bioihbjkbjnl/mcl2 huggingface dataset:
Oral Glucocorticoids Effect on Post Endodontic Pain
Condition: Pulpitis
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this single-center randomized, double-blind, placebo-controlled clinical trial is
      to assess the effect of preoperative, single, oral dose of prednisolone on postoperative pain
      and medication intake in patients with symptomatic, irreversible pulpitis in mandibular
      molars.
    

Detailed description: 
      Patients receive 40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis
      Intercontinental, Paris, France); and group B (Control), where patients received two placebo
      tablets. All patients receive the assigned premedication 30 minutes before the administration
      of local anesthesia
    

Intervention name(s): Prednisolone; Control
Intervention type(s): Drug; Other
Intervention description(s): 40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France); Milk Tablet
Other intervention name(s): Glucocorticoid; Placebo
Intervention MeSH terms: Prednisolone; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: symptomatic; irreversible
The Detection of Circulating Tumor Cells (CTCs) in Patients With Renal Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment
Condition: Neoplastic Cells, Circulating
MeSH terms: Neoplastic Cells, Circulating; Kidney Neoplasms
Study type: Observational

Summary: 
      Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time
      biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in
      renal cancer could play an important role in diagnosis, predicting the risk for tumor
      recurrence, and providing novel target therapy biomarkers. In view of these facts, the
      investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting
      human tumor cells of renal cancer in normal peripheral blood after cryosurgery with or
      without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators
      also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR)
      method.
    

Detailed description: 
      1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately
      17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients
      with renal cancer and healthy volunteers. The blood of the healthy volunteers will be used to
      evaluate the sensitivity and specificity and as negative control cells. To avoid
      contamination with skin cells, 2 mL blood will be discarded before the study samples will be
      taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for
      20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood
      cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear
      cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis
      of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in
      phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR.
      Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to
      choose an adequate therapy.
    

Intervention name(s): Flow cytometry (FCM); RT-PCR
Intervention type(s): Other; Other
Intervention description(s): Use FCM to test PBMCs/CTCs from volunteers/patients.; Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Ⅱ,Ⅲ,Ⅳ stage renal cancer come to Fuda Hospital for treatment.
      
Keywords: Renal Neoplasms; Circulating Tumor Cells
Single Dose Escalation Study FTIM in Order to Assess Safety and Tolerability of GSK610677
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first administration of GSK610677 to man. The main aim of this clinical
      study is to investigate the safety and tolerability of different doses of the investigational
      medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into
      this study. Individual subjects in each cohort will have up to 3 treatment periods. In each
      treatment period, subjects will receive a single inhaled dose of GSK610677 or placebo.
      Predicted doses are: 10, 30, 50 100 250 and 500ug.For individual subjects in each cohort,
      there will be a minimum wash out period of at least 10 days. In this period safety and
      tolerability data will be collected prior to dose to the next level.After safety review
      meetings between the site and the sponsor following the administration of the 500 ug dose, it
      was decided to add an extra cohort (Cohort III) of 8 subjects and administer 1000µg. Each
      subject in Cohort III will undergo a screening visit, one treatment period, and a follow up
      visit.
    


Intervention name(s): GSK610677; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK610677 Multi-Dose Powder Inhaler will be available in the strength of 10, 50, 100 and 25 microgram with dose levels of 10, 30, 50, 100, 250, 500 and 1000 microgram. Subjects will receive GSK610677 as single inhale dose.; Matching Placebo for GSK610677 will be available as Multi-Dose Powder Inhaler. Subjects will receive Placebo as single inhale dose.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: Healthy Volunteers
Recovery and Survival of EryDex in Non-patient Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, single-blind, single-center, concurrently controlled, exploratory,
      Phase I study to determine the in vivo kinetics (24-hour post-infusion recovery and T50
      survival) of EryDex System (EDS) -processed autologous red blood cells (RBC) in non-patient
      volunteers. A total of 12 non-patient volunteer subjects will be enrolled and assigned to one
      of the 2 groups (6 subjects in active arm group, 6 subjects in sham arm group).
    

