bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled
      insulin administration with 3 different inhalation regimens and with subcutaneous insulin
      administration.
    

Detailed description: 
      This first-in-human trial investigated the optimal particle size for absorption of Dance-501,
      an aerosolized liquid human insulin for inhalation (INH).

      Twelve subjects with type 1 diabetes received an INH dose (50 IU) using an inhaler on 4
      visits and 6 U insulin lispro (LIS) sc on a separate visit to assess relative bioavailability
      (FREL) of INH. The inhaler was configured to generate insulin aerosol particles sized 3.5-4.0
      μm (low output mesh; LOM), 4.3-4.8 μm (medium output mesh; MOM) or 5.0-5.5 μm (high output
      mesh; HOM) during low inspiratory flow. To assess within subject variability, MOM was used
      twice. Pharmacokinetics (PK) were measured up to 8 hours after dosing.
    

Intervention name(s): inhaled human insulin (INH); sc insulin lispro (LIS)
Intervention type(s): Drug; Drug
Intervention description(s): recombinant human insulin administered with Adagio-01 inhaler device; insulin lispro administered subcutaneously
Other intervention name(s): Dance-501
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Controlled Human Malaria Infection by Intradermal Injection of Plasmodium Falciparum Sporozoites in Tanzanian Adults
Condition: Malaria
MeSH terms: Infections; Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed trial will evaluate whether relatively non immune populations in endemic
      countries can be effectively infected with aseptic, purified, cryopreserved sporozoites
      (PfSPZ Challenge) given intradermally.
    

Detailed description: 
      Controlled human malaria infection (CHMI) is a critical component of malaria vaccine and drug
      development and is an important element of any strategy for accelerating the development of
      new tools for malaria control, elimination and eradication. Until now, CHMI has been
      performed in malaria naïve subjects from countries not endemic for malaria using both
      infectious mosquitoes and recently, aseptic, purified, cryopreserved Plasmodium falciparum
      sporozoites (PfSPZ). Results from these studies report significant infection success in all
      study subjects and an excellent safety profile.

      The conduct of CHMI studies in malaria endemic populations will allow early understanding of
      responses to new vaccines and drugs in endemic country populations and for direct comparisons
      between previously exposed and non-exposed individuals. Performing CHMI studies in malaria
      endemic countries will reduce associated costs, speed-up the process of testing and
      substantially contribute to the acceleration of the malaria vaccine and drug research and
      development processes.

      This study to be conducted in Bagamoyo, Tanzania, aims to see whether people in endemic
      countries with minimal previous history of malaria are suitable for CHMI using PfSPZ
      Challenge. This study will also assess whether the success rate of the experiment is improved
      by lowering the volume of injection and increasing the number of inoculations. Hence, the
      study will contribute towards improvements in the CHMI studies using syringe and needle
      inoculation of sporozoites.
    

Intervention name(s): PfSPZ Challenge; Saline
Intervention type(s): Biological; Biological
Intervention description(s): Aseptic, purified, vialed, cryopreserved, fully infectious NF54 Plasmodium falciparum sporozoites (PfSPZ Challenge); Saline
Other intervention name(s): Plasmodium falciparum sporozoites
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Malaria Challenge; Plasmodium falciparum; PfSPZ Challenge; Controlled; human; malaria infection
Audio and Video Brochures for Increasing Colorectal Cancer Screening Among Adults Living in Appalachia
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This clinical trial compares audio brochures and video brochures to usual care for increasing
      colorectal cancer (CRC) screening among adults living in Appalachia. Adults living in rural
      Appalachia experience increased rates of CRC, possibly due to the unique barriers to
      screening this population faces, such as lower socioeconomic status, limited health literacy,
      and less access to healthcare. The fecal immunochemical test (FIT) is a common CRC screening
      technique which allows individuals to complete the test at home and mail the kit back. A
      limitation of the current process for FIT screening outreach is that the instruction
      materials are heavy in text and not appropriate for individuals with limited health literacy.
      The audio and video brochures used in this clinical trial are instruction materials that have
      been specially designed to be appropriate for individuals of all health literacy levels.
      Providing these audio and video brochures with the FIT kits may increase CRC screening among
      adults living in Appalachia, compared to usual care.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. Conduct a pilot study of the two developed mail-based FIT outreach interventions versus
      (vs.) mailed usual care materials to establish acceptability and obtain preliminary efficacy
      data on increasing CRC screening.

