bioihbjkbjnl/mcl2 huggingface dataset:
Creation of a Normal Database for FluoroDeoxyGlucose-Positron Emission Tomography (FDG-PET) Neurological Examinations
Condition: Lymphoma
Study type: Interventional

Summary: 
      The purpose of this study is to define a reference population for FDG-PET neurological
      examinations starting from patients having FDG-PET to supervise a non-complicated lymphoma
      (tumor in remission, low disabling chronic tumor).
    

Detailed description: 
      This study will also check normality of cerebral functions in this population and analyse the
      influence of various variation factors, such as age, sex ratio, education level, professional
      activity and neuropsychological test results on normal data.

      This database could be later used as comparison to patient images defining the gravity and
      localization of their cerebral functional disorders.
    

Intervention name(s): FDG-PET
Intervention type(s): Device
Intervention description(s): FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Collecting and storing samples of blood and urine from patients with cancer to
      study in the laboratory may help doctors learn more about changes that may occur in DNA and
      identify biomarkers related to cancer.

      PURPOSE: This laboratory study is looking at biomarkers in patients undergoing transrectal
      ultrasound prostate biopsy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Identify unique proteins or peptides that are associated with prostate cancer by
           comparing the proteomic or metabolomic analysis of serum, plasma, and urine from
           patients with histological evidence of prostate cancer to those without prostate cancer
           (after transrectal ultrasound prostatic biopsy).

      Secondary

        -  Collect seminal fluid from a subset of patients to test the hypothesis that the fluid
           collected from the "target organ of injury" in prostate cancer will have a higher signal
           of proteins/peptides that are different from those without cancer and may help guide the
           identification of these differences in the serum, plasma, and urine.

      OUTLINE: This is a pilot study.

      Patients undergo collection of serum, plasma, and urine for biomarker/laboratory analysis.
      Samples are examined by proteomic/metabolomic analysis (by mass spectrometry) and
      immunoassays. Patients then undergo a transrectal ultrasonography prostatic biopsy.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): proteomic profiling; immunological diagnostic method; laboratory biomarker analysis; mass spectrometry; biopsy; ultrasound imaging
Intervention type(s): Genetic; Other; Other; Other; Procedure; Procedure
Keywords: prostate cancer
Cognitive Control Training for Remitted Depressed Patients
Condition: Major Depression in Remission
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effectiveness of an internet-delivered cognitive
      control training as a preventive intervention for remitted depressed patients.
    

Detailed description: 
      Prospective studies have linked impaired cognitive control to increased cognitive
      vulnerability for future depression. Importantly, experimental studies indicate that
      cognitive control training can be used to reduce rumination and depressive symptomatology in
      MDD samples. Furthermore, studies exploring the potential of cognitive control training in
      at-risk undergraduate students indicate that cognitive control training has beneficial
      effects on rumination, an important vulnerability factor for depression. Provided that
      remitted depressed patients form a high-risk group for developing future depressive episodes,
      the current study will explore whether internet-delivered cognitive control training can be
      used to reduce vulnerability for future depression in remitted depressed patients. The
      investigators will explore effects on depressive symptomatology, (mal-)adaptive emotion
      regulation (directly following training and at 3 months follow-up), and indices of
      functioning (at 3 months follow-up).
    

Intervention name(s): Cognitive Control Training; Low Cognitive Load Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 adaptive Paced Auditory Serial Addition Task (PASAT) sessions, 400 trials each; 10 low cognitive load sessions, 400 trials each
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients
Condition: Non Insulin Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Surgical treatment for type 2 diabetes has been taken note especially in less obese or non
      obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater
      than that of the obese.

      We are trying to do a prospective observational study for the evaluation of the effect of
      duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.

      The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral
      obesity, insulin use less than 10 years and the patients understanding the hypothesis of this
      study, risks, expecting effects and agreeing this study.

      We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some
      anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.

      We will compare the clinical factors at each time.
    


Intervention name(s): laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
Intervention type(s): Procedure
Intervention description(s): routine GBP with 80cm roux and biliopancreatic limb
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metabolic surgery; gastric bypass; duodenojejunal bypass; type 2 DM
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
Condition: Surgical Hemostasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether rThrombin is safe when used for controlling
      bleeding during skin graft surgery.
    

Detailed description: 
      This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety
      of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness
      autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing
      eligibility, study participants will be treated with topical spray rThrombin at the skin
      graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up
      period after the surgery.
    

Intervention name(s): rThrombin
Intervention type(s): Biological
Intervention description(s): 1000 U/mL applied topically
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemostasis; grafting, skin; hemostatics; phase 2
Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars
Condition: Acne Scars
MeSH terms: Acne Vulgaris; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the
      treatment of atrophic acne scars.
    


