bioihbjkbjnl/mcl2 huggingface dataset:
Optical Tomography in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This study is looking to see if a new device, diffuse optical tomography (DOT), can detect
      prostate cancer. The investigators will also see if DOT can tell the difference between high
      risk and low risk prostate cancers.
    

Detailed description: 
      While some of these tools have helped to guide therapy in patients with prostate cancer, they
      are imperfect and as a result many men undergo unnecessary treatment for a disease that would
      not have caused their deaths. An improved method to risk stratify men with prostate cancer
      prior to definitive therapy may reduce the over-treatment rate, while maintaining or
      improving mortality.

      Diffuse optical tomography (DOT) is a novel imaging modality that uses low-intensity,
      near-infrared light to characterize tissue. DOT analyzes the light being reflected and
      transmitted through tissue to generate three-dimensional images of chromophores and light
      scattering. As such, DOT serves as a functional imaging modality, measuring both tissue
      vascularity and architecture. The investigators believe that DOT will be able to detect
      prostate cancer in men suspected of the disease and will also be able to risk-stratify
      patients found to have prostate cancer to help guide treatment options. DOT may be able to
      directly measure two factors important in the prognosis of patients with prostate cancer: the
      Gleason score and microvessel density (MVD).
    

Intervention name(s): Diffuse Optical Tomography (DOT) System
Intervention type(s): Device
Intervention description(s): Diffuse optical tomography (DOT) is a novel imaging modality that uses low-intensity, near-infrared light to characterize tissue. As light of a specific wavelength travels through tissue, it is absorbed and scattered by different chromophores and cellular structures. Using four wavelengths of light allows the detection of four chromophores: oxyhemoglobin, deoxyhemoglobin, water and fat.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Diffuse Optical Tomography
Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Bone marrow transplantation and peripheral stem cell
      transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor
      cells.

      PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with
      carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell
      transplantation in treating patients who have advanced ovarian epithelial cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of carboplatin when combined with
      cyclophosphamide as high-dose therapy followed by autologous bone marrow and peripheral blood
      stem cell rescue in patients with platinum sensitive ovarian epithelial carcinoma. II.
      Determine the efficacy of this regimen in these patients.

      OUTLINE: This is a dose escalation study of carboplatin. Autologous bone marrow (ABM) is
      harvested on day -11, filgrastim (G-CSF) is administered subcutaneously (SC) on days -11 to
      -7, and autologous peripheral blood stem cells (PBSC) are harvested on day -6. Patients
      receive high dose chemotherapy comprising carboplatin IV over 15 minutes on days -5 and -4
      and cyclophosphamide IV over 1 hour on days -3 and -2. PBSC are reinfused on day -1, ABM is
      reinfused on day 0, and G-CSF is administered SC beginning on day 7 and continuing until
      blood counts recover. Cohorts of 2-4 patients receive escalating doses of carboplatin until
      the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no
      more than 10% of patients experience dose-limiting toxicity. A minimum of 6 patients receive
      carboplatin at the MTD. Patients are followed at 1 month and then every 3 months for 5 years.

      PROJECTED ACCRUAL: A minimum of 18 patients will be accrued for this study within 1 year.
    

Intervention name(s): filgrastim; carboplatin; cyclophosphamide; autologous bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Carboplatin
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; ovarian undifferentiated adenocarcinoma; ovarian mixed epithelial carcinoma; ovarian serous cystadenocarcinoma; ovarian mucinous cystadenocarcinoma; ovarian endometrioid adenocarcinoma; ovarian clear cell cystadenocarcinoma; fallopian tube cancer; primary peritoneal cavity cancer
Vibration Therapy Effects on Muscle Firing Patterns
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the effects of whole body vibration therapy on
      muscle firing patterns as measured by EMG analysis.
    

Detailed description: 
      Proprioception is the specialized sensory modality that informs the body as to movement,
      position, and spatial orientation through mechanisms that track sensations accompanying joint
      movement and position. Mechanoreceptors in joints, along with vestibular, visual, muscle
      spindle, Golgi tendon organ, ligament and tendon sensory receptors, comprise the
      propriosensory system, which conveys information to the motor system to maintain equilibrium
      on a reflexive, automatic basis. Alterations in somatosensory input from mechanoreceptors
      have been identified as causing aberrant muscle firing patterns.
    

