bioihbjkbjnl/mcl2 huggingface dataset:
Study of Adherence to Colonoscopy in Women
Condition: Colonoscopy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether women who are offered screening colonoscopy
      will be more likely to schedule and complete this procedure if they are given the option of a
      woman endoscopist.
    

Detailed description: 
      Colorectal cancer (CRC) is the third leading cause of cancer death in women. Although there
      are a variety of options for colon cancer screening, colonoscopy is thought to be the best
      modality for women. Despite recommendations by multiple societies, adherence to CRC screening
      among women is suboptimal. One possible barrier to adherence may be the gender of the
      endoscopist. Recent studies have shown that a large proportion of surveyed women would prefer
      a woman endoscopist. These studies suggest that having the option of a woman endoscopist
      would increase adherence to colonoscopy; however, there is no published literature that
      addresses this question.

      Hypothesis

      Women who are offered screening colonoscopy will be more likely to schedule and complete this
      procedure if they are given the option of a woman endoscopist.

      Specific Aims

      Primary

        -  Determine whether the option of a woman endoscopist is associated with increased woman
           patient adherence to screening colonoscopy.

        -  Assess the proportion of women who request a woman endoscopist when this option is made
           available to them.

      Secondary

      * Identify socio-demographic predictors of (a) completing a screening colonoscopy and (b)
      requesting a woman endoscopist (e.g. race/ethnicity, age, health insurance, marital status).
    

Intervention name(s): Woman endoscopist; Usual care
Intervention type(s): Other; Other
Intervention description(s): This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.; This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Adherence to screening colonoscopy in women
Acupuncture and Nausea/Vomiting in Pediatric Patients
Condition: Postoperative Vomiting and Nausea
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of intraoperative P6 acupuncture plus
      standard therapy on postoperative nausea and vomiting in pediatric patients undergoing
      tonsillectomy with or without adenoidectomy. 200 children will be randomly assigned to either
      the treatment or the control group.

        1. Treatment Group: Standard anti-emetic therapy plus bilateral P6 acupuncture after the
           induction of anesthesia

        2. Control Group: Standard anti-emetic therapy only

      This study will monitor nausea, retching, and vomiting events both directly after the surgery
      as well as the next day via a follow-up phone call to the parents of the study participant.
    


Intervention name(s): Acupuncture Needle
Intervention type(s): Device
Intervention description(s): A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
Other intervention name(s): Seirin Pyonex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Effects of Joint Effusion on Quadriceps Muscle
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Hydrarthrosis
Study type: Interventional

Summary: 
      The present study investigated whether the presence of fluid in the joint affected peak
      torque and the root mean square (RMS) values of surface electromyography (EMG) in patients
      symptomatic for osteoarthritis (OA).
    

Detailed description: 
      Several studies have shown that knee effusion influenced quadriceps muscle activity and
      induced quadriceps arthrogenic muscle inhibition in normal volunteers. However, the effect of
      joint effusion on the quadriceps of patients with OA is controversial,and few patients with
      OA have been included in studies of joint effusion.
    

Intervention name(s): normal saline injection; sham injection
Intervention type(s): Other; Other
Intervention description(s): 20 cc normal saline injection into knee joint; no saline injection
Other intervention name(s): normal saline; no normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Knee; Osteoarthritis; Effusion.
Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of the study was to compare rheumatoid arthritis symptom improvement in
      participants who were given ABP 710 to those who were given infliximab, 22 weeks after
      starting treatment.
    


Intervention name(s): ABP 710; Infliximab
Intervention type(s): Biological; Biological
Intervention description(s): Administered by intravenous infusion; Administered by intravenous infusion
Other intervention name(s): Remicade®
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic
      Solution 0.1% in Japanese children with allergic conjunctivitis.
    


Intervention name(s): Olopatadine hydrochloride ophthalmic solution 0.1%
Intervention type(s): Drug
Intervention description(s): 1-2 drops 4 times per day
Intervention MeSH terms: Olopatadine Hydrochloride; Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic conjunctivitis
Efficacy and Safety of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Common Cold and Flu Syndrome
Condition: Flu
MeSH terms: Common Cold; Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the efficacy and safety of a fixed combination of
      paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and
      flu-like illness in adults in a randomized, double-blind, controlled trial. The investigators
      included 146 healthy study subjects aged between 18 and 60 years who presented flu or common
      cold moderate to severe onset of less than 3 days (72 hours). After clinical and laboratory
      evaluation were randomized to receive active drug or placebo, five capsules a day, every 4
      hours for 48-72h.The outcomes to assess the effectiveness involve the measurement of symptom
      scores, overall duration of symptoms, return to usual activities, use of rescue medication,
      improvement of the fever.
    