Intervention name(s): Adapalene
Intervention type(s): Drug
Intervention description(s): Adapalene Gel 0.3%
Other intervention name(s): Differin 0.3%
Intervention MeSH terms: Adapalene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study on Hemodialysis: Illumination Effects
Condition: Sleep Problems
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional
Phase: Phase 3

Summary: 
      Previous research has shown that sleep quality in hemodialysis patients is disturbed. One of
      the possible explanations is an insufficient or disturbed melatonin rhythm. Melatonin rhythm
      is regulated by exposure to light. In this feasibility study, the investigators examine the
      effects of light therapy during dialysis on sleep, melatonin rhythm and mood.
    


Intervention name(s): light therapy with the device: EnergyLight
Intervention type(s): Procedure
Intervention description(s): 2 hr of light therapy during each hemodialysis session
Other intervention name(s): Philips Energylight
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep problems; melatonin; mood; Hemodialysis
PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and
      alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to
      treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We
      will treat the study participants either with PTH and alendronate, alendronate alone, or PTH
      alone. We will determine the effects of these treatments by looking for changes in bone
      mineral density in the hip and spine.
    

Detailed description: 
      The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the
      efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal
      women.

      238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1
      year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by
      alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by
      placebo for 1 year. The primary endpoints are changes in bone mineral density at several
      sites and changes in biochemical markers.

      In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin,
      deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to
      determine if they can predict the skeletal response to combination therapy. We will also
      determine whether PTH positively affects ultrasound measurements in the calcaneus.
    

Intervention name(s): PTH; Alendronate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PTH; Alendronate; Parathyroid hormone; Osteoporosis; Postmenopausal
A Dose-Escalation Study to Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed by an Open-Label Evaluation of LX214 in Patients With Keratoconjunctivitis Sicca (KCS)
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-man study for the purpose of determining the safety and tolerability of
      LX214 ophthalmic solution in healthy volunteers and in patients with dry eye syndrome.
    


Intervention name(s): voclosporin ophthalmic solution
Intervention type(s): Drug
Intervention description(s): 0.02%, 0.2% t.i.d. or b.i.d.
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children
Condition: Diphtheria, Tetanus and Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Observational

Summary: 
      Primary objective: This is a descriptive study and the primary objective is to determine the
      incidence of injection site and systemic adverse events after Triaxis administration as a 5th
      dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between 4-6 years of age who attend the investigator's office to receive a 5th
        dose of tetanus, diphtheria and pertussis Triaxis vaccine as part of the routine
        vaccination schedule, as described in the Spanish version of the EU SmPC and local
        vaccination calendar
Infant Feeding Practices in Transition: Breast Milk Intake, Complementary Feeding and Body Composition During Infancy
Condition: Breast Feeding
Study type: Observational

Summary: 
      Research Aim: We assessed human milk intakes of Thai infants during the first 6 months
      comparing exclusive (EBF), predominant (PBF) and partial (PartBF) breastfeeding.

      Methods: One-hundred and ten apparently healthy Thai lactating mother-infant pairs were
      followed from birth. Human milk intakes were determined at 6 weeks, 3 and 6 months, using the
      DTM method. Daily energy and protein intakes were assessed using 3-day non-consecutive
      24-hour recalls. Socio-demographic characteristics were collected using a questionnaire. For
      comparisons among breastfeeding practices, one-way ANOVA with Tukey's post hoc test was used
      for normally distributed data, or Kruskal-Wallis Test with Mann-Whitney U Test for not
      normally distributed data.
    

Detailed description: 
      Human milk intakes were comparable between the EBF and PBF infants during the first 6 months,
      and provided the sole source of energy and protein; infant formula largely replaced breast
      milk among PartBF infants.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): Measure human intake using stable isotope technique
Other intervention name(s): Observational study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The mother-infant pairs were recruited at the Ratchaburi hospital and Health promoting
        hospital, Health promotion center region 5, both situated in Ratchaburi province, central
        Thailand.
      
Biospecimen description: 
      Saliva sample
    
Keywords: human milk intake; dose-to-mother deuterium oxide; exclusive breastfeeding; predominant breastfeeding; partial breastfeeding
Effect of Exercise Training in Autonomic Modulation in Breast Cancer Patients
Condition: Breast Neoplasms; Autonomic Nervous System Diseases
MeSH terms: Breast Neoplasms; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of exercise training in the autonomic nervous
      system activity in breast cancer patients, who underwent doxorubicin medication.
    


Intervention name(s): Combined Exercise Training
Intervention type(s): Other
Intervention description(s): This intervention consisted in 4 weeks of strength, flexibility and aerobic exercises made at the hospital and at home.
Other intervention name(s): Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Benzydamine in Sore Throat Pain Relief (BePaiR Study)
Condition: Acute Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to generate new clinical data about the speed of relief provided by
      a single application of Benzydamine hydrochloride 0,3% oromucosal spray vs Benzydamine
      hydrochloride 3 mg lozenges mint flavour.
    

Detailed description: 
      The efficacy and safety of benzydamine local-applied, in the treatment of various throat
      inflammatory and painful conditions, had been widely demonstrated.

