bioihbjkbjnl/mcl2 huggingface dataset:
Vibe First In Human Study for the Assessment of Safety and Initial Performance of the Vibe Delivery System in Subjects With Idiopathic Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      This First In Human study is aimed to evaluate the safety and initial efficacy of the Vibe
      delivery system in delivering Botox (TM) to the bladder wall in patients diagnosed with
      overactive bladder.
    


Intervention name(s): Vibe Delivery system
Intervention type(s): Device
Intervention description(s): delivery of Botox (TM) to the bladder wall using an ultrasound technology with the Vibe delivery system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Pharmacokinetics of Golimumab in Japanese and Caucasian Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of golimumab in Japanese and
      Caucasian Males.
    

Detailed description: 
      This is a randomized (study medication assigned by chance), double-blind (both the physician
      and subject do not know the assigned study medication) study to assess the safety,
      tolerability, immune response, pharmacokinetics (what the body does to the drug), of
      golimumab (Simponi). The study population will consist of 24 healthy male Japanese subjects
      and 24 healthy male Caucasian subjects. Subjects will receive a single dose of either 200 mg
      or 400 mg golimumab or placebo. Subjects will be in the study for up to 16 weeks. Safety
      assessments will be performed throughout the study and include obtaining and evaluating
      laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of
      adverse events. A single dose of 200 mg or 400 mg golimumab, or placebo.
    

Intervention name(s): 400 mg golimumab or placebo; 200 mg golimumab or placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 400 mg subcutaneously; Single dose of 200 mg subcutaneously
Intervention MeSH terms: Golimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; Japanese male; Caucasian male; Simponi
Effect of Age and Device on Delivery of Fluticasone
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the effect of age and device on delivery of HFA-Fluticasone Propionate (FP) in
      children of different ages. Hypothesis -- passive inhalation in younger children through a
      valved holding chamber/mask (VHC) will reduce the relative amount of FP delivered to airways.
    

Detailed description: 
      The objective was to determine the effect of age and device on delivery of fluticasone
      propionate delivered by HFA-pMDI in children of different ages. The one-hour steady-state
      fluticasone plasma concentration which is an indirect measure of airway delivery and direct
      measure of systemic exposure, was determined. Sixty children with well-controlled persistent
      asthma received two actuations of 110 mcg twice daily for at least 3 days. A blood sample was
      collected one hour after the last dose when 100% adherence was documented by electronic
      monitor. Five groups of 12 each were studied: 1) 12-18 yr by actuator alone; 2) 5-9 yr by
      actuator alone; 3) 5-9 yr by antistatic VHC/mouthpiece; 4) 5-9 yr by antistatic VHC/mask and
      5) 1-4 yr by antistatic VHC/mask. Fluticasone concentrations were measured by LC-MS/MS assay.
      Fluticasone plasma concentration between groups was compared using one way ANOVA.
    

Intervention name(s): HFA FP MDI
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fluticasone; asthma therapy; spacer inhaler; HFA-134a
Isometric Muscle Training in Patients With Spinal Bony Metastases Under Radiation Therapy
Condition: Vertebral Bony Metastases
MeSH terms: Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      Standard indications for palliative radiation of bony metastases include pain, spinal cord
      compression, and impending pathologic fractures.

      Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid
      complications. Tailored training of the paravertebral musculature may support radiation
      therapy and improve above named factors. DISPO was designed to investigate the impact of
      tailored physical exercise in patients with vertebral metastases as compared to manual
      therapy (massage etc.). The trial includes patients with painful bony metastases, patients
      with spinal cord compression or impending pathological fractures are excluded. The
      investigations are carried out in a prospective randomized controlled phase-II parallel group
      design.
    

Detailed description: 
      Standard indications for palliative radiation of bony metastases include pain, spinal cord
      compression, and impending pathologic fractures.

