): Dietary Supplement: water with noncalorie sweetener; Activity: With noncalorie sweetener or glucose
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Girls
HPV Infections in Older Women
Condition: Papillomavirus Infections
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections
Study type: Observational

Summary: 
      The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year
      old women who report having used internet dating websites in the past year.
    

Detailed description: 
      Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV
      infections from new sex partners is largely unknown. This is a longitudinal study of
      predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who
      have used internet dating websites in the past year. 300 women will be recruited and mailed
      kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect four
      sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at
      the time of each self-collection. We will identify behavioral and health predictors of
      type-specific HR HPV infections, predictors of repeatedly-detected HR HPV infections, and
      evaluate study participants' experiences with self-collecting vaginal specimens and attitudes
      towards HPV vaccination and cervical cancer screening. This information is important for
      developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines
      in populations of older women.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        25 to 65 year old women who date online
      
Biospecimen description: 
      Vaginal swab samples for HPV DNA testing
University of California, San Diego (UCSD) Suramin Autism Treatment-1 (SAT1) Trial
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to test the safety and efficacy of a single, intravenous dose of
      suramin in autism spectrum disorders (ASD).
    

Detailed description: 
      This study is designed to test a new theory of the origin and treatment of ASD. In this
      theory, ASD is caused by both genes and environment interacting to produce a persistent cell
      danger response (CDR; Naviaux RK, 2014) that interferes with and alters normal child brain
      development. Gut microbiome and immune systems are also affected. In this theory, the
      pathological persistence of the cell danger response is traceable to mitochondria, and
      maintained by purinergic signaling mediated by the release of extracellular nucleotides like
      adenosine triphosphate (ATP), adenosine diphosphate (ADP), uridine triphosphate (UTP), and
      uridine diphosphate (UDP). Suramin inhibits excess purinergic signaling by acting as a
      competitive inhibitor of nucleotide signaling at both ionotropic purinergic (P2X) receptors,
      and G-protein coupled, metabotropic purinergic (P2Y) receptors. Suramin has been found to
      correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic
      and environmental mouse models of autism (Naviaux JC, et al. 2015; Naviaux JC, et al. 2014;
      Naviaux RK, et al. 2013). This study will test the safety and efficacy of a single dose of
      suramin in children with ASD. While it is not anticipated that a single dose will produce
      benefits for more than a few weeks, if successful, this study may lead to the development of
      newer and safer drugs for autism treatment.
    

Intervention name(s): Suramin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg/kg IV in 50 ml saline over 30 minutes; 50 ml IV over 30 minutes
Other intervention name(s): Germanin; Normal saline
Intervention MeSH terms: Suramin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mitochondria; purinergic signaling; cell danger response
Comparison of Post-operative Complications of Bone Augmentation at Anterior of Maxilla After Periosteal Releasing Incision With Two Techniques Diode Laser and Scalpel
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study was to investigate if using lasers instead of scalpel for flap
      advancement in bone augmentation procedures would reduce post-operative swelling and pain.
    

Detailed description: 
      Guided bone regeneration (GBR) is a well established method to augment excessive alveolar
      bone loss before and at the time of implant placement. Primary closure of soft tissue is a
      prerequisite for successful bone augmentation procedures. Adequate flap advancement is a key
      factor for tension free primary wound closure. The tension free flap is usually attained by
      incising the buccal flap using scalpels. However, this procedure, especially in cases with
      major flap advancement, results in increased patient morbidity after surgery. Swelling and
      hemorrhage during the first week after surgery have a negative effect on patient's quality of
      life.

      Currently, lasers are widely used as a tool for soft tissue management and diode laser
      appears to be an effective tool for incision and excision of the soft tissue. The major
      advantageous property of lasers is ablation of tissue together with effective hemostasis,
      minimal swelling and virtually no pain.
    