      The aim of this study is to generate new clinical data about the speed of relief provided by
      a single application of Benzydamine hydrochloride 0,3% oromucosal spray or Benzydamine
      hydrochloride 3 mg lozenges mint flavour.

      The study will be conducted at 15 sites located among Poland, Hungary and Russia (5 sites for
      each country).

      356 patients affected by acute sore throat will be enrolled in out-patient clinics or
      out-patient departments of city hospitals.
    

Intervention name(s): 0.3% benzydamine hydrochloride spray oromucosal solution; Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)
Intervention type(s): Drug; Drug
Intervention description(s): Single application of 0.3% benzydamine hydrochloride spray oromucosal solution. Drug applications will be performed at the investigational site, on the morning of Visit 0.
In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.; Single 3 mg lozenge of benzydamine hydrochloride (mint flavour). Drug applications will be performed at the investigational site, on the morning of Visit 0.
In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.
Intervention MeSH terms: Benzydamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, randomised, active-controlled, open label, parallel-group, international study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oromucosal spray; lozenges; Benzydamine hydrochloride 0.3%; Benzidamine hydrochloride 3 mg; acute sore throat
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized controlled trial will evaluate the effects of perioperative intravenous (IV)
      acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing
      vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive
      either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive
      1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control
      group will receive placebo saline infusions at the same time intervals. All subjects will
      receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS)
      regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to
      discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects
      receiving IV acetaminophen will have lower VAS scores and decreased total narcotic
      consumption in comparison to the control group.
    

Detailed description: 
      see brief summary
    

Intervention name(s): IV Acetaminophen
Intervention type(s): Drug
Intervention description(s): Details covered in arm description.
Other intervention name(s): Ofirmev
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: IV Acetaminophen; Vaginal Reconstruction; Pain, Postoperative
Erythropoietin Treatment in Extremely Low Birth Weight Infants
Condition: Infant, Low Birth Weight; Anemia
MeSH terms: Anemia; Body Weight; Birth Weight
Study type: Interventional

Summary: 
      Objective: To investigate whether recombinant EPO reduces the need for transfusion in
      extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.

      The concentrations of trace elements and of antioxidant enzymes were investigated in all
      patients, too.

      Study population: 219 patient randomized into 3 groups
    

Detailed description: 
      Methods: Blinded , multicenter trial, ELBW infants were randomized on day 3 to one of 3
      groups: early EPO group (rhEPO from the first week for 9 weeks , n= 74), late rhEPO group
      (rhWEPO from the fourth week for 6 weeks, n=74), or control group (no rhEPO, n= 71). All
      infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO ß dose was 750
      IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%.

      The concentrations of trace elements and of antioxidant enzymes were investigated in all
      patients, too. Clinical and nutritional data were recorded prospectively.
    

Intervention name(s): epoetin beta; epoetin beta
Intervention type(s): Drug; Drug
Intervention description(s): 250 IU/kg/week rhEPO treatment subcutaneously 3 times a week from the first week for 9 weeks, all infants received enteral iron 3-9 mg/kg/day; 250 IU/kg/week subcutaneously 3 times a week, from the fourth week for 6 weeks, all infants received enteral iron 3-9 mg/kg/day
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: extremely low birth weight infants; transfusion need; erythropoietin; trace elements; antioxidant enzymes; reduction of the transfusion need by EPO treatment; trace elements and antioxidant enzymes in blood
A Study to Investigate Whether Pharmacokinetic and Pharmacodynamic Interactions Exist Between Metformin and Canagliflozin (JNJ-28431754) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate whether there is a drug-drug interaction between
      multiple doses of canagliflozin (JNJ-28431754) and a single dose of metformin. The safety and
      tolerability of canagliflozin will also be assessed.
    

Detailed description: 
      This study is an open-label (all volunteers and study staff know the identity of the assigned
      treatment), fixed sequence (all volunteers receive the same medication on the same days),
      single and multiple-dose study to determine how metformin (a blood glucose-lowering agent
      used to treat patients with diabetes) affects the pharmacokinetics (ie, how the body affects
      the drug) and the pharmacodynamics (ie, how the drug affects the body) of canagliflozin (a
      drug currently being investigated for the treatment of type 2 diabetes mellitus). The effect
      of canagliflozin on the pharmacokinetics and pharmacodynamics of metformin will also be
      evaluated. The study will consist of 3 phases: a screening phase, an open-label treatment
      phase, and an end-of-study (or follow-up) phase. Each volunteer will participate in the study
      for approximately 39 days.
    

Intervention name(s): Metformin; Canagliflozin (JNJ-28431754)
Intervention type(s): Drug; Drug
Intervention description(s): One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8.; Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8.
Other intervention name(s): JNJ-28431754
Intervention MeSH terms: Metformin; Canagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Metformin; Pharmacokinetics; Pharmacodynamics