      Palliative radiation therapy serves to reduce pain, improve quality of life, and avoid
      complications. Tailored training of the paravertebral musculature may support radiation
      therapy and improve above named factors. DISPO was designed to investigate the impact of
      tailored physical exercise in patients with vertebral metastases as compared to manual
      therapy (massage etc.). The trial includes patients with painful bony metastases, patients
      with spinal cord compression or impending pathological fractures are excluded. The
      investigations are carried out in a prospective randomized controlled phase-II parallel group
      design.

      Patients are randomized to one of the following groups: patients in arm A carry out daily
      physical training consisting of three different isometric exercises under the guidance and
      supervision of a physiotherapist. Training starts day one (first radiotherapy session), 10
      daily units of 30 min each are scheduled during radiotherapy. Patients are expected to
      continue training until 12 weeks post completion of radiotherapy at home.

      Patients in arm B (control group) receive 10 daily sessions of 15 min manual therapy (i.e.
      massage, etc) starting from day one of radiotherapy.

      Follow-up of the patients is scheduled at 12 weeks post completion of radiotherapy incl. CT
      of the spine and physical examination.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): tailored isometric physical exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bony metastases; physical exercise
Cold Water Immersion Does Not Reduce Knee Joint Position Sense in Healthy Participants: a Randomised Cross-over Trial
Condition: Knee Joint Position Sense
Study type: Interventional

Summary: 
      The aim of this project is to assess the effect of cold water immersion on knee joint
      re-positional sense in healthy subjects. Cryotherapy, in the form of cold water immersion,
      had previously been shown to improve athletic performance however, debate exists within the
      existing literature regarding whether proprioception, in the form or joint position sense, is
      effected post treatment.

      Null hypothesis (H0): Water immersion has no effect on joint position sense (JPS).

      Alternate hypothesis (H1): Water immersion has an effect on joint position sense.
    

Detailed description: 
      This was a prospective, randomised, cross-over design where volunteers acted as their own
      controls. The volunteers were immersed at two temperatures (detailed below) and these
      sessions were separated by six to ten days. The order of the testing was randomly assigned
      using a random number generator. Ethical approval of the design of this trial was gained from
      the University of Limerick's Research Ethics Committee and signed informed consent was gained
      from each participant before any data collection took place.
    

Intervention name(s): Tepid water immersion
Intervention type(s): Other
Intervention description(s): 28°C ± 1°C for the cold water immersion for 30 minutes to the level of the umbilicus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cryotherapy; Joint Position Sense; Proprioception; Pre Cooling; Knee Injury; Physical Therapy Modalities; Physical Therapy Techniques; Weightbearing; NonWeightbearing; Randomised Control Trial
Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in
      combination with VRC07-523LS via intravenous or subcutaneous infusions in healthy,
      HIV-uninfected adult participants.
    

Detailed description: 
      This study will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity
      of the monoclonal antibody PGT121.414.LS administered alone and in combination with
      VRC07-523LS via intravenous (IV) or subcutaneous (SC) infusions in healthy, HIV-uninfected
      adult participants.

      The study will be conducted in two parts (Part A and B). Part A will include four groups
      (Groups 1, 2, 3, and 4) and Part B will include two groups (Groups 5 and 6).

      In Part A of the study, PGT121.414.LS will be administered via IV infusion at 3, 10, or 30
      mg/kg (Groups 1-3) or via SC infusion at 5 mg/kg (Group 4). Participants in Part B will
      receive consecutive administration of PGT121.414.LS followed by VRC07-523LS, at 20 mg/kg IV
      each per dose (Group 5) or 5 mg/kg SC each per dose (Group 6). Participants will be followed
      for 32 weeks after the last study product administration via IV infusion and 24 weeks after
      the last study product administration via SC infusion.

      Participants in Groups 1, 2, and 3 will attend 8 months of study visits. Participants in
      Group 4 will attend 6 months of study visits. Part B participants will attend 16 months of
      study visits. Study visits may include physical examinations, blood and urine collection, and
      questionnaires.
    