Intervention name(s): Laser-assisted surgery.; conventional surgery by blade
Intervention type(s): Procedure; Procedure
Intervention description(s): laser-assisted surgery; conventional surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post-operative pain; diode laser
Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the mutual interaction potential of digoxin, furosemide, metformin, and
      rosuvastatin when given alone or together as a cocktail, and to investigate the effect of
      high doses of metformin or furosemide on pharmacokinetics of the other cocktail compounds
    


Intervention name(s): Digoxin; Rosuvastatin; Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin; Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin; Metformin hydrochloride; Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin; Furosemide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose, fasted; single dose, fasted; fasted; fasted; single dose, fasted; fasted; single dose, fasted
Intervention MeSH terms: Metformin; Digoxin; Furosemide; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Low-level Laser Therapy on Exercise-induced Muscle Damage
Condition: Muscle Damage
Study type: Interventional

Summary: 
      Introduction: The effects of Low Level Laser Therapy (LLLT) on exercise-induced muscular
      damage have been studied over the last years. Studies have been conducted on animals and
      humans in order to try to show the benefits of the intervention, but there is still
      conflicting evidence about its protective and therapeutic effects.

      Objectives: To describe the effects of LLLT on pain, strength and muscular inflammation after
      plyometric exercise.

      Methods: A randomized, double-blinded, placebo-controlled trial with participation of 20 male
      healthy volunteers will be performed. Healthy and physically active individuals, aged between
      18 and 35 years, with no history of injury on the lower limbs or contra-indications to
      maximal exercise performance will be included. A protocol of 10 series with 10 repetitions of
      the countermovement jump will be used to induce muscle damage at the lower limbs. Immediately
      before or after the exercise protocol, LLLT will be applied on one lower limb, while the
      other will receive placebo treatment. Phototherapy will be applied with an equipment of 810nm
      and a cluster with 5 diodes on 8 different points of the knee extensor muscle, totalizing a
      dosage of 240J. The placebo treatment will be held on the same way, but the equipment will be
      turned off. The volunteers will be evaluated at baseline (before the exercise protocol) and
      at follow-up of 24, 48 and 72 hours. The following outcomes will be evaluated: knee extensors
      isometric peak torque by Isokinetic Dynamometer, pain by Visual Analogue Scale and muscular
      tissue echo intensity by Ultrasonography.
    


Intervention name(s): LLLT before muscle damage; Placebo LLLT before muscle damage; LLLT after muscle damage; Placebo LLLT after muscle damage
Intervention type(s): Device; Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phototherapy; Plyometric exercise; Muscle recovery
High(Deadlift) Versus Low Intensity Motor Control Exercises on Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate and compare the effects of high-intensity (deadlift)
      versus low-intensity motor control exercises on selfrated pain, function and symptoms on
      patients with peripherally mediated pain
    


Intervention name(s): High intensity motor control exercise (deadlift); Low intensity motor control exercise
Intervention type(s): Procedure; Procedure
Intervention description(s): 12 treatment sessions over a 8 week period is planned for the high intensity motor control exercise.; 12 sessions of low intensity motor control exercises over 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: deadlift; motor control; exercises; pain; function; functional capacity
ECigs, Inflammation and Oxidative Stress
Condition: E-cigarettes, Oxidative Stress, Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Randomized controlled trial of acute use of electronic cigarette effect on oxidative stress
      and inflammation.
    

Detailed description: 
      Participants will have an acute e-cig exposure on 2 occasions 1) e-cigarette 2) sham e-cig
      (empty e-cig) control. Blood will be collected before and after E-cig use and analyzed for
      biomarkers of inflammation and oxidative stress.
    

Intervention name(s): e-cigarette; empty (-cigarette sham control)
Intervention type(s): Other; Other
Intervention description(s): use e-cig for 30 minutes; use empty e-cig (sham control)
Other intervention name(s): e-cig; empty e-cig
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover with 2 week washout
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor
Condition: Lung Neuroendocrine Neoplasm
MeSH terms: Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is designed to collect safety/tolerability data and explore the efficacy of
      RAD001 in advanced pulmonary neuroendocrine tumor in Chinese patients.
    


Intervention name(s): RAD001
Intervention type(s): Drug
Other intervention name(s): Everolimus
Intervention MeSH terms: Everolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phase Ib,; RAD001,; advanced pulmonary neuroendocrine tumor