bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Uronext® in Women With Cystitis
Condition: Cystitis
MeSH terms: Cystitis
Study type: Interventional

Summary: 
      The study is designed as a prospective parallel open label, two-arm, single center study
      exploring efficacy and safety of the use of the dietary supplement Uronext in women with
      cystitis in the acute stage. 120 otherwise healthy women with acute cystitis infection
      confirmed with the urine bacteriological examinations, aged 18-18 years, will be recruited.
      The distribution of patients will be done in 1:1 ratio. Control group will receive standard
      therapy, Monural (fosfomycin trometamol) 3 g, at the first day of the trial. The second group
      will also receive Monural (fosfomycin trometamol) 3 g, at the first day of the trial as well
      as Uronext food supplement, 1 time per day for the first 7 days. After the 7 day break,
      participants in the second group will follow supplementation scheme for the next 3 month.

      Primary objective of the study is evaluation of the effectiveness of the dietary supplement
      Uronext in women with cystitis in the acute stage in the prevention of subsequent
      exacerbations of recurrent cystitis during 3 months of observation, measured as the number of
      relapses throughout the study period. Participnats will also fill in urination diary and
      questionnaires related to pain perception, quality of life and cystitis symptoms. Urine
      samples will be further examined at the follow up visits.

      Safety will be evaluated based on reported adverse events, assessment of vital signs and
      laboratory evaluation.
    


Intervention name(s): Monural; UroNext
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 1 sachet, only 1st day of trial; 1 sachet per day for the first 7 days, followed by 7 days break Same scheme to be repeated for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
Condition: COPD; Chronic Obstructive Pulmonary Disease; Moderate to Very Severe COPD
MeSH terms: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse
      cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to
      assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study
      is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the
      effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients
      with moderate to very severe COPD, as defined by the Global Initiative for Chronic
      Obstructive Lung Disease (GOLD) criteria.
    


Intervention name(s): Aclidinium Bromide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI); Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Intervention MeSH terms: Bromides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea
      during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen
      of Oracea® and MetroGel® 1%.
    

Detailed description: 
      Adult subjects with moderate to severe papulopustular rosacea will receive Oracea® and
      MetroGel® 1% once daily during phase 1 (baseline to week 12) of the study. Subjects will be
      eligible to enter phase 2 of the study based upon improvements in the Investigator's Global
      Assessment (IGA) score. During phase 2, subjects will receive either Oracea® or placebo once
      daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be
      discontinued from the study.
    

Intervention name(s): Doxycycline; Metronidazole; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads), oral, one capsule daily in the morning; During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area; During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning
Other intervention name(s): Oracea® Capsules 40 mg; Metrogel 1%
Intervention MeSH terms: Metronidazole; Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Nature Exposure Intervention on Soccer Performance Among Mentally Fatigued University Players
Condition: Mental Fatigue
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      The current study is going to investigate the nature exposure intervention on the ability of
      self-regulation and decision-making skills among mentally fatigued soccer players. The
      subjects will be instructed to view some nature photos, which can facilitate the recovering
      process for directed attention and the ability of self-regulation. Thus, to see the
      improvement in decision-making skills.
    

Detailed description: 
      The intervention of this study is nature exposure, specifically, instruct subjects to view
      and immerse in some nature photos due to the humanity of biophilia.

      The condition of mental fatigue will be induced by the Stroop task.

      Before the intervention or process of viewing photos, the baseline will be recorded to
      compare the post-test value of self-regulation and the score of decision-making skills.

      Moreover, the different durations of viewing photos will be implemented to identify the
      optimal selection.
    