Detailed description: 
      EryDex System (EDS) is a combination product used to administer dexamethasone sodium
      phosphate (DSP) by ex vivo encapsulation in autologous erythrocytes which are re-infused. DSP
      is dephosphorylated in RBCs to release dexamethasone.

      The 12 subjects who meet all of the inclusion/exclusion criteria will be assigned to one of
      the 2 groups, consisting of 6 subjects each, as follows:

        -  Group 1 (active drug arm): 15-20 mg DSP loaded in RBC using the EDS.

        -  Group 2 (sham arm): sham treated autologous RBC using the EDS

      One 50±5mL aliquot of blood collected from each subject will be treated using the EDS process
      (either active drug or sham) and the resultant processed RBCs will be radiolabeled with
      Chromium-51 (51Cr) for the in vivo kinetic study. A second 10±5mL simultaneously collected
      sample will be labeled with Technetium-99m (99mTc) to estimate the subject's blood volume.
      These labeled aliquots will be mixed, and simultaneously infused through a peripheral vein
      via butterfly or similar catheter (total dose 20-40 μCi). Blood samples will be collected
      from the subject's contralateral arm immediately pre-infusion and at 5, 7.5, 10, 12.5, 15,
      20, and 30 minutes (± 3 min), and on Day 1, 24 hours (±2 h) after completion of infusion.
      Vital signs will be assessed after the 30-min sample on Day 0 and again on Day 1 before the
      24-h sample is collected. Additional blood samples will be collected at 48 (±4 h) and 72 (±4
      h) hours and 7 (±1 d) days post-infusion, and then weekly through 49 days post-infusion, with
      a window of ±2 days for each visit.
    

Intervention name(s): DSP loaded RBC using EryDex System; Sham treated RBC using the EryDex System
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of 10 mg DSP encapsulated in autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC.; Intravenous infusion of sham treated autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC.
Other intervention name(s): EryDex System; EryDex System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: subjects
Effectiveness of Anti-Psychotic in GPs Setting
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Study type: Observational

Summary: 
      Evaluating the effectiveness of atypical antipsychotics in the community - a prospective,
      multicentre, observational study to evaluate the impact on Quality of Life of GP-based
      management of antipsychotic treatment in Belgium
    


Time perspective: Prospective
Keywords: Schizophrenia; Bipolar Disorder; manic episode; atypical antipsychotic; Schizophrenia or Bipolar Disorder (currently in a manic episode)
An Eight-Week Study to Evaluate the Efficacy and Safety of SR58611A in Patients With Generalized Anxiety Disorder
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of SR58611A in patients with
      Generalized Anxiety Disorder. The primary objective is to evaluate the efficacy of a 700 mg
      dose of SR58611A compared to placebo in patients with generalized anxiety disorder (GAD).The
      secondary objectives are to evaluate the efficacy of SR58611A on disability and quality of
      life in patients with GAD and to evaluate safety of SR58611A.
    

Detailed description: 
      The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo
      and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a
      1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. All
      randomized patients must complete a post-study visit 1 week after intake of the last dose of
      study medication.
    

Intervention name(s): SR58611A
Intervention type(s): Drug
Intervention MeSH terms: Amibegron; Amibegron hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anxiety; Anti-Anxiety Agents; Controlled Clinical Trial
Effect of Early Limited Formula Use on Breastfeeding Outcomes
Condition: Breastfeeding
Study type: Interventional

Summary: 
      The aim of this study is to conduct a pilot randomized controlled trial of the effect of
      early limited formula supplementation on breastfeeding-related outcomes for infants with high
      early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at
      24-48 hours of age and will randomly assign them to early limited formula supplementation
      following nursing (intervention group) or to no formula feeding (control group). Both groups
      will receive intensive lactation support. Outcome variables will include breastfeeding status
      on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and
      exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that
      early limited formula supplementation might help infants with early weight loss avoid
      eventual weight loss ≥ 10% and associated breastfeeding problems.
    


