bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Study D5553C00002 is a multicenter, randomized, double-blind, placebo-controlled, parallel
      group, Phase 3 study to compare the safety and efficacy of exenatide once weekly (EQW) added
      to titrated basal insulin glargine with or without metformin to placebo added to titrated
      basal insulin glargine with or without metformin in patients with type 2 diabetes mellitus
      (T2DM). Eligible patients will be randomized at Visit 5 (Day 1) to receive either EQW added
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, or placebo added
      to titrated basal insulin glargine, with or without metformin ≥1500 mg/day, during the
      28-week treatment period.
    


Intervention name(s): Exenatide; Exenatide matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg weekly suspension injection; Once weekly Placebo injection
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Exenatide; Diabetes drug; Treatment efficacy; Placebo; Metabolism; Cardiovascilar metabolic
Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial
Condition: Hallux Limitus
MeSH terms: Hallux Limitus; Hallux Rigidus
Study type: Interventional

Summary: 
      The purpose of this study is to regain range of motion of the great toe with dynamic
      splinting which will help reduce great toe's pain and swelling.
    

Detailed description: 
      Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a
      randomized, controlled trial.
    

Intervention name(s): Metatarsophalangeal Extension Dynasplint System; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day.; The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hallux Limitus; Dynamic Splinting; Dynasplint
A Study to Assess the Safety and Immunogenicity of a Malaria Vaccine Candidate, R21, Administered With AS01B
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical trial in which healthy volunteers will be administered an experimental
      malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B.

      All vaccinations will be administered intramuscularly. Each volunteer will receive three
      vaccinations in total.

      There are two different vaccine schedules:

      Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21 50µg
      with AS01B on days 0, 28, and 56.

      The study will assess the safety of the vaccine, and the immune responses to the vaccination.
      Immune responses are measured by tests on blood samples.

      Healthy adult volunteers will be recruited in Oxford and Southampton, England.
    


Intervention name(s): R21 with ASO1B
Intervention type(s): Biological
Intervention description(s): R21 with ASO1B
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Validate pulse oximeter sensor SpO2 accuracy from 70-100% during induced hypoxia.
    

Detailed description: 
      The testing is conducted on 10 healthy, consenting, non-smoking subjects in accordance with
      the IRB approved Protocol. The subjects shall be distributed across both genders and a range
      of skin tones as equally as practical.

      An arterial line will be placed in the radial artery of each subject's right arm, and sensors
      will be attached to each subject. The subjects will be placed in a semi-supine position and
      allowed to breathe through a mouthpiece while the nose is blocked with a nose-clip.

      Hypoxia will be induced by on each subject, as levels of oxyhemoglobin saturation (between
      70% and 100%) are achieved by breathing mixtures of nitrogen, room air and carbon dioxide.
      Inspired O2 concentration will be adjusted breath-by-breath using a computed saturation,
      based on end-tidal PO2 and PCO2, as sampled by a mass spectrometer. Predicted levels of
      oxyhemoglobin saturations will be attained and held stable. At a minimum of sixty seconds
      into each plateau, a 0.5cc waste blood draw through the arterial line, followed by the first
      1.0cc sample blood draw. After approximately thirty additional seconds, the second 1.0cc
      sample blood draw will be taken. The samples will immediately be analyzed by a Radiometer
      OSM-3 multi-wavelength co-oximeter and recorded. The SpO2 data from the oximeters will be
      collected via a laptop computer. Concurrent with the end of each blood draw, a marker will be
      generated on the laptop computers to identify the event.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy, consenting, non-smoking subjects, 18 years or older, both genders and a range of
        skin tones.
Performance of Two Toric Silicone Hydrogel Contact Lenses
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and
      senofilcon A toric contact lens after two weeks of wear.
    

Detailed description: 
      The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality
      toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.
    

Intervention name(s): fanfilcon A toric lens; senofilcon A toric lens
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Other intervention name(s): Avaira Vitality toric lens; Acuvue Oasys for Astigmatism
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Metagenomic and Metabolomic Reconstitution of Gut Microbiota After Broad Spectrum Antibiotic Therapy
Condition: Antibiotic Side Effect; Antibiotic-associated Diarrhea; Antibiotic-induced Dysbiosis; Antibiotic-induced Epithelial Barrier Disintegrity
MeSH terms: Diarrhea; Dysbiosis
Study type: Interventional

Summary: 
      In the United States, healthcare providers prescribe over 270 million antibiotic
      prescriptions each year. While antibiotics have transformed medicine and methods of treating
      life-threatening bacterial infection, broad spectrum antibiotics also induce disruption of
      resident gut microbial communities by altering both composition and function. This disruption
      of microbial community dynamics has been demonstrated at the taxonomic level, yet the extent
      of functional disruptions to microbial metabolic output and host cells remains understudied
      in humans. This study explores the impact of a broad spectrum antibiotic cocktail on
      microbial communities throughout the gastrointestinal tract, and the impact of a defined,
      multi-strain consortia of probiotic organisms following antibiotic exposure.
    