      OUTLINE: Participants are randomized to 1 of 3 arms.

      ARM I: Participants receive the FIT kit and usual care on study.

      ARM II: Participants receive the FIT kit with an audio brochure, disposable gloves and stool
      collection device, and scheduled reminder on study.

      ARM III: Participants receive the FIT kit with a video brochure, disposable gloves and stool
      collection device, and scheduled reminder on study.
    

Intervention name(s): Best Practice; Fecal Immunochemical Test; Health Education; Health Education; Scheduled Notification; Survey Administration
Intervention type(s): Other; Other; Behavioral; Behavioral; Other; Other
Intervention description(s): Receive usual care; Receive FIT kit; Receive audio brochure; Receive video brochure; Receive scheduled reminder; Ancillary studies
Other intervention name(s): standard of care; standard therapy; FIT; iFOBT; immunoassay fecal occult blood test; immunochemical fecal occult blood test; Immunochemical FOBT; immunologic fecal occult blood test; ScheduledNotification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effects of a Novel Physical Exercise Program in Patients With Cirrhosis (the LFN-exercise Protocol)
Condition: Cirrhosis; Portal Hypertension; Exercise
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Fibrosis
Study type: Interventional

Summary: 
      This study evaluates the effects of a structured exercise (The LFN-exercise protocol) program
      plus diet, on cerebral hemodynamics (cerebral blood flow) and hepatic hemodynamics (portal
      pressure), as well as on nutritional status (body composition and nutritional markers) in
      order to facilitate the prescription of exercise in patients with cirrhosis.
    


Intervention name(s): Exercise; nutritional therapy
Intervention type(s): Other; Other
Intervention description(s): aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.; individualised nutritional intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fecal Recovery of the Probiotic Bacteria Lactobacillus Rhamnosus GG (LGG) and Bifidobacterium Animalis Subspecies Lactis BB-12 (BB-12) in Healthy Humans Following Daily Consumption of a Probiotic Supplement
Condition: Fecal Analysis
Study type: Interventional
Phase: Phase 4

Summary: 
      The main hypothesis of this study is that there will be a significant increase of
      Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy
      humans following daily consumption of a probiotic supplement containing these specific
      strains of probiotic bacteria.
    

Detailed description: 
      To demonstrate recovery of live probiotic bacteria in the stool.
    

Intervention name(s): ProNutrients Probiotic
Intervention type(s): Dietary Supplement
Intervention description(s): Dosage is 1 individually wrapped packet (1 gram) containing probiotic powder per day for 21 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: probiotic; LGG; BB-12; fecal recovery; healthy subjects
Phase I/II Study of Z-208 in Advanced Hepatocellular Carcinoma (HCC)
Condition: Advanced Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced
      hepatocellular carcinoma
    

Detailed description: 
      This is an open-label, dose-escalation study PhaseI Treatments repeats for 28 days for 1
      course in the unacceptable toxicity

      Cohort of 3 patients receive escalating doses of Z-208 until the maximum tolerated dose (MTD)
      is determined. The MTD is defined as the dose preceding that at which 1 of 3 patients
      experience dose-limiting toxicity.

      PhaseII Treatments repeats for 28 days for 6 courses until absence of disease progression or
      unacceptable toxicity.
    