Intervention name(s): PGT121.414.LS; VRC07-523LS
Intervention type(s): Biological; Biological
Intervention description(s): Administered via IV infusion or SC infusion, depending on the arm; Administered via IV infusion or SC infusion, depending on the arm
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Condition: Candidiasis, Esophageal; HIV Infections
MeSH terms: Infections; Candidiasis
Study type: Interventional

Summary: 
      To compare the safety, tolerance, and effectiveness of fluconazole and ketoconazole in the
      treatment of candidal esophagitis in immunocompromised patients.
    


Intervention name(s): Ketoconazole; Fluconazole
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluconazole; Ketoconazole
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Immune Tolerance; Ketoconazole; Esophagitis; Fluconazole; Acquired Immunodeficiency Syndrome; Candidiasis, Oral
Phase IV Bioseal Study in Brain Tumor Surgery
Condition: Hemostasis; Meningioma Surgery
MeSH terms: Meningioma
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to observe the clinical utility and performance of Bioseal
      when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma
      surgery.
    


Intervention name(s): Bioseal Fibrin Sealant; Standard of Care (SoC)
Intervention type(s): Biological; Other
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Theracal Pulpotomy in Primary Molars
Condition: Deep Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol
      pulpotomy in primary molars.
    

Detailed description: 
      sixty primary molars were either treated with Theracal LC or formocresol pulpotomy. Teeth
      were followed up clinicaly and radiographically for 12 months.
    

Intervention name(s): Theracal LC; Formocresol
Intervention type(s): Drug; Drug
Intervention description(s): pulpotomy; Pulpotomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Theracal; formocresol; pulpotomy
Effect of Using a Birth Ball on Birth Satisfaction and Pain in Pregnant Women During Labor
Condition: Pain; Labor Pain; Satisfaction
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      H0: There is no difference between birth satisfaction and pain levels of pregnant women who
      used and did not use a birth ball during labor.

      H1: There is a difference between birth satisfaction and pain levels of pregnant women who
      used and did not use a birth ball during the birth process.
    


Intervention name(s): Birth Ball
Intervention type(s): Other
Intervention description(s): During labour, the pregnant woman was positioned using a birth ball.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sample size was 106 pregnant women, 53 in each group, with a known score using the G*Power 3.1.7 program (intervention group=29.19±5.86-control group=26.51±5.13) with 85% power, 0.48 effect size and 0.15 error. was calculated as. Considering data loss, it is planned to reach 10% more pregnant women. Intervention group=57, control group=54 pregnants, and the study was terminated. The women were divided into two groups using the random numbers table in the simple random sampling method. Single blinding was performed on the women participating in the study. However, in order to prevent bias, the researcher who collected the data gave codes to the questionnaire forms of the pregnant women.
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Birth ball; birth satisfaction; pain; midwifery care
PROSPR/PCIPS Project 3: Communication of Personalized Breast Cancer Risk
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      In order to better communicate personal risk of breast cancer to women who have not yet
      initiated breast cancer screening (mammography), The Annenberg School of Communication at the
      University of Pennsylvania has created a personal breast cancer screening decision aid tool.
      This tool will be pilot tested, and then implemented and tested in nine primary care and
      OB/GYN practices within the University of Pennsylvania Health System.
    

Detailed description: 
      In order to better communicate personal risk of breast cancer to women who have not yet
      initiated breast cancer screening (mammography), The Annenberg School of Communication at the
      University of Pennsylvania has created a personal breast cancer screening decision aid tool.
      This tool incorporates questions about a women's personal history of breast cancer and
      compares her to the average women her age in terms of breast cancer risk. The tool helps the
      women to understand the benefits and risks of breast cancer screening. This tool will be
      pilot tested using SSI to help develop the final version of the decision aid tool. The
      decision aid tool will then be implemented and tested in nine general internal medicine,
      family medicine, and OB/GYN practices within the University of Pennsylvania Health System.
    

