bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
Condition: Volatile Organic Compounds; Hypoglycemia; Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Observational

Summary: 
      The investigators are investigating the "biochemical fingerprint" of hypoglycemia (low blood
      sugar) in the breath of people with type 1 diabetes.
    

Detailed description: 
      The investigators aim through the use of proton-transfer-reaction mass spectrometry to
      perform comprehensive breath analysis to identify compounds of interest associated with
      glucose fluctuations. More than 500 different volatile organic compounds can be detected in
      human breath. Compounds such as ethane, pentane and isoprene (hydrocarbons), as well as
      acetone, acetaldehyde, methanol, ethanol, 2-propanol (oxygen-containing compounds), are most
      likely to be relevant and measurable in our study population. Hydrocarbons are stable
      end-products of lipid peroxidation and show only low solubility in blood and therefor are
      excreted into breath within minutes of their formation in tissues. There is evidence for
      increased hydrocarbon production in states of oxidative stress. Oxygen-containing compounds
      such as acetone/acetaldehyde (ketones) are also clinically relevant in the measurement of
      insulin deficient states of catabolism in patients with diabetes. A previous study of exhaled
      isoprene was found to be elevated during hypoglycemia. This study aims to expand on this to
      characterize the full range of changes in concentrations of volatile organic compounds in
      human breath during glucose fluctuations.

      Characterizing this "biochemical fingerprint" of hypoglycemia may provide clues about what
      so-called diabetes alert dogs are detecting as well as improve our understanding of
      hypoglycemia, the physiology behind hypoglycemia unawareness, and potentially identify a
      novel non-invasive measure of blood glucose.
    

Intervention name(s): Collect exhaled breath during low and normal blood sugar
Intervention type(s): Diagnostic Test
Intervention description(s): Collect exhaled breath during low and normal blood sugar to determine if there are any differences between the two in people with type 1 diabetes.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with type 1 diabetes between age 5-80.
      
Biospecimen description: 
      human breath samples collected in sealed bags and shipped to receiving/processing lab. Once
      processed, samples are destroyed.
Buprenorphine Treatment for Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription
      opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this
      patient population. The goal of this study is to determine if there are differences in
      clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high
      dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will
      be treatment retention, use of opioids, and the use of other drugs of abuse.
    

Detailed description: 
      This is a randomized, open-label clinical trial with approximately 9 Veteran opioid dependent
      men and women. Veterans were randomized to one of two treatment groups: low dose range of
      buprenorphine (<8mg) vs. high dose range of buprenorphine/naloxone (BUP/NLX (<16mg). During
      induction into buprenorphine, all participants will be started at a dose of 2mg, and this
      dose will be increased as needed for stabilization of opioid withdrawal symptoms, up to 8mg
      for the low dose group, and up to 16mg for the high dose group, within a 5 day period.
      Participants will be seen on a daily basis (excluding weekends) for the initial 5 day
      induction. At the end of the 12-week study, participants will either be referred to a
      buprenorphine clinic if they wish to continue this medication, or if they wish to be drug
      free, will undergo detoxification from buprenorphine for up to a 4-week period. Follow-up
      visits, scheduled at 1, 3, and 6 months after study completion.
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Other intervention name(s): Naloxone; Suboxone; Buprenex; Subutex
Intervention MeSH terms: Buprenorphine; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid Dependence; Buprenorphine
Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Observational

Summary: 
      In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin
      analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy
      with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This
      study was designed to evaluate short and long term efficacy of cabergoline in controlling
      IGF-I levels in acromegalic patients receiving octreotide.
    


Intervention name(s): cabergoline
Intervention type(s): Drug
Intervention description(s): cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal
Other intervention name(s): cabergoline-Dostinex
Intervention MeSH terms: Cabergoline
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nineteen acromegalic patients (Neuroendocrine Unit-UNIFESP)with active disease, resistant
        to octreotide were enrolled
      
Biospecimen description: 
      serum for IGI-I, GH and prolactin measures
    
Keywords: Acromegaly resistant; combined-treatment; dopamine agonist
Pre-surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60%
Condition: Antisepsis
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study evaluates the effects of bactericidal load reduction after surgical hand
      scrub antisepsis using the reference antiseptic product propanol-

      1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% in order to test
      if pass the standard european norm 12791.
    

Detailed description: 
      The investigators conducted a crossover clinical trial to evaluate the antiseptic
      effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by scrub using the
      reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub
      antisepsis with trocilosan 0.5% in order to test if pass the standard european norm 12791.
      Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.
    