Intervention name(s): nature exposure
Intervention type(s): Other
Intervention description(s): Nature exposure has different ways, such as walk in the real nature environment; viewing nature photos. Two main reasons make this study will not use the real nature environment: (1) the limitation of time before or amid the soccer competition; (2) the pandemic situation does not allow people go outside as frequently as before. Therefore, the current study will select some nature photos, which are restorative environments and can restore directed attention to counteract mental fatigue.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomly assign subjects into the experimental groups and the control group
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: decision-making skills; self-regulation; mental fatigue; soccer performance
Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults
Condition: Healthy
MeSH terms: Tissue Adhesions
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive
      quality of placebo (an inactive substance that is compared with a drug to test whether the
      drug has a real effect in a clinical trial]) JNJ-35685-AAA-G-023-G transdermal (through the
      skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch
      sizes (5.5 centimeter^2 [cm^2] and 44 cm^2).
    

Detailed description: 
      This study will assess 3 different scoring systems to evaluate the adhesive quality of
      "placebo" patch (an inactive patch that contains no active drug), JNJ-35685-AAA-G-023-G
      transdermal (through the skin) system. In this study, this patch is NOT being compared to a
      patch with a drug, and is NOT being used to test if the patch with the drug has a real effect
      in a clinical trial. The study consists 3 parts: Screening (21 days before study commences on
      Day 1), an adhesion assessment period (4 days), and an end of Study (EOS) assessment
      (recorded at 24 hours +/- 4 hours following patch removal). Total study duration per
      participant will be 26 days (including Screening). JNJ-35685-AAA-G-023 small (5.5 cm^2) and
      large (44 cm^2) patches will be applied on to left or right side of the paraspinal region
      based on randomization schedule. Adhesion assessments will be performed at patch application
      (hour 0, Baseline), and during the time interval of 8 to 10 hours, 24, 48, and 72 hours
      following patch application. Adhesion quality will be assessed by visual grading, United
      States Food and Drug Administration (FDA) scale, digital image analysis and visual grading
      grid system. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-35684-AAA-023: Size 1; small patch; JNJ-35684-AAA-023: Size 2; large patch
Intervention type(s): Drug; Drug
Intervention description(s): Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 5.5 centimeter square (cm^2) will be applied vertically to 1 side of the paraspinal region, replicated 3 times, and worn for 72 hours.; Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 44 cm^2 (Size 1; small patch) will be applied vertically to other side of the paraspinal region, replicated 3 times, and worn for 72 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-35685-AAA-G-023; Placebo; Transdermal delivery device system
Transversus Abdominus Plane Block
Condition: Nephrectomy
Study type: Interventional

Summary: 
      Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in
      patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP
      block will result in a significant reduction in pain scores and morphine requirements in the
      active group.
    


Intervention name(s): TAP block placement with placebo; Placement of block with ropivacaine
Intervention type(s): Procedure; Procedure
Intervention description(s): 20 ml of normal saline (placebo); 20 ml of 0.5% ropivacaine hydrochloride
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: nephrectomy
Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease
Condition: Graft vs Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether low-doses alemtuzumab and rituximab
      combination are effective in the treatment of chronic graft-versus-host disease (GVHD) after
      first-line therapy failure.
    

Detailed description: 
      Graft-versus-host disease (GVHD) is the most common long-term complication in patients who
      underwent allogeneic transplantation. First-line therapy for chronic GVHD is based on
      immunosuppressive agents (usually cyclosporine and corticosteroids) achieving satisfactory
      response in around 30% of patients. There is no ideal second-line treatment for chronic GVHD;
      however, numerous studies have been published with therapeutic options such as alemtuzumab
      (anti-CD52) and rituximab (anti-CD20).

      This is a prospective, longitudinal, nonrandomized study in which alemtuzumab and rituximab
      will be administered at low-doses to patients with refractory chronic GVHD. Clinical response
      will be evaluated based on the Working Group Report 2006, published by the National Institute
      of Health Consensus. Follow-up sessions will be weekly for four weeks, every two weeks until
      achieve response, and finally every four weeks.
    