Intervention name(s): Nutramigen infant formula
Intervention type(s): Dietary Supplement
Intervention description(s): Investigators will advise mothers to supplement with 10 cc of elemental formula immediately following each breastfeeding and to discontinue formula once mature milk production begins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breastfeeding outcomes; breastfeeding self-efficacy; infant weight loss
Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine the safety and efficacy of two oral doses
      of telapristone acetate administered to premenopausal women with pelvic pain associated with
      endometriosis confirmed within the last seven years and using prescription analgesics for
      symptomatic pain.
    

Detailed description: 
      This study is a phase 2, 3-arm-study with an 18-week active dosing period and an option for
      participants to receive 2 additional 16-week cycles of active treatment at their randomized
      dose [6 mg or 12 mg/day]. Placebo participants who elect additional treatment will receive
      treatment at 12 mg/day. The treatment dose will remain double-blind. The study will be
      conducted in 3 stages. The first stage is a no treatment baseline assessment period. This
      stage will last as long as it takes to record at least one full menstrual cycle (ovulation
      until ovulation).

      For stage 2, following the run-in stage, at Visit 3, 60 participants will be randomized into
      one of 3 arms in a 1-1-1 fashion. The start of dosing should commence as soon as possible
      after ovulation following the end of the previous menstrual event.

      For stage 3, participants who are eligible to receive additional cycles of treatment and who
      elect to continue treatment will be scheduled within a week before the second expected menses
      (+/- 2 days), following the off-drug interval. Participants will receive 2 cycles of
      treatment separated by an off-drug interval (ODI), after which they will be followed until
      menses has returned.
    

Intervention name(s): Placebo; Telapristone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Placebo matching capsules, orally, once daily for 18 weeks.; Telapristone acetate capsules, orally once daily for 18 weeks.
Other intervention name(s): Proellex®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Outlook Quality of Life Intervention Study
Condition: Cancer; Congestive Heart Failure (CHF); Chronic Obstructive Pulmonary Disease (COPD); End Stage Renal Disease (ESRD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Kidney Failure, Chronic; Heart Failure
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether discussions of life story, forgiveness, and
      future goals improve quality of life for patients with serious illness.
    

Detailed description: 
      This is a randomized control trial to evaluate the feasibility of the Outlook intervention.
      221 veterans with advanced cancer, congestive heart failure (CHF), chronic obstructive
      pulmonary disease (COPD) or end stage renal disease (ESRD) were randomly assigned to one of
      three intervention groups and completed a brief battery of pre-test measures. Subjects in the
      first group ("Outlook Intervention") were randomized to meet with a facilitator three times
      for a period of 45 min-1 hour. Participants were asked in the first session to discuss issues
      related to life review. They were asked in the second session to speak in more depth about
      issues of regret, forgiveness and things left undone. The subject of the final session was
      heritage and legacy. Participants in the attention control group were randomized to meet with
      a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided
      relaxation audio disc (CD). Participants in the third group ("treatment as usual") were
      exposed to no interventional sessions. Participants were assessed with post-test measures
      administered by a blinded interviewer one week and 3 weeks after the intervention window.
    

Intervention name(s): Life Completion; Attention Control
Intervention type(s): Other; Other
Intervention description(s): Subjects discussed life review, issues of forgiveness and heritage and legacy.; Subjects listened to a non-guided relaxation CD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: quality of life; end of life; self-disclosure; palliative care
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine multiple dose safety, tolerability and
      pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to
      determine the effect of single dose administration of ketoconazole on steady state ABT-333
      pharmacokinetics
    

Detailed description: 
      Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate
      the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-333
    

Intervention name(s): ABT-333; ketoconazole; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsule, or powder drug substance from the capsule powder mixed in an alternate vehicle. For additional information refer to arm description.; Tablet, see arms for intervention description; Capsule or powder drug substance from the capsule powder mixed in an alternative vehicle. For additional information refer to arm description.
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Symptomatic, Biomechanical and Radiographic Outcomes in Knee Osteoarthritis Following Gastric Bypass Surgery
Condition: Obesity; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      Weight is a risk factor for knee osteoarthritis

      Knee osteoarthritis is associated with abnormal gait biomechanics

      Gait biomechanics are evaluated in gastric bypass patients before and after losing 100
      pounds.
    