Intervention name(s): Whole Body Vibration
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: whole body vibration; muscle physiology
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label study to assess the pharmacokinetics, pharmacodynamics, safety,
      and tolerability of opicapone when administered orally once daily for 14 days as adjunctive
      therapy to carbidopa/levodopa in subjects with Parkinson's disease.
    


Intervention name(s): Opicapone; Carbidopa Levodopa
Intervention type(s): Drug; Drug
Intervention description(s): catechol-O-methyltransferase (COMT) inhibitor; Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor
Other intervention name(s): BIA 9-1067; Sinemet
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Opicapone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With a Sulfonylurea
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on
      glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients
      will be randomized into one of two AC2993 treatment arms or to placebo treatment and will
      continue with their required existing diabetes medication (sulfonylurea) throughout the
      study.
    


Intervention name(s): AC2993; AC2993; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 4 weeks / Placebo (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily; Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
Other intervention name(s): synthetic exendin-4; synthetic exendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitis
A Multiple-Dose Study of Intravenous BNZ132-1-40 in Healthy Adult Subjects
Condition: Safety and Tolerability in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, randomized, single-blind, placebo (PBO)-controlled,
      multiple-dose study to characterize the safety, tolerability, PK, and PD of IV BNZ-1
      administered to healthy adult subjects once weekly (QW) for 4 doses or once every other week
      (QOW) for 3 doses. Five cohorts of 6 subjects randomized 5 BNZ-1:1 PBO are planned to be
      enrolled in the trial. Participants will be followed for 4 weeks after the last dose for
      safety monitoring, and collection of PK and PD samples.
    


Intervention name(s): BNZ132-1-40; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injectable peptide antagonist of IL-2, IL-9 and IL-15; Normal Saline
Other intervention name(s): BNZ-1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cytokine inhibitor; IL-2; IL-9; IL-15
Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to better define the absorption and elimination pathways, and
      circulating metabolites of Pitolisant at steady state using Pitolisant radiolabelled, in
      healthy CYP2D6 genotyped male subject.
    


Intervention name(s): Pitolisant; [14C]-Pitolisant
Intervention type(s): Drug; Radiation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics
Condition: Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      Probiotics are live microorganisms that, when administered in adequate amounts, confer a
      health benefit on the host. One of the most common indications for probiotic treatment is the
      prevention of antibiotic-associated diarrhea (AAD). Unfortunately, many probiotic products
      used for AAD are not supported by rigorous independent research, and often results in
      non-evidence-based usage. The overarching objective is to move research forward for the most
      well-studied Bifidobacterium strain. The primary aim is to test the efficacy of high dose,
      BB-12-supplemented yogurt in preventing AAD, compared to yogurt without BB-12, in children
      receiving antibiotics. Other aims are to further assess the safety of yogurt supplemented
      with BB-12, and to carry out longitudinal community structure and gene expression analysis of
      fecal microbiota to evaluate the impact of high dose BB-12 in a pediatric population
      receiving antibiotics. The microbiota includes hundreds of species, and its disruption is
      hypothesized to be an important factor in the development of AAD.
    


Intervention name(s): Bifidobacterium animalis subsp. lactis BB-12; Control
Intervention type(s): Biological; Other
Intervention description(s): Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt; Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Treatment of Moderate to Severe Facial Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety
      and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the
      Investigator's Global Assessment (IGA) score and the absolute change from baseline in
      inflammatory lesion count in patients with moderate to severe facial acne vulgaris.
      Additionally, the absolute change from baseline in non-inflammatory and total lesions of the
      active study medication to placebo will be evaluated.
    


Intervention name(s): Doxycycline 0.6 mg/kg/day; Doxycycline 1.2 mg/kg/day; Doxycycline 2.4 mg/kg/day; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): doxycycline 40 mg/day, oral, 12 weeks; doxycycline 80 mg/day, 12 weeks; doxycycline 160 mg/day, 12 weeks; Placebo, 12 weeks
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is a multi-centre, open-label, safety and tolerability extension trial to the
      IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject
      pool at an optimal dose level. The trial is conducted in elderly Acute Myeloid Leukemia (AML)
      patients over the age of 60 years, in complete remission, and who are not eligible for
      allogeneic stem-cell transplantation. The dose given to the individual patient will be the
      same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for
      the 12 patients in an additional cohort.
    