Detailed description: 
      The upper respiratory infections are frequent in the population, and its treatment, in most
      cases involves the use of symptomatic drugs. Paracetamol is used as an analgesic and
      antipyretic, whereas chlorpheniramine and phenylephrine is an antihistamine with a
      vasoconstrictor decongestant function. The aim of this study is to evaluate the efficacy and
      safety of a fixed combination of paracetamol, phenylephrine and chlorpheniramine in
      symptomatic treatment of common cold and flu-like illness in adults in a randomized,
      double-blind, controlled trial.
    

Intervention name(s): Active; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule de active (fixed combination of acetaminophen, chlorpheniramine and phenylephrine) administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days; 1 capsule administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days
Other intervention name(s): Active Flu; Placebo Comparator Flu
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Symptomatic treatment; Common Cold; flu syndrome
A Brain Imaging PET Study of [11C]-Lu AF90103 in Healthy Adult Male Participants
Condition: Healthy Young Men
Study type: Interventional
Phase: Phase 1

Summary: 
      The main goals of the study are to assess uptake and distribution of Lu AF90103 in the brain
      when given at tracer levels (microdose) in healthy young men.
    


Intervention name(s): [11C]-Lu AF90103
Intervention type(s): Drug
Intervention description(s): PET ligand administrated as a single intravenous bolus injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine, in subjects with Type 2 Diabetes Mellitus:

        1. Whether glycemic control can be achieved at least as effectively with an insulin regimen
           involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection
           as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH
           insulin injections per day.

        2. The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6
           months, if any, on measures of pulmonary function.
    


Intervention name(s): Inhaled human insulin (EXUBERA™)
Intervention type(s): Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Reversal of Neuromuscular Blockade With Sugammadex Versus Neostigmine Plus Glycopyrolate in Patients Undergoing Burn Surgery
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to learn if there is a difference in recovery time when using
      sugammadex versus neostigmine. The researchers also hope to add further knowledge and data to
      the safety of using sugammadex in burn patients who are hypermetabolic.
    


Intervention name(s): Sugammadex; Neostigmine; Glycopyrrolate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sugammadex is indicated for the reversal of neuromuscular blockade.; Neostigmine is indicated for the reversal of neuromuscular blockade.; Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: muscle function
Comparative Study of Osteosynthesis for Chevron Osteotomy of Hallux Valgus Using Degradable Versus Non-degradable Metallic Device
Condition: Hallux Valgus
MeSH terms: Hallux Valgus
Study type: Interventional

Summary: 
      The purpose of the study is to show the equivalence of a new degradable metallic device to a
      non-degradable metallic device in patients with Hallux Valgus.
    


Intervention name(s): Fracture compressing screw ZfW 102 Königsee Implantate GmbH; Fracture compressing screw titanium Königsee Implantate GmbH
Intervention type(s): Device; Device
Intervention description(s): Comparison of two metallic implantable fracture compressing screws; Comparison of two metallic implantable fracture compressing screws
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c)
Condition: HIV Infections
MeSH terms: HIV Infections; Neurotoxicity Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      A phase IV, multicentre, randomised, open-label, pilot clinical trial to evaluate the
      Reversibility of abacavir/lamivudine/dolutegravir ( ABC/3TC/DTG) CNS-Related Neurotoxicity
      After Switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c)
    

Detailed description: 
      The investigators estimate that 55 participants will need to be included per group, 110
      patients in total, to demonstrate the benefit of switching ABC/3TC/DTG to TAF/FTC/DRV/c
    

Intervention name(s): Symtuza® (TAF/FTC/DRV/c); ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with TAF/FTC/DRV/c during 8 weeks since randomized; Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to TAF/FTC/DRV/c for 8 weeks
Intervention MeSH terms: Emtricitabine; Darunavir; Cobicistat
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A phase IV, multicentre, randomised, open-label, pilot clinical trial.
Masking: None (Open Label)
Primary purpose: Treatment
Oral Health Promotion Strategy for Persons With Intellectual/Developmental Disabilities
Condition: Oral Health
MeSH terms: Developmental Disabilities
Study type: Interventional

Summary: 
      A Phase II cluster randomized controlled trial of the (OHPROM) strategy/intervention will be
      conducted in partnership with several organizations that provide residential services for
      persons with intellectual developmental disabilities (IDD) in north central Kentucky and
      southern Indiana. The investigators have identified a purposive sample of group homes,
      caregivers, and persons with IDD and have the support of these organizations.
    

Detailed description: 
      The proposed intervention is comprised of four components : (a) planned action including a
      behavioral contract Activity 1) with caregivers and action planning for oral health (Activity
      2), (b) caregiver capacity building with didactic training (Activity 3), observational
      learning and caregiver practice (Activity 4); (c) environmental adaptations with location of
      oral health activities and reminder posters - physical environment (Activity 5) and
      administrative oral health support- (social environment (Activity 6); and (d) reinforcement
      with caregiver coaching (Activity 7).
    

Intervention name(s): Oral health promotion strategy
Intervention type(s): Behavioral
Intervention description(s): The proposed intervention is comprised of four components : (a) planned action including a behavioral contract Activity 1) with caregivers and action planning for oral health (Activity 2), (b) caregiver capacity building with didactic training (Activity 3), observational learning and caregiver practice (Activity 4); (c) environmental adaptations with location of oral health activities and reminder posters - physical environment (Activity 5) and administrative oral health support- (social environment (Activity 6); and (d) reinforcement with caregiver coaching (Activity 7).
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The primary objective of this study is to assess the direct effect of the OHPROM strategy on oral health status of persons with IDD at post intervention [4-month] and sustained [12-month] in comparison to the control group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Prevalence of Cachexia in Patients Undergoing Chemotherapy
Condition: Cancer; Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Study type: Observational

Summary: 
      Cachexia and low nutritional intake are a common phenomena in cancer patients undergoing
      chemotherapy. The purpose of this study is to assess prevalence of cachexia and low
      nutritional intake and the impact on quality of life, fatigue and mortality in patients
      undergoing chemotherapy. Furthermore interactions between these parameters, tumor disease and
      chemotherapy, respectively.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients will be selected in primary care clinics.
Role of Adenosine in the Control of Choroidal Blood Flow During Changes in Ocular Perfusion Pressure.
Condition: Ocular Physiology; Microcirculation
Study type: Interventional

Summary: 
      Autoregulation is the ability of a vascular bed to maintain blood flow despite changes in
      perfusion pressure. For a long time it had been assumed that the choroid is a strictly
      passive vascular bed, which shows no autoregulation. However, recently several groups have
      identified some autoregulatory capacity of the human choroid. In the brain and the retina the
      mechanism behind autoregulation is most likely linked to changes in transmural pressure. In
      this model arterioles change their vascular tone depending on the pressure inside the vessel
      and outside the vessel. In the choroid, several observations argue against a direct
      involvement of arterioles. However, the mechanism behind choroidal autoregulation remains
      unclear. Adenosine, an endogenous purine metabolic end product with a potent vasodilatory
      effect on multiple vascular beds, leads to an increase in retinal and choroidal vessel
      diameter. The present study aims to investigate whether adenosine plays a role in choroidal
      autoregulation during a decrease in ocular perfusion pressure, which will be achieved by an
      increase in intraocular pressure.

      Pressure/flow relationships will be investigated in the absence and presence of adenosine.
    


Intervention name(s): Adenosine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adenosine; Choroidal blood flow; Suction cup
Neocortical Epilepsies - Do They Progress?
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      This study will use MRI and PET scan to compare the brain imaging results between epilepsy
      patients and normal healthy controls, also to study changes in 3 years.
    

Detailed description: 
      We would like to continue analyzing the structural and metabolic differences between two
      epilepsy groups (JME and FLE) and the control to understand the imaging presentations of
      epilepsy patients
    

Intervention name(s): Arm 1: Juvenile Myoclonic Epilepsy; Arm 2: Frontal Lobe Epilepsy; Arm 3: Normal Controls
Intervention type(s): Device; Device; Device
Intervention description(s): Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI; Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI; Positron emission tomography (PET) fluorodeoxyglucose (FDG) (10 mCi) and MRI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Three different Groups in this study: Juvenile Myoclonic Epilepsy, Frontal Lobe Epilepsy, Normal Controls
Masking: None (Open Label)
Primary purpose: Diagnostic
Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc
      (UK-427,857) in patients with human immunodeficiency virus (HIV)
    


Intervention name(s): Maraviroc (UK-427,857); Maraviroc (UK-427,857); Maraviroc (UK-427,857); Maraviroc (UK-427,857); Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): 150 mg oral tablet twice daily while fasted on Days 1-9 and on Day 10 (morning dose only); 100 mg oral tablet once daily while fasted on Days 1-10; 300 mg oral tablet once daily while fasted on Days 1-10; 150 mg oral tablet twice daily with food on Days 1-9 and on Day 10 (morning dose only); Matching placebo oral tablet on Days 1-10 (fed and fasted)
Other intervention name(s): Celsentri, Selzentry; Celsentri, Selzentry; Celsentri, Selzentry; Celsentri, Selzentry
Intervention MeSH terms: Maraviroc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV Infections; Treatment Naïve
A Multi-center Study of Spherule-Derived Coccidioidin
Condition: Coccidioidomycosis
MeSH terms: Coccidioidomycosis; Coccidiosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test
      antigen was evaluated in three different populations of adult volunteers to determine the
      safety and efficacy of the product in the assessment of delayed-type hypersensitivity to
      Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered
      positive for exposure to C. immitis.
    


Intervention name(s): Spherule-derived coccidioidin
Intervention type(s): Biological
Intervention description(s): 1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.
Other intervention name(s): Coccidioidin SD (proposed trade name)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Coccidioidin; Coccidioidin SD; Spherule-derived coccidioidin; Coccidioidomycosis; Valley Fever; Coccidioides immitis