bioihbjkbjnl/mcl2 huggingface dataset:
12-Week Study Evaluating the Efficacy, Safety, and Tolerability of Adjunctive Infliximab for Bipolar I/II Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Studies show the presence of immuno-inflammatory disturbances in individuals with Bipolar
      Disorders (BD). Increased levels of circulating proteins known as cytokines that promote
      inflammation have been consistently reported in individuals with bipolar disorders. A
      particular cytokine referred to as Tumor Necrosis Factor (TNF)-alpha is among those cytokines
      that have been consistently identified across depressive, manic, and euthymic periods.
      Disturbances in inflammation however, are not seen in all individual with bipolar disorder.
      Those individuals with signs of inflammation also often present with higher prevalence of
      medical disorders that are also associated with inflammation. Those individuals with
      significant signs of inflammation may respond to anti-inflammatory treatments. In this study,
      individuals with bipolar depression who exhibit signs of high inflammation will be enrolled
      and treated with either an anti-inflammatory biologic known as infliximab or placebo
      (saline).
    


Intervention name(s): Infliximab; Saline
Intervention type(s): Drug; Other
Intervention description(s): Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation. Infliximab will be prescribed adjunctively to a conventional mood stabilizer or atypical antipsychotic agent.; Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency and will be administered adjunctively to conventional mood stabilizer or atypical antipsychotic agent.
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Disorder; Bipolar Depression; Inflammation; Bipolar
Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The aim of this prospective study is to evaluate the clinical performance of habitual wearers
      of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily
      wear.
    

Detailed description: 
      The aim of this prospective study is to evaluate the clinical performance of habitual wearers
      of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily
      wear.

      This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting
      characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira
      Vitality silicone hydrogel Toric lenses (fanfilcon A).
    

Intervention name(s): somofilcon A toric contact lens; fanfilcon A toric contact lens
Intervention type(s): Device; Device
Intervention description(s): Contact Lens; Contact Lens
Other intervention name(s): Habitual lens; Test Lens
Intervention model: Single Group Assignment
Intervention model description: First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) will be dispensed and worn for 4-weeks for daily wear.
Masking: None (Open Label)
Primary purpose: Other
Physical Work Capacity After Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether body weight supported treadmill training is
      more effective than traditional physical therapy at restoring gait in persons recovering from
      traumatic brain injury.
    


Intervention name(s): body weight supported treadmill training; traditional physical therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): BWSTT for 12 weeks, 3 times per week; traditional PT for 12 weeks, 3 times per week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; head injury; 3 months post injury; require manual assistance or walking aids to walk; very slow walking speed; able to follow two step commands
Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg
      doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to
      PF-00345439 Formulation X in the fasted state in healthy volunteers
    

Detailed description: 
      This study will estimate the effect of food (standard high-fat breakfast) on the
      pharmacokineticsand relative bioavailability of oxycodone following oral administration of
      single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.

      Additionally, the study will estimate the pharmacokinetics and relative bioavailability of
      oxycodone following oral administration of single 40 mg doses of the test PF-00345439
      Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions
      in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in
      PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.
    

Intervention name(s): Oxycodone; Oxycodone; Oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions; One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: food effect; pharmacokinetics; bioavailability; oxycodone; management of moderate to severe pain
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
Condition: Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome; Partial Fetal Alcohol Syndrome; Alcohol-related Neurodevelopmental Disorder; Prenatal Alcohol Exposure
MeSH terms: Fetal Alcohol Spectrum Disorders; Syndrome; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether choline supplementation can improve
      cognitive functioning of children with prenatal alcohol exposure.
    

Detailed description: 
      Despite the known damaging effects of alcohol on the developing fetus and the presence of
      warning labels on alcoholic beverages, many pregnant women continue to drink alcohol. The
      consequences include a range of physical, neurological, and behavioral effects referred to as
      fetal alcohol spectrum disorders (FASD). Unfortunately, there are currently no comprehensive
      treatments for individuals with FASD. This pilot study will examine whether a nutritional
      intervention could reduce the severity of cognitive deficits associated with prenatal alcohol
      exposure. Choline is an essential nutrient, necessary for brain and behavioral development.
      Animal studies have shown that prenatal or early postnatal choline supplementation can lead
      to long-lasting cognitive enhancement. Similarly, choline supplementation improves cognitive
      outcomes among rats exposed to alcohol during development, even when administered postnatally
      and after alcohol exposure has occurred. The present experiment translates these findings to
      a clinical population of individuals exposed to heavy prenatal alcohol exposure. Subjects
      will be randomly assigned to receive daily choline supplementation or placebo control for a
      period of 6 weeks (approximately 20 subjects per group). Performance on neuropsychological
      tasks that measure cognitive functioning will be measured prior to treatment and at 6 weeks.
      These data will provide important information regarding a potential nutritional intervention
      for fetal alcohol spectrum disorders.
    

