bioihbjkbjnl/mcl2 huggingface dataset:
Medication Development in Alcoholism: Apremilast Versus Placebo
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary hypotheses under test are that alcohol dependent subjects treated with apremilast
      will report decreased craving for alcohol following alcohol exposure in the laboratory and
      report significantly less drinking under naturalistic conditions, than those treated with
      placebo.
    


Intervention name(s): Apremilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.; Identical placebo pills taken orally for 14 days
Other intervention name(s): Otezla; Sugar Pill
Intervention MeSH terms: Apremilast
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment, Double Blind, Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Plyometric Exercise With Obese Children
Condition: Flat Feet
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      Obesity is one of the main factors that contribute to an acquired flat foot deformity which
      in turn impairs the balance strategies. The purpose of the current study was to compare the
      effect of plyometric exercises with flatfoot corrective exercise on balance, foot posture,
      and functional mobility in obese children with flexible flatfoot.
    

Detailed description: 
      A sample of 47 male children participated in the current study. The participants were
      selected from different elementary schools in Taif, Saudi Arabia. Their age ranged from 7 to
      11 years. the sample was randomly divided into 3 groups: the experimental group I, (EGI), the
      experimental group II, (EGII), and the control group (CG). The EGI received a plyometric
      exercise program. The EGII received the corrective exercises 2 sessions per week for 10
      weeks. The control group did not perform any planned physical activities during the
      intervention period but continued in their routine physical activities. The Prokin system was
      used to assess the static balance, timed up and go test was used to assess functional
      mobility, and Navicular drop test was used to assess the degree of flatfoot deformity, prior
      to and after the intervention for all groups.
    

Intervention name(s): plyometric exercises; Exercises for flat feet rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Exercises for strength and flexibility; Exercises for intrinsic muscles strength
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Pretest-posttest control group design was used. A sample of 47 male children participated in the current study. After gathering the baseline measurements, the participants were randomly assigned into three groups: experimental group I, (EGI) contained 16 participants, experimental group II (EGII) contained 16 participants, and control group, (CG) contained 15. The stratification was done using sealed envelopes. The children were not aware of their group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluating the Effect of Tooth Cleaning Devices on Oral Health
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      This is a study to evaluate the safety and the efficacy of tooth and interproximal cleaning
      modalities on oral health.
    


Intervention name(s): Manual Toothbrush; Interproximal Cleaning Device
Intervention type(s): Device; Device
Intervention description(s): A standard size manual toothbrush to clean visible tooth surfaces; An electronic device that combines water and air to clean between the teeth
Other intervention name(s): ADA Reference Toothbrush; Philips AirFloss
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental; dentist; plaque; IP Cleaning
DGB-01 Effects on Endurance Exercise
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this research is to evaluate the effects of DGB-01 on performance of a 40-km
      time trial in trained male cyclists. The investigators believe that DGB-01 will improve
      performance on the time trial as measured by a reduction in the amount of time required to
      complete the distance, using a computerized cycle ergometer.
    


Intervention name(s): DGB-01 Supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): Approximately one-half of the subjects will initially receive DGB-01. The other half of the subjects will receive casein. Investigators and subjects are blinded to the product the subject is receiving. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks.
Subsequently, all subjects will undergo a supplement-free washout period of at least four weeks duration. Following the washout period, the subjects who originally received DGB-01 will receive casein and the subjects who originally received casein will receive DGB-01. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks.
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Ergogenic aid; Exercise endurance; High performance; Time trial performance; Glutathione
Metformin Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection
Condition: Stage IA Pancreatic Adenocarcinoma; Stage IB Pancreatic Adenocarcinoma; Stage IIA Pancreatic Adenocarcinoma; Stage IIB Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Pancreatic cancer represents the most lethal of the common malignancies with a 5-year
      survival rate of less than 5%. For patients who are eligible for potentially curative
      resection, despite mortality and morbidity rates after surgery have improved, the recurrence
      rate is up to 85% within 2 years. Data from clinical trials indicate that adjuvant
      chemotherapy enhances 5-year survival to ~25% for patients who have undergone surgery to
      remove their tumor; and gemcitabine is the standard regimen of chemotherapy. Metformin is the
      first-line treatment for type 2 diabetes mellitus. Literatures reported that metformin might
      inhibit tumor growth by blocking some enzymes needed for cell growth. Some retrospective
      studies have revealed that diabetic patients taking metformin were less likely to develop
      pancreatic cancer. Additionally, pancreatic cancer patients treated with metformin showed a
      better survival than those without metformin. In this study, the researchers intend to
      investigate the activity and safety of the combination of gemcitabine and metformin in
      treating patients with pancreatic cancer that have removed by surgery.
    