Detailed description: 
      Weight is a major risk factor for development of knee osteoarthritis, but not hip or ankle
      arthritis. One possible mechanism for this is the generation of abnormal gait biomechanics
      secondary to obesity that are conducive to the development of knee osteoarthritis.

      We evaluate gait biomechanics, knee symptoms and knee radiographs in 35 obese patients before
      and after gastric bypass surgery to determine the effect of significant weight loss on gait
      biomechanics, knee symptoms and knee radiographs.
    

Intervention name(s): gastric bypass surgery
Intervention type(s): Procedure
Time perspective: Prospective
Keywords: obesity; gait biomechanics; knee osteoarthritis
Effects of Non Invasive Brain Stimulation During Prolonged Experimental Pain
Condition: Pain; Prolonged Experimental Pain
Study type: Interventional

Summary: 
      Non invasive brain stimulation (NIBS) of the primary motor cortex (M1) through transcranial
      direct current stimulation (tDCS) has been widely investigated in research and clinical
      settings in order to modulate brain plasticity and improve clinical pain. Interestingly,
      newly developed paradigms i.e. tDCS of the resting state motor network have proved higher
      modulatory effects in terms of corticospinal excitability when compared to traditional M1
      tDCS.

      However, little is known about the effects of tDCS on the frequency changes of alpha
      oscillations (alpha peaks).

      Interestingly, previous studies show a correlation between reduced frequencies of alpha peaks
      during 1-hour experimental pain in comparison to baseline.

      The present study aims to investigate the effects of tDCS of the resting state motor network
      on the frequency and power of alpha peaks during prolonged experimental pain during 24 hours.
    

Detailed description: 
      There is evidence that chronic pain alters the frequency of alpha peaks. Specifically, recent
      studies showed a correlation between decreased frequency of alpha peaks and perceived pain.
      Furthermore, a correlation was found between high pain sensitivity and slower alpha
      oscillations during prolonged pain during 1 hour.

      To date, the effects of prolonged experimental pain during 24 hours on brain oscillations has
      not been explored. Moreover, it is unknown whether non invasive brain stimulation (NIBS)
      through transcranial direct current stimulation (tDCS) can revert these pain-related feature.

      It is hypothesized that prolonged pain during 24 hours will reduce the frequency of alpha
      peaks and tDCS of the resting state motor network will revert it to baseline values.

      Furthermore, it is thought that decreased frequency of alpha peaks will be correlated with
      perceived pain intensity on Day 1 (before receiving the first tDCS session).
    

Intervention name(s): Transcranial direct current stimulation (tDCS) of the resting state motor network
Intervention type(s): Device
Intervention description(s): Transcranial direct current stimulation (tDCS) delivers a low intensity current of up to 4 mA per session through small and circular shaped electrodes applied over the scalp. This induces a weak but focal electrical field that may modify the excitability of the underlying cortical target in a polarity and activity dependent fashion.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The current studies have a randomized, parallel, sham-controlled and double-blinded design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers
Condition: Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules
      compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects. The results of this
      study are expected to support registration applications for androgenetic alopecia (AGA) in
      Japan and other international markets.
    


Intervention name(s): GI198745 0.1 mg; GI198745 0.5 mg
Intervention type(s): Drug; Drug
Intervention description(s): It is available as soft gelatin capsule to be administered as 5 X 0.1 mg capsules as single oral dose with approximately 250 mL of water.; It is available as soft gelatin capsule to be administered as 1 X 0.5 mg capsules as single oral dose with approximately 250 mL of water.
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Healthy Male Volunteers; Androgenetic Alopecia; Dutasteride; Safety; Tolerability