Intervention name(s): Alemtuzumab and rituximab
Intervention type(s): Drug
Intervention description(s): Alemtuzumab at 10mg subcutaneously daily for 3 doses (days 1, 2 and 3) Rituximab at 100mg intravenously weekly for 4 doses (days 4, 11, 18 and 25
Other intervention name(s): Campath; Rituxan
Intervention MeSH terms: Rituximab; Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Graft vs Host Disease; Alemtuzumab; Rituximab; Low-dose; Alemtuzumab and rituximab combination
Lornoxicam vs. Paracetamol After Lower Abdominal Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: The aim of this prospective, randomized, double-blind study is to determine the
      most effective supplemental analgesic, paracetamol or lornoxicam for postoperative pain
      relief after lower abdominal surgery.

      Methods: Sixty patients scheduled for lower abdominal surgery under general anesthesia were
      randomly allocated to receive either isotonic saline (Control group), intravenous paracetamol
      1 g every 6 h (Paracetamol group) or lornoxicam 16 mg then 8 mg after 12 h (Lornoxicam
      group). Additionally pain was treated postoperatively using morphine patient-controlled
      analgesia. Postoperative pain scores measured by the verbal pain score (VPS), morphine
      consumption and the incidence of side effects were measured at 1, 2, 4, 8, 12 and 24 hours
      postoperatively.
    


Intervention name(s): placebo; Paracetamol; Lornoxicam
Intervention type(s): Other; Drug; Drug
Intervention description(s): normal saline; IV paracetamol infusion; 16 mg at skin closure and 8 mg 12 hours postoperative
Other intervention name(s): 0.9 N sodium chloride; perfalgan; xefo
Intervention MeSH terms: Acetaminophen; Lornoxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lower abdominal surgery; Paracetamol; Lornoxicam; Morphine
A Study of Baricitinib When Administered With Ketoconazole or Fluconazole in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to look at the effect of ketoconazole and fluconazole on
      how much baricitinib gets into the blood stream. The study will also look at the tolerability
      of baricitinib and ketoconazole when given together and the tolerability of baricitinib and
      fluconazole when given together.

      Participants will be recruited into 1 of 2 treatment groups (Group A or Group B). Each
      treatment group will participate in 2 study periods. Participants will take baricitinib alone
      in 1 period and baricitinib with either ketoconazole or fluconazole in the other period. This
      study will last approximately 7 weeks.
    


Intervention name(s): Baricitinib; Ketoconazole; Fluconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LY3009104
Intervention MeSH terms: Fluconazole; Ketoconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Transcutaneous Spinal Cord Stimulation in Healthy Subjects to Activate Central Pattern Generator
Condition: Motor Activity
Study type: Interventional

Summary: 
      The purpose of this study is to determinate whether the application of transcutaneous spinal
      cord stimulation produce changes in the excitability of alpha moto neurone in healthy
      volunteers. Moreover evidence whether the effect of the electric currents can increase muscle
      strength.
    

Detailed description: 
      In the last years several experimental studies have evidenced that the transcutaneous spinal
      cord stimulation (tSCS) can evoque spinal reflex activity. The activation of propioceptive
      afferent would then activated motoneurons innervated at the same metameric and adjacent
      levels. The possibility of activating neural networks with non-invasive stimulation method
      opens a therapeutic window for the treatment of different neurological disorders. So the
      purpose of this study is quantify the modulation of the excitability of alpha motor neurone
      when the application of the current is in the central nervous system compared with a sham
      group.
    

Intervention name(s): Transcutaneous spinal cord stimulation
Intervention type(s): Device
Intervention description(s): Electrodes are placed over the back for a 10 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing current intensity during 30 second and decrease intensity subsequentl
Other intervention name(s): tSCS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcutaneous spinal cor stimulation; neuromodulation; motor activity
First-in-Human Single Ascending and Multiple Dose of GLPG0634
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)
      and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).

      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple
      oral administration will be evaluated, and, if applicable, the maximum tolerated dose
      determined.
    