Intervention name(s): Triclosan 0.5 % Topical Solution; propanolol
Intervention type(s): Drug; Drug
Intervention description(s): Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side; Hand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side
Other intervention name(s): Hand antisepsis with Triclosan 0.5% solution.; Hand antisepsis with Propanolol 60% solution
Intervention MeSH terms: Triclosan; Propranolol; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover design is used
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hand washing; presurgical antisepsis
Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
Condition: Stable Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      There is no evidence from prospective randomized clinical trials regarding the performance of
      conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive
      coronary angiography over the radial access.

      The aim of the present trial is to evaluate the efficacy and safety of different one-catheter
      concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins
      catheters in diagnostic coronary angiography via transradial access. Patients with stable
      angina pectoris will be randomly assigned to coronary angiography performed with the BLK or
      Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography
      duration.
    

Detailed description: 
      The aim of the present trial is to evaluate the efficacy and safety of a one-catheter concept
      using the BLK (Terumo, Somerset, USA) or the Tiger catheter (Terumo, Somerset, USA) compared
      to the standard Judkins catheters in diagnostic coronary angiography by the transradial
      access. Patients with stable angina pectoris will be randomly assigned to coronary
      angiography performed with the BLK (Group I), Tiger (Group II) or Judkins catheters (Group
      III). Primary endpoint is the time duration (sec) that is necessary to perform complete
      coronary angiography including 6 different projections for the left-coronary system and 3
      different projections of the right-coronary-system. Secondary endpoints will cover safety and
      imaging quality of the different catheter systems.
    

Intervention name(s): One-catheter concept; Standard catheter
Intervention type(s): Device; Device
Intervention description(s): Coronary angiography will be performed using the one-catheter concept.; Coronary angiography will be performed using a standard catheter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Papaverine on Renal Artery Blood Flow Volume
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow
      after declamping of renal artery.
    

Detailed description: 
      The purpose of this study is to evaluate the effect of papaverine on renal artery blood flow
      after declamping of renal artery in patients undergoing robot assisted partial nephrectomy.
    

Intervention name(s): Papaverine; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.; Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.
Intervention MeSH terms: Papaverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Persistent Postoperative Pain Incidence With Gabapentin Used
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The study's objective will be to evaluate the gabapentine efficiency in orally and long term
      used after painfully surgeries.
    

Detailed description: 
      This study will be: controlled, prospective, randomized and double blind.

      Its main objective will be to evaluate the pre and postoperative Gabapentin efficiency in
      orally doses and long term used of it in order to prevent or decrease persistent
      postoperative pain (PPP) in surgeries with high incidence of it (Pain). Patients will be
      randomly divided in two branches; one of them will take 600 mg of Gabapentin twice a day and
      the other group will take Placebo (twice a day also).

      Both groups of patients will have to take one pill the day before the surgery (300 mg) and
      other pill on the surgery day (300mg). After that, the patients will have to continue this
      treatment during 30 days (two doses per day of Gabapentin or placebo).

      After the surgery and after taking the second pill, it will be evaluated:

      postoperative sharp pain, sickness, vomiting, sedation and adverse effects.

      Patients will be evaluated in the pain treatment office (consulting room) the following
      times:

        1. 30 days after the surgery. (taking drugs suspended)

        2. 3 month after the surgery.

        3. 6 months after the surgery.

        4. 12 months after the surgery

      This monitoring treatment will be done in order to evaluate the presence or absence of
      persistent postoperative pain (PPP).
    

Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): gabapentin 300 mg per day, orally during 30 days; Placebo 300 mg per day, orally during 30 days
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Estudio Controlado, randomizado, prospectivo y ciego.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Gabapentin; prevention; incidence
Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Condition: HNSCC
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the trial is to study the efficacy of adding concomitant chemotherapy
      (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck
      cancer.
    


Intervention name(s): cetuximab; Carboplatin, 5FU concomitant; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): D-7, D1, D8, D15, D22, D29, D43, D50; Carboplatin 70mg/m²/D ; 5FU 600 mg/m²/D, D1-4, D22-25, D43-46; 70 Gy in 7 weeks
Intervention MeSH terms: Carboplatin; Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stage III; Stage IV; locally advanced
A Trial Comparing Risperidone Long-Acting Injection With Oral Antipsychotic in the Treatment of Early Psychosis
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness, safety and tolerability of
      risperidone long-acting injection (LAI) versus oral antipsychotics in participants with
      recent onset psychosis (abnormal thinking and/or hallucinations).
    