Intervention name(s): Z-208
Intervention type(s): Drug
Intervention description(s): Oral pills taken daily; 8mg, 12mg, 16mg, 4mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Z-208
Instant Messaging Program (Wechat) Improve the Quality of Bowel Preparation
Condition: Bowel Preparation
Study type: Interventional

Summary: 
      Colonoscopy is the gold standard in the diagnosis of colorectal disease. The success of
      colonoscopy depends on high-quality bowel preparation by patients. Inadequate bowel cleansing
      reduces the cecal intubation rate, and the polyp detection rate (PDR). It also increases
      costs, mostly due to repeated procedures. The quality of bowel cleansing has remained
      suboptimal even though numerous different products and regimens have been tested and compared
      in no fewer than six meta-analyses. Therefore, a completely different approach to improve
      bowel cleansing is welcome.

      Here the investigators assume that instant messaging program (Wechat) delivery the detail and
      FAQ (Frequently Asked Questions) of bowel preparation instructions would improve the quality
      of the bowel preparation. The Wechat program has some advantages, 1. Wechat supports over 400
      million users, nearly half of the mobile subscribers population in China; 2. Wechat provided
      a real time communications including voice messages, pictures and text exchange timely;
      3.Compare with telephone, Wechat is economical of both time and money; 4. Compare with bowel
      preparation instructional software and litera or cartoon educational booklet, Wechat is more
      interactive and responsive.
    


Intervention name(s): IMP interactive education
Intervention type(s): Other
Intervention description(s): The detail and FAQ (Frequently Asked Questions) of bowel preparation instructions is delivered by Wechat.
Other intervention name(s): Wechat education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: bowel preparation; instant messaging program
Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an Intravenous (i.v.) Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of
      occurrence and the severity of post dose symptoms that may occur during the 3 day period
      following a zoledronic acid infusion in post menopausal women with low bone mass.
    


Intervention name(s): Placebo; Acetaminophen; Fluvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: zoledronic acid; post dose symptoms; transient; acetaminophen; fluvastatin
Effectiveness of Physical Activity Prescription Among Hypertensive Patients of Primary Health Care.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a program to increase the
      physical activity of hypertensive patients using medical services and sports facilities of
      the Mexican Social Security Institute. The primary hypothesis to be proven is: The
      intervention will increase the proportion of hypertensive patients complying the physical
      activity minimum at week to get benefits on health in 20%, compare to patients in control
      group.
    

Detailed description: 
      Secondary Hypothesis:

      The intervention achieved a significant change in the group of hypertensive patients in the
      following variables:

        1. Decreased levels of systolic and diastolic blood pressure, biochemical markers such as
           total cholesterol, triglycerides and fasting blood glucose and increased HDL
           cholesterol.

        2. Increase muscular endurance and cardio-respiratory capacity according to the categories
           of risk stratification.

        3. Decreased body weight, body mass index and waist circumference.
    

Intervention name(s): Physical activity prescription to develop program in group.
Intervention type(s): Behavioral
Intervention description(s): Overall the intervention involves a medical reference in primary care (PHC) to hypertensive patients (during routine consultation) to assist the sports facilities of the same Institute, to develop a group program of physical activity which will last 24 weeks. Led by the trained staff in physical activity to patients with chronic diseases.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Physical activity; Hypertension; Scheme reference; Primary care
Effects of Rosiglitazone on Plasma BNP Levels and Left Ventricular Dysfunction
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study aimed to evaluate the effect of rosiglitazone treatment on cardiac function
      compared with metformin
    

Detailed description: 
      Large scale clinical trials have reported fluid retention and increase in plasma volume (6%
      to 7%) with glitazone therapy, with an increased incidence of peripheral edema occuring in 2%
      to 5% patients. Some evidence suggests that this effect may be related to increased
      endothelial cell permeability induced by glitazones therapy. Others report that glitazones
      may interfere with renal hemodynamics. In controlled clinical trials, the frequency of new
      onset congestive heart failure was very low in glitazones treated patients. The incidence of
      congestive heart failure is higher in patients receiving combination therapy with insulin and
      glitazones. Only few studies compared rosiglitazone and metformin on cardiac safety. Recently
      a study reported a reversible increase in endothelial cell permeability to albumin in
      cultured pulmonary arterial cells treated with rosiglitazone. To our knowledge, there is not
      any clinical study published for showing the reversibility of the cardiac adverse effects if
      the rosiglitazone treatment is continued.
    