Intervention name(s): GLPG0634; placebo; GLPG0634; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose); single dose, oral solution or capsule (matching corresponding study medication); multiple dose, capsule, 10 days; multiple dose, capsule, 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics
Endometrial Shedding Prior to Ovulation Induction Pilot Study
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study examining the feasibility of implementing a large randomized control
      trial looking at the effect of endometrial shedding with medroxyprogesterone acetate compared
      to no pre-treatment in women taking clomiphene citrate for ovulation induction for
      infertility due to oligo-ovulation or anovulation.
    

Detailed description: 
      The purpose of this pilot study is to assess the feasibility of implementing a randomized
      controlled trial assessing the effect of giving medroxyprogesterone acetate (MPA) to induce a
      withdrawal bleed compared to a control group of women not receiving MPA on pregnancy rates
      prior to ovulation induction with clomiphene citrate in oligo-ovulatory and anovulatory
      women. The primary outcome measure is the effective implementation of the study including a
      measure of time to recruit 50 patients, physician, nursing and patient compliance rate with
      the study protocol, and patient satisfaction. Secondary outcome measures include the
      pregnancy rate per ovulation (where pregnancy is defined as a positive fetal heart rate on
      ultrasound 2 weeks after a positive pregnancy test), the ovulation rate per cycle started,
      conception rate per cycle started (where conception is defined as a positive beta-human
      chorionic gonadotropin level), conception rate per ovulation, time to complete 3 stimulation
      cycles and endometrial thickness at time of luteinizing hormone surge.
    

Intervention name(s): Medroxyprogesterone acetate
Intervention type(s): Drug
Intervention description(s): Women in this arm of the study will be assigned to start medroxyprogesterone acetate 10mg per os x 10 days. This will be followed by vaginal bleeding. On the 3rd day of vaginal bleeding, women will start clomiphene citrate 50mg per os x 5 days for ovulation induction.
Other intervention name(s): Provera
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of Omalizumab in Japanese Children (6 - 15 Years)
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to examine whether the geometric mean of serum free IgE
      level at 24 weeks of the treatment period in Japanese pediatric patients (6 to 15 years of
      age) reaches under 25 ng/mL (target level). The investigators will also assess how well PK/PD
      data of Japanese children fit the global PK-PD modeling built from those of Caucasian adults
      and children, and assess efficacy and safety data in Japanese pediatric patients which will
      fulfill the Japanese health authority requirement for approval. Data obtained from the study
      is intended to be used to support the registration of pediatric indication of omalizumab in
      Japan.
    


Intervention name(s): omalizumab
Intervention type(s): Drug
Intervention MeSH terms: Omalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: omalizumab; allergic asthma; pediatric patients
Comparison of Intubating Condition of the Mcgrath Videolaryngoscope With and Without Muscle Relaxant
Condition: Muscle Relaxant
MeSH terms: Muscle Hypotonia
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate intubating condition using the McGrath® VL Series
      5, with and without muscle relaxant
    

Detailed description: 
      Thirty-four patients with ASA classification I-II, who required oroendotracheal tube
      intubation, were studied in this prospective, double-blinded, randomized, clinical trial.
      Anesthesia was induced using fentanyl 1.5 mcg/kg, xylocaine 1.5 mg/kg and propofol 3 mg/kg.
      Patients were randomly assigned to one of the two groups to receive either rocuronium 0.6
      mg/kg or saline intravenously. The Mcgrath® VL intubation was initiated after 90s, when the
      patients were fully relaxed. The primary outcome was to compare tracheal intubating
      conditions between two groups. The secondary outcomes were the success rate in the first
      attempt intubation, time to intubation, the required propofol dose for intubation and
      anesthetic complications. Statistical analyses were performed using the R program version
      2.14.2. The level of statistical significance was set at p < 0.05.
    

Intervention name(s): Videolaryngoscope
Intervention type(s): Device
Intervention description(s): Intubation with McGrath video laryngoscope after muscle relaxant
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: McGrath®; Videolaryngoscope; intubating condition; muscle relaxant; intubation