Detailed description: 
      This is an open-label (all people know identity of intervention), randomized (the study drug
      is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study
      in participants with schizophrenia (psychiatric disorder with symptoms of emotional
      instability, detachment from reality) or schizoaffective disorder (mixed psychiatric disorder
      relating to complex psychotic state that has features of both schizophrenia and mood
      disorder). Duration of this study will be 24 months. Study assessment visits will be
      conducted at Screening, Baseline, Week 2, every 4 weeks till Week 22, at Week 28, every 12
      weeks till Week 88 and at Week 104. All eligible participants will receive either risperidone
      long acting injection 25 milligram (mg) intramuscularly (into the muscle) along with their
      current oral medication (atypical antipsychotic - risperidone, quetiapine, olanzapine) or
      only their current oral medication. Efficacy will be evaluated primarily by Positive and
      Negative Syndromes Scale (PANSS), time to relapse and Social and Occupational Functioning
      Assessment Scale (SOFAS). Participants's safety will be evaluated throughout the study mainly
      by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and
      Simpson Angus Scale (SAS).
    

Intervention name(s): Risperidone long-acting injection (LAI); Oral Antipsychotic
Intervention type(s): Drug; Drug
Intervention description(s): Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion.; Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.
Intervention MeSH terms: Risperidone; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective disorder; Schizophreniform disorder; Risperidone; Risperdal Consta
Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder
Condition: Methamphetamine Use Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a
      combination of extended-release depot naltrexone plus extended-release bupropion as a
      potential pharmacotherapy for methamphetamine (MA) use disorder.
    

Detailed description: 
      Stage 1 will include 20 individuals with severe stimulant use disorder (methamphetamine type)
      enrolled across three study sites. Following a maximum 30-day screening period to establish
      eligibility, participants will receive a monthly injection of extended-release depot
      naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as
      Wellbutrin XL®) for 8 weeks. Take-home oral study medication (BRP) will be dispensed weekly
      for dosing on non-clinic days. Participants will be asked to attend clinic twice weekly for
      observed BRP dosing, collection of urine samples, assessments, and medical management.
      Following the 8-week active medication phase, participants will complete a follow-up phase,
      including a medication taper and post-medication phase follow-up visit during Week 9. If
      Stage 1 data document success (see criteria below) in at least 3 "responder" study
      participants, Stage 2 will follow utilizing the same protocol as in Stage 1, to enroll an
      additional group of 29 participants. Using the same criteria of "responder" success, if the
      combined stages document success in at least 9 of 49 study participants, the combination
      medication will be considered to have shown sufficient potential to advance to a large-scale
      placebo-controlled trial.
    

Intervention name(s): naltrexone plus bupropion
Intervention type(s): Drug
Intervention description(s): Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks.
Intervention MeSH terms: Naltrexone; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PET Imaging Study of Recovered Anorexics
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      Several studies in the past suggest that individuals who have or had anorexia nervosa may
      have alterations in brain serotonin. Serotonin seems to play an important role in regulating
      anxiety, mood, and other symptoms found in anorexia nervosa. We will be using a technology
      called Positron Emission Tomography (PET), which is a method used to take pictures of the
      body, in this case, the brain. Study participants will undergo two baseline PET scans on the
      first day of the study. The women who have recovered from anorexia will then be given a
      medication called fluoxetine (also know as Prozac) to take for 8 weeks. At the end of the 8th
      week, they will return for a third PET scan. By comparing the brain scans, before and after
      fluoxetine treatment, we can understand more about how treatment with fluoxetine affects the
      serotonin receptors in the brain. We will be comparing brain serotonin system in women who
      have recovered from anorexia before and after medication in order to gain a better
      understanding of changes in the serotonin system associated with eating disorders. This study
      may help shed light on how to make fluoxetine a more effective treatment for anorexia
      nervosa.
    


Intervention name(s): Fluoxetine
Intervention type(s): Drug
Intervention description(s): 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.
Other intervention name(s): Prozac
Intervention MeSH terms: Fluoxetine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: eating disorders; anorexia nervosa; anorexia; PET; brain imaging; serotonin; fMRI; Prozac; fluoxetine
Effects of Blueberry Juice Consumption on Cognitive Function in Healthy Older People
Condition: Cognitive Aging
Study type: Interventional

Summary: 
      Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties,
      which in rodent models are neuro-protective. The risk of developing dementia is reduced in
      people habitually consuming high flavonoid intakes, but data from human intervention studies
      is sparse. We therefore investigated whether 12 weeks of blueberry concentrate
      supplementation improved cognitive function in healthy elderly via increased brain activation
      and perfusion.
    


Intervention name(s): Blueberry; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science