Intervention name(s): Choline; placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline
Intervention MeSH terms: Choline; Glycerol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Choline; Glycerophosphocholine; Choline alphoscerate; Fetal alcohol spectrum disorders; Fetal alcohol syndrome; Partial fetal alcohol syndrome; Alcohol-related neurodevelopmental disorder; Prenatal alcohol exposure; Fetal Alcohol Effects; Pregnancy Complications; Alcohol-Induced Disorders; Alcohol-Related Disorders; Central Nervous System Agents; Therapeutic Uses
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Sleep Efficiency in Healthy Adults
Condition: Sleep
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3
      polyunsaturated fatty acid dietary supplements on a number of objective sleep measures
      (collected from Activity watches) and subjective sleep measures (collected from the Leeds
      Sleep Evaluation Questionnaire) before and after 26 weeks of supplementation
    


Intervention name(s): EPA-rich; DHA-rich; Olive oil Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 6 months omega 3 supplementation; 6 months omega 3 supplementation; 6 months placebo supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Sympathovagal Balance in Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study has the following primary aim:

      - the main objective of this study is to investigate the effects of smoking cessation during
      quit attempts on sympathovagal balance. These effects will be observed in smokers quitting
      smoking with pharmacological support or without.

      Secondary aims of this study are also:

        -  the definition of MSNA in smokers and non-smokers

        -  the investigation of other parameters concerning the autonomic nervous system, like
           baroreflex-sensitivity, heart rate-variability before and during the quit attempt.

        -  the definition of withdrawal symptoms and craving before, during and after the quit
           attempt.

        -  the investigation of effects of smoking cues on craving and sympathovagal balance

        -  the investigation of relapse rates after smoking cessation in correlation with the
           parameters mentioned above.
    


Intervention name(s): Varenicline; Placebo; Nicorette TX
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5-2 mg per day, oral use; 1-2 tablets per day, oral use; 10-15 mg per day, transdermal use (patches)
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: smoking cessation; varenicline; sympathovagal balance; quit attempts; MSNA
Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will explore the various advantages and possible disadvantages of pioglitazone and
      insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid
      profiles, quality of life and cost will be studied given a comprehensive set of data that may
      help future treatment decisions.
    


Intervention name(s): insulin glargine [rDNA origin] injection
Intervention type(s): Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
GTS400 Stent Implantation in Conjunction With Cataract Surgery in Subjects With Open-angle Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma; Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the GTS400 trabecular
      micro-bypass stent in reducing intraocular pressure (IOP) in subjects with open-angle
      glaucoma or ocular hypertension and co-existing cataract.
    

Detailed description: 
      Glaucoma is a collection of disorders characterized by progressive loss of visual field due
      to optic nerve damage. It is a leading cause of blindness in the United States, affecting
      1-2% of individuals aged 60 and over. Management of glaucoma requires chronic, life-long
      treatment with a spectrum of therapeutic options including medications, laser treatment and
      surgical implants. The common goal among the various therapies is to lower intraocular
      pressure to target levels in order to prevent loss of visual fields from excessive pressure
      on the optic nerve.
    

Intervention name(s): iStent Inject (GTS400); Cataract Surgery
Intervention type(s): Device; Procedure
Intervention description(s): Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery with subsequent implantation of GTS400 stents.; Subjects will be randomized to one of two groups. In this case, subjects will undergo cataract surgery only.
Other intervention name(s): Cataract surgery, stent implantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open angle; Glaucoma; Cataract; Surgery; Intraocular Pressure
Study Evaluating Bazedoxifene/CE in Postmenopausal Women
Condition: Postmenopause
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to study the blood levels of a drug (conjugated
      estrogens) in the body from one dosage form compared to another. The four formulations of the
      study drug that eligible participants will receive will contain the same amounts of the same
      medications. In addition, information will also be obtained regarding the safety and
      tolerability of the formulations given to healthy postmenopausal women.
    


Intervention name(s): Bazedoxifene/Conjugated Estrogens
Intervention type(s): Device
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Offering Proactive Tobacco Treatment
Condition: Tobacco Use Cessation
Study type: Interventional

Summary: 
      This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy
      (NRT) to increase the population impact of tobacco cessation treatment for diverse, low
      income smokers. Population impact is the product of treatment utilization (i.e., reach or
      exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize
      treatment).
    

Detailed description: 
      Participants will be randomized to receive either Usual (Reactive) Care or Proactive
      Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).
    