Intervention name(s): Gemcitabine; Metformin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment, and also receive placebo (Arm I)/ metformin (Arm II) on days 1-28. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.; Metformin will be administered at a dose of 500 mg twice daily. If well tolerated, the dose will be increased to 1000 mg twice daily in the second week. Treatment repeats every 4 weeks (2 g on days 1-28) for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.; Placebo will be administered at a dose of 500 mg twice daily. If well tolerated, the dose will be increased to 1000 mg twice daily in the second week. Treatment repeats every 4 weeks (2 g on days 1-28) for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
Other intervention name(s): GEMZAR; glucophage
Intervention MeSH terms: Metformin; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pancreatic Cancer; Pancreatic Adenocarcinoma; Metformin; Gemcitabine; Adjuvant Therapy
Efficacy and Safety Study of Nangibotide in Patients With COVID-19 Receiving Ventilatory Support
Condition: COVID19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, in which one dose of nangibotide will
      be tested versus placebo.

      All patients with a diagnosis of COVID-19, and a requirement for respiratory support will be
      considered for study participation. The applicable local requirements for informed consent
      will be followed. Where permissible, an emergency consent procedure will be followed for
      patients unable to provide consent by themselves. All potential study patients will receive
      standard of care treatment throughout the study. Patients will receive a continuous
      intravenous (i.v.) infusion of nangibotide at 1.0 mg/kg/h or a matching placebo. Treatment
      with study drug must be initiated as early as possible but no later than 48 hours after the
      initiation of ventilatory support (Patients will be treated for 5 days or until discharge
      from critical care, whichever is sooner). Follow-up visits will be performed on days 8 and
      14. The end of study visit is at day 28. A further follow up visit will be undertaken on day
      60.
    

Detailed description: 
      ESSENTIAL was a randomized, double-blind, placebo-controlled trial, in which one dose of
      nangibotide was tested versus placebo. It took place in 14 sites in France and Belgium. The
      study was overseen by an independent Data Monitoring Committee (DMC).

      The study was divided into two parts running sequentially without unblinding. Part 1
      evaluated safety and tolerability study and included 60 patients, randomized in a 2:1 ratio
      of nangibotide to placebo. Part 2 included all recruited patients with an initially planned
      sample size of 370 patients, randomized in a 1:1 ratio of nangibotide to placebo.

      All patients or their legally authorised representatives provided written informed consent
      or, in relevant countries, an independent physician, confirmed patient eligibility for
      enrolment in the trial.

      Patients received a continuous intravenous infusion of nangibotide at 1.0 mg/kg/h or a
      matching placebo for 5 days (or until discharge from ICU, whichever was sooner). The
      treatment was in addition to standard of care.
    

Intervention name(s): nangibotide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): nangibotide 1.0 mg/kg/h; matching placebo
Intervention MeSH terms: Nangibotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise Enhances Brain Function in Attention-deficit/Hyperactivity Disorder (ADHD)
Condition: Exercise; ADHD; Executive Dysfunction
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The aim of the study was to investigate the different effects of exercise types on inhibitory
      control in children with attention-deficit/ hyperactivity disorder.
    

Detailed description: 
      Study inclusion criteria were as follows: (1) age between 8 and 12 years; (2) diagnosed with
      ADHD by a pediatric psychiatrist; and (3) no history of brain injury or neurological
      conditions, such as exhibited epileptic seizures, serious head injuries, and periods of
      unconsciousness.
    

