bioihbjkbjnl/mcl2 huggingface dataset:
Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth
Condition: Weight Gain
MeSH terms: Weight Gain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this pilot study is to determine whether starting metformin in conjunction
      with a second-generation antipsychotic (SGA) and providing information about healthy eating
      and activity will prevent or reduce the amount of weight gain and the metabolic changes in
      adolescent youth typically seen with second-generation antipsychotic medication.
    

Detailed description: 
      This is a 24 week, placebo-controlled, random assignment pilot study in which participants
      will be randomized in a 1:1 ratio to receive either flexible-dose treatment with metformin
      for 6 months as well as a newly initiated second generation antipsychotic medication or to
      receive placebo and the newly initiated antipsychotic medication. All subjects will also be
      provided healthy lifestyle instruction. The study involves monthly visits for the duration of
      the study. Participants may be treated as inpatients or outpatients throughout the course of
      the study. Participants will receive a psychiatric evaluation, physical exam, lab work, ECG,
      medication treatment, and psychiatric care.

      The goal is to evaluate the safety and efficacy of means to prevent and treat weight gain and
      the associated endocrine, metabolic, and inflammatory changes caused by antipsychotic
      medications. Behavioral treatments to reduce weight gain and metabolic problems after weight
      gain has occurred have had little impact. Such interventions must be intensive and sustained
      over months, if not years to be effective. Although basic lifestyle instruction (diet and
      physical activity) should be the standard of care for all children and adolescents at risk
      for becoming overweight, pharmacologic interventions may be the best option for substantially
      augmenting behavioral approaches to weight management.
    

Intervention name(s): metformin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500mg tablets, 250mg to 2000mg/day, po, BID to TID, 26 weeks; 500/0mg tablets, 250-2000mg/day divided BID to TID, po, 26 weeks
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: antipsychotic; metformin; children; adolescents
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of KA34 when administered via
      intra-articular injection to subjects with osteoarthritis of the knee.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study to assess the safety,
      tolerability, pharmacokinetics, and pharmacodynamics of KA34 when administered via
      intra-articular injection to subjects with osteoarthritis of the knee. OA patients are
      randomized to receive either placebo or KA34 active drug in the range of 50-400 ug by
      intra-articular injection. The first portion of the study is with single ascending doses, the
      second portion of the study is with multiple ascending doses.
    

Intervention name(s): KA34; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 µg - 400 µg intra-articular injection (single or multiple doses); 50 µg - 400 µg intra-articular injection (single or multiple doses)
Other intervention name(s): KA-34
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Arthritis; Joint Disease; Osteoarthritis, Knee
Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hypertension; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .
    


Intervention name(s): atorvastatin; amlodipine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      Study Design

      This is a Phase 1, multi-center, extension study to collect safety data up to 75 ± 10 days
      postdose from the Phase 1 studies RPC01-1912, RPC01-1913 and RPC01-1914 (ie, the "parent
      studies") and PK/PD data up to 75 ± 10 days postdose from studies RPC01-1913 and RPC01-1914.
      This study consists of two parts:

        -  Mandatory data collection for safety: Subjects enrolled in the parent studies were
           consented to have data on adverse events (AEs), serious adverse events (SAEs), pregnancy
           test results, and concomitant medications up to the 75 ± 10 days postdose follow-up
           collected and reported in this study.

        -  Optional sparse sampling for PK/PD: Eligible subjects from studies RPC01-1913 and
           RPC01-1914 will be offered the opportunity to return to the clinical research unit (CRU)
           at four separate occasions for PK/PD sample collections up to the 75 ± 10 days postdose
           follow-up. After signing the informed consent form, eligible subjects will be randomized
           to one of three sequences with stratification by site/protocol. Subjects will return to
           the CRU in the morning (between approximately 8 am and 11 am) once at each of the four
           time windows.

      Study Population The approximate number of subjects will be 230 for safety data and 129 for
      PK/PD data.

      Length of Study The study duration is up to 84 days.
    


Intervention name(s): ozanimod
Intervention type(s): Drug
Intervention description(s): ozanimod
Intervention MeSH terms: Ozanimod
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The approximate number of subjects will be 230 for safety data (from parent studies
        RPC01-1912, RPC01-1913, and RPC01-1914) and 129 for PK/PD data (from parent studies
        RPC01-1913 and RPC01-1914).
      
Keywords: Pharmacodynamics; Pharmacokinetics; Ozanimod; Safety; Healthy Subjects
Effect of Simethicone on Screening Colonoscopy
Condition: Adenoma Colon
MeSH terms: Adenoma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is evaluating the effect of adding a high dose of simethicone to the standard
      polyethylene glycol preparation for screening colonoscopy in the quality of the preparation ,
      adenoma detection rate and withdrawal times.
    