Intervention name(s): Breast Cancer Screening Decision Aid
Intervention type(s): Behavioral
Intervention description(s): The intervention will include access to the personal decision aid tool for patients in the intervention arm of the study, determined by the randomized physician schedule and the patient's appointment time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single
      ascending doses in healthy male.
    

Detailed description: 
      A phase I, single-blind, randomised, placebo-controlled, single centre study to investigate
      the safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending
      doses in healthy male subjects.
    

Intervention name(s): MEDI8111; Placebo
Intervention type(s): Drug; Other
Intervention description(s): MEDI8111 lyophilisate for solution for infusion; Placebo for MEDI8111 saline solution for infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic
Cigar Packaging Study
Condition: Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of number of cigarillos per package on use
      behaviors, intensity of use and biomarkers of exposure.
    

Detailed description: 
      This laboratory-based study will aim to enroll 50 current cigarillo users to complete a
      20-day, randomized, parallel design protocol. After a 5-day period of smoking their own
      preferred brand of cigarillos, participants will begin a 15-day experimental period when they
      will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per
      pack, to examine how quantity per pack affects use patterns, including daily consumption and
      cigar smoking topography. Participants will be asked to attend 2 in-person sessions on Days 5
      and 20. On Days 0, 9, 12 and 16 participants will complete sessions with research staff
      remotely (i.e. by phone or video call). Sessions will occur every 3-5 days, for a total of 6
      sessions across 20 days.
    

Intervention name(s): Package Quantity (cigarillos)
Intervention type(s): Other
Intervention description(s): After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This project will recruit current cigarillo users to a 20-day, randomized, parallel design protocol. After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack, to examine how quantity per pack affects use patterns, including daily consumption and cigar smoking topography.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Cigarillo, Behavior
Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Extra virgin olive oil (EVOO) is known for its cardiovascular effects and its effect on
      glucose lowering. However, the effects of EVOO on the blood glucose of Type 2 Diabetes
      Mellitus Filipino patients has not been studied. The investigators aimed to determine whether
      a significant difference exists in meals containing EVOO versus meals without EVOO among Type
      2 Diabetes Mellitus patients.

      Thirteen patients were included in this randomized controlled cross-over trial. They were
      randomized to receive a meal with or without EVOO followed by a one week wash out period,
      where they were given the other intervention. The primary outcome is the trans-meal blood
      glucose, which is calculated as the percent change in 2-hour postprandial blood glucose.
    

Detailed description: 
      During their first visit, the participants were oriented on the conduct of the study. They
      were advised to be compliant with their medications throughout the duration of the trial.

      On their second visit, participants were asked to do a six to eight-hour overnight fast, and
      their fasting blood sugar was drawn. Serum samples were analyzed through the hexokinase
      method. The participants were then randomly allocated (first allocation) by the dietician
      through a coin toss to receive a standard breakfast without EVOO or a meal admixed with one
      tablespoon of EVOO. The standard meals were labeled with serial numbers, and both the
      participants and the investigator were blinded to the intervention. The meals were consumed
      steadily in 15 to 20 minutes, after which, the food containers were collected to ensure its
      full consumption. Breakfast was chosen in order to avoid a second meal bias. The participants
      were asked to sit in the waiting area of the laboratory until the 2-hour postprandial blood
      sugar was due to be drawn.

      After a one-week washout period, the participants were asked to come back for a cross over to
      the other treatment arm (second allocation). The participants were given the same test meal
      to ensure that that the glycemic index of the food remained constant.
    

Intervention name(s): Extra Virgin Olive Oil (EVOO)
Intervention type(s): Dietary Supplement
Intervention description(s): This study used the FDA approved Doña Elena Extra virgin olive oil, which is readily available in local supermarkets. Its free acidity expressed as oleic acid was found to be 0.26%, comparable with the International food standards.15
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized Controlled Crossover trial
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Diabetes Mellitus Type 2; Diet therapy; Extra virgin olive oil