Intervention name(s): Exercise type
Intervention type(s): Other
Intervention description(s): Aerobic exercise and Resistance exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: intensity; exercise; executive function; ADHD
Making Healthy Choices: Does Having an Online Health Coach Help?
Condition: Physical Activity; Dietary Modification
Study type: Interventional

Summary: 
      Participating in regular physical activity and consuming a diet high in fruits and vegetables
      can aid in the management of various acute and chronic side effects of cancer treatment;
      however, few rural-dwelling young adult cancer survivors are active enough and consume enough
      fruits and vegetables to accrue benefits. Telehealth interventions show promise for helping
      these young adults increase their motivation to participate in these behaviours by addressing
      barriers associated with accessing face-to-face behaviour counselling services (e.g., time
      commitment, travel distance). Yet, few researchers have examined the feasibility and
      acceptability of a telehealth intervention that provides motivational support grounded in
      self-determination theory for these health behaviours in rural-dwelling young adult cancer
      survivors. Based on previous research, the researchers reasoned that rural-dwelling young
      adult cancer survivors' physical activity and fruit and vegetable consumption would be more
      likely to increase if they participated in a telehealth intervention therefore, the
      researchers aim to test the feasibility, acceptability, and preliminary efficacy of the
      intervention. The researchers also aim to assess if changes in perceived basic psychological
      need satisfaction, behaviour regulation, and perceived autonomy support are associated with
      changes in physical activity and fruit and vegetable consumption.
    


Intervention name(s): interactive sessions
Intervention type(s): Behavioral
Intervention description(s): This arm will receive personalized health coaching (behaviour change counseling)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: physical activity; fruit and vegetable consumption; telehealth; young adult cancer survivors; rural-dwelling
Lake Washington Vascular VenaSeal™ Post-Market Evaluation (WAVES)
Condition: Venous Reflux
Study type: Interventional

Summary: 
      The VenaSeal Closure system offers an outpatient treatment option for the permanent closure
      of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through
      endovascular embolization with coaptation. VenaSeal is intended for use in adults with
      clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).
    


Intervention name(s): SP-402 VenaSeal™ Closure System
Intervention type(s): Device
Intervention description(s): A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..
Other intervention name(s): VenaSeal™
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Varicose Veins; Great Saphenous Vein; Venous Insufficiency
Prediction of Fluid Responsiveness in Children Undergoing Major Surgery
Condition: Hypovolemia
MeSH terms: Hypovolemia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate predictability of a respiratory variation in pulse
      oximeter plethysmography for fluid responsiveness in children undergoing major surgery.
    

Detailed description: 
      The purpose of this study is to evaluate predictability of a a respiratory variation in pulse
      oximeter plethysmography (delta POP) for fluid responsiveness in children undergoing major
      surgery.

      When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and
      central venous pressure less than 5 mmHg, the study will be started. At index fingers of both
      hand, pulse oximeter sensors are applied by gradually increasing the contact force (from 0 to
      1.4N, being increased by 0.2-0.3N). Then, pulse oximeter plethysmography (POP) waveforms are
      obtained for 90 seconds. Then, intravenous crystalloid fluid 10 mL/kg is infused for 15 min.

      To evaluate the change of cardiac output, transesophageal or transthoracic echocardiography
      is performed before and after fluid administration. In addition, hemodynamic parameters
      including pulse pressure variation, systolic pressure variation, pleth variability index and
      central venous pressure are also recorded before and after fluid administration.

      Finally, patients will be divided into fluid responder group and non-responder group. If
      stroke volume index measured using echocardiography increases over 15% after fluid
      administration, the patient will be fluid responder.

      Delta POP (%) obtained from each finger with different contact force is calculated as
      follows;(POPmax - POPmin)/{(POPmax + POPmin)/2}. Using receiver operating characteristic
      curve, diagnostic power of delta POPs from different contact forces for fluid responsiveness
      will be evaluated. In addition, difference between delta POP from low contact force and that
      from high contact force will be evaluated.
    