Detailed description: 
      A proper bowel preparation is key to a thorough and safe colonoscopy. Several factors affect
      the mucosal visualization during colonoscopy, and consequently the quality of such
      evaluation. Undoubtedly, this can have unfavorable implications like missed lesions. One of
      the most commonly encountered scenarios is the presence of multiple bubbles that interfere
      with mucosal visualization. When this occurs, simethicone (an antifoam agent used to reduce
      bloating when ingested orally) is injected through the colonoscope to eliminate the bubbles
      and get a clear view of the mucosa. A few studies have used oral simethicone in conjunction
      with oral preparation agents (PEG, magnesium citrate, sodium phosphate) in an attempt to
      improve the quality of the preparation. Unfortunately these studies have not used the exact
      same preparation agent with and without simethicone, making it difficult to draw conclusions
      on its efficacy. However, it is important to understand that simethicone is not intended to
      decrease the amount of stool in the colon, and it's purpose is to decrease the amount of
      bubbles interfering with the visualization of the mucosa provided that there is no stool
      present . Furthermore, it is unclear if adding simethicone to a standard bowel preparation
      makes a significant difference in key aspects of screening colonoscopy such as adenoma
      detection rate or withdrawal times. This prospective randomized controlled, observer blinded
      study at Texas Tech University Health Sciences Center in El Paso, aims at studying the effect
      of simethicone on the overall colon preparation as well as on adenoma detection rate and
      withdrawal times.
    

Intervention name(s): Simethicone Solution; Polyethylenglycol
Intervention type(s): Drug; Other
Intervention description(s): Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol; Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation
Other intervention name(s): mylicon
Intervention MeSH terms: Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Screening
Keywords: screening; adenoma detection rate; simethicone
Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)
Condition: Systemic Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in
      patients with sJIA.
    


Intervention name(s): MRA(Tocilizumab); placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Omega-3 Hydrogel and Prevention of Oral Mucositis
Condition: Mucositis Oral
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Oral mucositis (OM) is recognized as one of the most frequent debilitating sequela
      encountered by head and neck cancer (HNC) patients treated by radiotherapy. The objective of
      the study is to assess primarily the effect of topical oral Omega-3 hydrogel in prevention of
      radiation-induced oral mucositis and secondarily, to test the effect of topical oral Omega-3
      hydrogel on oral microbiome.
    


Intervention name(s): topical oral Omega-3 hydrogel; conventional preventive treatment
Intervention type(s): Drug; Drug
Intervention description(s): Topical oral Omega-3 hydrogel prepared from fish oil; topical treatment including antifungal agents, anti-inflammatory mouthwash, sodium bicarbonate mouthwash.
Topical anesthetics agent, topical analgesic gel as well as systemic analgesics (if needed)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Esmolol on Clinical Prognosis of Patients With Severe Sepsis
Condition: Severe Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effect of esmolol on hemodynamic
      parameters,tissue perfusion and the clinical prognosis of patients with severe sepsis
    

Detailed description: 
      enrollment:151 patients

      Inclusion criteria: (1) age > 18 years; (2) severe sepsis (acute organ dysfunction secondary
      to infection )diagnosis according to Campaign to Save Septic Patients: 2008 Treatment
      Guidelines for Severe Sepsis and Septic Shock, who (3) mechanical ventilation via
      endotracheal intubation with a tidal volume of 6 mL/kg; and (4) satisfactory sedation and
      analgesic treatment, with HR > 100 bpm.
    

Intervention name(s): Esmolol; natural saline
Intervention type(s): Drug; Drug
Intervention description(s): patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. The initial dose was 0.05 mg/kg/min and was adjusted based on heart rate (HR) (target HR: 70 bpm < HR < 100 bpm within 72 hours).
Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol.; Control group also received natural saline via a micro pump,
Other intervention name(s): β-blockers
Intervention MeSH terms: Esmolol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the dose response, safety, and efficacy of
      linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with
      Functional Constipation.
    


Intervention name(s): Linaclotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Linaclotide, capsules, mixed with water and administered orally, once daily in fasted state.; Matching placebo, capsules, mixed with water and administered orally, once daily in fasted state
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: There are 3 cohorts with ascending doses and an additional final cohort to repeat the highest dose determined to be safe
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Functional constipation in children; LINZESS
Functional Intermuscular Reduction of Spasticity
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      Investigators will use muscular dry needling in the calf of one lower extremity, followed by
      treadmill training with functional electrical stimulation.
    

Detailed description: 
      This study will be the first to combine a novel two-pronged approach to the management of
      spasticity (tightness of the muscle) in the calf muscles. First, investigators will decrease
      spasticity in an innovative way through dry needling. Second, investigators will follow this
      spasticity reduction technique using external electrical stimulation applied to the calf,
      while the participant walks on a harnessed treadmill (for safety). The investigators believe
      modulating tone in the calf with dry needling will allow for improved strength with
      electrical stimulation, while simultaneously improving the efficiency of the muscles during
      walking. The investigators hypothesize that decreasing spasticity will result in enhanced
      gait efficiency, and lower fatigue, all while allowing the participant to meet their personal
      mobility goals.10 The investigators are proposing an innovative study design. Assessing
      changes in muscle spasticity using electromyography and the Modified Ashworth scale before
      and after each portion of our two-pronged intervention will enable them to understand the
      immediate effects of dry needling, as well as the combined effects of function electrical
      stimulation with with treadmill training. Following the intervention assessments with
      pre-post functional tests will allow us to determine long term changes. This proposal offers
      a unique approach to management of spasticity in people with Multiple Sclerosis (MS), with
      the advantage of being minimally invasive and inexpensive. Results of this pilot study will
      inform the potential use in MS, and will allow for a larger study examining optimal
      intervention parameters for future use.
    