Intervention name(s): Ciprofloxacin + Metronidazole; SH-DS01; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be instructed to take 1 capsule of Ciprofloxacin (500mg) twice daily for 7 days and 1 capsule of Metronidazole (500mg) thrice daily for 7 days. Antibiotics should be taken at least 2 hours before or 6 hours after mineral supplements containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc.; SH-DS01 is a rationally defined microbial consortia consisting of 24 strains across 12 species, with polyphenolic and phenolic prebiotic bioactive compounds. Participants will be instructed to take 2 capsules daily for the duration of the trial.; Placebo capsules for SH-DS01 will contain rice flour matched for color and texture in an identical outer capsule shell. Participants will be instructed to take 2 capsules daily for the duration of the trial.
Intervention MeSH terms: Metronidazole; Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Gut microbiome; Dysbiosis; Antibiotic therapy; Rationally-defined consortia; Short-chain fatty acids; Gut metabolome; Metagenomic sequencing; Ciproflozacin; Metronidazole; Probiotic Therapy
Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases
Condition: Cancer; Squamous Cell Carcinoma; Adenocarcinoma; Malignancy
MeSH terms: Neoplasm Metastasis; Esophageal Neoplasms; Lymphatic Metastasis
Study type: Interventional

Summary: 
      There is no world-wide consensus on the oncological benefit versus increased morbidity
      associated with three field lymphadenectomy in patients with esophageal cancer and cervical
      lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three
      field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes.
      However, in Western countries patients with cervical lymph node metastases are generally
      precluded from curative treatment.
    

Detailed description: 
      Objective: To assess the safety and feasibility of curative esophagectomy combined with three
      field lymphadenectomy after chemo-radiation in Western patients with resectable thoracic
      esophageal carcinoma and cervical lymph node metastases. Secondary objective is to determine
      the effect on survival and recurrence.

      Study design: Mono centre prospective phase II single-arm feasibility study. Study
      population: Western patients diagnosed with resectable (cT1-4a, N1-3) intra thoracic
      esophageal carcinoma with histological or cytological proven cervical lymph node metastases
      in level III and/ or IV.

      Intervention: Transthoracic esophageal resection combined with three field lymphadenectomy
      after neoadjuvant chemo-radiation.

      Main study parameters/ endpoints: Primary outcome is the percentage of overall surgical
      complications grade 3b and higher as stated by the Modified Clavien-Dindo classification.
      Secondary outcomes are mortality, operation related events and postoperative recovery,
      including quality of life, disease free survival, overall survival and if applicable the
      location of recurrent disease.
    

Intervention name(s): esophagectomy with three-field lymphnode dissection
Intervention type(s): Procedure
Intervention description(s): robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: three-field lymphadenectomy; cervical metastases; esophagectomy
Quadruple Fortified Salt Clinical Trial
Condition: Anemia
Study type: Interventional

Summary: 
      Anaemia is the world leading cause of disability and is responsible for about more than
      115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in Africa
      and Asia. Despite the fact that there are several causes of anemia, the most important causes
      are due to micronutrients deficiency, namely iron, Folic acid and Vitamin B12. Low intakes of
      these micronutrients consequently affect a woman's health, pregnancy outcome and the
      nutritional status of breast-fed children. With these in mind we wish to test the
      effectiveness of salt fortified with these four micronutrients (Iodine, Iron, Folic acid and
      vitamin B12) in raising the Hemoglobin levels among the non-pregnant and non-lactating women
      of reproductive age.
    

Detailed description: 
      Anaemia is the low level of Haemoglobin based on the location. As per WHO a woman is termed
      anaemic if has HB <11g/dl but in high attitude is =<13g/dl
    

Intervention name(s): Iodised salt with Iron, Folic acid and Vitamin B12
Intervention type(s): Combination Product
Intervention description(s): Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt
Other intervention name(s): Iodised salt with Iron
Intervention MeSH terms: Folic Acid; Vitamin B 12; Hydroxocobalamin; Iron
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is the measure the levels of lasmiditan in the body of children aged
      6 to 17 with migraine. The study also will also examine the safety and tolerability of
      lasmiditan in children aged 6 to 17 with migraine.

      The study will last about 6 weeks, and includes 4 visits.
    


Intervention name(s): Lasmiditan
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): LY573144
Intervention MeSH terms: Lasmiditan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
BioWare for AUD and PTSD
Condition: PTSD; Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional

Summary: 
      This study examines the ability of an innovative telehealth technology system to enhance
      Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE)
      talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use
      disorder.
    