Intervention name(s): Pulse oximeter
Intervention type(s): Procedure
Intervention description(s): When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, POP waveforms are obtained from each index finger, which pulse oximeter sensor is applied by increasing contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then intravenous crystalloid 10 mL/kg is infused for 15 min.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Clinical Pharmacology Study of TS-143 in Nondialysis and Hemodialysis Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and
      hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single
      administration of TS-143.
    


Intervention name(s): TS-143
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dialysis, CKD
Safety and Efficacy Study of HYTOP® in the Treatment of Focal Chondral Defects.
Condition: Focal Chondral Defect in Femoro-tibial Compartment of the Knee Joint
MeSH terms: Cartilage Diseases
Study type: Interventional

Summary: 
      The two-layer bioresorbable HYTOP® matrix consists of an upper layer of highly purified
      porcine splint-skin which contains natural pores, and a lower layer of highly purified
      collagen fleece containing hyaluronan (HA).

      In this study, the medical device will be used and evaluated in a one-step procedure
      combining microfracturing with surgical implantation of HYTOP®. HYTOP® will support
      haemostasis in the articular cartilage defect, act as a support for cell growth and as a
      three-dimensional scaffold for cell differentiation. HYTOP® will protect the underlying
      tissue after cartilage debridement and/or microfracturing of the subchondral bone.

      The primary working hypothesis is that HYTOP® is safe and suitable as a cell-free matrix to
      support haemostasis, as a cover for the cartilage lesion and eventually to enhance cartilage
      regeneration in a one-step surgical procedure.
    


Intervention name(s): HYTOP®
Intervention type(s): Device
Intervention description(s): HYTOP® will be implanted once during surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cartilage tissue engineering; hyaluronan; hyaluronic acid
Protein and Energy Metabolism in Pediatric Crohn's Disease
Condition: Crohn's Disease; Protein Metabolism; Energy Metabolism
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The metabolic response to Crohn's disease, including increased proteolysis and lipolysis and
      changes in energy expenditure, plays a significant role in the resulting malnutrition from
      which these patients suffer. Tumor necrosis factor-alpha (TNF-alpha), a pro-inflammatory
      cytokine, has been found to be elevated in children with ulcerative colitis. TNF-alpha has
      been incriminated in the mechanism of weight loss in many different chronic diseases, and
      causes net protein and lipid catabolism. Anti-TNF-alpha antibody (infliximab) has been proven
      to be an effective therapy for ulcerative colitis.

      The purpose of this study is to compare changes in protein and lipid metabolism, as well as
      resting energy expenditure, before and after therapy with anti-TNF-alpha antibody
      (infliximab) or corticosteroids in children with recurrent Crohn's disease. Performing this
      study will better define the changes in nutrition status observed in these children following
      remission of active Crohn's disease, and potentially lead to changes in medical and
      nutritional management of these children.
    


Intervention name(s): Stable isotope infusions
Intervention type(s): Drug
Intervention description(s): Stable isotope infusion will be given via an intravenous catheter. Subjects will receive a priming dose and a continuous dose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pediatric; Crohn's disease; protein metabolism; energy metabolism
NHANES Urinary Sodium Calibration Study
Condition: Nutrition Assessment
Study type: Observational

Summary: 
      This proposed calibration study is designed to evaluate the correlation of urinary sodium
      excretion between NHANES timed urine and 24-hour urine collections.
    

Detailed description: 
      The study will be conducted with 400 volunteer participants aged 18-39 years old.
      Participants will be asked to collect urine samples over a 24-hour period. One-third of the
      participants (n=133) will be asked to collect a second 24-hour urine 4-11 days later. A
      24-hour dietary recall interview will be collected after the completion of each 24-hour urine
      collection. Results from this study will be used to assess how well the sodium excretion
      estimated from NHANES timed urine correlates with data from 24-hour urine collection. It will
      provide valuable information on the potential of NHANES timed urine collections to be used to
      characterize trends in U.S. population sodium intake.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study was conducted with 407 adult volunteer participants living in the Washington DC,
        Maryland areas who met the following criteria:
      
Biospecimen description: 
      urine specimens
    
Keywords: Sodium; Potassium; Iodine; Creatinine