Intervention name(s): IPH2101
Intervention type(s): Drug
Intervention description(s): IPH2101 fully human anti-KIR monoclonal antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Analgesic Efficacy of Ultrasound Guided Transversus Abdominal Plane Block After Abdominal Cancer Surgeries
Condition: Abdominal Cancer
MeSH terms: Abdominal Neoplasms
Study type: Interventional

Summary: 
      Effective postoperative pain control results in decreased cardiac and pulmonary
      complications, patient satisfaction and early mobilization. A prospective, randomized
      comparative study was done of analgesic efficacy, opioid requirement and side effects in
      patients undergoing lower abdominal cancer surgeries. In Study Group Ultrasound guided
      Transversus Abdominis Plane (TAP) block was given and control Group no TAP block was given.
      Patient controlled analgesia (PCA) with intravenous morphine was given to both group
      patients, and total good PCA demands in both the groups was studied.
    

Detailed description: 
      Adult patients of both sexes undergoing major lower abdominal cancer surgeries were enrolled
      in the study. After obtaining written informed consent from all the patients, they were
      randomly allotted to either Study (TAP) Group or Control group. Standard general anesthesia
      with endotracheal intubation was performed in all the patients. Preoperatively all patients
      received information about Visual Analogue Scale (VAS) for Pain Score from 1 to 10 depending
      on intensity of pain and about the use of Patient Controlled Analgesia (PCA) Pump. After the
      end of surgery and before extubation bilateral Ultrasound guided Transversus Abdominis Plane
      (TAP) block was performed with 16 G Tuohy needle and 18 G Braun Perifix epidural catheter was
      placed about 6-8 cms in situ. Bupivacaine 0.25 % 20 ml was given bilaterally and repeated 8
      hourly in the Postoperative Anaesthesia Care Unit (PACU) for first 24 hours. The PCA Pump was
      set to deliver bolus Intravenous Morphine 1 milligram ( mg ) with lock out interval 10
      minutes. In the PACU heart rate, Non invasive blood pressure, Visual Analogue Score at rest
      and on knee flexion, Sedation score, nausea and vomiting, any side effects as itching was
      noted by care provider at 0, 2, 4, 6, 12, 18 and 24 hours. Total and good PCA demands upto 24
      hours was recorded.
    

Intervention name(s): Bupivacaine (Transversus Abdominis Plane Block); Intravenous Patient Controlled Analgesia (PCA) Morphine
Intervention type(s): Drug; Drug
Intervention description(s): Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly up to 24 hours.; PCA Intravenous Morphine 1 milligram bolus on demand was given as rescue analgesia up to 24 hours.
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transverse Abdominis Plane (TAP) Block; Patient Control Analgesia (PCA)
Drug-Drug Interaction (DDI) Study for TD-9855
Condition: Drug Drug Interaction (DDI)
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the
      PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess
      the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and
      non-smokers.
    


Intervention name(s): TD-9855; Fluvoxamine; Itraconazole; Caffeine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablet, QD; oral tablet, QD; oral tablet solution, QD; oral solution, single dose
Intervention MeSH terms: Itraconazole; Fluvoxamine; Caffeine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DDI; Itraconazole; Fluvoxamine; TD-9855; Smoking; Caffeine; CYP1A2; CYP3A4
Efficacy of IV Lidocaine at Alleviating Pain Associated With Propofol Infusion in Pediatric Patients Undergoing Sedation
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This protocol describes a double-blind, placebo-controlled trial intended to demonstrate the
      effectiveness of lidocaine at reducing pain associated wiht propofol infusion for short-term
      deep sedation in children. Patients will be randomized to receive either placebo (saline) or
      one of two dosing regimens of IV lidocaine prior to initiating propofol infusion. The
      efficacy of the differing lidocaine doses will be compared to determine the minimum dose
      required to safely achieve alleviation of pain. We hypothesize that premedicating with
      lidocaine will significantly decrease pain experienced by pediatric patients receiving
      propofol for outpatient sedation.
    


Intervention name(s): normal saline; lidocaine; lidocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive saline placebo IV (Group A) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.; A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.25 mg/kg IV (Group B) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.; A blood pressure cuff is placed with its distal-most margin 10 cm proximal to the intravenous catheter insertion site and is inflated to 40 mmHg of pressure greater than the patient's pre-procedure systolic blood pressure. Subjects will receive lidocaine 0.5 mg/kg IV (Group C) prior to initiating propofol infusion. Five minutes after administration of the study agent, tourniquet pressure is released and propofol infusion will be immediately initiated.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: pain; propofol; lidocaine; sedation; pediatric