Intervention name(s): COPE
Intervention type(s): Behavioral
Intervention description(s): The COPE therapy is a talk-therapy in which individuals are asked about their trauma, alcohol use, mood, and behavior. The therapy occurs over 12 sessions and will be paired with a telehealth technology system to determine if it enhances the COPE therapy. The telehealth system is worn on the arm and hand during the out-of-office COPE homework assignments. It consists of a small camera (about the size of a pencil eraser), Bluetooth earpiece with microphone, monitors to measure and record heart rate and skin conductance, and a breathalyzer to assess blood alcohol content. The device will connect to an application on password protected cell phone that will monitor and record the above listed information as well as reported subjective units of distress and craving. A study coach will virtually guide participants through one out-of-office assignment per week using this technology. Interviews and surveys will be collected at study baseline and weekly during treatment.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices in Comparison With Laboratory CRP Testing.
Condition: Healthy and Acutely Ill Children & Adults
Study type: Interventional

Summary: 
      Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein
      devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.

      Research questions:

        1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP
           values measured at the clinical laboratory?

        2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable?
           2.1.1. Comparison of 2 measurements in the same patient on 1 device
           (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on
           2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices
           equally userfriendly in a general practice surgery? (userfriendliness
    


Intervention name(s): Point-of-Care C Reactive Protein measurement on capillary blood
Intervention type(s): Device
Intervention description(s): capillary blood fingerstick method to determine C Reactive Protein level in the blood
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion
Condition: Neurodegenerative Diseases
MeSH terms: Neurodegenerative Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Up to 80 healthy adult males, ≥ 18 and ≤ 55 years of age, are planned to be enrolled in the
      study.

      The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort
      will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2
      subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned
      for evaluation. A total of 21 blood samples will be collected in each cohort for PK analysis
      and a total of 14 blood samples will be collected in each cohort for PD analysis.
    

Detailed description: 
      The study will consist of 8 cohorts (Cohorts 1 to 8, 1 cohort per dose level). Each cohort
      will include 8 subjects (6 subjects receiving a single dose of the study drug NS101 and 2
      subjects receiving a single dose of a matching placebo), for a total of 64 subjects planned
      for evaluation.

      For each dose level, the dose to be administered to each subject for a single infusion will
      be calculated based on subject's body weight, measured on Day 1.

      In each cohort, subjects will receive a single infusion of NS101 or matching placebo under
      fasting conditions over a period of approximately 60 minutes at the target dose level. A
      total of 21 blood samples will be collected in each cohort for PK analysis and a total of 14
      blood samples will be collected in each cohort for PD analysis. A total of 6 immunogenicity
      blood samples will be collected for ADA and NAbs. For each subject in cohort 5 to 8 only, one
      single CSF sample will be collected via lumbar puncture over the study, for PK and PD
      analysis.
    

Intervention name(s): NS101 IV infusion
Intervention type(s): Drug
Intervention description(s): Approximately 1 hour prior to start of study drug infusion, an IV port will be inserted into the antecubital region and a sterile normal saline solution infusion will be initiated at fixed rate in order to keep the vein open. The study drug will be infused over approximately 60 minutes at a constant rate. At the end of the infusion, 3 mL of saline solution will be injected to flush the remaining drug into the IV catheter. The end of infusion will be set to the end of the 3 mL flush. For safety reason (e.g., administration of rescue medication), the IV line will remain opened for approximately 1 hour following completion of infusion.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: For each dose level, the dose to be administered to each subject for a single infusion will be calculated based on subject's body weight, measured on Day 1.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
4 Week Combination of BI 207127 NA With Peg-IFN and Ribavirin in Chronic HCV Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week
      combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C
      virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected
      patients.
    


Intervention name(s): BI 207127 middle dose +SOC; BI 207127 high dose+SOC; Placebo + SOC; BI 207127 low dose + SOC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BI 207127 middle dose tid + SOC; BI 207127 high dose tid +SOC; Placebo tid +SOC; BI 207127 low dose tid + SOC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Hearing Aid Signal Processing Comparative Study
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Participants will be fit with each of two hearing instruments in an ABA cross-over design.
      The study will consist of a total of three approximately 10-day home trials with the devices.
      Participants will be asked to provide qualitative feedback to investigators regarding the
      performance of and their preference for each hearing instrument.
    


Intervention name(s): Receiver-in-canal hearing instrument; Manufacturer A; Receiver-in-canal hearing instrument; Manufacturer B
Intervention type(s): Device; Device
Intervention description(s): Commercially available receiver-in-canal hearing instrument from manufacturer A; Commercially available receiver-in-canal hearing instrument from manufacturer B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Nasal Versus Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration
Condition: Lung Diseases
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to compare to nasal and buccal oxygen administration in patients
      undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .
    

Detailed description: 
      Anesthesia for Endobronchial Ultrasound (EBUS) may be range from routine bronchoscopy
      sedation to general anesthesia. During sedation to EBUS increased duration of anesthesia and
      sedative dosing put patients at increased risk for hypoxic events. To avoid this, oxygen
      supplementation is mandatory. There are different techniques for oxygen supplementation
      during the procedure. At this study we will compare to nasal and buccal oxygen
      supplementations during EBUS.
    

Intervention name(s): nasal oxygen; buccal oxygen
Intervention type(s): Other; Other
Intervention description(s): Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.; Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other