Intervention name(s): Rosiglitazone(drug), cardiac adverse effects
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Natriuretic Peptide, Brain; Heart Failure, Congestive
Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      multiple doses of TAK-058 in healthy non-elderly and elderly participants.
    

Detailed description: 
      The drug being tested in this study is TAK-058, which is under evaluation for the treatment
      of schizophrenia.

      This study will enroll approximately 32 healthy non-elderly and 8 healthy elderly
      participants. Participants will be randomly assigned (by chance, like flipping a coin) to one
      of the five treatment groups-which will remain undisclosed to the patient and study doctor
      during the study (unless there is an urgent medical need):

        -  Cohort 1 Non-elderly Healthy: TAK-058 25 mg

        -  Cohort 2 Non-elderly Healthy: TAK-058 75 mg

        -  Cohort 3 Non-elderly Healthy: TAK-058 150 mg

        -  Cohort 4 Elderly Healthy: TAK-058 25 mg

        -  Cohort 5 Non-elderly Healthy: TAK-058 300 mg

        -  Cohort 1-4 Non Elderly Placebo (dummy inactive solution) - this is an oral solution that
           looks like the study drug but has no active ingredient.

        -  Cohort 5 Elderly Placebo This single-center trial will be conducted in the United
           States. The overall time to participate in this study is 40 days if assigned to Cohort 1
           to 4. Participants will be confined to the clinic for 12 days, and will be contacted by
           telephone 11 and 30 days after last dose of study drug for a follow-up assessment (Days
           21 and 40).

      The overall time to participate in this study is 14 days if assigned to Cohort 5.
      Participants will be confined to the clinic for 4 days, and will be contacted by telephone 14
      days after last dose of study drug for a follow-up assessment (Day 14).
    

Intervention name(s): TAK-058; TAK-058 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-058 Solution; TAK-058 placebo-matching solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to
      reduce post-operative pain, opioid consumption and related side effects, and length of
      hospital stay. Current research demonstrates a modest improvement in these areas beginning on
      the third post-operative day. MIS fusion, however, incurs significant cost as the average
      time of the procedure is approximately one third greater (from 148 minutes to 191 on
      average). Epidural analgesia has clearly demonstrated benefits for conventional open
      laminectomy. In order to fully maximize the benefits of an MIS technique, early
      post-operative analgesia/pain must be improved. The aim of this study is to combine two
      techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized
      trial involving 32 patients undergoing MIS decompression and fusion with half the study group
      receiving active epidural and IV-PCA and the other half receiving epidural placebo and
      IV-PCA.

      The hypothesis is that epidural analgesia will reduce post-operative opioid consumption,
      improve pain scores, and decrease time to ambulation as well as discharge from hospital after
      MIS decompression and fusion.
    


Intervention name(s): Bupivicaine, Hydromorphone; Saline Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2; Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1
Intervention MeSH terms: Hydromorphone; Bupivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Minimally Invasive Decompression and Fusion; Postoperative analgesia; Epidural; Lumbar
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell
Study type: Interventional

Summary: 
      Clinical trial to determine the performance characteristics (sensitivity and specificity) of
      the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.
    

Detailed description: 
      Clinical trial to determine the performance characteristics (sensitivity and specificity) of
      the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients
      under monitoring for reccurrence of bladder cancer.
    

Intervention name(s): Bladder EpiCheck
Intervention type(s): Other
Intervention description(s): Urine test for the monitoring of bladder cancer recurrence
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Bladder cancer; Urine; Methylation