Intervention name(s): dry needling
Intervention type(s): Other
Intervention description(s): dry needling followed by functional electrical stimulation and treadmill training
Other intervention name(s): functional electrical stimulation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with a diagnosis of MS and spasticity
Transdermal Nitroglycerin and Nifedipine in Preterm Labor
Condition: Managing Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      One of the important complications of pregnancy is preterm labor (PTL) and delivery. There
      are different tocolytic agents to enhance the time of delivery. The aim of this study was to
      compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral
      nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted
      with diagnosis of PTL. Group one have received transdermal GTN whereas group two have
      received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as
      gestation age at the time of delivery have been monitored and evaluated in both groups of
      patient. Our main goal has been delay of delivery to have the most beneficial effect of
      primary corticosteroid administration for fetus.
    


Intervention name(s): Transdermal nitroglycerin; nifedipine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nifedipine; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Bioavailability of Different n-3 Fatty Acid Formulations
Condition: Health
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to examine differences in short term bioavailability between four
      n-3 FA formulations in healthy males.
    

Detailed description: 
      The long-chain n-3 fatty acids (n-3 FAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid
      (DHA) are known to positively affect the lipid profile, vascular tone and blood coagulation.
      Moreover, EPA and DHA possess anti-inflammatory effects and play a central role in the
      functioning of the brain and central nervous system. Therefore, an increased EPA and DHA
      intake is highly recommend. However, it is unknown whether different chemical formulations of
      EPA + DHA rich supplements (re-esterified triglycerides, ethyl-esters, phospholipids) have
      identical bioavailability. The objective of this study is to examine differences in short
      term bioavailability between four n-3 FA formulations:

        -  Supplement 1: EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil uncoated
           capsules

        -  Supplement 2: EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules
           (GArTG)

        -  Supplement 3: EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules

        -  Supplement 4: DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL)

      The study preparations are certificated supplements and available on the market.

      There are no comparative investigations, which analyzed the bioavailability of these four n-3
      FA formulations in a similar design.
    

Intervention name(s): rTG; GArTG; EE; KPL
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil; uncoated capsules (4 per day); 2016 mg n3 fatty acids daily (1008 mg EPA and 672 mg DHA); EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG); 4 capsules per day; 2016 mg n-3 fatty acids (1008 mg EPA and 672 mg DHA); EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules (4 per day); 2016 mg n-3 fatty acids (1008 mg EPA and 672 mg DHA); DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL); 7 capsules per day; 2100 mg n-3 fatty acids (1050 mg EPA and 630 mg DHA)
Other intervention name(s): re-esterified triglycerides; rTG in gastric acid resistant capsules; ethylesters; phospholipids from krill-oil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: bioavailability; marine n-3 fatty acids; EPA; DHA
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients
      with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or
      current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera
      1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24
      weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on
      study treatment is 48 weeks.
    


Intervention name(s): rituximab
Intervention type(s): Drug
Intervention description(s): 1000 mg intravenously on Days 1 and 15
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Releasing of Inflammatory Mediators During Retreatment of Root Canals
Condition: Inflammatory Response; Root Canal Infection
Study type: Interventional

Summary: 
      Nonsurgical root canal retreatment may become essential when the initial endodontic treatment
      fails because of the persistent intracanal or extracanal infections.The aim of this thesis
      study is to evaluate the effect of ProTaper Universal Retreatment (PTUR), Reciproc blue and
      XP-endo Finisher R file systems, which are used in the removal of root canal filling
      materials during retreatment with different motion kinetics on the release of Substance P,
      Calcitonin Gene-Related Peptide (CGRP), IL-6 and IL-10 inflammatory mediators in the
      periapical region
    

Detailed description: 
      Seventy-five individuals with asymptomatic and chronic apical periodontitis teeth with
      retreatment indication were included in the study. Individuals were randomly divided into
      three groups according to the file system used to remove root canal filling materials (n =
      25): ProTaper Universal Retreatment, Reciproc blue and XP-endo Finisher R.After the removal
      of the previous root canal filling materials, reshaping and disinfection of the root canals,
      periapical fluid samples were taken from the root tip of the teeth in all three groups. The
      amount of Substance P, CGRP, IL-6 and IL-10 mediators that cause pain, swelling and flare-up
      in periapical fluid samples were measured by ELISA test.
    

Intervention name(s): Protaper Universal Retreatment; Reciproc; XP-Endo finisher R
Intervention type(s): Other; Other; Other
Intervention description(s): D1-D2-D3 Retreatment files were used in 500 rpm and 3 Ncm with X-Smart endomotor; R25 retratment files were used with X-Smart endomotor in reciprocal motion; XP-Endo finisher r file were used in 1000 rpm 1 Ncm with X-Smart endomotor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment