bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Pilates and Aerobic Exercise in Patients With Ankylosing Spondylitis
Condition: Exercise; Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      The aim of our study is to investigate the effect of Clinical Pilates Exercises on functional
      status and quality of life when applied together with aerobic exercise in patients with
      ankylosing spondylitis (AS).
    

Detailed description: 
      According to the power analyzes 32 patients, who were diagnosed as Ankylosing spondylitis,
      will be taken to the study. In the first session their spinal mobility, flexibility, dynamic
      and static balance, back and lower limb muscle strength, pulmonary functions and pulmonary
      muscle strength, disease activity level, fatigue level, functional exercise capacity will be
      assessed to determine functional status by a physiotherapist. Also their quality of life and
      factors affecting the quality will be assessed. Then the patients will be divided into two
      exercise groups randomly. Patients in the first group will only do aerobic exercise, patients
      in the second group will do clinical pilates additional to the aerobic exercise which has the
      same protocol with the first group. Patients will do the exercise for 8 weeks, 3 times a day
      individually with a physiotherapist . At the end of the 8 weeks they will be assessed with
      the same tests again.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): clinical pilates on mat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; clinical pilates exercise; aerobic exercise; functional exercise capacity; pulmonary function
Lacticaseibacillus Rhamnosus GG Pili Study
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study was to investigate the host-microbe interaction effects of various
      Lacticaseibacillus rhamnosus GG strains, with different binding capacities to the mucus in
      the small intestine, in healthy individuals
    

Detailed description: 
      The project consisted in the supplementation of a) a wild-type LGG strain, b) a low-producing
      pili LGG strain or c) a high-producing pili LGG strain to study subjects. The individuals
      received the three treatment combinations in a randomised order. Each supplementation was
      given to the individuals every 30 min over a period of 6 hours. Eight biopsies from the
      duodenum were collected at the end of 6 h-solutions administration by flexible
      gastroduodenoscopy, likewise the routine procedure during this endoscopic investigation.
      Faecal samples were collected by the study subjects at home 1 day before, 2, 7 and 14 days
      days after administrations of each oral supplementation. The supplementations were separated
      by a 3-week wash-out period.
    

Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Other intervention name(s): LGG
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The individuals did receive the three treatment combinations in a randomised order.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Lacticaseibacillus rhamnosus GG; Probiotics; Pili; Gut microbiota; Transcriptomics; Small intestine
18F-FLT-PET in Breast Cancer (MK-0000-139)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell
      proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'[18F]-fluorothymidine
      (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy
      in participants with breast cancer.
    


Intervention name(s): 18F-FLT-PET/CT Imaging
Intervention type(s): Radiation
Intervention description(s): Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy.
Intervention MeSH terms: Alovudine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
SATIN WP4 Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red
      ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the
      short-term.
    

Detailed description: 
      A double-blind, randomised crossover design will be employed with an experimental (active)
      condition and a control condition at least one week apart. After having successfully
      completed screening procedures eligible participants will be invited for two separate test
      days, at least 7 days apart. On the two test days, the products will be provided in a
      randomized order as part of a fixed breakfast meal, and subjective appetite ratings will be
      measured every 30 min for the following 8 hours. Satiety and satiation will be measured
      through administration of test meals in the laboratory supplied with controlled food intake
      under free-living conditions
    

Intervention name(s): SATIN pineapple; SATIN pineapple control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Active juice with added fibre and ginseng; Control products without active ingredients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ad libitum energy intake; Appetite
Tracing the Path of an Ingested Plant Pigment Through the Human Body
Condition: Metabolism and Clearance of Cyanidin 3 Glucoside
Study type: Interventional

Summary: 
      This study will trace the path of a natural plant pigment, (cyanidin-3-glucoside; C3G),
      through the human body after consumption. C3G is the most abundant of the naturally occurring
      anthocyanin family of plant pigments and is responsible for the red to purple colour of many
      fruits and vegetables. Anthocyanins are promoted as being potentially beneficial to
      heart-health and also have anti-cancer properties, however little is known about how the body
      processes these compounds after they are eaten or how they are cleared from the digestive
      system. The investigators study aims to answer these questions and, in doing so, unravel how
      they may benefit everyone's health.

      In this BBSRC funded study, 8 healthy (18-45y) male participants will be recruited to a one
      day feeding study (lasting 8 hours) to establish the routes of clearance of anthocyanins from
      the body. After consent has been obtained, participants will be screened to establish their
      health (by NHS clinical staff). Eligible participants will be asked to consume a low
      anthocyanin diet for 7 days and to attend a study day at the Clinical Research & Trials Unit
      (CRTU, University of East Anglia). Participants will attend in a fasted state (at least 8h of
      water only) and will be asked to provide a urine (total morning void) and faecal (within the
      previous 72h) sample. Participants will then consume a C3G capsule and blood and breath
      samples will be collected at regular intervals after consumption (0.5, 1, 2, 4 and 6 hours).
      The capsule is roughly the size of a commercial vitamin-C tablet (500mg). Participants will
      then return in a fasted state on the following 2 mornings to provide further urine, faeces,
      breath and blood samples. Low anthocyanin meals will be provided throughout the study day and
      on the following 2 mornings. Participants will be reimbursed for their inconvenience
    


Intervention name(s): Cyanidin 3 glucoside
Intervention type(s): Dietary Supplement
Intervention description(s): Ingestion of 500mg of Cyanidin 3 glucoside (a naturally occurring plant pigment)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Flavonoids; Anthocyanin; Cyanidin 3 glucoside; Acute feeding trial; Stable isotope; Metabolism; Clearance; Bioavailability; Pharmacokinetics
A Study to Evaluate the Abuse Potential of Oxymorphone Compared to Other Mu Opioid Agonists.
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Significant public health concerns have arisen from the intravenous misuse of oxymorphone, a
      potent mu-opioid pain medication. However, little is known about its abuse potential relative
      to other mu-opioid analgesics. The present study is designed to examine the abuse liability
      of intravenous oxymorphone compared to other mu opioid agonists (oxycodone, and
      hydromorphone) among physically dependent opioid abusers.
    

Detailed description: 
      Significant public health concerns have arisen from the misuse of oxymorphone, a potent
      mu-opioid pain medication approved by the Food and Drug Administration as Opana and Opana ER.
      However, little is known about its abuse potential relative to other mu opioid analgesics.
      The present study is designed to examine the abuse liability of intravenous oxymorphone
      compared to other mu opioid agonists (oxycodone and hydromorphone). Participants who are
      physically dependent on opioids and who meet DSM 5 criteria for Opioid Use Disorder will
      complete the study across 2 sites, New York State Psychiatric Institute (NYSPI) and the
      University of Kentucky; a total of 6 additional participants across 2 sites will complete a
      pilot phase of the study in order to establish comparable opioid dose-response functions
      based on subjective ratings of Drug Liking. All participants will reside in clinical
      inpatient units for the duration of the studies (both the 8- to 9-week main and 4- to 5-week
      pilot studies; please note that the pilot study is identical in design to the first 4-5 weeks
      of the main study). The study design is based on the 2017 FDA Assessment of Abuse Potential
      of Drugs: Guidance for Industry [Center for Drug Evaluation and Research (CDER), 2017], which
      suggests the use of a double-blind, positive- and placebo-controlled design that includes a
      qualification phase and VAS measure of Drug Liking. The proposed study also examines the
      reinforcing effects of oxymorphone and other mu opioid agonists using two different drug
      self-administration procedures, namely Drug versus Money and Drug versus Drug choice
      procedures.
    

Intervention name(s): Intravenous Challenge Drug
Intervention type(s): Drug
Intervention description(s): Intravenous administration of opioid drugs (oxycodone, oxymorphone, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).
Other intervention name(s): Oxycodone, Oxymorphone, Hydromorphone, or Placebo
Intervention MeSH terms: Oxymorphone; Oxycodone; Hydromorphone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Intravenous Challenge Drug
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Ridaforolimus in Patients With Hepatic Insufficiency (MK-8669-046)
Condition: Healthy Volunteers; Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the pharmacokinetics of ridaforolimus including the area under the
      concentration-time curve (AUC[0-infinity]) and maximum concentration (Cmax) after
      administration of a single dose of ridaforolimus in patients with moderate hepatic
      insufficiency and healthy matched control subjects.
    


Intervention name(s): ridaforolimus
Intervention type(s): Drug
Intervention description(s): single oral dose administration 10 mg ridaforolimus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Hepatic Insufficiency
Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy
Condition: Urinary Tract Infections
MeSH terms: Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical trial is compare the incidence of symptomatic or asymptomatic
      bacteriuria after transrectal ultrasound guided prostate biopsy using a single dose of
      fosfomycin 3 g one hour before the biopsy compared to observed with the use of a single dose
      of ciprofloxacin 500 mg 1 hour before biopsy.
    

Detailed description: 
      Transrectal ultrasound guided (TRUS) prostate biopsy is the procedure of choice for the
      diagnosis of prostate cancer. This technique is usually safe and well tolerated with a low
      incidence of serious complications. However, one of these complications, the bacterial
      infection can be complicated and cause urinary sepsis. The investigators have developed
      different regimens of antibiotic prophylaxis. Most of them include administering oral
      fluoroquinolones. In this area, approximately 40% of the strains of E. coli are resistant to
      ciprofloxacin (fluoroquinolone). Therefore, research is warranted alternative prophylactic
      approaches. Fosfomycin is an antibiotic ancient underused in recent decades that in recent
      years has been proposed as an alternative treatment for infections caused by
      multidrug-resistant microorganisms.
    

Intervention name(s): Fosfomycin 3 g; Ciprofloxacin 500 mg
Intervention type(s): Drug; Drug
Intervention description(s): Unique oral dosis of fosfomycin 1 hour before biopsy; Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy
Intervention MeSH terms: Ciprofloxacin; Fosfomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Transrectal ultrasound-guided prostate biopsy; Bacteriuria; Antibiotic prophylaxis; Prostate-Specific antigen
A Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Cancer-related Pain
Condition: Pain, Burning; Pain, Crushing; Pain, Migratory; Pain, Radiating; Pain, Splitting
MeSH terms: Cancer Pain; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and effectiveness of JNJ-42160443 with
      placebo in the treatment of chronic, moderate to severe cancer-related pain in terminally ill
      patients with a diagnosis of active cancer.
    

Detailed description: 
      This is a randomized (study drug assigned by chance), double-blind (neither the physician nor
      the patient knows the name of the assigned drug) study to evaluate the safety and
      effectiveness of JNJ-42160443 compared with placebo in the treatment of men and women 18
      years of age or older who are terminally ill (ie, patients who are in or who are candidates
      for hospice or palliative [other medical care] care for end-of-life management) with moderate
      to severe, chronic, cancer-related pain that is not controlled by standard pain medications
      and who have a diagnosis of active cancer. The duration of the study will be approximately 62
      weeks (includes screening, the 4-week double-blind phase followed by the 48-week open-label
      [study doctor and patient knows the name of the assigned treatment] extension phase and a
      posttreatment phase). A single dose of JNJ-42160443 or matching placebo given as an
      (subcutaneous [SC]) injection under the skin during the double-blind treatment period. During
      the open-label period, JNJ-42160443 will be given once every 4 weeks for up to 48 weeks.
    

Intervention name(s): JNJ-42160443; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Type=1, unit=mg, number=10, form=solution for injection , route=subcutaneous use. SC injection (10mg/ml) once every 4 weeks for up to 52 weeks; Form=solution for injection, route=subcutaneous use. SC injection (0.9 mL matching placebo) once on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate to severe chronic, cancer-related pain related to an active cancer; Cancer-related pain; Moderate to severe chronic pain; JNJ-42160443
Multiple-dose Study of Levetiracetam Injection in Japanese and Caucasian Healthy Males
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute
      intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male
      subjects
    


Intervention name(s): Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
Intervention type(s): Drug
Intervention description(s): Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days
Other intervention name(s): E-Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Japanese; Caucasian
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
Condition: Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the
      Axium MicroFX coil system in 100 aneurysms.
    

Detailed description: 
      This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the
      Axium MicroFX coil system in 99 patients at 13 study centers. The primary endpoint of the
      trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram
      basedon the Raymond classification. Secondary endpoints included safety during the procedure,
      safety after the procedure, detachment system performance, stability of the embolization, and
      packing efficacy.
    

Intervention name(s): Axium™ MicroFX™ PGLA COILS
Intervention type(s): Device
Intervention description(s): Axium™ MicroFX™ PGLA COILS to treat aneurysms
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients presenting with an intracranial aneurysm will be evaluated by the neuro
        interventional team, in accordance with institutional practice, to establish an appropriate
        treatment plan based on the patient's medical condition and available diagnostic screening
        prior to recruitment
      
Keywords: Patients presenting with an intracranial aneurysm
Effect Of Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis; Kinesiophobia
Study type: Interventional

Summary: 
      Aim: Investigating the effects of Clinical Pilates Exercise on kinesiophobia, pain,
      functional status and quality of life of the patients diagnosed with osteoporosis.

      Method: 47 patients were assessed and randomly divided into 2 groups. Exercise group patients
      joined exercise program regularly that was held 3 times a week, 1 hour a day, during 6 weeks
      with physiotherapist. Control group patients continued their normal daily lives without any
      exercise. After 7 patients quit the study for various reasons, 40 women with primary
      osteoporosis (control group n=20, exercise group n= 20), completed the study and were
      assessed at the beginning and at the end of 6 weeks. As assesment' measurements Tampa
      Kinesiophobia Scale (TKS), Visual Analog Scale (VAS), Short Form McGill (SF-McGill), Pain
      Disability Index (PDI), Oswestry Disability Index (ODI), Berg Balance Test (BBT), Timed Up-
      Go Test (TUG), Chair Sit-Stand Test (CSST), Chair Sit and Reach Test (CSRT), Back Scratch
      Test (BST), Quality of life Questionnaire European Foundation for Osteoporosis (QUALEFFO-41),
      Hospital Anxiety and Depression Scale (HADS), Satisfaction with Life Scale (SLS) and Health
      Assesment Questionnaire (HAQ) were performed.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Clinical Pilates exercise were given for 6 weeks, 3 days in a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis; Clinic Pilates Exercise; Kinesiophobia; Pain
Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants
Condition: Total Parenteral Nutrition-induced Cholestasis
MeSH terms: Cholestasis
Study type: Interventional
Phase: Phase 3

Summary: 
      To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated
      cholestasis to receive Omegaven for compassionate use situations for which there are no
      satisfactory alternative treatments.
    


Intervention name(s): Omegaven; Omegaven; Omegaven
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.; Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 2 years.; If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.
Other intervention name(s): omega-3 enriched fat emulsion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: omegaven; cholestasis; parenteral nutrition associated liver disease