Intervention name(s): proactive outreach (PRO); telephone counseling (TC); Nicotine replacement therapy (NRT); Usual care (UC)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): a mailed invitation letter followed by telephone outreach; free telephone counseling; free nicotine replacement therapy (NRT); nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nicotine replacement therapy; smoking cessation; tobacco dependent
Gut Peptides and Intestinal Permeability in Celiac Disease and Irritable Bowel Syndrome
Condition: Celiac Disease; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Celiac Disease; Syndrome
Study type: Observational

Summary: 
      It is well known that the intestinal barrier is altered in celiac disease (CD), an autoimmune
      disease that develops in genetically predisposed subjects exposed to ingestion of wheat
      gliadin and of related prolamines of barley and rye. More recently, defective epithelial
      barrier has been implicated in the pathogenesis of other conditions such as irritable bowel
      syndrome (IBS). At present IBS is still considered a functional condition although low-grade
      inflammation has been associated with its manifestation, particularly that following
      infection. Different substances have been implicated in the (dis)regulation of intestinal
      barrier, among them zonulin seems to play a key role. Other gastrointestinal peptides are
      GPL-2, Ghrelin, and Epidermal growth factor (EGF). In order to shed light on the hormonal
      regulation of intestinal barrier function in celiac patients before undergoing a gluten free
      diet and possible differences with those of IBS patients, in the present study the
      investigators will apply the non-invasive lactulose/mannitol permeability test toward the
      evaluation of intestinal damage. The pattern of intestinal permeability and the GI peptides
      concentration will be compared in celiac patients, IBS patients and healthy controls.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients recruited in IRCCS "S. de Bellis"
      
Keywords: Celiac disease; IBS; Intestinal barrier; Intestinal permeability; GI peptides
Reducing Sedentary Time in Fibromyalgia Patients
Condition: Fibromyalgia; Veterans
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      This study evaluates the feasibility of a behavioral intervention designed to replace
      sedentary behavior with light physical activity in veterans with Fibromyalgia. The study will
      also evaluate the acceptability of the intervention among veterans and intervention effects
      on pain and physical function.
    

Detailed description: 
      Recent research suggests that individuals with Fibromyalgia (FM) who spend more time in
      sedentary behavior and less time in light physical activity experience greater clinical pain
      and overall impact of FM, irrespective of time spent in moderate to vigorous physical
      activity. To date, no studies have investigated the potential impact of reducing sedentary
      behavior on key clinical and physical function outcomes in FM. The overall objective of the
      pilot project is to design and evaluate the feasibility of an 8-week behavioral intervention
      designed to replace sedentary behavior with light physical activity in veterans with FM.
      Mixed (quantitative and qualitative) methods will be used to evaluate the behavioral
      intervention, which is based on constructs from social cognitive and self-regulatory theories
      that consistently identify important drivers of behavior change as: education, goal-setting,
      self-monitoring and behavioral prompts to move via an activity tracker and phone app, and
      feedback on behavior via weekly meetings.
    

Intervention name(s): ReSeT-FM intervention
Intervention type(s): Behavioral
Intervention description(s): The ReSeT-FM intervention focuses on behavior changes strategies aimed at reducing sedentary time and includes: education, goal setting, self-monitoring of behavior and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings with study coaches.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinics.
Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of extended dosing with IONIS
      GHR-LRx in participants with acromegaly as add-on to somatostatin receptor ligands (SRL)
      therapy.
    

Detailed description: 
      This extension study will include participants up to 60 participants with acromegaly from
      Study NCT03548415. All participants will remain on the same dose from the previous study and
      receive IONIS GHR-LRx (SC) injection once every 28 days as add-on to SRL therapy for 53
      weeks. At the end of 53 weeks, participants will enter a 14-week post-treatment (PT)
      evaluation period.
    

Intervention name(s): IONIS GHR-LRx; Somatostatin Receptor Ligand (SRL)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive IONIS GHR-LRx by subcutaneous injection.; Participants will receive Somatostatin Receptor Ligand (lanreotide, octreotide) once monthly.
Other intervention name(s): lanreotide; octreotide
Intervention MeSH terms: Octreotide; Lanreotide; Somatostatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acromegaly, IONIS-GHR-LRx
Breast Feeding Practice in High Risk Pregnant Women
Condition: Breast Feeding
Study type: Observational

Summary: 
      The American Academy of Paediatrics recognizes multiple benefits of breastfeeding to both the
      term and premature newborn, particularly with regard to protection from infectious agents.
      Studies have demonstrated decreased rates of bacteraemia, meningitis, respiratory and urinary
      tract infections, necrotizing enterocolitis, and otitis media among breastfed infants
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients attending Sohag general hospital